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MS210800 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Thirty elite tennis players were r and omly assigned to three groups to evaluate shoulder isokinetic internal and external rotation training : an isokinetic concentric group , an isokinetic eccentric group , and a control group with no training . Subjects were tested before and after training both concentrically and eccentrically using an isokinetic dynamometer . Functional output before and after training was assessed by the average and peak velocity of six maximal serves . The effect of training on serve velocity endurance was also assessed . Statisti cally significant concentric and eccentric strength gains ( 11 % ) were obtained in both training groups when com pared with controls ( decreased total average strain of 2 % ) ( P < 0.0004 ) . Serve velocity increased by greater than 11 % in both training groups , which was a signifi ca nt increase from the average of 1 % in the control group ( P < 0.0001 ) . In the endurance study , training group subjects displayed a tendency to maintain their serve velocity ( loss of approximately 2 % ) greater than controls ( loss of 6.4 % ) ( P < 0.05 ) . Isokinetic training led to increases in objective and functional output in elite tennis players . This training regimen may have signifi cance in the final stages of the rehabilitation of injured shoulders as well as in improved performance and re duced injury risk The purpose of this study was to determine whether cross-education , defined as the increase in strength of an untrained limb after training of the contralateral homologous limb , is specific to low and high velocity eccentric training . Twenty-six subjects were r and omized into two groups ( n=13 each ) that performed unilateral eccentric training of the elbow flexors on an isokinetic dynamometer at velocities of either 30 ° s-1 ( 0.52 rad s-1 ) or 180 ° s-1 ( 3.14 rad s-1 ) . Subjects trained three times per week for 8 weeks . Ten subjects served as controls and did not train . Subjects were tested before and after training for peak torque of the elbow flexors during eccentric and concentric contractions at 30 ° s-1 and 180 ° s-1 . Eccentric peak torque at the velocity of 180 ° s-1 in the untrained arm increased only for the group that trained at that velocity ( P<0.05 ) . There were no other changes in untrained arms for any of the groups at velocities of 30 ° s-1 or 180 ° s-1 . For the trained arm , the increase in eccentric torque ( pooled over velocities ) was greatest for the group training at 180 ° s-1 , whereas the increase in concentric torque was similar for the groups training at 30 ° s-1 and 180 ° s-1 . For the trained arm , there was no specificity for velocity or contraction type . We conclude that cross-education was specific to contraction type and velocity when fast ( but not slow ) eccentric contractions were used during training ; whereas there was no specificity of training in the trained arm O2 uptake ( VO2 ) kinetics and electromyographic ( EMG ) activity from the vastus medialis , rectus femoris , biceps femoris , and medial gastrocnemius muscles were studied during constant-load concentric and eccentric cycling . Six healthy men performed transitions from baseline to high-intensity eccentric ( HE ) exercise and to high-intensity ( HC ) , moderate-intensity ( MC ) , and low-intensity ( LC ) concentric exercise . For HE and HC exercise , absolute work rate was equivalent . For HE and LC exercise , VO2 was equivalent . VO2 data were fit by a two- or three-component exponential model . Surface EMG was recorded during the last 12 s of each minute of exercise to obtain integrated EMG and mean power frequency . Only in the HC exercise did VO2 increase progressively with evidence of a slow component ( phase 3 ) , and only in HC exercise was there evidence of a coincident increase with time in integrated EMG of the vastus medialis and rectus femoris muscles ( P < 0.05 ) with no change in mean power frequency . The phase 2 time constant was slower in HC [ 24.0 + /- 1.7 ( SE ) s ] than in HE ( 14.7 + /- 2.8 s ) and LC ( 16.7 + /- 2.2 s ) exercise , while it was not different from MC exercise ( 20.6 + /- 2.1 s ) . These results show that the rate of increase in VO2 at the onset of exercise was not different between HE and LC exercise , where the metabolic dem and was similar , but both had significantly faster kinetics for VO2 than HC exercise . The VO2 slow component might be related to increased muscle activation , which is a function of metabolic dem and and not absolute work rate We compared the effects of concentric ( Con ) and eccentric ( Ecc ) isokinetic training on quadriceps muscle strength , cross-sectional area , and neural activation . Women ( age 20.0 + /- 0.5 yr ) r and omly assigned to Con training ( CTG ; n = 16 ) , Ecc training ( ETG ; n = 19 ) , and control ( CG ; n = 19 ) groups were tested before and after 10 wk of unilateral Con or Ecc knee-extension training . Average torque measured during Con and Ecc maximal voluntary knee extensions increased 18.4 and 12.8 % for CTG , 6.8 and 36.2 % for ETG , and 4.7 and -1.7 % for CG , respectively . Increases by CTG and ETG were greater than for CG ( P < 0.05 ) . For CTG , the increase was greater when measured with Con than with Ecc testing . For ETG , the increase was greater when measured with Ecc than with Con testing . The increase by ETG with Ecc testing was greater than the increase by CTG with Con testing . Corresponding changes in the integrated voltage from an electromyogram measured during strength testing were 21.7 and 20.0 % for CTG , 7.1 and 16.7 % for ETG , and -8.0 and -9.1 % for CG . Quadriceps cross-sectional area measured by magnetic resonance imaging ( sum of 7 slices ) increased more in ETG ( 6.6 % ) than in CTG ( 5.0 % ) ( P < 0.05 ) . We conclude that Ecc is more effective than Con isokinetic training for developing strength in Ecc isokinetic muscle actions and that Con is more effective than Ecc isokinetic training for developing strength in Con isokinetic muscle actions . Gains in strength consequent to Con and Ecc training are highly dependent on the muscle action used for training and testing . Muscle hypertrophy and neural adaptations contribute to strength increases consequent to both Con and Ecc training The quantification of the progression of muscle fatigue during a sustained contraction is a valuable tool in several clinical applications , ranging from the evaluation of functional impairment to the development of specific rehabilitative and training protocol s. In these fields , great importance is given to isokinetic contractions . The aim of this paper was twofold : first , to propose signal processing methods for assessing the spectral changes of the surface myoelectric signal due to fatigue during isokinetic concentric and eccentric knee flexion-extension movements at a given angular velocity ( 60/spl deg//s ) ; second , to analyze the electrical manifestations of muscle fatigue of four thigh muscles ( vastus lateralis , vastus medialis , rectus femoris , and biceps femoris ) in the two contraction modalities ( i.e. concentric versus eccentric ) . We demonstrated that , when considering concentric contractions , localized muscle fatigue can be assessed by computing the mean frequency of the frequency marginal of the time-frequency distribution derived from the surface myoelectric signal collected during each contraction cycle . Stronger nonstationarities were observed in the surface myoelectric data recorded within each cyclical movement of the studied eccentric exercise . Thus we propose the computation of the instantaneous mean frequency of the signal based on an original cross-time-frequency algorithm , which proved more sensitive than the frequency marginal in tracking the spectral changes associated with localized muscle fatigue . We derived the average fatigue pattern of the investigated muscles from experimental data recorded from a sample population consisting of twenty healthy subjects and we statistically compared the two contraction modalities . Our results showed that the electrical manifestations of muscle fatigue during concentric contractions were higher than those found during eccentric contractions , although in the latter modality the torque exerted and the mechanical work produced by the subjects were larger than those recorded during the concentric exercise . The results presented in this paper have potential clinical application and they could play an important future role in investigations of muscle behavior during dynamic , highly fatiguing contractions This research was supported by a Duke University Research Council Grant . The purpose of this study was to examine mode and speed specificity of strength training by comparing concentric and eccentric isokinetic exercise of the quadriceps . Forty-eight healthy men ( mean age = 23.9 years ) were r and omly assigned to one of three groups : concentric training ( C ) , eccentric training ( E ) , or control ( K ) . Average force ( in Newtons ) of 3 concentric and of 3 eccentric quadriceps contractions on the KIN-COM(R ) dynamometer at 60 , 120 , and 180 degrees /sec was evaluated prior to and following a 6 week period during which only the C and E groups trained . Training sessions ( 3/week ) included 4 submaximal and 1 maximal warm-up followed by 10 maximal effort isokinetic contractions of the quadriceps at 120 degrees /sec for each leg . Group C subjects trained concentrically only while Group E subjects trained eccentrically only . A t-test for independent means showed no significant right/left differences . ANOVA and Scheffe 's F-tests were then used to assess the differences in training effects among the 3 groups for the left leg only . Results showed that although Group C increased slightly in both concentric and eccentric force at all speeds , the gains were significant only for concentric force at 180 degrees /sec . Group E showed significant gains ( p < 0.05 ) in eccentric force at all speeds but not in concentric force . The K group had no significant change in concentric or eccentric force at any speed . We conclude that the eccentric mode of isokinetic exercise has highly specific strength training effects while the concentric mode has less specific training effects . In addition , speed of exercise does not appear to have specific training effects . J Orthop Sports Phys Ther 1989;11(2):70 - 75 The purpose of this study was to compare the short-term strength and neural adaptations to eccentric and concentric training at equal force levels . Forty-two sedentary women ( age = 21.5 yr ) were ranked based on the initial quadriceps strength score , and trios of subjects were r and omly assigned to either an eccentric ( n = 14 ) , a concentric ( n = 14 ) , or a nonexercising control group ( n = 14 ) . Training involved a total of 824 eccentric or concentric quadriceps actions at 1.05 rad.s-1 administered in four sets of 6 - 10 repetitions , four times per week for 6 wk . Before and after training , all subjects were tested for unilateral maximal isometric and eccentric and concentric actions at 1.05 rad.s-1 and for a 40-repetition eccentric and concentric fatigue series of the left and right quadriceps . Surface electromyographic activity of the vastus lateralis and medialis was monitored during testing . Concentric training increased concentric ( 36 % , P < 0.05 ) , isometric ( 18 % , P < 0.05 ) , and eccentric strength ( 13 % ) , and eccentric training increased eccentric ( 42 % , P < 0.05 ) , isometric ( 30 % , P < 0.05 ) , and concentric ( 13 % ) strength . Eccentric training improved eccentric and isometric strength more ( P < 0.05 ) than did concentric training . The electromyographic adaptations were greater with eccentric training . Cross-education was 6 % , and neither training mode modified fatigability . The data suggest that training of the quadriceps muscle with submaximal eccentric actions brings about greater strength adaptations faster than does training with maximal-level concentric actions in women . This greater adaptation is likely to be mediated by both mechanical and neural factors The purpose of this study was to estimate the efficiency of ATP utilization for concentric , eccentric , and isometric muscle action in the human tibialis anterior and extensor digitorum longus in vivo . A dynamometer was used to quantitate muscle work , or tension , while simultaneous 31P-nuclear magnetic resonance data were collected to monitor ATP , phosphocreatine , inorganic phosphate , and pH. The relative efficiency of the actions was estimated in two ways : steady-state effects on high-energy phosphates and a direct comparison of ATP synthesis rates with work . In the steady state , the cytosolic free energy dropped to the lowest value with concentric activity , followed by eccentric and isometric action for comparative muscle tensions . Estimates of ATP synthesis rates revealed a mechanochemical efficiency [ i.e. , ATP production rate/work ( both in J/s ) ] of 15.0 + /- 1.3 % in concentric and 34.7 + /- 6.1 % in eccentric activity . The estimated maximum ATP production rate was highest in concentric action , suggesting an activation of energy metabolism under these conditions . By using direct measures of metabolic strain and ATP turnover , these data demonstrate a decreasing metabolic efficiency in human muscle action from isometric , to eccentric , to concentric action The objectives of this study were to determine whether the occurrence of delayed onset muscle soreness ( DOMS ) for the vastus lateralis muscle was associated with elevated intramuscular pressure ( IMP ) ; and to assess , whether high eccentric forces occurred at an increased muscle length ( as determined by joint angle ) . Therefore
Output:
| Meta-analyses showed that when eccentric exercise was performed at higher intensities compared with concentric training , total strength and eccentric strength increased more significantly .
However , compared with concentric training , strength gains after eccentric training appeared more specific in terms of velocity and mode of contraction .
Eccentric training performed at high intensities was shown to be more effective in promoting increases in muscle mass measured as muscle girth .
In addition , eccentric training also showed a trend towards increased muscle cross-sectional area measured with magnetic resonance imaging or computerised tomography .
Subgroup analyses suggest that the superiority of eccentric training to increase muscle strength and mass appears to be related to the higher loads developed during eccentric contractions .
The specialised neural pattern of eccentric actions possibly explains the high specificity of strength gains after eccentric training . |
MS210801 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: OBJECTIVE To determine the efficacy of chemo-mechanical caries removal using Carisolv and compare it to the conventional method of caries removal . DESIGN A quasi-experimental study . PLACE AND DURATION OF STUDY The Department of Operative Dentistry , Fatima Jinnah Dental College Hospital , Karachi , from October 2003 to March 2004 . PATIENTS AND METHODS Thirty patients with contralateral cariously involved m and ibular molars participated in the study . Patients were selected using convenience sampling . One side of each patient was r and omly selected for treatment with either Carisolv or the conventional method . In the study group , carious lesion was removed with Carisolv instruments , whereas in control group excavators and round steel burs were used . Single observer assessed all the treated lesions . Time required to remove caries and completeness of caries removal was observed for both techniques . Data was compared using ' Fisher 's exact test ' and ' Independent sample s t-test ' . RESULTS Time taken to remove caries using Carisolv was 12.19 ( SD 3.7 ) minutes , whereas time taken to remove caries by conventional method was 7.4 ( SD 3.21 ) minutes . The difference was statistically significant ( p-value<0.005 ) . Caries could not be removed in 3 teeth in the study group with Carisolv . Complete caries removal was , however , achieved in the control group . The difference was statistically insignificant ( p-value>0.005 ) . CONCLUSION Chemo-mechanical caries removal with Carisolv is as effective as conventional methods in removing dental caries , however , it is significantly more time-consuming OBJECTIVES The purpose of this study was to compare the chemomechanical caries-removal system ( Carisolv ) with high-speed excavation in cavitated occlusal caries of primary molars . Design and setting . The study was a r and omized controlled , clinical trial in which the two techniques were compared in each subject . Participants were chosen from public schools , in Maracaibo County , Zulia State , Venezuela . SAMPLE AND METHODS The sample consisted of 80 primary molars selected from 40 children ( mean age 7.7+/-0.7 years ) . Each patient had at least two contralateral primary molars with cavitated occlusal caries and approximately equal-size access to lesions . The outcome variables were : clinical ly complete caries removal , size of the opening of the cavity , volume of carious tissue removed , pain during caries removal , anaesthesia requested by the patient , caries-removal time , and behaviour and preference of patients . RESULTS All treated molars were clinical ly caries free whichever caries-removal procedure was used . When Carisolv ' was used the final cavity entrance sizes were smaller ( P<0.001 ) and the estimated volume of tissue removed was less ( P<0.001 ) . The time taken for caries removal was three times longer ( 7.51+/-1.83 min , P<0.001 ) . Some pain was reported by seven ( 17.5 % ) participants when Carisolv was used , compared with 16 ( 40 % ) when high-speed excavation was used ( P<0.05 ) . Using the Carisolv method there was a higher proportion of patients with positive behaviour ( P<0.01 ) , and 71.0 % ( P<0.05 ) preferred this treatment . CONCLUSION Carisolv is an effective clinical alternative treatment for the removal of occlusal dentinal caries in cavitated primary molars ; it is more conservative of dental tissue and appeared to be more comfortable for most patients , although the clinical time spent is longer than when using high-speed excavation PURPOSE The purpose of this controlled clinical trial was to compare the working time for caries removal in primary teeth , the need for local anesthesia and patient cooperation , when the chemomechanical Carisolv or the conventional mechanical method were used . METHODS The sample consisted of primary teeth of children who had occlusal or buccal carious lesions into dentin . High speed and /or low speed were used as the conventional mechanical method of caries removal . The efficiency in caries removal was judged on the basis of clinical criteria . Length of working time , need of local anesthesia , and level of patient cooperation were recorded for both methods . Statistical analysis was performed using the student 's t test and chi-square test . RESULTS Working time with the chemomechanical method was much more prolonged than with the mechanical method ( P < .001 ) , but it did not negatively affect children 's cooperation . Furthermore , the chemomechanical method reduced the need for administration of local anesthesia for Class V cavity preparations . CONCLUSIONS The chemomechanical method , although more prolonged , is effective in caries removal in primary teeth , does not influence children 's cooperation and may reduce the need of local anesthesia in Class V restorations Carisolv is a minimally invasive method for softening and removing dentine caries . A new , modified Carisolv gel has been developed in order to optimise the efficiency if its chemical caries dissolution . The aim of the present study was to compare the caries removal efficiency of the original gel with that of the new gel , which contains almost double the concentration of sodium hypochlorite . Ten dentists treated 202 cavities in 170 patients ; 104 cavities were r and omised to the new gel and 98 to the original gel . Their mean treatment times for caries removal were 6.7±4.1 min and 7.6±4.2 min , respectively ( P>0.05 ) . In close-to-pulp lesions , constituting 32 % of the cavities , the mean times for caries removal were 9.0±7.0 min and 11.6±4.4 min for the new and original gels , respectively ( P<0.01 ) . Question naires revealed that 81 % of the patients preferred chemomechanical treatment to drilling . In conclusion , the improved efficiency of the modified Carisolv gel did reduce the time for caries removal in deep lesions . However , it still needs more time than conventional drilling The purpose of this study was to evaluate the clinical performance of glass ionomer cement ( GIC ) restorations comparing two minimally invasive methods in permanent teeth after 12 months . Fifty pregnant women ( second trimester of pregnancy ) , mean age 22 ± 5.30 years , were treated by two previously trained operators . The treatment approaches tested were : chemomechanical method ( CarisolvTM ; MediTeam ) and atraumatic restorative treatment ( ART ) . A split-mouth study design was used in which the two treatments were r and omly placed in 50 matched pairs of permanent teeth . The chemomechanical method ( CM ) was the test group and the ART was the control group . The treatments were performed in Public Health Centers . The tested restorative material was a high-strength GIC ( Ketac Molar ; 3M/ESPE ) . The restorations were placed according to the ART guidelines . Two calibrated independent examiners evaluated the restorations in accordance with ART criteria . The interexaminer kappa was 0.97 . Data were analyzed using 95 % confidence interval on the binomial distribution and Fisher 's exact test at 5 % significance level . In a 12-month follow-up , 86 % of the restorations were evaluated . In the test group ( CM ) , 100 % ( CI=93.3 - 100 % ) of the restorations were considered successful . In the control group ( ART ) 97.6 % ( CI=87.4 - 99.9 % ) of the restorations were considered successful and 2.4 % unsuccessful ( marginal defect > 0.5 mm ) . There was no statistically significant difference between the 12-mounth success rate for both groups ( Fisher 's exact test : P=0.49 ) and between the two operators ( Fisher 's exact test : P=1.00 ) . Both minimally invasive methods , chemomechanical method and ART , showed a similar clinical performance after 12 months of follow up UNLABELLED The change in the concepts of cavity preparation and the development of reliable adhesive material s lead to the development of alternative methods of caries removal . Chemo-mechanical caries removal ( CMCR ) involves the chemical softening of carious dentin , followed by its removal with gentle excavation . OBJECTIVE The present study was conducted to evaluate clinical ly the efficiency of caries removal using a new chemo-mechanical agent ( Papacarie ) compared to the conventional drilling method including the need for local anesthesia , the need for drill , duration of the treatment and the pain reaction . STUDY DESIGN This study was split mouth design . The study was performed on thirty seven bilateral open carious lesions . They were divided into two equal groups according to method of caries removal . In Group I , caries was removed using the Papacarie system and in Group II , caries was removed with the conventional drill . RESULTS The results showed that the Papacarie was as efficient as the drill in caries removal from open carious lesions with no significant difference in the operating time . The new CMCR agent also reduced significantly the need for local anesthesia and the use of drill . In addition , Papacarie was also more comfortable than the traditional rotatory instruments . CONCLUSIONS It was concluded that Papacarie could be an effective caries removal method to treat children , particularly those who present with early childhood caries or management problems Objective . The purpose of this study was to make a clinical comparison of the chemomechanical method for caries removal and the conventional rotary instruments technique when used in children and adolescents . Material and Methods . The study comprised 120 patients aged 3–17 years r and omized into two groups : caries were removed chemomechanically in 60 patients and 60 patients received conventional treatment with rotary instruments . The outcome variables were : clinical ly complete caries removal , pain during caries removal , need for local anesthesia , treatment time , preferences of patients , and clinical success of the restorations during the 12-month evaluation period . Results . Complete caries removal was achieved in 92 % of chemomechanically treated teeth and in all teeth treated with rotary instruments ( p>0.05 ) . The chemomechanical method significantly reduced the need for local anesthesia ( p<0.001 ) . Eighty-five percent of patients treated with Carisolv and 47 % treated with rotary instruments were satisfied with the treatment ( p<0.05 ) . The mean time for chemomechanical caries removal was 11.2±3.3 min and 5.2±2.8 min for caries removal with rotary instruments ( p<0.001 ) . At the end of the 12-month evaluation period , there was no observed influence of the caries removal method on the survival of the restorations . Conclusions . The chemomechanical caries removal technique is an adequate alternative to the conventional rotary instruments method and is advantageous in pediatric dentistry Most systematic review s rely substantially on the assessment of the method ological quality of the individual trials . The aim of this study was to obtain consensus among experts about a set of generic core items for quality assessment of r and omized clinical trials ( RCTs ) . The invited participants were experts in the field of quality assessment of RCTs . The initial item pool contained all items from existing criteria lists . Subsequently , we reduced the number of items by using the Delphi consensus technique . Each Delphi round comprised a question naire , an analysis , and a feedback report . The feedback report included staff team decisions made on the basis of the analysis and their justification . A total of 33 international experts agreed to participate , of whom 21 completed all question naires . The initial item pool of 206 items was reduced to 9 items in three Delphi rounds . The final criteria list ( the Delphi list ) was satisfactory to all participants . It is a starting point on the way to a minimum reference st and ard for RCTs on many different research topics . This list is not intended to replace , but rather to be used alongside , existing criteria lists Dental fear is often associated with experience of pain , unpleasant sounds and uncomfortable vibrations caused by dental drills . Therefore patients welcome alternative , less painful excavating methods such as lasers , s and blasters and chemomechanical systems . The aim of this study was to compare a chemomechanical caries removal system ( Carisolv ) to traditional drilling with regard to patient acceptance and time consumption as well as the six-month success rate of fillings . Ninety-two primary teeth in 46 children were included in the study . From this study , the following conclusions can be drawn : patient acceptance of Carisolv-treatment compared to drilling is excellent , since 65 % would choose Carisolv and no one drilling when treated next time . The dentists rated patients ' degree of pain significantly lower in Carisolv situations than in drill situations . Time consumption is significantly higher when excavating with Carisolv ( 6.7 min . ) than with drill ( 3.3 min . ) . The durability of fillings six months after treatment is equal in the two groups AIM To test the null hypothesis that Carisolv is no more effective than 1 % sodium hypochlorite in cleaning uninstrumented , immature root canals . METHODOLOGY A total of 240 uniform , immature ovine incisors were decoronated at the CEJ level and r and omly divided into four groups of 60 . After gross pulp extirpation , canals were flooded with normal saline ( negative control ) , 1 % NaOCl , Carisolv or 5 % NaOCl ( positive control ) and incubated for 10 min ( group 1 ) , 20 min ( group 2 ) , 30 min ( group 3 ) or 30 min , refreshing irrigant at 10 and 20 min ( group 4 ) . SEM photomicrographs of canal wall debris in the apical , middle and coronal thirds were scored against a 5-point scale . Internal consistency was assessed by kappa statistics . Debris scores for different irrigant regimes at different canal levels were analysed by non-parametric tests ( P < 0.05 ) . RESULTS Canals were consistently
Output:
| Furthermore , the current scientific evidence shows that the sodium hypochlorite-based ( Carisolv ) chemomechanical caries removal method was more time consuming when compared to the enzyme-based ( Papacarie ) chemomechanical and the conventional caries removal methods . |
MS210802 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: PURPOSE Mutations affecting the KRAS gene are established predictive markers of outcome with anti-epithelial growth factor receptor ( EGFR ) antibodies in advanced colorectal cancer ( CRC ) . The relevance of these markers for anti-vascular endothelial growth factor ( VEGF ) therapy is controversial . This analysis was performed to assess the predictive and prognostic impact of KRAS and BRAF gene mutation status in patients receiving capecitabine with bevacizumab ( CG ) or capecitabine without bevacizumab in the phase III AGITG MAX ( Australasian Gastrointestinal Trials Group MAX ) study . PATIENTS AND METHODS Mutation status was determined for 315 ( 66.9 % ) of the original 471 patients . Mutation status was correlated with efficacy outcomes ( response rate , progression-free survival [ PFS ] , and overall survival [ OS ] ) , and a predictive analyses was undertaken . RESULTS Mutations in KRAS and BRAF genes were observed in 28.8 % and 10.6 % of patients , respectively . KRAS gene mutation status ( wild type [ WT ] v mutated [ MT ] ) had no prognostic impact for PFS ( hazard ratio [ HR ] , 0.89 ; CI , 0.69 to 1.14 ) or OS ( HR , 0.97 ; CI , 0.73 to 1.28 ) . BRAF mutation status ( WT v MT ) was not prognostic for PFS ( HR , 0.80 ; CI , 0.54 to 1.18 ) but was prognostic for OS ( HR , 0.49 ; CI , 0.33 to 0.73 ; P = .001 ) . By using the comparison of capecitabine versus capecitabine and bevacizumab ( CB ) and CB plus mitomycin ( CBM ) , KRAS gene mutation status was not predictive of the effectiveness of bevacizumab for PFS or OS ( test for interaction P = .95 and 0.43 , respectively ) . Similarly , BRAF gene mutation status was not predictive of the effectiveness of bevacizumab for PFS or OS ( test for interaction P = .46 and 0.32 , respectively ) . CONCLUSION KRAS gene mutation status was neither prognostic for OS nor predictive of bevacizumab outcome in patients with advanced CRC . BRAF gene mutation status was prognostic for OS but was not predictive of outcome with bevacizumab PURPOSE Mutations within the KRAS proto-oncogene have predictive value but are of uncertain prognostic value in the treatment of advanced colorectal cancer . We took advantage of PETACC-3 , an adjuvant trial with 3,278 patients with stage II to III colon cancer , to evaluate the prognostic value of KRAS and BRAF tumor mutation status in this setting . PATIENTS AND METHODS Formalin-fixed paraffin-embedded tissue blocks ( n = 1,564 ) were prospect ively collected and DNA was extracted from tissue sections from 1,404 cases . Planned analysis of KRAS exon 2 and BRAF exon 15 mutations was performed by allele-specific real-time polymerase chain reaction . Survival analyses were based on univariate and multivariate proportional hazard regression models . RESULTS KRAS and BRAF tumor mutation rates were 37.0 % and 7.9 % , respectively , and were not significantly different according to tumor stage . In a multivariate analysis containing stage , tumor site , nodal status , sex , age , grade , and microsatellite instability ( MSI ) status , KRAS mutation was associated with grade ( P = .0016 ) , while BRAF mutation was significantly associated with female sex ( P = .017 ) , and highly significantly associated with right-sided tumors , older age , high grade , and MSI-high tumors ( all P < 10(-4 ) ) . In univariate and multivariate analysis , KRAS mutations did not have a major prognostic value regarding relapse-free survival ( RFS ) or overall survival ( OS ) . BRAF mutation was not prognostic for RFS , but was for OS , particularly in patients with MSI-low ( MSI-L ) and stable ( MSI-S ) tumors ( hazard ratio , 2.2 ; 95 % CI , 1.4 to 3.4 ; P = .0003 ) . CONCLUSION In stage II-III colon cancer , the KRAS mutation status does not have major prognostic value . BRAF is prognostic for OS in MS-L/S tumors Purpose : Colon tumors with defective DNA mismatch repair ( dMMR ) have a well-characterized phenotype and accounts for ∼15 % to 20 % of sporadic colon cancer as well as those colon cancer patients with Lynch syndrome . Although the presence of dMMR seems to be a favorable prognostic marker , data suggest that these patients do not respond as well to adjuvant chemotherapy . Experimental Design : In this study , we examined the prognostic significance of tumor MMR deficiency and the presence of a specific mutation in BRAF ( V600E ) in a group of patients ( n = 533 ) who participated in a r and omized prospect i ve clinical trial through the North Central Cancer Treatment Group . Results : Tumors with dMMR were found to be associated with higher tumor grade ( P = 0.001 ) , proximal location ( P < 0.0001 ) , and improved overall and disease-free survival ( P = 0.05 and 0.04 , respectively ) . Among all cases examined , evaluation of the BRAF V600E mutation status revealed no statistically significant differences in either disease-free or overall survival . Patients were then grouped into four categories for further analysis : dMMR/BRAF(− ) , dMMR/BRAF(+ ) , pMMR/BRAF(− ) , and pMMR/BRAF(+ ) . The dMMR/BRAF(− ) group had a significantly improved overall survival ( 5-year overall survival of 100 % versus 73 % , P = 0.002 ) compared with all others . The remaining three groups had very similar survival outcomes . An additional cohort of tumors previously classified as having dMMR were also tested for the BRAF V600E alteration . Results remained significant ( P = 0.006 ) when the two groups were combined for analysis . Conclusions : Overall , these data suggest that the underlying molecular etiology of those tumors having dMMR may influence the disease outcome in these patients Purpose : Alterations in the RAS-RAF-MAP2 K (MEK)-MAPK signaling pathway are major drivers in colorectal carcinogenesis . In colorectal cancer , BRAF mutation is associated with microsatellite instability ( MSI ) , and typically predicts inferior prognosis . We examined the effect of BRAF mutation on survival and treatment efficacy in patients with stage III colon cancer . Methods : We assessed status of BRAF c.1799T > A ( p . V600E ) mutation and MSI in 506 stage III colon cancer patients enrolled in a r and omized adjuvant chemotherapy trial [ 5-fluorouracil and leucovorin ( FU/LV ) vs. irinotecan ( CPT11 ) , FU and LV ( IFL ) ; CALGB 89803 ] . Cox proportional hazards model was used to assess the prognostic role of BRAF mutation , adjusting for clinical features , adjuvant chemotherapy arm , and MSI status . Results : Compared with 431 BRAF wild-type patients , 75 BRAF-mutated patients experienced significantly worse overall survival [ OS ; log-rank P = 0.015 ; multivariate HR = 1.66 ; 95 % CI : 1.05–2.63 ] . By assessing combined status of BRAF and MSI , it seemed that BRAF-mutated MSS ( microsatellite stable ) tumor was an unfavorable subtype , whereas BRAF wild-type MSI-high tumor was a favorable subtype , and BRAF-mutated MSI-high tumor and BRAF wild-type MSS tumor were intermediate subtypes . Among patients with BRAF-mutated tumors , a nonsignificant trend toward improved OS was observed for IFL versus FU/LV arm ( multivariate HR = 0.52 ; 95 % CI : 0.25–1.10 ) . Among patients with BRAF wild-type cancer , IFL conferred no suggestion of benefit beyond FU/LV alone ( multivariate HR = 1.02 ; 95 % CI : 0.72–1.46 ) . Conclusions : BRAF mutation is associated with inferior survival in stage III colon cancer . Additional studies are necessary to assess whether there is any predictive role of BRAF mutation for irinotecan-based therapy . Clin Cancer Res ; 18(3 ) ; 890–900 . © 2011 AACR Background BRAF and K-ras proto-oncogenes encode components of the ERK signalling pathway and are frequently mutated in colorectal cancer . This study investigates the associations between BRAF and K-ras mutations and clinicopathological , lifestyle and dietary factors in colorectal cancers . Methods 186 adenocarcinomas and 16 adenomas from the EPIC Norfolk study were tested for BRAF and K-ras mutations . Diet and lifestyle data were collected prospect ively using seven day food diaries . Results BRAF V600E mutation was found in 15.6 % of colorectal cancers but at higher frequencies in cancers with proximal location , poor differentiation and microsatellite instability ( MSI ) ( all p < 0.001 ) . K-ras mutation ( mostly in codons 12 and 13 ) was found in 22.0 % of colorectal cancers but at higher frequencies in cancers of more advanced Dukes ' stage ( p = 0.001 ) , microsatellite stable ( MSS ) status ( p = 0.002 ) and in individuals with lower blood high-density lipoprotein concentrations ( p = 0.04 ) . Analysis of dietary factors demonstrated no link between BRAF mutation and any specific dietary constituent , however , K-ras mutation was found at higher frequencies in individuals with higher white meat consumption ( p < 0.001 ) . Further analysis of specific mutation type demonstrated that G to A transitions in K-ras were observed at higher frequencies in individuals consuming lower amounts of fruit ( p = 0.02 ) . Conclusion These data support the model of BRAF and K-ras mutations arising in distinct colorectal cancer subsets associated with different clinicopathological and dietary factors , acting as mutually exclusive mechanisms of activation of the same signalling pathway The aim of this study was to identify KRAS and BRAF gene mutations in colorectal cancer patients and to assess whether they are linked with clinicopathological features . The results of KRAS and BRAF mutation analysis could be used in the selection of patients for anti-EGFR therapy . All specimens were obtained during routine surgery of patients with colorectal carcinoma . The diagnoses were established by st and ard procedures and confirmed histopathologically . After DNA extraction , KRAS mutations were analyzed using quantitative real-time PCR and BRAF mutations were analyzed using real-time PCR by fluorescence melting curve analysis . Our results show that KRAS gene mutations were detected in 35.6 % sample s and the most frequent mutation was Gly12Val . BRAF gene mutation Val600Glu was detected in 8.5 % sample s. Statistical analysis revealed a significant association between the KRAS mutation and Dukes ' stage ( p=0.034 ) , with the lowest frequency in Dukes'A , and between the KRAS mutation and histological grade ( p=0.044 ) , with no KRAS mutation found in poor differentiated tumors . The first data about KRAS and BRAF mutational status in the sample of Croatian population with colorectal cancer shows that the incidence of KRAS and BRAF mutations is within generally valid limits . Prospect i ve studies are to be continued in order to determine whether these mutations contribute to progression of colorectal cancer
Output:
| This meta- analysis demonstrated that BRAFV600E mutation was significantly correlated with adverse pathological features of CRC and distinct clinical characteristics .
These data suggest that BRAFV600E mutation could be used to supplement st and ard clinical and pathological staging for the better management of individual CRC patients , and could be considered as a poor prognostic marker for CRC |
MS210803 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: The use of intraarticular triamcinolone hexacetonide in the management of persistent arthritis of the knee joint that is unresponsive to nonsteroidal anti-inflammatory drugs was prospect ively evaluated in 40 children with chronic arthritis . Of 49 knees that were injected , 63.3 % maintained complete resolution of effusion and other signs of inflammation at the 6-month followup . This favorable outcome correlated with a young age , a short disease duration , and a higher dose of triamcinolone hexacetonide . At the 12-month followup , 45 % of the injected knees remained in remission Background Children with arthritis may endure a lifetime of disfigurement , dysfunction , and pain if acute inflammation progresses to chronic changes in the joint cartilage and underlying bone . Intraarticular steroids have become an integral component of treatment , but at times are difficult to deliver to joints , such as the subtalar joint , that have complex anatomies . Objective We describe our technique and outcomes using fluoroscopically guided intraarticular subtalar steroid injection in patients with active symptoms of juvenile idiopathic arthritis ( JIA ) . Material s and methods Fluoroscopically guided subtalar joint injections were performed in 38 children ( mean age 6.7 years ) . Medical records were review ed retrospectively and improvement was evaluated clinical ly by the degree of foot movement in eversion and inversion . Results Subtalar joint injection was technically successful in 100 % of the JIA patients with improvement in physical symptoms in 34/38 ( 89 % ) . Of the 38 children , 32 were followed up within 13 weeks of the initial injection and , therefore , satisfied the eligibility criteria for resolution of arthritis . Of these 32 children , 14 showed clinical resolution ( 44 % ) . The mean duration of improvement was 1.2 ± 0.9 years . Children with a longer interval ( > 1 year ) from diagnosis to treatment had significantly less resolution ( P = 0.04 ) . Local subcutaneous atrophy or hypopigmentation were observed in 53 % of the children after steroid injection ( 20/38 ) . These minor complications were associated with a greater volume of steroid injected into the site per child ( P = 0.02 ) . Conclusion Fluoroscopically guided subtalar joint injection is an effective treatment for subtalar arthropathy . Prompt referral for intraarticular steroid treatment in the acute phase improves response . Skin changes often occur at the injection site , and specific pre caution s should be employed to reduce this risk . Prospect i ve study is indicated to determine the most effective treatment strategy to prevent long-term pain and disability OBJECTIVE To compare the efficacy and safety of intra-articular triamcinolone hexacetonide ( TH ) and triamcinolone acetonide ( TA ) in children with oligoarticular juvenile idiopathic arthritis ( JIA ) . METHODS One hundred and thirty joints of 85 patients undergoing intra-articular injections were r and omly treated with either TH or TA depending on the availability of the drug . The efficacy of both treatments was evaluated prospect ively in a blinded fashion . A good response was defined as a decrease in the articular score of > or = 60 % from baseline . Clinical , laboratory and immunological variables were noted in order to examine possible factors , other than treatment , predictive of the result . RESULTS Seventy injections were performed using TH and 60 with TA . The two groups were comparable for clinical , immunological and laboratory characteristics . The rate of response was significantly higher with TH than with TA : 81.4 % vs 53.3 % ( P = 0.001 ) at 6 months , 67.1 vs 43.3 % ( P = 0.006 ) at 12 months , and 60 vs 33.3 % ( P = 0.002 ) at 24 months . CONCLUSION At comparable doses TH appeared to be much more effective than TA for intra-articular use , in both short- and long-term follow-up . This result was not affected by disease duration or degree of local and systemic inflammation OBJECTIVE Pharmacokinetic studies have shown that the biological effect of triamcinolone acetonide ( TA ) is equivalent to that of triamcinolone hexacetonide ( TH ) , if used at double the dosage . In this study we compared the efficacy of intra-articular TA at a dose twice that of TH in symmetrically involved joints , in children with juvenile idiopathic arthritis ( JIA ) . METHOD Children with active arthritis and a similar degree of inflammation in two symmetrical joints were enrolled in the study . The symmetry was assessed by both clinical examination and synovial fluid analysis . The dose given was 1 mg/kg up to 40 mg of TH or 2.0 mg/kg up to 80 mg of TA . The identity of injected compound was blinded to the patient and to the physician . RESULTS Thirty-seven patients , 30 female , seven male , with JIA , entered the study . A total of 86 joints were injected . Twenty-one ( 53.8 % ) of the joints injected with TA relapsed first compared with only six ( 15.4 % ) of the joints injected with TH . In three ( 7.7 % ) relapse occurred simultaneously . Nine ( 23 % ) were still in remission after 24-month follow-up . The percentage of joints with lasting remission was higher with TH than with TA ( 80 vs 47.5 % after 12 months and 63.6 vs 32.4 % after 24 months , respectively ; log rank test P = 0.003 ) . CONCLUSION Even when TA is given at higher doses , TH is more effective and should be considered the drug of choice for intra-articular treatment of JIA Intraarticular steroid therapy in juvenile chronic arthritis ( JCA ) is performed because of high local efficacy with few side effects . Imaging is used for initial evaluation and for monitoring of treatment response . The aim of this study was to compare imaging findings in diseased hips and knees before and after therapy . A prospect i ve study was performed on 10 patients ( 15 joints ) scheduled for intraarticular therapy . Pretherapeutic assessment included clinical work-up , radiographs , ultrasound ( US ) , and magnetic resonance imaging ( MRI ) of affected joints . Following therapy , clinical and sonographic examinations were performed at 1 week and 1 month . MRI was repeated at 1 month . MRI and US demonstrated pannus formation and effusion , but differentiation was less distinct on US . Popliteal cysts and lymph nodes were visible in both modalities . MRI additionally revealed articular cartilage loss and subchondral cysts , not shown by US . Epiphyseal overgrowth and osteopenia were best seen radiographically . At present MRI is the best tool to assess the inflammatory changes of the joints in JCA . Initial staging of the joints may be done with plain films and MRI . US is useful to assess effusion and pannus and may be used to monitor treatment response OBJECTIVE To determine in a prospect i ve analysis whether baseline demographic , clinical , and laboratory variables predict the outcome of intraarticular corticosteroid ( IAC ) injection of the knees in children with juvenile idiopathic arthritis ( JIA ) . METHODS We studied consecutive patients who met the criteria for the diagnosis of JIA and received their initial injection of triamcinolone hexacetonide in one or both knees . Predictor variables included sex , age , age at onset of JIA , onset subtype , disease duration , drug therapy at the time of IAC injection , physician and parent global assessment of disease status , Childhood Health Assessment Question naire disability index , erythrocyte sedimentation rate ( ESR ) , C-reactive protein , involvement of other joints besides knees , amount of fluid aspirated , and dose of IAC injected . The primary outcome measure was persistence of complete clinical response at 6 months , i.e. , no evidence of synovitis clinical ly . RESULTS Ninety-four patients were available for analysis . At 6 months after the IAC injection , 65 ( 69 % ) patients showed a sustained complete clinical response , whereas 29 ( 31 % ) had had a recurrence of joint inflammation . Univariate statistical analyses showed that patients who had a sustained clinical response had a significantly higher ESR than those who did not ( p = 0.023 ) . The ESR was the only variable that remained in the best-fit model from multivariate logistic regression analysis ( OR 2.61 , p = 0.049 ) . CONCLUSION Our findings indicate that patients with JIA who have a higher ESR are more likely to benefit from IAC injection of the knees OBJECTIVE To determine if intraarticular ( i.a . ) injection of triamcinolone hexacetonide ( steroids ) used early in the course of pauciarticular juvenile rheumatoid arthritis ( pauci JRA ) is associated with less leg length discrepancy ( LLD ) or thigh circumference discrepancy ( TCD ) . METHODS Children with pauci JRA who had asymmetric lower-extremity arthritis diagnosed before age 7 years in Seattle , Washington ( WA ; n = 16 ) and in Chapel Hill and Durham , North Carolina ( NC ; n = 14 ) were retrospectively identified . WA children were given i.a . steroids within 2 months of diagnosis ; the injections were repeated if synovitis recurred in the same joint or in a different joint . These children were compared with NC children who were not treated with i.a . steroids . Thigh circumference was measured at 10 cm above the patella , and leg length was measured from the anterior superior iliac spine to the mid-medial malleolus , by a single observer . LLD and TCD are reported as the percentage of difference between leg measurements in each subject . RESULTS The WA and NC subjects had comparable disease severity and duration of followup ( in months ) . Twelve WA children had subsequent i.a . steroid injections ( mean 3.25 injections per child over mean + /- SD 42 + /- 11 months ) . The WA subjects had significantly less LLD ( P = 0.005 , by Student 's 2-sided t-test ) and prescriptions for shoe lifts ( P = 0.002 , by Fisher 's 2-sided exact test ) . There was not a significant difference in TCD between the 2 groups ( P = 0.139 , by Student 's 2-sided t-test ) . Similar findings were obtained when the analysis was limited to children with monarticular knee arthritis . CONCLUSION Early and continued use of i.a . steroids may be associated with less LLD in young children with pauci JRA . This may indicate decreased duration of synovitis The use of intra-articular steroids in one or both knees was evaluated in 21 children with type 1 pauciarticular juvenile chronic arthritis ( JCA ) . The beneficial effect of the injection was noted within 3 days with no significant adverse reactions . Remission exceeding 6 months was seen in 70 % of the knees and the arthritis remained inactive during the follow up period in 37 % . The beneficial effect of the injection did not correlate with sex , age of onset or the presence of antinuclear antibodies or HLA-B27 antigen and there was no relationship with the size of involved joints at onset , the ESR at onset , or the presence of uveitis . Intra-articular corticosteroids in this type of JCA may provide prompt relief of swelling and pain and reduce the need for other forms of therapy . Remission was long lasting in the majority of the children Both pragmatic and explanatory r and omised controlled trials have a useful role to play in the evaluation of health care interventions . In this descriptive article , the key steps in conducting a pragmatic trial are described . The strengths and limitations of pragmatic trials are also discussed . The main strength of pragmatic trials is that they can evaluate a therapy as it is used in normal practice . Comparisons are made between pragmatic and explanatory trials , on the underst and ing that trials may have aspects to them that make the trial more of a hybrid . A case is made for the appropriate use and relevance of pragmatic trials in the evaluation of alternative and complementary medicine OBJECTIVE To describe radiographic findings at disease onset and 3-year followup in patients with juvenile rheumatoid arthritis ( JRA ) and juvenile spondyloarthropathy ( JSpA ) , to assess radiographic progression and its predictors , and to prospect ively assess clinical outcome and predictors of persistent disease at 3-year followup . METHODS A total of 197 patients with JRA/JSpA were examined every 6 months for 3 years . Radiographic examination was performed at baseline and 3-year followup of knees and ankles ( all patients ) and of other joints on clinical indication . Remission was defined as minimum 6 months without medication and no clinical signs of active disease . RESULTS Radiographic abnormalities were found in 88 % of the patients at onset and in 81 % after 3 years . Frequency of swelling/osteoporosis decreased and frequency of abnormal growth increased from baseline to followup . Knees , h and s , and wrists had most frequently radiographic abnormalities . Radiographic progression occurred in 38 % of the patients . Joints with swelling/osteoporosis on radiographs , young age , and a large number of mobility-restricted joints at baseline were predictors of radiographic progression . At 3 years , 26 % of the patients were in remission and 7
Output:
| There was weak evidence for IACIs decreasing clinical signs and symptoms in the lower leg , improving joint range of motion , decreasing leg length discrepancy , and for imaging techniques detecting the effects of IACIs .
Conclusions There is some weak evidence for the efficacy of IACIs improving certain outcome measures . |
MS210804 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: Abstract Objectives : To examine the cost of providing hospital at home in place of some forms of inpatient hospital care . Design : Cost minimisation study within a r and omised controlled trial . Setting : District general hospital and catchment area of neighbouring community trust . Subjects : Patients recovering from hip replacement ( n=86 ) , knee replacement ( n=86 ) , and hysterectomy ( n=238 ) ; elderly medical patients ( n=96 ) ; and patients with chronic obstructive airways disease ( n=32 ) . Interventions : Hospital at home or inpatient hospital care . Main outcome measures : Cost of hospital at home scheme to health service , to general practitioners , and to patients and their families compared with hospital care . Results : No difference was detected in total healthcare costs between hospital at home and hospital care for patients recovering from a hip or knee replacement , or elderly medical patients . Hospital at home significantly increased healthcare costs for patients recovering from a hysterectomy ( ratio of geometrical means 1.15 , 95 % confidence interval 1.04 to 1.29 , P=0.009 ) and for those with chronic obstructive airways disease ( Mann-Whitney U test , P=0.01 ) . Hospital at home significantly increased general practitioners ' costs for elderly medical patients ( Mann-Whitney U test , P<0.01 ) and for those with chronic obstructive airways disease ( P=0.02 ) . Patient and carer expenditure made up a small proportion of total costs . Conclusion : Hospital at home care did not reduce total healthcare costs for the conditions studied in this trial , and costs were significantly increased for patients recovering from a hysterectomy and those with chronic obstructive airways disease . There was some evidence that costs were shifted to primary care for elderly medical patients and those with chronic obstructive airways disease . Key messages Hospital at home schemes are a popular alternative to st and ard hospital care , but there is uncertainty about their cost effectiveness In our r and omised controlled trial we compared the cost of hospital at home care with that of inpatient hospital care for patients recovering from hip replacement , knee replacement , and hysterectomy ; elderly medical patients ; and those with chronic obstructive airways disease There were no major differences in health service costs between the two arms of the trial for patients recovering from hip or knee replacement and elderly medical patients Hospital at home care increased healthcare costs for patients recovering from hysterectomy and for those with chronic obstructive airways disease Hospital at home care result ed in some costs shifting to general practitioners for elderly medical patients and those with chronic obstructive airways This paper reports the results of a r and omized experiment that tested the effects and costs of providing so-called homemaker services to a chronically ill population . The concept of homemaker services , as dis ? tinct from professional home health and ther ? apeutic nursing services , originally was de ? veloped for children by welfare agencies in the early part of the century . Later , the focus of such services changed from children to adults , with special emphasis on the chronically ill elderly . In the view of some long-term care specialists , homemaker or home health aide services for the elderly now should be regard ? ed as an accepted supplement to family health care , deserving a legitimate position in a con ? tinuum of care.1'2 Medicare policy has not shared this view . Regulations currently authorize a home health aide to perform personal care and only certain limited household services , which include changing the bed , light cleaning , food shop ? ping , and help in cooking.3 For a patient to receive home health aide services , he or she simultaneously must be receiving skilled nurs ? ing or another skilled service . State Medicaid programs are not required to follow these restrictive regulations , but by choice most state programs do . Separation of professional and therapeutic services from those provided by homemaker-home health aides has been advocated by some research ers and practitioners.4,5 Regrettably , little has been reported on the outcomes and costs of homemaker services , although there has been abundant literature on the efficacy and costs of home health care.6 - This study is part of a project that aim ed to increase the participation of informal caregivers in the hospital care for elderly patients . The staff who worked in the wards that were studied created activity programmes for caregivers and changed their ward policies to encourage the participation of the caregivers . In addition , quality assurance programmes were developed and primary nursing was introduced to ensure individualized , need-based and family centered care . In order to explore the changes in perceived quality of care , and to test the differences in care quality between the study and the control wards ( i.e. two wards in a university hospital , two wards in a geriatric unit and two wards of a nursing home ) , the interrupted time series with a non-equivalent control group time series design was used . During periods of 2 months in 1991 , 1992 and 1993 the data were collected from elderly patients ( n = 97 ) and their informal caregivers ( n = 369 ) using a structured question naire based on need theories . The results indicated that the quality of care was improved , especially in the study wards of the university hospital and of the nursing home . This care quality measure was found to be a useful tool for getting feedback from patients and their caregivers concerning care given . Aspects of nursing practice that needed to be improved were identified ( i.e. poor communication between the patient , their caregiver and staff , and lack of support to the patient and caregiver by staff ) Abstract Objective : To investigate the efficacy of intervention by a psychogeriatric team in the treatment of depression in elderly disabled people receiving home care from their local authority . Design : R and omised controlled trial with blind follow up six months after recruitment . Setting : Community of south east London . Subjects : 69 people aged 65 or over who received home care and were depressed according to criteria of the st and ardised automatic geriatric examination for computer assisted taxonomy ( AGECAT ) . 33 were r and omly allocated to an intervention group and 36 to a control group . Intervention : Members of the intervention group received an individual package of care that was formulated by the community psychogeriatric team in their catchment area and implemented by a research er working as a member of that team . The control group received normal general practitioner care . Main outcome measures : Recovery from depression ( AGECAT case at recruitment but non-case at follow up ) . Results : Data were analysed on an intention to treat basis . 19 ( 58 % ) of the intervention group recovered compared with only nine ( 25 % ) of the control group , a difference of 33 % ( 95 % confidence interval 10 % to 55 % ) . This powerful treatment effect persisted after controlling for possible confounders in logistic regression analysis , with members of the intervention group more likely than members of the control group to have recovered at follow up ( odds ratio 9.0 ( 2.0 to 41.5 ) ) . This did not seem to be a simple effect of antidepressant prescription : use of antidepressants at follow up did not have a significant effect ( multiply adjusted odds ratio 0.3 ( 0.0 to 1.9 ) ) . Conclusions : Depression is treatable in elderly people receiving home care . Therapeutic nihilism based on an assumed poor response to treatment in these socially isolated , disabled elderly people in the community is not supported . Key messages This r and omised controlled trial evaluated whether intervention by a psychi- atric team would improve depression in elderly people receiving home care Overall , 58 % of those receiving the intervention had recovered from their depression six months later compared with only 25 % of those receiving unsup- plemented general practitioner care These results should be achievable by other community old age psychiatry services The current comparative inaction on the part of health and social services needs to be This study compared the functional ability and perceived health status of stroke patients treated by a domiciliary rehabilitation team or by routine hospital-based services after discharge from hospital . Patients discharged from two acute and three rehabilitation hospitals in Nottingham were r and omly allocated in three strata ( Health Care of the Elderly , General Medical and Stroke Unit ) to receive domiciliary or hospital-based care after discharge . Functional recovery was assessed by the Extended Activities of Daily Living ( ADL ) scale three and six months after discharge and perceived health at six months was measured by the Nottingham Health Profile . A total of 327 eligible patients of 1119 on a register of acute stroke admissions were recruited over 16 months . Overall there were no differences between the groups in their Extended ADL scores at three or six months , or their Nottingham Health Profile scores at six months . In the Stroke Unit stratum , patients treated by the domiciliary team had higher household ( p = 0.02 ) and leisure activity ( p = 0.04 ) scores at six months than those receiving routine care . In the Health Care of the Elderly stratum , death or a move into long-term institutional care at six months occurred less frequently in patients allocated to the routine service , about half of whom attended a geriatric day hospital . Overall there was no difference in the effectiveness of the domiciliary and hospital-based services , although younger stroke unit patients appeared to do better with home therapy while some frail elderly patients might have benefited from day hospital attendance This paper describes a program ( Community Care Program ) in which some elderly hospital patients who were c and i date s for nursing home placement were placed in foster homes . Caregivers were carefully trained and supervised . A total of 112 elderly in patients were r and omly assigned to placement in a nursing home or a foster care home . Patients and caregivers were interviewed at 3 , 6 , 9 , and 12 months after placement . Community Care Program patients were more likely to maintain or improve ADL ( activities of daily living ) and mental status scores . They also had better nursing outcomes and were more likely to get out of the house than were nursing home patients . Nursing home patients had higher life satisfaction , and participated in more social and recreational activities . The Community Care Program was 17 per cent less costly than nursing home care . The results suggest that foster care may be a viable alternative for a segment of the nursing home population Abstract Objective : To compare effectiveness and acceptability of early discharge to a hospital at home scheme with that of routine discharge from acute hospital . Design : Pragmatic r and omised controlled trial . Setting : Acute hospital wards and community in north of Bristol , with a catchment population of about 224 000 people . Subjects : 241 hospitalised but medically stable elderly patients who fulfilled criteria for early discharge to hospital at home scheme and who consented to participate . Interventions : Patients ' received hospital at home care or routine hospital care . Main outcome measures : Patients ' quality of life , satisfaction , and physical functioning assessed at 4 weeks and 3 months after r and omisation to treatment ; length of stay in hospital and in hospital at home scheme after r and omisation ; mortality at 3 months . Results : There were no significant differences in patient mortality , quality of life , and physical functioning between the two arms of the trial at 4 weeks or 3 months . Only one of 11 measures of patient satisfaction was significantly different : hospital at home patients perceived higher levels of involvement in decisions . Length of stay for those receiving routine hospital care was 62 % ( 95 % confidence interval 51 % to 75 % ) of length of stay in hospital at home scheme . Conclusions : The early discharge hospital at home scheme was similar to routine hospital discharge in terms of effectiveness and acceptability . Increased length of stay associated with the scheme must be interpreted with caution because of different organisational characteristics of the services . Key messages Pressure on hospital beds , the increasing age of the population , and high costs associated with acute hospital care have fuelled the search for alternatives to inpatient hospital care There were no significant differences between early discharge to hospital at home scheme and routine hospital care in terms of patient quality of life , physical functioning , and most measures of patient satisfaction Length of stay for hospital patients was significantly shorter than that of hospital at home patients , but , owing to qualitative differences between the two interventions , this does not necessarily mean differences in effectiveness Early discharge to hospital at home provides an acceptable alternative to routine hospital care in terms of effectiveness and patient A survey was conducted on 1035 persons constituting a semi-r and om age-structured sample of the population s of three areas in the west of Scotl and . The object was to attempt to estimate the needs of this population for domiciliary services . A method was developed of classifying the subjects into 12 ' care groups ' based on two characteristics , those of ' potential need ' and ' solitude ' . ' Potential need ' was a measure of disability and its severity was grade d according to the intervals that elapsed between necessary periods of help . ' Solitude ' was a measure of the time during each day when potential sources of help were spontaneously available . ' Potential need ' was found to be related linearly to age but to be independent of the other variables studied . ' Solitude ' was commonest in the 75 - 84-year age group and varied in the three areas studied , but no relationship with any other variable was detected . An estimate was made of the domiciliary services which would be required to ensure a satisfactory st and ard of care for the subjects in the sample . Assuming present or slightly better levels of hospital provision and slightly lower provision of residential homes there is still a need for a very great increase in domiciliary services if satisfactory st and ards of community care are to be attained The purpose of this study was to compare health status outcomes in three alternative long-term care setting s in the Veterans Administration : 1 ) home care ; 2 ) community-based nursing home care ; and 3 ) hospital-based nursing home care . Patients were measured on a behavioral index of health status , at two points in time : when transferred from the acute care hospital to one of the three treatment programs ( pretest and three months later ( posttest ) . Since patients could not be r and omly distributed to programs , two methods were employed to control for potential sample selection bias : the choice of a nonequivalent control group design , and multivariate analytic techniques . First , within each program type , patients were r and omly selected from both a hospital that offered only that program as a long-term care alternative and from a hospital that provided all three treatment setting s. Second , multiple regression analysis was used to control for pretest differences among patients . Patients placed in the home care program displayed the greatest mean improvement in functional health status , holding all other variables constant
Output:
| No significant difference was found between the two groups when comparing functioning ( ADL and IADL ) , mental status , attitudes to perceived health , life satisfaction or mortality .
REVIEW ER 'S CONCLUSIONS There is insufficient evidence to estimate the likely benefits , harms and costs of institutional or at-home care for functionally dependent older people |
MS210805 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: Of 113 cyclosporine-treated primary renal allograft recipients , 60 were r and omized to receive st and ard therapy without diltiazem ( ND ) and 53 received st and ard therapy plus diltiazem ( D ) . There was no difference in CsA blood levels between ND and D at all intervals between 3 and 24 months follow-up , yet the D group required 35 % less CsA than the ND group ( measured at 12 months ) . At all intervals to 24 months there was no difference in blood pressure , renal function ( as measured by serum creatinine ) , or in the number of grafts lost between the 2 groups ( ND , 4 lost ; D , 3 lost ) . There was no significant difference in the total number of rejection episodes in the 2 groups ( ND , 89 episodes ; D , 71 episodes ) . However , the severity of rejection episodes was greater in the ND group as evidence d by a significant difference in the usage of OKT3 ( ND , 17 courses ; D , 8 courses of OKT3 , P<0.06 ) . Of the biopsy-proven episodes of rejection , there were more episodes of vascular rejection in the ND group ( ND , 14 episodes ; D , 3 episodes , P=0.005 ) . The incidence of primary nonfunction was less in the D group ( ND , 16 patients ; D , 5 patients , P=0.05 ) . It was concluded that the use of diltiazem was associated with a markedly reduced requirement for CsA without any adverse effect on graft function or graft outcome . Diltiazem with CsA was associated with fewer episodes of primary nonfunction and less-severe rejection episodes and in particular fewer episodes of vascular rejection BACKGROUND Hypertension and hyperuricaemia are common side-effects of cyclosporin A ( CsA ) treatment in renal transplant recipients . While it is well established that the calcium channel blocker amlodipine can control CsA-induced hypertension effectively in this patient population , recent evidence suggests amlodipine might also reduce hyperuricaemia . The present study was design ed to compare the effects of the calcium channel blocker amlodipine ( 5 - 10 mg/day ) and the beta-adrenoceptor antagonist tertatolol ( 5 - 10 mg/day ) on CsA-induced hyperuricaemia in post-renal transplant recipients with hypertension . METHODS Forty-eight hypertensive renal transplant recipients on a stable dose of CsA were r and omized in a double-blind , parallel-group manner to receive either amlodipine ( n = 24 ) or tertatolol ( n = 24 ) for 60 days . The primary outcome measure was the change from baseline in serum uric acid concentration . Secondary analyses of efficacy were based on changes in renal function and blood pressure . RESULTS Amlodipine significantly decreased serum uric acid levels from 483 + /- 99 to 431 + /- 110 microM/l ( P < 0.001 ) , while tertatolol significantly increased uric acid from 450 + /- 98 to 476 + /-84 microM/l ( P = 0.006 ) . Amlodipine also significantly increased glomerular filtration rate ( P = 0.0048 ) and the clearance rate of uric acid ( P = 0.023 ) and it reduced the fractional proximal tubular reabsorption of sodium ( P < 0.001 ) , compared with tertatolol . Renal plasma flow and filtered fraction were unaffected by both treatments , as was trough CsA blood concentration . Amlodipine lowered systolic blood pressure to a significantly greater extent than did tertatolol ( P = 0.007 ) . The time-dependent profile of diastolic blood pressure did not differ significantly between treatment groups . Both drugs were well tolerated . CONCLUSIONS Amlodipine could be more appropriate than tertatolol for CsA-induced hypertension and hyperuricaemia in renal transplant recipients BACKGROUND After successful kidney transplantation patients may suffer from the adverse effects due to the use of calcineurin inhibitors . Calcium channel blockers are effective in the treatment of hypertension and may ameliorate cyclosporine- ( CsA ) induced impairment of renal function after kidney transplantation . Calcium channel blockers may also modulate the immune-system which may result in reduction of acute rejection episodes . PATIENTS AND METHODS From June 1995 till 1997 the effect of isradipine ( Lomir ) on renal function , incidence and severity of delayed graft function ( DGF ) , and acute rejection after kidney transplantation , was studied in 210 renal transplant recipients , who were r and omized to receive isradipine ( n=98 ) or placebo ( n=112 ) after renal transplantation in a double-blind fashion . RESULTS In the isradipine group renal function was significantly better at 3 and 12 months ( P=0.002 and P=0.021 ) compared with the placebo group . DGF was present in both groups : isradipine : (28 + 6)/98 ( 35 % ) ; placebo : (35 + 9)/112 ( 40 % ) , P=0.57 . Severity of DGF was comparable in both groups ( isradipine : 9.1+/-8.7 vs. placebo : 9.3+/-8.1 days ) . No statistical difference was found in incidence or severity of biopsy-proven acute rejection [ isradipine : (42 + 6)/98 ( 49 % ) versus placebo : (46 + 9)/112 ( 49 % ) , P=1.00 ] . Renal vein thrombosis was observed in eight patients . This proved to be associated with the route of administration of the study medication [ 6/45 ( 13 % ) on i.v . medication versus 2/165 ( 1 % ) on oral medication , P<0.001 ] . CONCLUSIONS Addition of isradipine results in a better renal function after kidney transplantation , without effect on incidence or severity of DGF or acute rejection Intrarenal vasoconstriction is a characteristic feature of CsA nephrotoxicity . The influence of nifedipine , a dihydropyridine calcium channel blocker and potent renal vasodilator , on renal haemodynamics was investigated in 11 cyclosporin A (CsA)- and 9 azathioprine (Aza)-treated normotensive long-term renal allograft recipients . Baseline Cr51-EDTA clearance and effective renal plasma flow ( ERPF ) were similar in both groups . Nifedipine 20 mg twice daily for 28 days significantly increased Cr51-EDTA clearance ( + 14.8 % ) in the CsA group ; however , ERPF , renal vascular resistance ( RVR ) , and filtration fraction did not change . Nifedipine did not influence renal haemodynamics in the azathioprine group . The increase in Cr51-EDTA clearance in the CsA group did not correlate with baseline renal function , CsA dose or whole blood levels , donor age , duration of graft , or renal functional reserve capacity . This study suggests that nifedipine confers a beneficial effect on renal haemodynamics in long-term CsA-treated renal allograft recipients and appears to improve renal function by a non-haemodynamic mechanism Verapamil has proven effective in preventing acute renal failure in animal models if given prior to the insult and hence possibly has a role in the preservation of cadaveric renal tissue for transplantation . Twenty renal donors were r and omly assigned to treatment ( receiving verapamil 20 mg intravenously ) and control groups . Recipients were monitored for renal failure by urine output and serum creatinines on days 1 and 7 and dialysis requirement to one week . Early urine outputs and serum creatinines ( day 1 ) were significantly better in the treated than control group ( p greater than 0.01 , 0.05 respectively ) . We conclude therefore that verapamil may prevent post-transplant acute renal failure , but its optimal dosage and route of administration remain to be determined The purpose was to study whether the calcium entry blocker , felodipine , could reduce the nephrotoxic and hypertensive effect of cyclosporine . The effect of felodipine on glomerular filtration rate ( GFR ) , renal plasma flow ( RPF ) , fractional excretion of sodium , lithium clearance and blood pressure was measured in three r and omized , placebo-controlled studies of cyclosporine treated patients . In study one , 10 renal transplant recipients were examined within the first six months after transplantation in a cross-over design . Renal hemodynamics were determined after the acute ingestion of felodipine or placebo , with an interval of less than one week between the two examinations . In study two , 79 renal transplant recipients were r and omized to a treatment with felodipine or placebo just before transplantation , and renal hemodynamics were determined after twelve weeks . In study three , 18 patients , who were treated with cyclosporine due to dermatological diseases , were examined in a cross-over design to determine their renal hemodynamics after four weeks of treatment with felodipine or placebo . Felodipine increased renal hemodynamics in study one ( GFR 16 % , RPF 33 % , P < 0.01 for both ) , in study two ( GFR 23 % , RPF 28 % , P < 0.05 for both ) , and in study three ( GFR 13 % , RPF 26 % , P < 0.01 for both ) . FE(Na ) was significantly increased by felodipine in studies one and three , but not in study two . Lithium clearance was significantly increased and blood pressure significantly reduced by felodipine in all three studies . It can be concluded that felodipine counteracts both the cyclosporine induced impairment in renal hemodynamics and the increase in blood pressure in acute and short-term studies Background . Studies have provided conflicting results as to the protective role of calcium channel blockers ( CCB ) in cyclosporine-treated patients with regard to blood pressure control and preservation of renal graft function . Lacidipine is a dihydropyridine CCB that possesses antioxidative , anti-atherosclerotic , and anti-adhesion properties and was shown to prevent cyclosporine-induced nephrotoxicity in a rat model . Methods . We conducted a multicenter prospect i ve , r and omized , placebo-controlled study in 131 de novo recipients of a cadaveric renal allograft on cyclosporine therapy . The aim of this 2-year study was to assess the effects of lacidipine on graft function ( plasma iohexol clearance ) , renal plasma flow , anastomotic arterial blood flow , deterioration of renal function , blood pressure , acute rejection , and hospitalization rate . Results . A total of 118 recipients were available for intention-to-treat analysis on efficacy ( lacidipine : n=59 ; placebo : n=59 ) . Graft function assessed by serum creatinine concentration and glomerular filtration rate measured as plasma iohexol clearance , was persistently better in lacidipine-treated patients from 1 year onwards ( respectively , P<0.01 and P<0.05 ) . Renal plasma flow and anastomotic blood flow were not significantly higher in lacidipine-treated patients . Three patients on lacidipine therapy and four on placebo experienced treatment failure defined as an increase in serum creatinine from baseline of more than 60 % ( log-rank test : P=0.57 ) . Study groups did not differ in acute rejection rate , trough blood cyclosporine concentrations , blood pressure , number of antihypertensive drugs , hospitalization rate , and adverse event rate . Conclusions . The use of calcium channel blockers in cyclosporine-treated renal recipients results in a significantly better allograft function at 2 years and this effect is independent of blood pressure lowering A local measurement of the partial pressure of oxygen in the renal cortex was performed during renal transplantation in 40 patients aged between 10 and 62 years . During the measurement , 20 of the patients received the calcium channel blocker diltiazem . Accurate knowledge of the renal microcirculation in the postischemic phase became possible when PO2 tissue polarography was performed . Moreover , measurement in four live donors before removal of the kidneys allowed an exact comparison between the postischemic microcirulation and the native in situ perfusion . A good postischemic baseline histogram ( similar to the situation in a live donor ) or quick stabilization of the histogram during the course was found to correlate with a prompt initial renal function . Intra-arterial administration of diltiazem led to an insignificant improvement of the primary function rate . In the case of kidneys with longer cold ischemic periods and initially indifferent baseline histograms there was an especially pronounced benefit of diltiazem administration . Not only macroscopic examination , but also polarographic measurements revealed an improvement in the renal microcirculation throughout , with higher mean values for PO2 and homogeneity of all PO2 values measured after administration of diltiazem . In keeping with this , in such cases the incidence of primary renal function was distinctly higher . In cases with improved cortical circulation the a-v oxygen difference was less pronounced , so that evaluation of the avDO2 determinations suggests distinct perfusion improvement following diltiazem Calcium antagonists ( CATs ) have a role in the management of certain types of renal insufficiency . These include prophylaxis against post-transplant-associated acute renal failure and cyclos
Output:
| These results suggest that calcium channel blockers given in the peri-operative period may reduce the incidence of ATN post-transplantation . |
MS210806 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: BACKGROUND Radial artery spasm is one of the most common complications during coronary angiography via the transradial approach , causing patient discomfort or sometimes interrupting the procedure . This study was design ed to compare the spasmolytic effect between nicor and il and a cocktail during transradial coronary angiography . METHODS A r and omized study to compare 4 mg of nicor and il and a cocktail ( mixture of normal saline , 200 microg of verapamil ) was performed in 150 patients . We examined vasospasms of the radial artery that were expressed as stenosis of the radial artery vessel diameter after the procedure . RESULT The reductions of systolic and diastolic blood pressures showed no significant differences between the two groups ( 15.4+/-11.5/7.7+/-7.8 mmHg for nicor and il and 16.3+/-13.4/6.2 mmHg for cocktail ) . Both agents induced a significant radial artery vasodilation after transradial administration at proximal and mid segments ( P < 0.001 for all ) . Nicor and il showed a significant increase of the mean change of the radial artery diameter compared to the cocktail at mid-segment ( 0.32+/-0.23 mm for nicor and il and 0.24+/-0.15 mm for a cocktail , P < 0.05 ) . There was no statistically significant difference between the two groups in radial artery spasm ( 50.7 % vs. 52.0 % in nicor and il and a cocktail , respectively ) after catheterization . CONCLUSION Nicor and il with vasodilator effects by a dual mechanism was effective as the cocktail in preventing radial artery spasm during transradial coronary angiography Background Verapamil is traditionally applied prophylactically in transradial procedures to prevent radial artery spasm . However , verapamil may have side effects and is contraindicated in some clinical setting s. Methods and Results During an investigator‐initiated , r and omized , double‐blind trial , we evaluated the need for preventive verapamil administration . After vascular access was established , patients received either 5 mg verapamil ( n=297 ) or placebo ( n=294 ) . We compared the rate of access site conversions as primary end point using a superiority margin of 5 % . Occurrence of code breaks ( composite of conversions and unplanned use of verapamil ) , overall verapamil use , procedural and fluoroscopic times , contrast volume , and subjective pain were investigated as secondary end points . The rate of access site conversions was not different in the 2 arms ( placebo 1.7 % versus verapamil 0.7 % , P=0.28 , difference 1.0 % , 95 % CI for the difference −1.1 % to 3.3 % ) . Proportion of code breaks was similar in the 2 groups ( 3.4 % versus 1.3 % , P=0.11 ) , whereas overall verapamil use was markedly lower in the placebo arm ( 2.0 % versus 100 % , P<0.0001 ) . Procedural time ( median [ IQR ] 16.0 minutes [ 9.0 to 30.0 minutes ] versus 17.0 minutes [ 10.0 to 31.0 minutes ] , P=0.37 ) , fluoroscopic time ( 4.4 minutes [ 2.1 to 9.6 minutes ] versus 4.8 minutes [ 2.4 to 10.7 minutes ] , P=0.28 ) , contrast volume ( 72.5 mL [ 48.0 to 146.0 mL ] versus 75.5 mL [ 47.0 to 156.5 mL ] , P=0.74 ) , and pain score ( P for trend=0.12 ) were comparable in the 2 groups . Conclusions The preventive use of verapamil may be unnecessary for transradial procedures . The omission of prophylactic verapamil may not only reduce the rate of potential complications related to the drug but also allow the safe extension of the transradial method to those with contraindications to verapamil . Clinical Trial Registration URL : http://www . clinical trials.gov . Unique identifier : NCT01402427 OBJECTIVES This study sought to estimate the economic impact of same-day home discharge compared with overnight hospitalization after transradial percutaneous coronary intervention ( PCI ) . BACKGROUND Same-day home discharge after transradial PCI and a bolus-only abciximab regimen was found to be clinical ly noninferior to the abciximab st and ard therapy and overnight hospitalization in patients with various forms of acute coronary syndromes . METHODS In the EASY ( Early Discharge After Transradial Stenting of Coronary Arteries ) trial , 1,005 patients were r and omized after a bolus of abciximab and uncomplicated transradial coronary stenting , either to same-day home discharge and no infusion ( outpatient group ) or to overnight hospitalization and 12-h abciximab infusion ( overnight-stay group ) . We estimated post-PCI health care cost ( in Canadian dollars ) of trial subjects and short-term economic impact of same-day home discharge . As r and omization was done after the procedure , outcomes were similar , and PCI re source use showed minimal and nonsignificant differences , a post-PCI cost-minimization analysis was conducted . Detailed per-patient information of health care re sources used immediately after PCI up to 30 days was collected . RESULTS Mean post-PCI hospital stay was 8.9 h for out patients versus 26.5 h for overnight-stay patients ( p < 0.001 ) . At 30-day follow-up , the mean cumulative medical cost per outpatient was $ 1,117 ± $ 1,554 versus $ 2,258 ± $ 1,328 for overnight-stay patients . The mean difference of $ 1,141 ( 95 % confidence interval : $ 962 to $ 1,320 ) was mainly due to the extra night for overnight hospital stay . CONCLUSIONS In a real-world setting , same-day home discharge after uncomplicated transradial PCI and a bolus-only abciximab regimen result ed in a 50 % relative reduction in medical costs . Extension of this outpatient strategy would be welcomed by the hospitals and reimbursement systems in a context of increasing dem and for health care cost reduction . ( Early Discharge After Transradial Stenting of Coronary Arteries [ EASY ] ; NCT00169819 ) We examined the response of the radial artery to vasoactive agents ( isosorbide dinitrate , ISDN , 1 mg , 3 mg , and 5 mg ; verapamil , 1 mg , 3 mg , and 5 mg ; and lidocaine , 10 mg , 30 mg , and 50 mg ) in 100 consecutive patients admitted for elective coronary angiography . The drug solutions were directly injected into the radial artery from the puncture site . As a result , 5 mg of ISDN increased the diameter of the radial artery by 31 % and 28.8 % at the proximal and distal sites , respectively . Similarly , 5 mg of verapamil increased it by 9 % and 10.8 % at the proximal and distal site , respectively . But 10 mg of lidocaine decreased it by −15.6 % and −12.1 % at the proximal and distal site , respectively . At the doses utilized , ISDN was the most potent vasodilator for the radial artery and lidocaine caused paradoxical vasoconstriction . Cathet . Cardiovasc . Intervent . 49:253–256 , 2000 . © 2000 Wiley‐Liss , OBJECTIVE Radial artery spasm remains a major complication of transradial coronary interventions . The aim of this study was to compare the efficacy of three different intra-arterial vasodilating cocktails in reducing the incidence of radial artery spasm in patients undergoing transradial coronary angiography . The secondary goal was to assess the predictors of arterial spasm in this large group of patients . METHODS A total of 379 patients undergoing the procedure were r and omly enrolled in 1 of 3 groups . Every patient in each of the 3 groups received intra-arterial heparin , lidocaine and diltiazem . Along with that , patients in Group A received nitroglycerin ; patients in Group B received nitroprusside instead of nitroglycerin ; and patients in Group C received both nitroglycerin and nitroprusside . A single experienced operator , blinded to the study drug , subjectively determined the presence of spasm . RESULTS Of 379 patients , a total of 44 patients ( 11.6 % ) experienced spasm . The occurrence of spasm was similar , independent of the vasodilator cocktail used ( Group A : 12.2 % , Group B : 13.4 % , Group C : 9.5 % ; p = 0.597 ) . After multivariate analysis , the following variables were found to be independent predictors of spasm : radial artery diameter (RD)/height index ( p = 0.005 ) , RD/BSA index ( p = 0.012 ) , and sheath outer diameter (OD)/RD index ( p = 0.024 ) . CONCLUSION In this prospect i ve , r and omized trial , the addition of a direct nitric oxide donor to nitroglycerin in an antispastic cocktail did not reduce the risk of spasm , and the use of nitroglycerin was found to be as effective as nitroprusside . Also , morphometric and mechanical factors play a significant role in predicting the occurrence of radial spasm . The sex of the patient , presence of diabetes , body surface area and smoking history appeared to play no role in predicting the occurrence of radial spasm OBJECTIVE To evaluate the impact of the use , prior to the procedure , of injectable diltiazem to prevent complications . METHODS Between September 2000 and July 2001 , 50 patients underwent transradial coronary angiography and were r and omized to receive placebo ( GI ) or diltiazem ( GII ) through a catheter inserted into the radial artery . All patients received isosorbide mononitrate . Ultrasound analyses of the radial artery were performed before examination , 30 minutes afterwards , and 7 days afterwards to evaluate the flow , the diameter , and the artery output . RESULTS The radial artery diameter of GI was 2.4d + /- 0.5 mm before the procedure and 2.3 + /- 0.5 mm after 30 minutes ( NS ) , whereas in GII the diameter was 2.2 + /- 0.3 mm before the examination and + /- 2.5 0.4 mm 30 minutes after it ( P<0.001 ) . Radial artery output in group 1 was 7.3 + /- 5.l2 mL/min before the examination and 6.1 + /- 3.5 mL/min 30 minutes after the examination ( NS ) , and GII had an increase of 5.9 + /- 2.5 mL/min before examination to 9.05 + /- 7.78 mL/min after the examination ( P=0.04 ) . Complications ( spasm , occlusion , and partial obstruction ) occurred in 4 patients ( 17.4 % ) in GI and did not occur in GII ( P=0.04 ) . CONCLUSION The study suggests a decrease in vascular complications through the transradial access for coronary angiography with the use of diltiazem as an antispasmodic drug , result ing in the significant increase in the diameter of the radial artery and radial artery output OBJECTIVES This study sought to determine the relationships among access site practice , clinical presentation , and procedural outcomes in a large patient population . BACKGROUND Transradial access ( TRA ) has been associated with improved patient outcomes in selected population s in r and omized trials . It is unclear whether these outcomes are achievable in clinical practice . METHODS Using the BCIS ( British Cardiovascular Intervention Society ) data base , we investigated outcomes for percutaneous coronary intervention procedures undertaken between 2007 and 2012 according to access site practice . Patients were categorized as stable , non-ST-segment elevation acute coronary syndrome ( NSTEACS ) and ST-elevation acute coronary syndrome ( STEACS ) . The impact of access site on 30-day mortality , major adverse cardiac events , bleeding , and arterial access site complications was studied . RESULTS Data from 210,260 TRA and 229,687 transfemoral access procedures were analyzed . Following multivariate analysis , TRA was independently associated with a reduction in bleeding in all presenting syndromes ( stable odds ratio [ OR ] : 0.24 , p < 0.001 ; NSTEACS OR : 0.35 , p < 0.001 ; STEACS OR : 0.47 , p < 0.001 ) as well as access site complications ( stable OR : 0.21 , p < 0.001 ; NSTEACS OR : 0.19 ; STEACS OR : 0.16 , p < 0.001 ) . TRA was associated with reduced major adverse cardiac events only in patients with unstable syndromes ( stable OR : 1.08 , p = 0.25 ; NSTEACS OR : 0.72 , p < 0.001 ; STEACS OR : 0.70 , p < 0.001 )
Output:
| In this largest and up-to- date review on intra-arterial vasodilators use to reduce RAS , we have found that the verapamil at a dose of 5 mg or verapamil in combination with nitroglycerine are the best combinations to reduce RAS |
MS210807 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
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Input: We prospect ively estimated the prevalence of the polycystic ovary syndrome ( PCOS ) , as defined by the NIH/NICHHD 1990 endocrine criteria , in a population of 154 Caucasian women of reproductive age reporting spontaneously for blood donation . Anthropometric data ; the presence of hirsutism , acne , and and rogenic alopecia ; and the menstrual history were recorded by a single investigator . In 145 women , blood sample s were also obtained for measurement of serum and rogen levels . PCOS was defined by the presence of 1 ) oligomenorrhea , 2 ) clinical and /or biochemical hyper and rogenism , and 3 ) exclusion of hyperprolactinemia , thyroid disorders , and nonclassic 21-hydroxylase deficiency . Hirsutism was defined by a modified Ferriman-Gallwey score of 8 or more , acne was considered as a sign of hyper and rogenism when persistent after the second decade of life , and hyper and rogenemia was defined by an increase in circulating testosterone or dehydroepi and rosterone sulfate or an increase in the free and rogen index above the 95th percentile of the control values derived from the nonhirsute , nonacneic women having regular menses who were not receiving hormonal therapy . PCOS was present in 10(6.5 % ) , hirsutism was present in 11 ( 7.1 % ) , and acne was present in 19 ( 12.3 % ) of the 154 women . Our results demonstrate a 6.5 % prevalence of PCOS , as defined , in a minimally biased population of Caucasian women from Spain . The polycystic ovary syndrome , hirsutism , and acne are common endocrine disorders in women BACKGROUND Oral contraceptive is the most commonly used method of fertility control . Yasmin is a combination of a novel progestogen with anti- and rogenic and anti-mineralcorticoid activities ( 3 mg Drospirenone ( DRSP ) and 30 microg ethinylestradiol ( EE ) ) . It has been shown in many clinical trials that Yasmin is an efficacious oral contraceptive , lacking undesired effects as with other oral contraceptives such as weight gain . However the effects of Yasmin on sexual desire and libido have not been intensively investigated so far OBJECTIVE Investigate the effects of Yasmin on sexual desire , libido and changes in the free and rogen index ( FAI ) compare to Meliane ( 75 microg gestodene + 20 microg ethinylestradiol ) . MATERIAL AND METHOD The authors ' report the results of a double blind r and omized controlled study using a translated version of the Female Sexual Function Index question naire ( FSFI ) for the assessment of the sexual function . The free and rogen index was calculated from measurements of testosterone and sexual hormone binding globulin . RESULT The result shows statistically significant improvements regarding sexual desire , arousal and overall satisfaction in the Yasmin group . Additionally , an increased frequency of orgasms in the Meliane group was reported . Statistically significant differences between the two treatments regarding changes in the FSFI score and changes in the free and rogen index have not been observed . CONCLUSION The novel oral contraceptive containing drospirenone ( Yasmin ) and the non-anti- and rogenic progestin containing oral contraceptive ( Meliane ) do not show unfavorable effects on sexual response and libido The relationships between plasma free testosterone ( FT ) and measures of sexual attitude , sexual behavior , and gender role behavior were assessed in 55 oral contraceptive-using and 53 nonusing female undergraduates . Plasma FT and other measures of and rogenicity were substantially lower in the oral contraceptive ( OC ) group . Correlations between FT and certain behavioral and attitudinal measures were found in the OC users but not the nonusers . In the OC users , FT was positively associated with frequency of sexual intercourse but not with frequency of masturbation . It was negatively associated with restrictive sexual morality . Correlations between FT and measures of gender role behavior were negligible , and FT was unrelated to proceptivity , homosexual interest , or the use of sexual fantasy . The occurrence of some predicted correlations among pill-using women but not the nonusers requires explanation , particularly in view of the substantially lower levels of FT in the pill-using group . It is suggested that and rogen — behavior relationships in women are easily obscured by psychosocial influences and in this sample of young women such influences may have been more powerful among those not using OCs . Such psychosocial influences are likely to differ at different stages of women 's life cycles . The importance of controlling for such influences in any study of hormone — sexual behavior relationships in women is emphasized , and the need for prospect i ve studies of women before and after starting on steroidal contraception is recognized The aim of this study was to examine whether changes in plasma and rogen levels ( total testosterone ( T ) , free testosterone ( FT ) , and dehydro-epi and rosterone-sulfate ( DHEA-S ) ) induced by oral contraceptive ( OC ) use were related to changes in sexual interest or response or in mood . Sixty-one women provided blood sample s and were assessed , using interviews and st and ardized question naires , prior to starting , and after 3 months on OCs ( Ortho-Tricyclen , Ortho-Tricyclen-Lo , or Ortho-Cyclen , all containing the same progestagen , norgestimate ) . Significant decreases in T , FT , and DHEA-S were found after 3 months , although the extent of reduction was variable across women . There was some support for a relationship between the degree of reduction in total T and FT and the frequency of sexual thoughts after 3 months on OCs . However , some women had no loss of sexual interest in spite of substantial reduction in FT , and there was overall no evidence that reduction in FT affected enjoyment of sexual activity with a partner . The findings are consistent with the idea that some women may be more sensitive to changes in T than others . No relationship was found between negative mood , as assessed by the Beck Depression Inventory , and changes in T , FT , or The relationship between plasma testosterone ( T ) secretion and patterns of sexual behavior was examined in 18 women using oral contraceptives ( OCs ) and 13 nonusers matched for partner availability . Retrospective assessment s of perimenstrual symptoms , sexual attitudes , and sexual experience were obtained and women completed daily ratings of the frequency of sexual activities and the level of well-being for 1 month . Plasma levels of sex hormone binding globulin ( SHBG ) , progesterone , Total T , Free T , and non-SHBG bound T were determined by radioimmunoassay at four phases of the pill or menstrual cycle . Overall , women not using OCs had higher plasma levels of Total , Free , and non-SHBG bound T and lower plasma levels of SHBG than those of OC users . Further , only nonusers had perimenstrual decreases in plasma levels of Total and Free T. The two groups were comparable on most retrospective measures . However , OC users reported more satisfaction with their sexual partners than did nonusers and prospect i ve monitoring revealed that they engaged in sexual interactions more frequently than did nonusers across the cycle . In contrast , both groups reported a similar frequency of autosexual activities across the cycle . There were no correlations between average levels of T and levels of sexual desire , sexual interactions , or autosexuality . Moreover , only nonusers reported a decrease in levels of sexual desire during the perimenstrual period that was associated with the changes in Free T over the menstrual cycle BACKGROUND The ovaries provide approximately half the circulating testosterone in premenopausal women . After bilateral oophorectomy , many women report impaired sexual functioning despite estrogen replacement . We evaluated the effects of transdermal testosterone in women who had impaired sexual function after surgically induced menopause . METHODS Seventy-five women , 31 to 56 years old , who had undergone oophorectomy and hysterectomy received conjugated equine estrogens ( at least 0.625 mg per day orally ) and , in r and om order , placebo , 150 microg of testosterone , and 300 microg of testosterone per day transdermally for 12 weeks each . Outcome measures included scores on the Brief Index of Sexual Functioning for Women , the Psychological General Well-Being Index , and a sexual-function diary completed over the telephone . RESULTS The mean ( + /-SD ) serum free testosterone concentration increased from 1.2+/-0.8 pg per milliliter ( 4.2+/-2.8 pmol per liter ) during placebo treatment to 3.9+/-2.4 pg per milliliter ( 13.5+/-8.3 pmol per liter ) and 5.9+/-4.8 pg per milliliter ( 20.5+/-16.6 pmol per liter ) during treatment with 150 and 300 microg of testosterone per day , respectively ( normal range , 1.3 to 6.8 pg per milliliter [ 4.5 to 23.6 pmol per liter ] ) . Despite an appreciable placebo response , the higher testosterone dose result ed in further increases in scores for frequency of sexual activity and pleasure-orgasm in the Brief index of Sexual Functioning for Women ( P=0.03 for both comparisons with placebo ) . At the higher dose the percentages of women who had sexual fantasies , masturbated , or engaged in sexual intercourse at least once a week increased two to three times from base line . The positive-well-being , depressed-mood , and composite scores of the Psychological General Well-Being Index also improved at the higher dose ( P=0.04 , P=0.03 , and P=0.04 , respectively , for the comparison with placebo ) , but the scores on the telephone-based diary did not increase significantly . CONCLUSIONS In women who have undergone oophorectomy and hysterectomy , transdermal testosterone improves sexual function and psychological well-being INTRODUCTION Women may use new oral contraceptives ( OC ) having flexible extended-cycle regimens with a reduced hormone-free interval . AIM To study the changes of the quality of sexual life in users of the traditional 21/7 or extended-cycle 24/4 OC regimens both containing 3 mg drospirenone and 20 µg ethinyl estradiol . METHODS One hundred fifteen women ( age range 18 - 37 years ) were enrolled . Fifty-four women were r and omly placed on traditional OC st and ard regimen , administered for 21 days , followed by a 7-day hormone-free interval ( group A ) ; and 61 women were placed on extended-cycle OC regimen covering 24 days of the cycle with a 4-day hormone-free interval ( group B ) . The Short Form-36 ( SF-36 ) vali date question naire to assess quality of life ( QoL ) and the Short Personal Experience Question naire ( SPEQ ) to measure the changes of sexual behavior were administered before starting OC intake and at the 3rd and 6th cycle follow-ups . MAIN OUTCOME MEASURE The SF-36 and the SPEQ question naires . RESULTS Group A women reported QoL improvement during the 6th cycle on all the scales ( P < 0.05 ) . Group B women reported QoL improvement during the 3rd and 6th cycle ( P < 0.05 ) . Satisfaction with sexual activity , arousal , orgasm , and desire increased during the 3rd cycle in women on the group B ( P < 0.05 ) . Group A women did not report any change in all SPEQ items . At the 6th cycle , group B women reported better sexual experience than baseline in all SPEQ items ( P < 0.05 ) . All subjects who were affected by dyspareunia before OC intake reported decreased genital pain associated with intercourse at the 3rd and 6th cycle of both OC regimens ( P < 0.05 ) . CONCLUSION Women could use OCs in a subjective flexible modality . The extended-cycle OC might produce positive effects on the quality of sexual life , enforcing the concept of tailoring an OC to a woman The purpose of the study was to explore predictors of discontinuation of oral contraceptives ( OC ) including pre-OC use characteristics and adverse physical , emotional , and sexual effects of OCs . Women aged 18 + years in committed , sexually active relationships were assessed before starting OC and reassessed at 3 , 6 , and 12 months or shortly after discontinuation . Assessment included pre-OC use attitudes and expectations about the pill ; self-reported side effects and perimenstrual symptoms including premenstrual syndrome ( PMS ) ; physical and emotional well-being ; and sexual interest , enjoyment , and frequency of sexual activity . Seventy-nine women completed the study , 38 % continued OCs , 47 % discontinued , and 14 % switched to another OC . Emotional side effects , worsening of PMS , decreased frequency of sexual thoughts , and decreased psychosexual arousability correctly categorized 87 % of cases by using logistic regression . Emotional and sexual side effects were the best predictors of discontinuation/switching , yet such OC effects have been largely ignored in the research literature An open , r and omized , multicenter study was carried out to compare two oral contraceptives as regards their therapeutic efficacy in and rogenization symptoms such as acne , seborrhea and hirsutism in women . The preparations used were the combination of 2 mg cyproterone acetate ( CPA ) with 0.035 mg ethinyl estradiol ( EE ) ( Diane35 ® , Schering AG , Berlin‐West ) and 0.150 mg desogestrel ( DG ) with 0.03 mg ethinyl
Output:
| The majority of COC users report no significant change in libido although in most studies a decline in plasma levels of free testosterone and an increase in those of sex hormone binding globulin were observed |
MS210808 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: PURPOSE The purpose of this study was to examine the relationship between age at drinking onset and the development of DSM-IV alcohol abuse and dependence in a 12-year prospect i ve study of youth in the United States . METHODS Logistic regression analyses were used to quantify the relationship between age at drinking onset and the development of alcohol abuse and dependence controlling for sociodemographic factors and problem indicators . RESULTS The odds of alcohol dependence decreased by 5 % in 1989 and 9.0 % in 1994 for each year drinking onset was delayed . In 1994 , the odds of alcohol abuse increased by 7.0 % with each decreasing year of age at drinking onset , while age at drinking onset was not related to alcohol abuse in 1989 . Several other risk factors were found to be strong and consistent predictors of abuse and dependence in 1989 and 1994 , including being male , divorced , separated or never married , younger , and having an early history antisocial behaviors and marijuana use . IMPLICATION S Implication s of the results of this study are discussed in terms of other factors that may impact on the onset-abuse and onset-dependence relationship and the need to focus future prevention efforts This article describes a small efficacy trial of the Living in 2 Worlds ( L2W ) substance use prevention curriculum , a culturally adapted version of keepin ’ it REAL ( kiR ) re design ed for urban American Indian ( AI ) middle school students . Focused on strengthening resiliency and AI cultural engagement , L2W teaches drug resistance skills , decision making , and culturally grounded prevention messages . Using cluster r and om assignment , the research team r and omized three urban middle schools with enrichment classes for AI students . AI teachers of these classes delivered the L2W curriculum in two schools ; the remaining school implemented kiR , unadapted , and became the comparison group . AI students ( N = 107 ) completed a pretest question naire before they received the manualized curriculum lessons , and a posttest ( 85 % completion ) 1 month after the final lesson . We assessed the adapted L2W intervention , compared to kiR , with paired t tests , baseline adjusted general linear models , and effect size estimates ( Cohen ’s d ) . Differences between the L2W and kiR groups reached statistically significant thresholds for four outcomes . Youth receiving L2W , compared to kiR , reported less growth in cigarette use from pretest to posttest , less frequent use of the Leave drug resistance strategy , and less loss of connections to AI spirituality and cultural traditions . For other substance use behaviors and antecedents , the direction of the non-significant effects in small sample tests was toward more positive outcomes in L2W and small to medium effect sizes . Results suggest that evidence -based substance use prevention programs that are culturally adapted for urban AI adolescents , like L2W , can be a foundation for prevention approaches to help delay initiation and slow increases in substance use . In addition to study limitations , we discuss implementation challenges in delivering school-based interventions for urban AI population ABSTRACT Background : Early substance use threatens many American Indian/Alaska Native ( AI/AN ) communities , as it is a risk factor for maladaptive use and adverse health outcomes . Marijuana is among the first substances used by AI/AN youth , and its use becomes widespread during adolescence . Interventions that delay or reduce marijuana use hold the promise of curbing substance disorders and other health risk disparities in AI/AN population s. Objectives : We evaluated the effectiveness of the Circle of Life ( COL ) program in reducing marijuana use among young AI adolescents . COL is a culturally tailored , theory-based human immunodeficiency virus ( HIV ) and sexually transmitted disease ( STD ) intervention shown to delay sexual initiation among AI youths . Methods : We conducted secondary analyses of data from a school-based group r and omized trial conducted between 2006 and 2007 in all 13 middle schools on a rural , Northern Plains reservation ( N = 635 , 47 % female ) . We used discrete-time survival analysis ( DTSA ) to assess COL effectiveness on risk of marijuana initiation among AI youths and latent growth curve modeling ( LGCM ) to evaluate effects on frequency of marijuana use over time . Results : DTSA models showed that the overall risk of marijuana initiation was 17.3 % lower in the COL group compared to the control group . No intervention effect on frequency of marijuana use emerged in LGCM analyses . Conclusion : COL is a multifaceted , culturally tailored , skills-based program effective in preventing marijuana uptake among AI youth This paper reports on the evaluation of a culturally grounded prevention intervention targeting substance use among urban middle-school students . The curriculum consists of 10 lessons promoting antidrug norms and teaching resistance and other social skills , reinforced by booster activities and a media campaign . Three versions were delivered : Mexican American , combined African American and European American , and Multicultural . Thirty-five middle schools were r and omly assigned to 1 of the 3 versions or the control . Students completed baseline and follow-up question naires over a 2-year period ( total 6,035 respondents ) . Analyses utilizing a generalized estimating equations approach assessed the overall effectiveness of cultural grounding and the cultural matching hypothesis . Support was found for the intervention 's overall effectiveness , with statistically significant effects on gateway drug use as well as norms , attitudes , and resistance strategies but with little support for the cultural matching hypothesis . Specific contrasts found the Mexican American and Multicultural versions impacted the most outcomes PURPOSE Toward developing attractive and effective means to reduce cancer risks faced by Native American people , this study developed and tested interactive computer software to improve dietary choices and prevent tobacco use among Native American adolescents . METHODS Based on a legend of the Seneca Nation , a cancer prevention lesson was developed and programmed for software . A sample of 368 Native American adolescents were divided r and omly into intervention and control arms . Youths in both arms were pre-tested , youths in the intervention arm interacted with the software , and all youths were post-tested . Pre-test and post-test measures covered information and attitudes about cancer risks from dietary practice s and tobacco use . RESULTS Pre-test scores differed between the two arms on youths ' age and on one outcome variable . Relative to their counterparts in the control arm , youths in the intervention arm increased their post-test scores on 8 of 12 outcome measurement variables . Process data gathered during intervention delivery indicated that nearly all youths were involved with the interactive software and lesson . CONCLUSION Interactive computer software holds promise for delivering cancer risk reduction intervention aim ed at modifying dietary habits and preventing tobacco use among Native American youth Background The rate of smoking commercial tobacco products among American Indian youth is double the rate for white youth . Interventions are needed to reduce this disparity . Objective To test the feasibility of a Web-based intervention to influence attitudes toward and intentions about smoking cigarettes among American Indian youth who attended a Native summer camp in the Northern Plains . Methods The study website , the SmokingZine , was originally developed and tested in Canadian youth , then adapted to be appropriate for American Indian youth . We conducted a r and omized controlled trial to test the influence of exposure to the adapted SmokingZine website on smoking attitudes and behaviors among American Indian youth 12–18 years of age . Participants assigned to the intervention group were given access to the website for 1 hour per day during their camp experience and asked to sign in to the site and use it . Control group participants were not given access to the site . Results A total of 52 % of intervention youth signed in to the website at least once . Among nonsmokers , intentions to try a cigarette in the intervention group declined from 16 % to 0 % , and increased from 8 % to 25 % in the control group ( P < .05 ) . Compared with the control group , youth in the intervention group were more likely to help others quit ( 21 percentage point change in intervention versus no change in control ; P < .05 ) and had less positive attitudes about the drug effects of smoking ( –0.19 change in intervention versus 0.67 in control ; P < .05 ) . Conclusion These data indicate that SmokingZine needs more long-term , rigorous investigation as a way to keep American Indian youth from becoming regular smokers . Because the intervention group could use computers only 1 hour per day , increasing access might result in more visits and a greater effect of the website on smoking behaviors This article examines changes in the drug resistance strategies used by urban American Indian ( UAI ) middle school students during a pilot test of a substance use prevention curriculum design ed specifically for UAI youth , Living in 2 Worlds ( L2W ) . L2W teaches four drug resistance strategies ( refuse , explain , avoid , leave [ R-E-A-L ] ) in culturally appropriate ways . Data come from 57 UAI students ( 53 % female ; mean age = 12.5 years ) who participated in L2W during an academic enrichment class for Native youth at two Phoenix schools . Students completed a pre-test question naire before the L2W lessons and a post-test 7 months later . Questions assessed the use of R-E-A-L and alternative strategies commonly reported by UAI youth ( change the subject , use humor ) . Tests of mean differences from pre-test to post-test showed significant increases in use of refuse , explain , and leave , and an exp and ing R-E-A-L repertoire . Use of more passive strategies ( avoid , use humor ) did not change significantly , except for change the subject , which increased . Changes in the use of strategies did not differ significantly by gender , age , school grade s , parental education , or length of urban residence . The L2W curriculum appears effective in teaching culturally relevant communication strategies that exp and UAI youths ' repertoire of drug resistance skills This study developed and tested skills- and community-based approaches to prevent substance abuse among Native American youth . After completing pretest measurements , 1,396 third- through fifth- grade Native American students from 27 elementary schools in five states were divided r and omly by school into two intervention arms and one control arm . Following intervention delivery , youths in all arms completed posttest measurements and three annual follow-up measurements . Youths in schools assigned to the intervention arms learned cognitive and behavioral skills for substance abuse prevention . One intervention arm additionally engaged local community residents in efforts to prevent substance use among Native American youth . Outcome assessment batteries measured youths ' reported use of smoked and smokeless tobacco , alcohol , and marijuana . Over the course of the 3.5-year study , increased rates of tobacco , alcohol , and marijuana use were reported by youths across the three arms of the study . Though cigarette use was unaffected by intervention , follow up rates of smokeless tobacco , alcohol , and marijuana use were lower for youths who received skills intervention than for youths in the control arm . Community intervention components appeared to exert no added beneficial influence on youths ' substance use , beyond the impact of skills intervention components alone . Finally , gender differences were apparent across substances , measurements , and study arms , with girls smoking more cigarettes and boys using more smokeless tobacco , alcohol , and marijuana Objectives To evaluate the effectiveness of a multilevel intervention design ed to prevent underage alcohol use among youths living in the Cherokee Nation . Methods We r and omly assigned 6 communities to a control , Communities Mobilizing for Change on Alcohol ( CMCA ; a community-organizing intervention targeting alcohol access ) only , CONNECT ( a school-based universal screening and brief intervention ) only , or a combined condition . We collected quarterly surveys 2012 - 2015 from students starting in 9th and 10th grade s and ending in 11th and 12th grade s. Response rates ranged from 83 % to 90 % ; 46 % of students were American Indian ( of which 80 % were Cherokee ) and 46 % were White only . Results Students exposed to CMCA , CONNECT , and both showed a significant reduction in the probability over time of 30-day alcohol use ( 25 % , 22 % , and 12 % reduction , respectively ) and heavy episodic drinking ( 24 % , 19 % , and 13 % reduction ) compared with students in the control condition , with variation in magnitude of effects over the 2.5-year intervention period . Conclusions CMCA and CONNECT are effective interventions for reducing alcohol use among American Indian and other youths living in rural communities . Challenges remain for sustaining intervention effects
Output:
| Substance use prevention programs for Indigenous youth led to reductions in substance use frequency and intention to use ; improvements in substance-related knowledge , attitudes and resistance strategies ; and delay in substance use initiation .
Prevention programs have the potential to reduce substance use among Indigenous adolescents , especially when they are developed in partnership with Indigenous people . |
MS210809 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: A controlled evaluation of a single‐layer everting technique of suture versus a conventional two‐layer inverting technique has been attempted in clinical large‐bowel surgery . Thirty‐five patients suffering from carcinoma or other diseases of the large intestine were allocated r and omly to each technique in the conduct of various forms of colonic resection with anastomosis or closure of a transverse colostomy . There were 3 operative deaths after everting suture and 1 after inverting suture , all attributable mainly to anastomotic failure . A higher proportion of patients developed wound infection or peritonitis after everting than inverting suture—51 as against 35 per cent . Overt faecal fistulation was observed in no less than 43 per cent of the patients having everting suture , but in only 8·6 per cent of those treated by inverting suture . Late stricture formation was noted in 2 cases after everting suture , but in none after inverting suture BACKGROUND AND AIMS Sphincter-saving procedures for resection of mid and , in some cases , of distal rectal tumors have become prevalent as their safety have been established . Increased anastomotic leak rate , associated with the type of anastomosis and the distance from the anal verge , has been reported . To compare surgical outcomes of end-to-end and end-to-side anastomosis after anterior resection for T1-T2 rectal cancer . METHODS During the study period , a total of 298 rectal cancer patients were treated . Patients with T1-T2 rectal cancer ( i.e. , tumor level < or = 15 cm from the anal verge ) fit for surgery were asked to participate in the study . Patients were r and omized to receive either an end-to-end anastomosis or an end-to-side anastomosis using the left colon . Surgical results and complications were recorded . RESULTS Seventy-seven patients were r and omized . Thirty-seven end-to-end anastomoses and 40 end-to-side anastomoses were performed . Anastomotic leakage after end-to-end anastomosis was 29.2 % , while after end-to-side anastomosis was 5 % ( P = 0.005 ) . In the end-to-end group 11 patients had anastomotic leaks : nine patients needed a re-intervention with colostomy creation subsequently closed in seven cases . Two patients of the end-to-side group experienced anastomotic leakage and were successfully treated conservatively . CONCLUSIONS Regarding postoperative surgical complications , end-to-side anastomosis is a safe procedure Abstract . This study represents a European prospect i ve clinical multicenter trial and was undertaken to evaluate the applicability of the biofragmentable anastomosis ring ( BAR ) as a routine anastomotic tool in teaching hospitals . The trial results analyzed consisted of 1666 BAR anastomoses performed in 1360 patients from March 1989 to May 1996 in the upper ( 1042 anastomoses ) and lower ( 624 anastomoses ) gastrointestinal ( GI ) tract . Only patients selected for elective procedures and having previously undergone ortho grade bowel cleansing were entered into the trial . In the upper GI tract six anastomoses ( 0.58 % ) developed clinical ly relevant and radiologically detectable leaks with indications for reoperation . In the lower GI tract 42 ( 6.73 % ) anastomoses showed a radiologically detectable leak with clinical manifestations in 28 cases ( 4.48 % ) . Reoperation was performed in 18 cases ( 2.80 % ) . The overall leakage rate with clinical relevance was 2.04 % . Three gastrojejunostomy episodes of bleeding were observed ( 0.18 % ) at the BAR anastomotic site . During the early postoperative course there was no ileus due to obstruction of a BAR anastomosis . Re introduction of diet after the operation was not delayed . In two centers a follow-up evaluation reported no BAR-related late anastomotic stenoses . There were no intraoperative deaths , but 54 patients died postoperatively . Peritonitis following anastomotic leakage was responsible for postoperative deaths in four cases ; three of them were related to BAR anastomoses . In conclusion , the BAR anastomotic procedure is an established , rapid , simple to learn , highly st and ardized , safe technique with the advantage of no persistent foreign material in the anastomotic region and therefore no induction of stenosis . At present , the application of anastomoses in various segments of the GI tract , from the stomach to the middle third of the rectum , can be recommended Objective The authors compared both the initial and the long-term outcomes of patients undergoing stapled and sutured colorectal anastomoses . Summary Background Data Summary Background Data and stapled large bowel anastomoses are perceived to be equally safe , but concern has been raised about increased rates of tumor recurrence with the use of stapling instruments . Methods The outcome of patients with sutured and stapled colorectal anastomoses were compared in a prospect i ve , multicenter , r and omized study . Factors affecting long-term outcomes were assessed by both univariate and multivariate analysis . Results Results hundred thirty-two patients were recruited . There was a significant increase in radiologic leakage in the sutured group ( 14.4 % vs. 5.2 % , p < 0.05 ) , but there was no difference in clinical anastomotic leak rates , morbidity , or postoperative mortality . Tumor recurrence and cancer-specific mortality were higher in the sutured patients ( 7.5 % and 6.7 % , respectively ) and in patients with anastomotic leaks . Conclusions Conclusions study shows that suturing or stapling are equally safe in large bowel surgery . However , it also shows a long-term benefit of stapling in colorectal cancer patients OBJECTIVE To find out if there were any differences in postoperative complications and anastomotic leak rate between sutured and stapled anastomoses after bowel resection in patients exposed to the same preoperative management programme . DESIGN Prospect i ve observational non-r and omised study . SETTING Colorectal unit , Sweden . PATIENTS Between 1996 and 2000 bowel resections with anastomosis were done for 42 consecutive patients with Crohn 's disease . 20 patients had their anastomoses sutured ( sutured group ) and 22 had their anastomosis stapled ( stapled group ) over two successive periods . MAIN OUTCOME MEASURES Postoperative complications and anastomotic leak rate . RESULTS None of the patients were on immunosuppressive treatment and about half in each group had had several weeks of preoperative enteral nutrition . No anastomotic-related complications and few other postoperative complications were noted , irrespective of the anastomotic technique used . CONCLUSION A strategy to operate on Crohn patients without steroids and , if indicated , treated preoperatively with enteral nutrition and percutaneous drainage of abscesses result ed in no anastomotic leaks and few postoperative complications . These results were independent of the anastomotic technique used INTRODUCTION Although intestinal anastomoses are mainly made by staplers , manual anastomoses are still in use worldwide . In previous studies , single layer anastomosis has shown better results compared to double layer techniques . PURPOSE To test experimentally some aspects of three different single layer anastomotic techniques in order to identify advantages and disadvantages of each . MATERIAL AND METHODS The study was done on Sprague Dawley rats . Animals were r and omly divided into four groups . Three experimental groups consisted of 21 animals each , and the fourth sham group contained 10 animals . By 7 animals of each group were sacrificed on the 4th and the rest of 14 animals on the 7th postoperative day . In all groups the resected distal part of the colon was anastomosed using Halsted , Gambee and Gambee-Halsted technique . To evaluate each specific technique the following were used : postoperative complication frequency , biomechanical measurements , adhesion density , condition of intestinal lumen and histological parameters of the healing process . RESULTS The complication frequency was not significantly different between the tested techniques . The average bursting pressure and tensile strength were higher on both the 4th and 7th postoperative days with the Gambee technique . In the colon segments removed on the 4th postoperative day 97 % of pressure induced ruptures occurred in the anastomotic line , whereas on the 7th postoperative day 76 % of ruptures occurred about 1 cm distal to the anastomotic line . CONCLUSION The Gambee technique had significantly better biomechanical and histological results compare to the other two anastomotic techniques . Adhesion density was significantly lower in the control group ( p<0.001 ) 272 patients underwent r and omly 133 h and sewn anastomosis and 139 stapled anastomosis ( 159 proximal and 119 distal ) after elective colorectal resection for 194 carcinomas , and 78 sigmoid diverticulosis and benign tumors . Both groups were comparable with regard to mortality ( 3.3 p. cent ) , wound abcesses ( 3 p. cent ) extra abdominal post operative complications ( 20 p. cent ) . There were however more reoperations in the stapled group ( 10 versus 6 ) , and also more low intestinal anastomotic bleeding ( 9 versus 5 ) . Stapled anastomosis were associated with less clinical fistulas ( 8 p. cent versus 12 p. cent ) and only after low colorectal anastomosis ( 9 p. cent versus 20 p. cent ) . Stapling devices decrease the duration of the anastomosis by 8 mn , but this gained time does not influence the total duration of the operation . These advantages must be weighed against the risks inherent to their uses , mishaps ( 14 p. cent ) , hemorrhages ( 6.5 p. cent ) , strictures ( 8 p. cent ) , and their higher cost ( 15 times as much ) In a r and omized prospect i ve clinical trial one layer and two layer techniques have been compared in 92 patients undergoing colorectal anastomosis . The results were assessed radiologically by barium studies on the tenth postoperative day . There was no significant difference in the incidence of anastomotic breakdown with either technique when the anastomosis was performed above the pelvic peritoneal reflection . When the anastomosis was situated below the pelvic peritoneum the incidence of dehiscence was significantly greater when a two layer technique was used BACKGROUND Although used widely for supraperitoneal anastomoses , circular stapled anastomoses have never been proved better than h and -sewn anastomoses . In the one prospect i ve controlled trial that studied these anastomoses specifically , the only significant difference found was that there were more clinical ly obvious leakages with the circular stapled variety , but not in the overall clinical and roentgenologic leakage rates . METHODS One hundred fifty-nine consecutive patients ( 88 men and 71 women , mean age 65.8 + /- 12.1 years ) were r and omized to undergo h and -sewn ( n = 74 ) or circular stapled ( n = 85 ) supraperitoneal colorectal anastomosis after left colectomy . RESULTS Patient demographics were similar in both groups . Overall mortality was 1.3 % ( 2 of 159 ; one in each group ) . No statistically significant difference ( NS ) was found in the rate of early complications , including anastomotic leakage ( 4 of 74 versus 6 of 85 ) in the h and -sewn and stapled anastomoses , respectively ) . Mishaps ( n = 10 ) and hemorrhage ( n = 5 ) occurred in the stapled group only . Stapled anastomoses took an average of 8 minutes less to perform ( p < 0.001 ) , but this time gain did not significantly influence the overall duration of operation ( identical median times ) . The median duration of hospitalization was 13 and 14 days , respectively ( NS ) . At 8 months there were 2 of 74 strictures in the h and -sewn group and 4 of 85 strictures in the stapled group ( NS ) . CONCLUSIONS According to these results , there seems to be no advantage of routine or regular use of stapling instruments for supraperitoneal colorectal anastomosis Anastomotic leakage is a major complication of rectal cancer surgery . The aim of this study was to investigate risk factors associated with symptomatic anastomotic leakage after total mesorectal excision ( TME ) The aim of this retrospective non‐r and omized study was to evaluate the short‐term functional outcome following elective resectional surgery for complicated sigmoid diverticular disease , and to compare results of patients having h and ‐sewn or stapled end‐to‐end colonic anastomosis to the proximal rectum The merits of stapled versus h and sewn anastomosis were evaluated in a prospect i ve r and omized study of 60 patients undergoing resection for rectal cancer . The analysed factors included the time required for construction of anastomosis , post operative complications , local recurrence , disease free state and survival . H and sewn anastomosis was performed in two layers with 3/0 silk in 30 cases and the stapled anastomosis with EEA staplers in 30 cases . The anastomosis time averaged 24 minutes in the suture group and 16 minutes in the stapling group . Five post-operative complications occurred in each group . Six patients of the h and sewn group developed local recurrence as a first sign of treatment failure compared to four patients in the stapled group .
Output:
| Results show that , for many aspects of the h and -sewn colorectal anastomosis technique , evidence is lacking .
A single-layer continuous technique using inverting sutures with slowly absorbable monofilament material seems preferable .
However , in contrast to stapled and compression colorectal anastomoses , the technique for h and -sewn colorectal anastomoses is nonst and ardized with regard to intersuture distance , suture distance to the anastomotic edge , and tension on the suture . |
MS210810 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
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Input: Topical silicone gel sheeting and intralesional steroids are the only evidence -based recommendable forms of treatment to control the quality of a scar . The advantages and disadvantages of both are well known . This study was undertaken to verify the efficacy of a new topical silicone treatment : a self-drying spreadable gel that needs no means of fixation and can not be seen because of complete transparency . Fresh surgical scars treated with the tested product showed significantly better outcomes than those untreated in a prospect i ve trial involving a group of 160 patients . Patient compliance was particularly good , especially for scars on exposed areas such as the face , where the traditional gel sheeting is frequently discontinued at an early stage by patients who object to its visibility . The results of the self-drying silicone gel have indeed been satisfactory . Considering the effective results obtained and the good patient compliance , the authors currently rate this concept of treatment as the first choice for preventing hypertrophy of recent scars Purpose The purpose of this study was to determine if the use of antibiotic-impregnated fibrin sealant ( AFS ) was effective in preventing surgical site infections ( SSI ) associated with spinal instrumentation . Methods In a preliminary study , five pieces of vancomycin-impregnated fibrin sealant , five nuts that were not treated with the sealant , and five nuts that were treated with the sealant were subjected to agar diffusion testing . In a clinical study , the rates of deep SSI were compared between 188 patients who underwent procedures involving spinal instrumentation without AFS ( group 1 ) and 196 patients who underwent procedures involving spinal instrumentation with AFS ( group 2 ) . Results All five pieces of vancomycin-impregnated fibrin sealant and the five nuts treated with the sealant exhibited antimicrobial efficacy , while the five untreated nuts did not exhibit antimicrobial efficacy in the agar diffusion test . In the clinical study , 11 ( 5.8 % ) of the 188 patients in group 1 acquired a deep SSI , while none ( 0 % ) of the 196 patients in group 2 acquired a deep SSI . Conclusion The present study demonstrated that the application of AFS to spinal instrumentation yielded good clinical outcomes in terms of the prevention of postoperative spinal infections . It is hoped that limiting AFS use to patients requiring spinal instrumentation and those with risk factors for SSI will reduce the overall costs while preventing SSIs This study reports the results of a prospect i ve r and omised controlled trial that compared three non-adherent wound dressings applied to h and surgery wounds . Paraffin-impregnated gauze ( Jelonet ) was compared with a cellulose , acetate fibre dressing coated with a petrolatum emulsion ( Adaptic ) and a polyamide net dressing impregnated with silicone gel ( Mepitel ) . The dressings were assessed for their ease of application and removal , pain on removal and wound appearance . Results from 99 patients were available for analysis . Adaptic was significantly easier to remove ( p < 0.01 ) , required less soaking ( p < 0.05 ) , was less painful to remove ( p < 0.05 ) and caused less wound maceration ( p < 0.05 ) than Jelonet , but was significantly more difficult to apply ( p < 0.05 ) . Mepitel was also easier to remove but this did not reach statistical significance . It was also more difficult to apply than Jelonet ( p < 0.05 ) . We recommend that Adaptic should be used routinely as the non-adherent dressing for incisions or traumatic wounds on the h and . The slight increased difficulty in applying the dressing is outweighed by the major advantages associated with its removal BACKGROUND Topical 2-octylcyanoacrylate tissue adhesive is an alternative to traditional devices for closing short surgical incisions . METHODS An open-label , r and omized study compared a new high-viscosity formulation of 2-octylcyanoacrylate with commercially available devices , including low-viscosity 2-octylcyanoacrylate , for epidermal closure of incisions > or = 4 cm requiring subcutaneous and /or deep-dermal suturing . RESULTS Of patients with 1 to 3 wounds , 106 were treated with high-viscosity 2-octylcyanoacrylate and 103 with commercially available devices . The day-10 rates of healing by wound were 96 % and 97 % for study versus control treatment and 97 % and 95 % for new and old 2-octylcyanoacrylate formulations versus other controls , respectively . Day-10 infection rates by wound were 4 of 145 versus 7 of 131 for study versus control treatment and 6 of 207 and 5 of 69 for new and old 2-octylcyanoacrylate versus other controls , respectively . CONCLUSIONS The new tissue adhesive formulation provides epidermal wound closure equivalent to commercially available devices with a trend to decreased incidence of wound infection Forty-five surgical wounds were closed by suture technic and then treated with either a polyethylene oxide gel ( POG ) dressing or a povidone-iodine-impregnated polyethylene oxide gel ( PVPI-POG ) dressing . In the control group with the POG dressing alone , three wound infections , representing 25 % of those patients , were encountered . In the PVPI-POG dressing group no wound infections were encountered . Wound healing , in terms of reduced inflammation and faster epidermal approximation , appeared better in the PVPI-POG dressing group The aim of this study was to assess the feasibility of using Leptospermum honey in a r and omised trial to reduce the incidence of wound infection after microvascular free tissue reconstruction for cancer of the head and neck . During the one-year study period 70 consecutive patients were admitted to the regional maxillofacial ward for free tissue reconstruction . Of these , 56 ( 80 % ) consented to be r and omised and 49 ( 70 % ) were actually r and omised , 25 into the honey dressings group , and 24 into the conventional dressings group ( control ) . Six patients were missed when consent was required , 8 did not consent , and 7 who had given consent were missed at the r and omisation stage in theatre . Results of wound swabs were positive in 36 % of the honey group and 38 % of the control group . Methicillin-resistant Staphylococcus aureus ( MRSA ) was found in 28 % and 25 % , respectively . Of these , 38 % were deemed to require intervention . Honey dressings were acceptable to both patients and nurses . There was a reduction ( p<0.05 ) in duration of hospital stay in the honey group ( median 12 days , IQR 10 - 21 ) compared with the control ( median 18 days , IQR 13 - 28 ) . The cost of st and ard and honey dressings was similar . This feasibility study has shown that a r and omised controlled trial ( RCT ) is possible and that several hundreds of patients would be required to show a clinical benefit for honey . Further research is needed to confirm a shorter duration of hospital admission and if so , whether this is due to more rapid healing Purpose We prospect ively compared two types of dressing ( conventional gauze-based versus absorbing hydrofibre ) after primary total hip ( THA ) or knee ( TKA ) arthroplasties . Methods Eighty c and i date s for THA ( n = 40 ) or TKA ( s = 40 ) were r and omized : gauze-based versus hydrofibre absorbing ( Aquacel ® , ConvaTec ) . The two groups were comparable at baseline . Results There was a statistically significant decrease of dressing changes in the hydrofibre group ( p = 0.0006 ) . Two patients from the conventional group presented minor wound complications . Nurses ’ satisfaction was significantly higher in the hydrofibre group considering the adherence ( p = 0.04 ) and flexibility ( p = 0.03 ) . Patients experienced a higher satisfaction with respect to ease of movement ( p = 0.01 ) in the hydrofibre group . The cosmetic appearance of the scars six weeks after surgery was found to be similar between groups . Conclusions Our findings support an overall improved comfort for the patients and the medical staff by using hydrofibre dressings after primary THA and TKA . The reduction of required dressing changes was observed also A blinded r and omized clinical trial was undertaken to evaluate the effect of applying ointment to a wound before occlusive dressing , in comparison with no ointment or sterile paraffin OBJECTIVE To compare the performance of Hydrofiber and alginate dressings used in the treatment of primary hip arthroplasty wounds . METHOD Patients were r and omised into one of two groups , receiving either a Hydrofiber or an alginate dressing . Outcome measures , assessed by daily observations , included skin damage ( erythema , blisters and skin injuries ) and the dressing 's ability to h and le exu date s. Photos of the dressing and the skin area around wounds were taken . Patients noted skin problems , discomfort at mobilisation and pain at dressing removal . RESULTS In the alginate group , there were fewer blisters in the wound area compared with the Hydrofiber group ( 7 % versus 18 % , p=0.03 ) . During dressing removal , fewer patients in the alginate group reported pain than patients in the Hydrofiber group ( 2.1 % versus 15 % , p=0.01 ) CONCLUSION We recommend the use of both dressings following total hip arthroplasty , although the alginate would be our first choice , as we found fewer blisters when using alginate dressings as opposed to Hydrofiber dressings . CONFLICT OF INTEREST None BACKGROUND : Patients who undergo colorectal surgery have up to a 30 % chance of developing a surgical site infection postoperatively . Silverlon is a silver nylon dressing design ed to prevent surgical site infections , but only anecdotal evidence has previously supported its efficacy . OBJECTIVE : The aim of this study was to evaluate the effect of silver nylon dressings in patients undergoing colorectal surgery . DESIGN : We performed a prospect i ve , r and omized , controlled trial comparing a silver nylon dressing with gauze dressings in patients undergoing elective colorectal surgery . SETTING : The study was performed at a university-based , tertiary referral center . PATIENTS : We studied patients undergoing elective colorectal surgery with an abdominal skin incision of at least 3 cm . INTERVENTION : Patients were r and omly assigned to receive either a silver nylon or a gauze dressing . MAIN OUTCOME MEASURES : The primary end point was surgical site infection occurring within 30 days of surgery . RESULTS : One hundred ten patients were enrolled in the study and were r and omly assigned to 1 of 2 treatment groups . After a 30-day follow-up period , the incidence of surgical site infection was lower in the silver nylon group compared with the control group ( 13 % vs 33 % , P = .011 ) . Twenty-five patients in the study developed superficial surgical site infections , 5 in the silver nylon group and 14 in the control group ( P = .021 ) . Two patients in the study group developed deep wound infections compared with 4 in the control group ( P = .438 ) . Multivariate analysis revealed that patients in the control group had a 3-fold increase in risk of infection compared with patients in the silver nylon group ( P = .013 ) . LIMITATIONS : A limitation of this study is that the members of the surgical team were not blinded to the treatment groups . CONCLUSION : Silver nylon is safe and effective in preventing surgical site infection following colorectal surgery BACKGROUND 4 methods are used in pediatric laparoscopic surgery to close trocar wounds . While tissue adhesives or adhesive strips have been shown to produce fewer wound complications and a better cosmetic result compared to trans- or only subcutaneous sutures , the choice of technique is still often based on the surgeon 's personal experience . Thus , the objective of this trial was to assess the impact of tissue adhesives ( Dermabond ™ ) compared to adhesive strips ( Steri-Strip ™ ) on potential complications of wound healing , wound pain , cosmetic outcome , and patient satisfaction after laparoscopic appendectomy in children . METHODS 49 patients undergoing laparoscopic appendectomy were enrolled in this prospect i ve r and omized trial . In every patient , two 5-mm and one 10-mm port-site incision was closed either with Dermabond ™ or Steri-Strip ™ after placing subcuticular absorbable sutures ( 4 - 0 Vicryl ™ ) . Postoperative complications , pain , and patient satisfaction with scars were evaluated at follow-up on day 10 and day 90 after the operation using a question naire and a visual analogue scale ( VAS ) . Photographs of scars taken on day 90 were evaluated on a VAS by 2 pediatric surgeons blinded to the closure method used . RESULTS According to the surgeons ' evaluation of the cosmetic outcome , a significant difference between the 2 groups with regard to the cosmetic score was found on day 90 of follow-up , favoring Steri-Strip ™ wound closure ( p < 0.05 ) . On day 10 and 90 there were no statistical differences between the 2 methods as regards the result of patient evaluations ( p > 0.05 ) . Only one wound infection ( 4 % ) was observed in the Steri-Strip ™ group ( n = 25 ) on day 10 . At follow-up on day 90
Output:
| It is uncertain whether covering surgical wounds healing by primary intention with wound dressings reduces the risk of SSI , or whether any particular wound dressing is more effective than others in reducing the risk of SSI , improving scarring , reducing pain , improving acceptability to patients , or is easier to remove . |
MS210811 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: BACKGROUND MicroRNAs ( miRNAs ) can be used as prognostic biomarkers in many types of cancer . We aim ed to identify miRNAs that were prognostic in patients with nasopharyngeal carcinoma . METHODS We retrospectively analysed miRNA expression profiles in 312 paraffin-embedded specimens of nasopharyngeal carcinoma from Sun Yat-sen University Cancer Center ( Guangzhou , China ) and 18 specimens of non-cancer nasopharyngitis . Using an 873 probe microarray , we assessed associations between miRNA signatures and clinical outcome in a r and omly selected 156 sample s ( training set ) and vali date d findings in the remaining 156 sample s ( internal validation set ) . We confirmed the miRNAs signature using quantitative RT-PCR analysis in 156 sample s from a second r and omisation of the 312 sample s , and vali date d the miRNA signature in 153 sample s from the West China Hospital of Sichuan University in Chengdu , China ( independent set ) . We used the Kaplan-Meier method and log-rank tests to estimate correlations of the miRNA signature with disease-free survival ( DFS ) , distant metastasis-free survival ( DMFS ) , and overall survival . FINDINGS 41 miRNAs were differentially expressed between nasopharyngeal carcinoma and non-cancer nasopharyngitis tissues . A signature of five miRNAs , each significantly associated with DFS , was identified in the training set . We calculated a risk score from the signature and classified patients as high risk or low risk . Compared with patients with low-risk scores , patients with high risk scores in the training set had shorter DFS ( hazard ratio [ HR ] 2·73 , 95 % CI 1·46 - 5·11 ; p=0·0019 ) , DMFS ( 3·48 , 1·57 - 7·75 ; p=0·0020 ) , and overall survival ( 2·48 , 1·24 - 4·96 ; p=0·010 ) . We noted equivalent findings in the internal validation set for DFS ( 2·47 , 1·32 - 4·61 ; p=0·0052 ) , DMFS ( 2·28 , 1·09 - 4·80 ; p=0·030 ) , and overall survival ( 2·87 , 1·38 - 5·96 ; p=0·0051 ) and in the independent set for DFS ( 3·16 , 1·65 - 6·04 ; p=0·0011 ) , DMFS ( 2·39 , 1·05 - 5·42 ; p=0·037 ) , and overall survival ( 3·07 , 1·34 - 7·01 ; p=0·0082 ) . The five-miRNA signature was an independent prognostic factor . A combination of this signature and TNM stage had better prognostic value than did TNM stage alone in the training set ( area under receiver operating characteristics 0·68 [ 95 % CI 0·60 - 0·76 ] vs 0·60 [ 0·52 - 0·67 ] ; p=0·013 ) , the internal validation set ( 0·70 [ 0·61 - 0·78 ] vs 0·61 [ 0·54 - 0·68 ] ; p=0·012 ) , and the independent set ( 0·70 [ 0·62 - 0·78 ] vs 0·63 [ 0·56 - 0·69 ] ; p=0·032 ) . INTERPRETATION Identification of patients with the five-miRNA signature might add prognostic value to the TNM staging system and inform treatment decisions for patients at high risk of progression . FUNDING Science Foundation of Chinese Ministry of Health , National Natural Science Foundation of China , Pearl River Scholar Funded Scheme , Guangdong Key Scientific and Technological Innovation Program , Guangdong Natural Science Foundation , Fundamental Research Funds for the Central Universities Recent findings have reported that human serum microRNAs ( miRNAs ) can be used as prognostic biomarkers in various cancers . We aim ed to explore the prognostic value of serum miRNAs in nasopharyngeal carcinoma ( NPC ) patients . The level of serum miRNA was retrospectively analyzed in 512 NPC patients recruited between January 2001 and December 2006 . In the discovery stage , a microarray followed by reverse transcription‐quantitative polymerase chain reaction was used to identify differentially altered miRNAs in eight patients with shorter survival and eight patients with longer survival who were well matched by age , sex and clinical stage . The identified serum miRNAs were then vali date d in all 512 sample s , which were r and omly divided into a training set and a validation set . Four serum miRNAs ( miR‐22 , miR‐572 , miR‐638 and miR‐1234 ) were found to be differentially altered and were used to construct a miRNA signature . Risk scores were calculated to classify the patients into high‐ or low‐risk groups . Patients with high‐risk scores had poorer overall survival [ hazard ratio ( HR ) , 2.54 ; 95 % confidence interval ( CI ) , 1.57–4.12 ; p < 0.001 ] and distant metastasis‐free survival ( HR , 3.28 ; 95 % CI , 1.82–5.94 ; p < 0.001 ) than those with low‐risk scores in the training set ; these results were confirmed in the validation and combined sets . The miRNA signature and TNM stage were independent prognostic factors . The combination of the miRNA signature and TNM stage had a better prognostic value than the TNM stage or miRNA signature alone . The four‐serum miRNA signature may add prognostic value to the TNM staging system and provide information for personalized therapy in NPC Dysregulation of miRNA expression plays an important role in cancer development , and circulating miRNAs are biomarkers of several cancers . We explored whether the miRNAs in plasma could be useful clinical biomarkers for multiple myeloma . miRNA microarray was conducted to identify elevation of four miRNAs and reduced levels of eight miRNAs in the plasma of nine multiple myeloma patients and seven healthy controls . Increased miR-483 - 5p levels and decreased miR-20a were further vali date d in the plasma of 40 myeloma patients and 20 healthy controls using TaqMan quantitative real-time PCR . Receiver operating characteristic ( ROC ) analysis revealed that miR-483 - 5p and miR-20a had considerable diagnostic accuracy , yielding the areas under the ROC curve of 0.745 ( sensitivity 58 % , specificity 90 % ) and 0.74 ( sensitivity 63 % , specificity 85 % ) , respectively . Plasma levels of miR-483 - 5p were associated with ISS staging . Within 14 months of diagnosis , the median progression-free survival of patients with high levels of plasma miR-483 - 5p was 15 months , in comparison with 21 months for patients with low levels of plasma miR-483 - 5p ( p = 0.025 ) . However , miR-20a levels were not correlated with progression-free survival ( p > 0.05 ) . miR-483 - 5p has the potential to be a predictor of myeloma survival
Output:
| Conclusion To our knowledge , this is the first comprehensive systematic review and meta- analysis that examines the prognostic role of circulating miRNAs from blood in head and neck cancer patients .
The combined effect estimates a HR across multiple studies and also supports the previous individual findings that an alteration in miRNA expression is highly associated with poor prognosis . |
MS210812 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: AIMS To evaluate the prevalence , associated risk factors and the impact on health related quality of life ( HRQoL ) of overactive bladder ( OAB ) among men and women aged ≥18 years in China , using the 2002 International Continence Society ( ICS ) definition . METHODS The population -based , cross-sectional field survey was conducted between June 2009 and February 2010 in China using question naires regarding demographics , the prevalence and the HRQoL. A stratified r and om sample of men and women aged ≥18 years residing in China who were representative of the general population s was selected for demographic question naires first . The individuals meeting the diagnostic criteria of OAB ( urgency occurring once a week or more ) were further interviewed through King 's health question naire ( KHQ ) to estimate the impact of OAB on HRQoL. Data were stratified by city , age cohort , and gender . RESULTS A total of 21,513 individuals were contacted to participate in the survey , and 14,844 individuals ( 7,614 men , 7,230 women ) with complete data were included in this study . The prevalence of OAB was 6.0 % , OAB(dry ) 4.2 % , and OAB(wet ) 1.8 % . The prevalence varied slightly among six geographical regions of China . Nocturia was the most common OAB symptom besides urgency . Advanced age , higher BMI , lower education level , manual worker , alcohol consumption , and married were associated risk factors for OAB in men . Advanced age , lower education level , manual worker , alcohol consumption , married , menopause , more parities and vaginal delivery were potential risk factors for OAB in women . The symptoms of OAB had a detrimental effect on HRQoL , especially on Coping Measures , Sleep/Energy , General Health Perceptions , and Severity of Urinary Problems . CONCLUSIONS The prevalence of OAB in China is lower than that of most previous reports . Many known risk factors are associated with OAB . The symptoms of OAB have a detrimental effect on HRQoL. Efforts need to be made to improve public and professional education about the problems of OAB and decrease the unnecessary burden of this condition Study Type – Symptom prevalence ( prospect i ve cohort BACKGROUND Inside-out transobturator tape ( tension-free vaginal tape-obturator [ TVT-O ] ) is currently one of the most effective and popular procedures for the surgical treatment of female stress urinary incontinence ( SUI ) . However , data reporting long-term outcomes are lacking . OBJECTIVE To assess the efficacy and safety of TVT-O 10 yr after implantation for the treatment of female pure SUI . DESIGN , SETTING , AND PARTICIPANTS A multicenter , prospect i ve study was conducted in five tertiary referral centers in three countries . All consecutive women with urodynamically proven pure SUI treated by TVT-O were included . Patients with mixed incontinence and /or anatomic evidence of pelvic organ prolapse were excluded . INTERVENTION TVT-O implantation . OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS Data regarding subjective outcomes ( International Consultation on Incontinence Question naire-Short Form , Patient Global Impression of Improvement , and patient satisfaction scores ) , objective cure ( stress test ) rates , and adverse events were collected during follow-up . Univariable analysis was performed to investigate outcomes . RESULTS AND LIMITATIONS One hundred sixty-eight women had TVT-O implantation . At 10-yr follow-up , 160 patients ( 95 % ) were available for the evaluation . We did not find any significant change of the surgical outcomes during this time . At 10 yr after surgery , 155 of 160 patients ( 97 % ) declared themselves cured ( p=0.7 ) . Similarly , at 10-yr evaluation , 148 of 160 patients ( 92 % ) were objective ly cured . No significant deterioration of objective cure rates was observed over time ( p=0.4 ) . The history of failure of previous anti-incontinence procedures ( hazard ratio : 5.34 ; 95 % CI , 2.61 - 11.9 ; p=0.009 ) was the only predictor of recurrence of SUI . The onset of de novo overactive bladder was reported by 23 of 160 patients ( 14 % ) at 10-yr follow-up . No other late complications were reported . CONCLUSIONS The 10-yr results of this study showed that TVT-O is a highly effective and safe option for the treatment of SUI . PATIENT SUMMARY At long-term follow up , tension-free vaginal tape-obturator is highly effective and safe for the treatment of stress urinary incontinence BACKGROUND No studies have been published comparing the U- and H-type methods of the TVT SECUR ( TVT-S ) procedure . OBJECTIVE Our aim was to compare the efficacy and safety of the two types of TVT-S for female stress urinary incontinence ( SUI ) . DESIGN , SETTING , AND PARTICIPANTS Women with urodynamic SUI were enrolled in this 12-mo multicenter r and omized study . INTERVENTION Subjects were r and omly allocated to either the U- or H-type method of TVT-S. MEASUREMENTS Pre- and postoperative evaluations included a st and ing stress test , the S and vik question naire , the Incontinence Quality of Life ( I-QOL ) question naire , and the International Consultation on Incontinence Question naire-Female Lower Urinary Tract Symptoms ( ICIQ-FLUTS ) . Patients ' satisfaction and complications were evaluated . Objective and subjective cures were defined as no leakage on the stress test and responses on the S and vik question naire , respectively . We compared the surgical outcomes between the two methods . RESULTS AND LIMITATIONS Of 285 women , 144 had the U-type method and 141 had the H-type method . Objective cure rates were 87.5 % for the U-type method and 80.1 % for the H-type method ( p=0.091 ) . Subjective cure rates were 77.1 % for the U-type method and 75.7 % for the H-type method ( p=0.786 ) . Improvement in I-QOL and domain scores of the ICIQ-FLUTS ( filling and incontinence sum , QOL score ) , and patients ' satisfaction favored the U-type method . There were three cases of intraoperative vaginal wall perforation , one case of increased bleeding , and three cases of temporary postoperative retention . A power calculation was not performed , and some baseline characteristics were not balanced between the two methods . CONCLUSIONS Both methods of TVT-S provided comparable cure rates for female SUI . However , QOL and treatment satisfaction favored the U-type method . TRIAL REGISTRATION The protocol of this study was not registered OBJECTIVE To assess the efficacy and complications associated with use of the TVT SECUR System device with placement of the tape in either a " hammock " or " U " position for management of stress urinary incontinence ( SUI ) . METHODS A prospect i ve study of patients with SUI allocated into one of two groups : " hammock " or " U " tape placement . Preoperative urodynamic results were compared with results at the 6-month and 1-year follow up . Outcome measures were objective cough test assessment and subjective patient responses to a question naire at follow up . RESULTS Of 82 patients included in the study , 43 comprised the " hammock " group and 39 comprised the " U " group . The objective cure rate at 1-year follow up was 62.8 % ( n=27 ) in the " hammock " group and 71.8 % ( n=28 ) in the " U " group . At 1-year follow up , the subjective cure , improvement , and failure rates for the " hammock " group were 60.5 % , 13.9 % , and 25.7 % respectively , and 69.2 % , 12.8 % , and 17.9 % respectively , for the " U " group . CONCLUSION The efficacy of the TVT SECUR System was lower ( < 72 % ) than the cure rates reported for other TVT procedures ; further studies are required Introduction and hypothesisThe aim of this study was to compare the efficacy of the tension-free vaginal tape obturator ( TVT-O ) and single-incision tension-free vaginal tape ( Ajust ™ ) in the treatment of stress urinary incontinence in a r and omized two-arm study with a 1-year follow-up . Methods This single-centre r and omized trial compared the objective and subjective cure rates of TVT-O and Ajust using objective criteria ( cough test ) and subjective criteria ( International Consultation on Incontinence Question naire short form , ICIQ-UI SF ) . The objective cure rate was defined as the number of patients with a negative cough stress test . Subjective cure was defined as no stress leakage of urine after surgery based on the ICIQ-UI SF . The primary outcome was to establish differences in objective and subjective cure rates between the TVT-O and Ajust groups . We also compared postoperative pain profiles using a visual analogue scale ( VAS ) , improvement in quality of life using the ICIQ- UI SF and the Incontinence Quality of Life question naire , and overall satisfaction with the surgical procedure using a VAS and a five-item Likert scale . Inclusion criteria were age over 18 years , signed informed consent , and urodynamic stress urinary incontinence . Following a power calculation , 50 patients were enrolled into each group ( Ajust and TVT-O ) . Results The mean follow-up after surgery was 445 days ( SD 157.6 days ) in the TVT-O group and 451.8 days ( SD 127.6 days ) in the Ajust group ( p = 76.6 % ) . At 1 year , 47 patients were evaluated in the TVT-O group and 49 in the Ajust group . No differences in subjective cure rates or objective cure rates were observed . In the Ajust and TVT-O groups , the rates for no subjective stress leakage were 89.8 % and 91.5 % , respectively ( p = 1.0 , OR 1.22 , 95 % CI 0.24 – 6.58 ) , and the rates for a negative stress test were 89.8 % and 87.2 % , respectively ( p = 0.76 , OR 0.77 , 95 % CI 0.17 – 3.32 ) . In the Ajust group two patients reported de novo pain during sexual intercourse . Conclusions After a 1-year-follow-up , no significant differences were found with regard to subjective and objective outcomes between the single-incision tape Ajust and Background : Food and Drug Administration announcements have highlighted the st and ard rate of mesh-related complications . We aim ed to report the short-term results and complications of tension-free polypropylene mesh ( PROSIMA ™ ) surgical repair of pelvic organ prolapse ( POP ) using the st and ard category ( C ) , timing ( T ) , and site ( S ) classification system . Methods : A prospect i ve cohort study of 48 patients who underwent PROSIMA ™ mesh kit-related surgical repairs were followed for two years at Peking Union Medical College Hospital . Recurrence was defined as symptomatic POP quantification ( POP-Q ) Stage II or higher ( leading edge ≥ −1 cm ) . The Patient Global Impression of Change Question naire , the Chinese version of the Pelvic Floor Impact Question naire short-form-7 and POP/Urinary Incontinence Sexual Question naire short-form-12 were used to evaluate the self-perception and sexual function of each patient . Mesh-related complications conformed to the International Urogynecological Association/International Continence Society joint terminology . The paired- sample t-test , one-way analysis of variance , Fisher 's exact test , Kaplan-Meier survival analysis and log-rank test were used to analyze data . Results : All patients were followed up for ≥12 months ; 30 ( 62.5 % ) patients completed the 24 months study . We observed a 93.8 % ( 45/48 ) positive anatomical outcome rate at 12 months and 90.0 % ( 27/30 ) at 24 months . Recurrence most frequently involved the anterior compartment ( P < 0.05 ) . Pelvic symptoms improved significantly from baseline ( P < 0.05 ) , although the patients ’ impressions of change and sexual function were not satisfying . Vaginal complication was the main complication observed ( 35.4 % , 17/48 ) . The survival analysis did not identify any relationship between vaginal complication and anatomical recurrent prolapse ( POP-Q ≥ Stage II ) ( P = 0.653 ) . Conclusions : Tension-free polypropylene mesh (PROSIMA ™ )-related surgical repair of POP has better short-term anatomical outcomes at the apical and posterior compartments , but a low patient satisfaction rate . The mesh complications were not the definitive cause of recurrence Introduction and hypothesis Data on Altis ® ( Coloplast ) , a new adjustable single-incision sling ( SIS ) procedure for the treatment of female stress urinary incontinence ( SUI ) , are scarce . Our aim was to evaluate the efficacy and complication rates of this procedure . Methods In this prospect i ve observational study , a total of 52 women with SUI were implanted with an Altis ® sling in an ambulatory setting . Before and after intervention ( 3 , 6 , and 12 months ) , women completed the International Consultation on Incontinence Question naire Short Form (
Output:
| There is not enough evidence to support differences in the effects of the different types of sling with regard to this particular postoperative complication |
MS210813 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: AIM The aim of the present prospect i ve study was to evaluate the long-term outcome of implants placed simultaneously with guided bone regeneration ( GBR ) using resorbable and non-resorbable membranes . MATERIAL S AND METHODS The original study population consisted of 72 patients receiving a total of 265 implants . In all GBR-treated sites , demineralized bovine bone mineral ( DBBM ) was used in combination either with a collagen ( CM ) or an Exp and ed polytetrafluoroethylene ( e-PTFE ) membrane . A total of 112 implants was treated with CM , 41 implants were treated with e-PTFE membranes , and 112 served as a control group because implants were entirely surrounded by bone and did not need any GBR procedures . Clinical and radiographic analyses were performed after a period of 12 - 14 years . RESULTS The median follow-up time was 12.5 years ( range 12 - 14 years ) . A total of 58 patients participated in the present investigation , corresponding to 80.5 % of the original study population . The cumulative implant survival rate at the follow-up examination was 93.2 % . For the control group the cumulative survival rate was 94.6 % , for the CM 91.9 % , and for the e-PTFE 92.6 % . Differences among the groups were not statistically significant . The radiographically determined marginal bone level ( MBL ) amounted to : control 2.36 mm ( SD ) , CM 2.4 mm ( SD ) , e-PTFE 2.53 mm ( SD ) . There is no evidence ( P < 0.2 ) that the slope of bone level over time is different for the three treatment groups . CONCLUSION It is concluded that implants placed simultaneously with GBR procedures using resorbable or non-resorbable membranes reveal a high survival rate ranging from 91.9 % to 92.6 % , therefore it is considered to be a safe and predictable therapy . [ Correction added after online publication 30 November 2012 : the marginal bone level of CM , e-PTFE , and control was corrected to ' control 2.36 mm ( SD ) , CM 2.4 mm ( SD ) , e-PTFE 2.53 mm ( SD ) ' in the Results section ] BACKGROUND Two systematic review s have evaluated the quality of research and reporting of observational studies investigating the prevalence of , the incidence of and the risk factors for peri-implant diseases and of experimental clinical studies evaluating the efficacy of preventive and therapeutic interventions . MATERIAL S AND METHODS For the improvement of the quality of reporting for both observational and experimental studies , the STROBE and the Modified CONSORT recommendations were encouraged . RESULTS To improve the quality of research in peri-implant diseases , the following were recommended : the use of unequivocal case definitions ; the expression of outcomes at the subject rather than the implant level ; the implementation of study validation tools ; the reporting of potential sources of bias ; and the use of appropriate statistical methods . CONCLUSIONS In observational studies , case definitions for peri-implantitis were agreed . For risk factor determination , the progressive use of cross-sectional and case-control studies ( univariate analyses ) , to prospect i ve cohorts ( multilevel modelling for confounding ) , and ultimately to intervention studies were recommended . For preventive and interventional studies of peri-implant disease management , parallel arm RCTs of at least 6-months were encouraged . For studies of non-surgical and surgical management of peri-implantitis , the use of a composite therapeutic end point was advocated . The development of st and ard control therapies was deemed essential PURPOSE The aim of the present r and omized controlled clinical study was to test whether small bony dehiscence defects ( ≤5 mm ) left to heal spontaneously result in the same clinical and radiological outcome as defects treated with guided bone regeneration ( GBR ) . MATERIAL S AND METHODS Twenty-two patients who received at least one implant with a small bony dehiscence defect were enrolled in the study . If the defect height was ≤5 mm , the site was r and omly assigned to either the spontaneous healing ( SH ) group or the GBR group . In the SH group , the defect was left without any treatment . In the GBR group , the defects around the implants were grafted with deproteinized bovine bone mineral ( DBBM ) and covered with a native collagen membrane . Clinical and radiographic measurements were performed 6 months after implant placement with a reentry surgery and at the time of crown insertion and the subsequent follow-up appointments at 3 , 6 , 12 and 18 months after loading . For statistical analyses , the mixed linear model was applied for the clinical and radiographic measurements observed around the implants . Simple comparisons of the location of the measurements in the two independent groups are performed with the Mann-Whitney U-test . In addition , the mixed model assumptions were checked . RESULTS The implant and crown survival rate 18 months after loading was 100 % , revealing no serious biologic or prosthetic complication . The mean changes of the buccal vertical bone height between implant placement and reentry surgery after 6 months revealed a small bone loss of -0.17 ± 1.79 mm ( minimum -4 mm and maximum 2.5 mm ) for the SH group and a bone gain of 1.79 ± 2.24 mm ( minimum of -2.5 mm and maximum of 5 mm ) for the GBR group , respectively ( P = 0.017 ) . Radiographic measurements demonstrated a slight bone loss of -0.39 ± 0.49 mm for the SH group and a stable bone level of 0.02 ± 0.48 mm for GBR group after 18 months . All peri-implant soft tissue parameters revealed healthy tissues with no difference between the two groups . CONCLUSION Small bony dehiscence defects left for spontaneous healing demonstrated high implant survival rates with healthy and stable soft tissues . However , they revealed more vertical bone loss at the buccal aspect 6 months after implant insertion and also more marginal bone loss between crown insertion and 18 months after loading compared to sites treated with GBR OBJECTIVES The aim of this r and omized controlled trial was to assess the 10-year effects of three different augmentation techniques ( augmentation with chin bone , augmentation with chin bone plus a membrane and augmentation with a bone substitute plus a membrane ) for implant-supported restorations in the maxillary aesthetic region regarding clinical and radiographic parameters , and patient-centred outcomes . MATERIAL S AND METHODS Ninety-three patients requesting single tooth replacement and presenting with a horizontal bone deficiency were included . After augmentation , 93 implants were placed . Clinical variables , st and ardized radiographs and photographs and patient question naires were analysed to assess the impact of the various augmentation techniques 1 month ( T1 ) , 12 months ( T12 ) and 120 months ( T120 ) after final crown placement . RESULTS 10-years implant survival was 95.7 % and did not differ between the groups neither were significant differences observed in the other treatment outcomes assessed . Peri-implant bone loss was low , viz . 0.48 ± 1.19 mm ( mesial ) and 0.30 ± 1.24 mm ( distal ) at T120 . Loss of midbuccal marginal gingival level at T120 was 0.32 ± 0.83 mm . Mean overall satisfaction at T120 was 8.6 with 98.6 % of the patients satisfied . CONCLUSIONS Clinical , radiographic , aesthetic and patient centred outcomes were very favourable after 10 years and did not differ between the groups with different bone augmentation techniques OBJECTIVE The aim of this r and omized-controlled clinical trial was to evaluate the long-term outcome of implants placed in bone augmented with a xenogenic bone substitute material and a collagen membrane with or without the addition of recombinant human bone morphogenetic protein-2 ( rhBMP-2 ) . MATERIAL AND METHODS Eleven patients received a total of 34 implants placed into sites exhibiting lateral bone defects . In a split mouth design , the defects were r and omly treated with the graft material and the collagen membrane either with ( test ) or without ( control ) rhBMP-2 . The patients were examined 3 and 5 years after insertion of the prosthetic restoration . Student 's paired t-test was performed to detect differences between the two groups . RESULTS The survival rate at 3 and 5 years was 100 % for both groups . The peri-implant soft tissues were stable and healthy without any difference between the two groups . The prosthetic reevaluation demonstrated four loose prosthetic screws during the first 3 years and seven ceramic chippings after 3 and 5 years . The mean distance between the first bone to implant contact to implant abutment junction at 3 years was 1.37 mm ( test ) , 1.22 mm ( control ) , and 1.38 mm ( test ) , and 1.23 mm ( control ) at 5 years . The difference of < 0.2 mm between test and control implants was not statistically significant . The mean change of the marginal bone level between baseline and 5 years ranged from -0.07 mm ( mesial , test ) , -0.11 mm ( distal , test ) , -0.03 mm ( mesial , control ) , to + 0.13 mm ( distal , control ) . No statistically significant differences were observed between test and control sites . CONCLUSION Implants placed in bone augmented with and without rhBMP-2 revealed excellent clinical and radiological outcomes after 3 and 5 years OBJECTIVES To assess the clinical outcomes of simultaneous guided bone regeneration using native ( CM ) and cross-linked ( VN ) collagen membranes at 8 years . MATERIAL S AND METHODS A total of n = 19 patients ( 19 implants ) were available for the analysis . Each subject had received a simultaneous grafting of dehiscence-type defects using a natural bone mineral ( NBM ) and a r and om allocation to either CM and VN membranes ( submerged healing of 4 months ) . Clinical parameters ( e.g. , bleeding on probing - BOP , probing pocket depth - PD , mucosal recession - MR , clinical attachment level - CAL ) were recorded at 8 years after prosthesis installation . RESULTS At 8 years , CM and VN groups revealed comparable median BOP , PD , MR and CAL values at both vestibular and oral aspects . From 4 to 8 years ( n = 14 patients ) , median CAL at the vestibular aspect improved in both groups ; however , these changes were significantly higher at CM-treated sites ( CM : 0.7 mm vs. VN : 0.5 mm ) . CONCLUSION The clinical long-term outcomes at 8 years were comparable in both VN and CM groups PURPOSE The aim of this r and omized clinical trial was to compare the potential of deproteinized bovine bone added to autologous bone or corticocancellous allograft block with or without the addition of recombinant human platelet-derived growth factor-BB ( rhPDGF-BB ) to regenerate m and ibular atrophic ridges . MATERIAL S AND METHODS TRIAL DESIGN parallel , allocation ratio of 1:1 using a split-mouth model . Eligibility criteria for patients : adult patients ; bilateral atrophic edentulous areas in the posterior area of the m and ible ; a preoperatory cone beam computed tomography scan ; and absence of systemic diseases affecting the bone metabolism . Bone graft intervention for control group consisted of bone chips collected with a scraper mixed with deproteinized bovine bone covered with a resorbable membrane . Bone graft intervention for test group consisted of a corticocancellous allograft block , shaped before surgery , and protected with a collagen membrane . In addition , both groups received rhPDGF-BB or a saline solution as control . As primary outcome quantity , bone variation after a 1-year healing period was considered . A p-value of.05 was considered statistically significant . RESULTS Sixteen patients were enrolled in this trial . A total of 50 implants and 32 bone grafts were placed . All patients concluded the study ( no dropouts ) . Change at 1 year in bone volume was not significantly different between the two groups ( p-value = .25 ) . Effect of treatment in terms of change in bone volume at 1 year was not significant ( p-value = .89 ) when saline solution was used while was at limit of significance when rhPDGF-BB was used ( p-value = .052 ) . After 1 year , all the implants were successfully integrated . CONCLUSIONS The block allograft and the st and ard regenerative procedure showed similar results in terms of regenerated bone volume after 1 year of functional loading . The rhPDGF-BB positively influenced soft-tissue healing OBJECTIVES To investigate the impact of residual defect height ( RDH ) following guided bone regeneration ( GBR ) in dehiscence-type defects on the long-term stability of peri-implant health after a period of 4 years . MATERIAL AND METHODS The RDH values in dehiscence-type defects at titanium implants were clinical ly assessed after 4 months of submerged healing following augmentation using a natural bone mineral ( NBM ) and a r and omized application of either a cross-linked- ( VN ) or a native collagen membrane ( BG ) ( n=12 patients each ) . The RDH values were classified as absent ( 0 mm , control ; n=8 ) ,
Output:
| The results from this systematic review and meta- analysis have shown that lateral ridge augmentation procedures can maintain peri-implant health over time with low mucosal inflammatory changes and a relatively small incidence of peri-implant bone loss |
MS210814 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: BACKGROUND The proliferation marker Ki67 has been suggested as a promising cancer biomarker . As Ki67 needs an exact quantification , this marker is a prototype of a new generation of tissue-based biomarkers . In this study , we have systematic ally evaluated different cut points for Ki67 using three different clinical end points in a large neoadjuvant study cohort . PATIENTS AND METHODS We have evaluated pretherapeutic Ki67 levels by immunohistochemistry in 1166 breast cancer core biopsies from the neoadjuvant GeparTrio trial . We used the st and ardized cutoff-finder algorithm for three end points [ response to neoadjuvant chemotherapy ( pCR ) , disease-free ( DFS ) and overall-survival ( OS ) ] . The analyses were stratified for hormone receptor ( HR ) and HER2 status by molecular subtype radar diagrams ( MSRDs ) . RESULTS A wide range of Ki67 cut points between 3%-94 % ( for pCR ) , 6%-46 % ( for DFS ) and 4%-58 % ( for OS ) were significant . The three groups of Ki67 ≤ 15 % versus 15.1%-35 % versus > 35 % had pCR-rates of 4.2 % , 12.8 % , and 29.0 % ( P < 0.0005 ) , this effect was also present in six of eight molecular subtypes . In MSRD , Ki67 was significantly linked to prognosis in uni- and multivariate analysis in the complete cohort and in HR-positive , but not triple-negative tumors . CONCLUSIONS Ki67 is a significant predictive and prognostic marker over a wide range of cut points suggesting that data -derived cut point optimization might not be possible . Ki67 could be used as a continuous marker ; in addition , the scientific community could define st and ardized cut points for Ki67 . Our analysis explains the variability observed for Ki67 cut points in previous studies ; however , this should not be seen as weakness , but as strength of this marker . MSRDs are an easy new approach for visualization of biomarker effects on outcome across molecular subtypes in breast cancer . The experience with Ki67 could provide important information regarding the development and implementation of other quantitative biomarkers Background Recent studies have indicated that response to chemotherapy and the prognostic impact of a pathologic complete response ( pCR ) after neoadjuvant chemotherapy differ among breast cancer subtypes . Methods Women with Stage I to III breast cancer treated with anthracycline and taxane-based neoadjuvant chemotherapy ( four cycles of docetaxel every 3 weeks followed by four cycles of FEC every 3 weeks ) between 2006 and 2011 were retrospectively analyzed . Trastuzumab was concurrently added to docetaxel for HER2-positive breast cancer . Expression of estrogen receptor ( ER ) , progesterone receptor ( PgR ) , HER2 , and Ki67 was examined by immunohistochemistry in pre- and post-treatment specimens . Predictive factors for neoadjuvant chemotherapy and prognosis were analyzed by breast cancer subtype . Results Of 64 patients , 30 ( 47 % ) were ER-positive ( ER+ ) HER2-negative ( HER2− ) , including eight as luminal A ( Ki67 labeling index ( LI ) < 14 % ) and 22 as luminal B ( Ki67 LI ≥ 14 % ) subtypes , 11 ( 17 % ) were ER+ HER2-positive ( HER2 + ) , 12 ( 19 % ) were ER-negative ( ER− ) HER2 + , and 11 ( 17 % ) were ER− HER2−. The clinical response rates were significantly higher in luminal B , ER+ HER2 + , and ER− HER2 + subtypes compared with luminal A subtype . Patients whose tumors contained high Ki67 expression effectively responded to neoadjuvant chemotherapy . Ki67 LI was a predictive marker for pCR , and all patients whose tumors achieved pCR are currently disease-free . Furthermore , high Ki67 expression in post-treatment tumors was strongly correlated with poor disease-free and overall survival regardless of subtype . Conclusions It is necessary to establish additional strategies to improve survival for patients whose residual tumors show high Ki67 expression after neoadjuvant chemotherapy PURPOSE This is one of the first reports of weekly docetaxel ( Taxotere ) in the neoadjuvant treatment of stage II and III breast cancer . We evaluated docetaxel 's efficacy and safety and analyzed correlations between response and the expression of c-erbB2 , ER status , and Ki-67 labeling index . EXPERIMENTAL DESIGN Patients with previously untreated , stage II and III breast cancer were entered into the study . Docetaxel ( 40 mg/m(2 ) ) was given i.v . once weekly for the first 6 weeks of an 8-week cycle for 2 cycles . RESULTS A total of 56 patients were evaluated by intention-to-treat analysis for efficacy and safety . The overall clinical response rate was 68 % ( complete and partial response , 29 and 39 % , respectively ) . Nine patients ( 16 % ) achieved a pathological complete response . There was no correlation between response to docetaxel and the expression of molecular markers , however , the majority of the pathological complete responses were observed in patients with c-erbB2-negative tumors . Nonhematological toxicity was more common than hematological toxicity , with alopecia and asthenia the most frequently reported adverse events ( 89 and 77 % of patients , respectively ) . Severe hematological toxicity was rare . CONCLUSIONS Weekly docetaxel appears to be very effective in the neoadjuvant setting . A high pathological response rate was achieved with tolerable toxicity Abstract This r and omized , multicenter study compared the efficacy of docetaxel with or without capecitabine following fluorouracil/epirubicin/cyclophosphamide ( FEC ) therapy in operable breast cancer and investigated the role of Ki67 as a predictive biomarker . Patients were r and omized to 4 cycles of docetaxel/capecitabine ( docetaxel : 75 mg/m2 on day 1 ; capecitabine : 1,650 mg/m2 on days 1–14 every 3 weeks ) or docetaxel alone ( 75 mg/m2 on day 1 every 3 weeks ) after completion of 4 cycles of FEC ( 5-fluorouracil 500 mg/m2 , epirubicin 100 mg/m2 and cyclophosphamide 500 mg/m2 on day 1 every 3 weeks ) . The primary endpoint was the pathological complete response ( pCR ) rate . Predictive factor analysis was conducted using clinicopathological markers , including hormone receptors and Ki67 labeling index ( Ki67LI ) . A total of 477 patients were r and omized ; the overall response in the docetaxel/capecitabine and docetaxel groups was 88.3 and 87.4 % , respectively . There were no significant differences in the pCR rate ( docetaxel/capecitabine : 23 % ; docetaxel : 24 % ; p = 0.748 ) , disease-free survival , or overall survival . However , patients with mid-range Ki67LI ( 10–20 % ) showed a trend towards improved pCR rate with docetaxel/capecitabine compared to docetaxel alone . Furthermore , multivariate logistic regression analysis showed pre-treatment Ki67LI ( odds ratio 1.031 ; 95 % CI 1.014–1.048 ; p = 0.0004 ) to be a significant predictor of pCR in this neoadjuvant treatment setting . Docetaxel/capecitabine ( after 4 cycles of FEC ) did not generate significant improvement in pCR compared to docetaxel alone . However , exploratory analyses suggested that assessment of pre-treatment Ki67LI may be a useful tool in the identification of responders to preoperative docetaxel/capecitabine in early-stage breast cancer BACKGROUND Combinations of anthracyclines , taxanes and gemcitabine have shown high activity in breast cancer . This trial was design ed to evaluate a modified combination regimen as primary chemotherapy . Non-pegylated liposomal doxorubicin ( NPLD ) was used instead of conventional doxorubicin to improve cardiac safety . Gemcitabine was given 72 h after NPLD and docetaxel as a prolonged infusion over 4 h in order to optimize synergistic effects and accumulation of active metabolites . PATIENTS AND METHODS Forty-four patients with histologically confirmed stage II or III breast cancer were treated with NPLD ( 60 mg/m(2 ) ) and docetaxel ( 75 mg/m(2 ) ) on day 1 and gemcitabine as 4-h infusion ( 350 mg/m(2 ) ) on day 4 . Treatment was repeated every 3 weeks for a maximum of six cycles . All patients received prophylactically recombinant granulocyte colony-stimulating factor . Patients with axillary lymph node involvement after primary chemotherapy received adjuvant treatment with cyclophosphamide , methotrexate and fluorouracil . RESULTS The clinical response rate was 80 % , and complete remissions of the primary tumor occurred in 10 patients ( 25 % ) . Breast conservation surgery was performed in 19 out of 20 patients ( 95 % ) with an initial tumor size of less than 3 cm and in 14 patients ( 70 % ) with a tumor size < or=3 cm . Seven patients had histologically confirmed complete responses accounting for a pCR rate of 17.5 % . Expression of Ki--67 was the most important predictive parameter for response with high 38.9 % breast pCR rate in patients with elevated Ki--67 expression . Although the predominant toxicity was myelosuppression with grade 3/4 neutropenia in 61 % of patients few neutropenic complications result ed . Non-hematological toxicity was generally moderate with grade 3 or 4 toxicity in 10.0 % of cycles . Most common non-hematologic toxicities were nausea , vomiting , alopecia , mucositis , asthenia and elevation of liver enzymes . CONCLUSION The evaluated schedule provides a safe and highly effective combination treatment for patients with early breast cancer , which is suitable for phase III studies PURPOSE OF THE STUDY Trastuzumab combined with sequential chemotherapy with taxanes and anthracyclines as primary systemic therapy achieved high rates of pathologic complete response ( pCR ) . Non-pegylated liposome-encapsulated doxorubicin ( NPLD ) has shown equal efficacy but minor cardiotoxicity compared to doxorubicin . This phase II study aim ed to evaluate the activity and safety of trastuzumab with sequential chemotherapy for early or locally advanced HER2 positive BC . METHODS Preoperative treatment included NPLD ( 60 mg/mq iv ) plus cyclophosphamide ( 600 mg/mq iv ) every 3 weeks for 4 cycles followed by docetaxel ( 35 mg/mq iv ) plus trastuzumab ( 4 mg/mq loading dose iv , then 2 mg/mq iv ) weekly for 16 weeks . Primary endpoint was pCR defined as the absence of residual invasive cancer both in the breast and regional nodes . Clinical staging was exploratory evaluated by CT-PET . RESULTS 43 pts were treated from december 2005 to September 2011 , 39 of them were evaluable for the purpose of study . Median age was 53 years ( range : 31 - 78 ) , the majority of pts had tumour stage cT2 ( 63 % ) , tumour grade 3 ( 86 % ) , clinical nodes involvement N+ ( 77 % ) , ER positive ( 56 % ) and Ki-67 ≥20 % ( 77 % ) . pCR was reported in 19 ( 49 % ) of 39 pts . There was an association between Ki-67 ≥20 % at baseline and pCR ( p = 0.018 ) . No cardiac toxicity or discontinuation of trastuzumab was reported . CT-PET modified the clinical stage for 10 patients showing new loco-regional lymph nodes . CONCLUSIONS This study confirms that integrating anti-HER2 therapy in primary treatment for HER2 positive breast cancer is active . NPLD is a safe option to minimize cardiotoxicity Oestrogen receptor ( ER ) negative breast cancers are more likely to achieve a pathological complete response ( pCR ) to neoadjuvant chemotherapy compared to those with ER positive tumours . ER positive tumours exhibit low proliferation and ER negative cancers high proliferation . The aim of this study was to determine to what extent the better response of ER negative cancers correlates with proliferation rate . A retrospective analysis of a prospect ively maintained data base identified 175 neoadjuvant chemotherapy patients with tissue available for Ki67 analysis . On univariate analysis , pre-therapy Ki67 ( P = 0.04 ) , ER status ( P = 0.002 ) , HER2 status ( P = 0.004 ) and grade ( P = 0.0009 ) were associated with a pCR . In a multivariate model , HER2 was the only significant predictor of pCR . No significant relationship between pre-therapy Ki67 and relapse-free and overall survival was demonstrated . Ki67 is not an independent predictor of clinical CR or pCR . Aspects of
Output:
| Ki-67 could predict pCR in those who received anthracyclines plus taxanes , and anthracyclines only , and those from Asia and Europe .
High Ki-67 before NAC was a predictor for pCR in neoadjuvant setting for breast cancer patients |
MS210815 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Aims : To estimate the impact of school fruit tuck shops on children ’s consumption of fruit and sweet and savoury snacks . Design : Cluster r and omised effectiveness trial with school as the unit of r and omisation . Setting : 43 primary schools in deprived areas in south Wales and south-west Engl and with a range of school food policies . Intervention : Schools operated fruit tuck shops throughout one academic year . Control schools did not do so . Measures : Repeated cross-sections of children aged 9–11 years completed a computerised 24-hour recall question naire at baseline ( n = 1902 ) and at 1-year follow-up ( n = 1924 ) , when a brief question naire was also completed ( n = 1976 ) . Results : Approximately 70 000 fruits were sold in the 23 intervention schools over the year , equivalent to 0.06 fruits per student per day . Children in intervention schools were more likely to report eating fruit as a snack at school ‘ often ’ ( OR 1.49 , 95 % CI 1.15 to 1.95 ) . There were no significant differences in children ’s intake of fruit or other snacks . There was a significant interaction ( p<0.02 ) between the intervention group and school food policy : where students were only allowed to bring fruit to school , fruit consumption was 0.37 portions per day ( 0.11 to 0.64 ) higher in intervention schools , compared to 0.14 portions ( −0.30 to 0.58 ) where no food was allowed and −0.13 portions ( −0.33 to 0.07 ) where there were no restrictions . Conclusions : In isolation , fruit tuck shops were not effective in changing children ’s snacking behaviour in schools . However , the results suggest that fruit tuck shops had a greater impact when reinforced by school policies restricting the types of foods students were allowed to bring to school BACKGROUND Boy Scouts are an important channel to complement school-based programs to enable boys to eat more fruit , 100 % juice , and vegetables ( FJV ) for chronic disease prevention . The " 5 a Day Achievement Badge " program was presented on a pilot study basis to African-American Boy Scout troops in Houston . METHODS Troops were the unit of recruitment and r and om assignment to treatment and control groups . The badge program was presented in Fall 1997 by trained dietitians and included activities to increase availability and accessibility of fruit and vegetables at scouts ' homes , increase preferences for vegetables , and train in the preparation of FaSST ( fast , simple , safe , and tasty ) recipes . Weekly comic books demonstrated and reinforced what scouts were expected to do at home . A weekly newsletter with recipes was sent to parents . The program was revised and presented to the control group in Winter 1998 . Two 24-h recalls were the primary assessment tools . Telephone interviews were conducted with parents . RESULTS The intervention result ed in a 0.8 FJV serving difference ( post values of treatment versus control groups with pre value covaried ) . CONCLUSIONS The changes obtained suggest that the intervention was effective in promoting dietary change PURPOSE OBJECTIVES The purpose of this study is to report the impact of the three-year middle school-based HEALTHY study on intervention school vending machine offerings . There were two goals for the vending machines : serve only dessert/snack foods with 200 kilocalories or less per single serving package , and eliminate 100 % fruit juice and beverages with added sugar . METHODS Six schools in each of seven cities ( Houston , TX , San Antonio , TX , Irvine , CA , Portl and , OR , Pittsburg , PA , Philadelphia , PA , and Chapel Hill , NC ) were r and omized into intervention ( n=21 schools ) or control ( n=21 schools ) groups , with three intervention and three control schools per city . All items in vending machine slots were tallied twice in the fall of 2006 for baseline data and twice at the end of the study , in 2009 . The percentage of total slots for each food/beverage category was calculated and compared between intervention and control schools at the end of study , using the Pearson chi-square test statistic . RESULTS At baseline , 15 intervention and 15 control schools had beverage and /or snack vending machines , compared with 11 intervention and 11 control schools at the end of the study . At the end of study , all of the intervention schools with beverage vending machines , but only one out of the nine control schools , met the beverage goal . The snack goal was met by all of the intervention schools and only one of the four control schools with snack vending machines . APPLICATIONS TO CHILD NUTRITION PROFESSIONALS The HEALTHY study 's vending machine beverage and snack goals were successfully achieved in intervention schools , reducing access to less healthy food items outside the school meals program . Although the effect of these changes on student diet , energy balance and growth is unknown , these results suggest that healthier options for snacks can successfully be offered in school vending machines OBJECTIVE To assess lunchtime provision of food and drink in English primary schools and to assess both choices and consumption of food and drink by pupils having school lunches . These findings were compared with similar data collected in 2005 . DESIGN Cross-sectional data collected between February and April 2009 . In each school , food and drink provision , including portion weights and number of portions of each item served at lunchtime , were recorded over five consecutive days . Caterers provided school lunchtime menus and recipes . SETTING Engl and . SUBJECTS A r and om selection of 6696 pupils having school lunches in a nationally representative sample of 136 primary schools in Engl and . RESULTS Compared with 2005 , schools in 2009 provided significantly more fruit , fruit-based desserts , vegetables and salad , water and fruit juice , and less ketchup , sauces and gravy , starchy foods cooked in fat , snacks and confectionery ( P < 0·01 ) . Pupils were also making healthier choices , choosing an average of 2·2 portions of fruit and vegetables from their ' five a day ' , but about one-third to two-fifths of these were wasted . CONCLUSIONS Lunchtime food provision and consumption in primary schools have improved substantially since 2005 , following the introduction of new st and ards for school food in 2008 . However , improvements still need to be made to increase the Fe and Zn content and to decrease the Na content of recipes , and in encouraging pupils to eat more of the fruits and vegetables taken at lunchtime OBJECTIVES The effects of a Boy Scout Five-A-Day Badge program on fruit juice ( FJ ) and low-fat vegetable ( LV ) consumption were evaluated using a two-condition ( treatment , active-attention-placebo-control ) group r and omized trial , with three data collection periods ( baseline , immediate post , 6-month post ) . METHODS Forty-two Boy Scout troops ( n=473 , 10- to 14-year-old Scouts ) in Houston , TX , were r and omly assigned to condition . The 9-week program included approximately 30 min of weekly troop time , plus approximately 25 min of weekly Internet programming . The intervention was delivered in two waves ( Spring and Fall ) . Data were collected in 2003 - 2004 , and analyses were completed in 2008 . Main outcomes were FJ and LV consumption ( vali date d food frequency question naire ) . FV self-efficacy , preferences , and home availability were also measured . RESULTS Significant increases in FJ consumption ( p=.003 ) , FJ home availability ( p=.009 ) , and LV self-efficacy ( p=.004 ) were observed among the intervention group immediately following the intervention but were not maintained 6 months later . CONCLUSION A Boy Scout troop-plus-Internet intervention promoting FJ and LV consumption result ed in short-term changes in FJ consumption among U.S. Boy Scouts . Future research should investigate ways to extend these results to LV and maintain the increases over time To increase opportunities for healthy eating and physical activity , US school districts participating in the National School Lunch Program were required to create a Local Wellness Policy ( LWP ) by June 2006 . The What 's Working project described the initial influence of this m and ate on nutrition environments and policies . In 2005 and 2007 ( before and after the m and ate went into effect ) , a survey about school features related to nutrition and physical activity was sent to a r and om sample of 45 low-income , rural elementary foodservice managers and principals . Schools averaged 204 students , 27 % Hispanic . Districts ' LWPs were coded for strength and comprehensiveness . In addition , key informant interviews were conducted with foodservice managers almost 2 years after the LWP went into effect . Three improvements were observed : increases in the percent of schools with policies stipulating predominantly healthy items be offered in classroom parties ( 21.4 % in 2005 vs 48.7 % in 2007 ) , daily fresh fruit offerings in the lunchroom ( 0.80 choices in 2005 vs 1.15 choices in 2007 ) , and the percent of schools using skinless poultry ( 27 % in 2005 vs 59 % in 2007 ) . LWPs were weakly worded and rarely addressed energy content . Nutrition guideline elements most commonly addressed included vending machines , school stores , and à la carte food offerings . Seveny-three percent of foodservice managers were familiar with their district 's LWP but did not perceive it changed lunchroom practice s. Although LWPs offer a framework to support opportunities for healthy eating , few evidence -based practice s were implemented as a direct result of the m and ate . Schools need more information about evidence -based practice s , as well as technical and financial assistance for implementation OBJECTIVE Previous studies on the relationship of dietary intake to the neighbourhood food environment have focused on access to supermarkets , quantified by geographic distance or store concentration measures . However , in-store food availability may also be an important determinant , particularly for urban neighbourhoods with a greater concentration of small food stores . This study synthesis es both types of information - store access and in-store availability - to determine their potential relationship to fruit and vegetable consumption . DESIGN Residents in four census tracts were surveyed in 2001 about their fruit and vegetable intake . Household distances to food stores in these and surrounding tracts were obtained using geographical information system mapping techniques . In-store fruit and vegetable availability was measured by linear shelf space . Multivariate linear regression models were used to measure the association of these neighbourhood availability measures with consumption . SETTING Four contiguous census tracts in central -city New Orleans . SUBJECTS A r and om sample of 102 households . RESULTS Greater fresh vegetable availability within 100 m of a residence was a positive predictor of vegetable intake ; each additional metre of shelf space was associated with 0.35 servings per day of increased intake . Fresh fruit availability was not associated with intake , although having a small food store within this same distance was a marginal predictor of fruit consumption . CONCLUSIONS The findings suggest the possible importance of small neighbourhood food stores and their fresh produce availability in affecting fruit and vegetable intake The Nutrition , Prevention and Health for Children and Teenagers in Aquitaine program is a regional implementation of the French National Program of Nutrition and Health ( PNNS ) . The first of two surveys of a representative sample of Aquitaine preschools was conducted in 2004 - 2005 . This survey showed that more than 2/3 of teachers offered a morning snack to their pupils at around 10 o'clock in the morning , mainly composed of sweet cakes , cookies , or c and ies . Following this initial survey , actions were implemented starting in September 2005 , aim ing to stop systematic morning snacks or improve their composition . The same survey was repeated during 2007 - 2008 in order to analyze the changes in morning snack practice s in preschools between 2004 - 2005 and 2007 - 2008 . Data were collected from teachers of Aquitaine 's preschools who filled out question naires . Schools were r and omly chosen according to their size and whether or not they belonged to a priority education zone ( ZEP ) . The results show that 57.9 % of teachers organized a morning snack in 2007 - 2008 , versus 68.7 % in 2004 - 2005 . In 2004 - 2005 , 22 % of teachers considered the morning snack as " unjustified " compared to 44 % in 2007 - 2008 . The composition of morning snacks improved : 17.7 % of teachers offered fruit and /or milk in 2007 - 2008 versus 8.5 % in 2004 - 2005 . Morning snacks composed of other foods ( such as sweets , chocolate pieces , cookies , pastries , bread , fruit juice ) decreased from 60.2 % in 2004 - 2005 to 40.2 % in 2007 - 2008 . In 2007 - 2008 , 19 % of the teachers reported that children had snacks in their schoolbag versus 34 % in 2004 - 2005 . The proportion of teachers reporting children having snacks in their schoolbag decreased from 34 % in 2004 - 2005 to 19 % in 2007 - 2008 . Comparison between these two surveys is encouraging as it shows an improvement of the perception and practice s of teachers regarding morning snacks . These results encourage the partners of this program to continue the fieldwork actions
Output:
| The most promising strategies for improving the FV environment for children are through local school food service policies .
Similarly family interventions had no or small impact on home accessibility , with smaller impact on consumption . |
MS210816 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: In response to a recorded increasing incidence of diarrhoea in Tumpat District , Malaysia , a case-control study was performed to identify modifiable risk factors for the transmission of diarrhoea , in children aged 4 - 59 months . Ninety-eight pairs of children , matched on age and sex , were recruited prospect ively from health centres . Exposure status was determined during a home visit . Interviewers were ' blinded ' as to the disease status of each child . Odds ratios were measured through matched pair analysis and conditional logistic regression . Risk factors for diarrhoea identified were : reported -- drinking of unboiled water , storage of cooked food before consumption and bottle feeding ; and observations -- animals inside the house and absence of washing water in latrines . Water quality , source of drinking water , reported h and washing behaviour , indiscriminate defecation by children , cup use and the absence of a functional latrine were not associated with diarrhoea . Nonsignificant associations were found for : accessibility of washing water source , type of water storage container and use of fly covers for food Diarrhea has been recognized as a frequent health problem among children enrolled in day-care centers . Thus , we evaluated the effect of a h and washing program in two day-care centers ( HWC ) on the incidence of diarrhea among children when compared to children in two control centers ( CC ) . After the program was begun , the incidence of diarrhea at the HWC began to fall and after the second month of the study was consistently lower than that at the CC . The incidence of diarrhea in the HWC was approximately half that of the CC for the entire 35-week study period . Adenoviruses , rotavirus , Giardia lamblia , and enteropathogenic Escherichia coli were found in the stools of a small number of ill children , but not pathogen was identified in the stools of most children with diarrhea . These results suggest that a h and washing program will probably prevent at least some of the diarrhea in day-care centers A number of different outcome measures have been proposed for use in prospect i ve studies of morbidity associated with childhood diarrhea . These include the number of episodes experienced by each child over a defined period ( a measure of incidence ) and the number of days of diarrhea divided by the total number of days of observation for each child ( a measure denoted " longitudinal prevalence " ) . The authors examined data from Ghana to determine which of these measures is more strongly associated with weight gain over a 4-month period and subsequent mortality . Both diarrhea incidence and longitudinal prevalence were associated with weight gain in children aged 6 - 23 months , but a statistically stronger association was observed with longitudinal prevalence ( likelihood ratio statistic 28.95 on 1 degree of freedom against 19.70 for incidence ) . Neither measure was associated with weight gain in younger or older children . Longitudinal prevalence , but not incidence , was strongly associated with subsequent mortality ( p = 0.002 for longitudinal prevalence ; p = 0.557 for incidence ) . Although many epidemiologic studies of diarrhea focus on incidence , these data suggest that longitudinal prevalence is more strongly predictive of long-term health outcome . The authors conclude that longitudinal prevalence merits greater attention as a measure of outcome in diarrhea studies UNLABELLED BACKGROUND AND HYPOTHESES : A substantial percentage of school absenteeism among children is related to transmissible infection . Rates of transmission can be reduced by h and washing with soap and water , but such washing occurs infrequently . This study tested whether an alcohol-free instant h and sanitizer ( CleanH and s ) could reduce illness absenteeism in school-age children . METHODS A 10-week , open-label , crossover study was performed on 420 elementary school-age children ( ages 5 - 12 ) . Students were given a brief orientation immediately prior to the start of the study on the relationship of germs , illness , and h and washing . Each student in the treatment group then received the test product in individual bottles , with instructions to apply one to two sprays to the h and s after coming into the classroom , before eating , and after using the restroom , in addition to their normal h and washing with soap and water . The control group was instructed to continue h and washing as normal with non-medicated soap . After 4 weeks of treatment and a 2-week wash-out period , the control and experimental groups were reversed . Data gathered on absenteeism were classified as gastrointestinal or respiratory related and normalized for nonillness-related absenteeism and school holidays . RESULTS Compared to the h and washing-only control group , students using CleanH and s were found to have 41.9 % fewer illness-related absence days , representing a 28.9 % and a 49.7 % drop in gastrointestinal- and respiratory-related illnesses , respectively . Likewise , absence incidence decreased by 31.7 % , consisting of a 44.2 % and 50.2 % decrease in incidence of gastrointestinal- and respiratory-related illnesses , respectively . No adverse events were reported during the study . CONCLUSIONS Daily use of the instant h and sanitizer was associated with significantly lower rates of illness-related absenteeism BACKGROUND AND OBJECTIVES H and washing prevents communicable illness . We evaluated the effect of a m and atory , scheduled h and -washing program in elementary school children on absenteeism due to acute communicable illness . METHODS The study was conducted at Trombley Elementary School in Grosse Pointe Park , Mich. The intervention group , approximately half of the school children ( n = 143 , including all grade s 1 - 5 ) , washed their h and s a minimum of four scheduled times a day . The control group ( n = 162 ) continued h and -washing practice s as usual . RESULTS Of the 37 school days examined , children in the h and -washing group were absent fewer days than the control group due to all acute communicable illness ( relative risk = .75 ) . There were less days of absence due to gastrointestinal symptoms ( relative risk = .43 ) . The difference in absence due to respiratory symptoms was not statistically significant . CONCLUSIONS A scheduled h and -washing program will reduce acute communicable ( gastrointestinal ) illnesses in elementary school-age children Diarrheal diseases pose a major threat to the health of people living in developing countries , particularly where there is poverty and a poor environment . The effect of h and washing in reducing the incidence of diarrhea in day-care centers has been reported recently . The present study is a prospect i ve community based study conducted to evaluate the effect of h and washing on the incidence of diarrheal disease in Calcutta slums . H and washing was implemented in 1 slum and the other nearby slum , without h and washing program , served as control . The incidence of watery diarrhea during the 13 month period , between the study and control groups was not significantly different . However , the incidence of dysentery in individuals above 5 years of age in the control group was significantly higher as compared to those in the study group ( p 0.05 ) . The results of this study indicate that h and washing with soap may reduce the incidence of dysenteric cases in the community by interruption of transmission of the pathogens from 1 person to the other The most common types of situations that lend themselves to community- based assessment are described along with aspects of these trials that call for modification of the r and omized controlled design and the problems that doing this entails . Other possible design s that may lend themselves to these circumstances are suggested . Some interventions can only be effectively done on an area or population basis . Theoretically r and omized controlled trials are preferred . They are modified so that the community is investigated not the individual . However these studies are difficult to do . Sample size requirements may be large ; a small increase in the number of communities should be undertaken . A pilot study can be done to see which communities are similar at first . Evaluating changes in outcome values may be more sensitive than comparing postintervention values . Different community subgroups may be compared . Care must be taken in defining these subgroups . Also the r and om element is missing in these subgroups . Environmental changes and vector control procedures are 1 type of intervention that tries to reduce disease transmission . Another type is where intervention is done at the individual level but the goal is to reduce transmission in the whole community . Measures of intervening variables may be used to evaluate these studies . In clinical trials the population is captive . They have agreed to participate ; informed consent is obtained . Community-based interventions are often preventive measures done on a home-based population . This is only appropriate for common diseases . Agreement to participate must be gotten from the whole community . Case control or stepped wedge design s can be used as a research approach . Case control design s have many problems . They are costly both in personnel and in time . A clinic-based case control study is proposed . It is simple logistically . The stepped wedge design is applicable to evaluate new interventions which are introduced on a wide scale . Its rationale and use are described Background . Diarrheal infections are common in children who attend child care , and preventing transmission of disease in this setting depends on actions by child care staff . We set out to discover whether transmission of gastrointestinal infections in child care could be reduced by improved infection control procedures . Methods . We performed a cluster r and omized , controlled trial of an infection control intervention conducted in child care centers for 1 city in Australia . The intervention was training of child care staff about transmission of infection and h and washing and focused on both staff and child behavior . Implementation of the intervention was recorded by an observer . Illness was measured by parent report in telephone interviews every 2 weeks . Results . There were 311 child-years of surveillance for diarrheal episodes . The rate of episodes of diarrhea was 1.9 per child-year in intervention centers and 2.7 per child-year in control centers . Multivariable analysis showed that diarrheal episodes were significantly reduced in intervention center children by 50 % . However , the impact of the intervention was confined to children over 24 months of age . For those centers in which children 's compliance with h and washing was high , diarrheal episodes were reduced by 66 % . Conclusions . This trial supports education about infection control , for staff and children in child care , as a means of reducing transmission of diarrhea . Reduction in episodes of diarrhea in children in child care was limited to children over 24 months of age To identify risk factors for typhoid fever in Semarang city and its surroundings , 75 culture-proven typhoid fever patients discharged 2 weeks earlier from hospital and 75 controls were studied . Control subjects were neighbours of cases with no history of typhoid fever , not family members , r and omly selected and matched for gender and age . Both cases and controls were interviewed at home by the same trained interviewer using a st and ardized question naire . A structured observation of their living environment inside and outside the house was performed during the visit and home drinking water sample s were tested bacteriologically . Univariate analysis showed the following risk factors for typhoid fever : never or rarely washing h and s before eating ( OR = 3.28 ; 95 % CI = 1.41 - 7.65 ) ; eating outdoors at least once a week ( OR = 3.00 ; 95 % CI = 1.09 - 8.25 ) ; eating outdoors at a street food stall or mobile food vendor ( OR = 3.86 ; 95 % CI = 1.30 - 11.48 ) ; consuming ice cubes in beverage in the 2-week period before getting ill ( OR = 3.00 , 95 % CI = 1.09 - 8.25 ) and buying ice cubes from a street vendor ( OR = 5.82 ; 95 % CI = 1.69 - 20.12 ) . Water quality and living environment of cases were worse than that of controls , e.g. cases less often used clean water for taking a bath ( OR = 6.50 ; 95 % CI = 1.47 - 28.80 ) , for brushing teeth ( OR = 4.33 ; 95 % CI = 1.25 - 15.20 ) and for drinking ( OR = 3.67 ; 95 % CI = 1.02 - 13.14 ) . Cases tended to live in houses without water supply from the municipal network ( OR=11.00 ; 95 % CI = 1.42 - 85.2 ) , with open sewers ( OR = 2.80 ; 95 % CI = 1.0 - 7.77 ) and without tiles in the kitchen ( OR = 2.67 ; 95 % CI = 1.04 - 6.81 ) . Multivariate analysis showed that living in a house without water supply from the municipal network ( OR = 29.18 ; 95 % CI = 2.12 - 400.8 ) and with open sewers ( OR = 7.19 ; 95 % CI = 1.33 - 38.82 ) was associated with typhoid fever . Never or rarely washing h and s before eating ( OR = 3.97 ; 95 % CI = 1.22 - 12.93 ) and being unemployed or having a part-time job ( OR = 31.3 ; 95 % CI = 3.08 - 317.4 ) also were risk factors . In this population typhoid fever was associated with poor housing and inadequate food and personal hygiene
Output:
| On current evidence , washing h and s with soap can reduce the risk of diarrhoeal diseases by 42 - 47 % and interventions to promote h and washing might save a million lives . |
MS210817 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Objective We conducted a single-centre , r and omised , double-blinded , placebo-controlled phase II clinical study to test safety and efficacy of a 12-week therapy with low-dose ( 700 mg/daily ) or high-dose ( 2800 mg/daily ) of NAC . Methods Twenty-one patients ( ΔF508 homo/heterozygous , FEV1 > 40 % pred . ) were included in the study . After a 3-weeks placebo run-in phase , 11 patients received low-dose NAC , and 10 patients received high-dose NAC . Outcomes included safety and clinical parameters , inflammatory ( total leukocyte numbers , cell differentials , TNF-α , IL-8 ) measures in induced sputum , and concentrations of extracellular glutathione in induced sputum and blood . Results High-dose NAC was a well-tolerated and safe medication . High-dose NAC did not alter clinical or inflammatory parameters . However , extracellular glutathione in induced sputum tended to increase on high-dose NAC . Conclusions High-dose NAC is a well-tolerated and safe medication for a prolonged therapy of patients with CF with a potential to increase extracellular glutathione in CF airways BACKGROUND Inhaled hypertonic saline acutely increases mucociliary clearance and , in short-term trials , improves lung function in people with cystic fibrosis . We tested the safety and efficacy of inhaled hypertonic saline in a long-term trial . METHODS In this double-blind , parallel-group trial , 164 patients with stable cystic fibrosis who were at least six years old were r and omly assigned to inhale 4 ml of either 7 percent hypertonic saline or 0.9 percent ( control ) saline twice daily for 48 weeks , with quinine sulfate ( 0.25 mg per milliliter ) added to each solution to mask the taste . A bronchodilator was given before each dose , and other st and ard therapies were continued during the trial . RESULTS The primary outcome measure , the rate of change ( slope ) in lung function ( reflected by the forced vital capacity [ FVC ] , forced expiratory volume in one second [ FEV1 ] , and forced expiratory flow at 25 to 75 percent of FVC [ FEF25 - 75 ] ) during the 48 weeks of treatment , did not differ significantly between groups ( P=0.79 ) . However , the absolute difference in lung function between groups was significant ( P=0.03 ) when averaged across all post-r and omization visits in the 48-week treatment period . As compared with the control group , the hypertonic-saline group had significantly higher FVC ( by 82 ml ; 95 percent confidence interval , 12 to 153 ) and FEV1 ( by 68 ml ; 95 percent confidence interval , 3 to 132 ) values , but similar FEF25 - 75 values . The hypertonic-saline group also had significantly fewer pulmonary exacerbations ( relative reduction , 56 percent ; P=0.02 ) and a significantly higher percentage of patients without exacerbations ( 76 percent , as compared with 62 percent in the control group ; P=0.03 ) . Hypertonic saline was not associated with worsening bacterial infection or inflammation . CONCLUSIONS Hypertonic saline preceded by a bronchodilator is an inexpensive , safe , and effective additional therapy for patients with cystic fibrosis . ( Clinical Trials.gov number , NCT00271310 . Neutrophilic airway inflammation is a hallmark of cystic fibrosis ( CF ) . As high oxidant producers , airway neutrophils contribute largely to the systemic redox imbalance seen in CF . In turn , this chronic and profound imbalance can impact circulating neutrophils before their migration into airways . Indeed , in 18 CF patients with stable disease , blood neutrophils were readily deficient in the pivotal antioxidant glutathione ( P = 0.003 , compared with 9 healthy controls ) . In a phase 1 study , this deficiency was improved ( P = 0.025 ) by the glutathione prodrug N-acetylcysteine , given orally in high doses ( 0.6 to 1.0 g three times daily , for 4 weeks ) . This treatment was safe and markedly decreased sputum elastase activity ( P = 0.006 ) , the strongest predictor of CF pulmonary function . Consistently , neutrophil burden in CF airways was decreased upon treatment ( P = 0.003 ) , as was the number of airway neutrophils actively releasing elastase-rich granules ( P = 0.005 ) , as measured by flow cytometry . Pulmonary function measures were not improved , as expected with short-term treatment . After excluding data from subjects without baseline airway inflammation , positive treatment effects were more pronounced and included decreased sputum IL-8 levels ( P = 0.032 ) . Thus , high-dose oral N-acetylcysteine has the potential to counter the intertwined redox and inflammatory imbalances in CF S-nitrosoglutathione ( GSNO ) , a naturally occurring constituent of airway lining fluid , enhances ciliary motility , relaxes airway smooth muscle , inhibits airway epithelial amiloride-sensitive sodium transport , and prevents pathogen replication . Remarkably , airway levels of GSNO are low in patients with cystic fibrosis ( CF ) . We hypothesized that replacement of airway GSNO would improve gas exchange in CF . In a double-blind , placebo controlled study , we administered 0.05 ml/kg of 10 mM GSNO or phosphate buffered saline by aerosol to patients with CF and followed oxygen saturation , spirometry , respiratory rate , blood pressure , heart rate , and expired nitric oxide ( NO ) . Nine patients received GSNO and 11 placebo . GSNO inhalation was associated with a modest but sustained increase in oxygen saturation at all time points . Expired NO increased in the low ppb range with GSNO treatment , peaking at 5 minutes but remaining above baseline at 30 minutes . There were no adverse effects . We conclude that GSNO is well tolerated in patients with CF and improves oxygenation through a mechanism that may be independent of free NO . Further , GSNO breakdown increases expired NO . We suggest that therapy aim ed at restoring endogenous GSNO levels in the CF airway may merit study The aim of the present studies was to investigate the tolerability and activity of a novel mucolytic drug , Nacystelyn ( NAL ) , for the treatment of cystic fibrosis ( CF ) lung disease . In study 1 , involving 10 CF patients , the main objective was to determine the tolerability and potential efficacy of a range of single doses of NAL in comparison to a placebo , in order to establish an optimal dose for further testing . On five consecutive scheduled treatment days , patients inhaled either from two ( 4 mg ) to eight puffs ( 16 mg ) of a single dose of NAL from the range , administered in an open-label fashion , or 12 puffs of active NAL ( 24 mg ) versus 12 puffs of placebo , administered in a r and omized double-blind fashion . Pulmonary function data were unaffected and clinical ly-adverse effects were limited to wheezing in some patients that inhaled 12 puffs of either placebo or active drug . Subsequent rheological analysis of their sputum showed a dose-dependent decrease in sputum viscoelasticity , accompanied by a decrease in sputum solids content and an increase in chloride and sodium concentrations . In study 2 , involving 12 CF patients , the clinical safety and mucolytic activity of a single dose of NAL was monitored over 24 h. On different scheduled treatment days , 7 days apart , patients inhaled a single dose of 12 puffs of active NAL ( 24 mg ) or 12 puffs of placebo drug in a r and omized , double-blind sequence , with sputum sample s taken at intervals before and after inhalation . Mucus rigidity decreased following NAL inhalation , with the maximum effect observed at 4 h ; the 1- , 2- and 4-h NAL rheology results were significantly different from placebo . No adverse effects were observed . The drug was well tolerated in both studies . Sputum results were predictive of improved clearability by ciliary and cough transport mechanisms Twenty-seven patients with cystic fibrosis completed a controlled trial comparing the effects of an inhaled mucolytic drug , sodium-2-mercaptoethane sulphonate ( Mistabron , UCB Pharmaceutical Division , Brussels , Belgium ) , with inhaled iso-osmolar hypertonic saline . As a group the 22 patients with chronic sputum production showed small but statistically significant improvement in pulmonary function tests after Mistabron therapy , both when compared with a control period , and with iso-osmolar saline results . Subjective measurements by diary card failed to show any changes . No significant changes were found in five patients with no measurable sputum production . The inhalations were given after physiotherapy and were well tolerated . There were no significant side effects . The results suggest that Mistabron has a beneficial therapeutic effect unrelated to its high osmolality , and the intermittent inhalation of Mistabron may have a role in the treatment of selected patients with cystic fibrosis The effect of peroral N-acetylcysteine ( NAC ) in patients with cystic fibrosis ( CF ) and primary ciliary dyskinesia ( PCD ) was investigated . 41 CF patients and 13 PCD patients completed the study which was a double-blind , placebo-controlled , cross-over trial . The patients received either NAC or placebo for two periods of three months followed by a three month follow-up period . Active treatment consisted of NAC , either 200 mg x 3 daily ( patients weighing less than 30 kg ) or 400 mg x 2 daily ( greater than 30 kg ) . The effect was evaluated in terms of a subjective clinical score , weight , sputum bacteriology , blood leucocyte count , sedimentation rate , titres of specific antimicrobial antibodies , lung function parameters and measurement of the ciliary function . No effect was seen in PCD patients , but in CF patients an improved lung function was seen in the period when the patients suffer most from lower airway infections Examined in this study are the immediate effects of bronchial drainage preceded by the inhalation of aerosol solutions of a mucolytic agent , a bronchodilator , and their combination upon four measures of pulmonary function in 20 patients with cystic fibrosis . On three separate occasions , pulmonary function was tested preceding and following treatments consisting of one of the above three aerosol solutions followed by bronchial drainage . The order of solutions used was r and om and each subject received one treatment with each solution . The greatest overall improvement in function was seen with the bronchodilator and bronchial drainage . The combination of the bronchodilator/mucolytic agents and bronchial drainage was the next most effective technique . The mucolytic agent , when used alone with bronchial drainage , decreased function . Comparison of the pulmonary function scores indicated a significant difference among the three treatments The therapeutic efficacy of oral N-acetylcysteine ( NAC ) and ambroxol as compared with the effect of placebos was studied in 36 cystic fibrosis ( CF ) patients with mild to moderate pulmonary disease . The patients were r and omly assigned to one of three regimens , matched on the basis of age and Chrispin-Norman scores . The trial was conducted over a period of 12 weeks . Patients were assessed clinical ly and by extensive pulmonary function techniques ( body-plethysmography , maximal expiratory flow-volume curves , trapped air determination ) . Although no clinical differences could be observed between the three groups , significant impairment in the placebo group was found for trapped air and FEV1 when compared to the active groups , suggesting a therapeutic effect of ambroxol and NAC in CF BACKGROUND Respiratory disease in patients with cystic fibrosis is characterized by airway obstruction caused by the accumulation of thick , purulent secretions , which results in recurrent , symptomatic exacerbations . The viscoelasticity of the secretions can be reduced in vitro by recombinant human deoxyribonuclease I ( rhDNase ) , a bioengineered copy of the human enzyme . METHODS We performed a r and omized , double-blind , placebo-controlled study to determine the effects of once-daily and twice-daily administration of rhDNase on exacerbations of respiratory symptoms requiring parenteral antibiotics and on pulmonary function . A total of 968 adults and children with cystic fibrosis were treated for 24 weeks as out patients . RESULTS One or more exacerbations occurred in 27 percent of the patients given placebo , 22 percent of those treated with rhDNase once daily , and 19 percent of those treated with rhDNase twice daily . As compared with placebo , the administration of rhDNase once daily and twice daily reduced the age-adjusted risk of respiratory exacerbations by 28 percent ( P = 0.04 ) and 37 percent ( P < 0.01 ) , respectively . The administration of rhDNase once daily and twice daily improved forced expiratory volume in one second during the study by a mean ( + /- SD ) of 5.8 + /- 0.7 and 5.6 + /- 0.7 percent , respectively . None of the patients had anaphylaxis . Voice alteration and lary
Output:
| Although generally well-tolerated with no significant adverse effects , there was no evidence of significant clinical benefit in our primary outcomes in participants receiving these treatments .
Oral thiol derivatives were generally well-tolerated with no significant adverse effects , however there was no evidence of significant clinical benefit in our primary outcomes in participants receiving these treatments .
We found no evidence to recommend the use of either nebulized or oral thiol derivatives in people with cystic fibrosis . |
MS210818 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Manual circumlaryngeal therapy ( manual laryngeal musculoskeletal tension reduction ) was used to treat 25 consecutive functional dysphonia patients . Pre- and post-treatment audio recordings of connected speech and sustained vowel sample s were su bmi tted to auditory-perceptual and acoustical analysis to assess the immediate and long-term effects of a single treatment session . To complement audio recordings , subjects were interviewed in follow-up regarding the stability of treatment effects . Pre- and post-treatment comparisons demonstrated significant voice improvements . No significant differences were observed between post-treatment measures , suggesting that vocal gains were maintained . Interviews revealed 68 % of subjects reported occasional partial recurrences , typically less than 4 days in duration , which resolved spontaneously . These results replicate and extend previous research suggesting the utility of manual circumlaryngeal therapy for functional voice disorders A prospect i ve study was carried out to examine the degree to which a st and ard voice assessment could discriminate between the potential benefits of two different voice therapy programmes for individual patients . The study encompassed 200 dysphonia subjects who were referred for voice therapy and had completed treatment within a prescribed two-year period . A st and ard assessment procedure was carried out on first attendance for each patient and guidelines were used to assign patients to different treatment programmes on the basis of the assessment results . The assessment discriminated well between patients requiring voice therapy to change physiological parameters of voice usage and patients able to self adjust voice usage , and provided an objective means of measuring outcomes Although the terms " breathy " and " rough " are frequently applied to pathological voices , widely accepted definitions are not available and the relationship between these qualities is not understood . To investigate these matters , expert listeners judged the dissimilarity of pathological voices with respect to breathiness and roughness . A second group of listeners rated the voices on unidimensional scales for the same qualities . Multidimensional scaling analyses suggested that breathiness and roughness are related , multidimensional constructs . Unidimensional ratings of both breathiness and roughness were necessary to describe patterns of similarity with respect to either quality . Listeners differed in the relative importance given to different aspects of voice quality , particularly when judging roughness . The presence of roughness in a voice did not appear to influence raters ' judgments of breathiness ; however , judgments of roughness were heavily influenced by the degree of breathiness , the particular nature of the influence varying from listener to listener . Differences in how listeners focus their attention on the different aspects of multidimensional perceptual qualities apparently are a significant source of interrater unreliability ( noise ) in voice quality ratings After treatment for early glottic carcinoma , a considerable number of patients end up with voice problems that interfere with daily life activities . The objective of this r and omized and controlled study was to assess the efficacy of voice therapy in these patients Abstract Objectives : To assess the overall efficacy of voice therapy for dysphonia . Design : Single blind r and omised controlled trial . Setting : Outpatient clinic in a teaching hospital . Participants : 204 out patients aged 17 - 87 with a primary symptom of persistent hoarseness for at least two months . Interventions : After baseline assessment s , patients were r and omised to six weeks of either voice therapy or no treatment . Assessment s were repeated at six weeks on the 145 ( 71 % ) patients who continued to this stage and at 12 - 14 weeks on the 133 ( 65 % ) patients who completed the study . The assessment s at the three time points for the 70 patients who completed treatment and the 63 patients in the group given no treatment were compared . Main outcome measures : Ratings of laryngeal features , Buffalo voice profile , amplitude and pitch perturbation , voice profile question naire , hospital anxiety and depression scale , clinical interview schedule , SF-36 . Results : Voice therapy improved voice quality as assessed by rating by patients ( P=0.001 ) and rating by observer ( P<0.001 ) . The treatment effects for these two outcomes were 4.1 ( 95 % confidence interval 1.7 to 6.6 ) points and 0.82 ( 0.50 to 1.13 ) points . Amplitude perturbation showed improvement at six weeks ( P=0.005 ) but not on completion of the study . Patients with dysphonia had appreciable psychological distress and lower quality of life than controls , but voice therapy had no significant impact on either of these variables . Conclusion : Voice therapy is effective in improving voice quality as assessed by self rated and observer rated methods . What is already known on this topic Many patients with dysphonia are treated by voice therapy The effectiveness of voice therapy in a diverse group of patients is unknown What this study adds Voice therapy is an effective treatment for dysphonia in terms of report by patients and perceptual ratings by an expert Psychological distress and reduction in general health status are common in patients with dysphonia but are not significantly affected by a course of voice For many years all patients with dysphonia referred to in the literature as result ing from non-organic ( functional ) voice disorders were sent to speech therapy . Medical diagnoses were not taken into account . In our earlier Cochrane review on vocal cord nodules we discovered that evidence -based research in the area of benign voice disorders with dysphonia , and with or without slight benign swellings including nodules on the vocal cords , was lacking at that time . Therefore , a prospect i ve r and omised pilot study based on our Cochrane review has been made on dysphonic patients with non-organic ( function provoked ? ) voice disorders as the basis for further evidence -based studies .Medical treatment was based on the scientific approach that once a micro-organic disorder caused by reflux , infection , allergy or environmental irritatants ( e.g. , dust or noise in the workplace ) was discovered by very careful anamnesis and systematic objective routine analyses and was treated effectively , with documentation , the non-organic voice disorder disappeared , as , e.g. , in the case of a diagnosis and treatment of helicobakter pylori . The reason is that the mucosal swelling/dysfunction of the vocal cords is secondary .In order to try to underst and why the recommendation to all these patients for many years was only voice therapy , which the speech therapists “ felt to be effective ” , up date d voice-hygiene advice ( for posture , accents of the diaphragm , intonation pattern and resonance ) was given by experienced laryngologists , r and omised with the up date d medical diagnosis/therapy in order to eluci date what effect the training might have . No evidence -based studies in the literature document any effect . The crucial point seemed to be that doctors mostly did not examine any other diagnoses other than the “ dysphonia ” and did not dig down to any of the medical reasons when the vocal fold diagnosis of “ non- organic disorders ” was made . This should be changed in the future . This pilot study was based on a comparison of ten dysphonic patients with stroboscopic non- organic ( functional ) voice disorders , where a micro-organic diagnosis was search ed for and treated systematic ally in a medical regime ( for infections , allergies , gastrooesophageal reflux and environmental irritants such as dust , noise , etc . ) versus ten dysphonic patients with stroboscopically confirmed non-organic ( functional ) voice disorders , having only the traditional but optimal voice advice , which we can call medical voice-hygiene advice , including the use of the Accent method . A retrospective group of ten patients treated medically was included , too . A dem and can not be made that the functional group being treated by r and omisation with voice advice should also be medically treated at once , the medical approach being the new one . On the other h and , it is strange that no evidence -based research was made before . All patients were measured two times with stored videostroboscopy , a quality -of-life question naire and phonetograms with 1-month intervals . All patient groups improved . There was no statistical improvement in favour of the medical group with the voice-related quality -of-life score , also not for the group who received voice-hygiene advice . The geometrical mean values of the phonetogram areas in decibels times semitones were better in all groups , but a statistical difference was not found between the medically treated group and the voice-hygiene advice group . The pilot study showed that both medical treatment and medical voice-hygiene advice had a positive effect on dysphonia in non-organic ( functional ) voice disorders . There is need of an extensive prospect i ve r and omised trial on dysphonia including vocal cord nodules to find out which treatment should be used for this group of patients . It is suggested that an eventual r and omisation for microsurgical treatment or regular voice therapy should be made after a period of systematic medical diagnosis and treatment including medical voice-hygiene advice Previous studies of students study ing to be teachers have indicated that these students commonly have voice disorders . Ideally , voice disorders should be treated before students start their work as teachers , but the re sources for this treatment are often limited . This study examines whether group voice therapy is effective for teacher students . Accordingly , 20 teacher students with mild voice disorders received group voice therapy ( in three small groups ) , whereas 20 students with similar voice disorders served as a control group and consequently did not receive voice therapy . Two out of three outcome measures ( perceptual evaluation of voice quality and a question naire on the occurrence of vocal symptoms ) indicated significant changes in the treatment group compared with the control group . No differences between groups were noted in the laryngeal status . The results suggest that group voice therapy seems to be an effective method to treat students with mild voice disorders The aim of this study was to assess the effects on vocal function of voice therapy for vocal nodules . Perceptual and physiological progressive changes were examined during a strictly structured , behaviorally based voice therapy protocol in which 11 women with vocal nodules participated . R and omized audio recordings from pretherapy and from each of the therapy approaches ( vocal hygiene , respiration , direct facilitation , carryover ) were used for perceptual evaluations . Six speech- language pathologists rated ten voice quality parameters . Two evaluation procedures were performed and compared . Interlistener reliability was sufficiently high in both tests . Significant effects of therapy were found for decreased overall dysphonia , press , instability , gratings , roughness , vocal fry , and " scrape . " Nonsignificant group effects were found for breathiness , aphonic instances , and lack of sonority . No significant parameter changes occurred between baseline assessment and the completion of the initial ( vocal hygiene ) phase of therapy . Significant changes were found following the direct facilitation and respiration phases of therapy . Videostroboscopic evaluations made by two laryngologists showed that in no case were the nodules completely resolved . However , the nodules had decreased in size and edema was reduced after therapy for all clients , but one . Combined results suggest : ( 1 ) Alterations in vocal function were reflected in perceptual parameters , and ( 2 ) the voice therapy had a positive effect on voice quality , vocal status , and vocal function for the majority of the vocal nodule clients Traditional clinical review articles , also known as up date s , differ from systematic review s and meta-analyses . Up date s selectively review the medical literature while discussing a topic broadly . Non-quantitative systematic review s comprehensively examine the medical literature , seeking to identify and synthesize all relevant information to formulate the best approach to diagnosis or treatment . Meta-analyses ( quantitative systematic review s ) seek to answer a focused clinical question , using rigorous statistical analysis of pooled research studies . This article presents guidelines for writing an evidence -based clinical review article for American Family Physician . First , the topic should be of common interest and relevance to family practice . Include a table of the continuing medical education objectives of the review . State how the literature search was done and include several sources of evidence -based review s , such as the Cochrane Collaboration , BMJ 's Clinical Evidence , or the InfoRetriever Web site . Where possible , use evidence based on clinical outcomes relating to morbidity , mortality , or quality of life , and studies of primary care population s. In articles su bmi tted to American Family Physician , rate the level of evidence for key recommendations according to the following scale : level A ( r and omized controlled trial [ RCT ] , meta- analysis ) ; level B ( other evidence ) ; level C ( consensus/expert opinion ) . Finally , provide a table of key summary points BACKGROUND The use of outcome measures to monitor improved quality of care has been advocated for 20 years but has only achieved prominence with the increasing re source pressures and related changed in health service provision in the past 6 years . OBJECTIVE This paper describes the development of an approach to outcome measurement suitable for all patients receiving speech and language therapy . The measure , which is based on rating the dimensions of impairment , disability , h and icap and well-being , is tested to assess whether it can usefully be used to compare the services of different providers . METHOD Five trusts volunteered for the study . Service descriptions suggest that these services are typical for the purpose s of providing speech and language therapy . Twenty-five therapists were trained to use the Therapy Outcome Measure ( TOM ) ; their reliability was assessed and they provided prospect i ve data on clients with speech and language impairments related to dysphasia , stammering and dysphonia . RESULTS The study provides evidence indicating the differences in the types of patients being referred to different providers of speech and language therapy . Different services have different impacts on the number and type of domains and that services discharge patients at different points in their recovery . DISCUSSION Different outcomes by different providers may be associated with different referral policies , base population s , skills and work policies of therapists . Differences in outcomes associated with certain therapy services can initiate the task of analysing attributions and progress endeavours to provide equitable quality of care which is the philosophy underpinning the move towards benchmarking in health service delivery Transnasal flexible laryngoscopy ( TFL ) is an examination of laryngeal anatomy and physiology using continuous light . TFL is being used increasingly by voice pathologists in treatment but with little scientific evidence to support it . The purpose of this study was to evaluate the effectiveness and efficiency of TFL as a therapeutic tool . The study used a prospect i ve r and omized controlled trial . Fifty dysphonic subjects were recruited and r and
Output:
| In general , statistically significant positive but modest and varying therapy effects are found . |
MS210819 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: The aim of this study was to investigate the long-term effectiveness and safety of inhaled antibiotic treatment in non-cystic fibrosis patients with bronchiectasis and chronic infection by Pseudomonas aeruginosa , after st and ard endovenous and oral therapy for long-term control of the infection had failed . After completing a 2-week endovenous antibiotic treatment to stabilize respiratory status , 17 patients were r and omly allocated to a 12-month treatment either with inhaled ceftazidime and tobramycin ( group A ) or a symptomatic treatment ( group B ) . One patient from group A ab and oned inhaled treatment because of bronchospasm and another from group B died before the end of the study . The remaining 15 patients , seven from group A and eight from group B , completed the study . Both groups had similar previous characteristics . The number of admissions and days of admission ( mean + /- SEM ) of group A [ 0.6 ( 1.5 ) and 13.1 ( 34.8 ) ] were lower than those of group B [ 2.5 ( 2.1 ) and 57.9 ( 41.8 ) ] ( P < 0.05 ) . Forced vital capacity ( FVC ) , forced expiratory volume in 1 sec ( FEV1 ) , PAO2 and PACO2 were similar in the two groups at the end of follow-up , showing a comparable decline in these parameters . There were no significant differences either in the use of oral antibiotics or in the frequency of emergence of antibiotic-resistant bacteria between groups . Microbiological studies suggested that several patients had different Pseudomonas aeruginosa strains . None of the patients presented impaired renal or auditory function at the end of the study . This study suggests that long-term inhaled antibiotic therapy may be safe and lessen disease severity in non-cystic fibrosis patients with bronchiectasis and chronic bronchial infection by Pseudomonas aeruginosa which do not respond satisfactorily to antibiotics administered via other routes RATIONALE Bronchiectasis is a chronic debilitating disease with few evidence -based long-term treatments . OBJECTIVES A r and omized controlled trial assessing the efficacy of nebulized gentamicin therapy over 1 year in patients with non-cystic fibrosis bronchiectasis . METHODS Sixty-five patients were r and omized to either twice-daily nebulized gentamicin , 80 mg , or nebulized 0.9 % saline , for 12 months . All were review ed at three-monthly intervals during treatment and at 3 months ' follow-up . MEASUREMENTS AND MAIN RESULTS At each review the following were assessed : quantitative and qualitative sputum bacteriology ; sputum purulence and 24-hour volume ; FEV(1 ) , FVC , and forced expiratory flow , midexpiratory phase ; exercise capacity ; Leicester Cough Question naire and St. George 's Respiratory Question naire ; and exacerbation frequency . Fifty-seven patients completed the study . At the end of 12 months ' treatment , compared with the saline group , in the gentamicin group there was reduced sputum bacterial density with 30.8 % eradication in those infected with Pseudomonas aeruginosa and 92.8 % eradication in those infected with other pathogens ; less sputum purulence ( 8.7 % vs. 38.5 % ; P < 0.0001 ) ; greater exercise capacity ( 510 [ 350 - 690 ] m vs. 415 [ 267.5 - 530 ] m ; P = 0.03 ) ; and fewer exacerbations ( 0 [ 0 - 1 ] vs. 1.5 [ 1 - 2 ] ; P < 0.0001 ) with increased time to first exacerbation ( 120 [ 87 - 161.5 ] d vs. 61.5 [ 20.7 - 122.7 ] d ; P = 0.02 ) . The gentamicin group had greater improvements in Leicester Cough Question naire ( 81.4 % vs. 20 % ; P < 0.01 ) and St. George 's Respiratory Question naire ( 87.5 % vs. 19.2 % ; P < 0.004 ) score . No differences were seen in 24-hour sputum volume , FEV(1 ) , FVC , or forced expiratory flow , midexpiratory phase . No P. aeruginosa isolates developed resistance to gentamicin . At follow-up , all outcome measures were similar to baseline . CONCLUSIONS Regular , long-term nebulized gentamicin is of significant benefit in non-cystic fibrosis bronchiectasis but treatment needs to be continuous for its ongoing efficacy . Clinical trial registered with www . clinical trials.gov ( NCT 00749866 ) RATIONALE Chronic infection with Pseudomonas aeruginosa is associated with an increased exacerbation frequency , a more rapid decline in lung function , and increased mortality in patients with bronchiectasis . OBJECTIVES To perform a r and omized placebo-controlled study assessing the efficacy and safety of inhaled colistin in patients with bronchiectasis and chronic P. aeruginosa infection . METHODS Patients with bronchiectasis and chronic P. aeruginosa infection were enrolled within 21 days of completing a course of antipseudomonal antibiotics for an exacerbation . Participants were r and omized to receive colistin ( 1 million IU ; n = 73 ) or placebo ( 0.45 % saline ; n = 71 ) via the I-neb twice a day , for up to 6 months . MEASUREMENTS AND MAIN RESULTS The primary endpoint was time to exacerbation . Secondary endpoints included time to exacerbation based on adherence recorded by the I-neb , P. aeruginosa bacterial density , quality of life , and safety parameters . All analyses were on the intention-to-treat population . Median time ( 25 % quartile ) to exacerbation was 165 ( 42 ) versus 111 ( 52 ) days in the colistin and placebo groups , respectively ( P = 0.11 ) . In adherent patients ( adherence quartiles 2 - 4 ) , the median time to exacerbation was 168 ( 65 ) versus 103 ( 37 ) days in the colistin and placebo groups , respectively ( P = 0.038 ) . P. aeruginosa density was reduced after 4 ( P = 0.001 ) and 12 weeks ( P = 0.008 ) and the St. George 's Respiratory Question naire total score was improved after 26 weeks ( P = 0.006 ) in the colistin versus placebo patients , respectively . There were no safety concerns . CONCLUSIONS Although the primary endpoint was not reached , this study shows that inhaled colistin is a safe and effective treatment in adherent patients with bronchiectasis and chronic P. aeruginosa infection . Clinical trial registered with http://www.is rct n.org/ ( IS RCT N49790596 ) Rationale : Previous studies have demonstrated that long-term low-dose macrolides are efficacious in cystic fibrosis ( CF ) and diffuse panbronchiolitis , two chronic neutrophilic airway diseases . Aims : The aims of this study were to evaluate the efficacy and safety of low-dose neomacrolides as add-on therapy in patients with severe asthma and /or bronchiectasis and to identify predictors for therapeutic response . Methods : In a retrospective observational cohort study , we examined 131 adult , non-CF patients with severe asthma and /or bronchiectasis , receiving low-dose neomacrolides as add-on treatment . Pulmonary function tests and symptom scores were assessed at baseline and after 3 to 8 weeks of therapy . Results : After 3–8 weeks of treatment with low-dose neomacrolides , 108 patients were available for evaluation . In asthma patients ( n = 47 ) , pulmonary function tests and symptom scores improved significantly . Responders ( ≥7 % forced expiratory volume in one second predicted [ FEV1 % ] improvement ) were older ( 55 vs. 47 years ; p = 0.042 ) and had a longer duration of asthma ( 29 vs. 9 years ; p = 0.052 ) . In patients with bronchiectasis only ( n = 61 ) , symptom scores improved significantly . Responders ( ≥60 % symptom score improvement ) were older ( 61 vs. 53 years ; p = 0.004 ) , more frequently male ( 53 % vs. 27 % ; p = 0.043 ) , and there was a nonsignificant trend towards higher high-resolution CT ( H RCT ) score for bronchiectasis in responders ( 6.4 vs. 4.6 ; p = 0.053 ) . In multivariate logistic regression analysis , age and male gender were independent predictors for improvement in this group . Conclusion : The results of this retrospective study suggest that neomacrolides may be useful as an add-on therapy in patients with severe asthma and /or bronchiectasis . Older age may predict good response in patients with severe asthma , whereas older age , male gender and a higher H RCT score for bronchiectasis may predict therapeutic response in patients with bronchiectasis only . Prospect i ve controlled trials of neomacrolides in patients with severe asthma are needed to confirm these observations IMPORTANCE Macrolide antibiotics have been shown beneficial in cystic fibrosis ( CF ) and diffuse panbronchiolitis , and earlier findings also suggest a benefit in non-CF bronchiectasis . OBJECTIVE To determine the efficacy of macrolide maintenance treatment for adults with non-CF bronchiectasis . DESIGN , SETTING , AND PARTICIPANTS The BAT ( Bronchiectasis and Long-term Azithromycin Treatment ) study , a r and omized , double-blind , placebo-controlled trial conducted between April 2008 and September 2010 in 14 hospitals in The Netherl and s among 83 out patients with non-CF bronchiectasis and 3 or more lower respiratory tract infections in the preceding year . INTERVENTIONS Azithromycin ( 250 mg daily ) or placebo for 12 months . MAIN OUTCOME MEASURES Number of infectious exacerbations during 12 months of treatment . Secondary end points included lung function , sputum bacteriology , inflammatory markers , adverse effects , symptom scores , and quality of life . RESULTS Forty-three participants ( 52 % ) received azithromycin and 40 ( 48 % ) received placebo and were included in the modified intention-to-treat analysis . At end of study , the median number of exacerbations in the azithromycin group was 0 ( interquartile range [ IQR ] , 0 - 1 ) , compared with 2 ( IQR , 1 - 3 ) in the placebo group ( P < .001 ) . Thirty-two ( 80 % ) placebo-treated vs 20 ( 46 % ) azithromycin-treated individuals had at least 1 exacerbation ( hazard ratio , 0.29 [ 95 % CI , 0.16 - 0.51 ] ) . In a mixed-model analysis , change in forced expiratory volume in the first second of expiration ( percent of predicted ) over time differed between groups ( F1,78.8 = 4.085 , P = .047 ) , with an increase of 1.03 % per 3 months in the azithromycin group and a decrease of 0.10 % per 3 months in the placebo group . Gastrointestinal adverse effects occurred in 40 % of patients in the azithromycin group and in 5 % in the placebo group ( relative risk , 7.44 [ 95 % CI , 0.97 - 56.88 ] for abdominal pain and 8.36 [ 95 % CI , 1.10 - 63.15 ] for diarrhea ) but without need for discontinuation of study treatment . A macrolide resistance rate of 88 % was noted in azithromycin-treated individuals , compared with 26 % in the placebo group . CONCLUSIONS AND RELEVANCE Among adults with non-CF bronchiectasis , the daily use of azithromycin for 12 months compared with placebo result ed in a lower rate of infectious exacerbations . This could result in better quality of life and might influence survival , although effects on antibiotic resistance need to be considered . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00415350 Background The delivery of antipseudomonal antibiotics by inhalation to Pseudomonas aeruginosa-infected subjects with non-cystic fibrosis ( CF ) bronchiectasis is a logical extension of treatment strategies successfully developed in CF bronchiectasis . Dual release ciprofloxacin for inhalation ( DRCFI ) contains liposomal ciprofloxacin , formulated to optimise airway antibiotic delivery . Methods Phase II , 24-week Australian/New Zeal and multicentre , r and omised , double-blind , placebo-controlled trial in 42 adult bronchiectasis subjects with ≥2 pulmonary exacerbations in the prior 12 months and ciprofloxacin-sensitive P aeruginosa at screening . Subjects received DRCFI
Output:
| Studies of inhaled tobramycin have revealed conflicting results regarding quality of life ( QoL ) , exacerbations and admissions , but may result in sputum cultures negative for Pseudomonas aeruginosa , whereas studies investigating the effect of inhaled gentamycin have shown positive effects on sputum bacterial density , decrease in sputum cultures positive for P. aeruginosa , QoL and exacerbation rate , but no improvement in forced expiratory volume in first second ( FEV1 ) .
Oral azithromycin can reduce exacerbations , together with minor improvements in QoL and FEV1 .
Furthermore , oral erythromycin reduces exacerbations , but has no effect on lung function , symptoms or QoL. Inhaled ciprofloxacin may reduce P. aeruginosa in sputum cultures , but without changes in lung function , exacerbations or QoL. Although with limited evidence , inhaled colistin may have effects on P. aeruginosa density , exacerbations and QoL , whereas studies on aztreonam revealed no significant clinical improvements in the outcomes of interest , including exacerbation rate .
Adverse events , including bronchospasm , have been reported in association with tobramycin and aztreonam .
Several antibiotic treatment regimens have been shown to improve QoL and exacerbation rate , whereas findings regarding sputum production , lung function and admissions have been conflicting . |
MS210820 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: OBJECTIVES A r and omized , placebo-controlled , double-blind trial of the relative effectiveness of glucosamine sulphate and placebo in managing pain in osteoarthritis ( OA ) of the knee . METHODS Eighty patients with OA of the knee were recruited from a rheumatology out-patient clinic and received either glucosamine sulphate 1500 mg daily for 6 months or dummy placebo . The primary outcome measure was patients ' global assessment of pain in the affected knee . RESULTS Area under the curve analysis for the primary outcome measure showed no difference between placebo and glucosamine [ mean difference 0.15 mm , 95 % confidence interval ( CI ) -8.78 to 9.07 ] . The placebo response was 33 % . There was a statistically significant difference between groups in knee flexion ( mean difference 13 degrees , 95 % CI -23.13 to -1.97 ) , but this difference was small and could have been due to measurement error . CONCLUSIONS As a symptom modifier in OA patients with a wide range of pain severities , glucosamine sulphate was no more effective than placebo Objective : To investigate the efficacy of a Mediterranean diet ( MD ) versus an ordinary Western diet for suppression of disease activity in patients with rheumatoid arthritis ( RA ) . Methods : Patients with well controlled , although active RA of at least two years ’ duration , who were receiving stable pharmacological treatment , were invited to participate . All patients were r and omly allocated to the MD or the control diet ( CD ) . To achieve good compliance with prescribed diets all patients were for the first three weeks served the MD or the CD , respectively , for lunch and dinner at the outpatient clinic ’s canteen . Clinical examinations were performed at baseline , and again in the 3rd , 6th , and 12th week . A composite disease activity index ( DAS28 ) , a physical function index ( Health Assessment Question naire ( HAQ ) ) , a health survey of quality of life ( Short Form-36 ( SF-36 ) ) , and the daily consumption of non-steroidal anti-inflammatory drugs were used as primary efficacy variables . Results : From baseline to the end of the study the patients in the MD group ( n=26 ) showed a decrease in DAS28 of 0.56 ( p<0.001 ) , in HAQ of 0.15 ( p=0.020 ) , and in two dimensions of the SF-36 Health Survey : an increase in “ vitality ” of 11.3 ( p=0.018 ) and a decrease in “ compared with one year earlier ” of 0.6 ( p=0.016 ) . For the control patients ( n=25 ) no significant change was seen at the end of the study . This difference between the two treatment groups was notable only in the second half of the trial . Conclusion : The results indicate that patients with RA , by adjusting to a Mediterranean diet , did obtain a reduction in inflammatory activity , an increase in physical function , and improved vitality Background The purpose of the present study was to examine the effectiveness of an anti-inflammatory intervention as a treatment for neuropathic pain following spinal cord injury ( SCI ) . Methods This r and omized , parallel-group , controlled clinical trial ( NCT02099890 ) examined 20 participants with varying levels and severities of SCI , r and omized ( 3:2 ) to either a 12-week anti-inflammatory diet , or control group . Outcome measures consisted of self-determined indices of pain as assessed using the neuropathic pain question naire ( NPQ ) and markers of inflammation as assessed by various pro- and anti-inflammatory cytokines , as well as the eicosanoids PGE2 and LTB4 . Results A significant group × time interaction was found for sensory pain scores ( p < 0.01 ) . A Mann-Whitney test revealed that the change scores ( 3-month baseline ) were significantly different between groups for IFN-y ( U = 13.0 , p = 0.01 ) , IL-1β ( U = 14.0 , p = 0.01 ) , and IL-2 ( U = 12.0 , p = 0.01 ) . A Friedman test revealed the treatment group had a significant reduction in IFN-y ( x2 = 8.67 , p = 0.01 ) , IL-1β ( x2 = 17.78 , p < 0.01 ) , IL-6 ( x2 = 6.17 , p < 0.05 ) , while the control group showed no significant change in any inflammatory mediator . A stepwise backward elimination multiple regression analysis showed that the change in sensory neuropathic pain was a function of the change in the proinflammatory cytokines IL-2 and IFN-y , as well as the eicosanoid PGE2 ( R = 0.689 , R2 = 0.474 ) . Conclusions Overall , the results of the study demonstrate the efficacy of targeting inflammation as a means of treating neuropathic pain in SCI , with a potential mechanism relating to the reduction in proinflammatory cytokines and PGE2.Trial registration Clinical Trials.gov , Objective . To evaluate the effectiveness of a whole-foods , plant-based diet ( WFPB ) to reduce symptoms of osteoarthritis . Methods . Six-week , prospect i ve r and omized open-label study of patients aged 19–70 with osteoarthritis . Participants were r and omized to a WFPB ( intervention ) or continuing current diet ( control ) . Outcomes were assessed by mixed models analysis of participant self-assessed weekly SF-36v2 domain t scores , weekly Patient Global Impression of Change ( PGIC ) scales , and mean weekly Visual Analog Scale ( VAS ) pain assessment . Mixed models analysis also evaluated pre-post change from baseline level for st and ard clinical measures : weight , BMI , body temperature , pulse , and blood pressure . Results . Forty participants were r and omized . Thirty-seven of them , 18 control and 19 intervention , completed the study . The intervention group reported a significantly greater improvement than the control group in SF-36v2 energy/vitality , physical functioning , role physical , and the physical component summary scale . The differences between the intervention and control PGIC scales were statistically significant over time . Intervention group improvement in VAS weekly mean was also significantly greater than that of the control group from week 2 onward . Conclusion . Study results suggest that a whole-foods , plant-based diet significantly improves self-assessed measures of functional status among osteoarthritis patients Background Osteoarthritis ( OA ) is a slowly destructive process that may be influenced by a nutritional mineral balance in the body . Methods This small , double blind , placebo controlled pilot study investigated the impact of treatment with a natural multi-mineral supplement from seaweed ( Aquamin ) on 6 minute walking distance ( 6 MWD ) , range of motion ( ROM ) , and pain and joint mobility measured by the Western Ontario and McMaster Universities ( WOMAC ) Osteoarthritis Index in subjects with moderate to severe OA of the knee during gradual withdrawal of non-steroidal anti-inflammatory drugs ( NSAIDs ) that were being used daily for pain management . Subjects ( n = 29 ) with moderate to severe OA of the knee were r and omised to receive either Aquamin ( 2400 mg/d ) or Placebo for up to 12 weeks . Results Of the 29 subjects initially r and omized , only 22 subjects proceeded to treatment due to 7 subjects not meeting study selection criteria at baseline . Fourteen subjects completed the study and an ITT analysis ( n = 22 ) of the data showed no significant differences in WOMAC scores however , the data did reveal significant improvements in passive and active extension ROM ( 0.83 ° ± 1.54 vs. -1.54 ° ± 2.43 ; difference , 5.2 ° ± 2.2 , p = 0.028 ) and 6 MWD ( 150 ± 48 ft vs. 12.5 ± 31.5 ft ; difference , 136 ± 57 ft , p = 0.03 ) in the Aquamin group compared to the placebo group ; respectively , following a 50 % reduction in NSAID use . The treatments were well tolerated and the adverse event profiles were not significantly different between the groups . Conclusion This small preliminary study suggests Aquamin may increase range of motion and walking distances in subjects with OA of the knee and may allow partial withdrawal of NSAIDs over 12 weeks of treatment . Additional research is needed to confirm these preliminary observations . Trial registration Background and Aims : Patients with fibromyalgia frequently present with symptoms similar to those experienced by patients with gluten-related disorders , raising the possibility that a subgroup of these patients could be experiencing underlying gluten sensitivity . This study aim ed to evaluate the effects of a gluten-free diet ( GFD ) compared with a hypocaloric diet ( HCD ) among patients with fibromyalgia . Methods : Adult patients diagnosed with fibromyalgia were r and omly allocated to receive a GFD or a HCD over a 24-week period . The primary outcome measure was the change in the number of gluten sensitivity symptoms . The following secondary outcomes were evaluated : body mass index , Revised Fibromyalgia Impact Question naire , Pittsburgh Sleep Quality Index , Brief Pain Inventory , Beck Depression Inventory-II , State-Trait Anxiety Inventory , Short-Form Health Survey , Patient Global Impression Scale of Severity , Patient Global Impression Scale of Improvement , and adverse events . Results : Seventy-five subjects were r and omly allocated to receive either a GFD ( n=35 ) or an HCD ( n=40 ) . The least squares mean change in the total number of gluten sensitivity symptoms from baseline did not differ significantly between the GFD and HCD groups ( −2.44±0.40 for the GFD ; −2.10±0.37 for the HCD ; P=0.343 ) . Similarly , the 2 dietary interventions did not differ in any of the remaining measured secondary outcomes . Both dietary interventions were well tolerated . Conclusions : Both dietary interventions were associated with similar beneficial outcomes in reducing gluten sensitivity symptoms and other secondary outcomes . However , despite its specificity , GFD was not superior to HCD in reducing the number of gluten sensitivity symptoms or secondary outcomes Plants are rich natural sources of antioxidants in addition to other nutrients . Interventions and cross sectional studies on subjects consuming uncooked vegan diet called living food ( LF ) have been carried out . We have clarified the efficacy of LF in rheumatoid diseases as an example of a health problem where inflammation is one of the main concerns . LF is an uncooked vegan diet and consists of berries , fruits , vegetables and roots , nuts , germinated seeds and sprouts , i.e. rich sources of carotenoids , vitamins C and E. The subjects eating LF showed highly increased levels of beta and alfa carotenes , lycopen and lutein in their sera . Also the increases of vitamin C and vitamin E ( adjusted to cholesterol ) were statistically significant . As the berry intake was 3-fold compared to controls the intake of polyphenolic compounds like quercetin , myricetin and kaempherol was much higher than in the omnivorous controls . The LF diet is rich in fibre , substrate of lignan production , and the urinary excretion of polyphenols like enterodiol and enterolactone as well as secoisolaricirecinol were much increased in subjects eating LF . The shift of fibromyalgic subjects to LF result ed in a decrease of their joint stiffness and pain as well as an improvement of their self-experienced health . The rheumatoid arthritis patients eating the LF diet also reported similar positive responses and the objective measures supported this finding . The improvement of rheumatoid arthritis was significantly correlated with the day-to-day fluctuation of subjective symptoms . In conclusion the rheumatoid patients subjectively benefited from the vegan diet rich in antioxidants , lactobacilli and fibre , and this was also seen in objective measures Objective : Pain is a common complaint among postmenopausal women . It has been postulated that vascular dysfunction caused by estrogen decline at menopause plays a key role in the initiation and progression of degradative joint disease , namely age-related osteoarthritis . We evaluated whether supplementation with resveratrol , a phytoestrogen , could improve aspects of well-being such as chronic pain that is commonly experienced by postmenopausal women . Methods : A 14-week r and omized , double-blind , placebo-controlled intervention with trans-resveratrol ( 75 mg , twice daily ) was conducted in 80 healthy postmenopausal women . Aspects of well-being , including pain , menopausal symptoms , sleep quality , depressive symptoms , mood states , and quality of life were assessed by Short form-36 at baseline and at the end of treatment . Rating scales were averaged to provide a composite score representing overall well-being . Cerebral vasodilator responsiveness to hypercapnia was also assessed as a surrogate marker for cerebrovascular function . Results : Compared with placebo treatment , there was a significant reduction in pain and an improvement in total well-being after resveratrol supplementation . Both benefits , including measures of quality of life , correlated with improvements in cerebrovascular function . Conclusions : Our preliminary findings indicate potential for resveratrol treatment to reduce chronic pain in age-related osteoarthritis . Resveratrol consumption may also boost perceptions of well-being in postmenopausal women . Further investigation to eluci date underlying mechanisms is warr
Output:
| The meta- analysis found that , overall , nutrition interventions had a significant effect on pain reduction with studies testing an altered overall diet or just one nutrient having the greatest effect .
This review highlights the importance and effectiveness of nutrition interventions for people who experience chronic pain |
MS210821 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: PURPOSE The purpose of this prospect i ve study was to examine rates and risk factors for overuse injuries among 824 women during Marine Corps Recruit Depot basic training at Parris Isl and , SC , in 1999 . METHODS Data collected included training day exposures ( TDE ) , baseline performance on a st and ardized 1.5-mile timed run , and a pretraining question naire highlighting exercise and health habits . The women were followed during training for occurrence of stress fracture and other lower-extremity overuse injury . RESULTS There were 868 lower-extremity overuse injuries for an overall injury rate of 12.6/1000 TDE . Rates for initial and subsequent injury were 8.7/1000 and 20.7/1000 TDE , respectively . There were 66 confirmed lower-extremity stress fractures among 56 ( 6.8 % ) women ( 1.0/1000 TDE ) . Logistic regression modeling indicated that low aerobic fitness ( a slower time on the timed run ( > 14.4 min ) ) , no menses in six or more consecutive months during the past year , and less than 7 months of lower-extremity weight training were significantly associated with stress fracture incidence . Self-rated fair-poor fitness at baseline was the only variable significantly associated with other non-stress fracture overuse injury during basic training . CONCLUSIONS Among this sample of women , the risk of lower-extremity overuse injury was high , with a twofold risk of subsequent injury . The results suggest that stress fracture injury might be decreased if women entered training with high aerobic fitness and participated frequently in lower-extremity strength training . Furthermore , women reporting a history of menstrual irregularity at their initial medical exam may require closer observation during basic training Strenuously exercising young women with hypothalamic amenorrhea are hypoleptinemic and have low bone mineral density ( BMD ) and content ( BMC ) , which predispose them to increased fracture risk . Short-term leptin replacement in these women corrects many neuroendocrine abnormalities and increases circulating levels of bone formation markers . Whether treatment with recombinant methionyl human leptin ( metreleptin ) for a long period improves BMD and BMC remains unknown . We studied 20 strenuously exercising young women with hypoleptinemia ( leptin concentration < 5 ng/mL ) and hypothalamic amenorrhea of at least 6 months ' duration . Eleven were r and omized to metreleptin ( initial dose , 0.08 mg/[kg·d ] for 3 months ; altered thereafter to 0.12 mg/kg for lack of efficacy or 0.04 mg/[kg d ] for more than 5 % weight loss ) and 9 were r and omized to placebo for 9 months . After a 3-month washout period , subjects were reexamined at the 1-year time point . Six subjects elected to continue on open-label metreleptin treatment for another 12 months . Two subjects dropped out after 18 months , and 4 completed the entire 2-year study . The BMD and BMC of the total body , lumbar spine ( L1-L4 ) , hip , and radius were assessed by using dual-energy x-ray absorptiometry at baseline and at 3 , 6 , 9 , 12 , 18 , and 24 months of treatment . Metabolic and hormonal parameters and bone markers were measured in blood and urine . Metreleptin significantly increased BMC ( P = .034 ) and tended to increase BMD ( P = .069 ) at the lumbar spine at 9 months in the entire study group ( intention-to-treat analysis ) . In subjects who completed the entire 2-year study ( n = 4 ) , metreleptin significantly increased BMD ( P = .024 ) and BMC ( P = .049 ) at the lumbar spine by 4 % to 6 % . Changes were not significant at the whole body , hip , and radius . Changes in hormonal and metabolic parameters and bone markers were moderate during the first year of treatment , but metreleptin further increased insulin-like growth factor 1 and decreased cortisol and cross-linked C-terminal telopeptide of type 1 collagen concentrations in serum during the second year of treatment ( P < .05 ) . The incremental area under the estradiol concentration curve over the 2-year course of the study correlated positively with the corresponding increase in lumbar spine BMD ( ρ = 0.42 , P = .039 ) . Long-term metreleptin administration in strenuously exercising young women with hypothalamic amenorrhea and hypoleptinemia increases lumbar spine BMD and BMC and alters bone remodeling milieu to favor bone accretion . Results from this pilot study should be confirmed by future , larger clinical trials and need to be extended by study ing bone microarchitecture and fracture risk PURPOSE To identify risk factors for stress fracture among young female distance runners . METHODS Participants were 127 competitive female distance runners , aged 18 - 26 , who provided at least some follow-up data in a r and omized trial among 150 runners of the effects of oral contraceptives on bone health . After completing a baseline question naire and undergoing bone densitometry , they were followed an average of 1.85 yr . RESULTS Eighteen participants had at least one stress fracture during follow-up . Baseline characteristics associated ( P<0.10 ) in multivariate analysis with stress fracture occurrence were one or more previous stress fractures ( rate ratio [ RR ] [ 95 % confidence interval]=6.42 ( 1.80 - 22.87 ) , lower whole-body bone mineral content ( RR=2.70 [ 1.26 - 5.88 ] per 1-SD [ 293.2 g ] decrease ) , younger chronologic age ( RR=1.42 [ 1.05 - 1.92 ] per 1-yr decrease ) , lower dietary calcium intake ( RR=1.11 [ 0.98 - 1.25 ] per 100-mg decrease ) , and younger age at menarche ( RR=1.92 [ 1.15 - 3.23 ] per 1-yr decrease ) . Although not statistically significant , a history of irregular menstrual periods was also associated with increased risk ( RR=3.41 [ 0.69 - 16.91 ] ) . Training-related factors did not affect risk . CONCLUSION The results of this and other studies indicate that risk factors for stress fracture among young female runners include previous stress fractures , lower bone mass , and , although not statistically significant in this study , menstrual irregularity . More study is needed of the associations between stress fracture and age , calcium intake , and age at menarche . Given the importance of stress fractures to runners , identifying preventive measures is of high priority CONTEXT Stress fractures are common in endurance athletes . Whereas studies have described distal tibia bone structure in athletes , there are few data regarding hip geometric parameters . Hip structural analysis ( HSA ) using dual-energy x-ray absorptiometry is a vali date d technique to assess hip bone structure . OBJECTIVES The purpose of this study was to compare hip geometry in young oligoamenorrheic athletes ( AAs ) , eumenorrheic athletes ( EAs ) , and nonathletes using HSA . We hypothesized that AAs would have impaired bone structure compared with that of EAs . DESIGN This was a cross-sectional study . SETTING The setting was a clinical research center . SUBJECTS We enrolled 55 AAs , 24 EAs , and 23 nonathletes of normal weight who were 14 to 22 years old . Athletes ran ≥20 miles/wk or were engaged in weight-bearing sports for ≥4 hours/wk . MAIN OUTCOME MEASURES Dual-energy x-ray absorptiometry was used for HSA and hip areal bone mineral density ( aBMD ) . RESULTS Hip aBMD Z-scores were lower in AAs and in nonathletes than in EAs ( P = .002 ) . A larger proportion of AAs than EAs and nonathletes had hip Z-scores < -1 ( 30.9 , 4.2 , 17.4 % , P = .01 ) . At the narrow neck , trochanteric region , and femoral shaft , subperiosteal width , cross-sectional moment of inertia , and section modulus were higher in EAs than in nonathletes ; values in AAs did not differ from those of nonathletes . Cross-sectional area was lower in AAs and in nonathletes than in EAs . Groups did not differ for cortical thickness or buckling ratio . Group differences were lost after adjustment for lean mass but not aBMD . CONCLUSIONS In an eugonadal state , athletic activity confers benefits for hip structure independent of aBMD . This advantage is lost in AAs , who do not differ from nonathletes for most parameters and fare worse than EAs for cross-sectional area Studies of stress fracture ( SF ) incidence are limited in number and geographical location ; this study determined the incidence of SF injury in female endurance athletes based in the United Kingdom . A total of 70 athletes aged between 18 and 45 years were recruited and prospect ively monitored for 12 months . Question naires at baseline and 12 months assessed SF , menstrual and training history , eating psychopathology , and compulsive exercise . Peak lower leg muscle strength was assessed in both legs using an isometric muscle rig . Bone mineral density ( BMD ) of total body , spine , hip , and radius was assessed using dual X-ray absorptiometry . Among the 61 athletes who completed the 12-month monitoring , two sustained a SF diagnosed by magnetic resonance imaging , giving an incidence rate ( 95 % confidence intervals ) of 3.3 ( 0.8 , 13.1 ) % of the study population sustaining a SF over 12 months . The SF cases were 800 m runners aged 19 and 22 years , training on average 14.2 h a week , eumenorrheic with no history of menstrual dysfunction . Case 1 had a higher than average energy intake and low eating psychopathology and compulsive exercise scores , while the reverse was true in case 2 . BMD in both cases was similar to mean values in the non-SF group . The incidence of SF in our female endurance athlete population based in the United Kingdom was 3.3 % , which is lower than previously reported . Further work is needed to confirm the current incidence of SF and evaluate the associated risk factors Introduction Osteoporosis is associated with increased risk for fracture . However , most postmenopausal women have bone mineral density ( BMD ) within the normal or osteopenic range . The aim of this study was to determine the proportion of the population burden of fragility fractures arising from women at modest risk for fracture . Methods We measured baseline BMD in a population -based r and om sample of 616 postmenopausal women aged 60–94 years and followed these individuals for a median of 5.6 years ( IQR 3.9–6.5 ) to determine the incidence of fractures according to age , BMD and the presence of a prior fracture . Results Based on WHO criteria , 37.6 % of the women had normal total hip BMD , 48.0 % had osteopenia and 14.5 % had osteoporosis . The incidence of fracture during follow-up was highest in women with osteoporosis , but only 26.9 % of all fractures arose from this group ; 73.1 % occurred in women without osteoporosis ( 56.5 % in women with osteopenia , 16.6 % in women with normal BMD ) . Decreasing BMD , increasing age and prior fracture contributed independently to increased fracture risk ; in a multivariate model , the relative risk for fracture increased 65 % for each SD decrease in BMD ( RR=1.65 , 95%CI 1.32–2.05 ) , increased 3 % for every year of age ( RR=1.03 , 95%CI 1.01–1.06 ) and doubled with prevalent fracture ( RR=2.01 , 95 % CI 1.40–2.88 ) . A prevalent fracture increased the risk for fractures such that women with osteopenia and prevalent fracture had the same , if not greater , risk as women with osteoporosis alone . Conclusions Reducing the population burden of fractures requires attention to women with osteopenia , as well as osteoporosis , because over half of the fragility fractures in the population arise in these individuals , and women with osteopenia plus a prevalent fracture have the same fracture risk as women with osteoporosis A prospect i ve study of 295 infantry recruits has shown that the mediolateral width of the tibia measured radiographically at each of three different levels in the bone had a statistically significant correlation with the total incidence of stress fractures as well as with those in the tibia alone or the femur alone . A narrow tibial width was shown to be a risk factor , but cortical thickness was not found to be significant UNLABELLED The cumulative effect of the female athlete triad ( Triad ) risk factors on the likelihood of low bone mineral density ( BMD ) in exercising women is unclear . PURPOSE This study aim ed to determine the risk of low BMD in exercising women with multiple Triad risk factors . METHODS We retrospectively examined cross-sectional data from 437 exercising women ( mean ± SD age of 18.0 ± 3.5 yr , weighed 57.5 ± 7.1 kg with 24
Output:
| Bone area and cortical thickness at the tibia were identified as altered both in women with menstrual disturbances and in women with stress fractures ; however , there was inconsistency in the results observed for all bone parameters .
The majority of skeletal parameters of the lower extremities were not significantly different between exercising women with and without stress fractures and between those with and without menstrual disturbances .
The lack of observed differences in skeletal parameters suggests that risk factors other than bone geometry and structure may be the primary causes of stress fracture in these women |
MS210822 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: The effects of metformin therapy on whole body and splanchnic amino acid turnover are not known . Therefore , we have studied fasting and postpr and ial phenylalanine kinetics in type 2 diabetic subjects ( non-insulin-dependent diabetes mellitus ) , previously treated with diet only , both before and after 4 weeks of either metformin ( 850 mg twice a day ) ( n = 11 ) or placebo administration ( n = 6 ) . Phenylalanine kinetic was evaluated by means of a multiple isotope technique : tritiated phenylalanine was infused i.v . , whereas carbon-labeled phenylalanine was incorporated into a chemically-defined meal . Compared with placebo , metformin administration decreased both fasting ( from 162 + /- 17 to 141 + /- 20 mg/dl ) and postpr and ial ( from 217 + /- 20 to 164 + /- 20 mg/dl ) glucose concentrations ( P < 0.05-P < 0.01 ) . Fasting insulin concentrations were unaffected , but postmeal insulin tended to be lower ( P < 0.06 ) after metformin . Compared with the pretreatment period , metformin administration did not change total phenylalanine rate of appearance ( fasted state , 0.74 + /- 0.10 vs. 0.71 + /- 0.08 mumol/kg.min ; fed state , 0.77 + /- 0.10 vs. 0.75 + /- 0.08 mumol/kg.min , respectively ) , dietary and endogenous phenylalanine rate of appearance , dietary phenylalanine oxidation , and splanchnic uptake , similar to what was observed in the placebo group . Our data indicate that , at least after a 4-week treatment , metformin does not affect fasting and postpr and ial protein turnover , as indicated by phenylalanine data , in subjects with mild non-insulin-dependent diabetes mellitus Rosiglitazone , a thiazolidinedione , enhances peripheral insulin sensitivity in patients with type 2 diabetes . Because the synergic action of insulin and exercise has been shown to be decreased in insulin resistance , the aim of this study was to compare the effects of rosiglitazone and metformin on muscle insulin responsiveness at rest and during exercise in patients with type 2 diabetes . Therefore , 45 patients with newly diagnosed or diet-treated type 2 diabetes were r and omized for treatment with rosiglitazone ( 4 mg b.i.d . ) , metformin ( 1 g b.i.d . ) , or placebo in a 26-week double-blind trial . Skeletal muscle glucose uptake was measured using fluorine-18-labeled fluoro-deoxy-glucose and positron emission tomography ( PET ) during euglycemic-hyperinsulinemic clamp and one-legged exercise before and after the treatment period . Rosiglitazone ( P < 0.05 ) and metformin ( P < 0.0001 ) treatment lowered the mean glycosylated hemoglobin . The skeletal muscle glucose uptake was increased by 38 % ( P < 0.01 ) and whole-body glucose uptake by 44 % in the rosiglitazone group . Furthermore , the exercise-induced increment during insulin stimulation was enhanced by 99 % ( P < 0.0001 ) . No changes were observed in skeletal muscle or whole-body insulin sensitivity in the metformin group . In conclusion , rosiglitazone but not metformin 1 ) improves insulin responsiveness in resting skeletal muscle and 2 ) doubles the insulin-stimulated glucose uptake rate during physical exercise in patients with type 2 diabetes . Our results suggest that rosiglitazone improves synergic action of insulin and exercise Flaws in the design , conduct , analysis , and reporting of r and omised trials can cause the effect of an intervention to be underestimated or overestimated . The Cochrane Collaboration ’s tool for assessing risk of bias aims to make the process clearer and more OBJECTIVES This study was design ed to assess the effect of metformin on impaired endothelial function in type 2 diabetes mellitus . BACKGROUND Abnormalities in vascular endothelial function are well recognized among patients with type 2 ( insulin-resistant ) diabetes mellitus . Insulin resistance itself may be central to the pathogenesis of endothelial dysfunction . The effects of metformin , an antidiabetic agent that improves insulin sensitivity , on endothelial function have not been reported . METHODS Subjects with diet-treated type 2 diabetes but without the confounding collection of cardiovascular risk factors seen in the metabolic syndrome were treated with metformin 500 mg twice daily ( n = 29 ) or placebo ( n = 15 ) for 12 weeks . Before and after treatment , blood flow responses to intraarterial administration of endothelium-dependent ( acetylcholine ) , endothelium-independent ( sodium nitroprusside ) and nitrate-independent ( verapamil ) vasodilators were measured using forearm plethysmography . Whole-body insulin resistance was assessed on both occasions using the homeostasis model ( HOMA-IR ) . RESULTS Subjects who received metformin demonstrated statistically significant improvement in acetylcholine-stimulated flows compared with those treated with placebo ( p = 0.0027 by 2-way analysis of variance ) , whereas no significant effect was seen on nitroprusside-stimulated ( p = 0.27 ) or verapamil-stimulated ( p = 0.40 ) flows . There was a significant improvement in insulin resistance with metformin ( 32.5 % reduction in HOMA-IR , p = 0.01 ) , and by stepwise multivariate analysis insulin resistance was the sole predictor of endothelium-dependent blood flow following treatment ( r = -0.659 , p = 0.0012 ) . CONCLUSIONS Metformin treatment improved both insulin resistance and endothelial function , with a strong statistical link between these variables . This supports the concept of the central role of insulin resistance in the pathogenesis of endothelial dysfunction in type 2 diabetes mellitus . This has important implication s for the investigation and treatment of vascular disease in patients with type 2 diabetes mellitus BACKGROUND Sulfonylurea drugs have been the only oral therapy available for patients with non-insulin-dependent diabetes mellitus ( NIDDM ) in the United States . Recently , however , metformin has been approved for the treatment of NIDDM . METHODS We performed two large , r and omized , parallel-group , double-blind , controlled studies in which metformin or another treatment was given for 29 weeks to moderately obese patients with NIDDM whose diabetes was inadequately controlled by diet ( protocol 1 : metformin vs. placebo ; 289 patients ) , or diet plus glyburide ( protocol 2 : metformin and glyburide vs. metformin vs. glyburide ; 632 patients ) . To determine efficacy we measured plasma glucose ( while the patients were fasting and after the oral administration of glucose ) , lactate , lipids , insulin , and glycosylated hemoglobin before , during , and at the end of the study . RESULTS In protocol 1 , at the end of the study the 143 patients in the metformin group , as compared with the 146 patients in the placebo group , had lower mean ( + /- SE ) fasting plasma glucose concentrations ( 189 + /- 5 vs. 244 + /- 6 mg per deciliter [ 10.6 + /- 0.3 vs. 13.7 + /- 0.3 mmol per liter ] , P < 0.001 ) and glycosylated hemoglobin values ( 7.1 + /- 0.1 percent vs. 8.6 + /- 0.2 percent , P < 0.001 ) . In protocol 2 , the 213 patients given metformin and glyburide , as compared with the 210 patients treated with glyburide alone , had lower mean fasting plasma glucose concentrations ( 187 + /- 4 vs. 261 + /- 4 mg per deciliter [ 10.5 + /- 0.2 vs. 14.6 + /- 0.2 mmol per liter ] , P < 0.001 ) and glycosylated hemoglobin values ( 7.1 + /- 0.1 percent vs. 8.7 + /- 0.1 percent , P < 0.001 ) . The effect of metformin alone was similar to that of glyburide alone . Eighteen percent of the patients given metformin and glyburide had symptoms compatible with hypoglycemia , as compared with 3 percent in the glyburide group and 2 percent in the metformin group . In both protocol s the patients given metformin had statistically significant decreases in plasma total and low-density lipoprotein cholesterol and triglyceride concentrations , whereas the values in the respective control groups did not change . There were no significant changes in fasting plasma lactate concentrations in any of the groups . CONCLUSIONS Metformin monotherapy and combination therapy with metformin and sulfonylurea are well tolerated and improve glycemic control and lipid concentrations in patients with NIDDM whose diabetes is poorly controlled with diet or sulfonylurea therapy alone OBJECTIVE To determine the effect of metformin on the acute metabolic response to submaximal exercise , the effect of exercise on plasma metformin concentrations , and the interaction between metformin and exercise on the subsequent response to a st and ardized meal . RESEARCH DESIGN AND METHODS Ten participants with type 2 diabetes were recruited for this r and omized crossover study . Metformin or placebo was given for 28 days , followed by the alternate condition for 28 days . On the last 2 days of each condition , participants were assessed during a nonexercise and a subsequent exercise day . Exercise took place in the morning and involved a total of 35 min performed at three different submaximal intensities . RESULTS Metformin increased heart rate and plasma lactate during exercise ( both P ≤ 0.01 ) but lowered respiratory exchange ratio ( P = 0.03 ) without affecting total energy expenditure , which suggests increased fat oxidation . Metformin plasma concentrations were greater at several , but not all , time points on the exercise day compared with the nonexercise day . The glycemic response to a st and ardized meal was reduced by metformin , but the reduction was attenuated when exercise was added ( metformin × exercise interaction , P = 0.05 ) . Glucagon levels were highest in the combined exercise and metformin condition . CONCLUSIONS This study reveals several ways by which metformin and exercise therapies can affect each other . By increasing heart rate , metformin could lead to the prescription of lower exercise workloads . Furthermore , under the tested conditions , exercise interfered with the glucose-lowering effect of metformin BACKGROUND In patients with type 2 diabetes , intensive blood-glucose control with insulin or sulphonylurea therapy decreases progression of microvascular disease and may also reduce the risk of heart attacks . This study investigated whether intensive glucose control with metformin has any specific advantage or disadvantage . METHODS Of 4075 patients recruited to UKPDS in 15 centres , 1704 overweight ( > 120 % ideal bodyweight ) patients with newly diagnosed type 2 diabetes , mean age 53 years , had raised fasting plasma glucose ( FPG ; 6.1 - 15.0 mmol/L ) without hyperglycaemic symptoms after 3 months ' initial diet . 753 were included in a r and omised controlled trial , median duration 10.7 years , of conventional policy , primarily with diet alone ( n=411 ) versus intensive blood-glucose control policy with metformin , aim ing for FPG below 6 mmol/L ( n=342 ) . A secondary analysis compared the 342 patients allocated metformin with 951 overweight patients allocated intensive blood-glucose control with chlorpropamide ( n=265 ) , glibenclamide ( n=277 ) , or insulin ( n=409 ) . The primary outcome measures were aggregates of any diabetes-related clinical endpoint , diabetes-related death , and all-cause mortality . In a supplementary r and omised controlled trial , 537 non-overweight and overweight patients , mean age 59 years , who were already on maximum sulphonylurea therapy but had raised FPG ( 6.1 - 15.0 mmol/L ) were allocated continuing sulphonylurea therapy alone ( n=269 ) or addition of metformin ( n=268 ) . FINDINGS Median glycated haemoglobin ( HbA1c ) was 7.4 % in the metformin group compared with 8.0 % in the conventional group . Patients allocated metformin , compared with the conventional group , had risk reductions of 32 % ( 95 % CI 13 - 47 , p=0.002 ) for any diabetes-related endpoint , 42 % for diabetes-related death ( 9 - 63 , p=0.017 ) , and 3
Output:
| This study provides the precise effects of metformin monotherapy regarding the decreases in fasting plasma glucose and glycosated hemoglobin that physician can expected in drug-naive patients with type 2 diabetes mellitus .
No evidence was found for the effects on weight |
MS210823 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: PURPOSE To evaluate the diagnostic efficacy of macrocyclic paramagnetic gadolinium ( Gd ) chelates gadoterate ( 0.5 mmol/mL ) and gadobutrol ( 1.0 mmol/mL ) for the diagnosis of clinical ly significant abdominal/lower limb arterial diseases at 3.0 T . MATERIAL S AND METHODS This study was conducted as a prospect i ve , single-center , r and omized , double-blind , intraindividual study comparing single dose ( 0.1 mmol/kg ) gadoterate enhanced-MRA ( magnetic resonance angiography ) with gadobutrol enhanced-MRA at 3.0 T for their diagnostic potential in patients with peripheral artery disease . A total of 20 patients were included in this trial . RESULTS Fourteen patients were eligible for the final efficacy analysis . The overall image quality ( excellent/more than adequate ) was better rated with gadoterate than with gadobutrol ( 100 % vs. 78.6 % , 100 % vs. 92.9 % , 100 % vs. 85.7 % , 100 % vs. 85.7 % for readers 1 , 2 , 3 , 4 , respectively ) . Diagnostic confidence was rated high/excellent in 100 % ( readers 1 , 2 , and 3 ) and 92.9 % ( reader 4 ) with gadoterate compared to 92.9 % ( readers 1 and 2 ) and 85.7 % ( readers 3 and 4 ) with gadobutrol . Higher signal-to-noise ratio ( SNR ) and contrast-to-noise ratio ( CNR ) values were obtained for gadobutrol compared to gadoterate ( 26.1/23.4 , P = 0.01 , and 22.7/20.2 , P = 0.01 ) . For the secondary criteria , no differences between groups were reported . No adverse events were reported . CONCLUSION Gadobutrol yielded significantly higher SNR/CNR while gadoterate was better rated in terms of overall image quality and diagnostic confidence ( P > 0.05 ) Objective : To evaluate the diagnostic efficacy ( accuracy , sensitivity , specificity ) of 1.0 M gadobutrol versus 0.5 M gadopentetate for the classification of lesions as either benign or malignant in patients with known or suspected liver lesions . Methods and Material s : A multicenter , phase-III , r and omized , interindividually controlled comparison study with blinded reader evaluation was performed to investigate the diagnostic efficacy of a bolus injection of 1.0 M gadobutrol compared with 0.5 M gadopentetate at a dose of 0.1 mmol Gd/kg BW . The imaging protocol included a dynamic 3D-evaluation , static conventional , and fat saturated T1-weighted sequences . MR data sets were evaluated by 3 independent radiologists . The st and ard of reference was defined by an independent truth panel ( radiologist or hepatologist ) . The safety evaluation included adverse events , vital signs , and physical examination . Results : A total of 497 of 572 patients were eligible for the final efficacy analysis . Noninferiority of gadobutrol-enhanced magnetic resonance imaging ( MRI ) for the classification of liver lesions was demonstrated on the basis of diagnostic accuracy determined by the on-site investigators ( −0.098 , 0.021 ) as well as for the average reader of the blinded evaluation ( −0.096 , 0.014 ) ( 95 % confidence interval ) , compared with the predefined st and ard of reference . Very similar increases in sensitivity ( ranging from ∼10 % to ∼55 % ) and specificity ( ranging from ∼1%–∼18 % ) compared with precontrast MRI were also observed for the 2 contrast agent groups , with maximum differences of 4%.Very similar , low rates of adverse events were recorded for each of the 2 groups . No clinical ly relevant changes in vital signs or the results of the physical examination were observed in any patient . Conclusion : This study documents evidence for the noninferiority of a single i.v . bolus injection of 1.0 M gadobutrol ( 0.1 mmol/kg body weight ) to 0.5 M gadopentetate ( 0.1 mmol/kg body weight ) in the diagnostic assessment of liver lesions with contrast-enhanced MRI . The known excellent safety profile of gadobutrol was confirmed in this clinical trial and is similar to that of gadopentetate PURPOSE To prospect ively compare 0.5-M gadopentetate dimeglumine ( Gd-DTPA ) with 1.0-M gadobutrol for contrast-enhanced magnetic resonance angiography ( CE-MRA ) of the blood supplying arteries of the spinal cord in patients referred for open surgical repair of a thoracoabdominal aortic aneurysm ( TAAA ) . MATERIAL S AND METHODS A total of 11 patients with a TAAA underwent two three-dimensional CE-MRA exams of the aorta , segmental arteries ( SAs ) , artery of Adamkiewicz ( AKA ) , and anterior spinal artery ( ASA ) . Imaging was performed on two separate occasions using Gd-DTPA and gadobutrol as contrast agents at 0.3 mmol/kg . Images were evaluated by measuring signal-to-noise ( SNR ) and contrast-to-noise ( CNR ) ratios and were judged for different image quality criteria by two blinded observers . RESULTS In all patients both CE-MRA exams were of sufficient image quality to detect the AKA and ASA . No significant differences in SNR and CNR were observed between the two contrast agents . According to the observers , no significant differences in subjective image quality were found . CONCLUSIONS Using both contrast agents it was possible to visualize the ultrasmall spinal cord arteries in all cases . The use of the 1.0-M contrast agent did not improve image quality of CE-MRA images of the blood supplying arteries of the spinal cord compared to the 0.5-M contrast agent The purpose of this phase III clinical trial was to compare two different extracellular contrast agents , 1.0 M gadobutrol and 0.5 M gadopentate dimeglumine , for magnetic resonance imaging ( MRI ) in patients with known or suspected focal renal lesions . Using a multicenter , single-blind , interindividual , r and omized study design , both contrast agents were compared in a total of 471 patients regarding their diagnostic accuracy , sensitivity , and specificity to correctly classify focal lesions of the kidney . To test for noninferiority the diagnostic accuracy rates for both contrast agents were compared with CT results based on a blinded reading . The average diagnostic accuracy across the three blinded readers ( ‘ average reader ’ ) was 83.7 % for gadobutrol and 87.3 % for gadopentate dimeglumine . The increase in accuracy from precontrast to combined precontrast and postcontrast MRI was 8.0 % for gadobutrol and 6.9 % for gadopentate dimeglumine . Sensitivity of the average reader was 85.2 % for gadobutrol and 88.7 % for gadopentate dimeglumine . Specificity of the average reader was 82.1 % for gadobutrol and 86.1 % for gadopentate dimeglumine . In conclusion , this study documents evidence for the noninferiority of a single i.v . bolus injection of 1.0 M gadobutrol compared with 0.5 M gadopentate dimeglumine in the diagnostic assessment of renal lesions with CE-MRI PURPOSE To perform a quantitative and qualitative comparison of gadobutrol and gadoterate in three-station contrast enhanced magnetic resonance angiography ( CE-MRA ) of the lower limbs . MATERIAL S AND METHODS In this prospect i ve r and omized controlled trial , 52 patients with leg ischemia were r and omly assigned to one of two groups receiving either gadobutrol ( 1.0 mmol Gd/mL , 15 mL ) or gadoterate ( 0.5 mmol Gd/mL , 30 mL ) . Three-station 3D CE-MRAs from the pelvis to the ankles were performed with moving-table technique on a 1.5 T MR scanner . Injection time was identical in both groups . Signal-to-noise ( SNR ) and contrast-to-noise ratios ( CNR ) were calculated for 816 arteries . Contrast quality in 1196 vessel segments was evaluated separately by two blinded readers on a three-point scale . RESULTS Mean SNR ( 61.8 + /- 7.8 for gadobutrol vs. 61.9 + /- 9.1 for gadoterate , P = 0.257 ) , CNR ( 52.8 + /- 9.1 vs. 52.8 + /- 10.7 , P = 0.154 ) , and qualitative ranking ( 1.41 vs. 1.44 , P = 0.21 ) for all vessels did not differ significantly between the two patient groups . The overall quality was good in 90.4 % with gadoterate and 94.2 % with gadobutrol ( P = 0.462 ) . CONCLUSION High-concentration gadobutrol allows neither a higher CNR nor any qualitative advantage over the ordinary unspecific Gd agent gadoterate when the same Gd load and injection times are used in multistation CE-MRA of the peripheral arteries OBJECTIVE The purpose of this study was to compare a macrocyclic 1.0 M contrast agent with a linear ionic 0.5 M contrast agent at equimolar dosage in regard to image quality and number of vessel segments visualized at abdominal dynamic contrast-enhanced 3D MR angiography . SUBJECTS AND METHODS In an intraindividual comparative study , 15 patients ( six women , nine men ; mean age , 53 + /- 12.1 years ; range , 25 - 72 years ) underwent 32 1.5-T whole-body contrast-enhanced 3D MR angiographic examinations performed with parallel imaging technique . At r and om and in separate sessions , each patient was examined after IV injection of 0.1 mmol/kg body weight 1.0 M macrocyclic gadobutrol and 0.5 M linear ionic gadopentetate dimeglumine . Three-dimensional data sets were acquired in the arterial , portal venous , and venous phases with identical imaging protocol s. Quantitative analysis included contrast measurements of vessels compared with adjacent background tissue ( Student 's t test ) . Qualitative analysis was performed independently by two radiologists with regard to visualization of arterial and venous vessel segments and overall image quality ( Wilcoxon 's test ) . RESULTS Visualization of individual vessel segments was rated significantly better after administration of 1.0 M macrocyclic gadobutrol compared with 0.5 M linear ionic gadopentetate dimeglumine ( p < 0.001 ) . Overall image quality was superior with 1.0 M macrocyclic gadobutrol , but the difference was not significant . Vessel-to- background contrast after injection of 1.0 M macrocyclic gadobutrol was significantly higher ( arterial phase , 0.90 , p = 0.02 ; portal venous phase , 0.78 , p = 0.0002 ; venous phase , 0.74 , p = 0.0002 ) compared with 0.5 M linear ionic gadopentetate dimeglumine ( arterial phase , 0.89 ; portal venous phase , 0.73 ; venous phase , 0.67 ) . CONCLUSION At abdominal contrast-enhanced 3D MR angiography , depiction of small abdominal vessels was significantly better and vessel-to-tissue contrast significantly higher with 1.0 M macrocyclic gadobutrol than with an equimolar dose of 0.5 M linear ionic gadopentetate dimeglumine OBJECTIVE Two macrocyclic extracellular contrast agents , one-molar neutral gadobutrol and ionic gadoterate meglumine , were compared to determine the overall preference for one or the other in a clinical setting . MATERIAL S AND METHODS Multicenter , r and omized , single-blind , intra-individually controlled , comparison study with a corresponding blinded read . Efficacy analysis was based on 136 patients who underwent identical MRI examinations : group A first received 1.0 M gadobutrol followed by 0.5 M gadoterate meglumine 48 h to 7 days later ; group B had a reversed administration order . Three independent blinded readers assessed off-site their overall diagnostic preference ( primary efficacy parameter ) based on a matched pairs approach . RESULTS Superiority of gadobutrol over gadoterate meglumine was demonstrated for the qualitative assessment of overall preference across all readers by a statistically significant difference between both contrast agents for this primary endpoint . Preferences in lesion enhancement ( secondary endpoint ) were also found significantly in favor of gadobutrol . For preference in lesion delineation from surrounding tissue/edema and for internal structure only a trend towards a higher proportion for gadobutrol was found ( except for internal structure reported by one reader , which showed a result of statistical significance ) . Lesion contrast and relative lesion enhancement ( quantitative parameters ) were statistically significantly higher for gadobutrol compared to gadoterate meglumine . CONCLUSION Contrast-enhanced MRI of neoplastic brain lesions at a dose of 0.1 mmol Gd/kg body weight , assessed in a st and ardized off-site blinded reading , results in
Output:
| Conclusion Imaging differences between 0.5 M and 1.0 M GBCAs were essentially observed under non-equimolar delivery rates .
However , they did not result into greater diagnostic efficacy when performed under equimolar conditions |
MS210824 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: BACKGROUND The gastrointestinal microflora is an important constituent of the gut mucosal defense barrier . We have previously shown that a human intestinal floral strain , Lactobacillus GG ( ATCC 53103 ) , promotes local antigen-specific immune responses ( particularly in the IgA class ) , prevents permeability defects , and confers controlled antigen absorption . OBJECTIVE The aim of this study was to evaluate the clinical and immunologic effects of cow 's milk elimination without ( n = 14 ) and with ( n = 13 ) the addition of Lactobacillus GG ( 5 x 10(8 ) colony-forming units/gm formula ) in an extensively hydrolyzed whey formula in infants with atopic eczema and cow 's milk allergy . The second part of the study involved 10 breast-fed infants who had atopic eczema and cow 's milk allergy . In this group Lactobacillus GG was given to nursing mothers . METHODS The severity of atopic eczema was assessed by clinical scoring . The concentrations of fecal alpha 1- antitrypsin , tumor necrosis factor-alpha , and eosinophil cationic protein were determined as markers of intestinal inflammation before and after dietary intervention . RESULTS The clinical score of atopic dermatitis improved significantly during the 1-month study period in infants treated with the extensively hydrolyzed whey formula fortified with Lactobacillus GG . The concentration of alpha 1-antitrypsin decreased significantly in this group ( p = 0.03 ) but not in the group receiving the whey formula without Lactobacillus GG ( p = 0.68 ) . In parallel , the median ( lower quartile to upper quartile ) concentration of fecal tumor necrosis factor-alpha decreased significantly in this group , from 709 pg/gm ( 91 to 1131 pg/gm ) to 34 pg/gm ( 19 to 103 pg/gm ) ( p = 0.003 ) , but not in those receiving the extensively hydrolyzed whey formula only ( p = 0.38 ) . The concentration of fecal eosinophil cationic protein remained unaltered during therapy . CONCLUSION These results suggest that probiotic bacteria may promote endogenous barrier mechanisms in patients with atopic dermatitis and food allergy , and by alleviating intestinal inflammation , may act as a useful tool in the treatment of food allergy Perinatal administration of the probiotic Lactobacillus rhamnosus strain GG ( ATCC 53103 ) , reduces incidence of atopic eczema in at-risk children during the first 2 years of life ( infancy ) . We have therefore assessed persistence of the potential to prevent atopic eczema at 4 years . Atopic disease was diagnosed on the basis of a question naire and a clinical examination . 14 of 53 children receiving lactobacillus had developed atopic eczema , compared with 25 of 54 receiving placebo ( relative risk 0.57 , 95 % CI 0.33 - 0.97 ) . Skin prick test reactivity was the same in both groups : ten of 50 children previously given lactobacillus compared with nine of 50 given placebo tested positive . Our results suggest that the preventive effect of lactobacillus GG on atopic eczema extends beyond infancy Over the last two decades the incidence of allergic diseases has increased in industrialized countries , and consequently new approaches have to be explored Objectives : To examine the immunological and clinical influence of 4 months ' feeding with either yoghurt or partially skimmed milk or nothing , on 20 volunteers . Subjects : Thirteen subjects had a demonstrated allergic rhinopathy and seven were healthy subjects and participated as controls . Research design : Either a group of seven or a group of six rhinopathic patients were fed either 450 g yoghurt or 450 g partially skimmed milk , respectively , for 4 months between March and October 1999 . All subjects maintained their usual diet throughout the study .Peripheral blood mononuclear cells ( P BMC ) were isolated before and after the experimental period and cultured for periods of 40 and 64 h. Proliferation index assay and release of IFNγ and IL-4 without and with PHA stimulation were assessed . Allergic rhinopathy was evaluated before and after the 4 months period by performing the nasal functionality tests ( Active Anterior Rhinomanometry , Acoustic Rhinometry ) , the prick test , the nasal specific provocation test ( NPT ) , the dosage of specific IgE blood levels , the evaluation of the symptomatological score and the nasal mucociliary transport test . Results : No significant change of the proliferation index was noted among the three groups . Cultured P BMC of the group fed with yoghurt released more IFNγ and less IL-4 . Cytokine plasma levels were at and remained at basal levels . Prick test , specific serum IgEs and NPT remained immodified . Muco-ciliary transport time ( MCTt ) and symptomatological score showed a definitive improvement after yoghurt feeding . Conclusion : Yoghurt feeding appears to improve or prevent allergic recurrences in rhinopatic patients .Sponsorship : This study was funded , in part , by a grant from Parmalat , Parma , Italy Background : Lactobacillus casei strain Shirota ( LcS ) has been found to exert antiallergic effects in animal experiments , but there is little information about its clinical effects in human patients with allergy . Methods : We performed a r and omized double-blind , placebo-controlled study to investigate the effects of LcS in patients with allergic rhinitis triggered by Japanese cedar pollen ( JCP ) . Participants were asked to drink fermented milk containing LcS ( LcS group ) or placebo ( control group ) for 8 weeks . Clinical symptoms and immunological parameters were compared between the two groups . Results : Symptom-medication scores ( SMS ) worsened in accordance with the increase in the amount of scattered JCP . In terms of the nasal and ocular SMS , there was no significant difference between the LcS group and the placebo group during the ingestion period . In the subgroup of patients with moderate-to-severe nasal symptom scores before starting the ingestion of test sample s , supplementation with LcS tended to reduce nasal SMS . Conclusion : These results indicate that fermented milk containing LcS does not prevent allergic symptoms in patients sensitive to JCP , but may delay the occurrence of allergic symptoms in patients with moderate-to-severe nasal symptom scores
Output:
| concentration of exhaled nitric oxide was significantly greater in children receiving placebo than in those receiving L. rhamnosus strain GG , suggesting the possibility of more underdiagnosed or sub clinical cases of respiratory allergic diseases in the placebo group .
2 years , challenge-proven patients with mild-to-moderate eczema ) improved the eczema score significantly [ 7 ] .
Studies in infants with eczema supplemented with LGG have also shown benefit in decreasing gastrointestinal symptoms [ 8 ] .
To conclude , the available evidence neither supports nor refutes the role of probiotics in the prevention of allergic diseases .
In their informative review , the authors describe that there is no evidence that any probiotics prevent other allergic conditions apart from the eczema-reducing effect of Lactobacillus rhamnosus . |
MS210825 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: BACKGROUND Chronic kidney disease is an important cause of global mortality and morbidity . Data for epidemiological features of chronic kidney disease and its risk factors are limited for low-income and middle-income countries . The International Society of Nephrology 's Kidney Disease Data Center ( ISN-KDDC ) aim ed to assess the prevalence and awareness of chronic kidney disease and its risk factors , and to investigate the risk of cardiovascular disease , in countries of low and middle income . METHODS We did a cross-sectional study in 12 countries from six world regions : Bangladesh , Bolivia , Bosnia and Herzegovina , China , Egypt , Georgia , India , Iran , Moldova , Mongolia , Nepal , and Nigeria . We analysed data from screening programmes in these countries , matching eight general and four high-risk population cohorts collected in the ISN-KDDC data base . High-risk cohorts were individuals at risk of or with a diagnosis of either chronic kidney disease , hypertension , diabetes , or cardiovascular disease . Participants completed a self-report question naire , had their blood pressure measured , and blood and urine sample s taken . We defined chronic kidney disease according to modified KDIGO ( Kidney Disease : Improving Global Outcomes ) criteria ; risk of cardiovascular disease development was estimated with the Framingham risk score . FINDINGS 75,058 individuals were included in the study . The prevalence of chronic kidney disease was 14·3 % ( 95 % CI 14·0 - 14·5 ) in general population s and 36·1 % ( 34·7 - 37·6 ) in high-risk population s. Overall awareness of chronic kidney disease was low , with 409 ( 6 % ) of 6631 individuals in general population s and 150 ( 10 % ) of 1524 participants from high-risk population s aware they had chronic kidney disease . Moreover , in the general population , 5600 ( 44 % ) of 12,751 individuals with hypertension did not know they had the disorder , and 973 ( 31 % ) of 3130 people with diabetes were unaware they had that disease . The number of participants at high risk of cardiovascular disease , according to the Framingham risk score , was underestimated compared with KDIGO guidelines . For example , all individuals with chronic kidney disease should be considered at high risk of cardiovascular disease , but the Framingham risk score detects only 23 % in the general population , and only 38 % in high-risk cohorts . INTERPRETATION Prevalence of chronic kidney disease was high in general and high-risk population s from countries of low and middle income . Moreover , awareness of chronic kidney disease and other non-communicable diseases was low , and a substantial number of individuals who knew they were ill did not receive treatment . Prospect i ve programmes with repeat testing are needed to confirm the diagnosis of chronic kidney disease and its risk factors . Furthermore , in general , health-care workforces in countries of low and middle income need strengthening . FUNDING International Society of Nephrology BACKGROUND We investigated aspirin-prescribing patterns and potential benefits on cardiovascular morbidity and mortality in hemodialysis patients . STUDY DESIGN Cohort study . SETTING & PARTICIPANTS Data included 28,320 r and omly selected hemodialysis patients from the Dialysis Outcomes and Practice Patterns Study I and II . PREDICTOR Aspirin prescription at study baseline . OUTCOMES & MEASUREMENTS Prescription was investigated by means of logistic regression . All-cause mortality , all-cause hospitalization , cardiac event , myocardial infa rct ion , cerebrovascular ( CVA ) , gastrointestinal bleed , transient ischemic attack , and subdural hematoma were examined . Cox regression examined the risk of mortality and hospitalization . All models accounted for facility clustering and demographics and comorbid conditions . RESULTS Wide variation was found in aspirin prescription , from 8 % in Japan to 41 % in Australia and New Zeal and . Characteristics significantly associated with increased odds of prescription included coronary artery disease , cerebrovascular disease , diabetes , male sex , nonblack race , peripheral vascular disease , age , hypertension , and absence of gastrointestinal bleeding . Aspirin was associated with decreased risk of stroke in all patients ( relative risk [ RR ] , 0.82 ; P < 0.01 ) and increased risk of myocardial infa rct ion ( RR , 1.21 ; P = 0.01 ) and cardiac event ( RR , 1.08 ; P < 0.01 ) in all patients , with similar results for patients with coronary artery disease . There was no increase in gastrointestinal bleeding . LIMITATIONS Observational studies are not protected from biases , despite adjustments . There is potential for aspirin use to be underreported because of its availability without prescription . CONCLUSIONS The hypothesis that prescribing aspirin to hemodialysis patients decreases cardiovascular disease risk is not supported . Aspirin might decrease CVA and appears not to increase hemorrhagic risk . This should be an incentive for r and omized controlled trials BACKGROUND Patients with chronic kidney disease are at increased risk for cardiovascular disease , but the efficacy and safety of simvastatin and aspirin are unknown in this patient group . METHODS Patients were r and omly assigned in a 2 x 2 factorial design to the administration of : ( 1 ) 20 mg of simvastatin daily versus matching placebo , and ( 2 ) 100 mg of modified-release aspirin daily versus matching placebo . RESULTS Overall , 448 patients with chronic kidney disease were r and omly assigned ( 242 predialysis patients with a creatinine level > or = 1.7 mg/dL [ > or = 150 micromol/L ] , 73 patients on dialysis therapy , and 133 patients with a functioning transplant ) . Compliance with study treatments was 80 % at 12 months . Allocation to treatment with 100 mg of aspirin daily was not associated with an excess of major bleeds ( aspirin , 4 of 225 patients [ 2 % ] versus placebo , 6 of 223 patients [ 3 % ] ; P = not significant [ NS ] ) , although there was a 3-fold excess of minor bleeds ( 34 of 225 [ 15 % ] versus 12 of 223 patients [ 5 % ] ; P = 0.001 ) . Among those with predialysis renal failure or a functioning transplant at baseline , aspirin did not increase the number of patients who progressed to dialysis therapy ( 7 of 187 [ 4 % ] versus 6 of 188 patients [ 3 % ] ; P = NS ) or experienced a greater than 20 % increase in creatinine level ( 63 of 187 patients [ 34 % ] versus 56 of 188 patients [ 30 % ] ; P = NS ) . After 12 months of follow-up , allocation to 20 mg of simvastatin daily reduced nonfasting total cholesterol levels by 18 % ( simvastatin , 163 mg/dL [ 4.22 mmol/L ] versus placebo , 196 mg/dL [ 5.08 mmol/L ] ; P < 0.0001 ) , directly measured low-density lipoprotein cholesterol levels by 24 % ( 89 mg/dL [ 2.31 mmol/L ] versus 114 mg/dL [ 2.96 mmol/L ] ; P < 0.0001 ) , and triglyceride levels by 13 % ( 166 mg/dL [ 1.87 mmol/L ] versus 186 mg/dL [ 2.10 mmol/L ] ; P < 0.01 ) , but there was no significant effect on high-density lipoprotein cholesterol levels ( 2 % increase ; P = NS ) . Allocation to simvastatin therapy was not associated with excess risk for abnormal liver function test results or elevated creatine kinase levels . CONCLUSION During a 1-year treatment period , simvastatin , 20 mg/d , produced a sustained reduction of approximately one quarter in low-density lipoprotein cholesterol levels , with no evidence of toxicity , and aspirin , 100 mg/d , did not substantially increase the risk for a major bleeding episode . Much larger trials are now needed to assess whether these treatments can prevent vascular events OBJECTIVES The purpose of this study was to determine the benefit and risk associated with antiplatelet therapy in the chronic kidney disease ( CKD ) population . BACKGROUND Cardiovascular and possibly bleeding risks are elevated in patients with CKD . The balance of benefit and harm associated with antiplatelet therapy remains uncertain . METHODS The HOT ( Hypertension Optimal Treatment ) study r and omly assigned participants with diastolic hypertension to aspirin ( 75 mg ) or placebo . Study treatment effects were calculated using univariate proportional hazards regression models stratified by baseline estimated glomerular filtration rate ( eGFR ) with trends tested by adding interaction terms . End points included major cardiovascular events , total mortality , and major bleeding . RESULTS The study included 18,597 participants treated for 3.8 years . Baseline eGFR was < 60 ml/min/1.73 m(2 ) in 3,619 participants . Major cardiovascular events were reduced by 9 % ( 95 % confidence interval [ CI ] : -9 % to 24 % ) , 15 % ( 95 % CI : -17 % to 39 % ) , and 66 % ( 95 % CI : 33 % to 83 % ) for patients with baseline eGFR of ≥ 60 , 45 to 59 , and < 45 ml/min/1.73 m(2 ) , respectively ( p trend = 0.03 ) . Total mortality was reduced by 0 % ( 95 % CI : -20 % to 17 % ) , 11 % ( 95 % CI : -31 % to 40 % ) , and 49 % ( 95 % CI : 6 % to 73 % ) , respectively ( p trend = 0.04 ) . Major bleeding events were nonsignificantly greater with lower eGFR ( hazard ratio [ HR ] : 1.52 [ 95 % CI : 1.11 to 2.08 ] , HR : 1.70 [ 95 % CI : 0.74 to 3.88 ] , and HR : 2.81 [ 95 % CI : 0.92 to 8.84 ] , respectively ; p trend = 0.30 ) . Among every 1,000 persons with eGFR < 45 ml/min/1.73 m(2 ) treated for 3.8 years , 76 major cardiovascular events and 54 all-cause deaths will be prevented while 27 excess major bleeds will occur . CONCLUSIONS Aspirin therapy produces greater absolute reduction in major cardiovascular events and mortality in hypertensive patients with CKD than with normal kidney function . An increased risk of major bleeding appears to be outweighed by the substantial benefits A six year r and omised trial was conducted among 5139 apparently healthy male doctors to see whether 500 mg aspirin daily would reduce the incidence of and mortality from stroke , myocardial infa rct ion , or other vascular conditions . Though total mortality was 10 % lower in the treated than control group , this difference was not statistically significant and chiefly involved diseases other than stroke or myocardial infa rct ion . Likewise , there was no significant difference in the incidence of non-fatal myocardial infa rct ion or stroke — indeed , disabling strokes were somewhat commoner among those allocated aspirin . The lower confidence limit for the effect of aspirin on non-fatal stroke or myocardial infa rct ion , however , was a substantial 25 % reduction . Migraine and certain types of musculoskeletal pain were reported significantly less often in the treated than control group , but as the control group was not given a placebo the relevance of these findings was difficult to assess . There was no apparent reduction in the incidence of cataract in the treated group . The lack of any apparent reduction in disabling stroke or vascular death contrasts with the established value of antiplatelet treatment after occlusive vascular disease Background Patients with chronic kidney disease ( CKD ) are at high risk for developing cardiovascular events . However , limited evidence is available regarding the use of aspirin in CKD patients to decrease cardiovascular risk and to slow renal disease progression . Study Design Prospect i ve , multicenter , open-label r and omized controlled trial . Setting and Participants One hundred eleven patients with estimated glomerular filtration rate ( eGFR ) 15–60 ml/min/1.73 m2 without previous cardiovascular events . InterventionAspirin treatment ( 100 mg/day ) ( n = 50 ) or usual therapy ( n = 61 ) . Mean follow-up time was 64.8 ± 16.4 months . Outcomes The primary endpoint was composed of cardiovascular death , acute coronary syndrome ( nonfatal MI , coronary revascularization , or unstable angina pectoris ) , cerebrovascular disease , heart failure , or nonfatal peripheral arterial disease . Secondary endpoints were fatal and nonfatal coronary events , renal events ( defined as
Output:
| There was also no significant reduction in cardiovascular mortality and all-cause mortality .
Our review indicated that aspirin use in CKD patients had no prevention effect on cardiovascular events and no statistically significant reduction in risk of cardiovascular or all-cause mortality , with a significant increased risk of minor bleeding and renal events |
MS210826 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: BACKGROUND Propionibacterium acnes is a gram-positive anaerobe that can lead to devastating postoperative shoulder infections . The objective of this study was to investigate whether a benzoyl peroxide and clindamycin preoperative skin preparation reduces the incidence of P. acnes colonization during shoulder arthroscopy . METHODS Sixty-five shoulder arthroscopy patients were prospect ively enrolled . A skin culture specimen was taken at the preoperative visit from st and ard arthroscopic portal sites . Topical benzoyl peroxide 5 % and clindamycin 1.2 % ( BPO/C ) gel was applied to the shoulder every night before surgery . Skin culture was repeated in the operating room before preparation with chlorhexidine gluconate . Shoulder arthroscopy proceeded , with final culture specimens obtained from within the shoulder . RESULTS P. acnes skin colonization remained similar to prior studies at 47.7 % ( 31 of 65 patients . ) With > 1 application , BPO/C was 78.9 % ( 15 of 19 patients ) effective in eliminating P. acnes superficial colonization . With 1 application , it was 66.7 % ( 8 of 12 patients ) effective in eliminating superficial colonization . Deep colonization was reduced to 3.1 % ( 2 of 65 patients ) compared with previous studies of 15 % to 20 % ( P = .006 ) . BPO/C was 100 % effective at decreasing deep colonization with > 1 application . CONCLUSIONS P. acnes skin colonization is high at arthroscopic shoulder portals , especially in men . Despite st and ard skin preparation and prophylactic antibiotics , the rate of joint inoculation is much higher than the rate of infection reported in the literature . BPO/C effectively reduces P. acnes colonization in shoulder arthroscopy . It should be considered for use before shoulder procedures with a time-related trend of > 1 application PURPOSE To examine the contamination rate of the anchor-suture and to determine the efficacy of 2 different surgical skin preparation solutions with or without a plastic adhesive drape from suture contamination in arthroscopic rotator cuff repair . METHODS A prospect i ve r and omized study was undertaken to evaluate 126 consecutive patients undergoing arthroscopic rotator cuff repair . Each shoulder was prepared with one of 2 r and omly selected solutions according to an assigned envelope that indicated the procedure to be used : chlorhexidine-alcohol ( 1 % chlorhexidine gluconate and 70 % isopropyl alcohol ) or povidone-iodine . Then , each group was further divided according to the usage of a plastic drape . The first cut-tails of the anchor-suture after cuff fixation were su bmi tted to aerobic and anaerobic cultures . RESULTS The overall rate of Propionibacterium acnes-positive cultures was 47 % ( 14 of 31 cases ) in the povidone-iodine group , 33 % ( 11 of 33 cases ) in the povidone-iodine with a drape group , 33 % ( 10 of 30 cases ) in the chlorhexidine-alcohol group , and 9.3 % ( 3 of 32 cases ) in the chlorhexidine-alcohol with a drape group . The positive culture rate in the chlorhexidine-alcohol with a drape group was lower than that in the povidone-iodine group ( relative risk , 0.2 ; 95 % confidence interval : 0.064 - 0.63 ; number needed to treat , 2.7 ; P < .0001 ) . Coagulase-negative staphylococci were isolated in the povidone-iodine with a drape ( 1 case ) and chlorhexidine-alcohol with a drape group ( 2 cases ) . No other bacteria were isolated , and no infections occurred in any of the patients treated in this study during the minimum 12-month follow-up period . CONCLUSIONS Chlorhexidine-alcohol solution with an adhesive plastic drape was more effective than chlorhexidine-alcohol without a plastic drape and povidone-iodine with/without a plastic drape in eliminating P acnes suture contamination . However , the usage of a plastic drape slightly increased the risk of coagulase-negative Staphylococcus proliferation . LEVEL OF EVIDENCE Level I , therapeutic , prospect i ve , r and omized trial HYPOTHESIS Deep infection after shoulder surgery is a rare but devastating problem . This study tested the hypothesis that the home application of a 2 % chlorhexidine gluconate cloth before shoulder surgery would be more efficacious than a st and ard shower of soap and water at decreasing the preoperative cutaneous levels of pathogenic bacteria on the shoulder . MATERIAL S AND METHODS This r and omized , prospect i ve study evaluated 100 consecutive patients undergoing shoulder surgery . Patients were r and omly assigned to use 2 % chlorhexidine gluconate-impregnated cloths ( treatment group ) or to shower with soap and water before surgery ( control group ) . Cutaneous cultures were taken from the patients ' shoulders in the preoperative holding area . Patients were monitored for 2 months postoperatively for clinical signs of infection . RESULTS In the treatment group vs the control group , the overall positive culture rate was 66 % vs 94 % ( P = .0008 ) , and the positive culture rate for coagulase-negative Staphylococcus was 30 % vs 70 % ( P = .0001 ) . The positive culture rate for Propionibacterium acnes was 46 % in the treatment group vs 58 % in the control group ( P = .32 ) . No infections occurred in any patients at a minimum of 2-months after surgery . DISCUSSION The use of the 2 % chlorhexidine cloth was effective at decreasing overall bacterial culture rates before shoulder surgery and was particularly effective at decreasing the quantity of coagulase-negative Staphylococcus , a known causative agent of postoperative shoulder infections . CONCLUSION Use of chlorhexidine impregnated cloths prior to shoulder surgery may be a useful adjunct to presently used infection prevention strategies BACKGROUND : Benzoyl peroxide and clindamycin are the two most widely prescribed topical antimicrobials in the treatment of acne . AIM : To compare the antimicrobial efficacy , in vivo , of benzoyl peroxide and clindamycin against Propionibacterium acnes . METHODS : Two groups of 10 subjects each , with comparable mean P. acnes baseline counts of log 5.75 to 5.85 , underwent twice daily application of benzoyl peroxide or clindamycin for 14 days . RESULTS : The results of quantitatively sampling P. acnes after 3 , 7 and 14 days of treatment showed that TriazA 6 % benzoyl peroxide special gel produced faster and significantly greater reductions in P. acnes than did the 1 % clindamycin phosphate in Cleocin-TA lotion ( p < 0.01 ) . These results were paralleled by the greater reductions produced by Triaz versus Cleocin ( p < 0.05 ) in P. acnes fluorescence . CONCLUSION : Benzoyl peroxide formulations suppress the follicular population of P. acnes more rapidly and to a greater degree than topical antibiotics such as clindamycin BACKGROUND Propionibacterium acnes has arisen as the most common microorganism identified at the time of revision shoulder arthroplasty . There is limited evidence to suggest how frequently false-positive cultures occur . The purpose of this prospect i ve controlled study was to evaluate culture growth from specimens obtained during open shoulder surgery . METHODS Patients undergoing an open deltopectoral approach to the shoulder were prospect ively enrolled . Patients with a history of shoulder surgery or any concern for active or previous shoulder infection were excluded . Three pericapsular soft-tissue sample s were taken from the shoulder for bacterial culture and were incubated for fourteen days . A sterile sponge was also analyzed in parallel with the tissue cultures . In addition , similar cultures were obtained from patients who had undergone previous shoulder surgery . RESULTS Overall , 20.5 % of surgeries ( twenty-four of 117 ) yielded at least one specimen removed for culture that was positive for bacterial growth , and 13.0 % of sterile control specimens ( seven of fifty-four ) had positive culture growth ( p = 0.234 ) . P. acnes represented 83.0 % of all positive cultures ( thirty-nine of forty-seven ) at a median incubation time of fourteen days . Among the subjects who had not undergone previous surgery , 17.1 % ( fourteen of eighty-two ) had at least one positive P. acnes culture . Male sex was univariably associated with a greater likelihood of bacterial growth ( p < 0.01 ) , and patients who had not undergone previous surgery and had received two or more preoperative corticosteroid injections had a higher likelihood of bacterial growth ( p = 0.047 ) . CONCLUSIONS The clinical importance of positive P. acnes cultures from specimens obtained from open shoulder surgery remains uncertain . Male sex and preoperative corticosteroid injections were associated with a higher likelihood of bacterial growth on culture and are risk factors that merit further investigation . Previously reported incidences of positive P. acnes culture results from specimens from primary and revision shoulder arthroplasty may be overestimated because of a substantial level of culture contamination . CLINICAL RELEVANCE P. acnes is isolated via culture at a substantial rate from shoulders undergoing a deltopectoral approach . The clinical importance of culture growth by this low-virulence organism still remains uncertain . Further study is necessary to more specifically characterize culture growth by P. acnes as an infection , commensal presence , or contaminant PURPOSE To document the skin colonization and deep tissue inoculation rates associated with arthroscopic shoulder surgery and how these rates differ with procedural and demographic factors . METHODS We prospect ively recruited outpatient shoulder arthroscopy patients who agreed to participate and met the inclusion criteria from February 2013 to May 2014 . All patients received routine antibiotic prophylaxis intravenously . Initial cultures were obtained before the skin preparation by swabbing the skin at the 3 st and ard portal sites : posterior , anterosuperior , and anterolateral . The skin preparation used 4 % chlorhexidine scrub and 2 % chlorhexidine gluconate/70 % isopropyl alcohol paint applied to the entire shoulder . After completion of the arthroscopic procedure , a second culture was obtained through a cannula at the surgical site . All cultures were plated for 21 days using Brucella medium . RESULTS We enrolled 51 patients over a 15-month period . Cultures showed a 72.5 % Propionibacterium acnes superficial colonization rate : 46.1 % of female and 81.6 % of male patients ( P = .027 ) . We identified a deep culture-positive inoculation rate of 19.6 % , all with positive P acnes skin colonization . No correlation could be made concerning diagnosis , procedure , suture anchor use , age , or sex . CONCLUSIONS The rate of skin colonization with P acnes is high at arthroscopic portals , especially in men . Despite st and ard skin preparation and prophylactic antibiotics , the rate of deep tissue inoculation with P acnes in shoulder arthroscopy is much higher than the rate of infection reported in the literature . CLINICAL RELEVANCE Shoulder arthroscopy introduces a significant amount of P acnes into the deep tissues BACKGROUND To examine the rates and predictors of deep periprosthetic infections after shoulder hemiarthroplasty . METHODS We used prospect ively collected institutional registry data on all primary shoulder hemiarthroplasty patients from 1976 - 2008 . We estimated survival free of deep periprosthetic infections using Kaplan-Meier survival curves . Using univariate Cox regression analyses , we examined the association of patient-related factors ( age , sex , body mass index ) , comorbidity ( Deyo-Charlson index ) , American Society of Anesthesiologists grade , underlying diagnosis , and implant fixation with the risk of infection . RESULTS A total of 1,349 patients , with a mean age of 63 years ( SD , 16 years ) , 63 % of whom were women , underwent 1,431 primary shoulder hemiarthroplasties . Mean follow-up was 8 years ( SD , 7 years ) . Fourteen deep periprosthetic infections occurred during the follow-up , confirmed by medical record review . The most common organisms were Staphylococcus aureus , coagulase-negative Staphylococcus , and Propionibacterium acnes , each accounting for 3 cases ( 21 % each ) . The 5- , 10- , and 20-year prosthetic infection-free rates were 98.9 % ( 95 % confidence interval [ CI ] , 98.3%-99.5 % ) , 98.7 % ( 95 % CI , 98.1%-99.4 % ) , and 98.7 % ( 95 % CI , 98.1%-99.4 % ) , respectively . None of the factors evaluated were significantly associated with risk of prosthetic infection after primary shoulder hemiarthroplasty , except that an underlying diagnosis of trauma was associated with a significantly higher hazard ratio of 3
Output:
| The application of a topical benzoyl peroxide antibiotic in the days leading up to surgery in combination with preoperative antibiotic prophylaxis significantly reduces the prevalence of C acnes in shoulder arthroscopy patients |
MS210827 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Objective : To investigate HIV incidence during a trial of two voluntary counselling and testing ( VCT ) strategies . Counselling may promote beneficial behavioural change , although knowledge of negative status does not appear to contribute further benefit . Design : The parent cluster-r and omized trial demonstrated much greater uptake of VCT when counselling and rapid testing were available on-site ( intensive VCT ) than through pre-paid vouchers to an external provider ( st and ard VCT ) . Anonymous HIV tests had been requested from all employees at enrolment and after 2 years intervention . Methods : The study setting was 22 businesses in Harare , Zimbabwe . Participants were 3146 HIV-negative individuals remaining in employment at the end of intervention , of whom 2966 ( 94.3 % ) consented to repeat testing . VCT linked to basic HIV care was provided and the main outcome measures were HIV incidence under each study arm , as a retrospective secondary analysis . Results : Mean VCT uptake in this cohort was 70.7 and 5.2 % , respectively , in the intensive and st and ard arms . Crude HIV incidence was 1.21 per 100 person-years , with non-significantly higher rates in the intensive VCT arm [ mean site incidence 1.37 and 0.95 per 100 person-years , respectively ; adjusted rate ratio 1.49 ( 95 % confidence interval 0.79–2.80 ) . Conclusions : Highly acceptable VCT did not reduce HIV incidence in this predominantly male cohort . HIV incidence was highest in the high uptake VCT arm , lending support to a US trial in which rapid testing appeared to have adverse behavioural consequences in some HIV-negative clients . Careful comparison of outcomes under different counselling and testing strategies is needed to maximize HIV prevention from global scale-up of VCT OBJECTIVE To assess the possible impact of HIV infection on the management of general surgical patients at the Ga-Rankuwa Hospital . DESIGN A prospect i ve study . SETTING Ga-Rankuwa Hospital/Medical University of Southern Africa ( MEDUNSA ) Academic Complex , Pretoria , South Africa . SUBJECTS Nine hundred and forty one patients admitted to general surgical wards . MAIN OUTCOME MEASURES HIV infection and CD4 counts . RESULTS Nine hundred and forty one patients admitted to general surgical wards from January 1966 to December 1997 were tested for HIV infection . Twelve per cent tested positive . HIV positive patients were significantly younger [ 33 + /- 10 versus 41 + /- 7 ( men + /- SD ) years , Chi-square = 51 , p < 0.0001 ] . There was no correlation of HIV positivity to the patient 's sex ( p = 0.7 ) . In forty three HIV positive patients treated surgically , mortality was attributed to HIV/AIDS in only one patient with a CD4 count of 47/ul who died following laparotomy for peritonitis . CD4 counts done during follow up in thirty one HIV positive patients revealed a count of < 500/ul in eleven patients . CONCLUSION It is predicted that an increasing number of patients with HIV/AIDS will be admitted to general surgery wards of the Ga-Rankuwa Hospital . Surgeons are advised to take universal pre caution s to prevent HIV infection Background HIV counselling and testing is a key component of both HIV care and HIV prevention , but uptake is currently low . We investigated the impact of rapid HIV testing at the workplace on uptake of voluntary counselling and testing ( VCT ) . Methods and Findings The study was a cluster-r and omised trial of two VCT strategies , with business occupational health clinics as the unit of r and omisation . VCT was directly offered to all employees , followed by 2 y of open access to VCT and basic HIV care . Businesses were r and omised to either on-site rapid HIV testing at their occupational clinic ( 11 businesses ) or to vouchers for off-site VCT at a chain of free-st and ing centres also using rapid tests ( 11 businesses ) . Baseline anonymised HIV serology was requested from all employees . HIV prevalence was 19.8 % and 18.4 % , respectively , at businesses r and omised to on-site and off-site VCT . In total , 1,957 of 3,950 employees at clinics r and omised to on-site testing had VCT ( mean uptake by site 51.1 % ) compared to 586 of 3,532 employees taking vouchers at clinics r and omised to off-site testing ( mean uptake by site 19.2 % ) . The risk ratio for on-site VCT compared to voucher uptake was 2.8 ( 95 % confidence interval 1.8 to 3.8 ) after adjustment for potential confounders . Only 125 employees ( mean uptake by site 4.3 % ) reported using their voucher , so that the true adjusted risk ratio for on-site compared to off-site VCT may have been as high as 12.5 ( 95 % confidence interval 8.2 to 16.8 ) . Conclusions High-impact VCT strategies are urgently needed to maximise HIV prevention and access to care in Africa . VCT at the workplace offers the potential for high uptake when offered on-site and linked to basic HIV care . Convenience and accessibility appear to have critical roles in the acceptability of community-based VCT Background Voluntary HIV counselling and testing ( VCT ) is one of the key strategies in the prevention and control of HIV/AIDS in Ug and a. However , the utilization of VCT services particularly among men is low in Kasese district . We therefore conducted a study to determine the prevalence and factors associated with VCT use among men in Bukonzo West health sub-district , Kasese district . Methods A population -based cross-sectional study employing both quantitative and qualitative techniques of data collection was conducted between January and April 2005 . Using cluster sampling , 780 men aged 18 years and above , residing in Bukonzo West health sub-district , were sample d from 38 r and omly selected clusters . Data was collected on VCT use and independent variables . Focus group discussion s ( 4 ) and key informant interviews ( 10 ) were also conducted . Binary logistic regression was performed to determine the predictors of VCT use among men . Results Overall VCT use among men was 23.3 % ( 95 % CI 17.2–29.4 ) . Forty six percent ( 95 % CI 40.8–51.2 ) had pre-test counselling and 25.9 % ( 95%CI 19.9–31.9 ) had HIV testing . Of those who tested , 96 % returned for post-test counselling and received HIV results . VCT use was higher among men aged 35 years and below ( OR = 2.69 , 95%CI 1.77–4.07 ) , the non-subsistence farmers ( OR = 2.37 , 95%CI 2.37 ) , the couple testing ( OR = 2.37 , 95%CI 1.02–8.83 ) and men with intention to disclose HIV test results to sexual partners ( OR = 1.64 , 95%CI 1.04–2.60 ) . The major barriers to VCT use among men were poor utilization of VCT services due to poor access , stigma and confidentiality of services . Conclusion VCT use among men in Bukonzo West , Kasese district was low . In order to increase VCT use among men , the VCT programme needs to address HIV stigma and improve access and confidentiality of VCT services . Among the more promising interventions are the use of routine counselling and testing for HIV of patients seeking health care in health units , home based VCT programmes , and mainstreaming of HIV counselling and testing services in community development programmes Objectives : To assess self‐ selection in a population ‐based voluntary HIV testing and counseling ( VTC ) program by comparing the HIV risk characteristics of users and nonusers of VTC in rural Ug and a. Design : A 1994 to 1995 community‐r and omized trial in the Rakai District of Ug and a enrolled adults aged 15 to 59 years and ascertained their HIV status , sociodemographic characteristics , risk behaviors , and AIDS‐associated symptoms . All subjects were offered confidential individual VTC at no cost . Methods : We compared users and nonusers of VTC among 10,950 participants ( 4764 male and 6186 female ) enrolled at baseline using multivariate logistic regression . Results : Women were significantly less likely to receive VTC than men ( 31.5 % vs. 34.8 % , p < .001 ) . In multivariate analysis , younger age , HIV‐positive status , and having no sexual partners in the past 5 years ( and , significant for women only , having 2 or more sexual partners ) were associated with lower VTC participation for both men and women . Among women , higher VTC participation was associated with symptoms suggestive of AIDS and other illnesses and shopkeeper occupations . Conclusions : During the initial phase of a population ‐based free VTC program in rural Ug and a , certain high‐risk groups were underrepresented among VTC recipients . There is a need to target VTC to ensure participation by high‐risk individuals most in need of services Introduction According to the 2011–2012 HIV and Malaria Indicator Survey , the prevalence of HIV infection in Tanzania is 5.1 % , with limited information on its magnitude among older people , as the community believes that the elderly are not at risk . Consequently , little attention is given to the fight against HIV and AIDS in this group . The present study investigated the magnitude of HIV and AIDS infection among older people in rural and urban areas of the Tanzania mainl and . Subjects and methods The study was conducted in Mufindi and Babati districts of Iringa and Manyara regions , respectively , through multistage sampling procedures . Dried blood spot cards were used to collect blood sample s for HIV testing among consenting participants . HIV testing was done and retested using different enzyme-linked immunosorbent assay kits . Results A total of 720 individuals , 340 ( 47.2 % ) males and 380 ( 52.8 % ) females , were r and omly selected , of whom 714 ( 99.2 % ) consented to HIV testing while six ( 0.8 % ) refused to donate blood . The age ranged from 50 to 98 years , with a mean age of 64.2 years . Overall , a total of 56 ( 7.8 % ) participants were HIV-positive . Females had a higher prevalence ( 8.3 % ) than males ( 7.4 % ) , with Mufindi district recording the higher rate ( 11.3 % ) compared to the 3.7 % of Babati district . The prevalence was higher in the rural population ( 9.4 % ) compared to 6.4 % of their urban counterparts . Conclusion Although HIV/AIDS is considered a disease of individuals aged 15–49 years , the overall prevalence among the older people aged 50 years and above for Mufindi and Babati districts was higher than the national prevalence in the general population . These findings point to the need to consider strengthening interventions targeting older population s against HIV/AIDS in these districts while establishing evidence countrywide to inform policy decisions BACKGROUND Access to HIV-1 voluntary counselling and testing ( VCT ) is severely limited in less-developed countries . We undertook a multisite trial of HIV-1 VCT to assess its impact , cost , and cost-effectiveness in less-developed country setting s. METHODS The cost-effectiveness of HIV-1 VCT was estimated for a hypothetical cohort of 10000 people seeking VCT in urban east Africa . Outcomes were modelled based on results from a r and omised controlled trial of HIV-1 VCT in Tanzania and Kenya . Our main outcome measures included programme cost , number of HIV-1 infections averted , cost per HIV-1 infection averted , and cost per disability-adjusted life-year ( DALY ) saved . We also modelled the impact of targeting VCT by HIV-1 prevalence of the client population , and the proportion of clients who receive VCT as a couple compared with as individuals . Sensitivity analysis was done on all model parameters . FINDINGS HIV-1 VCT was estimated to avert 1104 HIV-1 infections in Kenya and 895 in Tanzania during the subsequent year . The cost per HIV-1 infection averted was US$ 249 and $ 346 , respectively , and the cost per DALY saved was $ 12.77 and $ 17.78 . The intervention was most cost-effective for HIV-1-infected people and those who received VCT as a couple . The cost-effectiveness of VCT was robust , with a range for the average cost per DALY saved of $ 5.16 - 27.36 in Kenya , and $ 6.58 - 45.03 in Tanzania . Analysis of targeting showed that increasing the proportion of couples to 70 % reduces the cost per DALY saved to $ 10.71 in Kenya and $ 13.39 in Tanzania , and that targeting a population with HIV-1 prevalence of 45 % decreased the cost per DALY saved to $ 8.36 in Kenya and $ 11.74 in Tanzania . INTERPRETATION HIV-1 VCT is highly cost-effective in urban east African setting s , but slightly less so than interventions such as improvement of sexually transmitted disease services and universal provision of nevirapine to pregnant women in high-prevalence setting s. With the
Output:
| Exp and ing home and mobile testing , self-testing and outreach to key population s with facilitated linkage can increase the proportion of men , young adults and high-risk individuals linked to HIV treatment and prevention , and decrease HIV burden . |
MS210828 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Study Design . A r and omized trial . Objective . To evaluate the effectiveness of a semi-intensive multidisciplinary rehabilitation for patients with chronic low back pain in an outpatient setting . Summary and Background Data . Systematic review s have shown that there is strong evidence that intensive multidisciplinary treatment ( > 100 hours ) , which includes functional restoration , improves function among chronic patients with low back pain , and moderate evidence that it reduces pain but contradictory evidence regarding improvement of working ability . However , there is paucity of data whether semi-intensive outpatient multidisciplinary rehabilitation in groups is more effective than individual physiotherapy . Material s and Methods . A total of 120 women employed as healthcare and social care professionals with nonspecific chronic low back pain were recruited from two occupational healthcare centers . The patients were r and omized into two intervention programs . Multidisciplinary rehabilitation ( n = 59 ) was conducted in groups and comprised of physical training , workplace interventions , back school , relaxation training , and cognitive-behavioral stress management methods for 70 hours . The individual physiotherapy ( n = 61 ) included physical exercise and passive treatment methods administered for 10 hours . Main outcome measures were : back pain and sciatic pain intensity , disability , sick leaves , healthcare consumption , symptoms of depression , and beliefs of working ability after 2 years . Results . There were no statistically significant differences between the two treatment groups in main outcome measures just after rehabilitation , at 6- , at 12- , or 24-month follow-up . In both intervention arms , however , the before- and -after comparison showed favorable effects , and the effects were still maintained at 2 years follow-up . Conclusions . The results of this study indicate that semilight outpatient multidisciplinary rehabilitation program for female chronic low back pain patients does not offer incremental benefits when compared with rehabilitation carried out by a physiotherapist having a cognitive-behavioral way of administering the treatment OBJECTIVES To evaluate the effectiveness of a back school program in pain , functional status , quality of life , and in anxiety and depression in patients with non-specific low back pain . METHODS Sixty patients with low back pain were r and omized to an intervention and control group . The intervention group underwent a five-weekly back school program . The control group was seen in weekly medical visits , without educative approaches . Both groups took acetaminophen as analgesic medication . All subjects were evaluated by a blind physiotherapist after r and omization , 30 , 60 and 120 days . Roll and -Morris , SF-36 , STAI and Beck question naires , pain visual analogical scale and Schober 's test were applied . Non-steroidal anti-inflammatory drugs ( NSAID ) consumption was considered co-intervention . The statistical analyses were performed using Pearson 's Chi-Square analysis and Student 's t-test to compare the baseline characteristics of the groups and the analysis of variance ( ANOVA ) with repeated measures to assess changes inter/intra groups . RESULTS There were no significant differences in the baseline characteristics between the two groups . Fifty-five patients completed the study . The intervention group showed a significant improvement in the general health domain , assessed by SF-36 , and also in the reduction of acetaminophen and NSAID intake . There was no significant difference between the groups in pain , functional status , anxiety or depression . CONCLUSION The back school program was more effective than any educational intervention in general health status and in decreasing acetaminophen and NSAID intake . It was ineffective in the other quality of life domains , in pain , functional status , anxiety and depression OBJECTIVE To evaluate the effectiveness of the addition of back school to exercise and physical treatment modalities in relieving pain and improving the functional status of patients with chronic low back pain . DESIGN A r and omized controlled trial . PATIENTS A total of 146 patients with chronic low back pain were enrolled in the study . METHODS Subjects were divided into 2 groups : the back school group received exercise , physical treatment modalities and a back school programme ; and the control group received exercise and physical treatment modalities . Treatment efficacy was evaluated at the end of treatment and 3 months post-treatment , in terms of pain , measured with the Visual Analogue Scale , and functional status , measured with the Oswestry Low Back Pain Disability Question naire . RESULTS In both groups , Visual Analogue Scale and Oswestry Low Back Pain Disability Question naire were significantly reduced after therapy ( p < 0.01 ) , but the difference between the scores at the end of treatment and 3 months post-treatment was not significant . There was a significant improvement in Visual Analogue Scale and Oswestry Low Back Pain Disability Question naire in the back school group compared with the control group at the end of therapy and 3 months post-treatment ( p < 0.05 ) . CONCLUSION The addition of back school was more effective than exercise and physical treatment modalities alone in the treatment of patients with chronic low back pain Background Different interventions can reduce the burden of the chronic low back pain . One example is the use of a ' Back School Programme ' . This is a brief therapy that uses a health education method to empower participants through a procedure of assessment , education and skill development . This study aim ed to evaluate to what extent the programme could improve quality of life in those who suffer from the condition . Methods This was a r and omized controlled trial . One-hundred and two female patients with low back pain ( n = 102 ) were r and omly allocated into two groups , matched in terms of age , weight , education , socioeconomic status , occupation and some aspects of risk behavior . Group 1 ( back school group , n = 50 ) but not group 2 ( clinic group , n = 52 ) received the ' Back School Programme ' . Then quality of life using the Short Form Health Survey ( SF-36 ) was assessed at two time points : at baseline and at three months follow-up . The findings were compared both within and between two groups . Results The ' Back School Programme ' was effective in improving patients ' quality of life ; significant differences were found on all eight subscales of the SF-36 for group 1 . In the clinic group ( group 2 ) , improvement was observed on three scales ( bodily pain , vitality and mental health ) but these improvements were less than in group 1 . The mean improvement over all eight subscales of the SF-36 was significantly better for the ' Back School Programme ' group . Conclusion The ' Back School Programme ' is an effective intervention and might improve the quality of life over a period of 3 months in patients who experience chronic low back pain Intensive group training using principles of grade d activity has been proven to be effective in occupational care for workers with chronic low back pain . Objective of the study was to compare the effects of an intensive group training protocol aim ed at returning to normal daily activities and guideline physiotherapy for primary care patients with non-specific chronic low back pain . The study was design ed as pragmatic r and omised controlled trial with a setup of 105 primary care physiotherapists in 49 practice s and 114 patients with non-specific low back pain of more than 12 weeks duration participated in the study . In the intensive group training protocol exercise therapy , back school and operant-conditioning behavioural principles are combined . Patients were treated during 10 individual sessions along 20 group sessions . Usual care consisted of physiotherapy according to the Dutch guidelines for Low Back Pain . Main outcome measures were functional disability ( Rol and Morris disability question naire ) , pain intensity , perceived recovery and sick leave because of low back pain assessed at baseline and after 6 , 13 , 26 and 52 weeks . Both an intention-to-treat analysis and a per- protocol analysis were performed . Multilevel analysis did not show significant differences between both treatment groups on any outcome measures during the complete follow-up period , with one exception . After 26 weeks the protocol group showed more reduction in pain intensity than the guideline group , but this difference was absent after 52 weeks . We finally conclude that an intensive group training protocol was not more effective than usual physiotherapy for chronic low back pain Study Design . R and omized , single blind , controlled trial . Objective . To determine the efficacy of 2 components of musculoskeletal physiotherapy on chronic low back disorder . Summary of Background Data . Musculoskeletal physiotherapy encompasses many treatment methods , however , manual therapy and exercises to rehabilitate spinal stabilization are the most frequently used . Despite their popularity , scant evidence supports their use on subjects with chronic low back disorder . Methods . A total of 346 subjects were r and omized to manual therapy , a 10-week spinal stabilization rehabilitation program , or a minimal intervention control group . Data were collected at baseline , and 3 , 6 , 12 , and 24 months after intervention . Outcome measures recorded intensity of low back pain , disability , h and icap , medication , and quality of life . There were 4 main variables combined in a primary component analysis to form a single outcome measure ( i.e. , a measure of dysfunction ) . Results . The results indicated statistically significant improvements in favor of the spinal stabilization group at the 6-month stage in pain ( 65.9 % reduction in symptoms ) and dysfunction ( combined mean reduction of 134 , st and ard error 23.84 ) , and at the 1-year stage in medication ( 34.3 % reduction in medication ) , dysfunction ( combined mean reduction of 134 , st and ard error 18.2 ) , and disability ( mean difference in change 15.71 Oswestry Disability Index , 95 % confidence interval 19.3–10.01 ) . Conclusions . As a component of musculoskeletal physiotherapy , the spinal stabilization program is more effective than manually applied therapy or an education booklet in treating chronic low back disorder over time . Both manual therapy and the spinal stabilization program are significantly effective in pain reduction in comparison to an active control . To our knowledge and up until now , this result has not been shown in patients with chronic low back disorder OBJECTIVE To evaluate a progressive fitness programme for patients with chronic low back pain . DESIGN Single blind r and omised controlled trial . Assessment s were carried out before and after treatment by an observer blinded to the study and included a battery of vali date d measures . All patients were followed up by postal question naire six months after treatment . SETTING Physiotherapy department of orthopaedic hospital . SUBJECTS 81 patients with chronic low back pain referred from orthopaedic consultants for physiotherapy . The patients were r and omly allocated to a fitness programme or control group . INTERVENTION Both groups were taught specific exercises to carry out at home and referred to a back-school for education in back care . Patients allocated to the fitness class attended eight exercise classes over four weeks in addition to the home programme and backschool . RESULTS Significant differences between the groups were shown in the changes before and after treatment in scores on the Oswestry low back pain disability index ( P < 0.005 ) , pain reports ( sensory P < 0.05 and affective P < 0.005 ) , self efficacy reports ( P < 0.05 ) , and walking distance ( P < 0.005 ) . No significant differences between the groups were found by the general health question naire or question naire on pain locus of control . A benefit of about 6 percentage points on the disability index was maintained by patients in the fitness group at six months . CONCLUSION There is a role for supervised fitness programmes in the management of moderately disabled patients with chronic low back pain . Further clinical trials , however , need to be established in other centres to confirm these findings BACKGROUND AND OBJECTIVES The aim of this trial is to search effectiveness of specifically adapted exercise programs on its own and with low back school on pain , disability , trunk and quadriceps muscle strength , walking performance , spinal mobility , quality of life ( QOL ) , and depression in the patients with chronic low back pain ( CLBP ) . MATERIAL AND METHOD A total of 121 patients with definite CLBP were included in this study . The patients were r and omized into two groups . Group 1 ( n=60 ) was given exercises only and accepted as the control group . Group 2 ( n=61 ) received back school program and exercises . The exercise treatment was performed 3 days a week , for 3 months . The pain ( visual analog scale , VAS ) , disability ( Oswestry Disability Question naire , ODQ ) , walking performance ( 6 minute walking test , 6MWT ) , depression ( Beck Depression Inventory scores , BDI ) , and QOL ( Short Form 36 , SF-36 ) of all participants were evaluated . The trunk and knee muscle strength were measured with a h and held dynamometer . Patients were assessed at baseline ( BT ) , at the end of treatment ( AT ) , and at the six month follow-up ( F ) . RESULTS Statistically significant improvements were found between groups regarding all of the clinical parameters over time . Pain , disability , muscle strength , endurance , 6MWT , mobility , QOL , and depression of both groups also showed improvements AT . These improvements persisted at 6-months follow-ups ( P < 0.05 ) . There were statistically significant differences between the groups for pain , disability , muscle strength , endurance , 6MWT , QOL , and depression regarding the change scores between AT-BT test and F-BT test ( P < 0.05 ) . Group 2 improved more than group 1 except for mobility . CONCLUSION Exercise programs can be modified and used successfully in CLBP and this effect can be increased with addition of back school further . LEVEL OF EVIDENCE Diagnostic study Level-I-I ( prospect i ve study ) Inpatient and outpatient treatments were compared with a control intervention in 288 men and 168 women , aged 35 - 54 , who were at work , but suffered from chronic or recurrent low back pain . Physical measurements and back pain assessment s were carried out before the intervention and at a 3-month follow-up . Physical fitness improved most in the in patients , but the out patients did not differ from the controls . Correl
Output:
| Meta-analyses for pain scores and functional outcomes revealed statistical superiority of back schools vs no intervention for some comparisons but not others .
No meta- analysis was feasible for the comparison of back schools vs other active treatments .
Adverse events were poorly reported so that no reliable conclusions regarding the safety of back schools can be drawn , although some limited reassurance in this regard may be derived from the fact that few adverse events and no serious adverse events were reported in the back school groups in the studies that did report on safety .
Overall , the evidence base for the use of back schools to treat chronic low back pain is weak ; in nearly a half-century since back schools were first trialled , no unequivocal evidence of benefit has emerged |
MS210829 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Sixty children aged 6 wk to 10 yr were studied . The children were undergoing cardiopulmonary bypass ( CPB ) for correction of congenital heart defects . The aim of the study was to provide prophylaxis for stress-induced gastric ulceration by elevating the gastric pH to at least 3.5 . Two infusion regimes of ranitidine were compared : 0.1 and 0.2 mg/kg.h . The period of study was from induction of anesthesia until the end of the first 24 h after surgery . Both regimes were effective . The 0.2-mg/kg.h infusion produced a significantly higher plasma concentration of ranitidine throughout the study period without any additional clinical benefit . Both regimes produced , within 3 h of cessation of CPB , a significant elevation in mean gastric pH to at least 5.3 . This paper concludes that 0.1-mg/kg.h infusion of ranitidine is a safe and efficacious regime for the critically ill pediatric patient Objective : To identify the incidence and factors related to upper gastrointestinal ( UGI ) bleeding in children requiring mechanical ventilation for longer than 48 hrs . Design : Prospect i ve analytic study . Setting : Ten-bed-pediatric intensive care unit of a tertiary care University Hospital . Patients : A total of 110 patients requiring mechanical ventilation for longer than 48 hrs from January 1 , 2005 to December 31 , 2005 . Measurements and Results : UGI bleeding was defined by evidence of blood in nasogastric aspirates , hematemesis , or melena within 5 days of pediatric intensive care unit admission . We prospect ively collected data on patient demographics , admission diagnosis , operative status , and pediatric risk of mortality score . UGI bleeding and the potential risk factors including organ failure , coagulopathy , maximum ventilator setting , enteral feeding , stress ulcer prophylaxis as well as sedation were daily monitored . Of the 110 patients who required mechanical ventilation for > 48 hrs , the incidence of UGI bleeding was 51.8 % , in which 3.6 % of the cases presented with clinical ly significant bleeding ( shock , requiring blood transfusion and /or surgery ) . Significant risk factors were thrombocytopenia , prolonged partial thromboplastin time , organ failure , high pressure ventilator setting ≥25 cm H2O , and pediatric risk of mortality score ≥ 10 using univariate analysis . However , the independent factors of UGI bleeding in the multivariate analysis were organ failure ( relative risk = 2.85 , 95 % confidence interval 1.18–6.92 ) and high pressure ventilator setting ≥25 cm H2O ( relative risk = 3.73 , 95 % confidence interval 1.59–8.72 ) . Conclusion : The incidence of UGI bleeding is high in children requiring mechanical ventilation . Organ failure and high pressure ventilator setting are significant risk factors for UGI bleeding Objective To estimate the mortality and length of stay in the intensive care unit ( ICU ) attributable to clinical ly important gastrointestinal bleeding in mechanically ventilated critically ill patients . Design Three strategies were used to estimate the mortality attributable to bleeding in two multicentre data bases . The first method matched patients who bled with those who did not ( matched cohort ) , using duration of ICU stay prior to the bleed , each of six domains of the Multiple Organ Dysfunction Score ( MODS ) measured 3 days prior to the bleed , APACHE II score , age , admitting diagnosis , and duration of mechanical ventilation . The second approach employed Cox proportional hazards regression to match bleeding and non-bleeding patients ( model-based matched cohort ) . The third method , instead of matching , derived estimates based on regression modelling using the entire population ( regression method ) . Three parallel analyses were conducted for the length of ICU stay attributable to clinical ly important bleeding . Setting Sixteen Canadian university-affiliated ICUs . Patients A total of 1666 critically ill patients receiving mechanical ventilation for at least 48 hours . Measurements We prospect ively collected data on patient demographics , APACHE II score , admitting diagnosis , daily MODS , clinical ly important bleeding , length of ICU stay , and mortality . Independent adjudicators determined the occurrence of clinical ly important gastrointestinal bleeding , defined as overt bleeding in association with haemodynamic compromise or blood transfusion . Results Of 1666 patients , 59 developed clinical ly important gastrointestinal bleeding . The mean APACHE II score was 22.9 ± 8.6 among bleeding patients and 23.3 ± 7.7 among non-bleeding patients . The risk of death was increased in patients with bleeding using all three analytic approaches ( matched cohort method : relative risk [RR]= 2.9 , 95 % confidence interval (CI)= 1.6–5.5 ; model-based matched cohort method : RR = 1.8 , 95 % CI = 1.1–2.9 ; and the regression method : RR = 4.1 , 95 % CI = 2.6–6.5 ) . However , this was not significant for the adjusted regression method ( RR = 1.0 , 95 % CI = 0.6–1.7 ) . The median length of ICU stay attributable to clinical ly important bleeding for these three methods , respectively , was 3.8 days ( 95 % CI = -0.01 to 7.6 days ) , 6.7 days ( 95 % CI = 2.7–10.7 days ) , and 7.9 days ( 95 % CI = 1.4–14.4 days ) . Conclusions Clinical ly important upper gastrointestinal bleeding has an important attributable morbidity and mortality , associated with a RR of death of 1–4 and an excess length of ICU stay of approximately 4–8 days Background No surveys of stress ulcer prophylaxis prescribing in the USA havebeen conducted since 1995 . Since that time , the most comprehensive meta- analysis and largest r and omized study to date concerning stress ulcer prophylaxis havebeen published . Results Three hundred sixty-eight surveys were sent to all members of theSection of Pharmacy and Pharmacology of the Society of Critical Care Medicine . One hundred fifty-three ( 42 % ) surveys were returned . Representatives from 86%of institutions stated that medications for stress ulcer prophylaxis are usedin a majority ( > 90 % ) of patients admitted to the intensive care unit (ICU).Twenty-two per cent of institutions have recommendations for both ICU and non-ICU setting s. Fifty-eight per cent of institutions stated that there wasone preferred medication for stress ulcer prophylaxis , and in 77 % of thesehistamine-2-antagonists were the most popular . Conclusions There are wide variations in prescribing practice s for stressulcer prophylaxis . Institutions should consult published literature and usepre-existing guidelines as templates for developing their own guidelines We determined the ranitidine dosage necessary to maintain gastric pH at or above 4 in 40 critically ill children . The patients were divided into four groups of ten patients each . They were treated with ranitidine in the following dosages : a ) 2 mg/kg by NG tube every 12 h ; b ) 4 mg/kg by NG tube every 12 h ; c ) 0.75 mg/kg iv every 6 h ; d ) 1.5 mg/kg iv every 6 h. The fourth group had a higher median pH than the other groups , in spite of also having the highest risk of acute gastric mucosal damage ( AGMD ) . Eight ( 80 % ) of ten patients in the fourth group had a pH greater than or equal to 4 or more than 80 % of the study period . We recommend 1.5 mg/kg iv every 6 h for gastric acid inhibition in AGMD prophylaxis in children OBJECTIVE To determine whether the dose of ranitidine recommended in commonly used pediatric drug dosage h and books ( 2 to 4 mg/kg/day i.v . ) results in successful gastric pH control ( pH of > 4 ) in critically ill children . DESIGN Prospect i ve sample . SETTING Pediatric intensive care unit in a tertiary care children 's hospital . PATIENTS Fifty consecutive patients who received > 24 hrs of scheduled intermittent intravenous ranitidine for stress ulcer prophylaxis were enrolled in the study . Patients with renal or hepatic dysfunction and those who received enteral nutrition through the nasogastric tube were excluded from enrollment . INTERVENTION Gastric pH was determined at the end of the ranitidine dosing interval , 1 hr after the dose , and at the midpoint between doses . All pH measurements were made from a sample of nasogastric aspirate , using pH sensitive paper . Gastric pH control with ranitidine was considered unsuccessful ( poorly controlled ) if the pH was < 4 for any of the three measurements . MEASUREMENTS AND MAIN RESULTS Forty-five patients ( median age 36 mos ; range 2 wks to 264 mos ) were included in the analysis . Eighty-two percent of the patients were mechanically ventilated , 16 % were pharmacologically paralyzed , 18 % required vasoactive infusions , 36 % were nourished via transpyloric feeding tubes , and 7 % received total parenteral nutrition . Gastric pH was poorly controlled in 36 % of patients . Among these patients , the pH at the end of the dosing interval was significantly lower than the pH measured at 1 hr or at the midpoint between doses ( p < .05 ) . Seventy-one percent of patients who received <3 mg/kg/day of ranitidine had poor gastric pH control as compared with 19 % who received a minimum of 3 mg/kg/day ( p < .05 ) . Poor control of gastric pH was not associated with feeding , intubation status , presence of pharmacologic paralysis , use of vasoactive infusions , or age ( p > .05 ) . CONCLUSIONS The minimum ranitidine dose recommended in commonly used pediatric drug references result ed in unsuccessful gastric pH control in a high percentage of pediatric intensive care unit patients . Critically ill children with normal renal and hepatic function should be treated with a minimum 3 mg/kg/day of intravenous ranitidine and the dose should be titrated to a gastric pH of > or = 4 Objectives . To determine the incidence , risk factors , and complications associated with or attributable to clinical ly significant upper gastrointestinal ( GI ) bleeding acquired in a pediatric intensive care unit ( ICU ) . Methods . Prospect i ve , descriptive epidemiologic study in a multidisciplinary pediatric ICU of a tertiary-care university hospital . Upper GI bleeding was considered to be present if hematemesis occurred or blood was present in the gastric tube . An upper GI bleed was qualified as clinical ly significant if two or three review ers independently assessed that at least one of the six complications considered for analysis was attributable to the upper GI bleed . Results . A cohort of 1114 consecutive admissions was enrolled ; 108 ( 9.7 % ) were excluded mostly ( 37.0 % ) because they already had an upper GI bleed at entry to the pediatric ICU . The final sample included 1006 admissions ( 881 patients ) ; 103 upper GI bleeds ( 10.2 % ) were diagnosed , including 16 clinical ly significant upper GI bleeds ( 1.6 % ) . Complications attributed to an upper GI bleed included : decreased hemoglobin concentration ( 10 cases ) , transfusion ( 10 ) , hypotension ( 3 ) , and surgery ( 1 ) . Three independent risk factors for clinical ly significant upper GI bleeding were retained by multivariate analysis : respiratory failure , coagulopathy , and pediatric risk of mortality score ≥10 . Nine of the 16 cases ( 56.3 % ) with clinical ly significant upper GI bleeding had three risk factors , 14 ( 87.5 % ) had two , and 1 ( 6.3 % ) had none . Conclusions . Clinical ly significant upper GI bleeds are rare in critically ill children . Prophylaxis to prevent them may be limited to patients who present with at least two risk factors PURPOSE The purpose of the study was to evaluate the effects of sucralfate , ranitidine , and omeprazole use on incidence of ventilatory-associated pneumonia ( VAP ) and mortality in ventilated pediatric critical care patients . MATERIAL S AND METHODS This prospect i ve study was conducted at the pediatric intensive care unit ( PICU ) between August 2000 and February 2002 . A total of 160 patients who needed mechanical ventilation were r and omized into 4 groups according to the computer-generated r and om number table : group ( S ) , ( n = 38 ) received sucralfate suspension 60 mg/kg/d in 4 doses via the nasogastric tube that was flushed with 10 mL of sterile water ; group ( R ) , ( n = 42 ) received ranitidine 2 mg/kg/d intravenously in 4 doses ; group ( O ) , ( n = 38 ) received omeprazole 1 mg/kg/d intravenously in 2 doses ; and group ( P ) , ( n = 42 ) did not receive any medication for stress ulcer prophylaxis . Treatment was begun within 6 hours of PICU admission . RESULTS Seventy patients ( 44 %
Output:
| No significant differences were found when comparing different drugs ( omeprazole , ranitidine , sucralfate , famotidine , amalgate ) , doses , or regimens for main outcomes ( deaths , endoscopic findings of erosion or ulcers , upper gastrointestinal bleeding , or pneumonia ) . |
MS210830 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: In patients with multiple myeloma ( MM ) , risk stratification by chromosomal abnormalities may enable a more rational selection of therapeutic approaches . In the present study , we analyzed the prognostic value of 12 chromosomal abnormalities in a series of 354 MM patients treated within the HOVON-65/GMMG-HD4 trial . Because of the 2-arm design of the study , we were able to analyze the effect of a bortezomib-based treatment before and after autologous stem cell transplantation ( arm B ) compared with st and ard treatment without bortezomib ( arm A ) . For allanalyzed chromosomal aberrations , progression-free survival ( PFS ) and overall survival ( OS ) were at least equal or superior in the bortezomib arm compared with the st and ard arm . Strikingly , patients with del(17p13 ) benefited the most from the bortezomib-containing treatment : the median PFS in arm A was 12.0 months and in arm B it was 26.2 months ( P = .024 ) ; the 3 year-OS for arm A was 17 % and for arm B it was 69 % ( P = .028 ) . After multivariate analysis , del(17p13 ) was an independent predictor for PFS ( P < .0001 ) and OS ( P < .0001 ) in arm A , whereas no statistically significant effect on PFS ( P = .28 ) or OS ( P = .12 ) was seen in arm B. In conclusion , the adverse impact of del(17p13 ) on PFS and OS could be significantly reduced by bortezomib-based treatment , suggesting that long-term administration of bortezomib should be recommended for patients carrying del(17p13 ) BACKGROUND Thalidomide plus dexamethasone ( TD ) is a st and ard induction therapy for myeloma . We aim ed to assess the efficacy and safety of addition of bortezomib to TD ( VTD ) versus TD alone as induction therapy before , and consolidation therapy after , double autologous stem-cell transplantation in newly diagnosed multiple myeloma . METHODS Patients ( aged 18 - 65 years ) with previously untreated symptomatic myeloma were enrolled from 73 sites in Italy between May , 2006 , and April , 2008 , and data collection continued until June 30 , 2010 . Patients were r and omly allocated ( 1:1 ratio ) by a web-based system to receive three 21-day cycles of thalidomide ( 100 mg daily for the first 14 days and 200 mg daily thereafter ) plus dexamethasone ( 40 mg daily on 8 of the first 12 days , but not consecutively ; total of 320 mg per cycle ) , either alone or with bortezomib ( 1·3 mg/m(2 ) on days 1 , 4 , 8 , and 11 ) . The r and omisation sequence was computer generated by the study coordinating team and was stratified by disease stage . After double autologous stem-cell transplantation , patients received two 35-day cycles of their assigned drug regimen , VTD or TD , as consolidation therapy . The primary endpoint was the rate of complete or near complete response to induction therapy . Analysis was by intention to treat . Patients and treating physicians were not masked to treatment allocation . This study is still underway but is not recruiting participants , and is registered with Clinical Trials.gov , number NCT01134484 , and with EudraCT , number 2005 - 003723 - 39 . FINDINGS 480 patients were enrolled and r and omly assigned to receive VTD ( n=241 patients ) or TD ( n=239 ) . Six patients withdrew consent before start of treatment , and 236 on VTD and 238 on TD were included in the intention-to-treat analysis . After induction therapy , complete or near complete response was achieved in 73 patients ( 31 % , 95 % CI 25·0 - 36·8 ) receiving VTD , and 27 ( 11 % , 7·3 - 15·4 ) on TD ( p<0·0001 ) . Grade 3 or 4 adverse events were recorded in a significantly higher number of patients on VTD ( n=132 , 56 % ) than in those on TD ( n=79 , 33 % ; p<0·0001 ) , with a higher occurrence of peripheral neuropathy in patients on VTD ( n=23 , 10 % ) than in those on TD ( n=5 , 2 % ; p=0·0004 ) . Resolution or improvement of severe peripheral neuropathy was recorded in 18 of 23 patients on VTD , and in three of five patients on TD . INTERPRETATION VTD induction therapy before double autologous stem-cell transplantation significantly improves rate of complete or near complete response , and represents a new st and ard of care for patients with multiple myeloma who are eligible for transplant . FUNDING Seràgnoli Institute of Haematology at the University of Bologna , Bologna , Italy The role of maintenance therapy in multiple myeloma is controversial . Recent studies have shown an improvement in both progression-free and overall survival for patients receiving maintenance treatment with a combination of interferon and glucocorticoids , compared with interferon alone . The role of glucocorticoids alone as maintenance therapy has not been previously addressed . We compared alternate-day , oral prednisone at 2 different dose levels ( 10 mg versus 50 mg ) for remission maintenance among previously untreated myeloma patients following a response to induction with st and ard-dose vincristine , doxorubicin , and dexamethasone with prednisone ( VAD-P ) or VAD-P plus quinine ( VAD-P/Q ) . There were 250 eligible patients registered on Southwest Oncology Group study 9210 and r and omized to receive VAD-P or VAD-P/Q. There were 125 patients achieving at least a 25 % tumor reduction following induction therapy who were r and omized to either physiologic ( 10 mg ) or pharmacologic ( 50 mg ) doses of alternate-day , oral prednisone until disease progression . At the time of study entry , patient characteristics were similar in VAD-P and VAD-P/Q patients and in the 2 arms r and omized to maintenance therapy . After a median follow-up of 53 months , there was no difference in either progression-free or overall survival between the 2 induction regimens . However , from the time of maintenance r and omization , both progression-free ( 14 versus 5 months ; P = .003 ) and overall survival ( 37 versus 26 months ; P = .05 ) were significantly improved in patients receiving 50 mg as compared with 10 mg alternate-day prednisone . There was no difference in treatment-related adverse events between the groups . Thus , 50 mg , oral , alternate-day prednisone is effective maintenance treatment for multiple myeloma patients who achieve a response to induction chemotherapy . ( Blood . 2002;99:3163 - 3168 Background and Objectives The proteasome inhibitor bortezomib is approved for the treatment of multiple myeloma ( MM ) and , in the US , for the treatment of mantle cell lymphoma following at least one prior therapy ; the recommended dose and schedule is 1.3 mg/m2 on days 1 , 4 , 8 and 11 of 21-day cycles , and the approved routes of administration in the US prescribing information are by intravenous and , following a recent up date , subcutaneous injection . Findings from a phase III study demonstrated that subcutaneous administration of bortezomib , using the same dose and schedule , result ed in similar efficacy with an improved systemic safety profile ( including significantly lower rates of peripheral neuropathy ) versus intravenous bortezomib in patients with relapsed MM . The objectives of this report were to present a comprehensive analysis of the pharmacokinetics and pharmacodynamics of subcutaneous versus intravenous bortezomib , and to evaluate the impact of the subcutaneous administration site , subcutaneous injection concentration and demographic characteristics on bortezomib pharmacokinetics and pharmacodynamics . Patients and Methods Data were analysed from the pharmacokinetic sub study of the r and omized phase III MMY-3021 study and the phase I CAN-1004 study of subcutaneous versus intravenous bortezomib in patients aged ≥18 ( MMY-3021 ) or ≤75 ( CAN-1004 ) years with symptomatic relapsed or refractory MM after 1–3 ( MMY-3021 ) or ≥1 ( CAN-1004 ) prior therapies . Patients received up to eight 21-day cycles of subcutaneous or intravenous bortezomib 1.3 mg/m2 on days 1 , 4 , 8 and 11 . Pharmacokinetic and pharmacodynamic ( 20S proteasome inhibition ) parameters of bortezomib following subcutaneous or intravenous administration were evaluated on day 11 , cycle 1 . Results Bortezomib systemic exposure was equivalent with subcutaneous versus intravenous administration in MMY-3021 [ mean area under the plasma concentration – time curve from time zero to the last quantifiable timepoint ( AUClast ) : 155 vs. 151 ng·h/mL ; geometric mean ratio 0.992 ( 90 % CI 80.18 , 122.80 ) ] and comparable in CAN-1004 ( mean AUClast : 195 vs. 241 ng·h/mL ) ; maximum ( peak ) plasma drug concentration ( Cmax ) was lower with subcutaneous administration in both MMY-3021 ( mean 20.4 vs. 223 ng/mL ) and CAN-1004 ( mean 22.5 vs. 162 ng/mL ) , and time to Cmax ( tmax ) was longer with subcutaneous administration in both studies ( median 30 vs. 2 min ) . Blood 20S proteasome inhibition pharmacodynamic parameters were also similar with subcutaneous versus intravenous bortezomib : mean maximum effect ( Emax ) was 63.7 versus 69.3 % in MMY-3021 and 57.0 versus 68.8 % in CAN-1004 , and mean area under the effect – time curve from time zero to 72 h was 1,714 versus 1,383 % · h in MMY-3021 and 1,619 versus 1,283 % · h in CAN-1004 . Time to Emax was longer with subcutaneous administration in MMY-3021 ( median 120 vs. 5 min ) and CAN-1004 ( median 120 vs. 3 min ) . Concentration of the subcutaneous injected solution had no appreciable effect on pharmacokinetic or pharmacodynamic parameters . There were no apparent differences in bortezomib pharmacokinetic and pharmacodynamic parameters between subcutaneous administration in the thigh or abdomen . There were also no apparent differences in bortezomib exposure related to body mass index , body surface area or age . ConclusionS ubcutaneous administration results in equivalent bortezomib plasma exposure to intravenous administration , together with comparable blood 20S proteasome inhibition pharmacodynamic effects . These findings , together with the non-inferior efficacy of subcutaneous versus intravenous bortezomib demonstrated in MMY-3021 , support the use of bortezomib via the subcutaneous route across the setting s of clinical use in which the safety and efficacy of intravenous bortezomib has been established In a r and omized , phase 3 study , superior complete/near-complete response ( CR/nCR ) rates and extended progression-free survival were demonstrated with bortezomib-thalidomide-dexamethasone ( VTD ) versus thalidomide-dexamethasone ( TD ) as induction therapy before , and consolidation after , double autologous stem cell transplantation for newly diagnosed myeloma patients ( intention-to-treat analysis ; VTD , n = 236 ; TD , n = 238 ) . This per- protocol analysis ( VTD , n = 160 ; TD , n = 161 ) specifically assessed the efficacy and safety of consolidation with VTD or TD . Before starting consolidation , CR/nCR rates were not significantly different in the VTD ( 63.1 % ) and TD arms ( 54.7 % ) . After consolidation , CR ( 60.6 % vs 46.6 % ) and CR/nCR ( 73.1 % vs 60.9 % ) rates were significantly higher for VTD-treated versus TD-treated patients . VTD consolidation significantly increased CR and CR/nCR rates , but TD did not ( McNemar test ) . With a median follow-up of 30.4 months from start of consolidation , 3-year progression-free survival was significantly longer for the VTD group ( 60 % vs 48 % for TD ) . Grade 2 or 3 peripheral neuropathy ( 8.1 % vs 2.4 % ) was more frequent with VTD ( grade 3 , 0.6 % ) versus TD consolidation . The superior efficacy of VTD versus TD as induction was retained despite readministration as consolidation therapy after double autologous transplantation . VTD consolidation therapy significantly contributed to improved clinical outcomes observed for patients r
Output:
| The corresponding cumulative meta-analyses of the rates of overall response rate , complete response and near complete response , and grade s 3 and 4 peripheral neuropathy supported the superiority of bortezomib-based maintenance therapy over consolidation therapy .
Bortezomib-based therapy after autologous stem cell transplantation , with tolerable AEs , could obviously improve the response as well as the outcome of multiple myeloma patients , particularly when bortezomib was administered as maintenance therapy |
MS210831 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: BACKGROUND And rogenetic alopecia ( male pattern hair loss ) is caused by and rogen-dependent miniaturization of scalp hair follicles , with scalp dihydrotestosterone ( DHT ) implicated as a contributing cause . Finasteride , an inhibitor of type II 5alpha-reductase , decreases serum and scalp DHT by inhibiting conversion of testosterone to DHT . OBJECTIVE Our purpose was to determine whether finasteride treatment leads to clinical improvement in men with male pattern hair loss . METHODS In two 1-year trials , 1553 men ( 18 to 41 years of age ) with male pattern hair loss received oral finasteride 1 mg/d or placebo , and 1215 men continued in blinded extension studies for a second year . Efficacy was evaluated by scalp hair counts , patient and investigator assessment s , and review of photographs by an expert panel . RESULTS Finasteride treatment improved scalp hair by all evaluation techniques at 1 and 2 years ( P < .001 vs placebo , all comparisons ) . Clinical ly significant increases in hair count ( baseline = 876 hairs ) , measured in a 1-inch diameter circular area ( 5.1 cm2 ) of balding vertex scalp , were observed with finasteride treatment ( 107 and 138 hairs vs placebo at 1 and 2 years , respectively ; P < .001 ) . Treatment with placebo result ed in progressive hair loss . Patients ' self- assessment demonstrated that finasteride treatment slowed hair loss , increased hair growth , and improved appearance of hair . These improvements were corroborated by investigator assessment s and assessment s of photographs . Adverse effects were minimal . CONCLUSION In men with male pattern hair loss , finasteride 1 mg/d slowed the progression of hair loss and increased hair growth in clinical trials over 2 years BACKGROUND Finasteride , a type II 5alpha-reductase inhibitor , reduces scalp and serum dihydrotestosterone and has been shown to be effective in men with and rogenetic alopecia ( AGA ) . OBJECTIVE The purpose of this study was to determine the effect of finasteride on scalp hair weight in men with AGA . METHODS Sixty-six men with AGA received finasteride , 1 mg/d , or placebo in a 48-week study , and 49 men continued in a 48-week extension . Efficacy was assessed by scalp hair weights and hair counts . RESULTS As expected , hair counts improved with finasteride ( net mean percent change + /- SE [ 95 % CI ] compared with placebo = 9.2 % + /- 2.8 % [ 3.8 , 14.6 ] and 15.4 % + /- 3.2 % [ 9.1 , 21.7 ] at 48 and 96 weeks , respectively ; P < .01 for both time points ) , and net improvements in hair weight were greater ( 25.6 % + /- 3.6 % [ 18.5 , 32.7 ] and 35.8 % + /- 4.6 % [ 26.7 , 44.8 ] at 48 and 96 weeks , respectively ; P < .001 for both time points ) . Finasteride was generally well tolerated . CONCLUSION In this study , finasteride , 1 mg , increased hair weight in men with AGA . Hair weight increased to a larger extent than hair count , implying that factors other than the number of hairs , such as increased growth rate ( length ) and thickness of hairs , contribute to the beneficial effects of finasteride in treated men BACKGROUND Finasteride , a specific inhibitor of type II 5alpha-reductase , decreases serum and scalp dihydrotestosterone and has been shown to be effective in men with vertex male pattern hair loss . OBJECTIVE This study evaluated the efficacy of finasteride 1 mg/day in men with frontal ( anterior/mid ) scalp hair thinning . METHODS This was a 1-year , double-blind , placebo-controlled study followed by a 1-year open extension . Efficacy was assessed by hair counts ( 1 cm2 circular area ) , patient and investigator assessment s , and global photographic review . RESULTS There was a significant increase in hair count in the frontal scalp of finasteride-treated patients ( P < .001 ) , as well as significant improvements in patient , investigator , and global photographic assessment s. Efficacy was maintained or improved throughout the second year of the study . Finasteride was generally well tolerated . CONCLUSION In men with hair loss in the anterior/mid area of the scalp , finasteride 1 mg/day slowed hair loss and increased hair growth BACKGROUND Male pattern hair loss ( MPHL ) is a potentially reversible condition in which dihydrotestosterone is an important etiologic factor . OBJECTIVE Our aim was to evaluate the efficacy of the type 1 and 2 5alpha-reductase inhibitor dutasteride in men with MPHL . METHODS Four hundred sixteen men , 21 to 45 years old , were r and omized to receive dutasteride 0.05 , 0.1 , 0.5 or 2.5 mg , finasteride 5 mg , or placebo daily for 24 weeks . RESULTS Dutasteride increased target area hair count versus placebo in a dose-dependent fashion and dutasteride 2.5 mg was superior to finasteride at 12 and 24 weeks . Expert panel photographic review and investigator assessment of hair growth confirmed these results . Scalp and serum dihydrotestosterone levels decreased , and testosterone levels increased , in a dose-dependent fashion with dutasteride . LIMITATIONS The study was limited to 24 weeks . CONCLUSION Dutasteride increases scalp hair growth in men with MPHL . Type 1 and type 2 5alpha-reductase may be important in the pathogenesis and treatment of MPHL Background Finasteride is a competitive inhibitor of 5 alpha-reductase enzyme , and is used for treatment of benign prostatic hyperplasia and and rogenetic alopecia . Animal studies have shown that finasteride might induce behavioral changes . Additionally , some cases of finasteride-induced depression have been reported in humans . The purpose of this study was to examine whether depressive symptoms or anxiety might be induced by finasteride administration . Methods One hundred and twenty eight men with and rogenetic alopecia , who were prescribed finasteride ( 1 mg/day ) were enrolled in this study . Information on depressed mood and anxiety was obtained by Beck Depression Inventory ( BDI ) , and Hospital Anxiety and Depression Scale ( HADS ) . Participants completed BDI and HADS question naires before beginning the treatment and also two months after it . Results Mean age of the subjects was 25.8(± 4.4 ) years . At baseline , mean BDI and HADS depression scores were 12.11(± 7.50 ) and 4.04(± 2.51 ) , respectively . Finasteride treatment increased both BDI ( p < 0.001 ) and HADS depression scores significantly ( p = 0.005 ) . HADS anxiety scores were increased , but the difference was not significant ( p = 0.061 ) . Conclusion This preliminary study suggests that finasteride might induce depressive symptoms ; therefore this medication should be prescribed cautiously for patients with high risk of depression . It seems that further studies would be necessary to determine behavioral effects of this medication in higher doses and in more susceptible patients A 24-month double-blind , r and omized , placebo-controlled , parallel-group , multicenter study of 424 men was conducted to determine the efficacy and tolerability of finasteride 1 mg on hair growth/loss in men aged 41 to 60 years with mild-to-moderate , predominantly vertex male pattern hair loss . Efficacy was evaluated by review of global photographs of the vertex scalp taken at baseline and at Months 6 , 12 , 18 , and 24 and by patient self- assessment s and investigator clinical assessment s of change from baseline in hair growth/loss collected at Months 6 , 12 , 18 , and 24 . Safety analyses included assessment of clinical and laboratory adverse experiences , including sexual adverse experiences . Analysis of global photographic assessment data showed significant improvement in hair growth for men in the finasteride group compared with those taking placebo beginning at Month 6 ( p < 0.001 ) and maintained through Month 24 ( p < 0.001 ) . Results of the patient self- assessment and investigator assessment s were consistent with those from the global photographic assessment . Finasteride 1 mg improved scalp hair growth in men aged 41 to 60 years with predominantly vertex male pattern hair loss compared with results seen with placebo . Improvement was evident by 6 months of treatment and continued through 24 months . Treatment with finasteride 1 mg was generally well tolerated BACKGROUND And rogenetic alopecia is a common condition of adult men . Finasteride , a type 2 5alpha-reductase inhibitor , decreases the formation of dihydrotestosterone from testosterone . OBJECTIVE Two separate clinical studies were conducted to establish the optimal dose of finasteride in men with this condition . METHODS Men from 18 to 36 years of age with moderate vertex male pattern hair loss received finasteride 5 , 1 , 0.2 , or 0.01 mg/day or placebo based on r and om assignment . Efficacy was determined by scalp hair counts , patient self- assessment , investigator assessment , and assessment of clinical photographs . Safety was assessed by clinical and laboratory measurements and by analysis of adverse experiences . RESULTS Efficacy was demonstrated for all end points for finasteride at doses of 0.2 mg/day or higher , with 1 and 5 mg demonstrating similar efficacy that was superior to lower doses . Efficacy of the 0.01 mg dose was similar to placebo . No significant safety issues were identified in the trials . CONCLUSION Finasteride 1 mg/day is the optimal dose for the treatment of men with male pattern hair loss and was subsequently identified for further clinical development BACKGROUND Data suggest that and rogenetic alopecia is a process dependent on dihydrotestosterone ( DHT ) and type 2 5alpha-reductase . Finasteride is a type 2 5alpha-reductase inhibitor that has been shown to slow further hair loss and improve hair growth in men with and rogenetic alopecia . OBJECTIVE We attempted to determine the effect of finasteride on scalp skin and serum and rogens . METHODS Men with and rogenetic alopecia ( N = 249 ) underwent scalp biopsies before and after receiving 0.01 , 0.05 , 0.2 , 1 , or 5 mg daily of finasteride or placebo for 42 days . RESULTS Scalp skin DHT levels declined significantly by 13.0 % with placebo and by 14.9 % , 61.6 % , 56 . 5 % , 64.1 % , and 69.4 % with 0.01 , 0.05 , 0.2 , 1 , and 5 mg doses of finasteride , respectively . Serum DHT levels declined significantly ( P < .001 ) by 49.5 % , 68.6 % , 71.4 % , and 72.2 % in the 0.05 , 0.2 , 1 , and 5 mg finasteride treatment groups , respectively . CONCLUSION In this study , doses of finasteride as low as 0.2 mg per day maximally decreased both scalp skin and serum DHT levels . These data support the rationale used to conduct clinical trials in men with male pattern hair loss at doses of finasteride between 0.2 and 5 mg BACKGROUND Finasteride 1 mg ( Propecia ) is indicated for the treatment of men with and rogenetic alopecia ( male pattern hair loss , MPHL ) . However , the long-term ( > 2 years ) efficacy and safety of finasteride in this population has not been previously reported . Objectives . To assess the efficacy and safety of finasteride in men with MPHL compared to treatment with placebo over five years . METHODS In two 1-year , Phase III trials , 1,553 men with MPHL were r and omized to receive finasteride 1 mg/day or placebo , and 1,215 men continued in up to four 1-year , placebo-controlled extension studies . Efficacy was evaluated by hair counts , patient and investigator assessment s , and panel review of clinical photographs . RESULTS Treatment with finasteride led to durable improvements in scalp hair over five years ( p 3/4 0.001 versus placebo , all endpoints ) , while treatment with placebo led to progressive hair loss . Finasteride was generally well tolerated and no new safety concerns were identified during long-term use . CONCLUSIONS In men with MPHL , long-term treatment with finasteride 1 mg/day over five years was well tolerated , led to durable improvements in scalp hair growth , and slowed the further progression of hair loss that occurred without treatment BACKGROUND Our practical experience indicates that sexual side-effects in subjects taking finasteride 1 mg ( Propecia ) for and rogenetic alopecia are much less common than reported in the literature . OBJECTIVE To evaluate the sexual function in subjects taking finasteride ( 1 mg ) compared with age-matched controls using the International Index of Erectile Function ( IIEF ) . METHODS The IIEF , a brief , reliable question naire , was self-administered to 236 patients taking Propecia and 236 age-matched males attending the Department of Dermatology of the University of Bologna . RESULTS Statistical analysis showed no differences between scores obtained with the IIEF in subjects taking finasteride and controls . CONCLUS
Output:
| Moderate- quality evidence suggests that daily use of oral finasteride increases hair count and improves patient and investigator assessment of hair appearance , while increasing the risk of sexual dysfunction |
MS210832 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: BACKGROUND Nearly two-thirds of elderly patients treated for depression fail to achieve symptomatic remission and functional recovery with first-line pharmacotherapy . In this study , we ask whether a mind-body exercise , Tai Chi Chih ( TCC ) , added to escitalopram will augment the treatment of geriatric depression design ed to achieve symptomatic remission and improvements in health functioning and cognitive performance . METHODS : One hundred twelve older adults with major depression age 60 years and older were recruited and treated with escitalopram for approximately 4 weeks . Seventy-three partial responders to escitalopram continued to receive escitalopram daily and were r and omly assigned to 10 weeks of adjunct use of either 1 ) TCC for 2 hours per week or 2 ) health education ( HE ) for 2 hours per week . All participants underwent evaluations of depression , anxiety , resilience , health-related quality of life , cognition , and inflammation at baseline and during 14-week follow-up . RESULTS Subjects in the escitalopram and TCC condition were more likely to show greater reduction of depressive symptoms and to achieve a depression remission as compared with those receiving escitalopram and HE . Subjects in the escitalopram and TCC condition also showed significantly greater improvements in 36-Item Short Form Health Survey physical functioning and cognitive tests and a decline in the inflammatory marker , C-reactive protein , compared with the control group . CONCLUSION : Complementary use of a mind-body exercise , such as TCC , may provide additional improvements of clinical outcomes in the pharmacologic treatment of geriatric depression Objective This study examined the feasibility , safety , and efficacy of using tai chi for treating major depressive disorder . Design Thirty-nine Chinese Americans with major depressive disorder were r and omized into a 12-wk tai chi intervention or a waitlisted control group in a 2:1 ratio . The key outcome measurement was the 17-item Hamilton Rating Scale for Depression . Positive response was defined as a decrease of 50 % or more on the 17-item Hamilton Rating Scale for Depression , and remission was defined as a score of 7 or lower on the 17-item Hamilton Rating Scale for Depression . Results Of the participants ( n = 39 ) , 77 % were women , and mean ( SD ) age was 55 ( 10 ) years . There were 26 ( 67 % ) participants in the tai chi intervention group and 13 ( 33 % ) in the control group . Of the participants in the tai chi group , 73 % completed the intervention ; no adverse events were reported . We observed trends toward improvement in the tai chi intervention group , compared with the control group , in positive treatment-response rate ( 24 % vs. 0 % ) and remission rate ( 19 % vs. 0 % ) , although the differences in our small sample did not reach statistical significance . Conclusions A r and omized controlled trial of tai chi is feasible and safe in Chinese American patients with major depressive disorder . These promising pilot study results inform the design of a more definitive trial BACKGROUND There appears to be consensus that patients with only one or two prior depressive episodes do not benefit from treatment with mindfulness-based cognitive therapy ( MBCT ) . AIMS To investigate whether the effect of MBCT on residual depressive symptoms is contingent on the number of previous depressive episodes ( trial number NTR1084 ) . METHOD Currently non-depressed adults with residual depressive symptoms and a history of depression ( ≤2 prior episodes : n = 71 ; ≥3 episodes : n = 59 ) were r and omised to MBCT ( n = 64 ) or a waiting list ( control : n = 66 ) in an open-label , r and omised controlled trial . The main outcome measured was the reduction in residual depressive symptoms ( Hamilton Rating Scale for Depression , HRSD-17 ) . RESULTS Mindfulness-based cognitive therapy was superior to the control condition across subgroups ( β = -0.56 , P<0.001 ) . The interaction between treatment and subgroup was not significant ( β = 0.45 , P = 0.16 ) . CONCLUSIONS Mindfulness-based cognitive therapy reduces residual depressive symptoms irrespective of the number of previous episodes of major depression Mental health problems continue topresent a global challenge and contributesignificantly to the global burden ofhuman disease ( DALYs ) . Depression isthe most common psychiatric disorder and is thought to affect 121 million adultsworldwide , and as such was rated as thefourth leading cause of disease burden in2000 ( Moussavi et al. , 2007 ) , projected tobecome the highest cause of disease bur-den by 2020 . Antidepressant drugs are aneffective and commonly used treatmentfor depression in primary care ( Arrollet al. , 2009 ) , although almost half of thosetreated do not achieve full remission oftheir symptoms , and there remains a riskof residual symptoms , relapse/recurrence(Fava and Ruini , 2002 ) . In those patients who do demonstrate improvements indepressive symptoms with antidepres-sant therapies , a time-lag in the onset oftherapeutic effects is frequently reported . Antidepressant drugs are associated withadverse side effects ( Agency for Health Research and Quality ( AHRQ ) , 2012 ) and an increased risk of cardiovascu-lar disease , particularly in those withpre-existing cardiovascular conditions ormajor cardiovascular risk factors ( Waring,2012 ) . Furthermore , adherence to antide-pressant medications is often poor and patients often prematurely discontinuetheir antidepressant therapy ; it has beensuggested that approximately 50 % of psy-chiatric patients and 50 % of primary care patients are non-adherent when assessed6-months after the initiation of treatment(Sansone and Sansone , 2012).Psychological treatments for depres-sion have been recommended in theUK National Institute for Health and Clinical Excellence ( NICE ) guidelines ( NICE , 2009 ) and are becoming morecommonplace for helping to reducesymptoms in depressed adults ( Ambresinet al. , 2012 ; Brakemeier and Frase , 2012),with even brief psychosocial interven-tions showing promise for improvingadherence to depression medication treat-ment in primary care setting s ( Sirey et al.,2010).However , attendance atpsychologi-cal intervention sessions can be poor sincemany depressed adults who may benefitfromsuch treatments choosenotto attendmental health clinics due to the perceivedstigma ofpsychological therapies . As such there has been an increasinginterest in the role of alternative inter-ventions for depression . Physical exercisehas been proposed as a complementarytreatment which may help to improveresidual symptoms of depression and pre-vent relapse ( Trivedi et al. , 2006 ) . Exercisehas been proposed by many as a poten-tial treatment for depression and meta- analysis has demonstrated that effect sizesin intervention studies range from -0.80to -1.1 ( Rethorst et al. , 2009 ) . However , the evidence is not always consistent;recent research has shown that that pro-vision of tailored advice and encourage-ment for physical activity did not improvedepression outcome or antidepressant usein depressed adults when compared withusual care ( Chalder et al. , 2012 ) . Other research ers have failed to find an antide-pressant effect of exercise in patients with major depression but have foundshort term positive effects on physical outcomes , body composition and mem-ory ( Krogh et al. , 2012 ) . Others haveargued that the nature of exercise deliv-ery is an important factor , with exer-cise of preferred ( rather than prescribed)intensity shown to improve psychological , physiological and social outcomes , and exercise participation rates in depressedindividuals(Callaghanet al. , 2011 ) . Research findings have beensummarized by a recent Cochrane review whichreportedthefindingsof32r and om-ized controlled trials in which exercisewas compared to st and ard treatment , no treatment or a placebo treatment inadults ( aged 18 and over ) with depression(Rimeretal.,2012).This review concludedthat exercise seems to improve depressivesymptoms in people with a diagnosis ofdepression when compared with no treat-ment or control intervention , althoughhighlighted that this should be interpretedwith caution since the positive effects ofexercise were smaller in method ologi-cally robust trials . Similarly , a systematic review found that physical exercise pro-grams obtain clinical ly relevant outcomes in the treatment of depressive symptomsin depressed older people Although cognitive-behavioural programmes for preventing depression have produced promising findings , their administration requires extensive training . Relaxation techniques are more straightforward psychological strategies , but they have not been investigated in the prevention of depression . This trial aim ed to compare the results of relaxation training ( RT ) with that of a cognitive-behavioural programme ( CBT ) for prevention of depression in university students with elevated depressive symptoms . The 133 participants ( mean age 23.3 years , 82 % women ) were r and omly assigned to CBT or RT . Both programmes were administered to groups of 5 or 6 participants in eight weekly 90-min sessions . Participants were evaluated by independent raters before , immediately after , and 3 and 6 months after taking part in the programmes . By itself , intervention type had no significant effect on either depression or anxiety scores . The scores were lower at the follow-up time points with respect to pre-intervention scores . Effect size was greatest between pre- and immediately post-intervention scores for CBT , d = 1.32 , 95 % CI [ 1.00 , 1.64 ] , and between pre- and 6-month post-intervention scores for RT , d = 0.75 , 95 % CI [ 0.47 , 1.03 ] . Anxiety symptoms were significantly improved by both interventions at 3-month follow-up , and by CBT at 6-month follow-up also . In the medium term ( 3 - 6 months ) , relaxation training produced similar reductions in depressive and anxiety symptoms as a more complex cognitive-behavioural programme CONTEXT Mindfulness-based cognitive therapy ( MBCT ) is a group-based psychosocial intervention design ed to enhance self-management of prodromal symptoms associated with depressive relapse . OBJECTIVE To compare rates of relapse in depressed patients in remission receiving MBCT against maintenance antidepressant pharmacotherapy , the current st and ard of care . DESIGN Patients who met remission criteria after 8 months of algorithm-informed antidepressant treatment were r and omized to receive maintenance antidepressant medication , MBCT , or placebo and were followed up for 18 months . SETTING Outpatient clinics at the Centre for Addiction and Mental Health , Toronto , Ontario , Canada , and St Joseph 's Healthcare , Hamilton , Ontario . PARTICIPANTS One hundred sixty patients aged 18 to 65 years meeting DSM-IV criteria for major depressive disorder with a minimum of 2 past episodes . Of these , 84 achieved remission ( 52.5 % ) and were assigned to 1 of the 3 study conditions . INTERVENTIONS Patients in remission discontinued their antidepressants and attended 8 weekly group sessions of MBCT , continued taking their therapeutic dose of antidepressant medication , or discontinued active medication and were switched to placebo . MAIN OUTCOME MEASURE Relapse was defined as a return , for at least 2 weeks , of symptoms sufficient to meet the criteria for major depression on module A of the Structured Clinical Interview for DSM-IV . RESULTS Intention-to-treat analyses showed a significant interaction between the quality of acute-phase remission and subsequent prevention of relapse in r and omized patients ( P = .03 ) . Among unstable remitters ( 1 or more Hamilton Rating Scale for Depression score > 7 during remission ) , patients in both MBCT and maintenance treatment showed a 73 % decrease in hazard compared with placebo ( P = .03 ) , whereas for stable remitters ( all Hamilton Rating Scale for Depression scores ≤7 during remission ) there were no group differences in survival . CONCLUSIONS For depressed patients achieving stable or unstable clinical remission , MBCT offers protection against relapse/recurrence on a par with that of maintenance antidepressant pharmacotherapy . Our data also highlight the importance of maintaining at least 1 long-term active treatment in unstable remitters This study evaluated mindfulness-based cognitive therapy ( MBCT ) , a group intervention design ed to train recovered recurrently depressed patients to disengage from dysphoria-activated depressogenic thinking that may mediate relapse/recurrence . Recovered recurrently depressed patients ( n = 145 ) were r and omized to continue with treatment as usual or , in addition , to receive MBCT . Relapse/recurrence to major depression was assessed over a 60-week study period . For patients with 3 or more previous episodes of depression ( 77 % of the sample ) , MBCT significantly reduced risk of relapse/recurrence . For patients with only 2 previous episodes , MBCT did not reduce relapse/recurrence . MBCT offers a promising cost-efficient psychological approach to preventing relapse/recurrence in recovered recurrently depressed patients OBJECTIVE To document the short-term efficacy of omega-3 supplementation in reducing depressive symptoms in patients experiencing a major depressive episode ( MDE ) . METHOD Inclusive , double-blind , r and omized , controlled , 8-week , parallel-group trial , conducted October 17 , 2005 through January 30 , 2009 in 8 Canadian academic and
Output:
| The strongest evidence currently exists for mindfulness-based interventions and St. John ’s Wort ( SJW ) as monotherapies , and there is relatively strong evidence to support the use of omega-3 fatty acids and exercise as adjunct therapies .
However , there remains an overall lack of method ologically rigorous research to support the efficacy of many other IntM techniques . |
MS210833 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: The aim of the present proof-of-concept study was to test a novel cognitive bias modification ( CBM ) programme in an analogue sample of people with sub clinical bulimic eating disorder ( ED ) psychopathology . Thirty participants with high levels of trait food craving were trained to make avoidance movements in response to visual food stimuli in an implicit learning paradigm . The intervention comprised ten 15-minute sessions over a 5-week course . At baseline , participants showed approach and attentional biases towards high-caloric palatable food that were both significantly reduced and turned into avoidance biases after the training . Participants also reported pronounced reductions in both trait and cue-elicited food craving and in ED symptoms as well . The overall evaluation of the training by the participants was positive . The specific CBM programme tested in this pilot trial promises to be an effective and feasible way to alter automatic action tendencies towards food in people suffering from bulimic ED psychopathology BACKGROUND Excessive discounting of future rewards has been observed in a variety of disorders and has been linked both to valuation of the past and to memory of past events . METHODS To explore the functionality of discounting and memory , we examined whether training of working memory would result in less discounting of future rewards . In this study , 27 adults in treatment for stimulant use were r and omly assigned to receive either working memory training or control training according to a yoked experimental design . Measures of delay discounting and several other cognitive behaviors were assessed pre- and posttraining . RESULTS Rates of discounting of delayed rewards were significantly reduced among those who received memory training but were unchanged among those who received control training ; other cognitive assessment s were not affected by memory training . Discount rates were positively correlated with memory training performance measures . CONCLUSIONS To our knowledge , this is the first study demonstrating that neurocognitive training on working memory decreases delay discounting . These results offer further evidence of a functional relationship between delay discounting and working memory The mere sight of foods may activate the brain ’s reward circuitry , and humans often experience difficulties in inhibiting urges to eat upon encountering visual food signals . Imbalance between the reward circuit and those supporting inhibitory control may underlie obesity , yet brain circuits supporting volitional control of appetite and their possible dysfunction that can lead to obesity remain poorly specified . Here we delineated the brain basis of volitional appetite control in healthy and obese individuals with functional magnetic resonance imaging ( fMRI ) . Twenty-seven morbidly obese women ( mean BMI = 41.4 ) and fourteen age-matched normal-weight women ( mean BMI = 22.6 ) were scanned with 1.5 Tesla fMRI while viewing food pictures . They were instructed to inhibit their urge to eat the foods , view the stimuli passively or imagine eating the foods . Across all subjects , a frontal cortical control circuit was activated during appetite inhibition versus passive viewing of the foods . Inhibition minus imagined eating ( appetite control ) activated bilateral precunei and parietal cortices and frontal regions spanning anterior cingulate and superior medial frontal cortices . During appetite control , obese subjects had lower responses in the medial frontal , middle cingulate and dorsal cau date nuclei . Functional connectivity of the control circuit was increased in morbidly obese versus control subjects during appetite control , which might reflect impaired integrative and executive function in obesity OBJECTIVE Obesity is largely attributable to excess caloric intake , in particular from " junk " foods , including salty snack foods . Evidence suggests that neurobiological preferences to consume highly hedonic foods translate ( via implicit processes ) into poor eating choices , unless overturned by inhibitory mechanisms or interrupted by explicit processes . The primary aim of the current study was to test the independent and combinatory effects of a computerized inhibitory control training ( ICT ) and a mindful decision-making training ( MDT ) design ed to facilitate de-automatization . METHODS We r and omized 119 habitual salty snack food eaters to one of four short , training conditions : MDT , ICT , both MDT and ICT , or neither ( i.e. , psychoeducation ) . For 7 days prior to the intervention and 7 days following the intervention , participants reported on their salty snack food consumption 2 times per day , on 3 portions of their days , using a smartphone-based ecological momentary assessment system . Susceptibility to emotional eating cues was measured at baseline . RESULTS Results indicated that the effect of MDT was consistent across levels of trait emotional eating , whereas the benefit of ICT was apparent only at lower levels of emotional eating . No synergistic effect of MDT and ICT was detected . CONCLUSIONS These results provide qualified support for the efficacy of both types of training for decreasing hedonically-motivated eating . Moderation effects suggest that those who eat snack foods for reasons unconnected to affective experiences ( i.e. , lower in emotional eating ) may derive benefit from a combination of ICT and MDT . Future research should investigate the additive benefit of de-automization training to st and ard weight loss interventions The choice of small immediate rewards as opposed to larger delayed rewards , or delay discounting , is an important dimension of impulsive decision making . The inability to delay gratification is related to obesity , as well as other maladaptive behaviors such as substance abuse , problem drinking , smoking , pathological gambling , and risky HIV behaviors . One way to reduce delay discounting ( DD ) may be to use prospect i ve imagery in the form of episodic future thinking ( EFT ) during inter-temporal decision making . We have recently shown that EFT reduces DD and ad libitum energy intake in obese individuals . However , no studies have examined whether the magnitude of the EFT effect differs between lean and overweight/obese individuals . We conducted a within-subject design experiment to compare the efficacy of EFT versus a control task in reducing DD between lean ( N=24 ) and overweight/obese ( N=24 ) women . Participants attended two sessions in which they engaged in either EFT or control episodic thinking during a DD task . We also examined whether individual differences such as trait time perspective , behavioral inhibition or behavioral activation moderated the EFT effect on DD . Results showed EFT reduced DD similarly for lean and overweight/obese individuals . The EFT effect was moderated by behavioral activation . This suggests EFT is just as effective in reducing impulsive decision making in obese individuals as it is in lean individuals and may be useful in reducing other impulsive obesity related behaviors Impulsive delayed reward discounting ( DRD ) is an important behavioral process in alcohol use disorders ( AUDs ) , reflecting incapacity to delay gratification . Recent work in neuroeconomics has begun to unravel the neural mechanisms supporting DRD , but applications of neuroeconomics in relation to AUDs have been limited . This study examined the neural mechanisms of DRD preferences in AUDs , with emphasis on dissociating activation patterns based on DRD choice type and level of cognitive conflict . Heavy drinking adult men with ( n = 13 ) and without ( n = 12 ) a diagnosis of an AUD completed a monetary DRD task during a functional magnetic resonance imaging scan . Participant responses were coded based on choice type ( impulsive versus restrained ) and level of cognitive conflict ( easy versus hard ) . AUD+ participants exhibited significantly more impulsive DRD decision‐making . Significant activation during DRD was found in several decision‐making regions , including dorsolateral prefrontal cortex ( DLPFC ) , insula , posterior parietal cortex ( PPC ) , and posterior cingulate . An axis of cognitive conflict was also observed , with hard choices associated with anterior cingulate cortex and easy choices associated with activation in supplementary motor area . AUD+ individuals exhibited significant hyperactivity in regions associated with cognitive control ( DLPFC ) and prospect i ve thought ( PPC ) and exhibited less task‐related deactivation of areas associated with the brain 's default network during DRD decisions . This study provides further clarification of the brain systems supporting DRD in general and in relation to AUDs OBJECTIVE The current study sought to examine executive function ( EF ) in overweight individuals with and without loss-of-control ( LOC ) eating . METHOD Eighty overweight and obese individuals entering a behavioural weight loss trial with ( n=18 ) and without ( n=62 ) LOC eating were administered a clinical interview and neuropsychological battery design ed to assess self-regulatory control , planning , delayed discounting and working memory . RESULTS After controlling for age , IQ and depression , individuals with LOC eating performed worse on tasks of planning and self-regulatory control and did not differ in performance on other tasks . DISCUSSION Results indicate that overweight individuals with LOC eating display relative deficits in EF compared with overweight individuals without LOC eating . Planning and self-regulatory control deficits in particular may contribute to dysregulated eating patterns , increasing susceptibility to LOC episodes . Future research should examine how EF deficits relate to treatment outcome Background Research has shown that obese individuals have cognitive deficiencies in executive function , leading to poor planning and impulse control , and decision-making difficulties . An intervention that could help reduce these deficits and in turn help weight loss maintenance is Cognitive Remediation Therapy for Obesity ( CRT-O ) . We aim to examine the efficacy of manualised CRT-O , which is intended to improve executive function , enhance reflective practice and help weight loss maintenance . Methods / Design A r and omised controlled trial ( registered with the Australian New Zeal and Clinical Trials Registry ) will be conducted . First , 90 obese adults ( body mass index > 30 kg/m2 ) in the community will receive three weekly sessions of a group Behaviour Weight Loss Treatment ( BWLT ) , and then will be r and omised either to receive CRT-O or to enter a no-treatment control group . CRT-O training will comprise twice-weekly sessions of 45 minutes over a 4 to 6 week period , for a total of eight sessions . Measurement points will be at baseline , post CRT-O ( or 4 to 6 weeks after BWLT for the no-treatment control ) , 3 months post treatment and 1 year post treatment . The primary outcome will be executive function and secondary outcome measures will include participants ’ body mass index , hip to waist ratio , eating behaviours and quality of life . Discussion This is the first study of its kind to examine the efficacy of Cognitive Remediation Therapy for obese adults through a r and omised controlled trial . Trial Registration Australian New Zeal and Clinical Trials Registry number : 12613000537752 . Date of registration : 14 May 2013 Obese individuals tend to behave more impulsively than healthy weight individuals across a variety of measures , but it is unclear whether this pattern can be altered . The present study examined the effects of a mindful eating behavioral strategy on impulsive and risky choice patterns for hypothetical food and money . In Experiment 1 , 304 participants completed computerized delay and probability discounting tasks for food-related and monetary outcomes . High percent body fat ( PBF ) predicted more impulsive choice for food , but not small-value money , replicating previous work . In Experiment 2 , 102 r and omly selected participants from Experiment 1 were assigned to participate in a 50-min workshop on mindful eating or to watch an educational video . They then completed the discounting tasks again . Participants who completed the mindful eating session showed more self-controlled and less risk-averse discounting patterns for food compared to baseline ; those in the control condition discounted similarly to baseline rates . There were no changes in discounting for money for either group , suggesting stimulus specificity for food for the mindful eating condition Although higher delay discounting rates have been linked to cigarette smoking , little is known about the stability of delay discounting , whether delay discounting promotes smoking acquisition , whether smoking contributes to impulsive choices , or if different relationships exist in distinct subgroups . This study sought to fill these gaps within a prospect i ve longitudinal cohort study ( N=947 ) spanning mid-adolescence to young adulthood ( age 15 - 21 years old ) . Smoking and delay discounting were measured across time . Covariates included peer and household smoking , academic performance , depression , novelty seeking , inattention and hyperactivity/impulsivity symptoms , and alcohol and marijuana use . The associated processes latent growth curve modeling ( LGCM ) with paths from the delay discounting level factor ( baseline measure ) and the trend factor ( slope ) to the smoking trend factor ( slope ) fit the data well , chi(2)((19,n=947 ) ) = 15.37 , p=.70 , CFI=1.00 , RMSEA=0 , WRMR=.36 . The results revealed that delay discounting did not change significantly across time . Baseline delay discounting had a significant positive effect on smoking trend ( beta=.08 , z=2.16 , p=.03 ) . A st and ard deviation ( SD=1.41 ) increase in baseline delay discounting result ed in an 11 % increase ( OR=1.11 , 95 % CI=1.03 , 1.23 ) in the odds of smoking uptake . The alternative path LCGM revealed that smoking did not significantly impact delay discounting ( p's>.05 ) . Growth mixture modeling identified three smoking trajectories : nonsmokers , early/fast smoking adopters , and slow smoking progressors . Delay discounting was higher in the smoking versus nonsmoking trajectories , but did not discriminate between the smoking trajectories , despite different acquisition patterns . Delay discounting may provide a variable by which to screen for smoking vulnerability and help identify subgroups to target for more intensive smoking prevention efforts that include novel behavioral components directed toward aspects of impulsivity OBJECTIVE A positive association between delay discounting and substance use has been documented ; substance users tend to discount
Output:
| Limited data suggest that BN , BED and obesity are associated with increased TD , whilst data in AN are mixed .
Aberrant neural activity in frontostriatal circuitry is implicated .
TD tasks vary widely and TD in ED/obesity may vary according to factors such as illness stage .
Our findings suggest altered self-regulatory control in ED and obesity . |
MS210834 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: BACKGROUND The role of rituximab in combination with different CHOP ( cyclophosphamide , doxorubicin , vincristine , and prednisone)-like chemotherapy regimens in young patients with good-prognosis diffuse large-B-cell lymphoma remains to be defined . We aim ed to compare CHOP-like chemotherapy and rituximab with CHOP-like chemotherapy alone in these patients . METHODS 824 patients who were from 18 countries ; aged 18 - 60 years ; and who had no risk factors or one risk factor according to age-adjusted International Prognostic Index ( IPI ) , stage II-IV disease , or stage I disease with bulk were enrolled . These patients were r and omly assigned to six cycles of CHOP-like chemotherapy and rituximab ( n=413 ) or to six cycles of CHOP-like chemotherapy alone ( n=411 ) . Bulky and extranodal sites received additional radiotherapy . The primary endpoint was event-free survival ; secondary endpoints were response , progression under therapy , progression-free survival , overall survival , and frequency of toxic effects . Analyses were done by intention to treat and per protocol . This trial is registered at http://www . clinical trials.gov , NCT 00064116 . FINDINGS After a median follow-up of 34 months ( range 0.03 - 61 ) , patients assigned chemotherapy and rituximab had increased 3-year event-free survival compared with those assigned chemotherapy alone ( 79 % [ 95 % CI 75 - 83 ] vs 59 % [ 54 - 64 ] ; difference between groups 20 % [ 13 - 27 ] , log-rank p<0.0001 ) , and had increased 3-year overall survival ( 93 % [ 90 - 95 ] vs 84 % [ 80 - 88 ] ; difference between groups 9 % [ 3 - 13 ] , log-rank p=0.0001 ) . Event-free survival was affected by treatment group , presence of bulky disease , and age-adjusted IPI : after chemotherapy and rituximab , a favourable subgroup ( ie , IPI=0 , no bulk ) could be defined from a less-favourable subgroup ( ie , IPI=1 or bulk , or both ) . Groups did not differ in the frequency of adverse events . INTERPRETATION Rituximab added to six cycles of CHOP is an effective treatment for young patients with good-prognosis diffuse large-B-cell lymphoma . The definition of two prognostic subgroups allows for a more refined therapeutic approach for these patients PURPOSE To compare low-dose ( 30 Gy ) radiotherapy ( RT ) with observation ( OBS ) in limited-stage aggressive lymphoma patients achieving complete remission ( CR ) after chemotherapy , and to measure conversion from partial response ( PR ) to CR with high-dose ( 40 Gy ) RT . PATIENTS AND METHODS From 1984 to 1992 , stage I ( with risk factors ) and II adults with diffuse aggressive lymphoma in CR after eight cycles of cyclophosphamide , doxorubicin , vincristine , and prednisone ( CHOP ) were r and omly assigned to 30 Gy involved-field RT or OBS . PR patients received 40 Gy RT . RESULTS Among 172 CR patients , the 6-year disease-free survival ( DFS ) was 73 % for low-dose RT versus 56 % for OBS ( two-sided P = .05 ) . Failure-free survival ( two-sided P = .06 ) , and time to progression ( two-sided P = .06 ) also favored RT . Intent-to-treat analyses yielded similar results . No survival differences were observed . Three RT versus 15 OBS patients relapsed in initial disease sites . At 6 years , failure-free survival was 63 % in PR patients ; conversion to CR did not significantly influence clinical outcome . CONCLUSION For patients in CR after CHOP , low-dose RT prolonged DFS and provided local control , but no survival benefit was observed . The majority of PR patients were event-free at 6 years despite residual radiographic abnormalities . Future efforts should be directed toward improved imaging and more effective systemic therapies BACKGROUND The MInT study was the first to show improved 3-year outcomes with the addition of rituximab to a CHOP ( cyclophosphamide , doxorubicin , vincristine , and prednisone)-like regimen in young patients with good-prognosis diffuse large-B-cell lymphoma . Extended follow-up was needed to establish long-term effects . METHODS In the r and omised open-label MInT study , patients from 18 countries ( aged 18 - 60 years with none or one risk factor according to the age-adjusted International Prognostic Index [ IPI ] , stage II-IV disease or stage I disease with bulk ) were r and omly assigned to receive six cycles of a CHOP-like chemotherapy with or without rituximab . Bulky and extranodal sites received additional radiotherapy . R and omisation was done central ly with a computer-based tool and was stratified by centre , bulky disease , age-adjusted IPI , and chemotherapy regimen by use of a modified minimisation algorithm that incorporated a stochastic component . Patients and investigators were not masked to treatment allocation . The primary endpoint was event-free survival . Analyses were by intention to treat . This observational study is a follow-up of the MInT trial , which was stopped in 2003 , and is registered at Clinical Trials.gov , number NCT00400907 . FINDINGS The intention-to-treat population included 410 patients assigned to chemotherapy alone and 413 assigned to chemotherapy plus rituximab . After a median follow-up of 72 months ( range 0·03 - 119 ) , 6-year event-free survival was 55·8 % ( 95 % CI 50·4 - 60·9 ; 166 events ) for patients assigned to chemotherapy alone and 74·3 % ( 69·3 - 78·6 ; 98 events ) for those assigned to chemotherapy plus rituximab ( difference between groups 18·5 % , 11·5 - 25·4 , log-rank p<0·0001 ) . Multivariable analyses showed that event-free survival was affected by treatment group , presence of bulky disease , and age-adjusted IPI and that overall survival was affected by treatment group and presence of bulky disease only . After chemotherapy and rituximab , a favourable subgroup ( IPI=0 , no bulk ) could be defined from a less favourable subgroup ( IPI=1 or bulk , or both ; event-free survival 84·3 % [ 95 % CI 74·2 - 90·7 ] vs 71·0 % [ 65·1 - 76·1 ] , log-rank p=0·005 ) . 18 ( 4·4 % , 95 % CI 2·6 - 6·9 ) second malignancies occurred in the chemotherapy-alone group and 16 ( 3·9 % , 2·2 - 6·2 ) in the chemotherapy and rituximab group ( Fisher 's exact p=0·730 ) . INTERPRETATION Rituximab added to six cycles of CHOP-like chemotherapy improved long-term outcomes for young patients with good-prognosis diffuse large-B-cell lymphoma . The definition of two prognostic subgroups allows a more refined therapeutic approach to these patients than does assessment by IPI alone . FUNDING Hoffmann-La Roche PURPOSE To analyze the long-term outcome of patients included in the Lymphome Non Hodgkinien study 98 - 5 ( LNH98 - 5 ) comparing cyclophosphamide , doxorubicin , vincristine , and prednisone ( CHOP ) to rituximab plus CHOP ( R-CHOP ) in elderly patients with diffuse large B-cell lymphoma . PATIENTS AND METHODS LNH98 - 5 was a r and omized study that included 399 previously untreated patients , age 60 to 80 years , with diffuse large B-cell lymphoma . Patients received eight cycles of classical CHOP ( cyclophosphamide 750 mg/m(2 ) , doxorubicin 50 mg/m(2 ) , vincristine 1.4 mg/m(2 ) , and prednisone 40 mg/m(2 ) for 5 days ) every 3 weeks . In R-CHOP , rituximab 375 mg/m(2 ) was administered the same day as CHOP . Survivals were analyzed using the intent-to-treat principle . RESULTS Median follow-up is 5 years at present . Event-free survival , progression-free survival , disease-free survival , and overall survival remain statistically significant in favor of the combination of R-CHOP ( P = .00002 , P < .00001 , P < .00031 , and P < .0073 , respectively , in the log-rank test ) . Patients with low-risk or high-risk lymphoma according to the age-adjusted International Prognostic Index have longer survivals if treated with the combination . No long-term toxicity appeared to be associated with the R-CHOP combination . CONCLUSION Using the combination of R-CHOP leads to significant improvement of the outcome of elderly patients with diffuse large B-cell lymphoma , with significant survival benefit maintained during a 5-year follow-up . This combination should become the st and ard for treating these patients PURPOSE R-CHOP ( rituximab plus cyclophosphamide , doxorubicin , vincristine , and prednisone ) is st and ard care for aggressive B-cell lymphoma . A prospect i ve trial was conducted to investigate the role of additive radiotherapy ( RT ) to bulky and extralymphatic disease . PATIENTS AND METHODS The best arm of the RICOVER-60 trial ( 6 × R-CHOP-14 + 2R [ R-CHOP administered once every 2 weeks plus two additional applications of rituximab ] plus involved-field RT [ 36 Gy ] to sites of initial bulky [ ≥ 7.5 cm ] disease and extralymphatic involvement ) was compared with a cohort receiving the same immunochemotherapy but without RT in an amendment to the RICOVER-60 trial ( RICOVER-noRTh ) in a prospect i ve fashion . RESULTS After a median observation time of 39 months , 164 of 166 RICOVER-noRTh patients were evaluable . In a multivariable analysis of the intention-to-treat population adjusting for International Prognostic Index risk factors and age ( > 70 years ) , event-free survival ( EFS ) of patients with bulky disease was inferior without additive RT ( hazard ratio [ HR ] , 2.1 ; 95 % CI , 1.3 to 3.5 ; P = .005 ) , with trends for inferior progression-free ( PFS ; HR , 1.8 ; 95 % CI , 1.0 to 3.3 ; P = .058 ) and overall survival ( OS ; HR , 1.6 ; 95 % CI , 0.9 to 3.1 ; P = .127 ) . In a per- protocol analysis with 11 patients in RICOVER-noRTh excluded for receiving unplanned RT , multivariable analysis revealed HRs of 2.7 ( 95 % CI , 1.3 to 5.9 ; P = .011 ) for EFS , 4.4 ( 95 % CI , 1.8 to 10.6 ; P = .001 ) for PFS , and 4.3 ( 95 % CI , 1.7 to 11.1 ; P = .002 ) for OS for patients not receiving RT to bulky disease . CONCLUSION Additive RT to bulky sites abrogates bulky disease as a risk factor and improves outcome of elderly patients with aggressive B-cell lymphoma . Whether RT can be spared in patients with ( metabolic ) complete remission after immunochemotherapy must be addressed in appropriately design ed prospect i ve trials BACKGROUND Chemoradiotherapy is st and ard treatment for localized aggressive lymphoma . To determine the optimal therapy for nonelderly persons with low-risk localized lymphoma , we conducted a r and omized trial comparing chemoradiotherapy with chemotherapy alone . METHODS Previously untreated patients less than 61 years old with localized stage I or II aggressive lymphoma and no adverse prognostic factors according to the International Prognostic Index were r and omly assigned to three cycles of cyclophosphamide , doxorubicin , vincristine , and prednisone ( CHOP ) plus involved-field radiotherapy ( 329 patients ) or chemotherapy alone with dose-intensified doxorubicin , cyclophosphamide , vindesine , bleomycin , and prednisone ( ACVBP ) plus sequential consolidation ( 318 patients ) . RESULTS With a median follow-up of 7.7 years , event-free and overall survival rates were significantly higher in the group given chemotherapy alone than in the group given CHOP plus radiotherapy ( P<0.001 and P=0.001 , respectively ) . The five-year estimates of event-free survival were 82 percent ( 95 percent confidence interval , 78 to 87 percent ) for
Output:
| Furthermore , in the subset of stage III/IV patients , the addition of radiotherapy statistically significantly improved local control and progression-free survival/eventfree survival , and yielded a trend toward improved OS . |
MS210835 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
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Input: This trial was design ed to compare the efficacy and safety between epirubicin ( E ) and carboplatin ( C ) in combination with paclitaxel ( P ) and trastuzumab ( H ) in neoadjuvant setting . In 13 Chinese cancer centers , 100 patients with HER2-positive , locally advanced breast cancer were 1:1 r and omized to receive medication as follows : trastuzumab and paclitaxel weekly combined with carboplatin weekly for PCH group , or epirubicin every 3 weeks for PEH group . Patients were given 4 to 6 cycles of chemotherapy . The primary endpoint was pathologic complete response ( pCR ) rate , which was no significant difference in PCH and PEH regimen ( 39.1 % vs. 48.8 % ; p=0.365 ) . However , PEH regimen achieved higher pCR in luminal-B ( HER2-poitive ) subgroup ( 55.0 % vs. 24.0 % ; p = 0.033 ) , but not in ERBB2 + subgroup ( 42.9 % vs. 57.1 % ; p = 0.355 ) . PEH regimen showed a favorable efficacy in PIK3CA mutated subgroup ( 69.2 % vs.23.5 % , p=0.012 ) . No significant difference was observed in the subgroup analysis of TP53 mutation status , PTEN expression , FCGR2A SNP and FCGR3A SNP . Both regimens as neoadjuvant chemotherapy achieve similar efficacy and safety . PEH might improve pCR rate , especially in the luminal-B subtype and PIK3CA mutation subtype . PEH is feasible and less likely to increase the incidence of acute cardiac events compared to PCH BACKGROUND We compared the efficacy and safety of the addition of lapatinib versus trastuzumab to anthracycline-taxane-based neoadjuvant chemotherapy . METHODS In the GeparQuinto r and omised phase 3 trial , patients with untreated HER2-positive operable or locally advanced breast cancer were enrolled between Nov 7 , 2007 , and July 9 , 2010 . Patients were eligible if their tumours were classified as cT3/4a-d , or hormone receptor (HR)-negative , HR-positive with clinical ly node-positive and cT2 disease ( cT2 cN+ ) , or HR-positive and pathologically node-positive in the sentinel lymph node for those with cT1 disease ( cT1 pN(SLN+ ) ) . Patients were r and omly assigned in a 1:1 ratio to receive neoadjuvant treatment with four cycles of EC ( epirubicin [ 90 mg/m(2 ) intravenously ] plus cyclophosphamide [ 600 mg/m(2 ) intravenously ] , every 3 weeks ) , and four cycles of docetaxel ( 100 mg/m(2 ) intravenously every 3 weeks ) with either trastuzumab ( 6 mg/kg intravenously , with a starting loading dose of 8 mg/kg , for eight cycles , every 3 weeks ) or lapatinib ( 1000 - 1250 mg per day orally ) throughout all cycles before surgery . R and omisation was done by dynamic allocation with the minimisation method of Pocock and patients were stratified by participating site , HR status , and extent of disease ( cT1 - 3 cN0 - 2 vs T4 or N3 ) . The primary endpoint was pathological complete response ( defined as ypT0 and ypN0 ) and was analysed in all patients who received at least one cycle of EC . Participants and investigators were not masked to treatment assignment . Pathologists in centres assessing surgery outcomes were masked to group assignment . This trial is registered with Clinical Trials.gov , number NCT00567554 . FINDINGS Of 620 eligible patients , 309 were r and omly assigned to chemotherapy with trastuzumab ( ECH-TH group ) and 311 to chemotherapy with lapatinib ( ECL-TL group ) . Two patients in the ECH-TH group and three patients in the ECL-TL group did not start treatment because of withdrawal of consent or immediate surgery . 93 ( 30·3 % ) of 307 patients in the ECH-TH group and 70 ( 22·7 % ) of 308 patients in the ECL-TL group had a pathological complete response ( odds ratio [ OR ] 0·68 [ 95%CI 0·47 - 0·97 ] ; p=0·04 ) . Chemotherapy with trastuzumab was associated with more oedema ( 119 [ 39·1 % ] vs 88 [ 28·7 % ] ) and dyspnoea ( 90 [ 29·6 % ] vs 66 [ 21·4 % ] ) , and ECL-TL with more diarrhoea ( 231 [ 75·0 % ] vs 144 [ 47·4 % ] ) and skin rash ( 169 [ 54·9 % ] vs 97 [ 31·9 % ] ) . 43 ( 14·0 % ) patients discontinued in the ECH-TH group and 102 ( 33·1 % ) in the ECL-TL group . 70 serious adverse events were reported in the ECH-TH group and 87 in the ECL-TL group . INTERPRETATION This direct comparison of trastuzumab and lapatinib showed that pathological complete response rate with chemotherapy and lapatinib was significantly lower than that with chemotherapy and trastuzumab . Unless long-term outcome data show different results , lapatinib should not be used outside of clinical trials as single anti-HER2-treatment in combination with neoadjuvant chemotherapy . FUNDING GlaxoSmithKline , Roche , and Sanofi-Aventis To report the results of the DECT trial , a phase II study of locally advanced or operable HER2‐positive breast cancer ( BC ) treated with taxanes and concurrent anthracyclines and trastuzumab . Eligible patients ( stage IIA‐IIIB HER2‐positive BC , 18–75 years , normal organ functions , ECOG ≤1 , and left ventricular ejection fraction ( LVEF ) ≥55 % ) received four cycles of neoadjuvant docetaxel , 100 mg/m2 intravenously , plus trastuzumab 6 mg/kg ( loading dose 8 mg/kg ) every 3 weeks , followed by four 3‐weekly cycles of epirubicin 120 mg/m2 and cyclophosphamide , 600 mg/m2 , plus trastuzumab . Primary objective was pathologic complete response ( pCR ) rate , defined as ypT0/is ypN0 at definitive surgery . We enrolled 45 consecutive patients . All but six patients ( 13.3 % ) completed chemotherapy and all underwent surgery . pCR was observed in 28 patients ( 62.2 % ) overall and in 6 ( 66.7 % ) from the inflammatory subgroup . The classification and regression tree analysis showed a 100 % pCR rate in patients with BMI ≥25 and with hormone negative disease . The median follow up was 46 months ( 8–78 ) . Four‐year recurrence‐free survival was 74.7 % ( 95%CI , 58.2–91.2 ) . Seven patients ( 15.6 % ) recurred and one died . Treatment was well tolerated , with limiting toxicity being neutropenia . No clinical cardiotoxicity was observed . Six patients ( 13.4 % ) showed a transient LVEF decrease ( < 10 % ) . In one patient we observed a ≥10 % asymptomatic LVEF decrease persisting after surgery . Notwithst and ing their limited applicability due to the current guidelines , our findings support the efficacy of the regimen of interest in the neoadjuvant setting along with a fairly acceptable toxicity profile , including cardiotoxicity . Results on BMI may invite further assessment in future studies . J. Cell . Physiol . 231 : 2541–2547 , 2016 . © 2016 The Authors . Journal of Cellular Physiology Published by Wiley Periodicals , Objective A previous study demonstrated that non-anthracycline-containing docetaxel plus cyclophosphamide ( TC ) regimen was inferior to docetaxel , anthracycline and cyclophosphamide ( TAC ) in neoadjuvant treatment of triple-negative breast cancer ( TNBC ) and human epidermal growth factor receptor-2-(HER2)-positive breast cancer in a short-term follow-up . Herein , long-term follow-up survival outcomes have been investigated . Methods TNBC or HER2-positive patients were r and omized to receive 6 cycles of TC or TAC neoadjuvant treatment . The primary endpoint was pathological complete remission ( pCR ) . Secondary endpoints included clinical response rate , event-free survival ( EFS ) , and overall survival ( OS ) . Results A cohort of 96 patients consisted of 45 in TC and 51 in TAC arm . With a median follow-up period of 53 ( range , 8–76 ) months , the patients achieving pCR post neoadjuvant chemotherapy exhibited superior EFS and OS than patients without pCR ( P<0.05 ) . TAC treatment result ed in consistently better EFS than TC treatment : the estimated 5-year EFS was 66.1 % vs. 29.8 % ( P=0.002 ) . Moreover , the estimated 5-year OS was also in favor of TAC : 88.4 % vs. 51.6 % ( P<0.001 ) . Multivariable analysis demonstrated that the treatment regimen was an independent prognostic factor , and patients treated with TAC had a superior EFS [ hazard ratio ( HR ) , 0.48 ; 95 % confidence interval ( 95 % CI ) , 0.26–0.90 ; P=0.021 ] and OS ( HR , 0.20 ; 95 % CI , 0.08–0.60 ; P=0.003 ) . Conclusions The up date d long-term follow-up data demonstrated a sustained benefit in EFS and OS from anthracycline-containing TAC treatment , indicating that anthracycline is an essential and effective drug in this clinical trial Purpose Combining anthracyclines and taxanes are to date the most active cytotoxic treatment option in the neoadjuvant and palliative therapy of breast cancer patients . Adding trastuzumab to these cytotoxic agents can improve outcome for women with human epidermal growth factor receptor 2 (HER2)-overexpressing advanced breast cancer . We conducted a pilot study of preoperative epidoxorubicin and docetaxel plus trastuzumab in outpatient patients suffering from breast cancer . Patients and methods Fourteen consecutive patients were enrolled in this prospect i ve clinical pilot trial . Preoperative treatment consisted of weekly trastuzumab ( 4 mg/kg body-weight loading dose , 2 mg/kg/week maintenance dose ) , in combination with weekly epidoxorubicin ( 30 mg/m2 body surface area [ BSA ] ) and docetaxel ( 35 mg/m2 BSA ) once a week for 6 weeks followed by 1 week off therapy . Results Patients received a total of 30 cycles ( median : 2 cycles , range : 2–3 cycles ) of this therapeutic regimen . Outpatient epidoxorubicin and docetaxel plus trastuzumab were well tolerated . A major response to this preoperative therapy regimen could be demonstrated in 12 of 14 patients ( 86 % ) leading to breast-conserving surgery in 11 of 14 patients ( 79 % ) . Conclusions We conclude that outpatient epidoxorubicin and docetaxel plus trastuzumab are safe in the neoadjuvant treatment of patients suffering from breast cancer , based on a favorable side-effect and activity profile . Thus , this regimen can be considered for further clinical trials BACKGROUND The monoclonal antibody trastuzumab has survival benefit when given with chemotherapy to patients with early , operable , and metastatic breast cancer that has HER2 ( also known as ERBB2 ) overexpression or amplification . We aim ed to assess event-free survival in patients with HER2-positive locally advanced or inflammatory breast cancer receiving neoadjuvant chemotherapy with or without 1 year of trastuzumab . METHODS We compared 1 year of treatment with trastuzumab ( given as neoadjuvant and adjuvant treatment ; n=117 ) with no trastuzumab ( 118 ) , in women with HER2-positive locally advanced or inflammatory breast cancer treated with a neoadjuvant chemotherapy regimen consisting of doxorubicin , paclitaxel , cyclophosphamide , methotrexate , and fluorouracil . R and omisation was done with a computer program and minimisation technique , taking account of geographical area , disease stage , and hormone receptor status . Investigators were informed of treatment allocation . A parallel cohort of 99 patients with HER2-negative disease was included and treated with the same chemotherapy regimen . Primary endpoint was event-free survival . Analysis was by intention to treat . This study is registered , number IS RCT N86043495 . FINDINGS Trastuzumab significantly improved event-free survival in patients with HER2-positive breast cancer ( 3-year event-free survival , 71 % [ 95 % CI
Output:
| In conclusion , the concurrent use of trastuzumab and anthracycline-based NAC for certain HER2-positive locally advanced breast cancers significantly improves the pCR rates without obvious increases in the cardiotoxicity |
MS210836 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: BACKGROUND Previous observational studies of self-reported dairy product consumption and stroke risk have reported mixed findings . Few studies have used circulating biomarkers that provide objective measures of dairy fat intake . OBJECTIVES We tested the hypothesis that the circulating biomarkers of dairy fat , pentadecanoic acid ( 15:0 ) , heptadecanoic acid ( 17:0 ) , and trans palmitoleate ( trans 16:1n-7 ) , were associated with lower incidence of stroke , especially ischemic stroke . Secondarily , we evaluated 14:0 , which is obtained from dairy products and beef , and also endogenously synthesized . DESIGN In participants from 2 large US cohorts ( the Health Professionals Follow-Up Study : 51,529 men ; the Nurses ' Health Study : 121,700 women ) with stored blood sample s in 1993 - 1994 ( n = 18,225 ) and 1989 - 1990 ( n = 32,826 ) , respectively , we prospect ively identified 594 incident stroke cases ( median follow-up : 8.3 y ) and matched them 1:1 to risk-set- sample d control subjects by age , sex , race , and smoking . Total plasma and red blood cell ( RBC ) fatty acids were measured by using gas-liquid chromatography . Covariates were assessed by using vali date d question naires . Stroke events and subtypes were adjudicated by using medical records or other supporting documentation . We used conditional logistic regression to estimate associations of fatty acids with incident stroke , and cohort-specific findings were combined by inverse-variance weights . RESULTS After adjustment for demographic characteristics , lifestyle , cardiovascular disease risk factors , diet , and other circulating fatty acids , no significant associations with total stroke were seen for plasma 15:0 ( pooled HR for highest compared with lowest quartiles : 0.85 ; 95 % CI : 0.54 , 1.33 ) , 17:0 ( 0.99 ; 0.67 , 1.49 ) , trans 16:1 n-7 ( 0.89 ; 0.55 , 1.45 ) , or 14:0 ( 1.05 ; 0.62 , 1.78 ) . Results were similar for ischemic and hemorrhagic stroke subtypes , for RBC fatty acids , and in several different sensitivity analyses . CONCLUSION In 2 large prospect i ve cohorts , circulating biomarkers of dairy fat were not significantly associated with stroke Background It may be useful to examine associations of fat intakes with total mortality as a basis for dietary recommendations . We aim ed to eluci date associations between dietary fat and total mortality among Japanese population s with low fat intake . Methods We conducted a prospect i ve study consisting of 58,672 men and women aged 40 to 79 years . Fat intakes were estimated using a food frequency question naire . Multivariate-adjusted hazard ratios ( HRs ) for mortality by sex were computed according to quintiles of energy-adjusted fat intakes . Results During the follow-up period ( median duration , 19.3 years ) , 11,656 deaths were recorded . In men , we found no clear association between total fat and total mortality . HRs across quintiles of total fat intake were 1.00 , 1.03 ( 95 % confidence interval [ CI ] , 0.95–1.12 ) , 1.02 ( 0.94–1.10 ) , 0.98 ( 0.90–1.07 ) , and 1.07 ( 0.98–1.17 ) . No significant association was detected in regard to types of fat . In women , HR was lowest in the fourth quintile of total fat intake followed by the top quintile ; HRs across quintiles were 1.00 , 1.03 ( 0.94–1.11 ) , 1.00 ( 0.92–1.09 ) , 0.88 ( 0.81–0.96 ) , and 0.94 ( 0.86–1.03 ) . Regarding types of fat in women , total mortality was inversely associated with intakes of saturated fatty acids ( SFA ) , monounsaturated fatty acids ( MUFA ) , and polyunsaturated fatty acids ( PUFA ) ; the lowest HR was in the top quintile of intake for SFA , MUFA , and PUFA : 0.91 ( 95 % CI , 0.83–1.00 ) , 0.91 ( 0.83–0.99 ) and 0.88 ( 0.80 - 0.97 ) , respectively ( trend P across quintiles , 0.020 , 0.012 , and 0.029 , respectively ) . Causes of death other than cancer and cardiovascular disease contributed most to decreases in HRs for total and types of fat . In women , analysis with finer categories revealed that the lowest risk for total mortality appeared at total fat intake of 28 % of energy . Conclusions Our findings from a large cohort study among population s with relatively low fat intake provide evidence regarding optimal levels of fat intakes Recently , there has been interest in whether intakes of specific types of fat are associated with breast cancer risk independently of other types of fat , but results have been inconsistent . We identified 8 prospect i ve studies that met predefined criteria and analyzed their primary data using a st and ardized approach . Holding total energy intake constant , we calculated relative risks for increments of 5 % of energy for each type of fat compared with an equivalent amount of energy from carbohydrates or from other types of fat . We combined study -specific relative risks using a r and om effects model . In the pooled data base , 7,329 incident invasive breast cancer cases occurred among 351,821 women . The pooled relative risks ( 95 % confidence intervals [ CI ] ) for an increment of 5 % of energy were 1.09 ( 1.00 - 1.19 ) for saturated , 0.93 ( 0.84 - 1.03 ) for monounsaturated and 1.05 ( 0.96 - 1.16 ) for polyunsaturated fat compared with equivalent energy intake from carbohydrates . For a 5 % of energy increment , the relative risks were 1.18 ( 95 % CI 0.99 - 1.42 ) for substituting saturated for monounsaturated fat , 0.98 ( 95 % CI 0.85 - 1.12 ) for substituting saturated for polyunsaturated fat and 0.87 ( 95 % CI 0.73 - 1.02 ) for substituting monounsaturated for polyunsaturated fat . No associations were observed for animal or vegetable fat intakes . These associations were not modified by menopausal status . These data are suggestive of only a weak positive association with substitution of saturated fat for carbohydrate consumption ; none of the other types of fat examined was significantly associated with breast cancer risk relative to an equivalent reduction in carbohydrate consumption Aims /hypothesis . The amount and quality of fat in the diet could be of importance for development of insulin resistance and related metabolic disorders . Our aim was to determine whether a change in dietary fat quality alone could alter insulin action in humans . Methods . The KANWU study included 162 healthy subjects chosen at r and om to receive a controlled , isoenergetic diet for 3 months containing either a high proportion of saturated ( SAFA diet ) or monounsaturated ( MUFA diet ) fatty acids . Within each group there was a second assignment at r and om to supplements with fish oil ( 3.6 g n-3 fatty acids/d ) or placebo . Results . Insulin sensitivity was significantly impaired on the saturated fatty acid diet ( -10 % , p = 0.03 ) but did not change on the monounsaturated fatty acid diet ( + 2 % , NS ) ( p = 0.05 for difference between diets ) . Insulin secretion was not affected . The addition of n-3 fatty acids influenced neither insulin sensitivity nor insulin secretion . The favourable effects of substituting a monounsaturated fatty acid diet for a saturated fatty acid diet on insulin sensitivity were only seen at a total fat intake below median ( 37E % ) . Here , insulin sensitivity was 12.5 % lower and 8.8 % higher on the saturated fatty acid diet and monounsaturated fatty acid diet respectively ( p = 0.03 ) . Low density lipoprotein cholesterol ( LDL ) increased on the saturated fatty acid diet ( + 4.1 % , p < 0.01 ) but decreased on the monounsaturated fatty acid diet ( MUFA ) ( –5.2 , p < 0.001 ) , whereas lipoprotein ( a ) [ Lp(a ) ] increased on a monounsaturated fatty acid diet by 12 % ( p < 0.001 ) . Conclusions /interpretation . A change of the proportions of dietary fatty acids , decreasing saturated fatty acid and increasing monounsaturated fatty acid , improves insulin sensitivity but has no effect on insulin secretion . A beneficial impact of the fat quality on insulin sensitivity is not seen in individuals with a high fat intake ( > 37E % ) . [ Diabetologia ( 2001 ) 44 : 312–319 Objectives To investigate the association between long term intake of individual saturated fatty acids ( SFAs ) and the risk of coronary heart disease , in two large cohort studies . Design Prospect i ve , longitudinal cohort study . Setting Health professionals in the United States . Participants 73 147 women in the Nurses ’ Health Study ( 1984 - 2012 ) and 42 635 men in the Health Professionals Follow-up Study ( 1986 - 2010 ) , who were free of major chronic diseases at baseline . Main outcome measure Incidence of coronary heart disease ( n=7035 ) was self-reported , and related deaths were identified by search ing National Death Index or through report of next of kin or postal authority . Cases were confirmed by medical records review . Results Mean intake of SFAs accounted for 9.0 - 11.3 % energy intake over time , and was mainly composed of lauric acid ( 12:0 ) , myristic acid ( 14:0 ) , palmitic acid ( 16:0 ) , and stearic acid ( 18:0 ; 8.8 - 10.7 % energy ) . Intake of 12:0 , 14:0 , 16:0 and 18:0 were highly correlated , with Spearman correlation coefficients between 0.38 and 0.93 ( all P<0.001 ) . Comparing the highest to the lowest groups of individual SFA intakes , hazard ratios of coronary heart disease were 1.07 ( 95 % confidence interval 0.99 to 1.15 ; Ptrend=0.05 ) for 12:0 , 1.13 ( 1.05 to 1.22 ; Ptrend<0.001 ) for 14:0 , 1.18 ( 1.09 to 1.27 ; Ptrend<0.001 ) for 16:0 , 1.18 ( 1.09 to 1.28 ; Ptrend<0.001 ) for 18:0 , and 1.18 ( 1.09 to 1.28 ; Ptrend<0.001 ) for all four SFAs combined ( 12:0 - 18:0 ) , after multivariate adjustment of lifestyle factors and total energy intake . Hazard ratios of coronary heart disease for isocaloric replacement of 1 % energy from 12:0 - 18:0 were 0.92 ( 95 % confidence interval 0.89 to 0.96 ; P<0.001 ) for polyunsaturated fat , 0.95 ( 0.90 to 1.01 ; P=0.08 ) for monounsaturated fat , 0.94 ( 0.91 to 0.97 ; P<0.001 ) for whole grain carbohydrates , and 0.93 ( 0.89 to 0.97 ; P=0.001 ) for plant proteins . For individual SFAs , the lowest risk of coronary heart disease was observed when the most abundant SFA , 16:0 , was replaced . Hazard ratios of coronary heart disease for replacing 1 % energy from 16:0 were 0.88 ( 95 % confidence interval 0.81 to 0.96 ; P=0.002 ) for polyunsaturated fat , 0.92 ( 0.83 to 1.02 ; P=0.10 ) for monounsaturated fat , 0.90 ( 0.83 to 0.97 ; P=0.01 ) for whole grain carbohydrates , and 0.89 ( 0.82 to 0.97 ; P=0.01 ) for plant proteins . Conclusions Higher dietary intakes of major SFAs are associated with an increased risk of coronary heart disease . Owing to similar associations and high correlations among individual SFAs , dietary recommendations for the prevention of coronary heart disease should continue to focus on replacing total saturated fat with more healthy sources of energy BACKGROUND Substitution of dietary polyunsaturated for
Output:
| Trans fats are associated with all cause mortality , total CHD , and CHD mortality , probably because of higher levels of intake of industrial trans fats than ruminant trans fats . |
MS210837 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Aims /hypothesisCardiac disease remains the leading cause of mortality in type 2 diabetes , yet few strategies to target cardiac dysfunction have been developed . This r and omised controlled trial aim ed to investigate high intensity intermittent training ( HIIT ) as a potential therapy to improve cardiac structure and function in type 2 diabetes . The impact of HIIT on liver fat and metabolic control was also investigated . Methods Using an online r and om allocation sequence , 28 patients with type 2 diabetes ( metformin and diet controlled ) were r and omised to 12 weeks of HIIT ( n = 14 ) or st and ard care ( n = 14 ) . Cardiac structure and function were measured by 3.0 T MRI and tagging . Liver fat was determined by 1H-magnetic resonance spectroscopy and glucose control by an OGTT . MRI analysis was performed by an observer blinded to group allocation . All study procedures took place in Newcastle upon Tyne , UK . Results Five patients did not complete the study and were therefore excluded from analysis : this left 12 HIIT and 11 control patients for the intention-to-treat analysis . Compared with controls , HIIT improved cardiac structure ( left ventricular wall mass 104 ± 17 g to 116 ± 20 g vs 107 ± 25 g to 105 ± 25 g , p < 0.05 ) and systolic function ( stroke volume 76 ± 16 ml to 87 ± 19 ml vs 79 ± 14 ml to 75 ± 15 ml , p < 0.01 ) . Early diastolic filling rates increased ( 241 ± 84 ml/s to 299 ± 89 ml/s vs 250 ± 44 ml/s to 251 ± 47 ml/s , p < 0.05 ) and peak torsion decreased ( 8.1 ± 1.8 ° to 6.9 ± 1.6 ° vs 7.1 ± 2.2 ° to 7.6 ± 1.9 ° , p < 0.05 ) in the treatment group . Following HIIT , there was a 39 % relative reduction in liver fat ( p < 0.05 ) and a reduction in HbA1c ( 7.1 ± 1.0 % [ 54.5 mmol/mol ] to 6.8 ± 0.9 % [ 51.3 mmol/mol ] vs 7.2 ± 0.5 % [ 54.9 mmol/mol ] to 7.4 ± 0.7 % [ 57.0 mmol/mol ] , p < 0.05 ) . Changes in liver fat correlated with changes in HbA1c ( r = 0.70 , p < 0.000 ) and 2 h glucose ( r = 0.57 , p < 0.004 ) . No adverse events were recorded . Conclusions /interpretationThis is the first study to demonstrate improvements in cardiac structure and function , along with the greatest reduction in liver fat , to be recorded following an exercise intervention in type 2 diabetes . HIIT should be considered by clinical care teams as a therapy to improve cardiometabolic risk in patients with type 2 diabetes . Trial registration : www.is rct n.com 78698481 Funding : Medical Research Council OBJECTIVE To evaluate the feasibility of free-living walking training in type 2 diabetic patients and to investigate the effects of interval-walking training versus continuous-walking training upon physical fitness , body composition , and glycemic control . RESEARCH DESIGN AND METHODS Subjects with type 2 diabetes were r and omized to a control ( n = 8) , continuous-walking ( n = 12 ) , or interval-walking group ( n = 12 ) . Training groups were prescribed five sessions per week ( 60 min/session ) and were controlled with an accelerometer and a heart-rate monitor . Continuous walkers performed all training at moderate intensity , whereas interval walkers alternated 3-min repetitions at low and high intensity . Before and after the 4-month intervention , the following variables were measured : VO2max , body composition , and glycemic control ( fasting glucose , HbA1c , oral glucose tolerance test , and continuous glucose monitoring [ CGM ] ) . RESULTS Training adherence was high ( 89 ± 4 % ) , and training energy expenditure and mean intensity were comparable . VO2max increased 16.1 ± 3.7 % in the interval-walking group ( P < 0.05 ) , whereas no changes were observed in the continuous-walking or control group . Body mass and adiposity ( fat mass and visceral fat ) decreased in the interval-walking group only ( P < 0.05 ) . Glycemic control ( elevated mean CGM glucose levels and increased fasting insulin ) worsened in the control group ( P < 0.05 ) , whereas mean ( P = 0.05 ) and maximum ( P < 0.05 ) CGM glucose levels decreased in the interval-walking group . The continuous walkers showed no changes in glycemic control . CONCLUSIONS Free-living walking training is feasible in type 2 diabetic patients . Continuous walking offsets the deterioration in glycemia seen in the control group , and interval walking is superior to energy expenditure – matched continuous walking for improving physical fitness , body composition , and glycemic control Exercise can have anti-inflammatory effects in obesity , but the optimal type and intensity of exercise are not clear . This study compared short-term high-intensity interval training ( HIIT ) with moderate-intensity continuous training ( MICT ) in terms of improvement in cardiorespiratory fitness , markers of inflammation , and glucose control in previously inactive adults at elevated risk of developing type 2 diabetes . Thirty-nine inactive , overweight/obese adults ( 32 women ) were r and omly assigned to 10 sessions over 2 wk of progressive HIIT ( n = 20 , four to ten 1-min sessions at ∼90 % peak heart rate , 1-min rest periods ) or MICT ( n = 19 , 20 - 50 min at ∼65 % peak heart rate ) . Before and 3 days after training , participants performed a peak O2 uptake test , and fasting blood sample s were obtained . Both HIIT ( 1.8 ± 0.4 vs. 1.9 ± 0.4 l/min , pre vs. post ) and MICT ( 1.8 ± 0.5 vs. 1.9 ± 0.5 l/min , pre vs. post ) improved peak O2 uptake ( P < 0.001 ) and lowered plasma fructosamine ( P < 0.05 ) . Toll-like receptor ( TLR ) 4 ( TLR4 ) expression was reduced on lymphocytes and monocytes after both HIIT and MICT ( P < 0.05 ) and on neutrophils after MICT ( P < 0.01 ) . TLR2 on lymphocytes was reduced after HIIT and MICT ( P < 0.05 ) . Plasma inflammatory cytokines were unchanged after training in both groups , but MICT led to a reduction in fasting plasma glucose ( P < 0.05 , 5.9 ± 1.0 vs. 5.6 ± 1.0 mmol/l , pre vs. post ) . Ten days of either HIIT or MICT can improve cardiorespiratory fitness and glucose control and lead to reductions in TLR2 and TLR4 expression . MICT , which involved a longer duration of exercise , may be superior for reducing fasting glucose Background — Exercise training reduces the symptoms of chronic heart failure . Which exercise intensity yields maximal beneficial adaptations is controversial . Furthermore , the incidence of chronic heart failure increases with advanced age ; it has been reported that 88 % and 49 % of patients with a first diagnosis of chronic heart failure are > 65 and > 80 years old , respectively . Despite this , most previous studies have excluded patients with an age > 70 years . Our objective was to compare training programs with moderate versus high exercise intensity with regard to variables associated with cardiovascular function and prognosis in patients with postinfa rct ion heart failure . Methods and Results — Twenty-seven patients with stable postinfa rct ion heart failure who were undergoing optimal medical treatment , including & bgr;-blockers and angiotensin-converting enzyme inhibitors ( aged 75.5±11.1 years ; left ventricular [ LV ] ejection fraction 29 % ; & OV0312;o2peak 13 mL · kg−1 · min−1 ) were r and omized to either moderate continuous training ( 70 % of highest measured heart rate , ie , peak heart rate ) or aerobic interval training ( 95 % of peak heart rate ) 3 times per week for 12 weeks or to a control group that received st and ard advice regarding physical activity . & OV0312;o2peak increased more with aerobic interval training than moderate continuous training ( 46 % versus 14 % , P<0.001 ) and was associated with reverse LV remodeling . LV end-diastolic and end-systolic volumes declined with aerobic interval training only , by 18 % and 25 % , respectively ; LV ejection fraction increased 35 % , and pro-brain natriuretic peptide decreased 40 % . Improvement in brachial artery flow-mediated dilation ( endothelial function ) was greater with aerobic interval training , and mitochondrial function in lateral vastus muscle increased with aerobic interval training only . The MacNew global score for quality of life in cardiovascular disease increased in both exercise groups . No changes occurred in the control group . Conclusions — Exercise intensity was an important factor for reversing LV remodeling and improving aerobic capacity , endothelial function , and quality of life in patients with postinfa rct ion heart failure . These findings may have important implication s for exercise training in rehabilitation programs and future studies Low-volume sprint interval training ( SIT ) , or repeated sessions of brief , intense intermittent exercise , elicits metabolic adaptations that resemble traditional high-volume endurance training ( ET ) . The effects of these different forms of exercise training on vascular structure and function remain largely unexplored . To test the hypothesis that SIT and ET would similarly improve peripheral artery distensibility and endothelial function and central artery distensibility , we recruited 20 healthy untrained subjects ( age : 23.3 + /- 2.8 yr ) and had them perform 6 wk of SIT or ET ( n = 5 men and 5 women per group ) . The SIT group completed four to six 30-s " all-out " Wingate tests separated by 4.5 min of recovery 3 days/wk . The ET group completed 40 - 60 min of cycling at 65 % of their peak oxygen uptake ( Vo2peak ) 5 days/wk . Popliteal endothelial function , both relative and normalized to shear stimulus , was improved after training in both groups ( main effect for time , P < 0.05 ) . Carotid artery distensibility was not statistically altered by training ( P = 0.29 ) in either group ; however , popliteal artery distensibility was improved in both groups to the same degree ( main effect , P < 0.05 ) . We conclude that SIT is a time-efficient strategy to elicit improvements in peripheral vascular structure and function that are comparable to ET . However , alterations in central artery distensibility may require a longer training stimuli and /or greater initial vascular stiffness than observed in this group of healthy subjects BACKGROUND The health benefits of leisure-time physical activity are well known , but whether less exercise than the recommended 150 min a week can have life expectancy benefits is unclear . We assessed the health benefits of a range of volumes of physical activity in a Taiwanese population . METHODS In this prospect i ve cohort study , 416,175 individuals ( 199,265 men and 216,910 women ) participated in a st and ard medical screening programme in Taiwan between 1996 and 2008 , with an average follow-up of 8·05 years ( SD 4·21 ) . On the basis of the amount of weekly exercise indicated in a self-administered question naire , participants were placed into one of five categories of exercise volumes : inactive , or low , medium , high , or very high activity . We calculated hazard ratios ( HR ) for mortality risks for every group compared with the inactive group , and calculated life expectancy for every group . FINDINGS Compared with individuals in the inactive group , those in the low-volume activity group , who exercised for an average of 92 min per week ( 95 % CI 71 - 112 ) or 15 min a day ( SD 1·8 ) , had a 14 % reduced risk of all-cause mortality ( 0·86 , 0·81 - 0·91 ) , and had a 3 year longer life expectancy . Every additional 15 min of daily exercise beyond the minimum amount of 15 min a day further reduced all-cause mortality by 4 % ( 95 % CI 2·5 - 7·0 ) and all-cancer mortality by 1 % ( 0·3 - 4·5 ) . These benefits were applicable to all age groups and both sexes , and to those with cardiovascular disease risks . Individuals who were inactive had a 17 % ( HR 1·17 , 95 % CI 1·10 - 1·24 ) increased risk of
Output:
| No differences were found between two modalities of exercises considering the outcomes HbA1c , systolic and diastolic blood pressure , total cholesterol , HDL and LDL cholesterol , triglycerides , BMI , and waist-to-hip ratio .
CONCLUSION HIIT induces cardiometabolic adaptations similar to those of MICT in prediabetes and T2D , and provides greater benefits to functional capacity in patients with T2D . |
MS210838 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Depression is an important target of psychological assessment in patients with end-stage renal disease because it predicts their morbidity , mortality , and quality of life . We assessed the effectiveness of cognitive-behavioral therapy in chronic hemodialysis patients diagnosed with major depression by the Mini International Neuropsychiatric Interview ( MINI ) . In a r and omized trial conducted in Brazil , an intervention group of 41 patients was given 12 weekly sessions of cognitive-behavioral group therapy led by a trained psychologist over 3 months while a control group of 44 patients received the usual treatment offered in the dialysis unit . In both groups , the Beck Depression Inventory , the MINI , and the Kidney Disease and Quality of Life-Short Form question naires were administered at baseline , after 3 months of intervention or usual treatment , and after 9 months of follow-up . The intervention group had significant improvements , compared to the control group , in the average scores of the Beck Depression Inventory overall scale , MINI scores , and in quality -of-life dimensions that included the burden of renal disease , sleep , quality of social interaction , overall health , and the mental component summary . We conclude that cognitive-behavioral group therapy is an effective treatment of depression in chronic hemodialysis patients BACKGROUND The medical risk factors associated with increased mortality in hemodialysis ( HD ) patients are well known , but the psychosocial factors that may affect outcome have not been clearly defined . Psychosocial factors could affect mortality through interaction with parents ' nutrition or their compliance with the dialysis prescription . We conducted a prospect i ve , longitudinal , multicenter study of urban HD patients to determine the contribution of compliance and psychosocial factors to patient survival . METHODS Patients were assessed using indices of social support , patient 's assessment s of their well-being , including illness effects ( IEQ ) , and satisfaction with life ( SWLS ) , the Beck Depression Inventory ( BDI ) , serum albumin concentration , Kt/V and protein catabolic rate ( PCR ) . Behavioral compliance was measured three ways : percent time actually dialyzed per treatment compared to prescribed time ( shortening behavior ) ; percent sessions attended ( skipping behavior ) and total integrated time compliance ( % TCOMP ) . A severity index , previously demonstrated to be a mortality marker , was used to grade medical comorbidity . The typed of dialyzer the patient was treated with was noted . A Cox proportional hazards model , controlling for age , medical comorbidity , albumin concentration and dialyzer type was used to assess relative mortality risk of variations in psychosocial factors and behavioral compliance . RESULTS A total of 295 patients ( 60.8 % of those eligible ) agreed to participate . The mean ( + /- SD ) age of our population was 54.6 + /- 14.1 year , mean PCR was 1.06 + /- 0.27 g/kg/day , and mean Kt/V 1.2 + /- 0.4 , suggesting the patients were well nourished and adequately dialyzed . The patients ' mean BDI was 11.4 + /- 8.1 ( in the range of mild depression ) . Patients ' SWLS was similar to that of a group of patients without chronic illness . After a 26 month mean follow-up period , higher levels of perceived social support , improved perception of the effects of illness and increased behavioral compliance were significantly associated with decreased relative mortality risk ( 0.8 , 0.77 , and 0.79 , respectively ) , controlled for variations in patients ' age , severity of illness , serum albumin concentration and dialyzer type . Variations in depression and Kt/V were not predictors of mortality during the observation period . CONCLUSIONS Lower levels of social support , decreased behavioral compliance with the dialysis prescription , and increased negative perception of the effects of illness are independently associated with increased mortality in ESRD patients treated with HD . The effects are of the same order of magnitude as medical risk factors . Such effects may be attributable to a relationship between a patients ' perception of social support and effects of illness and behavior , with other factors such as the provision of better medical care in patients with larger social networks . The mechanism underlying the relationship of psychosocial factors and compliance and survival , and the effect of interventions to improve perception of illness , and increase social support and compliance with the dialysis prescription in HD patients should be studied BACKGROUND The aim of this study was to evaluate the survival of patients initiating haemodialysis ( HD ) , and to analyse whether low health-related quality of life ( HRQoL ) levels are predictors of mortality in the short-term , controlling certain variables that had been shown in other studies to have a bearing on survival , and using scores , st and ardized for age and sex , of the HRQoL measurement tool employed . METHODS This is a multicentric prospect i ve study of all patients on HD in all the dialysis units in Asturias , a region with a little over one million inhabitants , from 1 January 2001 to 30 September 2002 . A total of 199 patients initiated HD in our region and survived the first 3 months . Of these , 137 patients who remained on HD for at least 3 months had complete responses on HRQoL measures . RESULTS It was observed that adjusted relative risk ( RR ) of death increased by 5 % for each year of age increase ( RR=1.05 , 95 % CI 1.01 - 1.09 : P=0.006 ) ; in the same way , for each increase in the Mental Component Summary ( MCS ) score , the adjusted RR of death diminished by 4 % ( RR=0.96 , 95 % CI 0.94 - 0.99 ; P=0.006 ) . CONCLUSION Mental health has been shown to be a factor independently associated with mortality ; as the MCS score worsens the adjusted RR of death of a patient on HD increases The aims of the present study were to determine the prevalence of depression in our dialysis patients , to detect the most powerful variables associated with depression , and to determine the role of depression in prediction of mortality . The prospect i ve follow-up study of 128 patients ( 77 HD and 51 CAPD , 65 male , aged 53.8 + /- 13.5 years , dialysis duration 64.7 + /- 64.8 months ) was carried out over 36 months . Depression by the Beck Depression Inventory-BDI-II score , laboratory parameters ( hemoglobin , serum albumin and creatinine concentration ) , immunological status ( cytokines and hsCRP ) , comorbidity by Index of Physical Impairment ( IPI ) and adequacy of dialysis by Kt/V were monitored . The overall prevalence of depression in the dialysis patients ( BDI score > or = 14 ) was 45.3 % , and 28.2 % , respectively , for moderate and severe depression ( BDI > or = 20 ) . The most powerful variable associated with depression was IL-6 , but associations with albumin , hemoglobin , creatinine and IPI score were also found . During the follow-up period 36 patients died , 7 patients left the cohort and 2 patients were transplanted . If IPI score was not included in the multivariate Cox analysis , the BDI score remained one of the best predictors of mortality along with albumin . In conclusion , because of the close association of depression with inflammation , malnutrition , and cardiovascular mortality , it could be speculated that depression is one branch of the MIA ( malnutrition , inflammation , atherosclerosis ) syndrome This study investigated whether social and /or psychologic factors help to predict older dialysis patients ' continued survival . A stratified ( by race and sex ) r and om sample of patients aged 60 + years was selected from the ESRD Network census of all patients in that age category residing in a single southeastern state ( Georgia ) and receiving chronic dialysis as of November 1987 ; personal interviews with patients were completed in 1988 . This analysis includes 287 patients ( mean age , 69 years ) receiving outpatient hemodialysis for whom primary cause of renal failure and functional status data were complete . Patient tracking and vital statistics data determined that 49 % of the sample survived as of October 31 , 1990 . Study variables included demographic , dialysis , health status , social situation , and psychologic outlook variables reported at the patients ' 1988 interviews . Log rank tests showed univariate associations between patients ' continued survival and race/gender , recovery time following dialysis treatments , cardiovascular co-morbidity , exercise activity score , freedom from health limitation of daily activity , functional status , leisure activity score , self-rated health status , overall life satisfaction , depression , and public religiosity . The Cox proportional hazards model was fit to the data , with continued survival from the time of the 1988 interview as the dependent variable . There was a significantly increased mortality risk for white men relative to the other race/gender groups and for patients reporting severely impaired functional status at the 1988 interview . With functional status in the model , no other social or psychologic variables were significant predictors of mortality . ( ABSTRACT TRUNCATED AT 250 WORDS Objective : To assess the effects of intradialytic exercise training on health-related quality of life indices in haemodialysis patients . Subjects/ patients : Thirty-five patients on haemodialysis , with a mean ( SD ) age of 48.8 ( 13.9 ) years , volunteered to participate in the study . They were r and omized either to rehabilitation group ( group A : 19 patients ) , following a 10-month intradialytic exercise training programme or to control group ( group B : 14 patients ) . After the r and omization , two of the patients , one of each group , withdrew from the study for reasons unrelated to exercise training . Method : All patients at the beginning and the end of the study underwent clinical examination , laboratory tests and a treadmill exercise testing with spiroergometric study for the evaluation of their aerobic capacity ( Vo2peak ) . A formal psychosocial assessment , which included affective ( Beck Depression Inventory ) , health-related quality of life ( Quality of Life Index , Living Question naire of Minnesota , Life Satisfaction Index and Short Form-36 question naire ) and personality ( Eysenck Personality Question naire ) parameters , was evaluated at beginning and end of the study . The dose of erythropoietin was changed as needed , according to the level of the haemoglobin , aim ing to keep it at 11 ( 2 ) g/dL during the study . Results : Baseline values were similar between the two groups . After training in group A , Vo2peak was increased by 21.1 % ( P<0.05 ) and exercise time by 23.6 % ( P<0.05 ) . Moreover , group A showed a decrease in self-reported depression ( Beck Depression Index ) of 39.4 % ( P<0.001 ) . In addition , trained patients demonstrated a significant improvement in Quality of Life Index ( from 6.5 ( 1.8 ) to 9.0 ( 1.3 ) , P<0.001 ) and Life Satisfaction Index ( from 44.8 ( 8.6 ) to 53.0 ( 5.6 ) , P<0.001 ) , and an increase in the Physical Component Scale of the SF-36 ( from 40.5 ( 5.6 ) to 44.5 ( 5.5 ) , P<0.05 ) , while the Mental Component Scale remained unchanged . Multiple regression analysis indicated that the improvement in quality of life depended on the participation in exercise programmes , the effects of training and the reduction in the level of depression . No changes were observed in Eysenck Personality Question naire by the end of the study , while all the above parameters remained almost unchanged in the controls . Conclusion : The results demonstrated that intradialytic exercise training improves both physical functioning and psychological status in haemodialysis patients , leading to an improvement of patients ' quality of life AIM To evaluate the prevalence and the influence on survival of depressive symptoms in a European cohort of end-stage renal disease ( ESRD ) patients on renal replacement therapy ( RRT ) . METHODS In a prospect i ve fashion , symptoms of depression were evaluated in ESRD patients on RRT using the depression subscore of the Hospital Anxiety and Depression Scale ( HADS ) . Fatal and non-fatal clinical events were determined during a 1-year follow-up . RESULTS Of 101 patients with ESRD , 42 % showed manifest depressive symptoms , defined as a HADS-D score > or = 7 . No association was found between depressive symptoms and severity of somatic disease . During follow-up , all-cause mortality was significantly higher in patients with depressive symptoms above threshold ( n = 42 , mortality : 26 % ) compared to patients with depressive symptoms below threshold ( n = 59 , mortality 8 % ) , ( crude HR 3.3 , CI 1.2 - 9.6 , P = 0.02 ) . The excess in mortality was mainly caused by a higher incidence of septicaemia ( 0 versus 12 % , P = 0.01 ) . After adjustment for clinical parameters , this association between depressive symptoms and mortality became even stronger . There was no significant difference observed in the incidence of cardiovascular events . CONCLUSIONS Patients with ESRD treated with dialysis show a high level of depressive symptoms that is independently associated with poor survival . Future research should address appropriate therapeutic regimens BACKGROUND The relationship between severity of depressive symptoms reported by incident dialysis patients and first-year outcomes is not known . METHODS We evaluated the association between self-report of depressive symptoms in incident hemodialysis patients admitted at Fresenius Medical Care North America facilities between 1 January and 31 December 2006 and mortality
Output:
| There is considerable between- study heterogeneity in reports of depressive symptoms in dialysis patients , likely caused by high variability in the way depressive symptoms are measured . |
MS210839 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: OBJECTIVE To test whether adding mobile application coaching and patient/provider web portals to community primary care compared with st and ard diabetes management would reduce glycated hemoglobin levels in patients with type 2 diabetes . RESEARCH DESIGN AND METHODS A cluster-r and omized clinical trial , the Mobile Diabetes Intervention Study , r and omly assigned 26 primary care practice s to one of three stepped treatment groups or a control group ( usual care ) . A total of 163 patients were enrolled and included in analysis . The primary outcome was change in glycated hemoglobin levels over a 1-year treatment period . Secondary outcomes were changes in patient-reported diabetes symptoms , diabetes distress , depression , and other clinical ( blood pressure ) and laboratory ( lipid ) values . Maximal treatment was a mobile- and web-based self-management patient coaching system and provider decision support . Patients received automated , real-time educational and behavioral messaging in response to individually analyzed blood glucose values , diabetes medications , and lifestyle behaviors communicated by mobile phone . Providers received quarterly reports summarizing patient ’s glycemic control , diabetes medication management , lifestyle behaviors , and evidence -based treatment options . RESULTS The mean declines in glycated hemoglobin were 1.9 % in the maximal treatment group and 0.7 % in the usual care group , a difference of 1.2 % ( P = 0.001 ) over 12 months . Appreciable differences were not observed between groups for patient-reported diabetes distress , depression , diabetes symptoms , or blood pressure and lipid levels ( all P > 0.05 ) . CONCLUSIONS The combination of behavioral mobile coaching with blood glucose data , lifestyle behaviors , and patient self-management data individually analyzed and presented with evidence -based guidelines to providers substantially reduced glycated hemoglobin levels over 1 year Introduction The role of mobile technology in patient-reported outcomes ( PRO ) and glycemic control in adults with type 1 diabetes ( T1D ) needs further evaluation . Methods The single-center , prospect i ve , 6-month , open-label , investigator-initiated study r and omized 100 subjects with T1D in a 1:1 fashion to a control group using self-monitoring of blood glucose ( SMBG ) with Accu-Chek Nano ® and an intervention group using SMBG with iPhone plus glucose meter ( iBGStar ® ) . The primary endpoint was the change in PRO ( hypoglycemia fear score , behavior and worry subscores ) . Secondary outcomes were the improvement in glycemic variability indices and the reduction in A1c values . Results Baseline demographics and glycosylated hemoglobin ( A1c ) values were similar in the two groups . There was a significant decrease in A1c value at 6 months in iBGStar ® group compared to the control group ( −0.16 vs. −0.51 , p = 0.04 ) . The total insulin dose increased significantly in the iBGStar ® group at 3 months but did not change at 6 months . The hypoglycemia fear scale ( PRO ) improved in both groups at 6 months ( −1.4 ± 10.0 vs. −3.9 ± 12.5 , p = 0.32 ) . Conclusion The use of iBGStar ® result ed in better glycemic control and improvement in some PRO ( hypoglycemia fear and behavior scores ) compared to the control group at 6 months with no increased risk of hypoglycemia . Clinical trial registration Clinical Trials.gov : NCT01825382 . Funding Sanofi Background Mobile health apps for diabetes self-management have different functions . However , the efficacy and safety of each function are not well studied , and no classification is available for these functions . Objective The aims of this study were to ( 1 ) develop and vali date a taxonomy of apps for diabetes self-management , ( 2 ) investigate the glycemic efficacy of mobile app-based interventions among adults with diabetes in a systematic review of r and omized controlled trials ( RCTs ) , and ( 3 ) explore the contribution of different function to the effectiveness of entire app-based interventions using the taxonomy . Methods We developed a 3-axis taxonomy with columns of clinical modules , rows of functional modules and cells of functions with risk assessment s. This taxonomy was vali date d by review ing and classifying commercially available diabetes apps . We search ed MEDLINE , EMBASE , the Cochrane Central Register of Controlled Trials , the Chinese Biomedical Literature Data base , and Clinical Trials.gov from January 2007 to May 2016 . We included RCTs of adult out patients with diabetes that compared using mobile app-based interventions with usual care alone . The mean differences ( MDs ) in hemoglobin A1c ( HbA1c ) concentrations and risk ratios of adverse events were pooled using a r and om-effects meta- analysis . After taxonomic classification , we performed exploratory subgroup analyses of the presence or absence of each module across the included app-based interventions . Results Across 12 included trials involving 974 participants , using app-based interventions was associated with a clinical ly significant reduction of HbA1c ( MD 0.48 % , 95 % CI 0.19%-0.78 % ) without excess adverse events . Larger HbA1c reductions were noted among patients with type 2 diabetes than those with type 1 diabetes ( MD 0.67 % , 95 % CI 0.30%-1.03 % vs MD 0.37 % , 95 % CI –0.12%-0.86 % ) . Having a complication prevention module in app-based interventions was associated with a greater HbA1c reduction ( with complication prevention : MD 1.31 % , 95 % CI 0.66%-1.96 % vs without : MD 0.38 % , 95 % CI 0.09%-0.67 % ; intersubgroup P=.01 ) , as was having a structured display ( with structured display : MD 0.69 % , 95 % CI 0.32%-1.06 % vs without : MD 0.69 % , 95 % CI –0.18%-0.53 % ; intersubgroup P=.03 ) . However , having a clinical decision-making function was not associated with a larger HbA1c reduction ( with clinical decision making : MD 0.19 % , 95 % CI –0.24%-0.63 % vs without : MD 0.61 % , 95 % CI 0.27%-0.95 % ; intersubgroup P=.14 ) . Conclusions The use of mobile app-based interventions yields a clinical ly significant HbA1c reduction among adult out patients with diabetes , especially among those with type 2 diabetes . Our study suggests that the clinical decision-making function needs further improvement and evaluation before being added to apps OBJECTIVE Widespread use of carbohydrate counting is limited by its complex education . In this study we compared a Diabetes Interactive Diary ( DID ) with st and ard carbohydrate counting in terms of metabolic and weight control , time required for education , quality of life , and treatment satisfaction . RESEARCH DESIGN AND METHODS Adults with type 1 diabetes were r and omly assigned to DID ( group A , n = 67 ) or st and ard education ( group B , n = 63 ) and followed for 6 months . A subgroup also completed the SF-36 Health Survey ( SF-36 ) and World Health Organization-Diabetes Treatment Satisfaction Question naire ( WHO-DTSQ ) at each visit . RESULTS Of 130 patients ( aged 35.7 ± 9.4 years ; diabetes duration 16.5 ± 10.5 years ) , 11 dropped out . Time for education was 6 h ( range 2–15 h ) in group A and 12 h ( 2.5–25 h ) in group B ( P = 0.07 ) . A1C reduction was similar in both groups ( group A from 8.2 ± 0.8 to 7.8 ± 0.8 % and group B from 8.4 ± 0.7 to 7.9 ± 1.1 % ; P = 0.68 ) . Nonsignificant differences in favor of group A were documented for fasting blood glucose and body weight . No severe hypoglycemic episode occurred . WHO-DTSQ scores increased significantly more in group A ( from 26.7 ± 4.4 to 30.3 ± 4.5 ) than in group B ( from 27.5 ± 4.8 to 28.6 ± 5.1 ) ( P = 0.04 ) . Role Physical , General Health , Vitality , and Role Emotional SF-36 scores improved significantly more in group A than in group B. CONCLUSIONS DID is at least as effective as traditional carbohydrate counting education , allowing dietary freedom for a larger proportion of type 1 diabetic patients . DID is safe , requires less time for education , and is associated with lower weight gain . DID significantly improved treatment satisfaction and several quality -of-life dimensions The dem and for new healthcare services is growing rapidly . Improving accessibility of the African population to diabetes care seems to be a big challenge in most countries where the number of care centers and medical staff is reduced . Information and communication technologies ( ICT ) have great potential to address some of these challenges faced by several countries in providing accessible , cost-effective , and high- quality health care services . This paper presents the Mobil Diab system which is a telemedical approach proposed for the management of long-term diseases . The system applies modern mobile and web technologies which overcome geographical barriers , and increase access to health care services . The idea of the system is to involve patients in the therapy process and motivate them for an active participation . For validation of the system in African context , a trial was conducted in the Democratic Republic of Congo . 40 Subjects with diabetes divided r and omly into control and intervention groups were included in the test . Results show that Mobil Diab is suitable for African countries and presents a number of benefits for the population and public health care system . It improves clinical management and delivery of diabetes care services by enhancing access , quality , motivation , reassurance , efficiency , and cost-effectiveness Background Adoptions of health behaviors are crucial for maintaining good health after type 2 diabetes mellitus ( T2DM ) diagnoses . However , adherence to glucoregulating behaviors like regular exercise and balanced diet can be challenging , especially for people living in lower-socioeconomic status ( SES ) communities . Providing cost-effective interventions that improve self-management is important for improving quality of life and the sustainability of health care systems . Objective To evaluate a health coach intervention with and without the use of mobile phones to support health behavior change in patients with type 2 diabetes . Methods In this noninferiority , pragmatic r and omized controlled trial ( RCT ) , patients from two primary care health centers in Toronto , Canada , with type 2 diabetes and a glycated hemoglobin/hemoglobin A1c ( HbA1c ) level of ≥7.3 % ( 56.3 mmol/mol ) were r and omized to receive 6 months of health coaching with or without mobile phone monitoring support . We hypothesized that both approaches would result in significant HbA1c reductions , although health coaching with mobile phone monitoring would result in significantly larger effects . Participants were evaluated at baseline , 3 months , and 6 months . The primary outcome was the change in HbA1c from baseline to 6 months ( difference between and within groups ) . Other outcomes included weight , waist circumference , body mass index ( BMI ) , satisfaction with life , depression and anxiety ( Hospital Anxiety and Depression Scale [ HADS ] ) , positive and negative affect ( Positive and Negative Affect Schedule [ PANAS ] ) , and quality of life ( Short Form Health Survey-12 [ SF-12 ] ) . Results A total of 138 patients were r and omized and 7 were excluded for a sub study ; of the remaining 131 , 67 were allocated to the intervention group and 64 to the control group . Primary outcome data were available for 97 participants ( 74.0 % ) . While both groups reduced their HbA1c levels , there were no significant between-group differences in change of HbA1c at 6 months using intention-to-treat ( last observation carried forward [ LOCF ] ) ( P=.48 ) or per- protocol ( P=.83 ) principles . However , the intervention group did achieve an accelerated HbA1c reduction , leading to a significant between-group difference at 3 months ( P=.03 ) . This difference was reduced at the 6-month follow-up as the control group continued to improve , achieving a reduction of 0.81 % ( 8.9 mmol/mol ) ( P=.001 ) compared with a reduction of 0.84 % ( 9.2 mmol/mol)(P=.001 ) in the intervention group . Intervention group participants also had significant decreases in weight ( P=.006 ) and waist circumference ( P=.01 ) while controls did not . Both groups reported improvements in mood , satisfaction with life , and quality of life . Conclusions Health coaching with and without access to mobile technology appeared to improve glucoregulation and mental health in a lower-SES , T2DM population . The accelerated improvement in the mobile phone group suggests the connectivity provided may more quickly improve adoption and adherence to health behaviors within a clinical diabetes management program . Overall , health coaching in primary care appears to lead to significant benefits for patients from lower-SES communities with poorly controlled type 2 diabetes . Trial Registration Clinical Trials.gov NCT02036892 ; http:// clinical trials.gov/ct2/show/NCT02036892 ( Arch
Output:
| Patients did not experience improvements in quality of life , blood pressure , or weight , regardless of app used or type of diabetes .
Discussion Limited evidence suggests that use of some commercially available apps , when combined with additional support from a healthcare provider or study staff , may improve some short-term diabetes-related outcomes .
The impact of these apps on longer-term outcomes is unclear . |
MS210840 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: Background Both low back pain ( LBP ) and neck pain ( NP ) are major occupational health problems . In the workplace , participatory ergonomics ( PE ) is frequently used on musculoskeletal disorders . However , evidence on the effectiveness of PE to prevent LBP and NP obtained from r and omised controlled trials ( RCTs ) is scarce . This study evaluates the process of the Stay@Work participatory ergonomics programme , including the perceived implementation of the prioritised ergonomic measures . Methods This cluster- RCT was conducted at the departments of four Dutch companies ( a railway transportation company , an airline company , a steel company , and a university including its university medical hospital ) . Directly after the r and omisation outcome , intervention departments formed a working group that followed the steps of PE during a six-hour working group meeting . Guided by an ergonomist , working groups identified and prioritised risk factors for LBP and NP , and composed and prioritised ergonomic measures . Within three months after the meeting , working groups had to implement the prioritised ergonomic measures at their department . Data on various process components ( recruitment , reach , fidelity , satisfaction , and implementation components , i.e. , dose delivered and dose received ) were collected and analysed on two levels : department ( i.e. , working group members from intervention departments ) and participant ( i.e. , workers from intervention departments ) . Results A total of 19 intervention departments ( n = 10 with mental workloads , n = 1 with a light physical workload , n = 4 departments with physical and mental workloads , and n = 4 with heavy physical workloads ) were recruited for participation , and the reach among working group members who participated was high ( 87 % ) . Fidelity and satisfaction towards the PE programme rated by the working group members was good ( 7.3 or higher ) . The same was found for the Stay@Work ergocoach training ( 7.5 or higher ) . In total , 66 ergonomic measures were prioritised by the working groups . Altogether , 34 % of all prioritised ergonomic measures were perceived as implemented ( dose delivered ) , while the workers at the intervention departments perceived 26 % as implemented ( dose received ) . Conclusions PE can be a successful method to develop and to prioritise ergonomic measures to prevent LBP and NP . Despite the positive rating of the PE programme the implementation of the prioritised ergonomic measures was lower than expected . Trial registration Current Controlled Trials IS RCT In web-based health promotion programs , large variations in participant engagement are common . The aim was to investigate determinants of high use of a worksite self-help web-based program for stress management . Two versions of the program were offered to r and omly selected departments in IT and media companies . A static version of the program including health screening tool , diary and information about stress was offered to the control group . Additional material s , i.e. interactive , cognitive-based and classical stress management exercises and a chat room , were offered to the intervention group . Baseline data regarding participants ' demographics , health ( self-ratings and biological measures ) , lifestyle , work-related factors and group membership were analyzed to study determinants of employees ' participation in the program during a period of 12 months . Multiple logistic regression analysis was used and found intervention group membership , being a woman , having at most a secondary education , regular physical exercise habits and having positive expectations of the program were significant predictors of high use . The findings demonstrate that the interactivity of a web-based program is an important factor for determining participation in a web-based worksite stress management program . Implication s for those developing and implementing future web-based health promotion activities are discussed OBJECTIVE To evaluate the effectiveness of a lifestyle intervention for male workers in the construction industry at risk of cardiovascular disease ( CVD ) . METHODS In a r and omized controlled trial performed in the Netherl and s between 2007 and 2009 , usual care was compared to 6 months of individual counseling using motivational interviewing techniques , delivered face to face and by telephone . Participants aim ed at improving energy balance-related behavior or smoking cessation . Linear regression analyses were performed to determine the effects . RESULTS Body weight had significantly decreased at 6 ( β=-1.9 , 95 % CI -2.6 ; -1.2 ) and 12 months ( β=-1.8 , 95%CI -2.8 ; -1.1 ) . The intervention effects were also significant for diastolic blood pressure at 6 months ( β=-1.7 , 95 % CI -3.3 ; -0.1 ) . Among participants who had aim ed at energy balance , the intervention had a significant favorable effect on body weight at 6 ( β=-2.1 , 95 % CI -2.9 ; -1.3 ) and 12 months ( β=-2.2 , 95 % CI -3.1 ; -1.3 ) and at HDL cholesterol ( β=0.05 , 95 % CI 0.01 ; 0.10 ) and HbA1c ( β=-0.06 , 95%CI -0.12 ; -0.001 ) at 12 months , although there was no intervention effect on these variables over time . CONCLUSION Individual-based counseling result ed in significant beneficial long-term effects on body weight . This is an important finding for occupational health , considering the rising prevalence of obesity and CVD BACKGROUND This study explored the experiences of university employees recruited to a 10-week r and omized controlled trial ( n = 64 ) . The trial compared " walking routes " with " walking-while-working " on daily step totals , showing that , compared with controls , interventions result ed in around 1000 extra steps per day . METHODS A sub sample of 15 academic and administrative employees from intervention groups completed interviews at the end of intervention . Interviews were transcribed verbatim and subject to inductive coding within the major themes of benefits /positives and problems/barriers . FINDINGS Both interventions benefited employee health and work productivity but were difficult to implement in the workplace . Involvement in walking routes was challenged by the difficulties of managing time pressures , and individuals assigned to walking-while-working had to deal with local management subcultures favoring physical presence and inactivity . CONCLUSIONS Findings highlight the need for further research , advocate the value of walking at work , and provide insights into the challenges that face staff in workplace interventions Background Only a few workplace initiatives among cleaners have been reported , even though they constitute a job group in great need of health promotion . The purpose of this trial was to evaluate the effect of either physical coordination training or cognitive behavioural training on musculoskeletal pain , work ability and sickness absence among cleaners . Methods A cluster-r and omised controlled trial was conducted among 294 female cleaners allocated to either physical coordination training ( PCT ) , cognitive behavioural training ( CBTr ) or a reference group ( REF ) . Question naires about musculoskeletal pain and work ability were completed at baseline and after one year 's intervention . Sickness absence data were obtained from the managers ' records . Analyses were performed according to the intention-to-treat-principle ( ITT ) . Results No overall reduction in musculoskeletal pain , work ability or sickness absence from either PCT or CBTr compared with REF was found in conservative ITT analyses . However , explorative analyses revealed a treatment effect for musculoskeletal pain of the PCT . People with chronic neck/shoulder pain at baseline were more frequently non-chronic at follow-up after PCT compared with REF ( p = 0.05 ) . Conclusions The PCT intervention appeared effective for reducing chronic neck/shoulder pain among the female cleaners . It is recommended that future interventions among similar high-risk job groups focus on the implementation aspects of the interventions to maximise outcomes more distal from the intervention such as work ability and sickness absence . Trial registration IS RCT N : IS RCT Background Low back pain ( LBP ) and neck pain ( NP ) are common among workers . Participatory Ergonomics ( PE ) is used as an implementation strategy to prevent these symptoms . By following the steps of PE , working groups composed and prioritised ergonomic measures , and developed an implementation plan . Working group members were responsible to implement the ergonomic measures in their departments . Little is known about factors that hamper ( barriers ) or enhance ( facilitators ) the implementation of ergonomic measures . This study aim ed to identify and underst and the possible barriers and facilitators that were perceived during implementation . Methods This study is embedded in a cluster r and omised controlled trial that investigated the effectiveness of PE to prevent LBP and NP among workers . For the purpose of the current study , question naires were sent to 81 working group members . Their answers were used to make a first inventory of possible barriers and facilitators to implementation . Based on the question naire information , 15 semi-structured interviews were held to explore the barriers and facilitators in more detail . All interviews were audio taped , transcribed verbatim , and analysed according to a systematic approach . Results All possible barriers and facilitators were obtained from question naire data , indicating that the semi-structured interviews did not yield information about new factors . Various barriers and facilitators were experienced . The presence of implementation plans for ergonomic measures that were already approved by the management facilitated implementation before the working group meeting . In these cases , PE served as a strategy to improve the implementation of the approved measures . Furthermore , the findings showed that the composition of a working group ( i.e. , including decision makers and a worker who led the implementation process ) was important . Moreover , stakeholder involvement and collaboration were reported to considerably improve implementation . Conclusions This study showed that the working group as well as stakeholder involvement and collaboration were important facilitating factors . Moreover , PE was used as a strategy to improve the implementation of existing ergonomic measures . The results can be used to improve PE programmes , and thereby may contribute to the prevention of LBP and NP.Trial registration numberIS RCT Background : Environmental interventions directed at portion size might help consumers to reduce their food intake . Objective : To assess whether offering a smaller hot meal , in addition to the existing size , stimulates people to replace their large meal with a smaller meal . Design : Longitudinal r and omized controlled trial assessing the impact of introducing small portion sizes and pricing strategies on consumer choices . Setting / participants : In all , 25 worksite cafeterias and a panel consisting of 308 consumers ( mean age=39.18 years , 50 % women).Intervention : A small portion size of hot meals was offered in addition to the existing size . The meals were either proportionally priced ( that is , the price per gram was comparable regardless of the size ) or value size pricing was employed . Main outcome measures : Daily sales of small and the total number of meals , consumers ’ self-reported compensation behavior and frequency of purchasing small meals . Results : The ratio of small meals sales in relation to large meals sales was 10.2 % . No effect of proportional pricing was found B=−0.11 ( 0.33 ) , P=0.74 , confidence interval ( CI ) : −0.76 to 0.54 ) . The consumer data indicated that 19.5 % of the participants who had selected a small meal often-to-always purchased more products than usual in the worksite cafeteria . Small meal purchases were negatively related to being male ( B=−0.85 ( 0.20 ) , P=0.00 , CI : −1.24 to −0.46 , n=178 ) . Conclusion : When offering a small meal in addition to the existing size , a percentage of consumers that is considered reasonable were inclined to replace the large meal with the small meal . Proportional prices did not have an additional effect . The possible occurrence of compensation behavior is an issue that merits further attention Objectives To study the effect of a participatory ergonomics intervention on psychosocial factors among kitchen workers . Design A cluster r and omised controlled trial . Setting Four cities in Finl and , 2002–2005 . Participants 504 workers in 119 municipal kitchens . Intervention Kitchens were r and omised to intervention ( n=59 ) and control ( n=60 ) groups . The intervention lasted 11–14 months and was based on the workers ' active participation in work analysis , planning and implementing the ergonomic changes aim ed at decreasing the physical and mental workload . Main outcome measures Mental stress , mental strenuousness of work , hurry , job satisfaction , job control , skill discretion , co-worker relationships and supervisor support . Data were collected by question naire at baseline , at the end of the intervention , and at a 12-month follow-up ( PI12 ) . Results At the end of the intervention , the OR of job dissatisfaction for the intervention group as compared with the control group was 3.0 ( 95 % CI 1.1 to 8.5 ) , of mental stress 2.3 ( 1.2 to 4.7 ) and of poor co-worker relationships 2.3 ( 1.0 to 5.2 ) . At the PI12 , the OR of job dissatisfaction was 3.0 ( 1.2 to 7.8 ) . Analysis of the independent and joint effects of the intervention and unconnected organisational reforms showed that adverse changes were accentuated among those with exposure to both . Conclusions No favourable effects on psychosocial factors at work were found . The adverse changes were due to a joint effect of the intervention and the unconnected organisational reforms . The findings do not support the usefulness of this kind of intervention in changing unsatisfactory psychosocial working conditions BACKGROUND Smoking is the leading preventable cause of premature death in the United States . Previous studies of financial incentives for smoking cessation in work setting s have not shown that such incentives have significant effects on cessation rates , but these studies have had limited power , and the incentives used may have been insufficient . METHODS We r and omly assigned 878 employees of a multinational company based in the United States to receive information about smoking-cessation programs ( 442 employees ) or to receive information about programs plus financial incentives ( 436
Output:
| The most frequently reported facilitator was strong management support .
Conclusions Process evaluations are not systematic ally performed alongside effectiveness studies for WHPPs .
The quality of the process evaluations is mostly poor to average , result ing in a lack of systematic ally measured barriers/facilitators .
The narrow focus on implementation makes it difficult to explore the relationship between effectiveness and implementation . |
MS210841 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
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***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: Ninety volunteers in a media organization were r and omly allocated to an Acceptance and Commitment Therapy ( ACT , n = 30 ) group that sought to enhance people 's ability to cope with work-related strain , an Innovation Promotion Program ( IPP , n = 30 ) that helped individuals to identify and then innovatively change causes of occupational strain , or a waitlist control group ( n = 30 ) . Both interventions lasted 9 hr , spread over 3 months . Improvements in mental health and work-related variables were found following both interventions . As hypothesized , changes in outcome variables in the ACT condition were mediated only by the acceptance of undesirable thoughts and feelings . In the IPP condition , outcome change was mediated only by attempts to modify stressors . Discussion focused on the importance of underst and ing the mechanisms underpinning change in occupational stress management interventions Swedish civil servants , who reported considerable stress while working in larger government authorities , were r and omized into either a work stress reduction intervention or a control group . Four work units constituted the intervention group ( n = 94 ) , and one unit formed the control group ( n = 35 ) . Participants in the two groups were of similar age and two thirds were women . Psychosocial , lifestyle , and physiological assessment s were made before , during , and after the 8-month intervention period . A significant decrease in apolipoprotein B/apolipoprotein A I ratio ( p < 0.05 ) occurred in the intervention group but not in the control group . No changes were seen in either group in smoking , eating , exercise , relative weight , or other lifestyle factors , which could explain the lipid profile changes . Stimulation from and autonomy over work increased in the intervention group ( p < 0.01 ) but remained the same in the control group . Results have implication s for the efficacy of work stress interventions in decreasing coronary risk This article describes a new method for ( 1 ) systematic ally prioritizing needs for intervention on hazardous substance exposures in manufacturing work sites , and ( 2 ) evaluating intervention effectiveness . We developed a checklist containing six unique sets of yes/no variables organized in a 2 x 3 matrix of exposure potential versus protection ( two columns ) at the levels of material s , processes , and human interface ( three rows ) . The three levels correspond to a simplified hierarchy of controls . Each of the six sets of indicator variables was reduced to a high/moderate/low rating . Ratings from the matrix were then combined to generate a single overall exposure prevention rating for each area . Reflecting the hierarchy of controls , material factors were weighted highest , followed by process , and then human interface . The checklist was filled out by an industrial hygienist while conducting a walk-through inspection ( N = 131 manufacturing processes/ areas in 17 large work sites ) . One area or process per manufacturing department was assessed and rated . Based on the result ing Exposure Prevention ratings , we concluded that exposures were well controlled in the majority of areas assessed ( 64 % with rating of 1 or 2 on a 6-point scale ) , that there is some room for improvement in 26 percent of areas ( rating of 3 or 4 ) , and that roughly 10 percent of the areas assessed are urgently in need of intervention ( rated as 5 or 6 ) . A second hygienist independently assessed a subset of areas to evaluate inter-rater reliability . The reliability of the overall exposure prevention ratings was excellent ( weighted kappa = 0.84 ) . The rating scheme has good discriminatory power and reliability and shows promise as a broadly applicable and inexpensive tool for intervention needs assessment and effectiveness evaluation . Validation studies are needed as a next step . This assessment method complements quantitative exposure assessment with an upstream prevention focus Objective : To test whether feedback and discussion of ergonomic and psychosocial working-environment data during one short session with individual , groups or supervisors of white-collar computer workers had an effect on activity to modify workplace design , working technique and psychosocial aspects of work . Methods : A total of 36 workgroups from nine organizations representing different trades was r and omized ( stratified for organization ) to three feedback conditions or control with no feedback . Data were collected 1 month before and 6 months after feedback sessions . The effects studied were : ( 1 ) change in the proportion of workgroup members who reported any modification regarding workplace design or working technique ; ( 2 ) change in the proportion of workgroup members who reported any modification regarding psychosocial aspects ; ( 3 ) average number of modification types regarding workplace design or working technique per individual in a workgroup ; ( 4 ) average number of modification types regarding psychosocial aspects per individual in a workgroup . Results : All feedback conditions differed positively from controls regarding change in the proportion of workgroup members who reported any modification in workplace design or working technique . No such effect was found for psychosocial aspects . For change in average number of psychosocial modification types per individual in a workgroup an effect was observed for feedback to supervisors . No intervention effect was observed for the average number of modifications in workplace design or working technique per individual in a workgroup . Conclusion : Feedback and discussion of ergonomic and psychosocial working-environment data during one short session with individual , groups or supervisors of white-collar computer workers may have a positive effect on how many people in a workgroup modify ( or have modifications done regarding ) workplace design and working technique . Feedback to supervisors may have an effect on the average number of psychosocial modification types per individual in a workgroup . Feedback to group supervisors appeared to be the most cost-effective variant Our objective was to evaluate the effect of 12 weeks of stress management training ( SMT ) , physical exercise ( PE ) and an integrated health programme ( IHP ) in a worksite setting on subjective health complaints . To do this , we r and omly split 860 employees into the following groups : control ( n = 344 ) , PE ( n = 189 ) , IHP ( comprising physical exercise and health information ) ( n = 165 ) and SMT ( n = 162 ) . There were no significant effects on subjective health complaints , sick leave or job stress . However , strong and specific positive effects were experienced for the particular goal areas defined for each intervention . The PE group showed improved general health , physical fitness and muscle pain , while the SMT group showed improved stress management . The IHP group showed the strongest effects , affecting most goals set for treatment A r and omized , clinical intervention focused on alleviating job strain was conducted over 6 months by mail and /or telephone with a total of 136 employees of Bank of America . Both the mail and mail plus telephone interventions evidence d positive results , with the mail plus telephone intervention being the more effective . Given the relative low cost of such mediated interventions , the results provide a basis for the further development of interventions that may demonstrate both clinical and cost effectiveness OBJECTIVES The effects of a stress reduction program on Japanese blue-collar workers were investigated using a controlled trial design . METHODS Two blue-collar worksites that showed higher depression scores ( Zung self-rating depression score ) were selected for the intervention group , after a survey of a large electric company in 1985 . Three blue-collar worksites were selected as a reference group whose workers were matched with the workers of the interventive worksites by mean age , worksite size and mean depression scores . A 1-year stress reduction program was conducted in the intervention group from 1986 to 1987 by worksite supervisors . Effects of the stress reduction program were assessed by comparing the initial depression scores , length of sick leave , and systolic and diastolic blood pressures with those after the follow-up . RESULTS The depression scores decreased during the follow-up in the intervention group , while the scores were almost the same in the reference group . An analysis of covariance with repeated measurements indicated a statistically significant intervention ( group x time interaction ) effect after control for gender and age ( P = 0.035 ) . Sick leave in the past year decreased in 1988 only in the intervention group ; generalized logit analysis with repeated measurements indicated a statistically significant intervention effect after control for gender and age ( P = 0.034 ) . No statistically significant intervention effects were observed on systolic and diastolic blood pressures or selected work stressors . CONCLUSIONS A stress reduction program directed towards worksite supervisors can be used to reduce depressive symptoms and sick leave among Japanese blue-collar workers
Output:
| Studies using high-rated approaches represent a growing proportion of the job-stress intervention evaluation literature .
Individual-focused , low-rated approaches are effective at the individual level , favorably affecting individual-level outcomes , but tend not to have favorable impacts at the organizational level .
Organizationally focused high- and moderate-rated approaches are beneficial at both individual and organizational levels . |
MS210842 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Background Abdominal aortic aneurysm is a multifactorial disorder in which inflammation is an important pathophysiological feature . In explant culture , aneurysm biopsies secrete large amounts of interleukin-6 ( IL-6 ) , and among aneurysm patients , the circulating concentration of IL-6 appears to be increased . Methods and Results We investigated , in 19 patients , whether aneurysm wall was an important source of circulating IL-6 . We also tested the hypotheses , in 466 patients with a small aneurysm , that ( 1 ) high concentrations of circulating IL-6 signaled rapid aneurysm growth and ( 2 ) the −174 G→C polymorphism in the IL-6 promoter predicted survival . For 19 patients with large or inflammatory aneurysms , the concentration of IL-6 was higher in the iliac arteries than the brachial arteries ( median difference 26.5 pg/mL , this difference increasing with aneurysm diameter , P = 0.01 ) . In 466 patients with small aneurysms , the frequency of the −174 C allele ( 0.40 ) was similar to that in a normal healthy population . Patients of GG genotype had lower plasma concentrations of IL-6 than patients of GC and CC genotypes ( medians 1.9 , 4.8 , and 15.6 pg/mL , respectively , Kruskal-Wallis P = 0.047 ) . Cardiovascular and all-cause mortalities were lower for patients of GG genotype than for patients of GC and CC genotype : hazard ratios 0.32 ( 95 % CI 0.12 to 0.93 ) , P = 0.036 , and 0.51 ( 95 % CI 0.25 to 1.00 ) , P = 0.05 , respectively . There was no association between plasma IL-6 or IL-6 genotype and aneurysm growth . Conclusions Aortic aneurysms appear to be an important source of circulating IL-6 , the concentration being influenced by genotype . For patients with small aneurysms , the −174 G→C IL-6 genotype predicts future cardiovascular mortality The native fibrin gel structure formed in vitro from plasma sample s was examined by liquid permeation of hydrated fibrin gel networks in 38 unselected men who had suffered a myocardial infa rct ion before the age of 45 years and in 88 age-matched population -based control men . Both the fibrin gel porosity ( permeability coefficient , Ks ) and the calculated fiber mass-length ratio varied considerably within the two groups , but were generally lower in the patients . Ks was 8.3 + /- 5.2 cm2 x 10(9 ) ( mean + /- SD ) in the patient group and 12.5 + /- 5.7 cm2 x 10(9 ) among controls ( p < 0.001 ) . The corresponding figures for fiber mass-length ratio were 13.1 + /- 7.7 and 16.5 + /- 7.5 Dalton/ cm x 10(-13 ) , respectively ( p < 0.01 ) . Around 50 % of the patients had Ks values below the 10th percentile of the control group . A strong inverse correlation was seen between plasma plasminogen activator inhibitor-1 ( PAI-1 ) activity and Ks ( r = -0.603 , p < 0.001 ) or fiber mass-length ratio ( r = -0.565 , p < 0.001 ) in the patient group . Corresponding weaker associations of PAI-1 with fibrin gel properties were also present in the control group . In addition , inverse relationships of very low density lipoprotein ( VLDL ) triglyceride concentrations to Ks ( r = -0.362 , p < 0.001 ) and fiber mass-length ratio ( r = -0.283 , p < 0.01 ) were found among the controls . Proneness to formation of tight and rigid fibrin gel networks with abnormal architecture in vitro is in vivo associated with myocardial infa rct ion at a young age . Impaired fibrinolytic function secondary to a raised plasma PAI-1 activity level is associated with abnormal fibrin gel structure Abdominal aortic aneurysms have traditionally been thought to be a consequence of severe atherosclerosis of the arterial wall . To date , the role of haemostatic factors in aneurysmal disease has not been extensively research ed . The aim of this study was to see if such factors were independently related to the occurrence of aortic aneurysm . Furthermore , were the associations maintained after taking into account the presence of underlying atherosclerotic disease ? Using data from the Edinburgh Artery Study , a nested case-control design was used involving 40 cases of aortic aneurysm , each being matched to five controls by sex and within a 5-year age b and . After adjustment for age and sex , both fibrinogen ( P × 0.01 ) and fibrin D-dimer ( P × 0.001 ) were each associated with a significant increased risk of aneurysm . Further adjustment for packyears , history of cardiovascular disease and the ankle brachial pressure index result ed in odds ratios of 1.51 ( 95 % CI 1.05 to 2.16 , P × 0.05 ) for fibrinogen and 3.75 ( 95 % CI 1.80 to 7.82 , P × 0.001 ) for fibrin D-dimer . These associations probably arise as a consequence of fibrin deposition and turnover within the aneurysmal sac , although further prospect i ve studies are needed before thrombotic factors can be used in the identification of a group who are at high risk of developing an abdominal aortic aneurysm OBJECTIVE To assess the incidence of lupus anticoagulant ( LAC ) in patients with peripheral vascular disease . DESIGN Prospect i ve clinical study . SETTING University Hospital . MATERIAL S 20 patients with claudication ( group 2 ) , 20 patients with critical ischaemia ( group 3 ) and 20 patients prior to elective abdominal aortic aneurysm surgery ( group 4 ) were compared to 20 general surgical controls ( group 1 ) . CHIEF OUTCOME MEASURES Venous blood sample s for coagulation assay . MAIN RESULTS Positive results for LAC by the Dilute Russell 's viper venom time ( DRVVT ) with the platelet neutralisation procedure were present in 26 out of 60 vascular patients compared with none of the 20 general surgical controls . The three vascular groups showed a similar prevalence of LAC and this differed significantly from that in the control group ( chi 2 = 10.94 , p = 0.0009 ) . Of the 26 positive results only three were associated with an abnormal activated partial thromboplastin time ( APTT ) , which has previously been used as a marker for the presence of LAC activity . Fibrinogen levels were raised in seven of 20 patients in group 2 but were normal in the remaining vascular groups ( p = 0.001 ) . The mean factor VII level ( 124.1 units dl-1 ) in group 2 was higher than the mean of the remaining vascular patients ( 109.3 units dl-1 , p < 0.05 ) . CONCLUSIONS The high prevalence of LAC in patients with peripheral vascular disease and the associated increased risk of early graft thrombosis may justify routine testing by DRVVT prior to reconstructive vascular surgery . Treatment of these patients with antiplatelet agents or formal anticoagulation perioperatively should be considered BACKGROUND A ruptured abdominal aortic aneurysm ( AAA ) is associated with high mortality . Postoperative complications such as hemorrhage , multiple organ failure , myocardial infa rct ion , and thromboembolism are common . An active and balanced hemostatic system is essential to avoid bleeding as well as thrombosis . When these activities are not properly regulated the patient is at risk of developing either excessive bleeding or thrombosis-related complications . Previous studies have shown a state of activated coagulation in patients with ruptured AAA . However , there are conflicting results regarding the fibrinolytic response . OBJECTIVES The aim of the present study was to investigate the fibrinolytic state pre-operatively in patients with ruptured and non-ruptured AAA in relation to the clinical outcome with special regard to the influence of shock . METHODS A prospect i ve study was performed on 95 patients who underwent surgery for a ruptured AAA with shock ( n = 43 ) , a ruptured AAA without shock ( n = 12 ) , and a non-ruptured AAA ( n = 40 ) . Forty-one controls without an aneurysm were matched to the AAA patients according to age , gender and smoking habits . Plasma levels of tissue plasminogen activator antigen ( tPAag ) , and plasminogen activator inhibitor type-1 ( PAI-1 ) were measured as markers of fibrinolytic activity . D-dimer , a marker of fibrin turnover , was also measured . RESULTS D-dimer was significantly higher in patients with a non-ruptured AAA compared with controls without AAA . There were significantly higher levels of D-dimer , tPAag , and PAI-1 in patients operated for ruptured compared with non-ruptured AAA . tPAag was also significantly higher in ruptured AAA patients with shock compared with without shock . No deaths occurred in patients operated on for a non-ruptured AAA or ruptured AAA without shock . There were 12 deaths after repair of a ruptured AAA with shock , of which two patients died from bleeding and the remaining 10 from multiple organ failure and cardiac failure . CONCLUSION Our results indicate a state of activated coagulation in patients with a non-ruptured AAA , the state being intensified by rupture . The present data show normal fibrinolytic activities in patients with a non-ruptured AAA , but increased systemic fibrinolysis , as demonstrated by elevated tPAag level , in patients with a ruptured AAA . The elevated PAI-1 level indicates a simultaneous inhibition of the systemic fibrinolysis . Furthermore , the hyperfibrinolytic state was reinforced by shock in this study . However , the clinical outcome , with a relatively high incidence of thrombosis-related deaths , indicate a prothrombotic state instead of a hyperfibrinolytic state as a major point of attention in patients with shock as a result of a ruptured AAA OBJECTIVES the aim of the study was to determine the effects of infrarenal asymptomatic abdominal aortic aneurysm ( AAA ) on platelet count and activation . DESIGN prospect i ve clinical study in a University Department of Vascular Surgery . PATIENTS one hundred and five patients with AAA . Thirty-two control patients with symptomatic carotid artery stenoses . METHODS platelet count ( PC ) , plasma glycocalicin levels , prothrombin ratio ( PTR ) , activated partial thromboplastin time ( APPT ) , fibrinogen and D-dimer were measured in 23 patients with AAA and 16 control patients with symptomatic carotid artery stenoses . PC alone was measured in a further 84 patients with AAA and 16 with carotid artery stenoses . RESULTS PC was below the normal range in 8/105 patients and mean PC ( 215x10(9)/l , S.D. 47.5 ) was significantly lower than that of a control population ( 242x10(9)/l , S.D. 16.8 ) and patients with carotid disease ( 269x10(9)/l , S.D. 57 ) . Glycocalicin level was above the normal range in 7/23 patients and the median level ( 28 fg/plt ) was significantly higher than that of a normal population ( 21.6 fg/plt ) and patients with carotid disease ( 12.3 fg/plt ) . Fibrinogen levels , PTR and APPT were all within the normal range . One patient had a minimally elevated level of D-dimer . CONCLUSIONS the combination of low PC and high glycocalicin levels suggests that there is increased platelet destruction , most likely due to activation within the aneurysm sac
Output:
| We found that plasma fibrinogen and D-dimer concentrations are likely to be higher in cases with AAA than control subjects .
Higher plasma fibrinogen and D-dimer concentrations may be associated with the presence of AAA |
MS210843 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: AIMS The aim of the study was to investigate preferences in the general population regarding type of treatment for alcohol problems and the preferred setting for delivery of treatment and reasons for not seeking treatment for alcohol problems . METHOD Data were from a r and om , cross-sectional , interview survey of 9005 of the Swedish general population . Proportions of respondents preferring a certain treatment and source of treatment , and reasons suggested for why people do not seek treatment , were analysed in relation to number of st and ard drinks , employment status , education and income . RESULTS Most frequently endorsed forms of treatment were alcoholics anonymous or similar support groups and psychotherapy . More than 50 % preferred psychiatric or addiction specialist treatment . Around 10 % preferred primary health care and around 20 % the occupational health services . About 5 % preferred the social services . Respondents rated ' feeling ashamed ' as the most important reason why people would not seek help for alcohol problems . CONCLUSION Large majorities of the respondents preferred treatment in the health care services and few in the social services . Internet-based treatment and pharmacological treatment attracted few respondents , the majority preferring more traditional forms of treatment . Alcohol treatment remains a stigmatized field , evidence d by shame being the most commonly reported reason for not seeking treatment Background : Public attitudes towards a given medical procedure can have a significant influence on the employment of that method . Electroconvulsive therapy ( ECT ) is a medical procedure that has received an exceptionally ambiguous public reception since its inception . Aim : To survey the level of information about and attitudes towards ECT in a general population sample of the Chuvash Republic of the Russian Federation . Methods : A r and omly selected cohort of 5,373 people was contacted by telephone . The respondents were asked three closed and three open questions . Results : The response rate was 74.7 % . Only 35.2 % of those interviewed said they knew anything about ECT . Health professionals and younger respondents were better informed . The two main sources of information about ECT were foreign films and the mass media . The main indication of ECT was thought to be schizophrenia . The majority ( 63.3 % ) of the respondents had negative opinions and emotions about ECT . Conclusion : Limited information about and generally negative attitudes towards ECT were found in the general population of the Chuvash Republic . Gender , age , education level , employment in the health industry , and information source were found to be the determining factors in the knowledge of and attitudes towards ECT Objective It is often assumed that individual stigmatizing attitudes toward the mentally ill are linked to stigmatizing attitudes in the social milieu and that both , individual and social stigmatizing attitudes are major barriers to mental health treatment seeking . This study aims to examine these assumptions . Method Data from the 2005–2006 Eurobarometer general population survey ( N = 29,248 ) are used to examine the association of social stigmatizing attitudes assessed in a r and om half of the sample with individual stigmatizing attitudes assessed in the other half of the sample , and to examine the association of both individual and social stigmatizing attitudes with willingness to seek professional help . Results Social stigmatizing attitudes are specifically and strongly associated with individual stigmatizing attitudes . Both social and individual stigmatizing attitudes are associated with willingness to seek professional help . Believing the mentally ill to be dangerous or not likely to recover , or living in a community with such beliefs , are associated with increased willingness to seek help ; whereas , believing the mentally ill to be unpredictable or blameworthy for their illness , or living in a community with strong beliefs in blameworthiness of the mentally ill , are associated with decreased willingness to seek professional help . Conclusion The view that all stigmatizing attitudes toward mental illness are associated with reluctance to seek professional help may be naive as some stigmatizing attitudes may be associated with increased willingness to seek help . The complex association of different stigmatizing attitudes with professional help seeking should be carefully considered in planning anti-stigma campaigns Objective : We investigated the lay public 's attitudes toward help seeking and preferences for treatment of Alzheimer 's disease ( AD ) in the city of São Paulo , Brazil . Method : Cross-sectional population -based r and om sample of 500 household residents over 18 years old participated in face-to-face interviews in São Paulo , which included a case vignette depicting AD and a structured question naire . Results : Public opinion rests firmly in the lay support system . Psychologists and self-help groups and close relatives were often rated as helpful . Many alternative treatments ( such as vitamins , physical exercise , vacation ) were often rated as helpful . Limited education , younger age and experience with psychiatric problems are associated with the ‘ medical ’ intervention model . Female sex and middle age are associated with ‘ alternative ’ interventions . Conclusion : Our results suggest that attitudes and belief systems have an important impact on help-seeking and treatment recommendations Objective . Public social policies in New Zeal and assume that there are fundamental differences between Maori views of health phenomena and non‐Maori perceptions . The biomedical model and a Maori model known as Te Whare Tapa Wha are commonly employed to characterise these differences . Using the categorical ethnicity demarcation ‘ Maori/non‐Maori ’ we investigate this cl aim with respect to mental health literacy about depression . Design . Participants were r and omly selected from the General and Maori Electoral Rolls and recruited by post ( N=205 ) . A vignette methodology was employed and involved the development of a fictional character as a target stimulus who exhibited the minimum DSM‐IV‐R criteria for a major depressive disorder . Participants responded to items regarding problem recognition , well‐being , causal attributions , treatment preferences , and likely prognosis . Results . The majority of Maori and non‐Maori participants correctly identified the problem the vignette character was experiencing and nominated congruent attributions for the causes of the problem . In relation to treatment strategies and likely prognosis , independent of self‐assigned ethnicity , participants rated professional treatments above alternative options . Overall the categorical ethnicity distinction ‘ Maori and non‐Maori ’ produced no systematic variation with regards to individual evaluative responses about a major depressive disorder . Conclusions . Contrary to the embedded assumption within New Zeal and 's public health strategies that there are essential differences between the way Maori and non‐Maori view health problems , and that the categorical ethnicity demarcation reliably reflects these differences , we found no evidence for the veracity of this cl aim using a major depressive disorder as a target for judgements . Alternative explanations are canvassed as to why this assumption about fundamental differences based on categorical ethnicity has gained ascendancy and prominence within the sphere of New Zeal and health OBJECTIVE Stigma associated with mental illness continues to be a significant barrier to help seeking , leading to negative attitudes about mental health treatment and deterring individuals who need services from seeking care . This study examined the impact of public stigma ( negative attitudes held by the public ) and internalized stigma ( negative attitudes held by stigmatized individuals about themselves ) on racial differences in treatment-seeking attitudes and behaviors among older adults with depression . METHOD R and om digit dialing was utilized to identify a representative sample of 248 African American and white older adults ( older than 60 years ) with depression ( symptoms assessed by the Patient Health Question naire-9 ) . Telephone-based surveys were conducted to assess their treatment-seeking attitudes and behaviors and the factors that impacted these behaviors . RESULTS Depressed older adult participants endorsed a high level of public stigma and were not likely to be currently engaged in or did they intend to seek mental health treatment . Results also suggested that African American older adults were more likely to internalize stigma and endorsed less positive attitudes toward seeking mental health treatment than their white counterparts . Multiple regression analysis indicated that internalized stigma partially mediated the relationship between race and attitudes toward treatment . CONCLUSION Stigma associated with having a mental illness has a negative influence on attitudes and intentions toward seeking mental health services among older adults with depression , particularly African American elders . Interventions to target internalized stigma are needed to help engage this population in psychosocial mental health treatments OBJECTIVE To identify changes in mental health literacy in regard to depression between 1998 and 2004 . DESIGN AND SETTING Face-to-face interviews with a r and om and representative sample of the South Australian population in 2004 , compared with a similarly conducted survey in 1998 that used the same vignette , questions and methodology . PARTICIPANTS 3015 r and omly selected participants , aged 15 years and over . MAIN OUTCOME MEASURES Responses to both open-ended and direct questions about symptoms and treatment options for depression . RESULTS The 3015 interviews conducted represented a response rate of 65.9 % . Compared with 1998 , in 2004 there was a significant increase in the proportion of people recognising depression in the vignette , acknowledging personal experience of depression , and perceiving professional assistance to be more helpful and less harmful . However , although more people nominated psychiatrists or psychologists as therapists of choice , the difference between 1998 and 2004 was not significant . CONCLUSIONS There has been a significant increase in mental health literacy , at least as regards depression , in the South Australian community between 1998 and 2004 . The lack of significant change in psychiatrists and /or psychologists being perceived as therapists of choice is of concern and suggests that community education about their expertise may be appropriate Background Mental ill health is a common condition in the general population , yet only about half of those with a mental disorder have treatment contact . Personal experience may affect attitudes , which in turn influence the help-seeking process . This study investigated differences in mental health literacy and attitudes among mentally healthy persons and in persons with symptoms of mental illness with and without treatment contact . Method A postal screening question naire was sent to a r and om sample of the general population aged 20–64 in the county of Skaraborg , Sweden in order to ascertain mental health status and history of treatment contact ; 3538 responded ( 49 % ) . Face-to-face interviews were carried out in r and om sub sample s of mentally healthy persons ( n = 128 ) and in mentally ill persons with ( n = 125 ) and without ( n = 105 ) mental health care contact . Mental health literacy and attitudes to treatment were assessed using questions based on a vignette depicting a person with depression . Past month mental disorder was diagnosed according to the Schedule for Clinical Assessment in Neuropsychiatry ( SCAN ) . Results Two thirds failed to recognize depression in a vignette ; recognition was equally poor in mentally healthy persons and in persons with symptoms of mental illness with and without treatment contact . In response to an open-ended question concerning appropriate interventions , one third suggested counselling and only one percent proposed antidepressant treatment . Again , proportions were similar in all groups . Persons with a history of mental health contact more often suggested that a GP would provide the best form of help . When presented with a list of possible interventions , those with a history of mental health contact were more positive to medical interventions such as antidepressants , hypnotics , and inpatient psychiatric treatment . When asked about the prognosis for the condition described in the vignette , persons with treatment contact were less likely to believe in full recovery without intervention ; mentally ill without treatment contact were more optimistic . Conclusion Mental health literacy , specially concerning attitudes towards interventions is associated with personal history of mental health care Objective A community survey evaluated whether the development of a shared mental health care intervention had an impact on health care perceptions and mental health status of subjects with common mental health problems ( MHP ) . Methods Adults < 70 years old with common MHP ( DSM-IV/CIDI-SF major depressive disorder , generalized anxiety or MHI-SF 36 psychic distress diagnoses ) , were r and omly drawn from the general population in the intervention area ( IA , n = 349 ) and in a control area ( CA , n = 360 ) , and evaluated twice at an interval of 18 months ( percentage of follow-up : IA = 69.3 % , CA = 71.9 % , P = .44 ) . CA and IA groups did not differ for the criteria of interest at baseline . Results At 18 months , compared to CA , IA reported significantly different help-seeking attitudes or behaviours ( P = .02 for all subjects and .006 for subjects with current MHP ) and greater general satisfaction with care ( P = .03 for both ) . Remission rates and daily life functioning did not differ . Conclusions After 4 years of development of a mental health network based on a consultation-liaison model , Shared Mental Health Care was associated with greater satisfaction and access with care among subjects with common MHP . The association was not found with mental health status , but the study lacked power to adequately address the issues BACKGROUND Most studies showed that patients would first go to their primary care physicians ( PCPs ) when depressed . This choice is probably due to PCP being the entry point into the health care system . We studied the general population 's initial choice of mental care in Hong Kong , where patients were unclear about family medicine and free to choose doctors of any specialty . METHODS A combined qualitative and quantitative approach was adopted . We held focus groups with participants recruited from community centers and a telephone survey with adults ages 18 or above r and omly selected from the domestic telephone directory . RESULTS Of 1,647 adults successfully interviewed , 49.0 % would seek help from their regular PCP , 19.3 % from psychiatrists , 4.8 % from any doctors , 16.5 % from non-medical re sources ; 6.9 % would not seek any help , and 3.5 % were uncertain of what to do . Those who did not seek any help were more likely to be male or without regular doctors . The focus group participants highlighted the stigmatizing effect of consulting psychiatrists and expressed strong expectation of empathic relationship , time , and communication skills from their care providers . Some participants were not aware that PCP could manage mental illness . CONCLUSIONS Given free choice of health care service , most people would first consult their regular doctors for treatment of de
Output:
| We found that professional help for mental disorders generally enjoys high esteem .
If respondents have to rank sources of help , they tend to favor mental health professionals , while open questions yield results more favorable to general practitioners .
Psychiatrists and psychologists/psychotherapists are equally recommended for the treatment of schizophrenia , while for depression psychologists/psychotherapists are more recommended , at least in Europe and America .
Psychotherapy is consistently preferred over medication .
Attitudes towards seeking help from psychiatrists or psychologists/psychotherapists as well as towards medication and psychotherapy have markedly improved over the last twenty-five years .
Biological concepts of mental illness are associated with stronger approval of psychiatric help , particularly medication .
Self-stigma and negative attitudes towards persons with mental illness decrease the likelihood of personally considering psychiatric help .
In conclusion , the public readily recommends psychiatric help for the treatment of mental disorders .
Psychotherapy is the most popular method of psychiatric treatment . |
MS210844 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Painful oral mucositis is a common complication after bone marrow transplantation ( BMT ) . Glutamine is a nutrient for rapidly dividing cells and the major energy source for intestinal epithelium . This study tested whether an oral glutamine preparation could decrease the severity of oral mucositis in patients undergoing BMT . Glutamine or a placebo ( glycine ) were administered from admission until day + 28 in 193 BMT patients in a r and omized , double-blind , placebo-controlled study at a dose of 1.0 g amino acid/m2/dose swish and swallow four times a day . In autologous BMT patients ( n = 87 ) glutamine was associated with significantly less mouth pain by self report and by opiate use ( 5.0 ± 6.2 days of morphine for glutamine vs 10.3 ± 9.8 days for placebo ; P = 0.005 ) . Matched sibling BMT patients had no effect by self report and an increased duration of opiate use ( 23.2 ± 5.7 days for glutamine vs 16.3 ± 8.3 days for placebo ) ( P = 0.002 ) . However , day 28 survival of allogeneic patients was improved by glutamine . No significant differences in TPN use , rate of relapse or progression of malignancy , parenteral antibiotic use , acute or chronic GVHD , or days of hospitalization were observed in either autologous or allogeneic recipients . No toxicity of glutamine was observed . We conclude that oral glutamine can decrease the severity and duration of oropharyngeal mucositis in autologous BMT patients but not in allogeneic BMT patients , possibly due to interaction with methotrexate The impact of prophylaxis with 400 mg/day fluconazole on fungal colonization at different body sites was assessed in a r and omized , double-blind , placebo controlled study among patients with leukaemia and those undergoing bone marrow transplantation . The study drug was given throughout the period of neutropenia and sample s were obtained at weekly intervals . Of the 23 patients in each group , 11 of those given fluconazole and 12 placebo recipients were colonized at entry . The commonest sites were the oropharynx and rectum and C and ida albicans was the most frequent isolate . Fluconazole led to a marked reduction in colonization by the second week of treatment to 29 % compared with 68 % for those given the placebo . Two-weeks after stopping the study regimen there was little change with yeast being isolated from 33 % and 81 % respectively . Fluconazole was particularly effective in reducing the carriage of C. albicans in the oropharynx from 46 % to 0 - 10 % and in maintaining this throughout prophylaxis . Recovery of C and ida ( Torulopsis ) glabrata from the perianal region steadily increased to around 30 % in both patient groups and while C and ida krusei species were found exclusively in patients given fluconazole , other c and ida were more common in the placebo group . These results demonstrate that by rapidly reducing the colonization of the alimentary tract , fluconazole eliminates the major reservoir for infection with yeasts other than C. glabrata and C. krusei during the critical period of neutropenia Fungal infections are a major problem in patients with hematologic malignancy . Attempts to reduce their frequency with antifungal agents have not been successful . A double-blind , controlled , single-center trial was conducted with 96 consecutive patients undergoing 154 episodes of chemotherapy . Patients received 400 mg of fluconazole or placebo until bone marrow recovery or initiation of intravenous amphotericin B infusions . End points were amphotericin B use , fungal infection , stable neutrophil count > 0.5 x 10(9)/L , toxicity precluding further fluconazole use , and death . By Kaplan-Meier estimation , the time to initiation of amphotericin B therapy was shorter in 76 patients treated with placebo than in 75 treated with fluconazole ( P = .003 ) . Also , fluconazole reduced the number of febrile days by 20 % ( P = .002 ) and prevented oropharyngeal c and idiasis ( 1/75 vs. 9/76 , P = .018 ) . The frequency of deep mycoses ( 8/76 vs. 8/75 ) and outcome were unaffected . Fluconazole did not have a favorable effect on infection-related health care costs and was associated with prolonged severe neutropenia ( P = .01 ) Oropharyngeal c and idiasis is frequently a complication of patients with altered immune states . Clotrimazole troches are effective in the treatment of C and ida and were evaluated in this study in a prophylaxis regimen . Patients with malignant neoplasms who were receiving chemotherapy and renal transplant recipients who were receiving immunosuppressives were r and omized to receive either clotrimazole ( 10 mg ) or placebo troches three times a day in a prospect i ve , double-blinded study . Eighty-four patients were r and omized into the study , 18 patients with leukemia , 19 patients with malignant neoplasms , and 47 patients with renal transplants . Among all patients , thrush developed in 57 % while receiving placebo compared with 13 % while receiving clotrimazole prophylaxis . Prophylaxis showed significant benefit for the renal transplant recipients and for patients with solid malignant neoplasms , but not for the leukemic patients . Clotrimazole troches are effective in preventing oral c and idiasis in a select group of patients We determined whether ketoconazole prophylaxis might reduce C and ida colonization and infections in adult patients with acute leukaemia . During first-remission induction therapy 50 patients were treated with 200 mg ketoconazole administered orally daily , while 57 patients received placebo in a double-blind , r and omized trial . The duration of severe neutropenia ( granulocytes less than 0.1 x 10(9 ) l-1 ) represented 36 % of the study period in the ketoconazole group and 26 % in the placebo group ( P = 0.043 ) . Although fewer patients presented with positive C and ida surveillance cultures and serological evidence of C and ida infection in the ketoconazole group compared to the placebo group , two c and idaemias and one Trichosporum fungaemia were observed in the ketoconazole group . Moreover , significantly more bacteraemias were noted in the ketoconazole group ( n = 37 ) than in the placebo group ( n = 21 ) ( P = 0.004 ) . Thus , although oral ketoconazole prophylaxis might be associated with less C and ida colonization and fewer seroconversions , it also result ed in more bacteraemias and longer duration of severe neutropenia , suggesting that caution should be exercised when ketoconazole ( or related drugs ) is given to this group of immunocompromised hosts Oral mucositis is a dose-limiting toxicity of intensive chemotherapy . It is caused directly by the cytotoxic effect of chemotherapeutic agents and indirectly by sustained neutropenia . Severe oral mucositis is an important predisposing factor for life-threatening septic complications during aplasia . It also reduces quality of life . At present , no effective causal prophylaxis or treatment against oral mucositis is established . We performed a prospect i ve r and omised placebo-controlled trial using topical oral r-metHuG-CSF ( filgrastim ) in high- grade lymphoma patients treated according to the B-NHL protocol , which contains high-dose methotrexate and causes severe oral mucositis ( WHO grade s I – IV ) in > 50 % of patients . Between August 1996 and July 1997 , a total of 32 chemotherapy cycles were documented in eight patients ( four male , four female ) . Mucosal erythema and ulceration were recorded . All patients assessed their oral pain and impact on swallowing daily , using a subjective scale from no to maximal discomfort ( 1–10 ) . In addition , oral mucositis was assessed according to the WHO score . Filgrastim was administered in 16 cycles as a viscous mouthrinse ( carboxymethyl- cellulose 2 % , oleum citrii ) 4 × 120 μg/day from days 10 to 16 . Sixteen cycles were given to control patients , of these 14 with placebo , and another two cycles with no treatment . Severe mucositis ( WHO grade III/IV ) was documented in 21 of 32 cycles ( 65.5 % ) . A difference of borderline significance was observed for the reduction of maximum severity of oral mucositis between G-CSF vs placebo ( P = 0.058 ) , with a reduction of WHO grade IV of 50 % ( four G-CSF vs eight control ) . The number of days in hospital was reduced significantly in the G-CSF group ( P = 0.02 ) . In conclusion , topical oral G-CSF mouthrinses may be beneficial to reduce oral mucositis In some clinical situations the endogenous production of glutamine may be insufficient to maintain optimal tissue structure and function such that glutamine becomes a conditionally essential amino acid . Studies in laboratory animals have demonstrated that glutamine supplementation can reduce the incidence and severity of cytotoxic-induced mucositis . This study examined the role of oral glutamine supplementation in the management of mucositis caused by 5-fluorouracil ( 5-FU ) and folinic acid . Twenty-eight patients with gastrointestinal cancers were r and omised to receive 16 g of glutamine per day for 8 days , or placebo , in a r and omised double-blind trial before crossing over to the alternative supplement during the second treatment cycle . The supplement was well tolerated with no apparent adverse effects , but failed to have any significant effect on oral mucositis assessed by the patients or investigator . The possible reasons for this apparent lack of benefit are discussed Disruption of the oral mucosal lining and the lack of normal defense mechanisms predispose bone marrow transplant ( BMT ) patients to life-threatening infections , often caused by oral flora . Chlorhexidine , used as an oral antiseptic , appears promising in limiting oral bacteria and fungi , and therefore , may decrease oral complications associated with BMT . The purpose of this study was to determine in pediatric BMT recipients if a 0.12 % chlorhexidine mouthrinse , used as an adjunct to normal in-hospital oral care regimens , would decrease the severity of oral mucositis as measured by oral ulcerations , bacteremia , and length of hospital stay . Forty-seven pediatric BMT subjects were included in this double-blind study . Subjects were instructed to use 15 ml of a mouthrinse 3 times daily to be swished and gargled for 30 sec. Each subject had 7 oral sites scored for the percentage of ulcerated mucosa twice weekly until day + 35 or hospital discharge or death . Blood was cultured daily during neutropenia . Additionally , the number of days from onset of cytoreduction to hospital discharge or death was recorded for each subject . Alpha was set at .05 . There was no significant difference in the severity of oral ulceration between the chlorhexidine and placebo groups ( P = .18 ) . Chlorhexidine did not reduce the development of bacteremia ( P greater than .5 ) , nor did it significantly decrease the length of hospital stay ( P = .68 ) . ( ABSTRACT TRUNCATED AT 250 WORDS From April 1993 to September 1993 , 15 patients with lymphoid or solid neoplasms underwent 16 non-cryopreserved peripheral stem cell transplantation courses using the ICE ( ifosfamide , carboplatin , etoposide ) program . They were r and omized in a double-blind clinical trial to received oral misoprostol or placebo for mucositis prophylaxis . The active drug or placebo administration began jointly with chemotherapy at day -4 and was continued until day 16 . The mucositis incidence and severity was significantly higher in patients who received misoprostol . We found no differences regarding myelosuppression , infections or other chemotherapy complications . Our results do not support the use of oral misoprostol as administered in this study , for high-dose chemotherapy-induced mucositis prophylaxis Fifty-six untreated patients with acute leukemia ( 38 acute myelogenous leukemia , 16 acute lymphoblastic leukemia , and 2 blast crisis of chronic granulocytic leukemia ) were r and omized on admission to one of three groups -- one to receive oral antic and idal prophylaxis through the period of remission induction chemotherapy with nystatin , another to receive natamycin , and the third to receive no antic and idal prophylaxis . Neither of the first two groups show any advantage over the last and it is concluded that provided gut sterilization regimes are not employed , prophylactic oral antic and idal treatment is of no value in these patients and should be reserved until there is clinical evidence of infection Patients receiving cytotoxic antineoplastic therapy often have treatment-associated stomatitis . A 0.12 % chlorhexidine
Output:
| In conclusion , there is weak and unreliable evidence that ice chips prevent mucositis .
There is evidence that prophylactic use of antifungal agents , which are absorbed or partially absorbed from the gastrointestinal tract , reduce the clinical signs of oral c and idiasis |
MS210845 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: OBJECTIVE The authors studied weight gain mechanisms and energy balance in patients treated with olanzapine . METHOD The body mass index of male schizophrenic adolescent in patients treated with olanzapine ( N=10 ) and of 10 matched patients treated with haloperidol ( N=10 ) were measured at baseline and after 4 weeks of treatment . For the patients treated with olanzapine , caloric intake , resting energy expenditure , and physical activity ( determined through accelerometry and heart rate monitoring ) were assessed at baseline and after 4 weeks of treatment . RESULTS Body mass index significantly increased in those treated with olanzapine but not in those given haloperidol . The increase in body mass index was due to an increase in caloric intake without change in diet composition . Olanzapine had no significant effect on resting energy expenditure . Daily energy expenditure was very low before and after treatment . CONCLUSIONS Olanzapine-induced weight gain is associated with a general increase in caloric intake OBJECTIVE Clinical factors predicting weight change in patients with schizophrenia and related disorders during acute treatment with the antipsychotic drugs olanzapine , risperidone , and haloperidol were sought through retrospective analyses . METHOD Six-week body-weight data from 2 trials , study 1 comparing olanzapine and haloperidol ( N = 1,369 ) and study 2 olanzapine and risperidone ( N = 268 ) , were analyzed . Effects of 8 clinical ly relevant covariates -- therapy , clinical outcome ( Brief Psychiatric Rating Scale ) , baseline body mass index ( B BMI ) , increased appetite , age , gender , race , and dose -- on weight were compared . RESULTS In study 1 , olanzapine ( vs. haloperidol ) therapy , better clinical outcome , lower B BMI , and nonwhite race significantly affected weight gain . Effects of increased appetite and male gender on weight gain were significant for olanzapine but not for haloperidol . In study 2 , better clinical outcome , lower B BMI , and younger age significantly affected weight gain . Increased appetite was more frequent during olanzapine treatment than during haloperidol , but not significantly different from risperidone . Significant differences in effect on weight change were found between olanzapine and haloperidol but not between olanzapine and risperidone . No evidence was found that lower antipsychotic drug doses were associated with lower weight gain . CONCLUSION This report identifies predictive factors of acute weight change in patients with schizophrenia . Similar factors across antipsychotic drugs in predicting greater weight gain included better clinical outcome , low B BMI , and nonwhite race . Factors differing between conventional ( haloperidol ) and atypical ( olanzapine ) agents included increased appetite and gender . Choice of atypical antipsychotic drug ( olanzapine vs. risperidone ) was of minor importance with regard to influence on acute weight gain The bilateral communication between the immune and neuroendocrine systems plays an essential role in modulating the adequate response of the hypothalamic – pituitary – adrenal ( HPA ) axis to the stimulatory influence of cytokines and stress-related mediators . Growing evidence suggests that neuro-immune-endocrine crosstalk may be impaired in schizophrenia . We determined the relationship between cortisol , cytokines interleukin-2 ( IL-2 ) and interleukin-6 ( IL-6 ) , and symptoms in schizophrenia during treatment with typical and atypical antipsychotic drugs . Subjects included 30 healthy controls ( HC ) and 78 schizophrenic ( SCH ) in- patients . SCH were r and omly assigned to 12-week treatment with 6 mg/day of risperidone or 20 mg/day of haloperidol using a double-blind design . Clinical efficacy was determined using the Positive and Negative Syndrome Scale ( PANSS ) . Serum cortisol and IL-2 levels were assayed by radioimmunometric assay , and serum IL-6 levels by quantitative enzyme-linked immunosorbent assay . Following a 2-week washout period , serum levels of cortisol , IL-2 , and IL-6 were increased in patients with schizophrenia compared to HC . Elevations in cortisol were associated with increase in both IL-2 and IL-6 in SCH . Moreover , elevations in cortisol were associated with negative symptoms and IL-2 with positive symptoms . In all , 12 weeks of risperidone treatment significantly decreased elevated cortisol and improved negative symptoms , but produced similar effects on IL-2 and IL-6 as well as on positive symptoms compared to haloperidol . The improvement of negative symptoms was related to the change in cortisol . Our results suggest that the imbalance in the HPA axis and cytokine system in patients with SCH is implicated in clinical symptoms , and is improved with atypical antipsychotic treatment The aim of this study was to determine the location of antipsychotic-induced weight gain in drug naïve , first episode patients with schizophrenia . Various fatness and fat distribution parameters ( by Computerized Tomography scanning and anthropometry ) and 1600 hr plasma cortisol were measured in 19 ( 15 men and 4 women ) subjects with schizophrenia ( mean age = 31.0 years ; mean body mass index [ BMI ] = 24.6 kg/m2 ) and an equal number of age- and sex- matched controls ( mean age = 32.6 yr ; mean BMI = 23.0 kg/m2 ) . Patients were then given either olanzapine or risperidone . Sixteen patients were re-tested following a treatment period lasting approximately 6 months . Patients with schizophrenia , had significantly more intra-abdominal fat [ IAF ] ( 116.8 + /- 20.2 cm2 vs. 38.0 + /- 4.8 cm2 , respectively ; t = 3.80 , df = 18 , p < 0.0001 ) and had higher levels of plasma cortisol ( 360.2 + /- 49.6 nmol/L vs. 192.7 + /- 19.7 nmol/L , respectively ; t = 3.13 , df = 18 , p < 0.003 ) than appropriately matched control subjects . Treatment with atypical antipsychotics did not result in a significant increase in IAF ( 116.8 + /- 20.2 cm2 vs. 131.7 + /- 20.9 cm2 ; p = NS ) though visceral fat stores still remained significantly higher than those seen in controls ( 38.0 + /- 4.8 cm2 ) ( F = 9.34 ; df = 2 , 51 ; p < 0.0003 ) . However , plasma levels of cortisol did significantly decrease ( 360.2 + /- 49.6 nmol/L + /- vs. 316.2 + /- 48.4 nmol/L ; p < 0.05 ) . Pre-treatment levels of IAF did not differ between those who received risperidone and those who were given olanzapine ( 123.0 + /- 35.9 cm2 vs. 113.1 + /- 15.7 cm2 , respectively ; t = 0.20 , df = 16 , p < 0.84 ) . The increase in IAF did not differ between those given risperidone and those who received olanzapine ( 26.9 + /- 12.1 cm2 vs. 18.24 + /- 11.44 cm2 , respectively ; t = 0.50 , df = 16 , p < 0.63 ) . Patients with drug naïve , first episode , schizophrenia have higher levels of visceral fats stores as compared to matched control subjects . Treatment with atypical antipsychotics does not result in a significant increase in IAF distribution Obesity results from chronic deregulation of energy balance , which may in part be caused by stress . Our objective was to investigate the effect of acute and psychological stress on food intake , using the eating in the absence of hunger paradigm , in normal and overweight men and women ( while taking dietary restraint and disinhibition into account ) . In 129 subjects ( BMI = 24.5 + /- 3.4 kg/m(2 ) and age = 27.6 + /- 8.8 years ) , scores were determined on the Three Factor Eating Question naire ( dietary restraint = 7.2 + /- 4.4 ; disinhibition = 4.5 + /- 2.6 ; feeling of hunger = 3.9 + /- 2.6 ) and State-Trait Anxiety Inventory ( trait score = 31.7 + /- 24.2 ) . In a r and omized crossover design , the " eating in absence of hunger " protocol was measured as a function of acute stress vs. a control task and of state anxiety scores . Energy intake from sweet foods ( 708.1 kJ vs. 599.4 kJ , P < 0.03 ) and total energy intake ( 965.2 kJ vs. 793.8 kJ , P < 0.01 ) were significantly higher in the stress condition compared to the control condition . Differences in energy intake between the stress and control condition were a function of increase in state anxiety scores during the stress task ( Delta state anxiety scores ) ( R(2 ) = 0.05 , P < 0.01 ) . This positive relationship was stronger in subjects with high disinhibition scores ( R(2 ) = 0.12 , P < 0.05 ) . Differences in state anxiety scores were a function of trait anxiety scores ( R(2 ) = 0.07 , P < 0.05 ) . We conclude that acute psychological stress is associated with eating in the absence of hunger , especially in vulnerable individuals characterized by disinhibited eating behavior and sensitivity to chronic stress
Output:
| RESULTS Patients with schizophrenia have a poor diet , mainly characterized by a high intake of saturated fat and a low consumption of fibre and fruit .
Such diet is more likely to increase the risk to develop metabolic abnormalities .
Subjects with schizophrenia show a poor diet that partly accounts for their higher incidence of metabolic abnormalities . |
MS210846 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: OBJECTIVE Despite the frequent use of the Positive and Negative Syndrome Scale ( PANSS ) for rating the symptoms of schizophrenia , the clinical meaning of its total score and of the cut-offs that are used to define treatment response ( e.g. at least 20 % or 50 % reduction of the baseline score ) are as yet unclear . We therefore compared the PANSS with simultaneous ratings of Clinical Global Impressions ( CGI ) . METHOD PANSS and CGI ratings at baseline ( n = 4091 ) , and after one , two , four and six weeks of treatment taken from a pooled data base of seven pivotal , multi-center antipsychotic drug trials on olanzapine or amisulpride in patients with exacerbations of schizophrenia were compared using equipercentile linking . RESULTS Being considered " mildly ill " according to the CGI approximately corresponded to a PANSS total score of 58 , " moderately ill " to a PANSS of 75 , " markedly ill " to a PANSS of 95 and severely ill to a PANSS of 116 . To be " minimally improved " according to the CGI score was associated with a mean percentage PANSS reduction of 19 % , 23 % , 26 % and 28 % at weeks 1 , 2 , 4 and 6 , respectively . The corresponding figures for a CGI rating " much improved " were 40 % , 45 % , 51 % and 53 % . CONCLUSIONS The results provide a better framework for underst and ing the clinical meaning of the PANSS total score in drug trials of schizophrenia patients with acute exacerbations . Such studies may ideally use at least a 50 % reduction from baseline cut-off to define response rather than lower thresholds . In treatment resistant population s , however , even a small improvement can be important , so that a 25 % cut-off might be appropriate The authors estimated components of variance and intraclass correlation coefficients ( ICCs ) to aid in the design of complex surveys and community intervention studies by analyzing data from the Health Survey for Engl and 1994 . This cross-sectional survey of English adults included data on a range of lifestyle risk factors and health outcomes . For the survey , households were sample d in 720 postal code sectors nested within 177 district health authorities and 14 regional health authorities . Study subjects were adults aged 16 years or more . ICCs and components of variance were estimated from a nested r and om-effects analysis of variance . Results are presented at the district health authority , postal code sector , and household levels . Between-cluster variation was evident at each level of clustering . In these data , ICCs were inversely related to cluster size , but design effects could be substantial when the cluster size was large . Most ICCs were below 0.01 at the district health authority level , and they were mostly below 0.05 at the postal code sector level . At the household level , many ICCs were in the range of 0.0 - 0.3 . These data may provide useful information for the design of epidemiologic studies in which the units sample d or allocated range in size from households to large administrative areas Remitted schizophrenic out patients were treated in order to prevent relapse with three doses of haloperidol or propericiazine for 1 year in a double-blind controlled study employing a r and omized design . The drug 's ability to prevent relapse was evaluated by counting the number of symptom-free days for each patient before any sign of relapse or over-dose appeared . Patients were r and omly assinged to the following drugs orally administered once per day at night : placebo ; haloperidol 1 mg , 3 mg , and 6 mg ; propericiazine 10 mg , 30 mg , and 60 mg . Serum prolactin levels in each patient were estimated by radioimmunoassay . All patients treated with placebo relapsed within 1 year and the relapse rate with placebo was significantly higher than with any dose of the two neuroleptics . Haloperidol increased the number of symptom-free days in a dose-dependent manner . Propericiazine at 10 mg and 30 mg also increased the number of symptom-free days dose-dependently but at 60 mg , the number decreased . It appears that propericiazine shows an inverted U-shaped dose-response curve . Prolactin levels were elevated dose-dependently by both drugs but failed to show a significant correlation with the number of symptom-free days . The present results indicate that haloperidol is superior to propericiazine from the viewpoint of the wider “ therapeutic window ” in maintenance treatment and antidopaminergic properties of neuroleptics , wherein it is important to prevent relapse even in remitted schizophrenics Remitted schizophrenic out patients were prophylactically treated to prevent relapse with three different doses of timiperone or sulpiride for a year in a double-blind controlled study employing a r and omized design . Each drug 's ability to prevent relapse was by counting the number of subjects with different outcomes ( remission , relapse , adverse reactions ) during the trial and /or the number of symptom-free days for each patient before any sign of relapse or adverse reactions appeared . Patients were r and omly assigned to the following drugs , which were orally administered once every night : placebo ; timiperone 1 mg , 3 mg , 6 mg ; sulpiride 100 mg , 300 mg , 600 mg . Data from previous studies involving haloperidol and propericiazine were utilized as a retrospective placebo group to compare the characteristics of the four drugs for maintenance treatment of remitted schizophrenic out patients . Both timiperone and sulpiride increased the number of patients in remission and decreased the number of patients who relapsed , compared with the placebo group . With timiperone , there was an especially marked increase in the number of patients who showed signs of adverse reactions compared with sulpiride . Sulpiride was the only drug that increased the number of dose-dependent symptom-free days . However , both of these drugs significantly increased the number of symptom-free days compared with placebo . By comparing the dose-response curves of four drugs tested in the same fashion , haloperidol and sulpiride were superior to propericiazine and timiperone because they displayed a wider dose range for the maintenance treatment of remitted schizophrenic out patients Forty-seven chronic hospitalized schizophrenics were treated in turn with placebos , pericyazine , and thioridazine for 12-week periods in a double blind cross-over trial lasting one year in all . The Wing rating scale was used for assessment . Both drugs were more effective than placebo , but neither was better in general than the pre-trial treatment . Pericyazine seemed less effective against the individual symptom of coherent delusions , and thioridazine scored significantly better against the symptom group socially embarrassing behaviour Its pharmacological action in animals is similar to that of the major tranquillizers . It has a five times more potent cataleptic action than prochlorperazine , seventeen times more potent antiemetic activity and four times more potent antiserotonin activity than chlorpromazine . In clinical studies propericiazine has been found to be an effective antipsychotic medication ( 1,3,4,6,7 ) . Furthermore , it was noted that the drug had particular usefulness in the treatment of character disorders ( 6 ) and in patients manifesting aggressive behaviour ( 2,5 ) . In a previous study propericiazine was tested for its calming effect when given as PRN ( prorenata ) medication to agitated hospitalized psychiatric patients under treatment with various other psychiatric drugs . The drug had a calming effect in forty-four of the fifty cases ( 7 ) . To further substantiate these findings in this study the efficacy and side effects of propericiazine were compared with BACKGROUND A recent review suggested an association between using unpublished scales in clinical trials and finding significant results . AIMS To determine whether such an association existed in schizophrenia trials . METHOD Three hundred trials were r and omly selected from the Cochrane Schizophrenia Group 's Register . All comparisons between treatment groups and control groups using rating scales were identified . The publication status of each scale was determined and cl aims of a significant treatment effect were recorded . RESULTS Trials were more likely to report that a treatment was superior to control when an unpublished scale was used to make the comparison ( relative risk 1.37 ( 95 % CI 1.12 - 1.68 ) ) . This effect increased when a ' gold-st and ard ' definition of treatment superiority was applied ( RR 1.94 ( 95 % CI 1.35 - 2.79 ) ) . In non-pharmacological trials , one-third of ' gold-st and ard ' cl aims of treatment superiority would not have been made if published scales had been used . CONCLUSIONS Unpublished scales are a source of bias in schizophrenia trials
Output:
| On the basis of very low quality evidence we are unable to determine the effects of pericyazine in comparison with typical or atypical antipsychotics for the treatment of schizophrenia . |
MS210847 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Background : Exercise training may be especially helpful for patients with generalized anxiety disorder ( GAD ) . We conducted a r and omized controlled trial to quantify the effects of 6 weeks of resistance ( RET ) or aerobic exercise training ( AET ) on remission and worry symptoms among sedentary patients with GAD . Methods : Thirty sedentary women aged 18–37 years , diagnosed by clinicians blinded to treatment allocation with a primary DSM-IV diagnosis of GAD and not engaged in any treatment other than pharmacotherapy , were r and omly allocated to RET , AET , or a wait list ( WL ) . RET involved 2 weekly sessions of lower-body weightlifting . AET involved 2 weekly sessions of leg cycling matched with RET for body region , positive work , time actively engaged in exercise , and load progression . Remission was measured by the number needed to treat ( NNT ) . Worry symptoms were measured by the Penn State Worry Question naire . Results : There were no adverse events . Remission rates were 60 % , 40 % , and 30 % for RET , AET , and WL , respectively . The NNT was 3 ( 95 % CI 2 to 56 ) for RET and 10 ( 95 % CI –7 to 3 ) for AET . A significant condition-by-time interaction was found for worry symptoms . A follow-up contrast showed significant reductions in worry symptoms for combined exercise conditions versus the WL . Conclusions : Exercise training , including RET , is a feasible , low-risk treatment that can potentially reduce worry symptoms among GAD patients and may be an effective adjuvant , short-term treatment or augmentation for GAD . Preliminary findings warrant further investigation The prevalence of mental health disorders among college students is rising and the increasing rates of anxiety and depression have important societal implication s. Physical activity has been proposed as an adjuvant to traditional treatment approaches ( i.e. psychotherapy or pharmacotherapy ) , and the internet is a potentially useful means of delivering physical activity information to the college-aged population . This r and omized pilot trial examined the effects of an internet-based physical activity intervention on physical activity , self-efficacy , depression , and anxiety in college students ( n = 47 ) receiving mental health counseling . Physical activity , depression , anxiety , exercise self-efficacy , and barriers self-efficacy were assessed at baseline and post-intervention . There was a significant time effect for physical activity , with both groups increasing their physical activity levels across the 10-week intervention but with a larger increase in the intervention condition ( d = 0.68 ) than the control condition ( d = 0.05 ) . Exercise and barriers self-efficacy declined across the intervention , but more so in the control than intervention condition . Effects on depression and anxiety were nonsignificant . Finally , correlation analyses showed increases in physical activity were associated with increases in exercise self-efficacy ( r = 0.62 ) and barriers self-efficacy ( r = 0.63 ) and decreases in depression ( r = −0.44 ) in the intervention condition , but not in the control condition . These results suggest that an internet-delivered physical activity intervention may be a promising approach to promoting physical activity among college students undergoing mental health counseling Background : Previous studies have suggested that physical exercise can reduce symptoms for subjects suffering from panic disorder ( PD ) . The efficacy of this intervention has so far not been compared to an established psychotherapy , such as cognitive behaviour therapy ( CBT ) . Assessment of controlled long-term effects and the clinical significance of the treatment are also lacking . Aim : To compare physical exercise to CBT as treatment for PD , and assess controlled long-term and clinical ly significant effects . Method : PD- patients were r and omized to either three weekly sessions of physical exercise ( n = 17 ) , or one weekly session of CBT ( n = 19 ) . Both treatments ran for 12 weeks , were manualized and administered in groups . Patients were assessed twice before the start of treatment , at post-treatment and at 6 and 12 months thereafter . Primary outcome - measures consisted of the Mobility Inventory ( MI ) , the Agoraphobia Cognitions Question naire ( ACQ ) and the Body Sensations Question naire ( BSQ ) . Results : A two-way repeated measures MANOVA of these measures demonstrated a significant effect of time , F(16 , 544 ) = 7.28 , p < .01 , as well as a significant interaction effect , F(16 , 544 ) = 1.71 , p < .05 , in favour of CBT . This finding was supported by the assessment of clinical ly significant changes of avoidant behaviour and of treatment-seeking one year later . Conclusion : Group CBT is more effective than group physical exercise as treatment of panic disorder , both immediately following treatment and at follow-up assessment A moderate to vigorous intensity exercise program is emerging as a promising strategy for reducing anxiety sensitivity ( AS ) . Initial evidence suggests that the effects of exercise on mental health outcomes may vary as a function of gender , with men benefitting more than women . Building upon this evidence , the present study tested the hypothesis that the effect of exercise on AS would vary as a function of gender , such that the effect would be stronger for men than for women . We tested this hypothesis using the data from a published study ( Smits , Berry , Rosenfield , et al. , 2008 ) . In this study , participants ( N = 60 ) with elevated levels of AS were r and omly assigned to a two-week exercise intervention [ EX ] or a waitlist control condition [ WL ] . Results revealed that males showed significantly greater initial AS reductions relative to females ( following 1 week of exercise ) . However , these gender differences were no longer evident at the end of the intervention . Possible mechanisms for the observed findings and directions for future research are discussed Background It is generally believed that exhaustive search es of bibliographic data bases are needed for systematic review s of health care interventions . The CENTRAL data base of controlled trials ( RCTs ) has been built up by exhaustive search ing . The CONSORT statement aims to encourage better reporting , and hence indexing , of RCTs . Our aim was to assess whether developments in the CENTRAL data base , and the CONSORT statement , mean that a simplified RCT search strategy for identifying RCTs now suffices for systematic review s of health care interventions . Methods RCTs used in the Cochrane review s were identified . A brief RCT search strategy ( BRSS ) , consisting of a search of CENTRAL , and then for variants of the word r and om across all fields ( r and om$.af . ) in MEDLINE and EMBASE , was devised and run . Any trials included in the meta-analyses , but missed by the BRSS , were identified . The meta-analyses were then re-run , with and without the missed RCTs , and the differences quantified . The proportion of trials with variants of the word r and om in the title or abstract was calculated for each year . The number of RCTs retrieved by search ing with " r and om$.af . " was compared to the highly sensitive search strategy ( HSSS ) . Results The BRSS had a sensitivity of 94 % . It found all journal RCTs in 47 of the 57 review s. The missing RCTs made some significant differences to a small proportion of the total outcomes in only five review s , but no important differences in conclusions result ed . In the post-CONSORT years , 1997–2003 , the percentage of RCTs with r and om in the title or abstract was 85 % , a mean increase of 17 % compared to the seven years pre-CONSORT ( 95 % CI , 8.3 % to 25.9 % ) . The search using r and om$.af . reduced the MEDLINE retrieval by 84 % , compared to the HSSS , thereby reducing the workload of checking retrievals . Conclusion A brief RCT search strategy is now sufficient to locate RCTs for systematic review s in most cases . Exhaustive search ing is no longer cost-effective , because in effect it has already been done for CENTRAL Abstract Anxiety sensitivity , or the belief that anxiety-related sensations can have negative consequences , has been shown to play an important role in the etiology and maintenance of panic disorder and other anxiety-related pathology . Aerobic exercise involves exposure to physiological cues similar to those experienced during anxiety reactions . The present study sought to investigate the efficacy of a brief aerobic exercise intervention for high anxiety sensitivity . Accordingly , 24 participants with high anxiety sensitivity scores ( Anxiety Sensitivity Index-Revised scores > 28 ) were r and omly assigned to complete either six 20-minute sessions of aerobic exercise or a no-exercise control condition . The results indicated that individuals assigned to the aerobic exercise condition reported significantly less anxiety sensitivity subsequent to exercise , whereas anxiety sensitivity scores among non-exercisers did not significantly change . The clinical research and public health implication s of these findings are discussed , and several potential directions for additional research are recommended Anxiety disorders are the most common mental illness , but are not uniform , many clinical diagnoses include the symptoms of anxiety . That is the reason why there are relatively small numbers of population surveys and r and omized-controlled trials which have examined the relationship between exercise and the various anxiety symptoms/ disorders . In our review we summarize meta-analytic studies , epidemiological surveys and r and omized controlled studies which examine the role of regular physical activity in the prevention and treatment of sub clinical anxiety/anxiety symptoms and anxiety disorders . The meta-analytic studies and r and omized-controlled trials examining the relationship between sub clinical anxiety disorders and anxiety symptoms demonstrated small to moderate effect of exercise in the decrease of anxiety symptoms , especially for moderate-intensity exercise . This relationship was confirmed for both acute and chronic exercise , for state and trait anxiety in different sex , age and state of health groups . In the case of the anxiety disorders based on review ed studies , we can conclude that there is a potential association between decreased symptoms of anxiety and exercise . The regular , moderate-intensity exercise can reduce and alleviate the symptoms of anxiety - at least in panic , agoraphobia and generalized anxiety disorders . The review ed studies have been highlighted the fact , that exercise can be effective in psychiatric practice as an alternative or adjuvant therapy . Physically healthy people with anxiety symptoms , or patients with anxiety disorders can perform exercise , there are no contraindications . Although based on previous studies , we can not assume that the relationship is causal , but we can not ignore the evidence s that are already available OBJECTIVE Effective treatments for social anxiety disorder ( SAD ) exist , but additional treatment options are needed for nonresponders as well as those who are either unable or unwilling to engage in traditional treatments . Mindfulness-based stress reduction ( MBSR ) is one nontraditional treatment that has demonstrated efficacy in treating other mood and anxiety disorders , and preliminary data suggest its efficacy in SAD as well . METHOD Fifty-six adults ( 52 % female ; 41 % Caucasian ; age mean [ M ] ± st and ard deviation [ SD ] : 32.8 ± 8.4 ) with SAD were r and omized to MBSR or an active comparison condition , aerobic exercise ( AE ) . At baseline and post-intervention , participants completed measures of clinical symptoms ( Liebowitz Social Anxiety Scale , Social Interaction Anxiety Scale , Beck Depression Inventory-II , and Perceived Stress Scale ) and subjective well-being ( Rosenberg Self-Esteem Scale , Satisfaction with Life Scale , Self-Compassion Scale , and UCLA-8 Loneliness Scale ) . At 3 months post-intervention , a subset of these measures was readministered . For clinical significance analyses , 48 healthy adults ( 52.1 % female ; 56.3 % Caucasian ; age [ M ± SD ] : 33.9 ± 9.8 ) were recruited . MBSR and AE participants were also compared with a separate untreated group of 29 adults ( 44.8 % female ; 48.3 % Caucasian ; age [ M ± SD ] : 32.3 ± 9.4 ) with generalized SAD who completed assessment s over a comparable time period with no intervening treatment . RESULTS A 2 ( Group ) x 2 ( Time ) repeated measures analyses of variance ( ANOVAs ) on measures of clinical symptoms and well-being were conducted to examine pre-intervention to post-intervention and pre-intervention to 3-month follow-up . Both MBSR and AE were associated with reductions in social anxiety and depression and increases in subjective well-being , both immediately post-intervention and at 3 months post-intervention . When participants in the r and omized controlled trial were compared with the untreated SAD group , participants in both interventions exhibited improvements on measures of clinical symptoms and well-being . CONCLUSION Nontraditional interventions such as MBSR and AE merit further exploration as alternative or complementary treatments for SAD A group r and omized trial of adding a home-based walking program to a st and ard group cognitive behavioral therapy ( GCBT+EX ) was compared with groups receiving GCBT and educational sessions ( GCBT+ED ) . The study was implemented in an outpatient clinic providing GCBT for clients diagnosed with panic disorder , generalized anxiety disorder or social phobia . Pre- and post-treatment measures included the self-report depression , anxiety , and stress scale ( DASS-21 ) and measures of physical activity . From January 2004 to May 2005 , six groups were allocated to GCBT+EX ( n=38 ) and five to GCBT+ED ( n=36 ) . Analysis of covariance for completed cases ( GCBT+EX , n=21 ; GCBT+ED , n=20 ) , adjusting for the group design , baseline DASS-21 scores , and anxiety diagnosis showed significant effect for GCBT+EX on depression , anxiety , and stress ( regression coefficients=-6.21 , -3.41 , and -5.14 , respectively , p
Output:
| There was no significant difference in outcomes between groups of patients with diagnosed anxiety disorders and patients who had raised anxiety on a rating scale .
Conclusions were limited by the small number of studies and wide variation in the delivery of exercise interventions .
Conclusion Exercise programmes are a viable treatment option for the treatment of anxiety .
High intensity exercise regimens were found to be more effective than low intensity regimens . |
MS210848 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: Abstract Objective : To evaluate the efficacy of pioglitazone for the prevention of macrovascular outcomes in Japanese patients with type 2 diabetes , without a recent history of macrovascular morbidity . Research design and methods : This 2.5–4 year , prospect i ve , r and omized , open-label , blinded-endpoint study was conducted in 20 Japanese centers . Patients received pioglitazone ± other oral glucose-lowering drugs ( excluding another thiazolidinedione ) [ n = 293 ] or oral glucose-lowering drugs excluding thiazolidinediones ( n = 294 ) . Treatment was adjusted to achieve HbA1c < 6.5 % . The primary endpoint was the time to onset of a macrovascular event . Results : Pioglitazone delayed the time to onset of macrovascular events and was associated with a lower cumulative incidence of such events ( 3.56 % vs. 4.49 % for controls ) . Neither finding achieved statistical significance . This was likely because of the type of patient included in the study ( i.e. no recent history of cardiovascular events ) and the high use of concomitant anti-diabetic agents . Reductions in HbA1c , fasting blood glucose and fasting blood insulin levels , and an increase in HDL-C were significantly greater with pioglitazone throughout most of the study ( p < 0.05 ) . Fewer patients in the pioglitazone group commenced permanent treatment with insulin ( 3.3 % vs. 13.7 % in the control group ) . Adverse events were reported by 97.6 % of the pioglitazone group and 96.9 % of the control group ( serious adverse events , including deaths , were 20.1 vs. 22.2 % , respectively ) . The only notable difference between the two groups was a higher incidence of edema in the pioglitazone group . The main limitation of this study was that too few patients were included to identify statistically significant differences in the primary endpoint . Conclusions : Pioglitazone produced good glycemic control in Japanese patients with type 2 diabetes , and significantly fewer patients treated with pioglitazone needed long-term insulin therapy . These changes were associated with a trend towards delayed onset of macrovascular events . Clinical trial registration : UMIN000001363 CARdiovascular Outcome Trial of LINAgliptin Versus Glimepiride in Type 2 Diabetes ( NCT01243424 ) is an ongoing , r and omized trial in subjects with early type 2 diabetes and increased cardiovascular risk or established complications that will determine the long-term cardiovascular impact of linagliptin versus the sulphonylurea glimepiride . Eligible patients were sulphonylurea-naïve with HbA1c 6.5%–8.5 % or previously exposed to sulphonylurea ( in monotherapy or in a combination regimen < 5 years ) with HbA1c 6.5%–7.5 % . Primary outcome is time to first occurrence of cardiovascular death , non-fatal myocardial infa rct ion , non-fatal stroke or hospitalization for unstable angina . A total of 631 patients with primary outcome events will be required to provide 91 % power to demonstrate non-inferiority in cardiovascular safety by comparing the upper limit of the two-sided 95 % confidence interval as being below 1.3 for a given hazard ratio . Hierarchical testing for superiority will follow , and the trial has 80 % power to demonstrate a 20 % relative cardiovascular risk reduction . A total of 6041 patients were treated with median type 2 diabetes duration 6.2 years , 40.0 % female , mean HbA1c 7.2 % , 66 % on 1 and 24 % on 2 glucose-lowering agents and 34.5 % had previous cardiovascular complications . The results of CARdiovascular Outcome Trial of LINAgliptin Versus Glimepiride in Type 2 Diabetes may influence the decision-making process for selecting a second glucose-lowering agent after metformin in type 2 diabetes BACKGROUND The cardiovascular effects of adding once‐weekly treatment with exenatide to usual care in patients with type 2 diabetes are unknown . METHODS We r and omly assigned patients with type 2 diabetes , with or without previous cardiovascular disease , to receive subcutaneous injections of extended‐release exenatide at a dose of 2 mg or matching placebo once weekly . The primary composite outcome was the first occurrence of death from cardiovascular causes , nonfatal myocardial infa rct ion , or nonfatal stroke . The co primary hypotheses were that exenatide , administered once weekly , would be noninferior to placebo with respect to safety and superior to placebo with respect to efficacy . RESULTS In all , 14,752 patients ( of whom 10,782 [ 73.1 % ] had previous cardiovascular disease ) were followed for a median of 3.2 years ( interquartile range , 2.2 to 4.4 ) . A primary composite outcome event occurred in 839 of 7356 patients ( 11.4 % ; 3.7 events per 100 person‐years ) in the exenatide group and in 905 of 7396 patients ( 12.2 % ; 4.0 events per 100 person‐years ) in the placebo group ( hazard ratio , 0.91 ; 95 % confidence interval [ CI ] , 0.83 to 1.00 ) , with the intention‐to‐treat analysis indicating that exenatide , administered once weekly , was noninferior to placebo with respect to safety ( P<0.001 for noninferiority ) but was not superior to placebo with respect to efficacy ( P=0.06 for superiority ) . The rates of death from cardiovascular causes , fatal or nonfatal myocardial infa rct ion , fatal or nonfatal stroke , hospitalization for heart failure , and hospitalization for acute coronary syndrome , and the incidence of acute pancreatitis , pancreatic cancer , medullary thyroid carcinoma , and serious adverse events did not differ significantly between the two groups . CONCLUSIONS Among patients with type 2 diabetes with or without previous cardiovascular disease , the incidence of major adverse cardiovascular events did not differ significantly between patients who received exenatide and those who received placebo . ( Funded by Amylin Pharmaceuticals ; EXSCEL Clinical Trials.gov number , NCT01144338 . Inhibitors of the sodium-glucose co-transporter-2 ( SGLT-2 ) are a novel class of glucose-lowering agents that show promising results . However , the use of canagliflozin has been associated with an increased risk of lower-limb amputation . Whether this risk concerns other SGLT-2 inhibitors is unclear , and our objective was to address this issue . We performed a disproportionality analysis using the WHO global data base of individual case safety reports ( VigiBase ) . Among the 8 293 886 reports available between January 2013 and December 2017 , we identified 79 reports of lower-limb amputation that were associated with SGLT-2 inhibitors . Among all blood glucose lowering drugs , the proportional reporting ratio ( PRR ) was increased only for SGLT-2 inhibitors ( 5.55 [ 4.23 , 7.29 ] ) . While we observed an expected signal for canagliflozin ( 7.09 [ 5.25 , 9.57 ] ) , the PRR was also high for empagliflozin ( 4.96 [ 2.89 , 8.50 ] ) and , for toe amputations only , for dapagliflozin ( 2.62 [ 1.33 , 5.14 ] ) . In conclusion , our results reveal a positive disproportionality signal for canagliflozin , and also for empagliflozin , and , for toe amputations only , for dapagliflozin . However , our analysis relies on a limited number of cases and is exposed to the biases inherent to pharmacovigilance studies . Further prospect i ve data are therefore needed to better characterize the risk of amputations with different SGLT-2 inhibitors ABSTRACT Review of : Neal B , Perkovic V , Mahaffey K , et al. Canagliflozin and cardiovascular and renal events in type 2 diabetes . N Engl J Med . 2017;377:644–657 . The report combines the data from two trials , CANVAS and CANVAS-Renal , which were design ed to evaluate the safety and effect of canagliflozin , an SGLT-2 inhibitor , on the appearance of cardiovascular and renal events in patients with type 2 diabetes . Enrollees were patients with type 2 diabetes of at least 30 years of age , with a glycated hemoglobin of > or equal to 7.0 % and < or equal to 10.5 % . Patients either had to have preexisting cardiovascular disease or to be at elevated risk for cardiovascular disease , and to have an estimated glomerular filtration rate ( eGFR ) of > 30 ml/min . Patients were r and omized to canagliflozin at doses of either 100 mg or 300 mg or matching placebo in CANVAS , and to canagliflozin 100 mg with a possible increase to 300 mg , or placebo , in CANVAS-Renal . Physicians were instructed to continue appropriate diabetic management and other therapies in accordance with the best practice s in their community . There was a significant 14 % reduction in the combined endpoint of cardiovascular events of death from cardiovascular causes , nonfatal myocardial infa rct ion , or nonfatal stroke in the canagliflozin treated patients . There was also a pattern of improvement in markers of renal disease , including the change in the level and nature of albuminuria , a 40 % decrease in the glomerular filtration rate , the need for renal replacement therapy , or death from renal causes . This study exp and s the scope of SGLT-2 inhibitor therapy to prevent cardiovascular disease in diabetic patients beyond those with preexisting cardiovascular disease studied in the previous empagliflozin study , raising the question as to whether SGLT-2 inhibitor therapy should be considered appropriate for most , if not all , type 2 diabetes patients , not only to control hyperglycemia but also to reduce cardiovascular and renal events BACKGROUND The provision of sufficient basal insulin to normalize fasting plasma glucose levels may reduce cardiovascular events , but such a possibility has not been formally tested . METHODS We r and omly assigned 12,537 people ( mean age , 63.5 years ) with cardiovascular risk factors plus impaired fasting glucose , impaired glucose tolerance , or type 2 diabetes to receive insulin glargine ( with a target fasting blood glucose level of ≤95 mg per deciliter [ 5.3 mmol per liter ] ) or st and ard care and to receive n-3 fatty acids or placebo with the use of a 2-by-2 factorial design . The results of the comparison between insulin glargine and st and ard care are reported here . The co primary outcomes were nonfatal myocardial infa rct ion , nonfatal stroke , or death from cardiovascular causes and these events plus revascularization or hospitalization for heart failure . Microvascular outcomes , incident diabetes , hypoglycemia , weight , and cancers were also compared between groups . RESULTS The median follow-up was 6.2 years ( interquartile range , 5.8 to 6.7 ) . Rates of incident cardiovascular outcomes were similar in the insulin-glargine and st and ard-care groups : 2.94 and 2.85 per 100 person-years , respectively , for the first co primary outcome ( hazard ratio , 1.02 ; 95 % confidence interval [ CI ] , 0.94 to 1.11 ; P=0.63 ) and 5.52 and 5.28 per 100 person-years , respectively , for the second co primary outcome ( hazard ratio , 1.04 ; 95 % CI , 0.97 to 1.11 ; P=0.27 ) . New diabetes was diagnosed approximately 3 months after therapy was stopped among 30 % versus 35 % of 1456 participants without baseline diabetes ( odds ratio , 0.80 ; 95 % CI , 0.64 to 1.00 ; P=0.05 ) . Rates of severe hypoglycemia were 1.00 versus 0.31 per 100 person-years . Median weight increased by 1.6 kg in the insulin-glargine group and fell by 0.5 kg in the st and ard-care group . There was no significant difference in cancers ( hazard ratio , 1.00 ; 95 % CI , 0.88 to 1.13 ; P=0.97 ) . CONCLUSIONS When used to target normal fasting plasma glucose levels for more than 6 years , insulin glargine had a neutral effect on cardiovascular outcomes and cancers . Although it reduced new-onset diabetes , insulin glargine also increased hypoglycemia and modestly increased weight . ( Funded by Sanofi ; ORIGIN Clinical Trials.gov number
Output:
| Insulin and sulfonylureas were associated with an increased risk of severe hypoglycemia .
CONCLUSIONS SGLT-2 inhibitors and GLP-1 agonists have the most beneficial effects , especially in T2D patients with previous CV diseases . |
MS210849 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: Background Recently , a number of studies using intra-articular application of tranexamic acid ( IA-TXA ) , with different dosage and techniques , successfully reduced postoperative blood loss in total knee replacement ( TKR ) . However , best of our knowledge , the very low dose of IA-TXA with drain clamping technique in conventional TKR has not been yet studied . This study aim ed to evaluate the effectiveness and dose-response effect of two low-dose IA-TXA regimens in conventional TKR on blood loss and blood transfusion reduction . Methods Between 2010 and 2011 , a triple-blinded r and omized controlled study was conducted in 135 patients undergoing conventional TKR . The patients were allocated into three groups according to intra-articular solution received : Control group ( physiologic saline ) , TXA-250 group ( TXA 250 mg ) , and TXA-500 group ( TXA 500 mg ) . The solution was injected after wound closure followed by drain clamping for 2 hours . Blood loss and transfusion were recorded . Duplex ultrasound was performed . Functional outcome and complication were followed for one year . Results There were forty-five patients per groups . The mean total hemoglobin loss was 2.9 g/dL in control group compared with 2.2 g/dL in both TXA groups ( p > 0.001 ) . Ten patients ( 22 % , control ) , six patients ( 13 % , TXA-250 ) and none ( TXA-500 ) required transfusion ( p = 0.005 ) . Thromboembolic events were detected in 7 patients ( 4 controls , 1 TXA-250 , and 2 TXA-500 ) . Functional outcome was non-significant difference between groups . Conclusions Combined low-dose IA-TXA , as 500 mg , with 2-hour clamp drain is effective for reducing postoperative blood loss and transfusion in conventional TKR without significant difference in postoperative knee function or complication . Trial registration Clinical Trials.gov NCT01850394 Background Total knee arthroplasty ( TKA ) is often associated with a severe local inflammatory reaction which , unless controlled , leads to persistent pain up to one year after surgery . St and ard and accelerated rehabilitation protocol s are currently being implemented after TKA , but no consensus exists regarding the long-term effects . Biophysical stimulation with pulsed electromagnetic fields ( PEMFs ) has been demonstrated to exert an anti-inflammatory effect , to promote early functional recovery and to maintain a positive long-term effect in patients undergoing joint arthroscopy . The aim of this study was to evaluate whether PEMFs can be used to limit the pain and enhance patient recovery after TKA . Methods A prospect i ve , r and omized , controlled study in 30 patients undergoing TKA was conducted . Patients were r and omized into experimental PEMFs or a control group . Patients in the experimental group were instructed to use I-ONE stimulator 4hours/day for 60days . Postoperatively , all patients received the same rehabilitation program . Treatment outcome was assessed using the Knee Society Score , SF-36 Health-Survey and VAS . Patients were evaluated pre-operatively and one , two , six and 12 months after TKA . Joint swelling and Non Steroidal Anti Inflammatory Drug ( NSAID ) consumption were recorded . Comparisons between the two groups were carried out using a two-tail heteroschedastic Student ’s t-test . Analysis of variance for each individual subject during the study was performed using ANOVA for multiple comparisons , applied on each group , and a Dunnet post hoc test . A p value < 0.05 was considered statistically significant . Results Pre-operatively , no differences were observed between groups in terms of age , sex , weight , height , Knee-Score , VAS , SF-36 and joint swelling , with the exception of the Functional Score . The Knee-Score , SF-36 and VAS demonstrated significantly positive outcomes in the I-ONE stimulated group compared with the controls at follow-ups . In the I-ONE group , NSAID use was reduced and joint swelling resolution was more rapid than in controls . The effect of I-ONE therapy was maintained after use of the device was discontinued . Conclusions The results of the study show early functional recovery in the I-ONE group . I-ONE therapy should be considered after TKA to prevent the inflammatory reaction elicited by surgery , for pain relief and to speed functional recovery . Trial registration Current Controlled Trials IS RCT OBJECTIVE Continuous femoral nerve block ( CFNB ) , guided by ultrasound combined nerve stimulations , offers advantages for both sides and provides effective postoperative analgesia after total knee arthroplasty ( TKA ) . The objective of this study was to evaluate the medium-term impact of continuous femoral nerve block on knee function and quality of life in patients following TKA . METHODS This was a follow-up study . Total 168 adult patients scheduled for elective TKA were r and omly allocated to receive postoperative continuous femoral nerve block guided by ultrasound combined nerve stimulator ( group CFNB , n = 82 ) or patient-controlled epidural analgesia ( group PCEA , n = 86 ) . Quality of life , knee function , patient satisfaction , pain medication and associated adverse effects were compared at 1 , 3 , 6 , and 12 months postoperatively . Quality of life was assessed using the Medical Outcomes Study Short Form-36 Health Survey ( MOS SF-36 ) , and clinical results were assessed using the Hospital for Special Surgery ( HSS ) Knee Scoring System . Patient satisfaction scores were divided into four categories . RESULTS A total of 162 patients completed the 12-month follow-up . The CFNB group patients had significantly improved SF-36 scores and physical function at 1 month postoperatively ( P < 0.05 ) ; the remaining seven dimensions were similar between the two groups . No differences were observed at 3 , 6 or 12 months . HSS scores for the four observational time points were comparable . The CFNB group patients reported less pain ; improved knee function , maximum flexion and strength ; less celecoxib consumption and fewer side effects at 1 month than the PCEA group patients . The satisfaction score at 12 months decreased significantly , compared with that at 1 month in both groups ( 3.6 to 2.95 and 3.4 to 2.45 , respectively ) . No difference in satisfaction score was observed between the two groups . CONCLUSIONS Continuous femoral nerve block not only could provide effective postoperative analgesia but also could improve joint function and quality of life in patients at one month postoperatively . Continuous femoral nerve block is a good choice for postoperative analgesia after TKA Purpose Despite the documented blood-saving effects of tranexamic acid ( TNA ) in total knee arthroplasty ( TKA ) , the question whether clinical values of TNA are identical in unilateral and bilateral TKAs remains unclear . This study was undertaken to determine the clinical values of TNA in unilateral and simultaneous bilateral TKAs under a contemporary blood-saving protocol in terms of efficacy ( total blood loss and transfusion rate ) and safety ( the incidences of symptomatic deep vein thrombosis and pulmonary embolism ) . Methods One hundred and eighty unilateral and 146 bilateral TKA patients were r and omized into TNA group or control group . In unilateral TKA patients , TNA ( 10 mg/kg ) was administered intravenously 20 min before tourniquet deflation and repeated 3 h after surgery . In bilateral TKA patients , one more dose ( 10 mg/kg ) was given before tourniquet deflation in the second TKA . A contemporary blood-saving protocol was applied to all patients . The TNA and control groups were compared separately in unilateral and bilateral TKA patients for the efficacy and safety variables . Results In unilateral TKA patients , the TNA group had less total blood loss ( 905 vs. 1,018 mL , p = 0.018 ) than the control group , but there was no difference in the allogenic transfusion rate ( 1 vs. 7 % , n.s . ) . In bilateral TKA patients , the TNA group showed no differences in total blood loss ( 1,282 vs. 1,379 mL , n.s . ) , but a significant reduction in the allogenic transfusion rate ( 7 vs. 27 % , p = 0.002 ) . No symptomatic deep vein thrombosis or pulmonary embolism was found in all patients . Conclusion This study demonstrates that the use of TNA reduces total blood loss , but the effects on the transfusion rate can differ depending on the type of TKAs ( unilateral vs. bilateral ) and the blood-saving protocol s . Level of evidence Therapeutic study , Level I ( double blind r and omized controlled trial ) Introduction The surgical wound of total knee arthroplasty ( TKA ) needs continuous flexion and extension movement . Silicone gel treatment is widely used to treat hypertrophic scars and keloids since it is easily applied and prevents scar pain and itching . The aim of this study was to evaluate the clinical efficacy and safety of silicone gel applied to surgical scars of TKA on postoperative scar pain and pruritus . Material s and methods One hundred TKAs were r and omized into a silicone gel group ( silicone gel was applied to the wound after stitch-out for 1 month ) or a placebo group . The postoperative scar pain and pruritus were evaluated with the use of a visual analog scale ( VAS ) at postoperative 3 months , 6 months and 1 year . Scar assessment was done using the Vancouver scar scale by evaluating scar pigmentation , vascularity , pliability , and height . Results Although silicone gel group showed better pigmentation and height scales than placebo group ( P < 0.05 ) , there were no significant differences in the postoperative scar pain and pruritus VAS scores between the groups ( P > 0.05 ) . Conclusions Application of silicone gel had no beneficial effects on scar pain and itching relief during the early postoperative period of TKA.Level of evidence I-R and omized Controlled Background Postoperative knee swelling is common and impairs early postoperative function following total knee arthroplasty . It was hypothesised that the use of a short-stretch , inelastic compression b and age would reduce knee swelling and improve pain and early function . The aim of this study was to provide preliminary data and test feasibility with a view to informing a larger , future trial . Methods Fifty consecutive patients selected for primary total knee arthroplasty underwent distance r and omisation to receive a short-stretch , inelastic compression b and age or a st and ard wool and crepe b and age for the first 24 h postoperatively . Study feasibility including recruitment rates , retention rates and complications were analysed . The Oxford Knee Score , the EQ-5D-3L index score , knee swelling , knee range of motion , visual analogue pain score and length of stay were compared between groups . Analysis of covariance ( ANCOVA ) was performed adjusting for the preoperative measurement . Results Sixty-eight percent of eligible patients were recruited into the trial . The retention rate was 88 % . There were no complications regarding compression b and age use . There was a greater mean but non-significant improvement in Oxford Knee Score ( p = 0.580 ; point estimate = 2.1 ; 95 % CI −3.288 to 7.449 ) and EQ-5D-3L index score ( p = 0.057 ; point estimate = 0.147 ; 95 % CI −0.328 to 0.005 ) in the compression b and age group at 6 months . There was no significant difference between groups regarding knee swelling , knee range of motion , visual analogue pain score , complications and length of stay . Conclusion Preliminary data suggests that the use of an inelastic , short-stretch compression b and age following total knee arthroplasty is a safe technique that is acceptable to patients . A larger , multicentre trial is required to determine its effect postoperatively . Trial registration The study was registered with Current Controlled Trials , identifier : IS RCT N86903140 . Registered on 30 May 2013 OBJECTIVES . To evaluate the effectiveness of our new multidisciplinary pathway for total knee replacement patients and compare outcomes after continuous femoral nerve blockade versus conventional patient-controlled analgesia for postoperative pain . DESIGN . R and omised controlled trial in a routine clinical setting . SETTING . Acute orthopaedic wards and operating theatres , Yan Chai Hospital , Hong Kong . PATIENTS . Sixty patients underwent elective unilateral total knee replacement under spinal anaesthesia from May 2009 to September 2011 and were r and omly assigned to continuous femoral nerve blockade or conventional patient-controlled analgesia ( 30 patients in each group ) . MAIN OUTCOME MEASURES . Quality of pain control was evaluated by pain scores at rest and during mobilisation , opioid consumption , frequency of side-effects , and patient satisfaction score . Rehabilitation progress was assessed according to the day of first starting weight-bearing exercise , day of independent walking in the ward with aid , Timed Up and Go test , and time elapsing till discharge . Surgical outcome was assessed by the Knee Society score 6 months after discharge , re-admissions , and occurrence of complications . RESULTS . Patients having continuous femoral nerve blockade tended to have less pain on movement and achieved earlier mobilisation than those having patient-controlled analgesia . The former group consumed less opioids , had fewer
Output:
| No concerns relating to long-term adverse events were reported .
For a range of treatments there was no evidence linking them with unfavourable pain outcomes .
Conclusions To prevent chronic pain after TKR , several perioperative interventions show benefits and merit further research .
Good- quality studies assessing long-term pain after perioperative interventions are feasible and necessary to ensure that patients with osteoarthritis achieve good long-term outcomes after TKR |
MS210850 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
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Input: PURPOSE To evaluate the efficacy and tolerability of two doses of gefitinib ( Iressa [ ZD1839 ] ; AstraZeneca , Wilmington , DE ) , a novel epidermal growth factor receptor tyrosine kinase inhibitor , in patients with pretreated advanced non-small-cell lung cancer ( NSCLC ) . PATIENTS AND METHODS This was a r and omized , double-blind , parallel-group , multicenter phase II trial . Two hundred ten patients with advanced NSCLC who were previously treated with one or two chemotherapy regimens ( at least one containing platinum ) were r and omly assigned to receive either 250-mg or 500-mg oral doses of gefitinib once daily . RESULTS Efficacy was similar for the 250- and 500-mg/d groups . Objective tumor response rates were 18.4 % ( 95 % confidence interval [ CI ] , 11.5 to 27.3 ) and 19.0 % ( 95 % CI , 12.1 to 27.9 ) ; among evaluable patients , symptom improvement rates were 40.3 % ( 95 % CI , 28.5 to 53.0 ) and 37.0 % ( 95 % CI , 26.0 to 49.1 ) ; median progression-free survival times were 2.7 and 2.8 months ; and median overall survival times were 7.6 and 8.0 months , respectively . Symptom improvements were recorded for 69.2 % ( 250 mg/d ) and 85.7 % ( 500 mg/d ) of patients with a tumor response . Adverse events ( AEs ) at both dose levels were generally mild ( grade 1 or 2 ) and consisted mainly of skin reactions and diarrhea . Drug-related toxicities were more frequent in the higher-dose group . Withdrawal due to drug-related AEs was 1.9 % and 9.4 % for patients receiving gefitinib 250 and 500 mg/d , respectively . CONCLUSION Gefitinib showed clinical ly meaningful antitumor activity and provided symptom relief as second- and third-line treatment in these patients . At 250 mg/d , gefitinib had a favorable AE profile . Gefitinib 250 mg/d is an important , novel treatment option for patients with pretreated advanced NSCLC [ corrected CONTEXT More persons in the United States die from non-small cell lung cancer ( NSCLC ) than from breast , colorectal , and prostate cancer combined . In pre clinical testing , oral gefitinib inhibited the growth of NSCLC tumors that express the epidermal growth factor receptor ( EGFR ) , a mediator of cell signaling , and phase 1 trials have demonstrated that a fraction of patients with NSCLC progressing after chemotherapy experience both a decrease in lung cancer symptoms and radiographic tumor shrinkages with gefitinib . OBJECTIVE To assess differences in symptomatic and radiographic response among patients with NSCLC receiving 250-mg and 500-mg daily doses of gefitinib . DESIGN , SETTING , AND PATIENTS Double-blind , r and omized phase 2 trial conducted from November 2000 to April 2001 in 30 US academic and community oncology centers . Patients ( N = 221 ) had either stage IIIB or IV NSCLC for which they had received at least 2 chemotherapy regimens . INTERVENTION Daily oral gefitinib , either 500 mg ( administered as two 250-mg gefitinib tablets ) or 250 mg ( administered as one 250-mg gefitinib tablet and 1 matching placebo ) . MAIN OUTCOME MEASURES Improvement of NSCLC symptoms ( 2-point or greater increase in score on the summed lung cancer subscale of the Functional Assessment of Cancer Therapy-Lung [ FACT-L ] instrument ) and tumor regression ( > 50 % decrease in lesion size on imaging studies ) . RESULTS Of 221 patients enrolled , 216 received gefitinib as r and omized . Symptoms of NSCLC improved in 43 % ( 95 % confidence interval [ CI ] , 33%-53 % ) of patients receiving 250 mg of gefitinib and in 35 % ( 95 % CI , 26%-45 % ) of patients receiving 500 mg . These benefits were observed within 3 weeks in 75 % of patients . Partial radiographic responses occurred in 12 % ( 95 % CI , 6%-20 % ) of individuals receiving 250 mg of gefitinib and in 9 % ( 95 % CI , 4%-16 % ) of those receiving 500 mg . Symptoms improved in 96 % of patients with partial radiographic responses . The overall survival at 1 year was 25 % . There were no significant differences between the 250-mg and 500-mg doses in rates of symptom improvement ( P = .26 ) , radiographic tumor regression ( P = .51 ) , and projected 1-year survival ( P = .54 ) . The 500-mg dose was associated more frequently with transient acne-like rash ( P = .04 ) and diarrhea ( P = .006 ) . CONCLUSIONS Gefitinib , a well-tolerated oral EGFR-tyrosine kinase inhibitor , improved disease-related symptoms and induced radiographic tumor regressions in patients with NSCLC persisting after chemotherapy e19011 Background : The phase III BMS099 trial investigated cetuximab ( C ) added to taxane/carboplatin ( TC ) for 1st line treatment of advanced NSCLC . Progression-free survival ( PFS ) was not significantly different with C ; response rate ( RR ) was significantly higher . Median overall survival ( OS ) was longer , with a difference not statistically significant , but similar in magnitude to the significant OS improvement from the FLEX trial ( cisplat/vinorelb±C ) . A secondary objective of the BMS099 study was to assess the effect of C on Lung Cancer Symptoms ( LCS ) . METHODS Chemonaïve patients ( pts ) with stage IIIB/IV NSCLC ( any histology or EGFR expression status ) were r and omized to TC±C. LCS were measured using the functional assessment of cancer treatment-lung cancer subscale question naire ( FACT-LCS ) , given at baseline and before each therapy cycle until disease progression ( scoring 7 symptoms : breath loss , weight loss , clear thinking , coughing , appetite , chest tightness , breath ease , on a 0 - 4 scale ) . The main endpoints were rates of symptom response/progression ( ≥ 2 point improvement/decrease from baseline in 2 consecutive assessment s ) , compared between arms with a stratified Cochran-Mantel-Haenszel ( CMH ) test ; a stratified log-rank test was used to compare time to symptomatic progression . A Wei-Lachin test was used to compare between arms the changes from baseline in LCS score , and a longitudinal model was constructed to measure treatment effect on those score changes . RESULTS With 676 patients r and omized , the baseline compliance rates for the FACT-LCS question naire were 99.4 % and 99.1 % for CTC and TC respectively , decreasing by week 18 to 74.0 % and 66.4 % . Baseline FACT-LCS scores were similar across treatment arms ( median , 19.0 ) . Symptom response rates were similar with CTC vs TC ( 32.6 % vs 28.5 % , CMH P=0.26 ) , and time to symptomatic progression was not significantly different ( log-rank P=0.58 ) . Changes from baseline in FACT-LCS scores did not differ significantly between arms ( Wei Lachin P=0.912 ; longitudinal model P=0.81 ) . CONCLUSIONS The addition of C to TC for the 1st treatment of advanced NSCLC result ed in similar symptom response/progression rates and did not affect trends in LCS score changes throughout treatment . [ Table : see text ] PURPOSE Epidermal growth factor receptor ( EGFR ) gene copy number detected by fluorescent in situ hybridization ( FISH ) has proven to be useful for selection of non-small-cell lung cancer ( NSCLC ) patients for treatment with EGFR tyrosine kinase inhibitors . Here , we evaluate EGFR FISH as a predictive marker in NSCLC patients receiving the EGFR monoclonal antibody inhibitor cetuximab plus chemotherapy . PATIENTS AND METHODS Two hundred twenty-nine chemotherapy-naive patients with advanced-stage NSCLC were enrolled onto a phase II selection trial evaluating sequential or concurrent chemotherapy ( paclitaxel plus carboplatin ) with cetuximab . RESULTS EGFR FISH was assessable in 76 patients with available tumor tissue and classified as positive ( four or more gene copies per cell in > /= 40 % of the cells or gene amplification ) in 59.2 % . Response ( complete response/partial response ) was numerically higher in FISH-positive ( 45 % ) versus FISH-negative ( 26 % ) patients ( P = .14 ) , whereas disease control rate ( complete response/partial response plus stable disease ) was statistically superior ( 81 % v 55 % , respectively ; P = .02 ) . Patients with FISH-positive tumors had a median progression-free survival time of 6 months compared with 3 months for FISH-negative patients ( P = .0008 ) . Median survival time was 15 months for the FISH-positive group compared with 7 months for patients who were FISH negative . ( P = .04 ) . Furthermore , survival favored FISH-positive patients receiving concurrent therapy . CONCLUSION These results are the first to suggest that EGFR FISH is a predictive factor for selection of NSCLC patients for cetuximab plus chemotherapy . Prospect i ve validation of these findings is warranted PURPOSE Epidermal growth factor receptor ( EGFR ) tyrosine kinase inhibitors have demonstrated antitumor activity in patients with non-small-cell lung cancer ( NSCLC ) . This study examined the safety profile of the monoclonal antibody EGFR inhibitor , cetuximab , when added to paclitaxel and carboplatin in untreated patients with stage IV NSCLC . Secondary objectives included efficacy and paclitaxel and carboplatin pharmacokinetics during cetuximab treatment . PATIENTS AND METHODS Patients with tumor evidence of EGFR by immunohistochemistry , performance status of 0 to 2 , and measurable disease received paclitaxel 225 mg/m2 with carboplatin area under the curve = 6 on day 1 every 3 weeks . Cetuximab was administered at 400 mg/m2 , 1 week before paclitaxel and carboplatin , then weekly at 250 mg/m2 . The regimen continued until disease progression or intolerable toxicity . RESULTS Thirty-one of 32 enrolled patients were treated . The most common cetuximab toxicity was rash in 84 % of patients ( grade 3 in 13 % ) . Pharmacokinetic sampling did not reveal an interaction between carboplatin , paclitaxel , and cetuximab . An objective response was observed in eight patients ( 26 % ) . With a median follow-up of 19 months , the median time to progression was 5 months , median survival was 11 months , and the 1- and 2-year survival rates were 40 % and 16 % , respectively . CONCLUSION The combination of cetuximab , paclitaxel , and carboplatin was safe and well tolerated in this population of stage IV patients . The response rate , time to progression , and median survival were slightly superior to historical controls treated with paclitaxel and carboplatin alone . A r and omized phase II trial has completed accrual BACKGROUND Use of cetuximab , a monoclonal antibody targeting the epidermal growth factor receptor ( EGFR ) , has the potential to increase survival in patients with advanced non-small-cell lung cancer . We therefore compared chemotherapy plus cetuximab with chemotherapy alone in patients with advanced EGFR-positive non-small-cell lung cancer . METHODS In a multinational , multicentre , open-label , phase III trial , chemotherapy-naive patients ( > or=18 years ) with advanced EGFR-expressing histologically or cytologically proven stage wet IIIB or stage IV non-small-cell lung cancer were r and omly assigned in a 1:1 ratio to chemotherapy plus cetuximab or just chemotherapy . Chemotherapy was cisplatin 80 mg/m(2 ) intravenous infusion on day 1 , and vinorelbine 25 mg/m(2 ) intravenous infusion on days 1 and 8 of every 3-week cycle ) for up to six cycles . Cetuximab-at a starting dose of 400 mg/m(2 ) intravenous infusion over 2 h on day 1 , and from day 8 onwards at 250 mg/m(2 ) over 1 h per week-was continued after the end of chemotherapy until disease progression or unacceptable toxicity had occurred . The primary endpoint was overall survival . Analysis was by intention to treat . This study is registered with Clinical Trials.gov , number NCT00148798 . FINDINGS Between October , 2004 , and January , 2006 , 1125 patients were r and omly assigned to chemotherapy plus cet
Output:
| Our data showed that the addition of cetuximab to chemotherapy would improve overall survival and overall response rate .
It may provide new option for clinical treatment for untreated advanced non-small-cell lung cancer .
The side effects of E-chemo are predictable and manageable |
MS210851 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: People with sickle cell disease have a chronically activated coagulation system and display hemostatic perturbations , but it is unknown whether they experience an increased risk of venous thromboembolism . We conducted a case-control study of venous thromboembolism that included 515 hospitalized black patients and 555 black controls obtained from medical clinics . All subjects were assayed for hemoglobin S and hemoglobin C genotypes . The prevalence of the S allele was 0.070 and 0.032 for case patients and controls , respectively ( P < .001 ) . The odds that a patient had sickle cell trait were approximately twice that of a control , indicating that the risk of venous thromboembolism is increased approximately 2-fold among blacks with sickle cell trait compared with those with the wild-type genotype ( odds ratio = 1.8 with 95 % confidence interval , 1.2 - 2.9 ) . The odds ratio for pulmonary embolism and sickle cell trait was higher , 3.9 ( 2.2 - 6.9 ) . The prevalence of sickle cell disease was also increased among case patients compared with controls . We conclude that sickle cell trait is a risk factor for venous thromboembolism and that the proportion of venous thromboembolism among blacks attributable to the mutation is approximately 7 % OBJECTIVE Our purpose was to determine the rate of preeclampsia in women who are positive for sickle cell trait . STUDY DESIGN All African-American women were tested for sickle cell trait with the " sickledex " screen at the fist prenatal visit and prospect ively enrolled in this study from March 1994 to June 1995 . " Sickledex " screens were confirmed with hemoglobin electrophoresis . Demographic data were collected at the time of enrollment . Outcome data , including preeclampsia ( as defined by The American College of Obstetricians and Gynecologists criteria ) , gestational age at delivery , birth weight , and postpartum endometritis were collected immediately post partum . Assuming a 10 % rate of positive sickle cell trait , 1100 patients were required to demonstrate a doubling in the rate of preeclampsia with 80 % power and p < 0.05 . The Student t test , the Mann-Whitney U test , chi 2 analysis , and Fisher 's exact tests were used for statistical analysis . RESULTS Of 1584 women enrolled in the study , 162 were positive for sickle cell trait . Sickle cell trait-positive women were older than the sickle cell trait-negative women ( 24.4 + /- 4.6 vs 23.0 + /- 4.4 years , p < 0.001 ) , but there was no significant difference in parity . The rate of preeclampsia was significantly increased in sickle cell-positive women ( 24.7 % vs 10.3 % , p < 0.0001 ) . There was no significant difference in the rate of chronic hypertension , diabetes , or smoking . Parous sickle cell-positive women more frequently gave a history of preeclampsia in a previous pregnancy ( 21.4 % vs 9.3 % , p < 0.0001 ) . There was a statistically significant decrease in gestational age at delivery and birth weight in sickle cell trait-positive women ( 36.7 + /- 2.7 vs 37.7 + /- 3.0 weeks , p < 0.0001 ; and 3082 + /- 591 vs 3369 + /- 573 gm , p < 0.0001 ) . The rate of postpartum endometritis was significantly increased in the women positive for sickle cell trait ( 12.3 % vs 5.1 % , p < 0.001 ) , although both groups had a similar cesarean section rate ( 14.8 % vs 12.6 % , not significant ) . CONCLUSION This is the first prospect i ve study to demonstrate that sickle cell trait-positive women are at significantly higher risk for development of perinatal complications that have traditionally been associated with sickle disease Forty-three homozygous ( SS ) female sickle cell anemic patients with a history of at least one painful crisis per month and desiring a reversible contraceptive were administered DMPA/3 months or Microgynon monthly . A third group of 16 surgically sterilized patients served as control . Patients were followed for 1 year to assess possible effects of the contraceptives on the patients ' painful crises . No changes were observed in any of the groups in the hematological parameters . At the end of the study , 70 % of the patients receiving DMPA were pain-free and only 16 % of those still reporting painful crises rated them as intense . Patients receiving Microgynon also had an amelioration of the painful crises , although at a lower rate ; after 12 months , 45.5 % still experienced some crises . Although less marked than in the other groups , 50.5 % of the control patients also reported an improvement of their painful crisis , which may be a result of closer medical care Objective To determine the maternal and fetal outcomes of pregnancy in women with sickle cell disease . Methods The subjects were part of a cohort recruited from 19 centers for a prospect i ve study of the clinical course of sickle cell disease . Each participant was evaluated using a structured protocol in which steady-state data and information on both sickle- and non-sickle-related events were colleted . The rates of antepartum and intrapartum complications were tallied for pregnancies carried to delivery . Fetal outcome was assessed according to gestational age , birth weight , and Apgar score . Differences among genotypes in event rates were assessed using Fisher exact test . Differences in gestational age and birth weight , and predictors of these outcomes , were assessed using analyses of covariance . Results Two hundred eighty-six of the 445 reported pregnacies proceeded to delivery . Non-sickle-related antepartum and intrapartum complication rates were comparable with those of African-American women who did not have sickle cell disease . One of the two deaths observed during this study was directly related to the presence of sickle cell disease . Rates of maternal morbidity from sickle cell disease were the same during pregancy as during the nonpregnant state . Ninety-nine percent of those pregnancies carried to delivery result ed in a live birth . Twenty-one percent of the infants born to women of the SS genotype were small for gestational age ( SGA ) . Preclampsia and acute anemic events were identified as risk factors for SGA infants . Conclusion Those caring for women with sickle cell disease should support them if they desire to have children 16 male and 28 female patients experiencing moderately severe pain during episodes of sickle-cell disease at least once in 3 months with little or no fever or exacerbations of jaundice were selected for a cross-over trial of low doses of steriods against saline solution . The patients each completed 4 - 6 months of treatment . All patients were on regular folates and had high or normal serum-iron values . Weights ranged from 24 - 134 pounds and ages from 2 - 35 years . Male patients were r and omly assigned to either testosterone in oil ( 10 mg in 1 ml ) or physiological sodium chloride solution ( 1 ml ) . Females were r and omly assigned to progesterone in oil ( 10 mg in 1 ml ) or physiological saline solution . A score was computed each month reflecting the severity , duration , and frequency of episodes of pain . About 80 % of the individuals on steriods had good responses and about the same proportion of the sodium chloride group had very poor responses . 22 of the original 31 patients stopped taking saline injections after the 1st 2 weeks . The packed-cell volumes in the steroid group rose during the period of steroid injections , while there was no appreciable change in the sodium chloride group . There were no sex differences in the pattern of response and no deleterious side effects were noted OBJECTIVE To assess the safety of Norplant contraceptive implant use by women with mild-moderate homozygous sickle cell disease ( HbSS ) . METHOD Prospect i ve observation of women pre- and post-insertion of Norplant , with each woman serving as her own control . PARTICIPANTS 25 women 18 - 40 years of age who attended a hospital sickle cell clinic ; post-insertion data were available for 23 women . OUTCOME MEASURES Changes in hematologic parameters including PCV , MCV , reticulocytes , ISCs , HbF and bilirubin ; changes in biochemical parameters including HDL cholesterol , aspartate transaminase , alkaline phosphate , serum creatinine and serum albumin . RESULT With a mean follow-up of 12.4 months ( range 1 - 29 months ) , there were no clinical ly or statistically significant group or individual changes in the hematologic or biochemical parameters after Norplant insertion . CONCLUSION Norplant appears to be a safe and appropriate contraceptive for women with mild-moderate HbSS disease
Output:
| CONCLUSION While data are limited , there is no evidence to suggest that hormonal contraceptive use among women with sickle cell disease is associated with an increased risk of clinical complications |
MS210852 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
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Input: Background —Endothelial function is impaired in coronary artery disease and may contribute to its clinical manifestations . Increased oxidative stress has been linked to impaired endothelial function in atherosclerosis and may play a role in the pathogenesis of cardiovascular events . This study was design ed to determine whether endothelial dysfunction and vascular oxidative stress have prognostic impact on cardiovascular event rates in patients with coronary artery disease . Methods and Results —Endothelium-dependent and -independent vasodilation was determined in 281 patients with documented coronary artery disease by measuring forearm blood flow responses to acetylcholine and sodium nitroprusside using venous occlusion plethysmography . The effect of the coadministration of vitamin C ( 24 mg/min ) was assessed in a subgroup of 179 patients . Cardiovascular events , including death from cardiovascular causes , myocardial infa rct ion , ischemic stroke , coronary angioplasty , and coronary or peripheral bypass operation , were studied during a mean follow-up period of 4.5 years . Patients experiencing cardiovascular events ( n=91 ) had lower vasodilator responses to acetylcholine ( P < 0.001 ) and sodium nitroprusside ( P < 0.05 ) , but greater benefit from vitamin C ( P < 0.01 ) . The Cox proportional regression analysis for conventional risk factors demonstrated that blunted acetylcholine-induced vasodilation ( P = 0.001 ) , the effect of vitamin C ( P = 0.001 ) , and age ( P = 0.016 ) remained independent predictors of cardiovascular events . Conclusions —Endothelial dysfunction and increased vascular oxidative stress predict the risk of cardiovascular events in patients with coronary artery disease . These data support the concept that oxidative stress may contribute not only to endothelial dysfunction but also to coronary artery disease activity OBJECTIVES The study was done to determine whether radial artery applanation tonometry can be used as a noninvasive method of assessing global endothelial function . BACKGROUND ; It is known that beta(2)-receptor stimulation results in endothelial release of nitric oxide . Furthermore , for over a century glyceryl trinitrate ( GTN ) has been known to markedly affect the arterial pressure waveform , even in the absence of significant blood pressure ( BP ) changes . Therefore , it was hypothesized that the change in the peripheral pressure waveform , as measured using tonometry and quantified using the augmentation index ( AIx ) and in response to Salbutamol ( Salb ) , would allow assessment of global endothelial function . METHODS The study contained three parts . In the first study , Salb ( 400 microg ) was administered to 11 healthy subjects via inhalation after either intravenous N-omega-nitro-monomethyl-L-arginine ( L-NMMA ) ( 3 mg/kg over 5 min ) or control solution ( normal saline ) in the supine , rested , fasted condition . The BP , heart rate and waveform responses were recorded each 5 min following Salb for 20 min . Next , GTN was given and responses recorded 5 min later . In the second study , both the reproducibility of Salb and the GTN responses were assessed in 9 subjects studied twice on separate days . In the third study , the Salb and GTN responses of 12 subjects with angiographic coronary artery disease ( CAD ) were compared with 10 age-matched control subjects with no atherosclerotic risk factors . RESULTS After control infusion , AIx decreased following Salb , from 50.8 + /- 4.3 % to 44.8 + /- 4.2 % , a change of -11.8 + /- 3.7 % , p < 0.01 . After L-NMMA , AIx did not significantly change following Salb ( 54.2 + /- 5.1 % vs. 52.9 + /- 5.3 % , -2.0 + /- 3.1 % ) . The GTN-induced decreases in AIx were similar after either infusion ( 35.1 + /- 3.3 % vs. 36.5 + /- 3.3 % ) . Reproducibility of Salb-induced changes in AIx between studies performed on separate days was good ( r = 0.80 , p < 0.01 ) . Salb-induced changes in AIx in CAD patients were significantly less compared to control subjects ( -2.4 + /- 1.9 % vs. -13.2 + /- 2.4 % , respectively , p < 0.002 ) . The GTN-induced changes were not significantly different ( -27.6 + /- 4.2 vs. -38.9 + /- 4.4 % , p = 0.07 ) . CONCLUSIONS The peripheral arterial pressure waveform is sensitive to beta(2)-stimulation . Changes are related to nitric oxide release , are reproducible and can distinguish between clinical subject groups . Arterial waveform changes following Salb may thus provide a noninvasive method of measuring " global " arterial endothelial function Epidemiological studies indicate that diets rich in fruits and vegetables ( F&V ) are protective against CVD . Puréed F&V products retain many beneficial components , including flavonoids , carotenoids , vitamin C and dietary fibres . The present study aim ed to establish the physiological effects of acute ingestion of a F&V purée-based drink ( FVPD ) on vasodilation , antioxidant status , phytochemical bioavailability and other CVD risk factors . A total of twenty-four subjects , aged 30 - 70 years , completed the r and omised , single-blind , controlled , crossover test meal study . Subjects consumed 400 ml of the FVPD , or a fruit-flavoured sugar-matched control , after following a low-flavonoid diet for 5 d. Blood and urine sample s were collected throughout the study day , and vascular reactivity was assessed at 90 min intervals using laser Doppler iontophoresis . The FVPD significantly increased plasma vitamin C ( P= 0·002 ) and total nitrate/nitrite ( P= 0·001 ) concentrations . There was a near significant time by treatment effect on ex vivo LDL oxidation ( P= 0·068 ) , with a longer lag phase after consuming the FVPD . During the 6 h after juice consumption , the antioxidant capacity of plasma increased significantly ( P= 0·003 ) and there was a simultaneous increase in plasma and urinary phenolic metabolites ( P < 0·05 ) . There were significantly lower glucose and insulin peaks after ingestion of the FVPD compared with control ( P= 0·019 and 0·003 ) and a trend towards increased endothelium-dependent vasodilation following FVPD consumption ( P= 0·061 ) . Overall , FVPD consumption significantly increased plasma vitamin C and total nitrate/nitrite concentrations , with a trend towards increased endothelium-dependent vasodilation . Puréed F&V products are useful vehicles for increasing micronutrient status , plasma antioxidant capacity and in vivo NO generation , which may contribute to CVD risk reduction Background — Observational evidence has consistently linked increased fruit and vegetable consumption with reduced cardiovascular morbidity ; however , there is little direct trial evidence to support the concept that fruit and vegetable consumption improves vascular function . This study assessed the dose-dependent effects of a fruit and vegetable intervention on arterial health in subjects with hypertension . Methods and Results — After a 4-week run-in period during which fruit and vegetable intake was limited to 1 portion per day , participants were r and omized to consume either 1 , 3 , or 6 portions daily for the next 8 weeks . Endothelium-dependent and -independent arterial vasodilator responses were assessed by venous occlusion plethysmography in the brachial circulation before and after intervention . Compliance was monitored with serial contemporaneous 4-day food records and by measuring concentrations of circulating dietary biomarkers . A total of 117 volunteers completed the 12-week study . Participants in the 1- , 3- , and 6-portions/d groups reported consuming on average 1.1 , 3.2 , and 5.6 portions of fruit and vegetables , respectively , and serum concentrations of lutein and & bgr;-cryptoxanthin increased across the groups in a dose-dependent manner . For each 1-portion increase in reported fruit and vegetable consumption , there was a 6.2 % improvement in forearm blood flow responses to intra-arterial administration of the endothelium-dependent vasodilator acetylcholine ( P=0.03 ) . There was no association between increased fruit and vegetable consumption and vasodilator responses to sodium nitroprusside , an endothelium-independent vasodilator . Conclusions — The present study illustrates that among hypertensive volunteers , increased fruit and vegetable consumption produces significant improvements in an established marker of endothelial function and cardiovascular prognosis BACKGROUND Although numerous human studies have shown consistent effects of some polyphenol-rich foods on several intermediate markers for cardiovascular diseases , it is still unknown whether their action could be specifically related to polyphenols . OBJECTIVE We investigated the effect of orange juice and its major flavonoid , hesperidin , on microvascular reactivity , blood pressure , and cardiovascular risk biomarkers through both postpr and ial and chronic intervention studies . DESIGN Twenty-four healthy , overweight men ( age 50 - 65 y ) were included in a r and omized , controlled , crossover study . Throughout the three 4-wk periods , volunteers daily consumed 500 mL orange juice , 500 mL control drink plus hesperidin ( CDH ) , or 500 mL control drink plus placebo ( CDP ) . All measurements and blood collection s were performed in overnight-fasted subjects before and after the 4-wk treatment periods . The postpr and ial study was conducted at the beginning of each experimental period . RESULTS Diastolic blood pressure ( DBP ) was significantly lower after 4 wk consumption of orange juice or CDH than after consumption of CDP ( P = 0.02 ) , whereas microvascular endothelium-related reactivity was not significantly affected when measured after an overnight fast . However , both orange juice and CDH ingestion significantly improved postpr and ial microvascular endothelial reactivity compared with CDP ( P < 0.05 ) when measured at the peak of plasma hesperetin concentration . CONCLUSIONS In healthy , middle-aged , moderately overweight men , orange juice decreases DBP when regularly consumed and postpr and ially increases endothelium-dependent microvascular reactivity . Our study suggests that hesperidin could be causally linked to the beneficial effect of orange juice . This trial is registered at clinical trials.gov as NCT00983086 OBJECTIVES Our objective was to determine if long-term daily administration of phytonutrient supplements can prevent the immediate adverse impact of a high-fat meal and increase the production of nitric oxide . BACKGROUND Ingestion of a high-fat meal impairs flow-mediated vasodilation of the brachial artery for at least 4 h ; however , co-ingestion of vitamin antioxidants or a green salad has been shown to prevent this effect . METHODS Flow-mediated brachial artery reactivity test ( BART ) both before and 3 h after a 900 calorie 50 g fat meal was evaluated in 38 healthy volunteers ( age 36.4 + /- 10.1 years ) . Subjects were r and omized to four weeks of daily supplementation with a powdered fruit vegetable juice concentrate ( Juice Plus [ JP ] ) along with a complex supplement providing nutritional antioxidants and various herbal extracts ( Vineyard [ V ] ) , JP alone , or a matching placebo . At three and four weeks , BART was repeated both before and after the high-fat meal . Serum nitrate/nitrite concentrations were measured at baseline and at four weeks . RESULTS Four weeks of the JP-V combination blunted the detrimental effect of the high-fat meal ( -47.5 + /- 23.4 % at baseline vs. -1.7 + /- 9.7 % at four weeks [ p < 0.05 ] ) . Four weeks of JP alone had a similar beneficial effect ( -45.1 + /- 19.7 % at baseline vs. -16.6 + /- 10.3 % at four weeks [ p < 0.05 ] ) , whereas there was no substantial effect of the placebo . In the subjects treated with supplements , concentrations of serum nitrate/nitrite increased from 78 + /- 39 to 114 + /- 62 microm/l ( p < 0.02 ) . CONCLUSIONS Daily ingestion of modest amounts of a fruit/vegetable juice concentrate with or without adjunctive phytonutrient supplementation can reduce the immediate adverse impact of high-fat meals on flow-mediated vasoactivity and increase nitrate/nitrite blood concentration K-rich fruit and vegetables may lower blood pressure ( BP ) and improve vascular function . A r and omised controlled trial ( IS RCT N50011192 ) with a cross-over design was conducted in free-living participants with early stages of hypertension ( diastolic BP>80 and < 100 mmHg , not receiving BP-lowering medication ) to test this hypothesis . Following a 3-week run-in period on a control di
Output:
| Potassium appears to improve endothelial function with a dose of > 40 mmol/d , however the mechanisms for this effect remain unclear .
Potassium may improve measures of vascular function however this effect may be dependent on the effect of potassium on blood pressure .
The effect of fruit and vegetables on endothelial function independent of confounding variables is less clear .
Increased fruit and vegetable intake may improve vascular function only in high risk population s. CONCLUSION Increasing dietary potassium appears to improve vascular function but the effect of increasing fruit and vegetable intake per se on vascular function is less clear |
MS210853 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
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Input: The aim of this study of the present experiment was to study the marginal periimplant tissues at intentionally non-submerged ( 1-stage implants ) and initially submerged and subsequently exposed implants ( 2-stage implants ) . 5 beagle dogs , about 1-year-old , were used , 3 months after the extraction of the m and ibular premolars , fixtures of the Astra Tech Implants Dental System , the Brånemark System and the Bonefit -- ITI system were installed . In each m and ibular quadrant , 1 fixture of each implant system was installed in a r and omised order . The installation procedure followed the recommendations given in the manuals for each system . Thus , following installation , the bone crest coincided with the fixture margin of the Astra Tech Implants Dental System and the Brånemark System , whereas the border between the plasma sprayed and the machined surface of the Bonefit-ITI implant system was positioned at the level of the bone crest . Following a healing period of 3 months , abutment connection was carried out in the 2-stage systems ( the Astra Tech Implants Dental System and the Brånemark system ) . A 6-month period of plaque control was initiated . The animals were sacrificed and biopsies representing each important region dissected . The tissue sample s were prepared for light microscopy and exposed to histometric and morphometric measurements . The mucosal barrier which formed to the titanium surface following 1-stage and 2-stage implant installations comprised an epithelial and a connective tissue component , which for that 3 systems studied , had similar dimensions and composition . The amount of lamellar bone contained in the periimplant region close to the fixture part of the 3-implant systems was almost identical . It is suggested that correctly performed implant installation may ensure proper conditions for both and hard tissue healing , and that the geometry of the titanium implant seems to be of limited importance OBJECTIVES To ( i ) investigate the influence of different extensions of a laser microgrooved abutment zone on connective tissue attachment and ( ii ) assess the impact of a repeated abutment dis-/reconnection on soft- and hard-tissue healing . MATERIAL S AND METHODS Titanium implants were inserted epicrestally in the lower jaws of six dogs . Healing abutments with either partially ( LP ) or completely ( LC ) laser microgrooved margins or machined surface margins ( M ) were r and omly allocated either to a single (1 × )/repeated ( 2 × ) dis-/reconnection at 4 and 6 weeks ( test ) , respectively , or left undisturbed ( control ) . At 6 and 8 weeks , histomorphometrical ( e.g. most coronal level of bone in contact with the implant [ CBI ] , subepithelial connective tissue attachment [ STC ] ) and immunohistochemical ( Collagen Type-I [ CI ] ) parameters were assessed . RESULTS At control sites , LP/LC groups revealed lower mean CBL ( 8 weeks , 0.95 ± 0.51 vs. 0.54 ± 0.63 vs. 1.66 ± 1.26 mm ) , higher mean STC ( 8 weeks , 82.58 ± 24.32 % vs. 96.37 ± 5.12 % vs. 54.17 ± 8.09 % ) , but comparable CI antigen reactivity . A repeated abutment manipulation was associated with increased mean CBL ( 8 weeks , 1.53 ± 1.09 vs. 0.94 ± 0.17 vs. 1.06 ± 0.34 mm ) , decreased STC ( 8 weeks , 57.34 ± 43.06 % vs. 13.26 ± 19.04 % vs. 37.76 ± 37.08 % ) and CI values . CONCLUSIONS It was concluded that ( i ) LC > LP abutments enhanced subepithelial connective tissue attachment and preserved crestal bone levels , ( ii ) repeated abutment dis-/reconnection during the initial healing phase ( 4 - 6 weeks ) may be associated with increased soft- and hard-tissue changes and ( iii ) LP and LC should be considered using a one abutment , one time approach Limited information exists regarding soft tissue and hard tissue responses to abutments with different material composition . The aim of this study is to evaluate soft and hard tissue responses to titanium and polymer healing abutments over a 3-month period . Sixteen patients were included in this prospect i ve trial . Implants were provisionalized with either titanium or polymer healing abutments . Changes of marginal bone level and soft tissue dimensions were recorded at implant installation and at 3 months Previous research has demonstrated the effectiveness of laser-ablated microgrooves placed on implant collars to support direct connective tissue attachments to altered implant surfaces . Such a direct connective tissue attachment serves as a physiologic barrier to the apical migration of the junctional epithelium and prevents crestal bone resorption . The current prospect i ve pre clinical trial sought to evaluate bone and soft tissue healing patterns when laser-ablated microgrooves were placed on the abutment . A canine model was selected for comparison to previous investigations that examined the negative bone and soft tissue sequelae of the implant-abutment microgap . The results demonstrate significant improvement in peri-implant hard and soft tissue healing compared to traditional machined abutment surfaces OBJECTIVE To evaluate the marginal soft and hard tissue healing at titanium and Polyetheretherketone ( PEEK ) healing implant abutments over a 4-month period . MATERIAL AND METHODS In six Labrador dogs , all m and ibular premolars and first molars were extracted . After 4 months of healing , flaps were elevated , and two implants were installed at each side of the m and ible , one in the premolar and the other in the molar regions . Four different types of healing abutments were positioned on the top of each implant : ( i ) titanium ( Ti ) ; ( ii ) PEEK material bonded to a base made of titanium ( Ti-P ) , r and omly positioned in the premolar region ; ( iii ) PEEK , pristine ( P ) ; and ( iv ) PEEK , roughened ( P-R ) , r and omly positioned in the molar region . The flaps were sutured to allow a non-submerged healing , and after 4 months , the animals were sacrificed and ground sections obtained for histological evaluation . RESULTS A higher resorption of the buccal bone crest was observed at the PEEK bonded to a base made of titanium abutments ( 1.0 ± 0.3 mm ) compared to those made of titanium ( 0.3 ± 0.4 mm ) . However , similar dimensions of the peri-implant mucosa and similar locations of the soft tissues in relation to the implant shoulder were observed . No statistically significant differences were seen in the outcomes when the pristine PEEK was compared with the roughened PEEK abutments . The mean apical extension of the junctional epithelium did not exceed the implant shoulder at any of the abutment types used . CONCLUSIONS The coronal level of the hard and soft tissues allows the conclusion that the use of PEEK as healing abutments may be indicated OBJECTIVE Microorganisms harboring the oral cavity , mainly those related to periodontal diseases , are the most potential etiologic factor of failure in long-term implant treatment . The material used for abutment components may influence the adhesion and colonization of microbial species . The aim of this in vivo investigation was to evaluate the biofilm formation on machined ( MPT ) or cast titanium ( CPT ) and zirconia abutments ( Zc ) . METHODS Six healthy subjects were enrolled in this r and omized crossover clinical investigation . The study was conducted in three phases according to abutment surface evaluated . Each subject used an individual oral splint containing four disks of the same tested substrate , two located in the anterior and two in the posterior region , totalizing 12 specimens for subject . Participants were asked to use the removable intraoral splint during 24 h. DNA checkerboard hybridization method was used to identify and quantify 38 bacterial species colonizing formed biofilm on the abutment substrates . RESULTS Pathogens and non-pathogens species were found colonizing the three substrates surfaces . Fusobacterium nucleatum , Neisseria mucosa , Porphyromonas aeruginosa , Peptostreptococcus anaerobios , Staphylococcus aureus , Streptococcus gordonii , Streptococcus parasanguinis , and Tanerella forsythia were the only species with no significant differences over the tested material s ( P > 0.05 ) . All the other target species presented significant differences sought by Friedman test ( P < 0.0001 ) . CONCLUSIONS There was a significant difference in the total bacterial count between the three groups . CPT presented the higher mean counts , followed by MPT and Zc . CPT group also showed a higher mean incidence of species than MPT and Zc . The anterior or posterior region of disks placement did not show significant differences in relation to bacterial adhesion OBJECTIVE The aim of the present study was to analyze the soft tissue barrier formed to implant abutments made of different material s. MATERIAL AND METHODS Six Labrador dogs , about 1 year old , were used . All m and ibular premolars and the first , second and third maxillary premolars were extracted . Three months later four implants ( OsseoSpeed , 4.5 x 9 mm , Astra Tech Dental , Mölndal , Sweden ) were placed in the edentulous premolar region on one side of the m and ible and healing abutments were connected . One month later , the healing abutments were disconnected and four new abutments were placed in a r and omized order . Two of the abutments were made of titanium ( Ti ) , while the remaining abutments were made of ZrO(2 ) or AuPt-alloy . A 5-months plaque control program was initiated . Three months after implant surgery , the implant installation procedure and the subsequent abutment shift were repeated in the contra-lateral m and ibular region . Two months later , the dogs were euthanized and biopsies containing the implant and the surrounding soft and hard peri-implant tissues were collected and prepared for histological analysis . RESULTS It was demonstrated that the soft tissue dimensions at Ti- and ZrO(2 ) abutments remained stable between 2 and 5 months of healing . At Au/Pt-alloy abutment sites , however , an apical shift of the barrier epithelium and the marginal bone occurred between 2 and 5 months of healing . In addition , the 80-mum-wide connective tissue zone lateral to the Au/Pt-alloy abutments contained lower amounts of collagen and fibroblasts and larger fractions of leukocytes than the corresponding connective tissue zone of abutments made of Ti and ZrO(2 ) . CONCLUSION It is suggested that the soft tissue healing to abutments made of titanium and ZrO(2 ) is different to that at abutments made of AuPt-alloy OBJECTIVES To investigate ( i ) the impact of different titanium implant surfaces on soft tissue integration over 6 months , and ( ii ) the influence of frequent clinical probing during the healing phase on the established mucosal seal . MATERIAL AND METHODS St and ardized clinical probing was r and omly performed ( 12 dogs , probing versus control ) at different transmucosal surfaces [ machined ( M ) , s and -blasted/acid-etched ( SLA ) , and chemically modified acid-etched ( modA ) , modSLA ] at 2 , 4 , 8 , and 12 weeks ( i.e. 1 x , 2 x , 3 x , and 4 x ) . Histomorphometrical analysis ( e.g. mucosal margin ( PM ) - apical extension of the junctional epithelium ( aJE ) , PM - coronal level of bone-to-implant contact ( CBI ) was performed at 4 , 8 , 12 , and 24 weeks . RESULTS While M and SLA groups revealed a split formation , epithelial cells and connective tissue were in close contact to modA and modSLA surfaces . Frequent clinical probing ( i.e. 3 x and 4 x ) increased mean pocket depths , PM-aJE , and aJE-CBI values in all groups and markedly disrupted the epithelial and connective tissue attachment . CONCLUSIONS It was concluded that irrespective of the surface characteristics , a frequent clinical probing at short intervals during the healing phase was associated with dimensional and structural changes of the mucosal seal
Output:
| Comparable results in terms of peri-implant attachment dimensions between test and control groups were found , except for a significantly higher apical junctional epithelium to coronal bone to implant ( ajE-CBI ) distance for chemically modified acid-etched compared with titanium machined surfaces .
Non-meta-analyzable and /or qualitative results highlighted some improved properties also for microgrooved and oxidized surfaces .
Limited data from animal studies suggest that some characteristics of the transmucosal implant components may affect peri-implant soft-tissue adhesion and stabilization but do not allow definitive conclusions . |
MS210854 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: Effective management of severe endodontic pain is often a major problem . The analgesic effect of ketorolac tromethamine ( Toradol , 10 mg p.o . ) was compared with acetaminophen codeine ( 325 mg/15 mg p.o . ) in patients with severe pain due to acute apical periodontitis in a double-blind clinical study . A total of 66 patients presenting with severe pain ( defined as 7 cm and more using a visual analog scale ) were r and omly assigned to receive either ketorolac tromethamine or acetaminophen codeine ( 33 patients in each group ) , and recorded their pain score once every 10 min for 90 min after administration . Results indicate that patients in the ketorolac group had significantly less pain than those who received acetaminophen codeine ( p = 0.005 ) The purpose of this noninferiority trial was to compare postoperative pain relief after one-visit root canal therapy ( O RCT ) with a pulpotomy performed with a new endodontic calcium-enriched mixture cement ( PCEM ) in human permanent molars with irreversible pulpitis . A total of 407 selected patients were r and omly allocated into the O RCT group ( n = 202 ) or the PCEM group ( n = 205 ) . Numerical Rating Scale question naires were used to record pain intensity ( PI ) by the patients during the first 7 days after treatment . While there was no statistically significant difference in the mean PI at baseline between the two study groups ( P = 0.45 ) , changes in mean PI were significantly different between them ( P < 0.001 ) . In the O RCT group , pain relief was achieved after 36 h [ 95 % confidence interval ( CI ) , 27.00–45.00 ] , compared to 18 h in the PCEM group ( 95 % CI , 15.00–21.00 ) , a significant difference ( P < 0.01 ) . Comparison of the mean PI sum recorded over 7 days showed that patients in the O RCT group experienced significantly more pain than those in the PCEM group ( P < 0.001 ) ; a similar difference was observed for pain in response to percussion tests ( P < 0.001 ) . Treatment with PCEM thus had the better pain-reducing effects than O RCT in irreversible pulpitis cases Purpose The aim of this study was to compare the effect of white mineral trioxide aggregate ( MTA ) to that of formocresol ( FC ) as pulp dressing agents in pulpotomised primary molars . Methods In this clinical trial study , 60 lower second primary molars of 46 children were treated by a conventional pulpotomy technique . The teeth were r and omly assigned to the MTA ( experimental ) and FC ( control ) groups by r and om numbered table . Following removal of the coronal pulp and haemostasis , the pulp stumps were covered with an MTA paste in the experimental group . In the control group , FC was placed with a cotton pellet over the pulp stumps . The teeth of both groups were restored with stainless steel crowns . Children arrived for clinical and radiographic follow-up evaluation after 6 , 12 and 24 months . Results The treated teeth in FC group ( n = 18 ) were clinical ly and radiographically successful after 24 months . The radiographic follow-up evaluation revealed one failure ( furcation involvement ) in 18 molars treated with MTA after 24 months . The treated teeth in MTA group were clinical ly successful 24 months postoperatively . Pulp canal obliteration was observed in one of the teeth treated with MTA and four of the teeth treated with FC . Conclusion MTA could be used as a safe medicament for pulpotomy in cariously exposed primary molars and could be a substitute for FC Objectives Root canal therapy ( RCT ) and tooth extraction have been conventional treatment options for management of human mature teeth with irreversible pulpitis . Excellent short-term treatment outcomes of vital pulp therapy with calcium-enriched mixture cement ( VPT/CEM ) , as a new treatment option , on postoperative pain relief was demonstrated ; if intermediate- and long-term treatment outcomes of the new treatment are also non-inferior compared to RCT , then VPT/CEM may become a viable treatment option for management of mature teeth with irreversible pulpitis . Material s and methods In 23 healthcare centers , 407 9- to 65-year-old patients were r and omly allocated into two study arms including one-visit RCT ( reference treatment ; n = 202 ) and VPT/CEM ( alternative treatment ; n = 205 ) . Six- and twelve-month clinical and radiographic successes were assessed . Results Mean follow-up times at 6- and 12-month follow-ups were “ 6.70 ± 0.68 and 6.72 ± 0.71 months ” and “ 12.96 ± 0.67 and 12.90 ± 0.66 months ” in the available cases of RCT and VPT/CEM arms , respectively . Favorable clinical success rates in the two study arms did not show statistical difference ; however , the radiographic success rate in the VPT/CEM was significantly greater than RCT arm at the two follow-ups ( P < 0.001 ) . The patients ’ age had no effect on the treatment outcomes ( P = 0.231 ) . Conclusions Treatment outcomes of VPT/CEM may be superior to RCT in mature molars with irreversible pulpitis . The performance of bio material s such CEM cement may assist in the shift towards more biologic treatments . Clinical relevance VPT/CEM may be a realistic alternative treatment for human mature molar teeth with symptoms of irreversible pulpitis ; the use of VPT/CEM is highly beneficial for patients as well as general dentists OBJECTIVE To conduct a r and omized clinical trial to compare the post-operative pain experience as well as clinical and radiographic outcomes of pulpotomy in human permanent molars with irreversible pulpitis using calcium enriched mixture ( CEM ) cement or mineral trioxide aggregate ( MTA ) . MATERIAL S AND METHODS A total of 413 patients met the inclusion criteria and consented to participate . The patients were r and omly allocated into two study arms : MTA pulpotomy ( PMTA : n = 208 ) and CEM pulpotomy ( PCEM : n = 205 ) . Numerical rating scale question naires were utilized by the patients to record pain intensity ( PI ) over 7 days post-operatively . The patients were followed-up for 12 months to assess the clinical and radiographic outcomes of treatment . The data was analyzed using Chi-square , Cohen 's kappa and t-tests . RESULTS There was no significant difference in the mean PI recorded during the 7 post-operative days between the two study arms ( p = 0.221 ) . The clinical and radiographic success rates for PMTA at 12-month follow-up were 98 and 95 % , respectively ; and 97 and 92 % for PCEM , respectively . There was no significant differences in clinical ( p = 0.7 ) and radiographic ( p = 0.4 ) success rates between the two arms . CONCLUSIONS Excellent treatment outcomes occurred in molar teeth with irreversible pulpitis undergoing pulpotomy with MTA and CEM bio material Acute pain and swelling following endodontic treatment are a challenge for both the patient and the dentist . According to previous studies , the incidence of flare-ups increases after endodontic treatment of teeth with necrotic pulps . Calcium hydroxide is currently used as a multi- purpose drug in root canal therapy . The aim of this study was to evaluate the incidence and severity of flare-ups after treatment of pulpless teeth using calcium hydroxide as an intracanal dressing . Sixty patients with single-root necrotic teeth participated in this study . These patients were r and omly divided into three groups of 20 . The patients were treated in Group A in a single-visit approach , in group B with a two-visit approach without any intracanal dressing and group C with a two-visit approach using calcium hydroxide as an intracanal dressing for one week . All of the patients were followed for 72 hours after each treatment session . The information about the incidence and severity of pain and swelling was recorded in tables , using a modified Visual Analogue Scale for pain severity measurement and a scale with four degrees for measuring the severity of swelling . The data were analyzed by chi-square test and GENMODE procedure INTRODUCTION Achieving pulp anesthesia with irreversible pulpitis is difficult . This study evaluated whether nonsteroidal anti-inflammatory drugs assist local anesthesia . METHODS In a r and omized double-blinded clinical trial , 150 patients ( 50 per group ) with irreversible pulpitis were given placebo , 600 mg ibuprofen , or 75 mg indomethacin 1 hour before local anesthesia . Each patient recorded their pain score on a visual analog scale before taking the medication , 15 minutes after anesthesia in response to a cold test , during access cavity preparation and during root canal instrumentation . No or mild pain at any stage was considered a success . Data were analyzed by the chi-square and analysis of variance tests . RESULTS Overall success rates for placebo , ibuprofen , and indomethacin were 32 % , 78 % , and 62 % , respectively ( p < 0.001 ) . Ibuprofen and indomethacin were significantly better than placebo ( p < 0.01 ) . There was no difference between ibuprofen and indomethacin ( p = 0.24 ) . CONCLUSIONS Premedication with ibuprofen and indomethacin significantly increased the success rates of inferior alveolar nerve block anesthesia for teeth with irreversible pulpitis AIM To compare the treatment outcomes of calcium-enriched mixture ( CEM ) cement and mineral trioxide aggregate ( MTA ) as pulp dressing bio material s in vital pulpotomy of carious primary molars . STUDY DESIGN split-mouth r and omised clinical trial . MATERIAL S AND METHODS Forty children aged 4 - 8 years with 2 carious teeth requiring pulpotomy were selected and r and omly assigned to MTA ( n = 40 ) or CEM ( n = 40 ) groups . After coronal pulp removal , the remaining radicular pulp was covered with an appropriate bio material ; the teeth were then permanently restored . Clinical /radiographic success/failures were blindly evaluated at 6- , 12- and 24-month follow-ups . STATISTICS the recorded data were analyzed with McNemar test and GEE . RESULTS A total of 36 , 33 and 35 patients were available for 6- , 12- and 24-month follow-ups , respectively . At the 12-month follow-up only one and three teeth in the CEM and MTA groups had pathologic external root resorption , respectively . The resorbed teeth were then missed due to extraction /exfoliation at the 24-month follow-up ; all other treated teeth were sign/symptom-free . Overall , clinical and radiographic outcomes in both MTA/CEM groups were comparable at the three follow-ups without significant differences . Time had no significant effect on the success . CONCLUSION MTA and CEM demonstrated favourable treatment outcomes for pulpotomy of carious primary molars ; CEM may be an effective pulp dressing bio material BACKGROUND Amitriptyline is one of the most common tricyclic antidepressants , which binds to pain sensory nerve fibers close to the sodium channel ; hence , it could interact to some degree with receptors of local anesthetics . This study was design ed to assess the additional analgesic effects of 2 % Amitriptyline local gel administration in irreversible pulpitis pain of the molars . MATERIAL S AND METHODS This study was a r and omized , double-blind clinical trial that was performed on 56 consented adult patients who did not receive enough analgesia after a lidocaine nerve block for their tooth pulpitis pain . Patients were treated with 0.2 ml of either 2 % amitriptyline or placebo , which was directly injected into their m and ibular molar pulp chamber after they had received two routine lidocaine injections . Patients were asked to score their pain as a mark on a 10-cm Visual Analogue Scale ( VAS ) at different timepoints : 0 ( just before gel administration ) , 1 , 3 , 5 , 7 , and 9 minutes after the treatments . RESULTS There was a 92.5 % decrease in VAS scores of patients 9 minutes after amitriptyline administration compared to Time 0 , while in the placebo group this difference was only 13.5 % . Further , in the amitriptyline group , the VAS score at all timepoints was statistically different from Time 0 ( P < 0.01 ) . The overall pain reduction and its trend was significantly higher in the amitriptyline group compared with the placebo group ( P < 0.001 ) . CONCLUSION Inter-pulp space administration of amitriptyline 2 % gel for completing analgesia in irreversible pulpitis pain could be effective and useful as a conjunctive therapy to injections of local anesthetics Previous papers in this series on evidence -based dentistry have discussed the first 2 steps in seeking answers to clinical problems formulating a clear question and strategically search ing for evidence . The next step , critical appraisal of the evidence , is made easier if one underst and s the basic concepts of clinical research design . The strongest design , especially for questions related to therapeutic or preventive interventions , is the r and omized , controlled trial . Questions relating to diagnosis , prognosis and causation are often studied with observational , rather than experimental , research design s. The strongest study design should be used whenever possible . Rules have been established to grade research evidence . This paper , the fourth in the series ,
Output:
| Vital pulp therapy was the most important topic amongst endodontic high level evidence articles |
MS210855 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: Abstract Hypoxia is an important modulator of endurance exercise‐induced oxidative adaptations in skeletal muscle . However , whether hypoxia affects resistance exercise‐induced muscle adaptations remains unknown . Here , we determined the effect of resistance exercise training under systemic hypoxia on muscular adaptations known to occur following both resistance and endurance exercise training , including muscle cross‐sectional area ( CSA ) , one‐repetition maximum ( 1RM ) , muscular endurance , and makers of mitochondrial biogenesis and angiogenesis , such as peroxisome proliferator‐activated receptor‐γ coactivator‐1α ( PGC‐1α ) , citrate synthase ( CS ) activity , nitric oxide synthase ( NOS ) , vascular endothelial growth factor ( VEGF ) , hypoxia‐inducible factor‐1 ( HIF‐1 ) , and capillary‐to‐fiber ratio . Sixteen healthy male subjects were r and omly assigned to either a normoxic resistance training group ( NRT , n = 7 ) or a hypoxic ( 14.4 % oxygen ) resistance training group ( HRT , n = 9 ) and performed 8 weeks of resistance training . Blood and muscle biopsy sample s were obtained before and after training . After training muscle CSA of the femoral region , 1RM for bench‐press and leg‐press , muscular endurance , and skeletal muscle VEGF protein levels significantly increased in both groups . The increase in muscular endurance was significantly higher in the HRT group . Plasma VEGF concentration and skeletal muscle capillary‐to‐fiber ratio were significantly higher in the HRT group than the NRT group following training . Our results suggest that , in addition to increases in muscle size and strength , HRT may also lead to increased muscular endurance and the promotion of angiogenesis in skeletal muscle To test the hypothesis that severe hypoxia during low-resistance/high-repetition strength training promotes muscle hypertrophy , 19 untrained males were assigned r and omly to 4 weeks of low-resistance/high-repetition knee extension exercise in either normoxia or in normobaric hypoxia ( FiO2 0.12 ) with recovery in normoxia . Before and after the training period , isokinetic strength tests were performed , muscle cross-sectional area ( MCSA ) measured ( magnetic resonance imaging ) and muscle biopsies taken . The significant increase in strength endurance capacity observed in both training groups was not matched by changes in MCSA , fibre type distribution or fibre cross-sectional area . RT-PCR revealed considerable inter-individual variations with no significant differences in the mRNA levels of hypoxia markers , glycolytic enzymes and myosin heavy chain isoforms . We found significant correlations , in the hypoxia group only , for those hypoxia marker and glycolytic enzyme mRNAs that have previously been linked to hypoxia-specific muscle adaptations . This is interpreted as a small , otherwise undetectable adaptation to the hypoxia training condition . In terms of strength parameters , there were , however , no indications that low-resistance/high-repetition training in severe hypoxia is superior to equivalent normoxic training This study was performed to explore changes in gene expression as a consequence of exercise training at two levels of intensity under normoxic and normobaric hypoxic conditions ( corresponding to an altitude of 3,850 m ) . Four groups of human subjects trained five times a week for a total of 6 wk on a bicycle ergometer . Muscle biopsies were taken , and performance tests were carried out before and after the training period . Similar increases in maximal O(2 ) uptake ( 8.3 - 13.1 % ) and maximal power output ( 11.4 - 20.8 % ) were found in all groups . RT-PCR revealed elevated mRNA concentrations of the alpha-subunit of hypoxia-inducible factor 1 ( HIF-1 ) after both high- ( + 82.4 % ) and low (+78.4%)-intensity training under hypoxic conditions . The mRNA of HIF-1alpha(736 ) , a splice variant of HIF-1alpha newly detected in human skeletal muscle , was shown to be changed in a similar pattern as HIF-1alpha . Increased mRNA contents of myoglobin ( + 72.2 % ) and vascular endothelial growth factor ( + 52.4 % ) were evoked only after high-intensity training in hypoxia . Augmented mRNA levels of oxidative enzymes , phosphofructokinase , and heat shock protein 70 were found after high-intensity training under both hypoxic and normoxic conditions . Our findings suggest that HIF-1 is specifically involved in the regulation of muscle adaptations after hypoxia training . Fine-tuning of the training response is recognized at the molecular level , and with less sensitivity also at the structural level , but not at global functional responses like maximal O(2 ) uptake or maximal power output PURPOSE Recent studies have shown that low-intensity resistance training with vascular occlusion ( kaatsu training ) induces muscle hypertrophy . A local hypoxic environment facilitates muscle hypertrophy during kaatsu training . We postulated that muscle hypertrophy can be more efficiently induced by placing the entire body in a hypoxic environment to induce muscle hypoxia followed by resistance training . METHODS Fourteen male university students were r and omly assigned to hypoxia ( Hyp ) and normoxia ( Norm ) groups ( n = 7 per group ) . Each training session proceeded at an exercise intensity of 70 % of 1 repetition maximum ( RM ) , and comprised four sets of 10 repetitions of elbow extension and flexion . Students exercised twice weekly for 6 wk and then muscle hypertrophy was assessed by magnetic resonance imaging and muscle strength was evaluated based on 1RM . RESULTS Muscle hypertrophy was significantly greater for the Hyp-Ex ( exercised flexor of the hypoxia group ) than for the Hyp-N ( nonexercised flexor of the hypoxia group ) or Norm-Ex flexor ( P < .05 , Bonferroni correction ) . Muscle hypertrophy was significantly greater for the Hyp-Ex than the Hyp-N extensor . Muscle strength was significantly increased early ( by week 3 ) in the Hyp-Ex , but not in the Norm-Ex group . CONCLUSION This study suggests that resistance training under hypoxic conditions improves muscle strength and induces muscle hypertrophy faster than under normoxic conditions , thus representing a promising new training technique In skeletal muscle , phosphocreatine ( PCr ) recovery from submaximal exercise has become a reliable and accepted measure of muscle oxidative capacity . During exercise , O2 availability plays a role in determining maximal oxidative metabolism , but the relationship between O2 availability and oxidative metabolism measured by 31P-magnetic resonance spectroscopy ( MRS ) during recovery from exercise has never been studied . We used 31P-MRS to study exercising human gastrocnemius muscle under conditions of varied fractions of inspired O2 ( FIO2 ) to test the hypothesis that varied O2 availability modulates PCr recovery from submaximal exercise . Six male subjects performed three bouts of 5-min steady-state submaximal plantar flexion exercise followed by 5 min of recovery in a 1.5-T magnet while breathing three different FIO2 concentrations ( 0.10 , 0 . 21 , and 1.00 ) . Under each FIO2 treatment , the PCr recovery time constants were significantly different , being longer in hypoxia [ 33 . 5 + /- 4.1 s ( SE ) ] and shorter in hyperoxia ( 20.0 + /- 1.8 s ) than in normoxia ( 25.0 + /- 2.7 s ) ( P < /= 0.05 ) . End-exercise pH was not significantly different among the three treatments ( 7.08 + /- 0.01 for 0.10 , 7.04 + /- 0.01 for 0.21 , and 7.04 + /- 0.02 for 1.00 ) . These results demonstrate that PCr recovery is significantly altered by FIO2 and suggest that , after submaximal exercise , PCr recovery , under normoxic conditions , is limited by O2 availability Flaws in the design , conduct , analysis , and reporting of r and omised trials can cause the effect of an intervention to be underestimated or overestimated . The Cochrane Collaboration ’s tool for assessing risk of bias aims to make the process clearer and more Purpose The aim of this study was to analyze the effect of hypoxia on metabolic and acid – base balance , blood oxygenation , electrolyte , and half-squat performance variables during high-resistance circuit ( HRC ) training . Methods Twelve resistance-trained subjects participated in this study . After a 6RM testing session , participants performed three r and omized trials of HRC : normoxia ( NORM : FiO2 = 0.21 ) , moderate hypoxia ( MH : FiO2 = 0.16 ) , or high hypoxia ( HH : FiO2 = 0.13 ) , separated by 72 h of recovery in normoxic conditions . HRC consisted of two blocks of three exercises ( Block 1 : bench press , deadlift and elbow flexion ; Block 2 : half-squat , triceps extension , and ankle extension ) . Each exercise was performed at 6RM . Rest periods lasted for 35 s between exercises , 3 min between sets , and 5 min between blocks . Peak and mean force and power were determined during half-squat . Metabolic , acid – base balance , blood oxygenation and electrolyte variables , arterial oxygen saturation ( SaO2 ) , and rating of perceived exertion ( RPE ) were measured following each block . Results During the first set , peak force and power were significantly lower in HH than MH and NORM ; whereas in the second set , mean and peak force and power were significantly lower in HH than NORM . At the end of the HRC training session , blood lactate and RPE in HH were significantly higher than in MH and NORM . SaO2 , pH , HCO3− , and pO2 values were significantly lower in all hypoxic conditions than in NORM . Conclusion These results indicate that simulated hypoxia during HRC exercise reduce blood oxygenation , pH , and HCO3− , and increased blood lactate ultimately decreasing muscular performance Abstract The aim of the present study was to evaluate the effects of a 6 week resistance training protocol under hypoxic conditions ( FiO2 = 12.9 % , 4000 m ) on muscle hypertrophy . The project included 12 resistance trained male subjects , r and omly divided into two experimental groups . Group 1 ( n = 6 ; age 21 ± 2.4 years ; body height [ BH ] 178.8 ± 7.3 cm ; body mass [ BM ] 80.6 ± 12.3 kg ) and group 2 ( n = 6 ; age 22 ± 1.5 years ; BH 177.8 ± 3.7 cm ; BM 81.1 ± 7.5 kg ) . Each group performed resistance exercises alternately under normoxic and hypoxic conditions ( 4000 m ) for 6 weeks . All subjects followed a training protocol that comprised two training sessions per week at an exercise intensity of 70 % of 1RM ; each training session consisted of eight sets of 10 repetitions of the bench press and barbell squat , with 3 min rest periods . The results indicated that strength training in normobaric hypoxia caused a significant increase in BM ( p < 0.01 ) and fat free mass ( FFM ) ( p < 0.05 ) in both groups . Additionally , a significant increase ( p < 0.05 ) was observed in IGF-1 concentrations at rest after 6 weeks of hypoxic resistance training in both groups . The results of this study allow to conclude that resistance training ( 6 weeks ) under normobaric hypoxic conditions induces greater muscle hypertrophy compared to training in normoxic conditions OBJECTIVES To investigate the effect of blood flow restriction or normobaric hypoxic exposure combined with low-load resistant exercise ( LRE ) , on muscular strength and endurance . DESIGN A r and omised controlled trial . METHODS Well-trained netball players ( n=30 ) took part in a 5 weeks training of knee flexor and extensor muscles in which LRE ( 20 % of one repetition maximum ) was combined with ( 1 ) an occlusion pressure of approximately 230mmHg around the upper thigh ( KT , n=10 ) , ( 2 ) hypoxic air to generate blood oxyhaemoglobin levels of approximately 80 % ( HT , n=10 ) or ( 3 ) with no additional stimulus ( CT , n=10 ) . The training was of the same intensity and amount in all groups . One to five days before and after training , participants performed a series of strength and endurance tests of the lower limbs ( 3-s maximal voluntary contraction [ MVC3 ] , area under 30-s force curve [ MVC30 ] , number of repetitions at 20 % 1RM [ Reps201RM ] ) . In addition , the cross-sectional area ( CSA ) of the quadriceps and hamstrings were measured . RESULTS Relative to CT , KT and HT increased MVC3 ( 11.0±11.9 % and 15.0±13.1 % ) , MVC30 ( 10.2±9.0 % and 18.3±17.4 % ) and Reps201RM ( 28.9±23.7 % and 23.3±24.0 % , mean±90 % confidence interval ) after training . CSA increased by 6.6±4.5 % , 6.1±5.1 % and 2.9±2.7 % in the KT , HT and CT groups respectively . CONCLUSIONS LRE in conjunction with
Output:
| Although RTH improved muscle size and strength , this protocol did not provide significant benefit over resistance training in normoxia . |
MS210856 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: BACKGROUND Intensive exercise training can lead to improvement in strength and functional performance in older people living at home and nursing home residents . There is little information whether intensive physical exercise may be applicable and effective in elderly patients suffering from the acute sequelae of injurious falls or hip surgery . OBJECTIVE To assess the feasibility , safety and efficacy of intensive , progressive physical training in rehabilitation after hip surgery . DESIGN Prospect i ve , r and omised , placebo-controlled intervention study of a 3-months training intervention and a 3-months ' follow-up . SETTING Physical training 6 - 8 weeks after hip surgery . SUBJECTS Twenty-eight ( 15 intervention , 13 control ) elderly patients with a history of injurious falls admitted to acute care or inpatient rehabilitation because of acute fall-related hip fracture or elective hip replacement . METHODS Progressive resistance and functional training to improve strength and functional performance . RESULTS No training-related medical problems occurred in the study group . Twenty-four patients ( 86 % ) completed all assessment s during the intervention and follow-up period . Adherence was excellent in both groups ( intervention : 93 , 0+/-13 , 5 % versus control : 96 , 7+/-6 , 2 % ) . Training significantly increased strength , functional motor performance and balance and reduced fall-related behavioural and emotional problems . Some improvements in strength persisted during 3-months follow-up while other strength variables and functional performances were lost after cessation of training . Patients in the control group showed no change in strength , functional performance and emotional state during intervention and follow-up . CONCLUSIONS Progressive resistance training and progressive functional training are safe and effective methods to increase strength and functional performance during rehabilitation in patients after hip surgery and a history of injurious falls . Because part of the training improvements were lost after stopping the training , a continuing training regime should be established Postoperative length of stay ( LOS ) may be affected by more intensive physical therapy following surgery . This study was design ed to assess whether LOS could be affected by weekend physical therapy following surgery in patients who had undergone total hip arthroplasty ( THA ) or total knee arthroplasty ( TKA ) . Weekend coverage for these patients was made possible by increased staffing in the Physical Therapy Department . The study group consisted of 84 patients who had undergone THA or TKA and had physical therapy treatment the weekend following surgery . The Control group consisted of 53 patients who had undergone THA or TKA prior to the implementation of the weekend intervention program . A retrospective chart audit was used to obtain pertinent information about control group patients . In the total sample mean LOS following weekend therapy ( 10.84 days ) was significantly different ( p < 0.05 ) from mean LOS prior to implementation of the study ( 12.28 days ) . Significant decreases in postoperative LOS were also found within the two subgroups of patients who had undergone THA and TKA . The results indicate that physical therapy treatment the weekend following THA or TKA significantly decreases postoperative LOS when physical therapy re sources are increased to accommo date this increase in coverage OBJECTIVE To compare treadmill training with partial body-weight support ( TT-BWS ) and conventional physical therapy ( PT ) in ambulatory patients with hip arthroplasty . DESIGN R and omized controlled trial . SETTING Rehabilitation center . PARTICIPANTS Eighty patients with a fully loadable implant who could walk independently with crutches after unilateral total hip arthroplasty were r and omized to receive either TT-BWS ( treatment group ) or conventional PT ( controls ) , for 10 working days . INTERVENTIONS Each patient received 45 minutes of individualized PT , either treadmill training plus PT in the experimental or PT alone in the control group . MAIN OUTCOME MEASURES The Harris score , recorded by blind assessors , served as the primary outcome measure . Secondary outcome measures were the hip extension deficit , gait velocity , gait symmetry , affected hip abductor power ; hip abductor amplitude of electromyographic activation ; and the interval from surgery to ab and oning crutches . RESULTS At the end of training , the treatment group 's Harris score was 13.6 points higher ( P<.0001 ) than the control group 's score . Further , hip extension deficit was 6.8 degrees less ( P<.0001 ) , gait symmetry was 10 % greater ( P=.001 ) , affected hip abductor was stronger ( Medical Research Council grade s 4.24 vs 3.73 ; P<.0001 ) , and the amplitude of gluteus medius activity was 41.5 % greater ( P=.001 ) than those measures for controls . Gait velocity did not differ in the 2 groups . These significant differences in favor of the treatment group persisted at 3 and 12 months . The treatment group ab and oned crutches sooner than the control group ( 3 vs 8wk ) . In the treatment group , 39 patients finished treatment , 35 appeared at 3 , and 26 at 12 months for follow-up . In the control group , the corresponding numbers were 40 , 35 , and 24 patients , respectively . CONCLUSION TT-BWS is more effective than conventional PT at restoring symmetrical independent walking after hip replacement The ability to develop muscle force rapidly may be a very important factor to prevent a fall and to perform other tasks of daily life . However , information is still lacking on the range of training-induced neuromuscular adaptations in elderly humans recovering from a period of disuse . Therefore , the present study examined the effect of three types of training regimes after unilateral prolonged disuse and subsequent hip-replacement surgery on maximal muscle strength , rapid muscle force [ rate of force development ( RFD ) ] , muscle activation , and muscle size . Thirty-six subjects ( 60 - 86 yr ) were r and omized to a 12-wk rehabilitation program consisting of either 1 ) strength training ( 3 times/wk for 12 wk ) , 2 ) electrical muscle stimulation ( 1 h/day for 12 wk ) , or 3 ) st and ard rehabilitation ( 1 h/day for 12 wk ) . The nonoperated side did not receive any intervention and thereby served as a within-subject control . Thirty subjects completed the trial . In the strength-training group , significant increases were observed in maximal isometric muscle strength ( 24 % , P < 0.01 ) , contractile RFD ( 26 - 45 % , P < 0.05 ) , and contractile impulse ( 27 - 32 % , P < 0.05 ) . No significant changes were seen in the two other training groups or in the nontrained legs of all three groups . Mean electromyogram signal amplitude of vastus lateralis was larger in the strength-training than in the st and ard-rehabilitation group at 5 and 12 wk ( P < 0.05 ) . In contrast to traditional physiotherapy and electrical stimulation , strength training increased muscle mass , maximal isometric strength , RFD , and muscle activation in elderly men and women recovering from long-term muscle disuse and subsequent hip surgery . The improvement in both muscle mass and neural function is likely to have important functional implication s for elderly individuals This preliminary study examined , in a restricted r and omized trial , the effects of a 6-week arm-crank rehabilitation training program in elderly osteoarthrosis patients after total hip arthroplasty , first on physiological and perceptual responses and second on physical function . Two groups of patients were studied : a training group ( N = 7 , mean age = 74.9 yr , st and ard deviation [ SD ] = 5.0 yr ) who followed a training program in addition to traditional rehabilitation , and a control group who followed traditional rehabilitation only ( N = 7 mean age = 75.4 yr , SD = 5.1 yr ) . At the beginning of the training program , the heart rate and the perceived exertion were not significantly correlated during the exercise session . However , at the end of the training program , five patients had a significant heart rate/perceived exertion relationship ( p < 0.05 ) . Furthermore , positive effects of the arm-crank rehabilitation training program were observed on cardioventilatory and functional responses in the training group compared with the control group . These results suggest that after an habituation period , most of our elderly osteoarthrosis patients experienced physical sensations that were connected to physiological responses . Therefore , perceived exertion could be useful in these patients to regulate exercise intensity , especially at the end of and after the rehabilitation period To determine the effect of minimal exercise on functional fitness following total hip replacement in elderly women , 20 women ( 13 exercisers , 7 controls ) who had undergone unilateral or bilateral hip replacement surgery for primary osteoarthritis were studied . An exercise treadmill test with respiratory gas and blood lactate analyses , and a field test of walking speed on a measured course , were administered before and after a twice weekly exercise programme of three months ' duration . Markers of cardiorespiratory fitness , including peak achieved oxygen uptake ( VO2 ) and ventilatory and lactate thresholds were measured . Maximum self-selected walking speed was also measured over a flat course . Peak VO2 increased in the exercise group when compared to baseline ( P < 0.05 ) but did not differ from the control group . The exercise group significantly improved their walking speed by 10.1 % compared with non-exercising controls ( 1.41 vs 1.20 m/sec , P < 0.05 ) , and increased VO2 at lactate threshold . The improvements occurred despite the twice weekly exercise sessions being below the recommended frequency of exercise for improving cardiorespiratory fitness . Minimal exercise in elderly women after hip surgery can substantially improve submaximal exercise capacity , as well as walking speed Providing physical therapy service on Sundays is a much debated topic among hospital administrators . The purpose of this study was to determine if 7 days per week of physical therapy coverage results in shorter lengths of stay and differing discharge status than 6 days per week . A total of 140 subjects with hip or knee arthroplasty participated ; there were 80 in the 6-day groups and 60 in the 7-day groups . Data on postoperative length of stay , discharge destination , and discharge disposition were collected by retrospective medical record review . The Mann-Whitney U test was used to test for differences in length of stay data , and the chi-squared test was used to test for differences in discharge disposition and discharge destination . No significant differences in postoperative length of stay , discharge destination , nor discharge disposition existed between the 6- and 7-day physical therapy coverage hip or knee arthroplasty groups . However , the power of the statistical tests applied was low . This study provides no evidence that 7-day per week physical therapy results in shortened postoperative length of stay , differing discharge destination , nor differing discharge disposition for patients undergoing hip or knee arthroplasty OBJECTIVE To investigate the influence of an arm-interval exercise program for the upper limbs on health status and walking ability in elderly patients after total hip arthroplasty . DESIGN A r and omized controlled investigation . After surgery , a control group started a general rehabilitation program , and a training group combined it with an arm-interval exercise program . SUBJECTS Fourteen patients ( age 75.1 + /- 4.8 years ) were r and omly assigned to the control group ( n = 7 ) and the training group ( n = 7 ) . METHODS A Western Ontario and MacMaster University ( WOMAC ) Osteoarthritis Index was completed and an incremental exercise test on an arm crank ergometer was also performed 1 month before ( T(-1 ) ) and 2 months after surgery ( T2 ) . Moreover , a 6-minute walk test was performed at T2 . RESULTS Both groups significantly improved all dimensions of WOMAC , except in WOMAC physical function subscale in the control group . The training group covered a significantly longer distance in the walking test than the control group and also presented significantly higher VO2 peak value at T2 . Correlation analyses indicate that VO2 peak value and the distance covered in the 6-minute walking test were significantly associated with functional status . After calculating the ratio distance covered/score at WOMAC physical function , we observed a significantly higher ratio value in the training group than in the control group . CONCLUSION Preliminary results indicate that the improvement in physical fitness and functional status of the training group seems to be associated with better health status Organized physiotherapy starting two months after uncomplicated total hip replacements for primary arthrosis did not improve the rehabilitation . Six months after surgery there were no significant differences between 14 patients with and 16 patients without physiotherapy regarding improvement of passive hip motion , or hip or knee muscle strength of the operated limb . Neither were there any differences in walking ability or activities of daily living OBJECTIVE To assess the efficacy of a home exercise program in increasing hip muscle strength , walking speed , and function in patients more than 1.5 years after total hip replacement ( THR ) . DESIGN R and omized controlled trial . SETTING Kinesiology laboratory . PARTICIPANTS Fifty-three patients with unilateral THR were r and omly assigned to the training ( n=26 ) and control ( n=27 ) groups . Patients in the training group were further divided into exercise-high ( n=13 ) and exercise-low ( n=13 ) compliance groups according to their practice ratio ( high , > or = 50 % ) . INTERVENTION The training group underwent a 12-week home program that included hip flexion range of motion exercises for both hip joints ; strengthening exercises for bilateral hip flexors , extensors , and abductors ; and a 30-minute walk every day . The control group did not receive any training . MAIN OUTCOME MEASURES Strength of bilateral hip muscles , free and fast walking speeds while walking over 3 different terrains , and functional performance were assessed by using a dynamometer , videotape analysis , and the functional activity part of
Output:
| Results indicate that physiotherapy exercise after discharge following total hip replacement has the potential to benefit patients .
Conclusion Insufficient evidence exists to establish the effectiveness of physiotherapy exercise following primary hip replacement for osteoarthritis . |
MS210857 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: BACKGROUND Alveolar bone grafting is a st and ard procedure used to achieve good occlusion for both functional and aesthetic purpose s in patients with cleft lip and palate . At the past , main methods used to evaluate bone bridge formation after bone grafting are radiographs , such as dental , occlusal , and panoramic . PURPOSE To evaluate bone bridge both qualitatively and quantitatively , we used CT scans ( conventional and QCT ) . Quantitative computed tomography ( QCT ) has previously been used for measuring bone mineral density of the lumbar vertebrae . PATIENTS AND METHODS The study comprised 26 male and 15 female patients who underwent alveolar bone grafting . We analyzed bone bridge with regard to four factors : marginal bone level , vertical height , anteroposterior bone width and bone mineral density using dental radiographs , and CT scans such as conventional and QCT . The clinical results of orthodontic treatment were evaluated more than 2 years postoperatively . RESULTS Orthodontic treatment was considered to be successful when the bone bridge satisfied the following criteria : marginal bone level > = 3 , vertical height > = 6.5 mm , anteroposterior bone width > = 5 mm , and bone mineral density < 350 mg Ca(5 ) ( PO(4 ) ) OH/mL. CONCLUSION we could predict the prognosis of patients ' orthodontic treatment in early stage after bone grafting PURPOSE The aim of this study was to assess the 3-dimensional facial surface changes after cleft alveolar bone grafting with digital surface photogrammetry . PATIENTS AND METHODS In a prospect i ve study , 22 patients with cleft lip and palate underwent alveolar bone grafting . Before the procedure and 6 weeks postoperatively and before the continuation of orthodontic treatment , 3-dimensional images were taken with digital surface photogrammetry . Seven st and ard craniofacial l and marks on the nose and the upper lip were identified . Their spatial change because of bone grafting was assessed . Statistical analysis was performed with analysis of variance and t test . RESULTS A significant increase in anterior projection on the operative side ( P < .05 ) was found for the labial insertion points of the alar base ( subalare ) . No significant changes were detected for the position of the labial l and marks . CONCLUSION Our results show 3-dimensionally that there is a positive influence of the alveolar bone graft on the projection of the alar base on the cleft side Yardsticks have been developed to measure dental arch relations in cleft lip and palate ( CLP ) patients as diagnostic proxies for the underlying skeletal relationship . Travelling with plaster casts to compare results between CLP centres is inefficient so the aim of this study was to investigate the reliability of using digital models or photographs of dental casts instead of plaster casts for rating dental arch relationships in children with complete bilateral cleft lip and palate ( CBCLP ) . Dental casts of children with CBCLP ( n=20 ) were included . Plaster casts , digital models and photographs of the plaster casts were available for all the children at 6 , 9 , and 12 years of age . All three record formats were scored using the bilateral cleft lip and palate ( BCLP ) yardstick by four observers in r and om order . No significant differences were found for the BCLP yardstick scores among the three formats . The interobserver weighted kappa scores were between 0.672 and 0.934 . Comparison between the formats per observer result ed in weighted kappa scores between 0.692 and 0.885 . It is concluded that digital models and photographs of dental casts can be used for rating dental arch relationships in patients with CBCLP . These formats are a reliable alternative for BCLP yardstick assessment s on conventional plaster casts OBJECTIVES To evaluate the reliability of clinical assessment , two-dimensional color transparencies and three-dimensional imaging for evaluating the residual facial deformity in patients with repaired complete unilateral cleft lip and palate ( UCLP ) and compare the ratings of facial deformity made by health care professionals with those made by lay assessors . PATIENTS AND PARTICIPANTS Thirty-one r and omly selected subjects aged 10 to 30 years with repaired complete UCLP . Five professionals and five laypersons evaluated each subject 's residual cleft-related facial deformity using clinical assessment , two-dimensional color transparencies , and three-dimensional images . MAIN OUTCOME MEASURES The facial deformity of the full face , lip , nose , and midface were scored using a 5-point ordinal scale on two occasions with a 1-month interval . Intra- and interexaminer agreements were calculated from weighted kappa statistics . Bootstrap permutation tests were used to detect any differences in agreement . RESULTS Assessment of facial deformity showed good reproducibility across the three assessment media ( kappa = 0.42 to 0.83 , SE 0.08 ) . Clinical assessment among lay assessors , however , was poor to moderate ( kappa = 0.16 to 0.58 , SE 0.07 ) . For all assessors , there was no difference in the two non clinical media relative to the st and ard clinical assessment for assessment s of the full face ( p = .377 ) . For assessment s of the lip or nose , transparency scores were in greater agreement with the clinical scores than were the three-dimensional assessment scores ( p = .017 and .011 , respectively ) . For rating the midface , the three-dimensional scores were in greater agreement with the clinical scores than were the color transparencies scores ( p = .047 ) . CONCLUSIONS In comparison with lay assessors , clinical assessment among professionals was more reproducible . This was not so for non clinical media . The equivalence of using the color transparencies and three-dimensional media relative to the clinical assessment depends on the region of the face being considered Aim : Rapid Maxillary Expansion ( RME ) and Delaire facemask are a well-established treatment method for patients with cleft lip and palate and Class III malocclusion . Several roentgenocephalometric studies on skeletal effects of this therapy are known . However , there are no systematic studies on soft tissue changes . The aim of this study was to analyze three-dimensionally the soft tissue changes in facial morphology of children with cleft lip and palate and Class III malocclusion under therapy with RME and Delaire facemask . Patients and Method : A prospect i ve longitudinal clinical trial was undertaken . 29 children between 4.1 and 6.4 years were divided into four groups : eight patients with unilateral cleft lip and palate ( group 1 ) , six patients with isolated cleft palate ( group 2 ) , eight patients with Class III malocclusion ( group 3 ) . The mean treatment period with RME and Delaire mask was 8.2 months . Seven untreated children with no need of orthodontic treatment were chosen as the control ( group 4 ) . Two 3D images , one at the beginning and one at the end of the study , were generated with the DSP 400 © imaging system . Both images were superimposed ten times and measured ten times . Results : We detected significant forward rotation and forward displacement of the soft tissue in the lower midface with the dentoalveolar areas in all patient groups . No significant asymmetric forward displacement of the soft tissue in the maxilla could be verified in the lower or upper midface , not even in the unilateral cleft lip and palate patients . Among the groups , the Class III malocclusion patients showed greater maxillary soft tissue changes . Conclusion : The RME and the Delaire facemask demonstrated the greatest effectiveness in the lower midface soft tissue in terms of forward displacement and forward rotation in the cleft lip and palate patients , particularly in the Class III patients . The 3D data allowed us to discriminatively interpret the effects of the orthopedic mask on the entire maxillary complex and maxillary alveolar process . In the unilateral cleft lip and palate patients , there was descriptively both symmetric and asymmetric advancement of the midface soft tissue . ZusammenfassungZiel : Die Gaumennahterweiterung ( GNE ) und Delaire-Maske stellen ein etabliertes Therapieverfahren bei Patienten mit Lippen- Kiefer-Gaumen-(LKG-)Spalten und Klasse-III-Anomalien dar . Viele röntgenkephalometrische Studien zum skelettalen Effekt dieser Therapie liegen vor . Systematische Untersuchungen zu Weichgewebeveränderungen fehlen jedoch . Ziel dieser Studie war es , die Weich gewebeveränderungen der Gesichtsmorphologie von Kindern mit Spaltbildungen und Klasse-III-Anomalien unter Therapie mit GNE und Delaire-Maske dreidimensional aufzuzeigen . Patienten und Method ik : Es wurde eine klinische prospektive Longitudinaluntersuchung mit 29 in vier Gruppen eingeteilten Kindern zwischen 4,1 und 6,4 Jahren durchgeführt . Acht Patienten mit einseitiger LKG-Spalte ( Gruppe 1 ) , sechs mit isolierter Gaumenspalte ( Gruppe 2 ) und acht mit Klasse-III-Anomalie ( Gruppe 3 ) wurden i m Durchschnitt 8,2 Monate mit GNE und Delaire-Maske beh and elt und untersucht . Sieben unbeh and elte Kinder ohne kieferorthopädischen Beh and lungsbedarf dienten als Kontrolle ( Gruppe 4 ) . Zwei 3D-Abbildungen , eine zum Untersuchungsbeginn und eine zum Untersuchungsende , wurden mit dem DSP-400 © -System generiert , zehnfach überlagert und zehnfach vermessen . Ergebnisse : In allen Gruppen konnte eine signifikante Vorschwenkung und Vorverlagerung des Weichgewebes i m unteren Mittelgesicht mit den dento-alveolären Bereichen nachgewiesen werden . Keine signifikante asymmetrische Vorverlagerung der Maxilla , weder i m unteren noch i m oberen Mittelgesicht , konnte beobachtet werden – auch nicht bei den einseitigen LKG-Spalten . Zwischen den Gruppen zeigten die Klasse-III-Patienten die größeren maxillären Weichgewebeveränderungen . Schlussfolgerungen : Die GNE und die Delaire-Maske zeigten bei den Spaltpatienten und vor allem bei den Klasse-III-Patienten eine deutliche Beeinflussbarkeit auf das Weichgewebe i m Sinne einer Vorverlagerung und einer Vorschwenkung i m unteren Mittelgesicht . Die Wirkungen der orthopädischen Maske auf den gesamten Maxillakomplex sowie auf den maxillären Alveolarfortsatz ließen sich anh and der 3D- Date n unterschiedlich interpretieren . Bei einseitigen LKG-Spalten kam es i m Mittelgesicht deskriptiv sowohl zu symmetrischer als auch asymmetrischer Vorverlagerung des Weichgewebes OBJECTIVE To supply quantitative information about the facial soft tissues of adult operated patients with cleft lip and palate ( CLP ) . DESIGN , SETTING , AND PATIENTS The three-dimensional coordinates of soft tissue facial l and marks were obtained using an electromagnetic digitizer in 18 Caucasian patients with CLP ( 11 males and 7 females aged 19 to 27 years ) and 162 healthy controls ( 73 females and 89 males aged 18 to 30 years ) . From the l and marks , 15 facial dimensions and two angles were calculated . Data were compared with those collected in healthy individuals by computing z-scores . Two summary anthropometric measurements for quantifying craniofacial variations were assessed in both the patients and reference subjects : the mean z-score ( an index of overall facial size ) , and its SD , called the craniofacial variability index ( an index of facial harmony ) . RESULTS In treated patients with CLP , facial size was somewhat smaller than in normal individuals , but in all occasions the mean z-score fell inside the normal interval ( mean + /- 2 SD ) . Almost all patients had a craniofacial variability index larger than the normal interval , indicating a global disharmonious appearance . Overall , in patients pronasale , subnasale , and pogonion were more posterior , the nose was shorter and larger , the face was narrower , and the soft tissue profile and upper lip were flatter than in the reference population . CONCLUSIONS The facial soft tissue structures of adult operated patients with CLP differed from those of normal controls of the same age , sex , and ethnic group . In this patient group , surgical corrections of CLP failed to provide a completely harmonious appearance , even if the deviations from the reference were limited . Further analyses of larger groups of patients are needed Objective To evaluate three-dimensional nasal morphology following primary reconstruction in children with unilateral cleft lip and palate relative to contemporaneous noncleft data . Design Prospect i ve , cross-sectional , controlled study . Setting Glasgow Dental Hospital and School , Faculty of Medicine , Glasgow University . Patients and Participants Two groups of 3-year-old children ( 21 with unilateral cleft lip and palate and 96 controls ) with facial images taken using a three-dimensional , vision-based capture technique . Method Three-dimensional images of the face were reflected so the cleft was on the left side to create a homogeneous group for statistical analysis . Three-dimensional coordinates of anthropometric l and marks were extracted from facial images by a single operator . A set of linear measurements was used to compare cleft and control subjects on right and left sides , adjusting for sex differences . Results The mean nasal base width and the width of the nostril floor on right and left sides differed significantly between control and unilateral cleft lip and palate groups . The measurements were greater in children with unilateral cleft lip and palate . The differences in the mean nasal height and mean nasal projection between the groups were not statistically significant . Mean columellar lengths were different between the left and right sides in children with unilater
Output:
| These techniques are mainly used for soft tissue analysis , evaluation of bone grafting , and changes in the craniofacial skeleton .
Digital dental casts are used to evaluate treatment and changes over time .
Available evidence implies that 3D imaging methods can be used for documentation of CLP patients .
No data are available yet showing that 3D methods are more informative than conventional 2D methods . |
MS210858 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Background Safety surveillance of widely used artemisinin-based combination therapy ( ACT ) is essential , but tolerability data in the over five years age group are largely anecdotal . Methods Two open-label , r and omized trials were conducted in Nimba County , Liberia : i ) the main tolerability trial with 1,000 Plasmodium falciparum malaria patients aged over five years ( Study -T ) , and , ii ) an efficacy trial with a secondary objective of collecting tolerability data among 300 children age six to 59 months ( Study -E ) . In both studies patients were r and omized to fixed-dose artesunate-amodiaquine ( ASAQ Winthrop ® ) or artemether-lumefantrine ( AL , Coartem ® ) , respectively . Clinical - and laboratory-adverse events ( AEs ) were recorded until day 28 . Results Study -T : most patients experienced at least one AE . Severe AEs were few , primarily asymptomatic blood system disorders or increased liver enzyme values . No treatment or study discontinuation occurred . Mild or moderate fatigue ( 39.8 % vs 16.3 % , p < 0.001 ) , vomiting ( 7.1 % vs 1.6 % , p < 0.001 ) , nausea ( 3.2 % vs 1.0 % , p = 0.01 ) , and anaemia ( 14.9 % vs 9.8 % , p = 0.01 ) were more frequently recorded in the ASAQ versus AL arm . Study -E : mild or moderate AEs were common , including anaemia , fatigue , vomiting or diarrhoea . The few severe events were asymptomatic blood system disorders and four clinical events ( pneumonia , malaria , vomiting and stomatitis ) . Conclusion Both ASAQ and AL were well tolerated in patients of all age groups . No unexpected AEs occurred . Certain mild or moderate AEs were more frequent in the ASAQ arm . St and ardised safety surveillance should continue for all forms of ACT.Trial registration The protocol s were registered with Current Controlled Trials , under the identifier numbers IS RCT N40020296 , IS RCT N51688713 , ( http://www.controlled-trials.com ) Background Malaria is a very important cause of anaemia in tropical countries . Anaemia is assessed either by measurement of the haematocrit or the haemoglobin concentration . For comparisons across studies , it is often necessary to derive one measure from the other . Methods Data on patients with slide-confirmed uncomplicated falciparum malaria were pooled from 85 antimalarial drug trials conducted in 25 different countries , to assess the haemoglobin/haematocrit relationship at different time points in malaria . Using a linear r and om effects model , a conversion equation for haematocrit was derived based on 3,254 measurements from various time points ( ranging from day 0 to day 63 ) from 1,810 patients with simultaneous measurements of both parameters . Haemoglobin was also estimated from haematocrit with the commonly used threefold conversion . Results A good fit was obtained using Haematocrit = 5.62 + 2.60 * Haemoglobin . On average , haematocrit/3 levels were slightly higher than haemoglobin measurements with a mean difference ( ± SD ) of -0.69 ( ± 1.3 ) for children under the age of 5 ( n = 1,440 measurements from 449 patients ) . Conclusion Based on this large data set , an accurate and robust conversion factor both in acute malaria and in convalescence was obtained . The commonly used threefold conversion is also valid Background Home-management of malaria ( HMM ) strategy improves early access of anti-malarial medicines to high-risk groups in remote areas of sub-Saharan Africa . However , limited data are available on the effectiveness of using artemisinin-based combination therapy ( ACT ) within the HMM strategy . The aim of this study was to assess the effectiveness of artemether-lumefantrine ( AL ) , presently the most favoured ACT in Africa , in under-five children with uncomplicated Plasmodium falciparum malaria in Tanzania , when provided by community health workers ( CHWs ) and administered unsupervised by parents or guardians at home . Methods An open label , single arm prospect i ve study was conducted in two rural villages with high malaria transmission in Kibaha District , Tanzania . Children presenting to CHWs with uncomplicated fever and a positive rapid malaria diagnostic test ( RDT ) were provisionally enrolled and provided AL for unsupervised treatment at home . Patients with microscopy confirmed P. falciparum parasitaemia were definitely enrolled and review ed weekly by the CHWs during 42 days . Primary outcome measure was PCR corrected parasitological cure rate by day 42 , as estimated by Kaplan-Meier survival analysis . This trial is registered with Clinical Trials.gov , number NCT00454961 . Results A total of 244 febrile children were enrolled between March-August 2007 . Two patients were lost to follow up on day 14 , and one patient withdrew consent on day 21 . Some 141/241 ( 58.5 % ) patients had recurrent infection during follow-up , of whom 14 had recrudescence . The PCR corrected cure rate by day 42 was 93.0 % ( 95 % CI 88.3%-95.9 % ) . The median lumefantrine concentration was statistically significantly lower in patients with recrudescence ( 97 ng/mL [ IQR 0 - 234 ] ; n = 10 ) compared with reinfections ( 205 ng/mL [ 114 - 390 ] ; n = 92 ) , or no parasite reappearance ( 217 [ 121 - 374 ] ng/mL ; n = 70 ; p ≤ 0.046 ) . Conclusions Provision of AL by CHWs for unsupervised malaria treatment at home was highly effective , which provides evidence base for scaling-up implementation of HMM with AL in Tanzania BACKGROUND Adherence to antimalarial drug regimens is improved by simple dosing . If the fixed antimalarial drug combination artemether-lumefantrine ( AL ) could be given once daily , this should improve adherence and thus effectiveness and lower the risk of selecting for resistance . METHODS In an open r and omized study , 43 patients with uncomplicated falciparum malaria were given equivalent doses of AL with 200 ml flavoured milk either as the conventional twice-daily regimen or as a single daily dose for 3 days . The primary end point was a comparison of the areas under the plasma lumefantrine concentration-time curves ( AUC ) . Secondary end points were the day 42 polymerase chain reaction (PCR)-adjusted cure rates and the tolerability profiles . RESULTS Lumefantrine pharmacokinetic profiles were obtained for 36 patients . The AUC((0 - ->infinity ) ) of the once-daily regimen was 30 % lower than that in the conventional regimen ( P = 0.011 ) with a median ( range ) value of 306 ( 114 - 5781 ) microg/ml h , compared with 432 ( 308 - 992 ) microg/ml h. There was no significant difference in the peak plasma concentrations reached . PCR-adjusted cure rate estimates at day 42 of follow-up were 94 % ( 95 % CI : 84 - 100 ) in the six-dose arm and 85 % ( 70 - 100 ) in the three-dose arm ( P = 0.3 ) . CONCLUSION Artemether-lumefantrine efficacy is reduced by once-daily dosing , because absorption of lumefantrine is dose limited . At currently recommended doses , this antimalarial should be given twice daily in a 3-day regimen , with food containing fat Objectives Co-administration of artemether/lumefantrine with antiretroviral therapy has potential for pharmacokinetic drug interactions . We investigated drug – drug interactions between artemether/lumefantrine and efavirenz or nevirapine . Methods We performed a cross-over study in which HIV-infected adults received st and ard six-dose artemether/lumefantrine 80/480 mg before and at efavirenz or nevirapine steady state . Artemether , dihydroartemisinin , lumefantrine , efavirenz and nevirapine plasma concentrations were measured and compared . Results Efavirenz significantly reduced artemether maximum concentration ( Cmax ) and plasma AUC ( median 29 versus 12 ng/mL , P < 0.01 , and 119 versus 25 ng · h/mL , P < 0.01 ) , dihydroartemisinin Cmax and AUC ( median 120 versus 26 ng/mL , P < 0.01 , and 341 versus 84 ng · h/mL , P < 0.01 ) , and lumefantrine Cmax and AUC ( median 8737 versus 6331 ng/mL , P = 0.03 , and 280 370 versus 124 381 ng · h/mL , P < 0.01 ) . Nevirapine significantly reduced artemether Cmax and AUC ( median 28 versus 11 ng/mL , P < 0.01 , and 123 versus 34 ng · h/mL , P < 0.01 ) and dihydroartemisinin Cmax and AUC ( median 107 versus 59 ng/mL , P < 0.01 , and 364 versus 228 ng · h/mL , P < 0.01 ) . Lumefantrine Cmax and AUC were non-significantly reduced by nevirapine . Artemether/lumefantrine reduced nevirapine Cmax and AUC ( median 8620 versus 4958 ng/mL , P < 0.01 , and 66 329 versus 35 728 ng · h/mL , P < 0.01 ) , but did not affect efavirenz exposure . Conclusions Co-administration of artemether/lumefantrine with efavirenz or nevirapine result ed in a reduction in artemether , dihydroartemisinin , lumefantrine and nevirapine exposure . These drug interactions may increase the risk of malaria treatment failure and development of resistance to artemether/lumefantrine and nevirapine . Clinical data from population pharmacokinetic and pharmacodynamic trials evaluating the impact of these drug interactions are urgently needed BACKGROUND Artemisinin-based combination therapies are the recommended first-line treatments of falciparum malaria in all countries with endemic disease . There are recent concerns that the efficacy of such therapies has declined on the Thai-Cambodian border , historically a site of emerging antimalarial-drug resistance . METHODS In two open-label , r and omized trials , we compared the efficacies of two treatments for uncomplicated falciparum malaria in Pailin , western Cambodia , and Wang Pha , northwestern Thail and : oral artesunate given at a dose of 2 mg per kilogram of body weight per day , for 7 days , and artesunate given at a dose of 4 mg per kilogram per day , for 3 days , followed by mefloquine at two doses totaling 25 mg per kilogram . We assessed in vitro and in vivo Plasmodium falciparum susceptibility , artesunate pharmacokinetics , and molecular markers of resistance . RESULTS We studied 40 patients in each of the two locations . The overall median parasite clearance times were 84 hours ( interquartile range , 60 to 96 ) in Pailin and 48 hours ( interquartile range , 36 to 66 ) in Wang Pha ( P<0.001 ) . Recrudescence confirmed by means of polymerase-chain-reaction assay occurred in 6 of 20 patients ( 30 % ) receiving artesunate monotherapy and 1 of 20 ( 5 % ) receiving artesunate-mefloquine therapy in Pailin , as compared with 2 of 20 ( 10 % ) and 1 of 20 ( 5 % ) , respectively , in Wang Pha ( P=0.31 ) . These markedly different parasitologic responses were not explained by differences in age , artesunate or dihydroartemisinin pharmacokinetics , results of isotopic in vitro sensitivity tests , or putative molecular correlates of P. falciparum drug resistance ( mutations or amplifications of the gene encoding a multidrug resistance protein [ PfMDR1 ] or mutations in the gene encoding sarco-endoplasmic reticulum calcium ATPase6 [ PfSERCA ] ) . Adverse events were mild and did not differ significantly between the two treatment groups . CONCLUSIONS P. falciparum has reduced in vivo susceptibility to artesunate in western Cambodia as compared with northwestern Thail and . Resistance is characterized by slow parasite clearance in vivo without corresponding reductions on conventional in vitro susceptibility testing . Containment measures are urgently needed . ( Clinical Trials.gov number , NCT00493363 , and Current Controlled Trials number , IS RCT N64835265 . Background To date no comparative trials have been done , to our knowledge , of fixed-dose artemisinin combination therapies ( ACTs ) for the treatment of Plasmodium
Output:
| The highest risk of recrudescence was observed in areas of emerging artemisinin resistance and very low transmission intensity .
Current artemether-lumefantrine dosing recommendations achieve day 7 lumefantrine concentrations ≥200 ng/ml and high cure rates in most uncomplicated malaria patients . |
MS210859 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: The long pentraxin-3 ( PTX3 ) is a key component of the humoral arm of the innate immune system . PTX3 is produced locally in response to pro-inflammatory stimuli . To investigate PTX3 levels and its use as a biomarker in patients with systemic inflammation , we developed a solid-phase enzyme-linked immunosorbent assay based on novel anti-PTX3 monoclonal antibodies detecting PTX3 with high sensitivity . The assay was applied on 261 consecutive patients admitted to an intensive care unit prospect ively monitored with the systemic inflammatory response syndrome ( SIRS ) . 100 blood donors were included as controls . PTX3 levels were elevated in patients ( median = 71.3 ng/ml ) compared with the controls ( median = 0 ng/ml ) ( Mann-Whitney , p<0.0001 ) . ROC analysis showed that PTX3 levels were significantly specific ( 85.0 % ) and sensitive ( 89.1 % ) to discriminate between healthy controls and patients ( area under the curve ( AUC ) 0.922 ( 95 % CI 0.892 to 0.946 , p<0.0001 ) ) . Higher levels of PTX3 were associated with the development of sepsis , severe sepsis and septic shock ( p = 0.0001 ) . The serum levels of PTX3 correlated significantly with SAPS2 score ( Spearman 's rho 0.28 , p<0.0001 ) . Patients with high levels of PTX3 at admission did have a higher 90 day mortality rate than patients with the 25 % lowest levels ( Cox regression analysis , hazard ratio 3.0 , p = 0.0009 ) . In conclusion , we have established a highly sensitive and robust assay for measurement of PTX3 and found that its serum concentrations correlated with disease severity and mortality in patients with SIRS and sepsis Background New biomarkers are needed to assess the severity of necrotizing soft tissue infection ( NSTI ) at an early stage and to individualize treatment strategies . We assessed pentraxin-3 ( PTX3 ) as a marker of disease severity and risk of death in patients with NSTI . Methods We conducted a prospect i ve , observational study in the intensive care unit at Copenhagen University Hospital , where treatment of NSTI is central ized at a national level . We compared PTX3 , procalcitonin and C-reactive protein in septic shock versus nonshock patients and in amputated versus nonamputated patients using the Mann-Whitney U test . The prognostic value of the markers for 180-day mortality was assessed using Cox regression analyses . Results Patients with NSTI ( n = 135 ) were included over 25 months with up to 2.5-year follow-up ; 71 % had septic shock , amputation was undertaken in 20 % and the 180-day mortality was 27 % . Baseline plasma PTX3 level was significantly higher in patients with septic shock ( 67.3 versus 24.6 ng/mL , p < 0.0001 ) and in patients who underwent amputation ( 118.6 versus 43.6 ng/mL , p = 0.019 ) . No significant differences in baseline procalcitonin or C-reactive protein levels were found according to amputation ( 25.2 versus 7.0 μg/L , p = 0.060 and 202 versus 225 mg/L , p = 0.123 ) , respectively . Baseline PTX3 level above the median was associated with death ( p = 0.009 , log-rank test ) and the univariate Cox regression analysis revealed a significant association between PTX3 level upon admission and 180-day mortality ( hazard ratio 2.60 ( 95 % confidence interval 1.28–5.29 ) , p = 0.008 ) . When adjusted for age , sex , chronic disease and Simplified Acute Physiology Score II , no significant association was found . Conclusions High PTX3 level is associated with septic shock , amputation and risk of death in patients with NSTI , but it is not an independent predictor of 180-day mortality in this patient group . Trial registration Clinical Trials.gov Identifier : NCT02180906 . Date of registration : June 29 , 2014 Purpose Pentraxin 3 ( PTX3 ) is an inflammatory mediator produced by neutrophils , macrophages , myeloid dendritic and endothelial cells . During sepsis a massive inflammatory activation and coagulation/fibrinolysis dysfunction occur . PTX3 , as a mediator of inflammation , may represent an early marker of severity and outcome in sepsis . Methods This study is based on a prospect i ve trial regarding the impact of glycemic control on coagulation in sepsis . Ninety patients admitted to three general intensive care units were enrolled when severe sepsis or septic shock was diagnosed . At enrollment , we recorded sepsis signs , disease severity , coagulation activation [ prothrombin fragments 1 + 2 ( F1 + 2 ) ] and fibrinolysis inhibition [ plasminogen activator inhibitor-1 ( PAI-1 ) ] . We measured plasma PTX3 levels at enrollment , everyday until day 7 , then at days 9 , 11 , 13 , 18 , 23 and 28 . Mortality was recorded at day 90 . Results Although not different on day 1 , PTX3 remained significantly higher in non-survivors than in survivors over the first 5 days ( p = 0.002 by general linear model ) . On day 1 , PTX3 levels were higher in septic shock than in severely septic patients ( p = 0.029 ) . Day 1 PTX3 was significantly correlated with platelet count ( p < 0.001 ) , SAPS II score ( p = 0.006 ) and SOFA score ( p < 0.001 ) . Day 1 PTX3 was correlated with F1 + 2 concentration and with PAI-1 activity and concentration ( p < 0.05 for all ) . Conclusions Persisting high levels of circulating PTX3 over the first days from sepsis onset may be associated with mortality . PTX3 correlates with severity of sepsis and with sepsis-associated coagulation/fibrinolysis dysfunction Abstract Objectives : To determine the diagnostic values of plasma C-reactive protein ( CRP ) , procalcitonin ( PCT ) , and interleukin-6 ( IL-6 ) using an electrochemiluminescence immunoassay ( ECLIA ) method ( Roche Diagnostics GmbH , Mannheim , Germany ) to identify severe sepsis in an emergency room ( ER ) setting . Methods : This was a single-centre prospect i ve follow-up study of 539 consecutive adult patients admitted to the ER with suspected infection . Blood sample s were taken concurrently with blood cultures at admission . Patients were divided into 5 groups on the basis of systemic inflammatory response syndrome ( SIRS ) criteria , documentation of bacterial infection , and organ dysfunction . Fifty-nine patients with no SIRS or bacterial infection , 68 patients with bacterial infection but no SIRS , 54 patients with SIRS but no bacterial infection , 309 patients with sepsis ( SIRS and bacterial infection ) , and 49 patients with severe sepsis ( sepsis and organ failure ) were evaluated . Results : In a logistic regression model , the odds ratio ( OR ) for PCT was 1.58 ( 95 % confidence interval ( CI ) 1.37–1.82 , p < 0.0001 ) , for IL-6 was 1.54 ( 95 % CI 1.32–1.80 , p < 0.0001 ) , and for CRP was 1.33 ( 95 % CI 1.01–1.75 , p = 0.045 ) . The area under the curve ( AUC ) was 0.77 ( 95 % CI 0.71–0.84 ) for PCT , 0.72 ( 95 % CI 0.64–0.80 ) for IL-6 , and 0.60 ( 95 % CI 0.51–0.69 ) for CRP . PCT emerged as the best marker for severe sepsis , but the difference in AUC was not significant between PCT and IL-6 . In multivariate logistic regression analysis , after adjusting for confounders , PCT and IL-6 remained significant independent predictors of severe sepsis . Conclusions : PCT and IL-6 proved superior to CRP in detecting patients with severe sepsis . The findings thus support the use of either PCT or IL-6 as an early tool to diagnose severe sepsis . The automatic ECLIA method allows even night-shift measurements Background : Useful biomarkers that can serve as prognostic predictors are of great value in clinical practice because of the complex individual response to sepsis . Pentraxin 3 ( PTX3 ) , as a multifunctional pattern‐recognition molecule , has been reported to be closely associated with the severity of infectious diseases in intensive care units ( ICU ) . The aim of this study was to investigate whether PTX3 could serve as a potential prognostic biomarker in patients with septic shock . Material s and Methods : This single‐center prospect i ve observational study was conducted during May 2012‐May 2015 in the ICU of Taizhou People 's Hospital . We compared the clinical data and laboratory tests in surviving and deceased patients with septic shock within 28 days from admission . Potential independent prognostic factors for septic shock were analyzed by using univariate and multiple Cox proportional hazards regression analyses . Results : A total of 112 patients admitted to the ICU with septic shock were enrolled in our study with an overall 28‐day mortality of 25.9 % ( 29 of 112 patients ) . PTX3 level was the only independent risk factor for the 28‐day mortality by univariate and multivariate Cox analysis ( hazard ratio = 3.87 ; 95 % CI : 1.66‐8.81 , P = 0.004 ) . The deceased patients had significant higher levels of PTX3 at the 4 different points ( baseline , day 1 , day 2 and day 3 ) versus the survivors ( P < 0.001 ) . Results from Kaplan‐Meier curves and log‐rank test revealed that high PTX3 level ( above the median value ) was statistically associated with a lower 28‐day survival rate ( P = 0.014 ) . Conclusions : The baseline PTX3 level was an independent predictor for 28‐day mortality in patients with septic shock OBJECTIVES The aim was to assess the diagnostic and prognostic value of measuring pentraxin 3 ( PTX3 ) together with C-reactive protein ( CRP ) in patients with ventilator-associated pneumonia ( VAP ) . BACKGROUND The PTX3 values increase rapidly during multiple inflammatory conditions , but little is known about its characteristics in VAP . METHODS Measurement of PTX3 and CRP levels in plasma from 136 consecutive patients receiving mechanical ventilation > 48 h in a prospect i ve single center study . RESULTS A PTX3 threshold of > 16.43 ng/ml provided a specificity of 74.0 % and a sensitivity of 68.6 % for the diagnosis of VAP . PTX3 correlated with severity of sepsis and peaked earlier than CRP in patients with confirmed VAP . Multivariate Cox regression analysis showed PTX3 was the independent predictor for mortality of VAP . CONCLUSIONS PTX3 was not superior to CRP as a biomarker to diagnose VAP , but it was an early indicator of inflammation and had better prognostic value to predict mortality than CRP OBJECTIVE To estimate the diagnostic value of serum PCT , CRP , leukocyte count and temperature as markers of sepsis in critically ill ICU burn patients . DESIGN AND SETTING Prospect i ve , observational study in a four bed Burn Intensive Care Unit . PATIENTS Forty-three patients admitted in a Burn ICU were included in our study . MEASUREMENTS AND RESULTS Serum PCT , CRP concentrations , WCC ( white cell count ) , neutrophils and temperature were measured within the first 24h after-burn and daily thereafter . Severity of organ failure was estimated by sequential organ failure assessment ( SOFA ) score . Every day we classified all patients in one of the following three categories : non-systemic inflammatory condition ( non-SIRS ) , SIRS non-infected and SIRS 2 infected or sepsis . Patients with infected SIRS differ significantly from non-infected SIRS in PCT ( 11.8+/-15.8 versus 0.63+/-0.0.43 , respectively , p < 0.001 ) . On the other h and , WCC , temperature and neutrophils did not differ significantly between patients with SIRS non-infected and infected SIRS . CRP was elevated in all three groups but did n't differ significantly between SIRS non-infected and septic patients . Area under receiver operating curves was 0.975 and showed reasonable discriminative power ( p = 0.002 , 95 % CI , 0.91 - 1.035 ) in predicting of sepsis only for PCT . CONCLUSIONS Serum procalcitonin levels can be used as an early indicator of septic complication in patients with severe burn injury BACKGROUND The long pentraxin PTX3 is a key component of the humoral arm of inn
Output:
| CONCLUSIONS PTX-3 significantly predicts disease severity and mortality in sepsis |
MS210860 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: The authors examined sources of variance in self-reported physical activity in a cohort of healthy adults ( n = 580 ) from Worcester , Massachusetts ( the Seasonal Variation of Blood Cholesterol Study , 1994 - 1998 ) . Fifteen 24-hour physical activity recalls of total , occupational , and nonoccupational activity ( metabolic equivalent-hours/day ) were obtained over 12 months . R and om effects models were employed to estimate variance components for subject , season , day of the week , and residual error , from which the number of days of assessment required to achieve 80 % reliability was estimated . The largest proportional source of variance in total and nonoccupational activity was within-subject variance ( 50 - 60 % of the total ) . Differences between subjects accounted for 20 - 30 % of the overall variance in total activity , and seasonal and day-of-the-week effects accounted for 6 % and 15 % , respectively . For total activity , 7 - 10 days of assessment in men and 14 - 21 days of assessment in women were required to achieve 80 % reliability . For nonoccupational activity , 21 - 28 days of assessment were required . This study is among the first to have examined the sources of variance in daily physical activity levels in a large population of adults using 24-hour physical activity recall . These findings provide insight for underst and ing the strengths and limitations of short term and long term physical activity assessment s employed in epidemiologic studies Background and Purpose — More than 70 % of individuals who have a stroke experience upper limb deficits that impact daily activities . Increased amount of upper limb therapy has positive effects ; however , practical and inexpensive methods of therapy are needed to deliver this increase in therapy . Methods — This was a multi-site single blind r and omized controlled trial to determine the effectiveness of a 4-week self-administered grade d repetitive upper limb supplementary program ( GRASP ) on arm recovery in stroke . 103 in patients with stroke were r and omized to the experimental group ( GRASP group , n=53 ) or the control group ( education protocol , n=50 ) . The primary outcome measure was the Chedoke Arm and H and Activity Inventory ( CAHAI ) , a measure of upper limb function in activities of daily living . Secondary measures were used to evaluate grip strength and paretic upper limb use outside of therapy time . Intention-to-treat analysis was performed . Group differences were tested using analysis of covariance . Results — At the end of the 4-week intervention ( approximately 7 weeks poststroke ) , the GRASP group showed greater improvement in upper limb function ( CAHAI ) compared to the control group ( mean difference 6.2 ; 95 % CI : 3.4 to 9.0 ; P<0.001 ) . The GRASP group maintained this significant gain at 5 months poststroke . Significant differences were also found in favor of the GRASP protocol for grip strength and paretic upper limb use . No serious adverse effects were experienced . Conclusion — A self-administered homework exercise program provides a cost- , time- , and treatment-effective delivery model for improving upper limb recovery in subacute stroke Objective : To compare the outcome of robot-assisted therapy with dose-matched active control therapy by using accelerometers to study functional recovery in chronic stroke patients . Design : Prospect i ve , r and omized , controlled trial . Setting : Stroke units in three medical centres . Subjects : Twenty patients post stroke for a mean of 22 months . Intervention : Robot-assisted therapy ( n = 10 ) or dose-matched active control therapy ( n = 10 ) . All patients received either of these two therapies for 90–105 minutes each day , 5 days per week , for four weeks . Main measures : Outcome measures included arm activity ratio ( the ratio of mean activity between the impaired and unimpaired arm ) and scores on the Fugl-Meyer Assessment Scale , Functional Independence Measure , Motor Activity Log and ABILH AND question naire . Results : The robot-assisted therapy group significantly increased motor function , hemiplegic arm activity and bilateral arm coordination ( Fugl-Meyer Assessment Scale : 51.20 ± 8.82 , P = 0.002 ; mean arm activity ratio : 0.76 ± 0.10 , P = 0.026 ; ABILH AND question naire : 1.24 ± 0.28 , P = 0.043 ) compared with the dose-matched active control group ( Fugl-Meyer Assessment Scale : 40.90 ± 13.14 ; mean arm movement ratio : 0.69 ± 0.11 ; ABILH AND question naire : 0.95 ± 0.43 ) . Conclusions : Symmetrical and bilateral robotic practice , combined with functional task training , can significantly improve motor function , arm activity , and self-perceived bilateral arm ability in patients late after stroke OBJECTIVE To examine the psychometric properties of an objective method for assessing real-world arm activity in a large sample with subacute stroke . DESIGN Validation study . SETTING Community . PARTICIPANTS Persons 3 to 9 months poststroke ( N=169 ) with mild to moderate motor impairment of their hemiparetic arm enrolled in a multisite , r and omized clinical trial of constraint-induced movement therapy . INTERVENTIONS Not applicable . MAIN OUTCOME MEASURES Participants wore an accelerometer on each arm outside the laboratory for 3 days before and after treatment or an equivalent no-treatment period . They also completed the Actual Amount of Use Test ( AAUT ) , which is an observational measure of spontaneous more-impaired arm use , and the Motor Activity Log ( MAL ) , which is an interview assessing more-impaired arm use in daily life . RESULTS Low-pass-filtered accelerometer recordings were reliable ( r range , > .8 ) and stable ( P range , > .48 ) . Their validity was also supported . Correlations calculated across all participants at baseline between the ratio of more-impaired to less-impaired arm accelerometer recordings and AAUT and MAL scores were .60 and .52 , respectively . CONCLUSIONS Accelerometry provides an objective , real-world index of more-impaired arm activity with good psychometric properties Aim : The aim of the present study was the evaluation of actigraphy as a tool to objectify the recovery process after motor paresis due to stroke . Methods : The motor activity of both arms of patients suffering from stroke was actigraphically recorded at four different time points during the course of rehabilitation : 24–36 h , 5–7 days , 3 months , and 6 months after stroke . Results : Motor activity monitored by wrist-worn actigraphs located at the impaired side revealed an increase in activity between the first two time points and the subsequent ones . Additionally , actigraphic recordings showed lower total motor activity at the impaired side as compared to the nonimpaired side . A significant positive correlation was found between the actigraphically recorded motor activity and the results of the Sc and inavian Stroke scale , the Barthel Index , the Rankin Scale Score and with the Motoricity Index during the 1st week , which corresponds to the time when neurological deficits were most pronounced . Conclusion : Our results suggest that actigraphy is a useful tool in the objective evaluation of motor activity after stroke . Moreover , actigraphy covers additional aspects that are not reflected by the usual stroke scales in a clinical situation
Output:
| The efficacy of a rehabilitation intervention was assessed using accelerometry by three studies : in two studies both accelerometry and clinical test scores detected a post-treatment difference but in one study accelerometry data did not change despite clinical test scores showing motor and functional improvements . |
MS210861 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: INTRODUCTION Various methods and material s are used in the treatment of dentin hypersensitivity . The aim of this r and omized prospect i ve controlled clinical trial was to evaluate and compare the desensitizing effects of the neodymium-doped yttrium aluminium garnet ( Nd : YAG ) laser and fluoride varnish by considering the degree of pre- and posttreatment pain , discomfort , and functional complications . METHODS Twenty patients with clinical ly diagnosed cervical dentin hypersensitive teeth were included and r and omly allocated to either the application of fluoride varnish ( group fluoride ) or Nd : YAG laser ( 100 mJ , 20 Hz ; group Nd : YAG ) . The assessment of pain and discomfort was performed by a visual analog scale after an air blast at baseline , immediately after treatment , and at patient visits on weeks 1 , 2 , 3 , and 4 . RESULTS Laser treatment result ed in significant improvements of discomfort immediately after treatment and after 1 week . At the 2- , 3- , and 4-week examination , the discomfort in group fluoride decreased up to nearly 75 % to 85 % of baseline scores , whereas the effect of the laser stayed nearly unchanged . The visual analog scale scores for pain at 4 weeks examination were significantly lower in the fluoride group compared with those in the laser group ( p < 0.05 ) . CONCLUSIONS Nd : YAG laser is a suitable tool for the immediately successful reduction of dentinal hypersensitivity and has better patient satisfaction and shorter treatment time Sixty adult patients were examined for dentin hypersensitivity prior to periodontal surgery . Stimuli used included mechanical , cold water and compressed air blasts . A subjective assessment of the degree of hypersensitivity for each stimulus was recorded . This presurgical examination revealed 249 hypersensitive areas among 60 subjects . Following surgery there was over a 100 % increase in the pain ( hypersensitivity ) score . Desensitization with a 10 % strontium chloride hexahydrate dentifrice was begun 1 week after surgical treatment . After 7 weeks of dentifrice use the pain score was reduced 75.5 % in the test group . This was a reduction to a point below the preoperative level . The placebo group showed a reduction of 34.2 % which was still above the preoperative level . These results agree with other clinical studies that have demonstrated a desensitizing effect of strontium chloride OBJECTIVE The aim of the present study was to evaluate and compare the efficacy of CO(2 ) and Er : YAG lasers alone and in combination with topical sodium fluoride ( NaF ) in the management of dentine hypersensitivity . MATERIAL S AND METHODS A group of 50 patients presenting with a total of 420 hypersensitive teeth were r and omly allocated into five groups . Group 1 was treated with 2 % NaF , groups 2 and 3 were lased by a CO(2 ) ( 1 W , continuous wave mode , for 10 sec ) or Er : YAG ( 30 Hz , 60 mJ for 10 sec , without water/air spray ) laser , and groups 4 and 5 received NaF plus the CO(2 ) and the Er : YAG laser , respectively . The scanning speed of the laser was 0.8 mm/sec . The degree of thermal sensitivity was determined with an evaporative stimulus consisting of a 1-sec air blast at a distance of 2 mm from each site tested . Quantification of the degree of discomfort was determined according to a four-point pain scale before treatment and 1 wk , 1 mo , and 6 mo after treatment . RESULTS All treatment forms result ed in significant improvement of discomfort . At 1 wk , 1 mo , and 6 mo , cold air blast scores were significantly reduced compared to baseline scores , except for the NaF group . In the NaF group , there was a statistically significant increase in mean degree of discomfort at 6 mo compared with 1 wk ( p + /- 0.01 ) and 1 mo ( p + /- 0.001 ) . Comparison of the other treatment regimens revealed that cold air blast scores were significantly lower for the other four treatments than for NaF gel alone ( p + /- 0.001 ) . No superiority was found for desensitization among the CO(2 ) , Er : YAG , CO(2 ) + NaF , and Er : YAG + NaF groups . CONCLUSIONS We concluded that both the CO(2 ) and Er : YAG lasers have promising potential for the treatment of dentine hypersensitivity . Lasers in combination with NaF gel appear to show better efficacy compared to either treatment modality alone OBJECTIVE To compare the clinical efficacy of the GaAlAs laser and dentin bonding agent in treating dentin hypersensitivity . METHODS One hundred and forty teeth from 70 patients diagnosed with dentin hypersensitivity , were divided into two groups : In group I , teeth were irradiated with 30 mW GaAlAs laser for 1 min and in group II , teeth were applied with dentin bonding agent . Sensitivity was assessed by tactile and thermal tests , measured with the criteria proposed by Uchida at baseline and after treatment ; immediately , at 15 and at 30 days . RESULTS The reduction of dentin hypersensitivity was observed in both treatments using the GaAlAs laser and dentin bonding agent . However , a greater reduction was observed over time up to day 15 and no significant change was observed between days 15 and 30 . Statistically significant differences in the level of dentin hypersensitivity between bonding agent and the GaAlAs laser were found at each observation period ( p < 0.05 ) . CONCLUSION The GaAlAs laser had less desensitizing efficacy compared with dentin bonding agent . However , the desensitizing effect of the GaAlAs laser still could be considered an effective therapy for treating dentin hypersensitivity Our previous in vitro study indicated that Nd : YAG laser irradiation on dentin could melt normal dentin surface and close the exposed dentinal tubule orifices without creating surface cracks . This study evaluated the morphologic changes of hypersensitive dentin after Nd : YAG laser irradiation . Thirty patients with clinical ly diagnosed cervical dentin hypersensitive teeth were treated with a Nd : YAG laser of 30 mJ intensity at 10 pulses per second for 2 min . An impression of the sensitive area was taken before and after laser treatment and then examined with a scanning electron microscope . The impression of the dentin surface after Nd : YAG laser treatment showed no protrusive rods , in contrast with the presence of numerous rods before laser irradiation . Because protrusive rods are a measure of open dentinal tubules , we interpret these data to support the hypothesis that Nd : YAG laser irradiation at specifications of 30 mJ , 10 pulses per second , and 2 min can be used to seal the exposed dentinal tubules Clinical trials on dentine hypersensitivity have been numerous and protocol s varied . To date there is little consensus as to the conduct of studies on this poorly-understood yet common and painful dental condition . A committee of interested persons from academia and industry was convened to discuss the subject of clinical trials on dentine hypersensitivity and a consensus report is presented . A double-blind r and omized parallel groups design is recommended , although cross-over design s may be used for the preliminary screening of agents . Subjects may have multiple sites scored . Sample size will be determined by estimating the variability in the study population , the effect to be detected and the power of the statistical test to be used . Subject selection is based on a clinical diagnosis of dentine hypersensitivity , excluding those with conflicting characteristics such as currently-active medical or dental therapy . The vestibular surfaces of incisors , cuspids and bicuspids are preferred as sites to be tested . A range of sensitivity levels should be included . Tactile , cold and evaporative air stimuli should be applied . Negative and benchmark controls should be incorporated . Most trials should last 8 weeks . Sensitivity may be assessed either in terms of the stimulus intensity required to evoke pain or the subjective evaluation of pain produced by a stimulus using a visual analog or other appropriate scale . The subject 's overall assessment may be determined by question naire . Outcomes should be expressed in terms of clinical ly significant changes in symptoms . Follow-up evaluation is required to determine the persistence of changes . At least 2 independent trials should be conducted before a product receives approval Various methods and material s used in the treatment of dentin hypersensitivity are thought to achieve a therapeutic benefit by tubule occlusion . The aim of the present study was to evaluate the combined occluding effect of sodium fluoride varnish and Nd : YAG laser irradiation on human dentinal tubules . Thirty-six dentin specimens with exposed dentinal tubule orifices were used in this study . The sample s were r and omly divided into four groups . Groups A , B , and C were varnished by sodium fluoride , whereas group D served as a control . Then , group C was lased by 30 mJ of Nd : YAG laser , 10 pulses/s for 2 min by light painting . Three hours later , groups B and C were brushed by an electrical toothbrush for 30 min . Under SEM observation , the control group showed numerous exposed dentinal tubule orifices , and the sodium fluoride varnished specimens showed closure of exposed dentinal tubule orifices . After electrical toothbrushing , most of the sodium fluoride varnish was brushed away , except in the specimens that were irradiated by Nd : YAG laser . Over 90 % of the dentinal tubule orifices were occluded by sodium fluoride varnish combined with Nd : YAG laser irradiation OBJECTIVES This study evaluated the immediate and 3 month clinical effects of a low-level gallium-aluminum-arsenide ( GaAlAs ) laser and a 3 % potassium oxalate gel for the treatment of dentinal hypersensitivity . MATERIAL S AND METHODS A total of 164 teeth from 30 patients with clinical diagnoses of dentinal hypersensitivity were selected for this r and omized , placebo-controlled , double-blind clinical study . The teeth were r and omized to three groups : GaAlAs laser , oxalate gel , and placebo gel . The treatment sessions were performed at 7 d intervals for four consecutive weeks . The degree of sensitivity in response to an air blast and tactile stimuli was assessed according to a visual analogue scale at baseline , immediately after the fourth application , and then 3 months after the fourth application . The reductions in dentinal hypersensitivity from baseline at the two follow-up assessment s were evaluated as the main outcome . RESULTS In both the active and control groups , there were statistically significant reductions in dentinal hypersensitivity immediately after and 3 months after the treatments , when compared with the hypersensitivity at baseline . No significant differences among the three groups could be detected in their efficacy at either the immediate or 3 month evaluations irrespective of the stimulus . CONCLUSIONS The treatments under study were effective for reducing dentinal hypersensitivity , and longer observational periods could enhance the ability of studies to detect differences between active and placebo groups Dentine hypersensitivity has of long been known to be a common clinical problem in dental practice s. Lasers have recently come to play a prominent role in the treatment of this disorder . They might , however , cause dental pulp damage . This study was conducted to evaluate the effect of Nd : yttrium – aluminum – garnet ( YAG ) laser on partial oxygen saturation of pulpal blood in sensitive anterior teeth . In this clinical trial , 65 hypersensitive teeth were selected and r and omly allocated to two groups . The study group involved Nd : YAG laser treatment , while no treatment was employed for the control group . Using a pulse oximetry system , evaluations were preformed of the partial oxygen saturation in the pulpal blood before , immediately after , 1 week after , and 1 month after the treatment . The results were analyzed using the SPSS software and repeated- measures analysis of variance and paired- sample s t tests . The mean partial oxygen saturation of the blood was found to be 85.4 % in the study group , which was not significantly different from that of the control group . No significant differences were observed in the control group between the means obtained from pretreatment and post-treatment intervals ( P > 0.05 ) . The Post-treatment partial oxygen saturation mean rose to 89.3 % ( P = 0.001 ) and remained constant throughout the following week after it . However , no significant differences were found between the pretreatment partial oxygen saturation mean and the same measurement 1 month after treatment ( P = 0.702 ) . Nd : YAG laser therapy for dentine desensitization of anterior teeth caused no persistent changes in the partial oxygen saturation of pulpal blood . It may , therefore , be concluded that the diffusion of heat induced by the Nd : YAG laser into the pulp within the limit of the desensitization parameters cause no irreversible damages in the dental pulp BACKGROUND , AIMS Promising results using Nd : YAG laser against dentin hypersensitivity have been reported . The aim of this double-blind , controlled , split-mouth design ed clinical trial was to assess the effect of a single Nd : YAG laser application on alleviating hypersensitivity . METHODS / RESULTS Seventeen subjects participated in the study . Each of them had two teeth treated ; one with the laser activated and one with nonactivated ( placebo ) , for 2 min The assessment of pain was performed by a VAS , after an air blast at baseline immediately after treatment , at 1 week , 4 weeks and 16 weeks . Mean values of VAS for test and control teeth were compared by paired t-test ( alpha = 0.05 ) . The results showed mean baseline VAS values of 6.59 ( + /- 1.65 ) and 6.14(+/- 1.95 ) for test and control teeth , respectively
Output:
| The remaining studies involved Nd : YAG laser , Er : YAG laser and CO2 laser , and all showed that the three types of lasers were superior to topical desensitising agents , but the superiority was slight .
A systematic review of the literature indicates the likelihood that laser therapy has a slight clinical advantage over topical medicaments in the treatment of dentine hypersensitivity . |
MS210862 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: BACKGROUND Dietary intake of fish and the omega-3 fatty acids have been associated with lower risk of Alzheimer disease and stroke . OBJECTIVE To examine whether intakes of fish and the omega-3 fatty acids protect against age-related cognitive decline . DESIGN Prospect i ve cohort study . SETTING Geographically defined Chicago , Ill , community . PARTICIPANTS Residents , 65 years and older , who participated in the Chicago Health and Aging Project . MAIN OUTCOME MEASURE Change in a global cognitive score estimated from mixed models . The global score was computed by summing scores of 4 st and ardized tests . In-home cognitive assessment s were performed 3 times over 6 years of follow-up . RESULTS Cognitive scores declined on average at a rate of 0.04 st and ardized units per year ( SU/y ) . Fish intake was associated with a slower rate of cognitive decline in mixed models adjusted for age , sex , race , education , cognitive activity , physical activity , alcohol consumption , and total energy intake . Compared with a decline rate in score of -0.100 SU/y among persons who consumed fish less than weekly , the rate was 10 % slower ( -0.090 SU/y ) among persons who consumed 1 fish meal per week and 13 % slower ( -0.088 SU/y ) among persons who consumed 2 or more fish meals per week . The fish association was not accounted for by cardiovascular-related conditions or fruit and vegetable consumption but was modified after adjustment for intakes of saturated , polyunsaturated , and trans fats . There was little evidence that the omega-3 polyunsaturated fatty acids were associated with cognitive change . CONCLUSIONS Fish consumption may be associated with slower cognitive decline with age . Further study is needed to determine whether fat composition is the relevant dietary constituent Tissue levels of n-3 fatty acids reflect dietary intake , but quantitative data about rate of incorporation and levels as a function of intake are scarce . We fed 58 men 0 , 3 , 6 , or 9 g/d of fish oil for 12 months and monitored fatty acids in serum cholesteryl esters , erythrocytes , and subcutaneous fat during and after supplementation . Eicosapentaenoic acid ( EPA ) in cholesteryl esters plateaued after 4 - 8 weeks ; the incorporation half-life was 4.8 days . Steady-state levels increased by 3.9 + /- 0.3 mass % points ( + /- SE ) for each extra gram of EPA eaten per day . Incorporation of docosahexaenoic acid ( DHA ) was erratic ; plateau values were 1.1 + /- 0.1 mass % higher for every g/d ingested . Incorporation of EPA into erythrocyte membranes showed a half-life of 28 days ; a steady state was reached after 180 days . Each g/d increased levels by 2.1 + /- 0.1 mass % . C22:5n-3 levels increased markedly . Changes in DHA were erratic and smaller . EPA levels in adipose tissue rose also ; the change after 6 months was 67 % of that after 12 months in gluteal and 75 % in abdominal fat . After 12 months each gram per day caused an 0.11 + /- 0.01 mass % rise in gluteal fat for EPA , 0.53 + /- 0.07 for C22:5n-3 , and 0.14 + /- 0.03 for DHA . Thus , different ( n-3 ) fatty acids were incorporated with different efficiencies , possibly because of interconversions or different affinities of the enzymatic pathways involved . EPA levels in cholesteryl esters reflect intake over the past week or two , erythrocytes over the past month or two , and adipose tissue over a period of years . These findings may help in assessing the intake of ( n-3 ) fatty acids in epidemiological studies BACKGROUND Plasma fatty acids may affect the risk of cognitive decline in older adults . OBJECTIVES We prospect ively studied the association between plasma fatty acids and cognitive decline in adults aged 50 - 65 y at baseline and conducted a subgroup analysis . DESIGN From 1987 through 1989 , the Atherosclerosis Risk in Communities ( ARIC ) Study analyzed plasma fatty acids in cholesteryl esters and phospholipids in whites residing in Minneapolis , MN . From 1990 through 1992 and from 1996 through 1998 , 3 neuropsychological tests in the domains of delayed word recall , psychomotor speed , and verbal fluency were administered . We selected cutoffs for statistically reliable cognitive decline in each of these domains and a measure of global cognitive change computed by principal-components analysis . Multivariate logistic regression was conducted . Focusing on n-3 highly unsaturated fatty acids ( HUFAs ) , a subgroup analysis assessed differential association across potential effect modifiers implicated in oxidative stress and increased risk of neurodegenerative disease . RESULTS In the 2251 study subjects , the risk of global cognitive decline increased with elevated palmitic acid in both fractions and with high arachidonic acid and low linoleic acid in cholesteryl esters . Higher n-3 HUFAs reduced the risk of decline in verbal fluency , particularly in hypertensive and dyslipidemic subjects . No significant findings were shown for psychomotor speed or delayed word recall . CONCLUSIONS Promoting higher intakes of n-3 HUFAs in the diet of hypertensive and dyslipidemic persons may have substantial benefits in reducing their risk of cognitive decline in the area of verbal fluency . However , clinical trials are needed to confirm this finding BACKGROUND Very-long-chain n-3 polyunsaturated fatty acids ( n-3 PUFAs ) are suggested to be related to cognitive performance in older adults . However , limited data exist on the association between n-3 PUFAs and performance in specific cognitive domains . OBJECTIVE We evaluated the association between plasma n-3 PUFA proportions and cognitive performance in 5 cognitive domains and determined whether plasma n-3 PUFA proportions predict cognitive change over 3 y. DESIGN We used data from the FACIT trial , in which participants received folic acid or placebo capsules for 3 y. Fatty acid proportions in plasma cholesteryl esters at baseline were measured in 807 men and women aged 50 - 70 y. Cognitive performance for memory , sensorimotor speed , complex speed , information-processing speed , and word fluency was assessed at baseline and after 3 y. The cross-sectional analyses were based on all 807 participants ; the longitudinal analyses were based only on 404 participants in the placebo group . RESULTS Higher plasma n-3 PUFA proportions predicted less decline in sensorimotor speed ( multiple linear regression coefficient , z score = 0.31 ; 95 % CI : 0.06 , 0.57 ) and complex speed ( 0.40 ; 95 % CI : 0.10 , 0.70 ) over 3 y. Plasma n-3 PUFA proportions did not predict 3-y changes in memory , information-processing speed , or word fluency . The cross-sectional analyses showed no association between plasma n-3 PUFA proportions and performance in any of the 5 cognitive domains . CONCLUSIONS In this population , plasma n-3 PUFA proportions were associated with less decline in the speed-related cognitive domains over 3 y. These results need to be confirmed in r and omized controlled trials CONTEXT Higher adherence to a Mediterranean-type diet is linked to lower risk for mortality and chronic diseases , but its association with cognitive decline is unclear . OBJECTIVE To investigate the association of a Mediterranean diet with change in cognitive performance and risk for dementia in elderly French persons . DESIGN , SETTING , AND PARTICIPANTS Prospect i ve cohort study of 1410 adults ( > or = 65 years ) from Bordeaux , France , included in the Three-City cohort in 2001 - 2002 and reexamined at least once over 5 years . Adherence to a Mediterranean diet ( scored as 0 to 9 ) was computed from a food frequency question naire and 24-hour recall . MAIN OUTCOME MEASURES Cognitive performance was assessed on 4 neuropsychological tests : the Mini-Mental State Examination ( MMSE ) , Isaacs Set Test ( IST ) , Benton Visual Retention Test ( BVRT ) , and Free and Cued Selective Reminding Test ( FCSRT ) . Incident cases of dementia ( n = 99 ) were vali date d by an independent expert committee of neurologists . RESULTS Adjusting for age , sex , education , marital status , energy intake , physical activity , depressive symptomatology , taking 5 medications/d or more , apolipoprotein E genotype , cardiovascular risk factors , and stroke , higher Mediterranean diet score was associated with fewer MMSE errors ( beta = -0.006 ; 95 % confidence interval [ CI ] , -0.01 to -0.0003 ; P = .04 for 1 point of the Mediterranean diet score ) . Performance on the IST , BVRT , or FCSRT over time was not significantly associated with Mediterranean diet adherence . Greater adherence as a categorical variable ( score 6 - 9 ) was not significantly associated with fewer MMSE errors and better FCSRT scores in the entire cohort , but among individuals who remained free from dementia over 5 years , the association for the highest compared with the lowest group was significant ( adjusted for all factors , for MMSE : beta = -0.03 ; 95 % CI , -0.05 to -0.001 ; P = .04 ; for FCSRT : beta = 0.21 ; 95 % CI , 0.008 to 0.41 ; P = .04 ) . Mediterranean diet adherence was not associated with the risk for incident dementia ( fully adjusted model : hazard ratio , 1.12 ; 95 % CI , 0.60 to 2.10 ; P = .72 ) , although power to detect a difference was limited . CONCLUSIONS Higher adherence to a Mediterranean diet was associated with slower MMSE cognitive decline but not consistently with other cognitive tests . Higher adherence was not associated with risk for incident dementia IMPORTANCE Oxidative stress and vascular impairment are believed to partly mediate age-related cognitive decline , a strong risk factor for development of dementia . Epidemiologic studies suggest that a Mediterranean diet , an antioxidant-rich cardioprotective dietary pattern , delays cognitive decline , but clinical trial evidence is lacking . OBJECTIVE To investigate whether a Mediterranean diet supplemented with antioxidant-rich foods influences cognitive function compared with a control diet . DESIGN , SETTING , AND PARTICIPANTS Parallel-group r and omized clinical trial of 447 cognitively healthy volunteers from Barcelona , Spain ( 233 women [ 52.1 % ] ; mean age , 66.9 years ) , at high cardiovascular risk were enrolled into the Prevención con Dieta Mediterránea nutrition intervention trial from October 1 , 2003 , through December 31 , 2009 . All patients underwent neuropsychological assessment at inclusion and were offered retesting at the end of the study . INTERVENTIONS Participants were r and omly assigned to a Mediterranean diet supplemented with extravirgin olive oil ( 1 L/wk ) , a Mediterranean diet supplemented with mixed nuts ( 30 g/d ) , or a control diet ( advice to reduce dietary fat ) . MAIN OUTCOMES AND MEASURES Rates of cognitive change over time based on a neuropsychological test battery : Mini-Mental State Examination , Rey Auditory Verbal Learning Test ( RAVLT ) , Animals Semantic Fluency , Digit Span subtest from the Wechsler Adult Intelligence Scale , Verbal Paired Associates from the Wechsler Memory Scale , and the Color Trail Test . We used mean z scores of change in each test to construct 3 cognitive composites : memory , frontal ( attention and executive function ) , and global . RESULTS Follow-up cognitive tests were available in 334 participants after intervention ( median , 4.1 years ) . In multivariate analyses adjusted for confounders , participants allocated to a Mediterranean diet plus olive oil scored better on the RAVLT ( P = .049 ) and Color Trail Test part 2 ( P = .04 ) compared with controls ; no between-group differences were observed for the other cognitive tests . Similarly adjusted cognitive composites ( mean z scores with 95 % CIs ) for changes above baseline of the memory composite were 0.04 ( -0.09 to 0.18 ) for the Mediterranean diet plus olive oil , 0.09 ( -0.05 to 0.23 ; P = .04 vs controls ) for the Mediterranean diet plus nuts , and -0.17 ( -0.32 to -0.01 ) for the control diet . Respective changes from baseline of the frontal cognition composite were 0.23 ( 0.03 to 0.43 ; P = .003 vs controls ) , 0.03 ( -0.25 to 0.31 ) , and -0.33 ( -0.57 to -0.09 ) . Changes from baseline of the global cognition composite were 0.05 ( -0.11 to 0.21 ; P = .0
Output:
| n‐3 fatty acids were associated with better global cognition and some specific cognitive domains though some results were conflicting .
Adherence to the MedDiet was also significantly associated with better cognitive performance and less cognitive decline .
Finally , better cognitive performance was observed in men compared to women and mixed results were also found for the influence of APOE4 genotype on the association between n‐3 fatty acids or MedDiet and cognition .
Conclusions : Studies suggest that n‐3 fatty acids in the diet and adherence to the MedDiet are beneficial in slowing age‐related cognitive decline .
Highlightsn‐3 fatty acids were associated with better cognitive performance in the older population .Greater adherence to the Mediterranean diet was related with better cognitive performance .
Greater adherence to the Mediterranean diet was associated with less cognitive decline |
MS210863 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: This study evaluated a two-year multidisciplinary early intervention pilot programme for back-injured nurses employed at a large teaching hospital , using a pre- versus post-programme analysis . The purpose was to ascertain whether this programme could reduce the incidence , morbidity , time lost and cost due to back injuries in the 250 nurses employed on ten targeted high-risk wards . Injuries in the remaining 1395 nurses employed on the other 45 wards were monitored concurrently for comparison . The programme consisted of prompt assessment , treatment and rehabilitation through modified work . Evaluative data were gathered by one research nurse on st and ardized forms at the time of injury , weekly until return to work , and at a six-month follow-up . Time lost and cost data for up to one-year post-injury were derived from workers ' compensation statements . Compared to the two years prior to introduction of the programme , the rates of back injuries and lost-time back injuries decreased by 23 % and 43 % , respectively , on the targeted wards , while these increased on the control wards . Combined expenditure was 32 % lower per injury and 34 % lower per lost-time injury for those in the targeted group who consented to take part in the programme compared to their counterparts on the control wards , as the increased assessment and treatment costs per case attributable to the programme were more than offset by the savings in lower compensation ( wage loss ) costs . This programme thus reduced the incidence and time lost due to back injuries and was cost-beneficial OBJECTIVE Musculoskeletal soft tissue injuries consume considerable re sources in personal suffering , medical care , work absenteeism , and compensation benefits . Our aim was to determine specific clinical and behavioral factors that prognostically influence return to work following musculoskeletal work related injuries . METHODS A longitudinal cohort study was conducted on 148 r and omly selected workers who had not returned to work in 3 months following musculoskeletal soft tissue injury . The cohort was identified from the files of the Workers ' Compensation Board of Ontario , Canada . The workers were interviewed and assessed at 3 , 9 , 15 , and 21 months after injury . The WHO Classification of Impairment , Disabilities and H and icap was used as the conceptual framework . The analysis employed a proportional hazards regression model with allowance for time dependent covariates . RESULTS The rate of return to work for men was 1.5 times that for women , and 20 % less for every 10 year increase in age . Controlling for sex and age , psychological distress and functional disability were associated with a slower rate of return to work . The rate of return to work for workers who were provided with modified jobs was 2 times higher than for those with no such accommodation in employment . CONCLUSION The negative effect of psychological distress and functional disability on return to work rates must be considered in the design and delivery of rehabilitation programming for workers with musculoskeletal soft tissue injuries . The employer 's provision of a " modified job " is important in the prevention of continued disability Study Design . R and omized controlled trial . Objectives . To investigate the effectiveness and costs of a mini-intervention , provided in addition to the usual care , and the incremental effect of a work site visit for patients with subacute disabling low back pain . Summary of Background Data . There is lack of data on cost-effectiveness of brief interventions for patients with prolonged low back pain . Methods . A total of 164 patients with subacute low back pain were r and omized to a mini-intervention group ( A ) , a work site visit group ( B ) , or a usual care group ( C ) . Groups A ( n = 56 ) and B ( n = 51 ) underwent one assessment by a physician plus a physiotherapist . Group B received a work site visit in addition . Group C served as controls ( n = 57 ) and was treated in municipal primary health care . All patients received a leaflet on back pain . Pain , disability , specific and generic health-related quality of life , satisfaction with care , days on sick leave , and use and costs of health care consumption were measured at 3- , 6- , and 12-month follow-ups . Results . During follow-up , fewer subjects had daily pain in Groups A and B than in Group C ( Group A vs. Group C , P = 0.002 ; Group B vs. Group C , P = 0.030 ) . In Group A , pain was less bothersome ( Group A vs. Group C , P = 0.032 ) and interfered less with daily life ( Group A vs. Group C , P = 0.040 ) than among controls . Average days on sick leave were 19 in Group A , 28 in Group B , and 41 in Group C ( Group A vs. Group C , P = 0.019 ) . Treatment satisfaction was better in the intervention groups than among the controls , and costs were lowest in the mini-intervention group . Conclusions . Mini-intervention reduced daily back pain symptoms and sickness absence , improved adaptation to pain and patient satisfaction among patients with subacute low back pain , without increasing health care costs . A work site visit did not increase effectiveness Aims : To develop a model of prognosis for time receiving workers ’ compensation wage replacement benefits in the first year . Methods : A prospect i ve cohort of 907 injured workers off work because of soft tissue injuries was followed for one year through structured telephone interviews and administrative data sources . Workers were recruited at workers ’ compensation cl aim registration . Only those still off work at four weeks post- registration were included in the analysis . Data from several domains ( demographics , clinical factors , workplace factors , recovery expectations ) were collected at approximately two weeks and a subset again at four weeks . Outcome was duration on total temporary wage replacement benefits . Variable selection was carried out in two steps using content experts and backward elimination with the Cox model . Results : Body region specific functional status , change in pain , workplace offers of arrangements for return to work , and recovery expectations were independently predictive of time on benefits . Change in pain and workplace offers interacted , so the largest mutual association occurred for those whose pain was getting worse — that is , reduction in median duration from 112.5 to 32.5 days . Across observed values , widely different recovery profiles of groups of workers result ed ; for example , at four months , only one third of the highest risk group had gone off benefits while over 95 % of the lowest risk group had done so . Conclusions : Focus on a relatively small set of prognostic factors should enable occupational health practitioners to triage injured workers within the first month and concentrate on those requiring additional assistance to return to work This paper describes a participatory ergonomics program aim ed at early return to regular work of workers suffering from subacute occupational back pain and assesses the perceptions of the participants on the implementation of ergonomic solutions in the workplace . The participatory ergonomics program was used in the rehabilitation of workers suffering from subacute back pain for more than 6 weeks , a program that was associated with an increased rate of return to work . The perceptions of the participatory ergonomics participants were assessed 6 months after completion of the ergonomic intervention through a question naire sent to employer representatives , union representatives and injured workers of participating workplaces . About half of the ergonomic solutions were implemented according to the perception of the participants , with a substantial agreement between respondents Study Design . Population ‐based r and omized clinical trial . Objectives . To develop and test a model of management of subacute back pain , to prevent prolonged disability . Summary of Background Data . The present management of back pain seems inadequate , and development of innovative models has been urged . Methods . A model for the treatment of subacute work‐related back pain has been developed and evaluated in a population ‐based r and omized clinical trial . Workers ( n = 130 ) from eligible workplaces in the Sherbrooke area ( N = 31 ) , who had been absent from work for more than 4 weeks for back pain , were r and omized , based on their workplace , in one of four treatment groups : usual care , clinical intervention , occupational intervention , and full intervention ( a combination of the last two ) . The duration of absence from regular work and from any work was evaluated using survival analysis . Functional status and pain were compared at study entry and after 1 year of follow‐up . Results . The full intervention group returned to regular work 2.41 times faster than the usual care intervention group ( 95 % confidence interval 1.19‐4.89 ; P = 0.01 ) . The specific effect of the occupational intervention accounted for the most important part of this result , with a rate ratio of return to regular work of 1.91 ( 95 % confidence interval = 1.18‐3.10 ; P < 0.01 ) . Pain and disability scales demonstrated either a statistically significant reduction or a trend toward reduction in the three intervention groups , compared with the trend in the usual care intervention group . Conclusions . Close association of occupational intervention with clinical care is of primary importance in impeding progression toward chronicity of low back pain Two years of prospect i ve data on 416 back injuries were gathered at a 1100-bed acute and tertiary care hospital to assist target prevention efforts . The rate of injury among 1645 nurses was found to be highest for those working on orthopaedic , medicine , neurology , spinal and surgery wards , indicating priorities for prevention . In fact , 51 % of the orthopaedic nurses sustained at least one back injury during the two-year period . Gender did not significantly affect the risk of back injury ; however , injuries were slightly more common in nurses with less seniority and younger nurses were found to be at significantly increased risk of back injury . Almost 63 % of the back injuries which occurred in nurses working 8 h shifts on the high-risk wards occurred during the first two hours of the shift . Lifting and transferring patients with assistance were the two most common mechanisms for back injury ( 22.6 % and 23.3 % , respectively ) . In total , injured nurses attributed 52.3 % of their injuries to inadequate training ; inadequate staffing was given as the primary reason for 13.8 % of the injuries . The results suggest that training in the indications for and use of mechanical devices for lifting/transferring patients requires intensification , and a ' warm-up ' period should also be considered in the face of injuries occurring early in the shift if work activities can not be evenly planned Aims : To test the long term cost-benefit and cost-effectiveness of the Sherbrooke model of management of subacute occupational back pain , combining an occupational and a clinical rehabilitation intervention . Methods : A r and omised trial design with four arms was used : st and ard care , occupational arm , clinical arm , and Sherbrooke model arm ( combined occupational and clinical interventions ) . From the Quebec WCB perspective , a cost-benefit ( amount of consequence of disease costs saved ) and cost-effectiveness analysis ( amount of dollars spent for each saved day on full benefits ) were calculated for each experimental arm of the study , compared to st and ard care . Results : At the mean follow up of 6.4 years , all experimental study arms showed a trend towards cost benefit and cost effectiveness . These results were owing to a small number of very costly cases . The largest number of days saved from benefits was in the Sherbrooke model arm . Conclusions : A fully integrated disability prevention model for occupational back pain appeared to be cost beneficial for the workers ’ compensation board and to save more days on benefits than usual care or partial interventions . A limited number of cases were responsible for most of the long term disability costs , in accordance with occupational back pain epidemiology . However , further studies with larger sample s will be necessary to confirm these results STUDY DESIGN Cluster r and omized controlled trial . OBJECTIVE To evaluate the effectiveness of two strategies to improve the use of active sick leave ( ASL ) for patients with low back pain . SUMMARY OF BACKGROUND DATA ASL is a public sickness benefit scheme offered to promote early return to modified work for temporarily disabled workers . It was poorly used , and the authors design ed two community interventions to strengthen the implementation of ASL based on the results of a study of barriers to use among back pain patients , employers , general practitioners ( GPs ) , and local National Insurance Administration staff . METHODS Sixty-five municipalities in three counties in Norway , r and omly assigned to a passive intervention , a proactive intervention , or a control group . The interventions were targeted at patients on sick leave for low back pain for more than 16 days ( n = 6176 ) , their GPs , employers , and local insurance officers . The passive intervention included reminders about ASL on the sick leave form that GPs must complete , a st and ard agreement to facilitate ASL , targeted information , and a desktop summary for GPs of clinical practice guidelines for low back pain , emphasizing the importance of advice to stay active . The proactive intervention included these elements plus a re source person to facilitate the use of ASL and a continuing education workshop for GPs . The main outcome measure reported here is the proportion of eligible patients that used ASL . RESULTS ASL was used significantly more in the proactive intervention municipalities ( 17.7 % ) compared with the passive intervention and control municipalities ( 11.5 % , P = 0.018 ) . CONCLUSIONS A passive intervention that addressed identified barriers to the use of ASL did not increase its use . Although modest , a proactive intervention did increase its use . The main impact of the intervention was through direct contact and motivating telephone calls to patients . To the extent that GPs ' practice was changed , it was either patient mediated or by patients bypassing their GP Background The causes of prolonged disability due to back pain are multiply determined , involving medical , social , and environmental factors . Possible solutions to the problem of prolonged back pain disability have emerged from recent research but few efforts have been made to transfer evidence -based programs to large community setting s. Objective This article describes three phases of the process of transfer of evidence from rehabilitation research to community practice in the province of Quebec . Methods and Results Phase A : Based on literature review and expert knowledge , the Sherbrooke model was developed and assessed through a population -based , r and omized clinical trial . Results at 1-year follow-up showed
Output:
| There was strong evidence that work disability duration is significantly reduced by work accommodation offers and contact between healthcare provider and workplace ; and moderate evidence that it is reduced by interventions which include early contact with worker by workplace , ergonomic work site visits , and presence of a RTW coordinator .
For these five intervention components , there was moderate evidence that they reduce costs associated with work disability duration .
Conclusions : Our systematic review provides the evidence base supporting that workplace-based RTW interventions can reduce work disability duration and associated costs , however the evidence regarding their impact on quality -of-life outcomes was much weaker |
MS210864 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Pilot studies for phase III trials - which are comparative r and omized trials design ed to provide preliminary evidence on the clinical efficacy of a drug or intervention - are routinely performed in many clinical areas . Also commonly know as " feasibility " or " vanguard " studies , they are design ed to assess the safety of treatment or interventions ; to assess recruitment potential ; to assess the feasibility of international collaboration or coordination for multicentre trials ; to increase clinical experience with the study medication or intervention for the phase III trials . They are the best way to assess feasibility of a large , expensive full-scale study , and in fact are an almost essential pre-requisite . Conducting a pilot prior to the main study can enhance the likelihood of success of the main study and potentially help to avoid doomed main studies . The objective of this paper is to provide a detailed examination of the key aspects of pilot studies for phase III trials including : 1 ) the general reasons for conducting a pilot study ; 2 ) the relationships between pilot studies , proof-of-concept studies , and adaptive design s ; 3 ) the challenges of and misconceptions about pilot studies ; 4 ) the criteria for evaluating the success of a pilot study ; 5 ) frequently asked questions about pilot studies ; 7 ) some ethical aspects related to pilot studies ; and 8) some suggestions on how to report the results of pilot investigations using the CONSORT format This is a prospect i ve study of clinical questions generated in primary care consultations and a comparison of two approaches to answering those clinical questions . Twenty-one doctors in a university-based primary care clinic su bmi tted 78 clinical questions arising from patient consultations during 24 clinic days ( 0.01 question per patient encounter ) . These doctors subsequently found answers to 40 % of their questions but were satisfied with only 67 % of these answers . The investigators were able to provide answers for 95 % of the questions asked and the doctors rated these answers as satisfactory in 86 % of instances . Answers obtained by investigators had significantly higher satisfaction score than those obtained by doctors ' search ( p = 0.002 ) . The two main findings of this study are ( 1 ) almost all questions arising in clinic setting could be answered by intensive search ; ( 2 ) answers found by intensive search es were judged to be more satisfactory than those found routinely by doctors . Provision of an information retrieval service in addition to training in the search ing and appraisal of medical literature are possible solutions to the information needs of busy clinicians OBJECTIVE To evaluate the quality of evidence reporting , breadth of coverage , and timeliness of content updating of 10 selected online medical texts . STUDY DESIGN AND SETTING Each text was assessed for quality based on an 11-item scale , which included items related to editorial policy and updating , appraisal , and transparent incorporation of newly published clinical research and evidence -based guidelines . Breadth of coverage was determined by the percentage of 60 r and omly selected International Classification of Diseases 10 ( ICD-10 ) codes covered by each of the texts . The same 60 ICD-10 codes were used to obtain a sample of topic chapters for the assessment of timeliness of up date s. RESULTS Quality scores ranged from a high of 9 of 11 points ( Clinical Evidence ) to a low of 0 of 11 points ( PEPID ) , with a mean score of 6.7 . Breadth of coverage ranged from 83 % of r and omly selected topics covered ( UpTo Date ) to 25 % ( Clinical Evidence ) , with 6 of 10 texts covering 60 % or more ; average coverage across all texts was 57 % . Variability was also observed with regard to average time since last content up date , ranging from 3.5 ( DynaMed ) to 29 months ( First Consult ) , with an average time since up date of 12.4 months . CONCLUSION No single re source was ideal and those seeking answers to clinical questions are well-advised not to rely solely on a single point-of-care product OBJECTIVE Usage of computer re sources at the point of care has a positive effect on physician decision making . Pediatricians ' information-seeking behaviors are not well characterized . The goal of this study was to characterize quantitatively the information-seeking behaviors of general pediatricians and specifically compare their use of computers , including digital libraries , before and after an educational intervention . METHODS General pediatric residents and faculty at a US Midwest children 's hospital participated . A control ( year 1 ) versus intervention group ( year 2 ) research design was implemented . Eligible pediatrician pools overlapped , such that some participated first in the control group and later as part of the intervention . The intervention group received a 10-minute individual training session and h and out on how to use a pediatric digital library to answer professional questions . A general medical digital library was also available . Pediatricians in both the control and the intervention groups were surveyed using the critical incident technique during 2 6-month time periods . Both groups were telephoned for 1- to 2-minute interviews and were asked , " What pediatric question ( s ) did you have that you needed additional information to answer ? " The main outcome measures were the differences between the proportion of pediatricians who use computers and digital libraries and a comparison of the number of times that pediatricians use these re sources before and after intervention . RESULTS A total of 58 pediatricians were eligible , and 52 participated ( 89.6 % ) . Participant demographics between control ( N = 41 ; 89.1 % ) and intervention ( N = 31 ; 70.4 % ) were not statistically different . Twenty pediatricians were in both groups . Pediatricians were slightly less likely to pursue answers after the intervention ( 94.7 % vs 89.2 % ) ; the primary reason cited for both groups was a lack of time . The pediatricians were as successful in finding answers in each group ( 95.7 % vs 92.7 % ) , but the intervention group took significantly less time ( 8.3 minutes vs 19.6 minutes ) . After the intervention , pediatricians used computers and digital libraries more to answer their questions and spent less time using them . CONCLUSION This study showed higher rates of physician questions pursued and answered and higher rates of computer use at baseline and after intervention compared with previous studies . Pediatricians who seek answers at the point of care therefore should begin to shift their information-seeking behaviors toward computer re sources , as they are as effective but more time-efficient BACKGROUND Clinicians often rely on review material rather than analysis of primary research to guide therapy . Systematic review s use methods to insure thoroughness and to minimize bias , but many clinicians are not familiar with systematic review s and continue to rely on narrative review s. OBJECTIVES To determine whether a traditional narrative review or a systematic review is perceived to be more useful . METHODS A clinical scenario ( patient with chronic Crohn 's disease considered for azathioprine therapy ) was circulated to gastroenterologists , along with a narrative review of therapy ( including azathioprine ) for inflammatory bowel disease written by an acknowledged expert , or with a systematic Cochrane review of the use of azathioprine for this disease . Whether knowledge of authors hip and journal source influences the perception of usefulness of a narrative review was investigated . RESULTS The Cochrane review was rated significantly more highly than the narrative review on a 100 mm visual analogue scale ( 21.3 mm ; 95 % CI 14.5 to 28 mm ) . The proportion of respondents who considered the review to be a useful guide was also higher in the group that received the Cochrane review ( 91 % ) than in the group that received the narrative review , with author and journal concealed ( 62 % ) or identified ( 70 % ) ( P<0.001 for both comparisons ) . Ratings from the two groups that received the narrative review were not significantly different . CONCLUSIONS The focused systematic review was perceived to be more useful than a traditional broad narrative review as a guide to making a decision concerning the use of specific therapy . The possible strengths of systematic review s should be more fully investigated . If there is additional evidence supporting their greater value to clinicians , they should be made more widely available to clinicians and their strengths should be publicized OBJECTIVE To measure the effects of a summary -of- findings ( SoF ) table on user satisfaction , underst and ing , and time spent finding key results in a Cochrane review . STUDY DESIGN AND SETTING We r and omized participants in an evidence -based practice workshop ( r and omized controlled trial [ RCT ] I ) and a Cochrane Collaboration entities meeting ( RCT II ) to receive a Cochrane review with or without an SoF table . In RCT I , we measured user satisfaction . In RCT II , we measured correct comprehension and time spent finding key results . RESULTS RCT I : Participants with the SoF table ( n=47 ) were more likely to " agree " or " strongly agree " that it was easy to find results for important outcomes than ( n=25 ) participants without the SoF table-68 % vs. 40 % ( P=0.021 ) . RCT II : Participants with the SoF table ( n=18 ) were more likely to correctly answer two questions regarding results than ( n=15 ) those without the SoF table : 93 % vs. 44 % ( P=0.003 ) and 87 % vs. 11 % ( P<0.001 ) . Participants with the SoF table spent an average of 90 seconds to find key information compared with 4 minutes for participants without the SoF table ( P=0.002 ) . CONCLUSION In two small trials , we found that inclusion of an SoF table in a review improved underst and ing and rapid retrieval of key findings compared with review s with no SoF table R and omised controlled trials are widely accepted as the most reliable method of determining effectiveness , but most trials have evaluated the effects of a single intervention such as a drug . Recognition is increasing that other , non-pharmacological interventions should also be rigorously evaluated.1 - 3 This paper examines the design and execution of research required to address the additional problems result ing from evaluation of complex interventions —that is , those “ made up of various interconnecting parts.”4 The issues dealt with are discussed in a longer Medical Research Council paper ( www.mrc.ac.uk/complex_packages.html ) . We focus on r and omised trials but believe that this approach could be adapted to other design s when they are more appropriate . # # # # Summary points Complex interventions are those that include several components The evaluation of complex interventions is difficult because of problems of developing , identifying , documenting , and reproducing the intervention A phased approach to the development and evaluation of complex interventions is proposed to help research ers define clearly where they are in the research process Evaluation of complex interventions requires use of qualitative and quantitative evidence There are specific difficulties in defining , developing , documenting , and reproducing complex interventions that are subject to more variation than a drug . A typical example would be the design of a trial to evaluate the benefits of specialist stroke units . Such a trial would have to consider the expertise of various health professionals as well as investigations , drugs , treatment guidelines , and arrangements for discharge and follow up . Stroke units may also vary in terms of organisation , management , and skill mix . The active components of the stroke unit may be difficult to specify , making it difficult to replicate the intervention . The box gives other examples of complex interventions . # # # # Examples of complex interventions Service delivery and organisation : Stroke units Hospital at home Interventions directed at health professionals ' behaviour : Strategies for implementing guidelines Computerised decision support Community interventions : Community
Output:
| Conclusions Agreement between investigators in assessing participants ’ answers is satisfactory .
The results indicate that conducting a full-scale trial is feasible . |
MS210865 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: This study assessed the effects of regular coffee drinking on 24-hour ambulatory blood pressure ( ABP ) in normotensive and hypertensive older men and women . Twenty-two normotensive and 26 hypertensive , nonsmoking men and women , with a mean age of 72.1 years ( range , 54 to 89 years ) , took part in the study . After 2 weeks of a caffeine-free diet , subjects were r and omized to continue with the caffeine-free diet and abstain from caffeine-containing drinks or drink instant coffee ( 5 cups per day , equivalent to 300 mg caffeine per day ) in addition to the caffeine-free diet for a further 2 weeks . Change in systolic and diastolic blood pressures ( SBP , DBP ) determined by 24-hour ambulatory BP monitoring showed significant interactions between coffee drinking and hypertension status . In the hypertensive group , rise in mean 24-hour SBP was greater by 4.8 ( SEM , 1.3 ) mm Hg ( P=0.031 ) and increase in mean 24-hour DBP was higher by 3.0 ( 1.0 ) mm Hg ( P=0.010 ) in coffee drinkers than in abstainers . There were no significant differences between abstainers and coffee drinkers in the normotensive group for 24-hour , daytime , or nighttime SBP or DBP . In older men and women with treated or untreated hypertension , ABP increased in coffee drinkers and decreased in abstainers . Restriction of coffee intake may be beneficial in older hypertensive individuals CONTEXT Caffeine acutely increases blood pressure , but the association between habitual consumption of caffeinated beverages and incident hypertension is uncertain . OBJECTIVE To examine the association between caffeine intake and incident hypertension in women . DESIGN , SETTING , AND PARTICIPANTS Prospect i ve cohort study conducted in the Nurses ' Health Studies ( NHSs ) I and II of 155,594 US women free from physician-diagnosed hypertension followed up over 12 years ( 1990 - 1991 to 2002 - 2003 question naires ) . Caffeine intake and possible confounders were ascertained from regularly administered question naires . We also tested the associations with types of caffeinated beverages . MAIN OUTCOME MEASURE Incident physician-diagnosed hypertension . RESULTS During follow-up , 19,541 incident cases of physician-diagnosed hypertension were reported in NHS I and 13,536 in NHS II . In both cohorts , no linear association between caffeine consumption and risk of incident hypertension was observed after multivariate adjustment ( NHS I , P for trend = .29 ; NHS II , P for trend = .53 ) . Using categorical analysis , an inverse U-shaped association between caffeine consumption and incident hypertension was found . Compared with participants in the lowest quintile of caffeine consumption , those in the third quintile had a 13 % and 12 % increased risk of hypertension , respectively ( 95 % confidence interval in NHS I , 8%-18 % ; in NHS II , 6%-18 % ) . When study ing individual classes of caffeinated beverages , habitual coffee consumption was not associated with increased risk of hypertension . By contrast , consumption of cola beverages was associated with an increased risk of hypertension , independent of whether it was sugared or diet cola ( P for trend < .001 ) . CONCLUSION No linear association between caffeine consumption and incident hypertension was found . Even though habitual coffee consumption was not associated with an increased risk of hypertension , consumption of sugared or diet cola was associated with it . Further research to eluci date the role of cola beverages in hypertension is warranted Coffee consumption has been associated with elevated plasma cholesterol . One hundred eighty-one men consumed a st and ard caffeinated coffee for 2 mo followed by r and omization to continue caffeinated coffee ( control ) , change to decaffeinated coffee or no coffee for 2 mo . Plasma low-density-lipoprotein ( LDL ) cholesterol and apolipoprotein B concentrations increased significantly ( 0.12 + /- 0.65 mmol/L , P less than 0.025 ; 0.06 + /- 0.12 g/L , P less than 0.0004 , respectively ) in the group that changed to decaffeinated coffee . In a subgroup ( n = 51 ) , post-heparin lipoprotein lipase decreased significantly more ( -270 mmol free fatty acids . L-1.h-1 , P less than 0.003 ) in the decaffeinated-coffee group . Resting heart rate and blood pressure did not change significantly . Change from caffeinated to decaffeinated coffee increased plasma LDL cholesterol and apolipoprotein B whereas discontinuation of caffeinated coffee revealed no change . This finding suggests that a coffee component other than caffeine is responsible for the LDL cholesterol , apolipoprotein B , and lipase activity changes reported in this investigation BACKGROUND Only 2 prospect i ve studies have previously investigated the association between coffee consumption and incident hypertension , and the findings are equivocal . OBJECTIVE The objective was to determine the relation between coffee consumption and the incidence of antihypertensive drug treatment . DESIGN We prospect ively followed 24 710 Finnish subjects aged 25 - 64 y without a history of antihypertensive drug treatment , coronary heart disease , or stroke at baseline . Daily coffee consumption was assessed by question naires . RESULTS During a mean follow-up period of 13.2 y , 2505 participants started antihypertensive drug treatment . The multivariate-adjusted ( age , sex , study year , education , leisure-time physical activity , smoking , body mass index , high total cholesterol , history of diabetes , and alcohol , tea , fruit , vegetable , sausage , and bread consumption ) hazard ratios for antihypertensive drug treatment associated with the amount of coffee consumed daily ( 0 - 1 , 2 - 3 , 4 - 5 , 6 - 7 , or > or=8 cups ) were 1.00 , 1.29 ( 95 % CI : 1.09 , 1.54 ) , 1.26 ( 95 % CI : 1.06 , 1.49 ) , 1.24 ( 95 % CI : 1.04 , 1.48 ) , and 1.14 ( 95 % CI : 0.94 , 1.37 ) ( P for trend = 0.024 ) , respectively . This trend became marginally significant after additional adjustment for baseline systolic blood pressure ( P for trend = 0.077 ) . CONCLUSIONS The results indicate that coffee drinking seems to increase the risk of antihypertensive drug treatment , and this risk was higher in subjects with low-to-moderate coffee intakes ; however , there was no significantly increased trend in drinkers of approximately 1 cup ( 100 mL)/d or > or=8 cups/d BACKGROUND AND AIM Coffee is rich in chlorogenic acids ( CGA ) , whose metabolites may have beneficial effects such as anti-hypertensive effects . However , trial results concerning the effects of coffee on blood pressure ( BP ) are not consistent . A recent study suggested that hydroxyhydroquinone ( HHQ ) , produced by the roasting of green coffee beans , inhibits the effect of CGA . In the present study , the dose-response for CGA in HHQ-free coffee on BP were investigated in mildly hypertensive men and women . METHODS AND RESULTS The trial design was a double-blind , r and omized controlled trial , with five study groups including , control , zero-dose , low-dose , middle-dose and high-dose . The control beverage was identical to ordinary coffee . The others contained reduced HHQ levels , compared to ordinary coffee , and the CGA were adjusted in target concentration . A total of 203 subjects were r and omly allocated . Each subject drank one cup of coffee per day . The study involved a screening and a baseline observation period of 6 weeks and an intervention period of 4 weeks . BP response showed CGA has an anti-hypertensive effect in a dose-dependent manner in HHQ-free coffee , and ordinary coffee showed almost no effect . As a result , a significant correlation between BP change and the three dose-response patterns was observed ( p<0.001 ) . CONCLUSIONS This study demonstrates a dose-dependent decrease in BP for CGA in HHQ-free coffee The effects of coffee on blood pressure and heart-rate and the mediating effect of two common brewing methods , were studied in a r and omized trial in 107 young , normotensive adults . After a three-week run-in period , subjects were r and omly assigned to one of three groups , receiving either ( 1 ) 4 - 6 cups filtered coffee per day , ( 2 ) 4 - 6 cups boiled coffee per day , or ( 3 ) no coffee at all for a period of nine weeks . Because all participants consumed filtered coffee before the trial , the group continuing on filtered coffee was considered as the reference group . Both systolic ( SBP ) and diastolic blood pressure ( DBP ) decreased in the abstinence group . Compared to the filter group , only the fall in SBP after 9 weeks was statistically significant , -6.1 mmHg ( 95 % confidence limits -10.8 , -1.4 ) . After adjustment for SBP at baseline and body weight change during the study , the observed reduction decreased , to -3.4 mmHg ( -7.1 , 0.3 ) . The patterns for SBP and DBP were remarkably similar in the groups using either filtered coffee or boiled coffee . After 9 weeks of boiled coffee , mean changes from baseline for SBP and DBP were 0.4 mmHg ( -3.7 , 4.5 ) and -0.1 mmHg ( -3.4 , 3.2 ) , compared to the filter group . The heart rate showed a slight , non-significant decrease in the abstinence group . In conclusion , these findings suggest that abstinence from coffee for a period of several weeks may slightly reduce blood pressure in young normotensive subjects In a double-blind crossover trial , the effect of 4 week daily ingestion of eight cups of regular coffee ( corresponding to 504 mg caffeine ) vs eight cups of decaffeinated coffee was studied . Blood pressure , heart rate and urinary catecholamines were measured in eight healthy , young volunteers . In both groups , regular coffee immediately led to a significant increase in mean blood pressure ( + 3 and + 5 mm Hg respectively ) . The difference between both groups , however , existed only in the first 3 to 5 days of ingestion of regular coffee . On day 5 after ingestion of regular coffee , and thereafter in weekly intervals , no significant increase in catecholamine excretion was observed . The data suggest that long-term consumption of large amounts of coffee leads to only a small and transient rise in mean blood pressure . This may be due to an adaptation phenomenon . Therefore , continuous heavy coffee ingestion ( eight cups/day for 4 weeks ) by young persons does not appear to involve a risk of the development of hypertension Objective : Earlier studies and trials have shown a serum cholesterol raising effect of unfiltered coffee , which is reduced by about 80 % in filtered coffee . Recent cross-sectional studies and trials , however , have indicated that filtered coffee may have a more pronounced serum cholesterol raising effect than previously anticipated . The objective of this controlled study was to assess the effects of the intake and abstention of filtered brewed coffee on blood lipids . Design : A prospect i ve , controlled study with four consecutive trial periods . The first and third periods were 3 weeks of total coffee abstention . The second and fourth periods consisted of 4 weeks with the subjects consuming 600 ml filter brewed coffee/day . Setting : Free-living population . Volunteers . Subjects : A total of 121 healthy , nonsmoking men and women aged 29–65 y. Interventions : Not applicable . Main outcome measures : Serum total cholesterol , serum HDL cholesterol , serum triglycerides , serum lipoprotein ( a ) ( Lp(a ) ) , blood pressure and heart rate . Results : The two coffee abstention periods were associated with a decline in serum cholesterol of 0.22 mmol/l ( 95 % CI −0.31 , −0.13 ) and 0.36 mmol/l ( 95 % CI −0.46 , −0.26 ) , respectively . Filtered coffee/day 600 ml increased serum cholesterol by 0.25 mmol/l ( 95 % CI 0.15 , 0.36 ) and 0.15 mmol/l ( 95 % CI 0.04 , 0.26 ) during the two coffee drinking periods . Conclusions : Coffee abstention for 3 weeks decreased total serum cholesterol by 0.22–0.36 mmol/l . A volume of 600 ml ( about four cups ) of filtered coffee/day during 4 weeks raised total serum cholesterol by 0.15–0.25 mmol/l . Sponsorship : None Background . The longitudinal relationship between coffee use and hypertension is not well known . Aim . We did a prospect i ve study to investigate if there is a temporal relationship between coffee consumption and development of sustained hypertension . Method . We assessed 1107 white subjects with elevated blood pressure who were followed up for 6.4 years . Coffee intake and other life‐style factors were ascertained from regularly administered question naires . Incident
Output:
| Low- quality evidence did not show any statistically significant effect of coffee consumption on BP or the risk of hypertension .
Given the quality of the currently available evidence , no recommendation can be made for or against coffee consumption as it relates to BP and hypertension |
MS210866 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: A previous r and omized , controlled trial of tai chi showed improvements in objective ly measured balance and other motor-related outcomes in patients with Parkinson 's disease . This study evaluated whether patient-reported outcomes could be improved through exercise interventions and whether improvements were associated with clinical outcomes and exercise adherence . In a secondary analysis of the tai chi trial , patient-reported and clinical outcomes and exercise adherence measures were compared between tai chi and resistance training and between tai chi and stretching exercise . Patient-reported outcome measures were perceptions of health-related benefits result ing from participation , assessed by the Parkinson 's Disease Question naire ( PDQ-8 ) and Vitality Plus Scale ( VPS ) . Clinical outcome measures included motor symptoms , assessed by a modified Unified Parkinson 's Disease Rating Scale – Motor Examination ( UPDRS-ME ) and a 50-foot speed walk . Information on continuing exercise after the structured interventions were terminated was obtained at a 3-month postintervention follow-up . Tai chi participants reported significantly better improvement in the PDQ-8 ( −5.77 points , P = 0.014 ) than did resistance training participants and in PDQ-8 ( −9.56 points , P < 0.001 ) and VPS ( 2.80 points , P = 0.003 ) than did stretching participants . For tai chi , patient-reported improvement in the PDQ-8 and VPS was significantly correlated with their clinical outcomes of UPDRS-ME and a 50-foot walk , but these correlations were not statistically different from those shown for resistance training or stretching . However , patient-reported outcomes from tai chi training were associated with greater probability of continued exercise behavior than were either clinical outcomes or patient-reported outcomes from resistance training or stretching . Tai chi improved patient-reported perceptions of health-related benefits , which were found to be associated with a greater probability of exercise adherence . The findings indicate the potential of patient perceptions to drive exercise behavior after structured exercise programs are completed and the value of strengthening such perceptions in any behavioral intervention Objective The short-term benefits of exercise for persons with Parkinson disease ( PD ) are well established , but long-term adherence is limited . The aim of this study was to explore the feasibility , acceptability , and preliminary evidence of the effectiveness of a virtual exercise coach to promote daily walking in community-dwelling persons with Parkinson disease . Design Twenty subjects with Parkinson disease participated in this phase 1 , single-group , nonr and omized clinical trial . The subjects were instructed to interact with the virtual exercise coach for 5 mins , wear a pedometer , and walk daily for 1 mo . Retention rate , satisfaction , and interaction history were assessed at 1 mo . Six-minute walk and gait speed were assessed at baseline and after the intervention . Results Fifty-five percent of the participants were women , and the mean age was 65.6 yrs . At the study completion , there was 100 % retention rate . The subjects had a mean satisfaction score of 5.6/7 ( with 7 indicating maximal satisfaction ) with the virtual exercise coach . Interaction history revealed that the participants logged in for a mean ( SD ) of 25.4 ( 7 ) days of the recommended 30 days . The mean adherence to daily walking was 85 % . Both gait speed and the 6-min walk test significantly improved ( P < 0.05 ) . No adverse events were reported . Conclusions Sedentary persons with Parkinson disease successfully used a computer and interacted with a virtual exercise coach . Retention , satisfaction , and adherence to daily walking were high for 1 mo , and significant improvements were seen in mobility This study was carried out to evaluate progression in Parkinson 's disease ( PD ) by analyzing time taken to transit from one Hoehn and Yahr ( H&Y ) stage to the next stage and to investigate the variables that would be associated with H&Y transition times using a large PD data base that contained prospect ively collected information . Data were obtained from the movement disorder data base of the National Neuroscience Institute in Singapore . Kaplan-Meier ( KM ) survival analysis was adopted to investigate the time taken to progress through various H&Y stages . Cox regression analysis was used to examine the association between the baseline variables at the entry point of each H&Y stage and the progression to the next stage . A total of 695 patients ( mean age : 65.2 , male : 57.3 % ) were studied . Using KM analysis , the median time taken to transit from H&Y stage 1 to 2 , 2 to 2.5 , 2.5 to 3 were 20 , 62 , and 25 months , respectively ; whereas the median time taken to progress from stage 3 to 4 and 4 to 5 were 24 and 26 months , respectively . Cox regression analysis revealed that older age-at-diagnosis , longer PD duration , and higher Unified Parkinson 's Disease Rating Scale ( UPDRS ) motor scores at baseline were associated with a significantly faster progression through various H&Y stages . Gender and ethnicity were not associated with disease progression . In conclusion , H&Y transition time is a useful measure of disease progression in PD and may be utilized in clinical studies evaluating therapeutic interventions and prognostic factors in PD OBJECTIVES We recently completed the ParkFit study , a two-year r and omized controlled trial including 586 sedentary Parkinson 's disease ( PD ) patients , that evaluated a multifaceted intervention ( ParkFit program ) to promote physical activity . The results showed that the ParkFit program enables PD patients to become physically more active , suggesting that this intervention should now be further implemented into clinical practice . To facilitate this process , we here evaluate the implementation of the ParkFit program . METHODS The ParkFit program was evaluated in three ways : ( a ) experiences of patients and physiotherapists , as investigated using interviews and question naires ; ( b ) factors associated with changed activity levels ; and ( c ) subgroup analyses to identify differential effects in subgroups of patients based on baseline physical activity level , age , gender , disease severity , disease duration , and mobility . RESULTS The ParkFit program was well received : 73 % of patients indicated they would recommend the program to other patients , and 90 % of physiotherapists indicated they wanted to use the ParkFit program in other patients . Multiple forward regression analysis result ed in a model with two variables : less baseline physical activity , and better mobility were associated with larger changes in levels of physical activity ( R(2)=38 % ) . The program was effective in almost all subgroups . In women , most sedentary patients and patients with higher disease severity , the estimated effect size was largest . CONCLUSION We conclude that the ParkFit program was effective in almost all specific subgroups . Therapists and patients experienced no major hurdles . Suggestions for improvement are : ( 1 ) improve education for therapists with respect to theories about behavioral change ; ( 2 ) formulate concrete and specific examples of exercise goals ; and ( 3 ) pay more specific attention to patients with co morbidities , cognitive dysfunction and a lack of motivation during education OBJECTIVE The expected emotional consequences of future actions are thought to play an important role in health behavior change . This research examined whether anticipated affective consequences of success and failure vary across stages of physical activity change and differentially predict physical activity adoption as compared to maintenance . DESIGN Using a prospect i ve design over a 3-month period , a community sample of 329 healthy , middle-aged adults were assessed at 2 time points . MAIN OUTCOME MEASURES Anticipated positive and negative emotions , stage of behavior change ( precontemplation [ PC ] , contemplation [ C ] , preparation [ P ] , action [ A ] , maintenance [ M ] ) , and level of physical activity . RESULTS At baseline , anticipated positive emotions were greater in C versus PC , whereas anticipated negative emotions were greater in M versus A and in M versus P. Higher anticipated positive but not negative emotions predicted physical activity adoption and maintenance after 3 months . CONCLUSION Although the expected affective consequences of future success and failure differentiated among individuals in the early and later stages of physical activity change , respectively ; only the anticipated affective consequences of success predicted future behavior AIM This study aim ed to evaluate the feasibility and cultural considerations of a minimally supervised , home-based exercise program in Jordan . METHODS Quantitative and qualitative approaches were used . Thirty participants were r and omly allocated to either an 8-week intervention group ( n = 16 ) , or a st and ard care group ( n = 14 ) . The intervention incorporated the home use of an exercise DVD , walking program and initial instructional sessions and weekly phone calls provided by a physiotherapist . Interviews were used to explore feasibility . Unified Parkinson 's disease rating scale ( UPDRS-III ) ; balance and walking speed were assessed . RESULTS The retention rate was 86.7 % and mean adherence rate was 77 % . Personal and sociocultural barriers of adherence to the exercise program were identified . UPDRS-III at follow-up was lower in the intervention group . CONCLUSION A home exercise program was feasible . Sociocultural barriers specific to Arabic culture may affect the uptake of such an intervention in Parkinson 's disease in these countries
Output:
| Conclusion : This review revealed that people with Parkinson 's disease viewed physical activity as an enjoyable and positive experience , which aided with control of their symptoms and enhanced their wellbeing and quality of life .
Aligned with evidence from older adults and those with long-term conditions , this review identified disease presentation , intrapersonal characteristics , program design , external support and the social and physical environment as contributory factors which influenced the ability of people with Parkinson 's disease to sustain engagement in physical activity .
The unique contribution and weighting of these factors will affect an individual 's participation in physical activity .
These qualitative findings give healthcare providers an insight into the views and experiences of people with Parkinson 's disease and are useful , alongside quantitative evidence of effectiveness , for the design of physical activity programs that are meaningful for this population .
However , a limitation of this review is that it does not address the views and experiences of people with Parkinson 's disease who are inactive |
MS210867 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Summary Purpose Pre clinical data has demonstrated the potential of simvastatin to overcome cetuximab resistance in KRAS mutant CRC patients . Therefore , we design ed a study using simvastatin/cetuximab/irinotecan for KRAS mutant CRC patients who are refractory to irinotecan and oxaliplatin-based chemotherapy . Patients and methods In this phase II study , patients received 500 mg/m2 cetuximab , 150–180 mg/m2 ( day 1 ) , and 80 mg simvastatin ( once daily , days 1–14 , every 2 weeks ) . The primary endpoint was the objective response rate ( ORR ) . Secondary endpoints were progression-free survival ( PFS ) , overall survival ( OS ) , the disease control rate ( DCR ) , and safety . We also analyzed the relationship between the RAS gene expression signature score and treatment response to simvastatin/cetuximab/irinotecan . Results Fifty-two KRAS mutant CRC patients were enrolled . The ORR ( complete response [ CR ] , 0 ; partial response [ PR ] , 1 ) was 1.9 % ( 95 % confidence interval [ CI ] , −1.8–5.6 ) . The DCR ( CR , 0 ; PR , 1 ; stable disease , 33 ) was 65.4 % ( 95 % CI , 52.5–78.3 ) . The median PFS and OS from the time of study drug administration were 7·6 months ( 95 % CI , 4.4–10.8 ) and 12.8 months ( 95 % CI , 9.5–16.2 ) , respectively . The most common grade 3/4 adverse events were anemia ( 28.8 % ) , neutropenia ( 13.5 % ) , and diarrhea ( 7.7 % ) . The RAS signature score was significantly correlated with the maximal change in target lesions from baseline ( r = 0.57 , P = 0.014 ) . Conclusion The simvastatin/cetuximab/irinotecan regimen showed promising efficacy and safety in KRAS mutant CRC patients who failed irinotecan and oxaliplatin-based chemotherapy . The RAS signature may be a novel predictor of treatment response to cetuximab-combined chemotherapy in CRC patients BACKGROUND & AIMS Statin use has been associated with a reduced incidence of colorectal cancer and might also affect survival of patients diagnosed with colon cancer . Statins are believed to inhibit Ras signaling and may also activate the bone morphogenetic protein ( BMP ) signaling pathway in colorectal cancer cells . We investigated the effects of statins on overall survival of patients with a diagnosis of colon cancer , and whether their effects were associated with changes in KRAS or the BMP signaling pathways . METHODS Data were derived from the PHARMO data base network ( Netherl and s ) and linked to patients diagnosed with colon cancer from 2002 through 2007 , listed in the Eindhoven Cancer Registry . We obtained information on causes of death from statistics Netherl and s. We constructed a tissue microarray of 999 colon cancer specimens from patients who underwent surgical resection from 2002 through 2008 . Survival was analyzed with statin user status after diagnosis as a time-dependent covariate . Multivariable Poisson regression survival models and Cox analyses were used to study the effect of statins on survival . Tumor tissues were analyzed by immunohistochemistry for levels of SMAD4 , BMPR1A , BMPR1B , and BMPR2 proteins . Tumor tissues were considered to have intact BMP signaling if they contained SMAD4 plus BMPR1A , BMPR1B , or BMPR2 . DNA was isolated from tumor tissues and analyzed by quantitative polymerase chain reaction to detect mutations in KRAS . The primary outcome measures were overall mortality and cancer-specific mortality . RESULTS In this cohort , 21.0 % of the patients ( 210/999 ) were defined as statin users after diagnosis of colon cancer . Statin use after diagnosis was significantly associated with reduced risk of death from any cause ( adjusted relative risk [ RR ] , 0.67 ; 95 % confidence interval [ CI ] , 0.51 - 0.87 ; P = .003 ) and death from cancer ( adjusted RR , 0.66 ; 95 % CI , 0.49 - 0.89 ; P = .007 ) . Statin use after diagnosis was associated with reduced risk of death from any cause or from cancer for patients whose tumors had intact BMP signaling ( adjusted RR , 0.39 ; 95 % CI , 0.22 - 0.68 ; P = .001 ) , but not for patients whose tumors did not have BMP signaling ( adjusted RR , 0.81 ; 95 % CI , 0.55 - 1.21 ; P = .106 ; P < .0001 for the interaction ) . Statin use after diagnosis was not associated with reduced risk of death from any cause or from cancer for patients whose tumors did not contain KRAS mutations ( adjusted RR , 0.81 ; 95 % CI , 0.56 - 1.18 ; P = .273 ) or whose tumors did have KRAS mutations ( adjusted RR , 0.59 ; 95 % CI 0.35 - 1.03 ; P = .062 ; P = .90 for the interaction ) . CONCLUSIONS In an analysis of 999 patients with a diagnosis of colon cancer , we associated statin with reduced risk of death from any cause or from cancer . The benefit of statin use is greater for patients whose tumors have intact BMP signaling , independent of KRAS mutation status . R and omized controlled trials are required to confirm these results BACKGROUND Treatment with cetuximab , a monoclonal antibody directed against the epidermal growth factor receptor , improves overall and progression-free survival and preserves the quality of life in patients with colorectal cancer that has not responded to chemotherapy . The mutation status of the K-ras gene in the tumor may affect the response to cetuximab and have treatment-independent prognostic value . METHODS We analyzed tumor sample s , obtained from 394 of 572 patients ( 68.9 % ) with colorectal cancer who were r and omly assigned to receive cetuximab plus best supportive care or best supportive care alone , to look for activating mutations in exon 2 of the K-ras gene . We assessed whether the mutation status of the K-ras gene was associated with survival in the cetuximab and supportive-care groups . RESULTS Of the tumors evaluated for K-ras mutations , 42.3 % had at least one mutation in exon 2 of the gene . The effectiveness of cetuximab was significantly associated with K-ras mutation status ( P=0.01 and P<0.001 for the interaction of K-ras mutation status with overall survival and progression-free survival , respectively ) . In patients with wild-type K-ras tumors , treatment with cetuximab as compared with supportive care alone significantly improved overall survival ( median , 9.5 vs. 4.8 months ; hazard ratio for death , 0.55 ; 95 % confidence interval [ CI ] , 0.41 to 0.74 ; P<0.001 ) and progression-free survival ( median , 3.7 months vs. 1.9 months ; hazard ratio for progression or death , 0.40 ; 95 % CI , 0.30 to 0.54 ; P<0.001 ) . Among patients with mutated K-ras tumors , there was no significant difference between those who were treated with cetuximab and those who received supportive care alone with respect to overall survival ( hazard ratio , 0.98 ; P=0.89 ) or progression-free survival ( hazard ratio , 0.99 ; P=0.96 ) . In the group of patients receiving best supportive care alone , the mutation status of the K-ras gene was not significantly associated with overall survival ( hazard ratio for death , 1.01 ; P=0.97 ) . CONCLUSIONS Patients with a colorectal tumor bearing mutated K-ras did not benefit from cetuximab , whereas patients with a tumor bearing wild-type K-ras did benefit from cetuximab . The mutation status of the K-ras gene had no influence on survival among patients treated with best supportive care alone . ( Clinical Trials.gov number , NCT00079066 . BACKGROUND Although pre clinical and epidemiological data suggest that statins may have antineoplastic properties , the impact of statin use on patient survival after a curative resection of stage III colon cancer is unknown . METHODS We conducted a prospect i ve observational study of 842 patients with stage III colon cancer enrolled in a r and omized adjuvant chemotherapy trial from April 1999 to May 2001 to investigate the relationship between statin use and survival . Disease-free survival ( DFS ) , recurrence-free survival ( RFS ) , and overall survival ( OS ) were investigated by Kaplan-Meier curves and log-rank tests in the overall study population and in a subset of patients stratified by KRAS mutation status ( n = 394 ) , and Cox proportional hazards regression was used to assess the simultaneous impact of confounding variables . All statistical tests were two-sided . RESULTS Among 842 patients , 134 ( 15.9 % ) reported statin use after completing adjuvant chemotherapy . DFS among statin users and nonusers was similar ( hazard ratio [ HR ] of cancer recurrence or death = 1.04 , 95 % confidence interval [ CI ] = 0.73 to 1.49 ) . RFS and OS were also similar between statin users and nonusers ( adjusted HR of cancer recurrence = 1.14 , 95 % CI = 0.77 to 1.69 ; adjusted HR of death = 1.15 , 95 % CI = 0.77 to 1.71 ) . Survival outcomes were similar regardless of increasing duration of statin use before cancer diagnosis ( P(trend ) = .63 , .63 , and .59 for DFS , RFS , and OS , respectively ) . The impact of statin use did not differ by tumor KRAS mutation status , with similar DFS , RFS , and OS for statin use among mutant and wild-type subgroups ( P(interaction ) = .84 , .67 , and .98 for DFS , RFS , and OS , respectively ) . CONCLUSION Statin use during and after adjuvant chemotherapy was not associated with improved DFS , RFS , or OS in patients with stage III colon cancer , regardless of KRAS mutation status BACKGROUND : Achieving a pathologic complete response to neoadjuvant chemoradiation improves prognosis in rectal cancer . Statin therapy has been shown to enhance the impact of treatment in several malignancies , but little is known regarding the impact on rectal cancer response to neoadjuvant chemoradiation . OBJECTIVE : The purpose of this study was to determine whether statin use during neoadjuvant chemoradiation improves pathologic response in rectal cancer . DESIGN : This was a retrospective cohort study based on data from a prospect ively maintained colorectal cancer data base . The 2 cohorts were defined by statin use during neoadjuvant chemoradiation . SETTING : This study was performed at a single tertiary referral center . PATIENTS : Four hundred seven patients with primary rectal adenocarcinoma who underwent neoadjuvant therapy then proctectomy between 2000 and 2012 were included . Ninety-nine patients ( 24.3 % ) took a statin throughout the entire course of neoadjuvant therapy . MAIN OUTCOME MEASURES : The primary outcome measure was pathologic response to neoadjuvant chemoradiotherapy as defined by the American Joint Committee on Cancer tumor regression grading system , grade s 0 to 3 . RESULTS : Patients in the statin cohort had a lower median regression grade ( 1 vs 2 , p = 0.01 ) and were more likely to have a better response ( grade s 0–1 vs 2–3 ) than those not taking a statin ( 65.7 % vs 48.7 % , p = 0.004 ) . Statin use remained a significant predictor of an American Joint Committee on Cancer grade 0 to 1 ( OR , 2.25 ; 95 % CI , 1.33–3.82 ) in multivariate analyses . Although statin use itself did not significantly improve oncologic outcomes , an American Joint Committee on Cancer grade 0 to 1 response was associated with statistically significant improvements in overall survival , disease-free survival , cancer-specific mortality , and local recurrence . LIMITATIONS : This was a retrospective study and subject to nonr and omization of patients and incorporated patients on variable statin agents and doses . CONCLUSIONS : Statin therapy is associated with an improved response of rectal cancer to neoadjuvant chemoradiation . These data provide the foundation for a prospect i ve clinical trial
Output:
| For post-diagnosis statin uses , there is no difference in ACM when stratified by KRAS gene ( KRAS ) mutation status .
Our meta- analysis demonstrates that both pre-diagnosis and post-diagnosis statin uses are associated with reduced ACM and CSM for CRC patients |
MS210868 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: The purpose of our study is to estimate the effect of tourniquet release and cementing in perioperative blood loss associated with total knee arthroplasty . Eighty patients were r and omly allocated into two equal groups concerning the timing of tourniquet release . Group A : patients with tourniquet release and haemostasis before wound closure and group B : patients with tourniquet release after skin closure and compressive b and aging . These groups were further subdivided in two subgroups ( + and - ) depending on cementing or not of the tibial tray only . The total blood loss averaged 961 ml in group A and 692 ml in group B , while it was estimated 763 ml in the cemented group and 890 ml in the non-cemented group . The total blood loss within subgroups was Group A+ 904 ml , Group A- 1017 ml , Group B+ 622 ml and Group B- 762 ml . The mean number of blood units transfused per patient was 4.7 in Group A and 4.0 in Group B , while the mean operating time was 79 min and 66 min , respectively . Complications such as deep vein thrombosis , haematomata and minor wound complications occurred in patients of Group A and Group B , 0 and 2 , 0 and 2 , 8 and 11 , respectively . Intraoperative tourniquet release seems to be related with significantly greater blood loss ( P<0.001 ) and dem and s in blood transfusion P<0.05 as well as a longer operating time ( P<0.001 ) . Cementing of total knee replacements has a better haemostatic role compared to non-cemented prosthesis ( P<0.05 ) . Even though complications were more in postoperative tourniquet release group , no statistically significant difference was found between group A and B. Postoperative tourniquet release seems to offer better conditions of haemostasis probably due to the better controlled fibrolytic activity Background In patients undergoing total knee arthroplasty , intraoperative pulmonary embolic events are rare , and most occur following tourniquet deflation . This embolization can be observed using transesophageal echocardiography . However , the authors have encountered sudden decreases in arterial oxygen partial pressure while a tourniquet is still inflated . Therefore , the current investigation was design ed to detect emboli during the tourniquet inflation phase and to identify the composition of the echogenic material . Methods Forty-six patients were r and omly assigned to undergo total knee arthroplasty without ( control , n = 24 ) or with a tourniquet ( n = 22 ) . Hemodynamic monitoring , blood gas analysis , and continuous transesophageal echocardiography were performed during the total knee arthroplasty procedure . Right jugular blood specimens were collected whenever echogenic material was seen in the atrium . Results In the tourniquet group , embolic events occurred in 27 % of patients during femoral reaming and in 100 % after tourniquet deflation . In the control group , emboli were detected in 54 % of patients during femoral reaming . Most of the patients exhibited cardiopulmonary impairment after severe echogenic embolism , even while the tourniquet was inflated ( two patients ) . None of the blood sample s aspirated from the central catheters contained detectable material . Conclusions This prospect i ve study showed that embolic events occurred during total knee arthroplasty , even while a tourniquet was inflated . An inflated tourniquet does not completely prevent pulmonary emboli BACKGROUND Total knee arthroplasty ( TKA ) is commonly performed using a tourniquet . However , some studies have reported that several complications were associated with the use of a tourniquet in TKA . In this study we investigate whether the limited use of a tourniquet in TKA would reduce complications and facilitate postoperative recovery . METHODS Sixty patients were r and omly divided into two groups ( 30 cases/group ) : group A using the tourniquet throughout the surgical procedure , and group B using the tourniquet starting from the cementation to the completion of the procedure . Operation time , total measured blood loss , and incidence of complications were all recorded . RESULTS There was no significant difference in operation time , total measured blood loss , and hemoglobin concentration between the two groups . Incidence of postoperative complications in group B was significantly decreased in comparison to that in group A. The limb circumference at 10 cm above the superior patellar pole or below the inferior patellar pole and the pain score in group B were significantly decreased compared with that in group A at any time point . Range of motion in group B was significantly increased at three and 5 days postoperatively in comparison to that in group A. CONCLUSIONS The limited use of a tourniquet in TKA provides the benefit of decreased limb swelling and knee joint pain while not compromising the operation time or blood loss and recovery . LEVEL OF EVIDENCE Level I ( Therapeutic ) . TRIAL REGISTRATION NUMBER NCT02102581 In surgical practice , hemostasis is used to minimize postoperative bleeding in total knee arthroplasty . We performed a prospect i ve r and omized study to determine the influence of tourniquet use and the timing of its release on amount of bleeding . Eighty four patients ( 96 knees ) were scheduled for total knee arthroplasty and r and omly divided into three groups . Posterior cruciate retaining bicompartmental total knee prostheses were used in all . In group I , no tourniquet was used . In group II , a tourniquet was used and was deflated for hemostasis once all components had been inserted . In group III , the tourniquet was deflated after wound closure and application of a compressive dressing . Mean blood drainage , mean volume of blood transfusion , hemoglobin ( Hb ) and hematocrit ( Hct ) values and operative time were compared between the three groups . Mean blood drainage was 810 mL ( 300 - 1300 ) in groups I 720 mL ( 240 - 1200 ) in group II and 705 mL ( 250 - 1150 ) in group III ( p = 0.062 ) . The Hb and Hct values , tourniquet time ( for groups II and III ) and volume of blood transfusion were similar . The operative time was significantly longer for first group ( p = 0.012 ) . Using tourniquet and its intraoperative release with hemostasis , does not reduce blood loss in total knee arthroplasty , but using tourniquet reduces operation time significantly Introduction A tourniquet is used during the total knee replacement surgery to improve the visibility , to reduce the blood loss and for better cementation . Indirectly it decreases the duration of surgery and enhances the recovery of the patient . Their use however is controversial due to some side effects associated with the use of tourniquet . They may increase the risk of deep vein thrombosis and pulmonary embolism by causing venous stasis , endothelial damage and increased platelet adhesion secondary to distal limb ischemia . Material and Methods We conducted a r and omized controlled trial ( RCT ) to examine the benefits and risks associated with the use of long duration over short duration tourniquets during TKA . The study was a prospect i ve r and omised control trial with a total of 80 knees ( 40 knees in each group ) included in the study . The knees selected for surgery were r and omly allocated to one of the two groups : Group A - long duration tourniquet ( LT-group ) or Group B - short duration tourniquet ( ST-group ) . Result The average operating time in Group A ( 43.53±3.11 minutes ) was statistically less significant than that of Group B ( 51.7±2.56 minutes ) . Intra-operative blood loss in Group B , was significantly more than that of Group A. Post-operative blood loss in the drain was more in long duration tourniquet group . Total blood loss ( intra-operative + post-operative ) was more in short duration tourniquet group . Pain score ( using VAS scale ) was comparable in both the groups at the end of the second and sixth week . At sixth weeks there was no significant difference in the range of motion in both the groups . The KSS score was not significantly different in both the groups in post operative period at first , second , and six weeks . There were no events of thrombo-embolism and deep vein thrombosis in either groups . In 11 patients ( 27.5 % ) of long duration tourniquet group , swelling , and redness of knee was seen post operatively as compared to three patients ( 7.5 % ) of short duration tourniquet group . Conclusion The use of a short duration tourniquet during TKA gives better symptomatic pain relief in the early postoperative period as compared to long duration use of tourniquet . However , this is associated with increased blood loss , more operating time and not having a clear operative field . We suggest that a rational thinking and reconsidering the practice of routine use of long duration tourniquet in each and every case of TKA is required Background Total knee arthroplasty with the use of a tourniquet during the entire operation has not been shown to improve the performance of the operation and may increase the risk of complications . Questions / purpose sWe asked whether the limited use of a tourniquet for cementation only would affect ( 1 ) surgical time ; ( 2 ) postoperative pain and motion of the knee ; ( 3 ) blood loss ; or ( 4 ) complications such as risk of nerve injuries , quadriceps dysfunction , and drainage compared with use of a tourniquet throughout the procedure . Methods Seventy-one patients ( 79 knees ) were r and omized to either use of a tourniquet from the incision through cementation of the implants and deflated for closure ( operative tourniquet group ) or tourniquet use only during cementation ( cementation tourniquet group ) . The initial study population was a minimum of 30 knees in each group as suggested for r and omized studies by American Society for Testing and Material s st and ards ; termination of the study was determined by power analysis performed after 40 knees in each group showed any statistical solution to our questions would require a minimum of 260 more cases . Patients were excluded who were considered in previous r and omized studies as high risk for complications , which might be attributed to the tourniquet . Results There were no differences in terms of surgical time , pain scores , pain medicine requirements , range of motion , hemoglobin change , or total blood loss . One major complication ( compartmental syndrome ) occurred in a patient with tourniquet inflation until closure . No other complications were attributed to the use of a tourniquet . Conclusions With the numbers available , our results suggest that there are no important clinical differences between patients who had a tourniquet inflated throughout the procedure compared with those who had it inflated only during cementation . Tourniquet inflation for cementation only provides the benefit of bloodless bone for fixation and may eliminate the risks associated with prolonged tourniquet use . Level of Evidence Level I , therapeutic study . See Guidelines for Authors for a complete description of levels of evidence AIM To reduce blood loss in total knee arthroplasty various physical measures including the use of a tourniquet are recommended . The question of an early tourniquet release is still unsettled . PATIENTS AND METHOD To confirm our theory that blood loss and need of blood transfusions might be reduced while removing the tourniquet for meticulous hemostasis before wound closure we analysed 70 ( 41 male , 29 female ) consecutive patients with total knee arthroplasty for osteoarthritis performed by a single surgeon in a prospect ive-r and omized study between 1/1996 to 6/1998 . In group I the tourniquet was released before , in group II after wound closure . RESULTS We could n't find any significant differences in the estimated blood loss , the decrease of hemoglobin and hematocrit level , and the transfusion need . In Group II we observed two cases of deep vein thrombosis . This difference was not significant . CONCLUSION We conclude that tourniquet release for hemostasis is not an effective tool in reducing blood loss or transfusion need in total knee arthroplasty Today the use of pneumatic tourniquet is commonly accepted in total knee arthroplasty ( TKA ) to reduce perioperative blood loss . There are a few prospect i ve r and omised and nonr and omised studies that compare the effect of tourniquet release timing in cementless or cemented unilateral TKA . However , many of these studies show an inadequate reporting and methodology . This r and omized prospect i ve study was design ed to investigate the efficiency of tourniquet release timing in preventing perioperative blood loss in a simultaneous bilateral TKA study design . To our knowledge , this is the first study of its kind , in which the effect of tourniquet release timing on perioperative blood loss was investigated in simultaneous bilateral cemented TKA to compare both techniques intraindividually . In 20 patients ( 40 knees ) one knee was operated with tourniquet release and hemostasis before wound closure , and the other knee with tourniquet release after wound closure and pressure dressing . We found no significant difference in total blood loss between both techniques ( p=0.930 ) , but a significant difference in operating time ( p=0.035 ) . There were no postoperative complications at a follow-up of 6 month . Other studies report an increase the blood loss in early tourniquet release and an increase the risk of early postoperative complications in deflation of tourniquet after wound closure . In this study we found no significant difference in perioperative blood loss and no increase of postoperative complications . Therefore , we recommend a tourniquet release after wound closure to reduce the duration of TKA procedure and to avoid possible risks of extended anaesthesia We included 46 total knee arthroplasties ( 43 patients ) in a prospect i ve , r and omised study , dividing them into two groups : group A ( 23 knees , 21 patients ) in which the ischa
Output:
| Despite the decrease in IBL with a tourniquet , no difference was found in TBL .
In conclusion , not using a tourniquet or only using it during the cementation of implants was preferable based on the faster functional recovery , lower rate of DVTs and complications compared with using a tourniquet throughout the TKA procedure . |
MS210869 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: We studied the acute effects of 4 different chest physical therapy regimens using a r and omised cross-over design in 14 patients with cystic fibrosis . Treatment A consisted of postural drainage , percussion and vibration ; treatment B of postural drainage and periodic application of a face mask with positive expiratory pressure ( PEP ) ; treatment C of PEP in the sitting position ; treatment D of the forced expiration technique in the sitting position . In terms of sputum expectorated , treatments B and C were superior to treatment D and especially to treatment A ( p less than 0.05 ) . Skin oxygen tension , PSO2 was monitored continuously during and for 35 min after treatment . A substantial and prolonged decay in PSO2 was observed during treatment A , quite different from other patterns seen . During and even following treatment C , an increase in PSO2 was noted . PEP was well accepted by the patients , who preferred treatment C , and we suggest it is incorporated in chest physical therapy regimens if the therapeutic objective is to increase expectoration It has previously been shown that unproductive coughing in both healthy subjects and patients with airways obstruction is not effective in clearing lung secretions . This study investigates the regional mucus transport in a group of subjects with airways obstruction who failed to expectorate following instructed cough and forced expiration technique . Fourteen patients ( mean + /- SEM age : 68 + /- 2 years ) with airways obstruction ( mean + /- SEM percent predicted . FEV1 : 54 + /- 5 ; daily wet weight sputum : 9.1 + /- 2.0 g ) took part in the study which was a r and omized , three-way crossover within-patient design . Each patient underwent three treatment maneuvers : control , cough ( 30 coughs over a 10-min period ) , and forced expiration ( 30 forced expirations over a 10-min period ) . An objective radioaerosol technique was used to monitor regional mucus movement within the lungs of the patients . The lungs were divided arbitrarily into four regions of interest : tracheal , inner , intermediate , and outer . Peak expiratory flow rate during cough and forced expiration was measured at the mouth . There was no correlation between the radioaerosol clearance from all regions and ( 1 ) mean peak flow during cough and forced expiration , and ( 2 ) mean 24-h sputum production prior to the study day . There were no differences in regional radioaerosol clearance between cough and forced expiration . However , both cough and forced expiration result ed in significant clearance compared with control for all regions with the exception of the forced expiration in the outer region . To our knowledge , this study is the first to demonstrate that unproductive cough and forced expiration result in movement of secretions proximally from all regions of the lung in patients with airways obstruction Background High frequency chest wall oscillation ( HFCWO ) is st and ard treatment for airway clearance in the USA and has recently been introduced in the UK and Europe . There is little published research comparing HFCWO with airway clearance techniques ( ACTs ) frequently used in the UK and Europe . The aim of this study was to compare the short-term effects of HFCWO with usual ACTs in patients with cystic fibrosis hospitalised with an infective pulmonary exacerbation . Methods A 4-day r and omised crossover design was used . Patients received either HFCWO on days 1 and 3 and usual ACTs on days 2 and 4 or vice versa . Wet weight of sputum , spirometry and oxygen saturation were measured . Perceived efficacy , comfort , incidence of urinary leakage and preference were assessed . Data were analysed by mixed model analysis . Results 29 patients ( 72 % male ) of mean ( SD ) age 29.4 ( 8.4 ) years and mean ( SD ) forced expiratory volume in 1 s ( FEV1 ) percentage predicted ( FEV1 % ) 38 ( 16.7 ) completed the study . Significantly more sputum was expectorated during a single treatment session and over a 24 h period ( mean difference 4.4 g and 6.9 g , respectively ) with usual ACTs than with HFCWO ( p<0.001 ) . No statistically significant change in FEV1 % or oxygen saturation was observed after either HFCWO or usual ACTs compared with baseline . 17 patients ( 55 % ) expressed a preference for their usual ACT . Conclusions During both a finite treatment period and over 24 h , less sputum was cleared using HFCWO than usual ACT . HFCWO does not appear to cause any adverse physiological effects and may influence adherence The Flutter VRP1 ( Flutter ) is cl aim ed to increase the clearance of excess bronchial secretions and to improve lung function and oxygenation , but these cl aims were based on computer models , laboratory assisted experiments and uncontrolled clinical trials . A prospect i ve r and omized clinical trial was undertaken , in subjects with cystic fibrosis , using the active cycle of breathing techniques as the ' gold st and ard ' . The cl aims could not be substantiated and the possibility of sputum retention was of concern when the Flutter was used as significantly more sputum ( P < 0.001 ) was cleared with the active cycle of breathing techniques alone . There were no significant changes in lung function or oxygenation Chest physiotherapy is an essential part of the management of cystic fibrosis , yet comparatively few studies have investigated the commonly used forms of chest physiotherapy during acute respiratory exacerbations . Fifteen subjects with cystic fibrosis and predominantly mild pulmonary impairment completed a r and omised cross-over trial with 24 hours between treatments . The active cycle of breathing techniques ( ACBT ) assisted by a physiotherapist was compared with the ACBT performed independently by the patient . Measurement outcomes included pulmonary function tests , indirect calorimetry and oximetry parameters . Energy expenditure was not significantly different between the two treatment regimens , though significant improvements in pulmonary function were apparent 24 hours following the therapist-assisted ACBT . In this group of subjects , neither form of treatment proved superior in terms of energy consumption , but a reduction in airways obstruction was observed as a carry-over effect following the therapist-assisted ACBT BACKGROUND --In vitro studies have suggested that both the viscoelastic properties of lung secretions and the peak flow attained during simulated cough influence clearance . This study examines the possible association of the viscoelastic properties of sputum and maximum expiratory flow with measured effectiveness of mucus clearance induced by instructed cough and by forced expiration technique ( FET ) in patients with airways obstruction . METHODS --Nineteen patients ( 11 men and eight women ) of mean ( SE ) age , % predicted FEV1 , and daily sputum wet weight of 64 ( 2 ) years , 52 (6)% , and 37.5 ( 7.9 ) g respectively participated in the study . Mucus movement from proximal and peripheral lung regions was measured by an objective non-invasive radioaerosol technique . Each patient underwent three assessment s : control , cough , and FET . During cough and FET , maximum expiratory flow was measured at the mouth level . Apparent viscosity and elasticity of the expectorated sputum sample s were measured with a viscometer . RESULTS --Compared with the control run ( mean ( SE ) clearance : 16 (3)% ) there was an increase in clearance from the whole lung during cough ( 44 (5)% ) and FET ( 42 (5)% ) , and also an enhanced clearance of inhaled , deposited radioaerosol from the trachea , inner and intermediate regions of the lungs , but not from the outer region . There were , however , no differences in regional clearance between cough and FET . Neither regional nor total clearance correlated with maximum expiratory flow , apparent viscosity , elasticity , or daily sputum wet weight . CONCLUSIONS --These results confirm that cough and FET both promote effective clearance but suggest that , unlike in vitro studies , sputum production and viscoelasticity , as well as maximum expiratory flow , provide no guide to clearance efficacy in humans We studied the effectiveness of some of the components of a physiotherapy regimen on the removal of mucus from the lungs of 6 subjects with cystic fibrosis . On 5 r and omized study days , after inhalation of a 99mTc-human serum albumin aerosol to label primarily the large airways , the removal of lung radioactivity was measured during 40 min of ( a ) spontaneous cough while at rest ( control ) , ( b ) postural drainage , ( c ) postural drainage plus mechanical percussion , ( d ) combined maneuvers ( postural drainage , deep breathing with vibrations , and percussion ) administered by a physiotherapist , ( e ) directed vigorous cough . Measurements continued for an additional 2 h of quiet rest . Compared with the control day , all forms of intervention significantly improved the removal of mucus : cough ( p less than 0.005 ) , physiotherapy maneuvers ( 0.005 less than or equal to p less than 0.01 ) , postural drainage ( p less than 0.05 ) , and postural drainage plus percussion ( p less than 0.01 ) . However , there was no significant difference between regimented cough alone and therapist-administered combined maneuvers , nor between postural drainage alone and with mechanical percussion . We conclude that in cystic fibrosis , vigorous , regimented cough sessions may be as effective as therapist-administered physiotherapy in removing pulmonary secretions . Postural drainage , although better than the control maneuver , was not as effective as cough and was not enhanced by mechanical percussion . Frequent , vigorous self-directed cough sessions are potentially as useful as more complex measures for effective bronchial toilet Background : Chest physiotherapy is essential to the management of cystic fibrosis ( CF ) . However , respiratory muscle fatigue and oxygen desaturation during treatment have been reported . The aim of this study was to determine whether non-invasive ventilation ( NIV ) during chest physiotherapy could prevent these adverse effects in adults with exacerbations of CF . Methods : Twenty six patients of mean ( SD ) age 27 ( 6 ) years and forced expiratory volume in 1 second ( FEV1 ) 34 (12)% predicted completed a r and omised crossover trial comparing st and ard treatment ( active cycle of breathing technique , ACBT ) with ACBT + NIV . Respiratory muscle strength ( PImax , PEmax ) , spirometric parameters , and dyspnoea were measured before and after treatment . Pulse oximetry ( Spo2 ) was recorded during treatment . Sputum production during treatment and 4 and 24 hours after treatment was evaluated . Results : There was a significant reduction in PImax following st and ard treatment that was correlated with baseline PImax ( r=0.73 , p<0.001 ) . PImax was maintained following NIV ( mean difference from st and ard treatment 9.04 cm H2O , 95 % confidence interval ( CI ) 4.25 to 13.83 cm H2O , p=0.006 ) . A significant increase in PEmax was observed following the NIV session ( 8.04 cm H2O , 95 % CI 0.61 to 15.46 cm H2O , p=0.02 ) . The proportion of treatment time with Spo2 ⩽90 % was correlated with FEV1 ( r=−0.65 , p<0.001 ) . NIV improved mean Spo2 ( p<0.001 ) and reduced dyspnoea ( p=0.02 ) . There were no differences in FEV1 , forced vital capacity ( FVC ) or sputum weight , but FEF25–75 increased following NIV ( p=0.006 ) . Conclusion : Reduced inspiratory muscle strength and oxygen desaturation during chest physiotherapy are associated with inspiratory muscle weakness and severity of lung disease in adults with exacerbations of CF . Addition of NIV improves inspiratory muscle function , oxygen saturation and small airway function and reduces dyspnoea The aim of the study was an estimation of effectiveness of selected autodrainage methods used in the treatment of children with cystic fibrosis and an assessment of patients ' preference in relation to investigated methods . We also estimated the patients and their families ' relation to chest physiotherapy methods , which have been used at home for many years . We studied 17 patients , aged 10 - 18 ( x 13.35 ) , who were hospitalised in the Institute of Mother and Child Paediatric Clinical Dept . We compared four autodrainage methods : 1- force expiratory technique , 2- Flutter(R ) , 3- Flutter ( R ) with relaxation , 4- PEP system . Every investigated drainage methods were tested by each patient according to a determined procedure . The following indices were measured : weight of coughed up sputum , oxygen saturation ( SaO2 ) before , during and after drainage , peak expiratory flaw ( PEF ) before and after drainage . Patients ' relation to autodrainage methods was estimated on the ground of their subjective assessment in 0 - 5-point scale . The results showed that the force expiration technique and the Flutter(R ) with relaxation are the most efficient autodrainage methods determined by their coughed up sputum weight . Patients using these methods coughed up x 1.36 g and x 1.319 g sputum . Using Flutter(R ) without relaxation , patients expectorated 1.199 g sputum . PEP system turned out the least effective . Patients using the PEP system coughed up x 0.87 g sputum . In comparison , patients using postural drainage with clapping expectorated x 0.63 g sputum . We observed that the P
Output:
| No significant difference was seen in quality of life , sputum weight , exercise tolerance , lung function , or oxygen saturation between the active cycle of breathing technique and autogenic drainage or between the active cycle of breathing technique and airway oscillating devices .
There was no significant difference in lung function and the number of pulmonary exacerbations between the active cycle of breathing technique alone or in conjunction with conventional chest physiotherapy .
There is insufficient evidence to support or reject the use of the active cycle of breathing technique over any other airway clearance therapy .
Five studies , with data from eight different comparators , found that the active cycle of breathing technique was comparable with other therapies in outcomes such as participant preference , quality of life , exercise tolerance , lung function , sputum weight , oxygen saturation , and number of pulmonary exacerbations .
Longer-term studies are needed to more adequately assess the effects of the active cycle of breathing technique on outcomes important for people with cystic fibrosis such as quality of life and preference |
MS210870 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Abstract Variability in patients ' response to interventions in pain and other clinical setting s is large . Many explanations such as trial methods , environment or culture have been proposed , but this paper sets out to show that the main cause of the variability may be r and om chance , and that if trials are small their estimate of magnitude of effect may be incorrect , simply because of the r and om play of chance . This is highly relevant to the questions of ‘ How large do trials have to be for statistical accuracy ? ’ and ‘ How large do trials have to be for their results to be clinical ly valid ? ’ The true underlying control event rate ( CER ) and experimental event rate ( EER ) were determined from single‐dose acute pain analgesic trials in over 5000 patients . Trial group size required to obtain statistically significant and clinical ly relevant ( 0.95 probability of number‐needed‐to‐treat within ±0.5 of its true value ) results were computed using these values . Ten thous and trials using these CER and EER values were simulated using varying group sizes to investigate the variation due to r and om chance alone . Most common analgesics have EERs in the range 0.4–0.6 and CER of about 0.19 . With such efficacy , to have a 90 % chance of obtaining a statistically significant result in the correct direction requires group sizes in the range 30–60 . For clinical relevance nearly 500 patients are required in each group . Only with an extremely effective drug ( EER>0.8 ) will we be reasonably sure of obtaining a clinical ly relevant NNT with commonly used group sizes of around 40 patients per treatment arm . The simulated trials showed substantial variation in CER and EER , with the probability of obtaining the correct values improving as group size increased . We contend that much of the variability in control and experimental event rates is due to r and om chance alone . Single small trials are unlikely to be correct . If we want to be sure of getting correct ( clinical ly relevant ) results in clinical trials we must study more patients . Credible estimates of clinical efficacy are only likely to come from large trials or from pooling multiple trials of conventional ( small ) size & NA ; There is uncertainty over whether the patient group in which acute pain studies are conducted ( pain model ) has any influence on the estimate of analgesic efficacy . Data from four recently up date d systematic review s of aspirin 600/650 mg , paracetamol 600/650 mg , paracetamol 1000 mg and ibuprofen 400 mg were used to investigate the influence of pain model . Area under the pain relief versus time curve equivalent to at least 50 % maximum pain relief over 6 h was used as the outcome measure . Event rates with treatment and placebo , and relative benefit ( RB ) and number needed to treat ( NNT ) were used as outputs from the meta‐analyses . The event rate with placebo was systematic ally statistically lower for dental than postsurgical pain for all four treatments . Event rates with analgesics , RB and NNT were infrequently different between the pain models . Systematic difference in the estimate of analgesic efficacy between dental and postsurgical pain models remains unproven , and , on balance , no major difference is likely Background Previous analysis of a single data set in acute pain following third molar extraction demonstrated a strong relationship between the speed of reduction of pain intensity and overall pain relief , as well as need for additional analgesia . Methods Individual patient data analysis of a single r and omized , double-blind trial of placebo , paracetamol 1000 mg , ibuprofen sodium 400 mg and ibuprofen-poloxamer 400 mg following third molar extraction . Visual analogue scale pain intensity ( VASPI ) and other measurements were made at baseline , every 5–45 min , and at 60 , 90 , 120 , 180 , 240 , 300 and 360 min . Results Most patients produced consistent VASPI results over time . For placebo and paracetamol , few patients achieved low VASPI scores and maintained them . For both ibuprofen formulations , VASPI scores fell rapidly during the first hour and were then typically maintained until later re-medication . Analysis of all patients showed that rapid VASPI reduction in the first hour was strongly correlated with good overall pain relief ( high total pain relief over 0–6 h ) , and with lesser need for additional analgesia within 6 h. Results for this analysis were in very good agreement with a previous analysis , validating the relationship between fast initial pain intensity reduction and overall good pain relief in this setting . Conclusions In acute pain following third molar extraction , faster acting analgesic formulations provide earlier onset of pain relief , better overall pain relief and a less frequent need for additional analgesia , indicating longer lasting pain relief Abstract A previously established relationship for deriving dichotomous from continuous information in r and omised controlled trials ( RCTs ) of analgesics has been tested using an independent data set . Individual patient information from 18 RCTs of parallel‐group design in acute postoperative pain ( after abdominal , gynaecological and oral surgery ) was used to calculate the percentage of the maximum possible pain relief score ( % maxTOTPAR ) and the proportion of patients with > 50%maxTOTPAR for the different treatments . The relationship between the measures was investigated in 85 treatments with over 3400 patients . In 80 of 85 treatments ( 94 % ) agreement between calculated and actual number of patients with > 50%maxTOTPAR was within four patients per treatment and in 72 ( 85 % ) was within three ( average of 40 patients per treatment , range 21–58 patients ) . Summing the positive and negative differences between actual and calculated numbers of patients with > 50%maxTOTPAR gave an average difference of 0.30 patients per treatment arm . Reports of RCTs of analgesics frequently describe results of studies in the form of mean derived indices , rather than using discontinuous events , such as number or proportion of patients with 50 % pain relief . Because mean data inadequately describe information with a non‐normal distribution , combining mean data in systematic review s may compromise the results . Showing that dichotomous data can reliably be derived from mean data in acute pain studies enables data published as means to be used for quantitative systematic review s which require data in dichotomous form & NA ; Reports of RCTs of analgesics frequently describe results of studies in the form of mean derived indices , rather than using discontinuous events — such as number or proportion of patients with 50 % pain relief . Because mean data inadequately describe information with a non‐normal distribution , combining mean data in systematic review s may compromise the results . Showing that dichotomous data can reliably be derived from mean data , at least in acute pain models , indicates that more meaningful overviews or meta‐ analysis may be possible . This study investigated the relationship between continuous and dichotomous analgesic measures in a set of individual patient data , and then used that relationship to derive dichotomous from continuous information in r and omised controlled trials ( RCTs ) of analgesics . Individual patient information from 13 RCTs of parallel‐group and crossover design in acute postoperative pain was used to calculate the percentage of the maximum possible pain relief score ( % maxTOTPAR ) and the proportion of patients with greater than 50 % pain relief ( > 50%maxTOTPAR ) for the different treatments . The relationship between the measures was investigated in 45 actual treatments and 10 000 treatments simulated using the underlying actual distribution ; 1283 patients had 45 separate treatments . Mean % maxTOTPAR correlated with the proportion of patients with > 50%maxTOTPAR ( r2 = 0.90 ) . The relationship calculated from all the 45 treatments predicted to within three patients the number of patients with more than 50 % pain relief in 42 of 45 treatments , and 98.8 % of 10 000 simulated treatments . For seven effective treatments , actual numbers‐needed‐to‐treat ( NNT ) to achieve > 50%maxTOTPAR compared with placebo were very similar to those derived from calculated data OBJECTIVES To survey the frequency of use of indirect comparisons in systematic review s and evaluate the methods used in their analysis and interpretation . Also to identify alternative statistical approaches for the analysis of indirect comparisons , to assess the properties of different statistical methods used for performing indirect comparisons and to compare direct and indirect estimates of the same effects within review s. DATA SOURCES Electronic data bases . REVIEW METHODS The Data base of Abstract s of Review s of Effects ( DARE ) was search ed for systematic review s involving meta- analysis of r and omised controlled trials ( RCTs ) that reported both direct and indirect comparisons , or indirect comparisons alone . A systematic review of MEDLINE and other data bases was carried out to identify published methods for analysing indirect comparisons . Study design s were created using data from the International Stroke Trial . R and om sample s of patients receiving aspirin , heparin or placebo in 16 centres were used to create meta-analyses , with half of the trials comparing aspirin and placebo and half heparin and placebo . Methods for indirect comparisons were used to estimate the contrast between aspirin and heparin . The whole process was repeated 1000 times and the results were compared with direct comparisons and also theoretical results . Further detailed case studies comparing the results from both direct and indirect comparisons of the same effects were undertaken . RESULTS Of the review s identified through DARE , 31/327 ( 9.5 % ) included indirect comparisons . A further five review s including indirect comparisons were identified through electronic search ing . Few review s carried out a formal analysis and some based analysis on the naive addition of data from the treatment arms of interest . Few method ological papers were identified . Some valid approaches for aggregate data that could be applied using st and ard software were found : the adjusted indirect comparison , meta-regression and , for binary data only , multiple logistic regression ( fixed effect models only ) . Simulation studies showed that the naive method is liable to bias and also produces over-precise answers . Several methods provide correct answers if strong but unverifiable assumptions are fulfilled . Four times as many similarly sized trials are needed for the indirect approach to have the same power as directly r and omised comparisons . Detailed case studies comparing direct and indirect comparisons of the same effect show considerable statistical discrepancies , but the direction of such discrepancy is unpredictable . CONCLUSIONS Direct evidence from good- quality RCTs should be used wherever possible . Without this evidence , it may be necessary to look for indirect comparisons from RCTs . However , the results may be susceptible to bias . When making indirect comparisons within a systematic review , an adjusted indirect comparison method should ideally be used employing the r and om effects model . If both direct and indirect comparisons are possible within a review , it is recommended that these be done separately before considering whether to pool data . There is a need to evaluate methods for the analysis of indirect comparisons for continuous data and for empirical research into how different methods of indirect comparison perform in cases where there is a large treatment effect . Further study is needed into when it is appropriate to look at indirect comparisons and when to combine both direct and indirect comparisons . Research into how evidence from indirect comparisons compares to that from non-r and omised studies may also be warranted . Investigations using individual patient data from a meta- analysis of several RCTs using different protocol s and an evaluation of the impact of choosing different binary effect measures for the inverse variance method would also be useful Abstract One way to ensure adequate sensitivity for analgesic trials is to test the intervention on patients who have established pain of moderate to severe intensity . The usual criterion is at least moderate pain on a categorical pain intensity scale . When visual analogue scales ( VAS ) are the only pain measure in trials we need to know what point on a VAS represents moderate pain , so that these trials can be included in meta‐ analysis when baseline pain of at least moderate intensity is an inclusion criterion . To investigate this we used individual patient data from 1080 patients from r and omised controlled trials of various analgesics . Baseline pain was measured using a 4‐point categorical pain intensity scale and a pain intensity VAS under identical conditions . The distribution of the VAS scores was examined for 736 patients reporting moderate pain and for 344 reporting severe pain . The VAS scores corresponding to moderate or severe pain were also examined by gender . Baseline VAS scores recorded by patients reporting moderate pain were significantly different from those of patients reporting severe pain . Of the patients reporting moderate pain 85 % scored over 30 mm on the corresponding VAS , with a mean score of 49 mm . For those reporting severe pain 85 % scored over 54 mm with a mean score of 75 mm . There was no difference between the corresponding VAS scores of men and women . Our results indicate that if a patient records a baseline VAS score in excess of 30 mm they would probably have recorded at least moderate pain on a 4‐point categorical scale
Output:
| We found no information on many of the commonly available low dose codeine combinations .
For ibuprofen plus paracetamol , adverse event rates were lower than with placebo .
The proportion of people with acute pain who get good pain relief with any of them ranges from around 70 % at best to less than 20 % at worst ; low doses of some drugs in fast acting formulations were among the best .
Adverse events were generally no different from placebo . |
MS210871 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Purpose Hepatectomy is considered as the potentially curative treatment for hepatocellular carcinoma ( HCC ) and used in some selected Stage IIIA HCC , which include multiple tumors more than 5 cm or tumor involving a major branch of the portal or hepatic vein(s ) ( UICC TNM staging system , sixth edition ) . Transcatheter arterial chemoembolization ( TACE ) was used in retrospective studies to improve the survival outcome of resected HCC . However , its beneficial effect on the survival outcomes of the Stage IIIA patients has not been evaluated . The present study is to evaluate if hepatectomy combining with adjuvant TACE for Stage IIIA HCC result in better long-term survival outcome when compared with hepatectomy alone . Methods From January 2001 to March 2004 , we conducted a prospect i ve r and omized trial in patients with Stage IIIA HCC ( NCT00652587 ) , recruiting 115 Stage IIIA HCC patients to undergo hepatectomy with adjuvant TACE ( HT arm ) or to undergo hepatectomy alone ( HA arm ) in our cancer center . Survival outcomes of the two arms were analyzed . Results The demographic data were well matched between the two arms . There were no significant differences in the morbidity and in-hospital mortality between the two arms of patients . The most significant toxicities associated with adjuvant TACE were nausea/vomiting ( 54.4 % ) and transient hepatic toxicity ( elevation of aminotransferase , 52.6 % ) . Although there was no significant difference in the rate of recurrence between the two arms ( 50/57 vs. 56/58 , P = 0.094 ) , HT arm seemed to have more proportion of single lesion of recurrent HCC ( χ2 = 3.719 , P = 0.054 ) and more proportion of potential curative therapy for recurrence ( χ2 = 4.456 , P = 0.035 ) . Until the time of censor , 92 patients had died . The 1- , 3- , and 5-year overall survival rates and median overall survival for HT arm were 80.7 , 33.3 , 22.8 % and 23.0 months , respectively . The corresponding overall survival rates and median overall survival for HA arm were 56.5 , 19.4 , 17.5 % and 14.0 months , respectively . The difference was significant ( stratified log-rank test , P = 0.048 ) . The 1- , 3- , and 5-year disease-free survival rates and median disease-free survival for HT arm were 29.7 , 9.3 , 9.3 % and 6.0 months , respectively ; correspondingly , for HA arm were 14.0 , 3.5 , 1.7 % and 4.0 months , respectively ( stratified log-rank test , P = 0.004 ) . Conclusions For Stage IIIA HCC , hepatectomy with adjuvant TACE efficaciously and safely improved survival outcomes when compared with hepatectomy alone OBJECTIVE To explore the effect of postoperative adjuvant transarterial chemoembolization ( TACE ) upon early recurrence of hepatocellular carcinoma ( HCC ) patients after radical resection . METHODS Between November 2000 and December 2007 , 2591 HCC patients undergoing radical resection were retrospectively recruited . Patients undergoing resection alone were selected as control group while those receiving post-operative adjuvant TACE as intervention group . The patients were further stratified into tumor < or = 5 cm with low or high risk factors for residual tumor and tumor > 5 cm with low or high risk factors for residual tumor . A low risk factor for residual tumor was defined as single tumor and without microscopic tumor thrombus while a high risk factor for residual tumor was defined as 2 - 3 nodules or with the presence of microscopic tumor thrombus . The effect of adjuvant TACE upon early ( < or = 2 years ) recurrence was evaluated . RESULTS Recurrent rates of tumor < or = 5 cm with low or high risk factors for residual tumor and tumor > 5 cm with low or high risk factors for residual tumor at Month 3 post-resection were 1.34 % , 3.17 % , 5.33 % and 8.43 % in the control group versus 4.14 % ( P = 0.002 ) , 8.15 % ( P = 0.011 ) , 12.88 % ( P = 0.002 ) and 14.29 % ( P = 0.045 ) respectively in the intervention group ; recurrence rates at Month 6 post-resection were 4.63 % , 8.73 % , 11.50 % and 19.46 % in the control group versus 6.71 % ( P = 0.133 ) , 13.48 % ( P = 0.070 ) , 21.02 % ( P = 0.052 ) and 23.94 % ( P = 0.210 ) respectively in the intervention group . For patients remaining recurrence free within the first 6 months post-resection , there were no significant differences in recurrence rates at Months 9 , 12 , 18 and 24 post-operation between each intervention group and control group . CONCLUSION Postoperative adjuvant TACE has no preventive effect upon early recurrence , but may be of benefit to detect residual tumor and early recurrence Flaws in the design , conduct , analysis , and reporting of r and omised trials can cause the effect of an intervention to be underestimated or overestimated . The Cochrane Collaboration ’s tool for assessing risk of bias aims to make the process clearer and more BACKGROUND / AIMS Prevention of recurrence is the most important strategy to improve long-term survival after resection of hepatocellular carcinoma ( HCC ) . This comparative study aim ed to evaluate the outcome of adjuvant transarterial chemoembolization ( TACE ) after hepatectomy . METHODOLOGY From February 1996 and September 2001 , 721 consecutive patients ( adjuvant TACE treatment vs. control group ; 145 vs. 576 ) with R0 resection for HCC were analyzed . The prospect i ve data was analyzed retrospectively . RESULTS After a median follow-up of 75 months , 89 patients ( 61.4 % ) in the adjuvant TACE group and 355 patients ( 61.6 % ) in the control group had recurrent disease . There was no significant difference in the tumor recurrence rate between the 2 groups . There was significant difference in the tumor recurrence time between the 2 groups . The 1- , 3- and 5-year overall survival rates were 96.5 % , 70.0 % and 55.9 % , respectively , for the adjuvant TACE group and 80.8 % , 49.7 % and 38.8 % , respectively , for the control group . The 1- , 3- and 5-year disease-free survival rates were 79.9 % , 54.9 % and 48.4 % , respectively , for the adjuvant TACE group and 60.2 % , 39.8 % and 31.5 % , respectively , for the control group . The differences in the disease-free survival rates and the overall survival rates between the 2 groups were significant . In subgroup analysis , there was significant survival benefit in the adjuvant TACE group in the subgroup of patients with risk factors of recurrence - large tumor size , presence of satellite tumor nodules and narrow resection margin . CONCLUSIONS Adjuvant TACE improved surgical outcome in those patients with risk factors of HCC recurrence BACKGROUND Recurrence of hepatitis B-related hepatocellular carcinoma ( HCC ) after curative resection is the leading factor influencing the prognosis of the disease . Therefore , further improvement of long-term survival may depend on the prevention and treatment of the recurrent tumor . The aim of this research was to investigate the role of antiviral therapy and postoperative transcatheter arterial chemoembolization ( TACE ) in the prevention and treatment of hepatitis B-related HCC recurrence . METHODS One hundred and twenty patients who underwent curative resection of hepatitis B-related HCC between January 2005 and June 2008 at our hospital were enrolled . Patients were divided into four groups according to the post-operative adjuvant therapy they received , i.e. , control , antiviral therapy group , TACE group , and combined group . The disease-free survival ( DFS ) and the 12- , 24- , 36-month cumulative recurrence rates were studied . RESULTS There was no significant difference between isolated postoperative antiviral therapy group and control in terms of disease-free survival ( P = 0.283 ) , while it was significantly higher in the TACE group compared to control ( P = 0.019 ) . In all patients , however , viral prophylactic therapy combined with/without TACE brought a favorable result compared to those only with/without TACE ( P < 0.001 ) . Similarly , no matter combined with or without antiviral treatment , postoperative TACE prolonged DFS ( P = 0.015 ) . Naturally , a combination of viral prophylactic therapy on the baseline TACE significantly benefited patients ' postoperative DFS ( P = 0.047 ) and vice verse ( P = 0.002 ) . The 24-month cumulative recurrence rates of combined group were significantly lower than that of isolated control group and antiviral therapy ( P < 0.001 and P = 0.011 respectively ) . However , 36-month recurrence rate was significantly different in the control group compared to the TACE group and combined group ( P = 0.040 and 0.002 respectively ) ; same as the antiviral group compared to the combined group ( P = 0.034 ) . CONCLUSIONS Post-operative TACE prevents early recurrence while antiviral therapy prevents late recurrence of HCC . Combination of antiviral therapy and TACE are suggested for prevention in HCC patients with high risk of recurrence Objective : To explore the value of postoperative transarterial chemoembolization ( TACE ) and portal vein chemotherapy ( PVC ) in patients with hepatocellular carcinoma ( HCC ) in the prevention of recurrence , and to evaluate prognostic factors in a r and omized study . Method : 131 patients with HCC were r and omly divided into 3 groups : operation only ( group A , n = 45 ) ; operation plus TACE ( group B , n = 39 ) , and operation plus TACE and PVC ( group C , n = 47 ) . Disease-free survival rates as well as prognostic factors were analyzed . Results : Most of the side effects and complications related to the operation , catheters and local chemotherapy were liver decompensation ( 16.1 % ) , catheter obstruction ( 12.9 % ) , and nausea and loss of appetite ( 25.8 % ) , respectively . The disease-free survival curves were significantly different between the 3 groups as estimated by the Kaplan-Meier method ( p < 0.05 ) . Group C had a significantly higher disease-free survival rate compared to group A ( p < 0.05 ) . But no statistical differences were found between groups A and B and groups B and C ( both p > 0.05 ) . Tumor number and treatment modalities were independent prognostic factors for HCC patients ( p < 0.05 ) . Conclusion : Postoperative TACE combined with PVC may benefit the survival of patients with HCC . In specialized medical centers , aggressive methods such as TACE and PVC should be attempted on HCC patients without contraindications Vascular invasion and intrahepatic metastasis by hepatocellular carcinoma are important factors predisposing to tumor recurrence . Recurrences of this malignancy occur frequently in residual liver , and its prevention is one of the most important factors in obtaining better surgical survival . Fifty patients who underwent hepatectomy for invasive hepatocellular carcinoma with vascular invasion and /or intrahepatic metastases were studied to evaluate the effect of adjuvant bolus hepatic arterial infusion of iodized poppyseed oil ( Lipiodol ) containing anticancer drugs in preventing recurrence and in prolonging survival . Patients were assigned to two treatment groups . Twenty-three of the fifty patients received adjuvant bolus infusion of Lipiodol containing doxorubicin and mitomycin C , whereas 27 patients received no therapy . The disease-free survival rate for the patients who received adjuvant therapy was significantly better ( p < 0.05 ) than that for those who did not when measured at 172 , 516 , 688 and 860 days after hepatectomy , and the disease-free survival curve for patients with adjuvant therapy was significantly ( p = 0.0237 ) better than that without adjuvant therapy . The cumulative survival rates and curves were not significantly different between the two groups . While adjuvant hepatic arterial infusion of Lipiodol containing anticancer drugs was effective in improving disease-free survival , the effect was not satisfactory . Further trials of adjuvant chemotherapy are required to improve the surgical survival of hepatocellular carcinoma patients From April 1990 to December 1993 , 140 patients were recruited to a r and omized study to evaluate transcatheter hepatic arterial chemoembolization ( TACE ) as an adjuvant therapy for primary liver carcinoma after hepatectomy . This study investigated the principle , techniques and results of TACE . The
Output:
| Conclusion Post-operative aTACE is safe and improves overall and disease-free survival , with the greatest benefit in MVI-positive patients . |
MS210872 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: CONTEXT Prospect i ve studies have established an association between depressive symptoms and risk of dementia , but how depressive symptoms change during the evolution of dementia is uncertain . OBJECTIVE To test the hypothesis that depressive symptoms increase during the prodromal phase of Alzheimer disease ( AD ) . DESIGN Prospect i ve cohort study . PARTICIPANTS AND SETTING For up to 13 years , 917 older Catholic nuns , priests , and monks without dementia at study onset completed annual clinical evaluations that included administration of the 10-item Center for Epidemiologic Studies Depression Scale and clinical classification of mild cognitive impairment and AD . MAIN OUTCOME MEASURE Change in depressive symptoms reported on the Center for Epidemiologic Studies Depression Scale . RESULTS At baseline , participants reported a mean ( SD ) of 1.0 ( 1.5 ) depressive symptoms . Those who developed AD ( n = 190 ) showed no increase in depressive symptoms before the diagnosis was made , and this finding was not modified by age , sex , education , memory complaints , vascular burden , or personality . There was no systematic change in depressive symptoms after the AD diagnosis , although symptoms tended to decrease in women relative to men and in those with a higher premorbid level of openness and a lower premorbid level of agreeableness . Among those without cognitive impairment at baseline , depressive symptoms did not increase in those who subsequently developed mild cognitive impairment . CONCLUSION We found no evidence of an increase in depressive symptoms during the prodromal phase of AD BACKGROUND Subjects with a mild cognitive impairment ( MCI ) have a memory impairment beyond that expected for age and education yet are not demented . These subjects are becoming the focus of many prediction studies and early intervention trials . OBJECTIVE To characterize clinical ly subjects with MCI cross-sectionally and longitudinally . DESIGN A prospect i ve , longitudinal inception cohort . SETTING General community clinic . PARTICIPANTS A sample of 76 consecutively evaluated subjects with MCI were compared with 234 healthy control subjects and 106 patients with mild Alzheimer disease ( AD ) , all from a community setting as part of the Mayo Clinic Alzheimer 's Disease Center/Alzheimer 's Disease Patient Registry , Rochester , Minn. MAIN OUTCOME MEASURES The 3 groups of individuals were compared on demographic factors and measures of cognitive function including the Mini-Mental State Examination , Wechsler Adult Intelligence Scale-Revised , Wechsler Memory Scale-Revised , Dementia Rating Scale , Free and Cued Selective Reminding Test , and Auditory Verbal Learning Test . Clinical classifications of dementia and AD were determined according to the Diagnostic and Statistical Manual of Mental Disorders , Revised Third Edition and the National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer 's Disease and Related Disorders Association criteria , respectively . RESULTS The primary distinction between control subjects and subjects with MCI was in the area of memory , while other cognitive functions were comparable . However , when the subjects with MCI were compared with the patients with very mild AD , memory performance was similar , but patients with AD were more impaired in other cognitive domains as well . Longitudinal performance demonstrated that the subjects with MCI declined at a rate greater than that of the controls but less rapidly than the patients with mild AD . CONCLUSIONS Patients who meet the criteria for MCI can be differentiated from healthy control subjects and those with very mild AD . They appear to constitute a clinical entity that can be characterized for treatment interventions Background : Apathy is a common symptom in various neuropsychiatric diseases including mild cognitive impairment ( MCI ) and dementia . Apathy may be associated with an increased risk of cognitive decline . The objective of this study was to investigate if apathy predicts the progression from MCI to Alzheimer ’s disease ( AD ) . Methods : The Alzheimer ’s Disease Neuroimaging Initiative is a prospect i ve multicentre cohort study . At baseline , 397 patients with MCI without major depression were included . Clinical data and the Geriatric Depression Scale at baseline were used . Apathy was defined based on the 3 apathy items of the 15-item Geriatric Depression Scale . The main outcome measure was the association of apathy with progression from MCI to AD . Results : During an average follow-up of 2.7 years ( SD 1.0 ) , 166 ( 41.8 % ) patients progressed to AD . The presence of symptoms of apathy without symptoms of depressive affect increased the risk of progression from MCI to AD ( hazard ratio = 1.85 , 95 % CI = 1.09–3.15 ) . Apathy in the context of symptoms of depressive affect or symptoms of depressive affect alone , without apathy , did not increase the risk of progression to AD . Conclusions : Symptoms of apathy , but not symptoms of depressive affect , increase the risk of progression from MCI to AD . Apathy in the context of symptoms of depressive affect does not increase this risk . Symptoms of apathy and depression have differential effects on cognitive decline Studies on humans show that depressive disorder is associated with an increased risk of developing cognitive dysfunction , and animal studies suggest that antidepressants may have neuroprotective abilities . On the basis of these observations , it was hypothesized that treatment with antidepressants may decrease the risk of developing dementia in patients with depression . We investigated whether continued treatment with antidepressants is associated with a decreased rate of dementia in a population of patients discharged from psychiatric healthcare service with a diagnosis of depression . We used register data on all prescribed antidepressants in all patients discharged from psychiatric healthcare service with a diagnosis of depression and with subsequent diagnoses of dementia in Denmark from 1995 to 2005 . A total of 37 658 patients with a diagnosis of depression at their first psychiatric contact and who were exposed to antidepressants after discharge were included in the study . A total of 2007 patients ( 5.3 % ) were subsequently diagnosed with dementia of any kind . The rate of dementia decreased during periods of two or more prescriptions of older antidepressants compared with the period of only one prescription of older antidepressants [ relative risk (RR)=0.83 ( 95 % confidence interval (CI)=0.70–0.98 ) ] . This finding was replicated with Alzheimer ’s disease as the outcome [ RR=0.66 ( 95 % CI=0.47–0.94 ) ] but not with dementia of other kinds as the outcome [ RR=0.88 ( 95 % CI=0.73–1.06 ) ] . In contrast , during periods of continued use of selective serotonin reuptake inhibitors or newer nonselective serotonin reuptake inhibitors , the rate of dementia was not decreased , regardless of the subtype of dementia . It was concluded that continued long-term treatment with older antidepressants is associated with a reduced rate of dementia in patients treated in psychiatric healthcare setting s , whereas continued treatment with other kinds of antidepressants is not . Method ological reasons for these findings can not be excluded because of the nonr and omized nature of data Identification of potentially modifiable risk factors for cognitive deterioration is important . We conducted a prospect i ve study of 5,607 subjects with normal cognition and 2,500 subjects with mild cognitive impairment ( MCI ) at 30 Alzheimer 's Disease Centers in the Unites States between 2005 and 2011 . Cox regression was used to determine whether depression predicted transition from normal to MCI , or MCI to Alzheimer 's disease ( AD ) . Over an average of 3.3 visits , 15 % of normal subjects transitioned to MCI ( 62/1000 per year ) , while 38 % of MCI subjects transitioned to AD ( 146/1000 per year ) . At baseline , 22 % of participants had recent ( within the last two years ) depression defined by clinician judgment ; 9 % and 17 % were depressed using the Geriatric Depression Scale ( GDS score ≥5 ) and the Neuropsychiatric Inventory Question naire ( NPI-Q ) , respectively . At baseline , depressed subjects performed significantly worse on cognitive tests . Those always depressed throughout follow-up had an increased risk for progression from normal to MCI ( RR = 2.35 ; 95 % CI 1.93 - 3.08 ) versus never depressed . Normal subjects , identified as depressed at first visit but subsequently improved , were found to have lower risk of progression ( RR 1.40 ( 1.01 - 1.95 ) ) . The ' always depressed ' had only a modest increased risk of progression from MCI to AD ( RR = 1.21 ( 1.00 - 1.46 ) . Results were similar using time-dependent variables for depression or when defining depression via the GDS or NPI-Q. We found no effect of earlier depression ( > 2 years past ) . The effect of recent depression did not differ by antidepressant treatment , APOE4 allele status , or type of MCI . In conclusion , late-life depression is a strong risk factor for normal subjects progressing to MCI Objective : To examine risk factors for mild cognitive impairment ( MCI ) and progression to dementia in a prospect i ve community-based study of subjects aged 65 years and over . Methods : 6892 participants who were over 65 and without dementia were recruited from a population -based cohort in three French cities . Cognitive performance , clinical diagnosis of dementia , and clinical and environmental risk factors were evaluated at baseline and 2-year and 4-year follow-ups . Results : 42 % of the population were classified as having MCI at baseline . After adjustment for confounding with logistic regression models , men and women classified as having MCI were more likely to have depressive symptomatology and to be taking anticholinergic drugs . Men were also more likely to have a higher body mass index , diabetes and stroke , whereas women were more likely to have poor subjective health , to be disabled , to be socially isolated , and to suffer from insomnia . The principal adjusted risk factors for men for progression from MCI to dementia in descending order were ApoE4 allele ( OR = 3.2 , 95 % CI 1.7 to 5.7 ) , stroke ( OR = 2.8 , 95 % CI 1.2 to 6.9 ) , low level of education ( OR = 2.3 , 95 % CI 1.3 to 4.1 ) , loss of Instrumental Activities of Daily Living ( IADL ) ( OR = 2.2 , 95 % CI 1.1 to 4.5 ) and age ( OR = 1.2 , 95 % CI 1.1 to 1.2 ) . In women , progression is best predicted by IADL loss ( OR = 3.5 , 95 % CI 2.1 to 5.9 ) , ApoE4 allele ( OR = 2.3 , 95 % CI 1.4 to 4.0 ) , low level of education ( OR = 2.2 , 95 % CI 1.3 to 3.6 ) , sub clinical depression ( OR = 2.0 , 95 % CI 1.1 to 3.6 ) , use of anticholinergic drugs ( OR = 1.8 , 95 % CI 1.0 to 3.0 ) and age ( OR = 1.1 , 95 % CI 1.1 to 1.2 ) . Conclusions : Men and women have different risk profiles for both MCI and progression to dementia . Intervention programmes should focus principally on risk of stroke in men and depressive symptomatology and use of anticholinergic medication in women OBJECTIVE The authors conducted a prospect i ve cohort study to estimate the risk of incident mild cognitive impairment in cognitively normal elderly ( aged ≥70 years ) individuals with or without neuropsychiatric symptoms at baseline . The research was conducted in the setting of the population -based Mayo Clinic Study of Aging . METHOD A classification of normal cognitive aging , mild cognitive impairment , and dementia was adjudicated by an expert consensus panel based on published criteria . Hazard ratios and 95 % confidence intervals were computed using Cox proportional hazards model , with age as a time scale . Baseline Neuropsychiatric Inventory Question naire data were available for 1,587 cognitively normal persons who underwent at least one follow-up visit . RESULTS The cohort was followed to incident mild cognitive impairment ( N=365 ) or censoring variables ( N=179 ) for a median of 5 years . Agitation ( hazard ratio=3.06 , 95 % CI=1.89 - 4.93 ) , apathy ( hazard ratio=2.26 , 95 % CI=1.49 - 3.41 ) , anxiety ( hazard ratio=1.87 , 95 % CI=1.28 - 2.73 ) , irritability ( hazard ratio=1.84 , 95 % CI=1.31 - 2.58 ) , and depression ( hazard ratio=1.63 , 95 % CI=1.23 - 2.16 ) , observed initially , increased risk for later mild cognitive impairment . Delusion and hallucination did not . A secondary analysis , limited in significance by the small number of study participants , showed that euphoria , disinhibition , and nighttime behaviors were significant predictors of nonamnestic mild cognitive impairment but not amnestic mild cognitive impairment . By contrast ,
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| DISCUSSION Our results provide additional evidence that depressive symptoms determine an additive risk effect to the progression to dementia in subjects with MCI .
The comorbidity between depression and cognitive impairment can be an intervention target for prevention of dementia in MCI subjects . |
MS210873 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
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***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: INTRODUCTION Smoking cessation pharmacotherapies tested in persons with opioid use disorder have produced low quit rates . Electronic cigarettes ( e-cigarettes ) have been used by many methadone-maintained ( MMT ) smokers , but controlled trials evaluating cessation and reduction outcomes have not been performed in this population with deleterious tobacco-related health consequences . METHODS In this open trial of NJOY e-cigarettes , MMT smokers received 6 weeks of treatment and were instructed to use only e-cigarettes . Outcomes included carbon monoxide confirmed 7-day point smoking cessation prevalence at week 7 ( end of treatment ) and self-reported change in mean cigarettes per day ( CPD ) at each 2-week assessment . The final assessment was 2 weeks after treatment ended ( week 9 ) . RESULTS The 12 participants averaged 46 years old and 50 % were male . On average , participants reported smoking 17.8 ( ±5.3 ) CPD . One person had a biochemically confirmed quit at week 7 . Participants tended to report marked reductions in mean CPD between quit day ( week 1 ) and the week 3 assessment . Relative to baseline , statistically significant reductions in mean CPD were observed at all follow-up assessment s. Mean reductions in CPD were -12.4 ( 95 % confidence interval [ CI ] : -15.0 , -9.9 ; P < .001 ) , -14.8 ( 95 % CI : -17.4 , -12.2 ; P < .001 ) , -13.9 ( 95 % CI : -16.6 , -11.2 ) , and -10.8 ( 95 % CI : -13.4 , -8.2 ; P < .01 ) at the 3- , 5- , 7- , and 9-week assessment s , respectively . Adherence to e-cigarettes was 89.1 % during the 6 treatment weeks . CONCLUSIONS E-cigarettes were associated with reductions in cigarette use . Smoking cessation rates in MMT smokers are low and whether long-term smoking reductions can persist and produce health benefits should be studied . IMPLICATION S E-cigarettes were associated with reduced tobacco use in MMT smokers . Adherence to e-cigarettes is high among methadone smokers . Week-7 smoking quit rates are similar to pharmacotherapies tested in this population Background People with mental illness have higher rates of smoking than the general population and are at greater risk of smoking-related death and disability . In smokers from the general population , electronic cigarettes ( e-cigarettes ) have been shown to have a similar effect on quit rates as nicotine replacement therapy , but little is known about their effect in smokers with mental illness . Methods Secondary analysis of data from the ASCEND trial involving 657 dependent adult smokers motivated to quit , r and omised to 16 mg nicotine e-cigarette , 21 mg nicotine patch , or 0 mg nicotine e-cigarette , with minimal behavioural support . Using self-reported medication use and the Anatomical Therapeutic Chemical Classification System , we identified 86 participants with mental illness and analysed their cessation and smoking reduction outcomes . Results For e-cigarettes alone , and all interventions pooled , there was no statistically significant difference in biochemically verified quit rates at six months between participants with and without mental illness , nor in smoking reduction , adverse events , treatment compliance , or acceptability . Rates of relapse to smoking were higher in participants with mental illness . Among this group , differences between treatments were not statistically significant for cessation ( patch 14 % [ 5/35 ] , 16 mg e-cigarette 5 % [ 2/39 ] , 0 mg e-cigarette 0 % [ 0/12 ] , p = 0.245 ) , adverse events or relapse rates . However , e-cigarette users had higher levels of smoking reduction , treatment compliance , and acceptability . Conclusions The use of e-cigarettes for quitting appears to be equally effective , safe , and acceptable for people with and without mental illness . For people with mental illness , e-cigarettes may be as effective and safe as patches , yet more acceptable , and associated with greater smoking reduction . Trial registration Australian New Zeal and Clinical trials Registry , number : ACTRN12610000866000 BACKGROUND Electronic cigarettes ( e-cigarettes ) can deliver nicotine and mitigate tobacco withdrawal and are used by many smokers to assist quit attempts . We investigated whether e-cigarettes are more effective than nicotine patches at helping smokers to quit . METHODS We did this pragmatic r and omised-controlled superiority trial in Auckl and , New Zeal and , between Sept 6 , 2011 , and July 5 , 2013 . Adult ( ≥18 years ) smokers wanting to quit were r and omised ( with computerised block r and omisation , block size nine , stratified by ethnicity [ Māori ; Pacific ; or non-Māori , non-Pacific ] , sex [ men or women ] , and level of nicotine dependence [ > 5 or ≤5 Fagerström test for nicotine dependence ] ) in a 4:4:1 ratio to 16 mg nicotine e-cigarettes , nicotine patches ( 21 mg patch , one daily ) , or placebo e-cigarettes ( no nicotine ) , from 1 week before until 12 weeks after quit day , with low intensity behavioural support via voluntary telephone counselling . The primary outcome was biochemically verified continuous abstinence at 6 months ( exhaled breath carbon monoxide measurement < 10 ppm ) . Primary analysis was by intention to treat . This trial is registered with the Australian New Zeal and Clinical Trials Registry , number ACTRN12610000866000 . FINDINGS 657 people were r and omised ( 289 to nicotine e-cigarettes , 295 to patches , and 73 to placebo e-cigarettes ) and were included in the intention-to-treat analysis . At 6 months , verified abstinence was 7·3 % ( 21 of 289 ) with nicotine e-cigarettes , 5·8 % ( 17 of 295 ) with patches , and 4·1 % ( three of 73 ) with placebo e-cigarettes ( risk difference for nicotine e-cigarette vs patches 1·51 [ 95 % CI -2·49 to 5·51 ] ; for nicotine e-cigarettes vs placebo e-cigarettes 3·16 [ 95 % CI -2·29 to 8·61 ] ) . Achievement of abstinence was substantially lower than we anticipated for the power calculation , thus we had insufficient statistical power to conclude superiority of nicotine e-cigarettes to patches or to placebo e-cigarettes . We identified no significant differences in adverse events , with 137 events in the nicotine e-cigarettes group , 119 events in the patches group , and 36 events in the placebo e-cigarettes group . We noted no evidence of an association between adverse events and study product . INTERPRETATION E-cigarettes , with or without nicotine , were modestly effective at helping smokers to quit , with similar achievement of abstinence as with nicotine patches , and few adverse events . Uncertainty exists about the place of e-cigarettes in tobacco control , and more research is urgently needed to clearly establish their overall benefits and harms at both individual and population levels . FUNDING Health Research Council of New Zeal and INTRODUCTION Up to 75 % of people with serious mental illness ( SMI ) smoke , and most are highly dependent on nicotine , consuming more cigarettes per day than smokers without mental illness . Even with evidence -based treatment , relapses are common , result ing in high morbidity and early mortality from tobacco-related diseases . Electronic cigarettes ( e-cigarettes ) are theoretically safer because they deliver no tar or carbon monoxide ; however , their appeal is largely untested in people with SMI . METHODS We enrolled 21 chronic smokers with SMI who had failed a quit attempt and were not engaged in cessation treatment . Research staff provided e-cigarettes and instructions on how to use them , and assessed participants weekly for 4weeks . RESULTS Of the enrolled participants , 19 completed weekly assessment s. From baseline to the final study visit , mean self-reported use of combustible tobacco declined from 192 to 67cigarettes/week ( t=3.62 , df=17 , p=0.005 ) , confirmed by reduction in breath carbon monoxide from 27ppm to 15ppm ( t=3.246 , df=18 , p=0.004 ) . Use of e-cigarettes did not escalate over the 4weeks . Temporary and mild side effects , including dry/sore throat , nausea , dizziness , and cough , were reported by 58 % of participants . End of trial ratings of enjoyment , satisfaction compared to regular cigarettes , and willingness to buy e-cigarettes were high ( ranging from 3.82 - 4.51 on a 5-point scale ) . CONCLUSIONS Results of this study suggest that people with SMI may find e-cigarettes an appealing substitute for combustible cigarettes . We found no evidence of increasing nicotine dependence . Further r and omized studies are needed to better assess e-cigarette appeal and toxicity Background : Cigarette smoking is a tough addiction to break . This dependence is the most common dual diagnosis for individuals with schizophrenia . Currently three effective drugs are approved for smoking cessation : nicotine replacement therapy ( NRT ) , varenicline and bupropion . However , some serious side effects of varenicline have been reported , including depression , suicidal thoughts , and suicide . The use of bupropion also has side effects . It should not be used by people who have epilepsy or any condition that lowers the seizure threshold , nor by people who take a specific class of drugs called monoamine oxidase inhibitors . Hence , there are pharmacodynamic reason to believe they could precipitate or exacerbate psychosis . For its capacity to deliver nicotine and provide a coping mechanism for conditioned smoking cues by replacing some of the rituals associated with smoking gestures , electronic-cigarettes may reduce nicotine withdrawal symptoms without serious side effects . Our recent work with ECs in healthy smokers not intending to quit consistently show surprisingly high success rates . We hypothesised that these positive findings could be replicated in difficult patients with schizophrenia This tool may help smokers with schizophrenia remain abstinent during their quitting attempts or to reduce cigarette consumption . Efficacy and safety of these devices in long-term smoking cessation and /or smoking reduction studies have never been investigated for this special population . Methods : In this study we monitored possible modifications in smoking habits of 14 smokers ( not intending to quit ) with schizophrenia experimenting with the “ Categoria ” e-Cigarette with a focus on smoking reduction and smoking abstinence . Study participants were invited to attend six study visits : at baseline , week-4 , week-8 , week-12 week-24 and week 52 . Product use , number of cigarettes smoked , carbon monoxide in exhaled breath ( eCO ) and positive and negative symptoms of schizophrenia levels were measured at each visit . Smoking reduction and abstinence rates were calculated . Adverse events were also review ed . Results : Sustained 50 % reduction in the number of cig/day at week-52 was shown in 7/14 ( 50 % ) participants ; their median of 30 cig/day decreasing significantly to 15 cig/day ( p = 0.018 ) . Sustained smoking abstinence at week-52 was observed in 2/14 ( 14.3 % ) participants . Combined sustained 50 % reduction and smoking abstinence was shown in 9/14 ( 64.3 % ) participants . Nausea was observed in 2/14 ( 14.4 % ) of participants , throat irritation in 2/14 ( 14.4 % ) of participants , headache in 2/14 ( 14.4 % ) of participants , and dry cough in 4/14 ( 28.6 % ) of participants . However , these adverse events diminished substantially by week-24 . Overall , one to two cartridges/day were used throughout the study . Positive and negative symptoms of schizophrenia are not increased after smoking reduction/cessation in patients using e-cigarettes . Conclusions : We have shown for the first time that the use of e-cigarette substantially decreased cigarette consumption without causing significant side effects in chronic schizophrenic patients who smoke not intending to quit . This was achieved without negative impacts on the symptoms of schizophrenia as assessed by SAPS and SANS symptoms scales Objectives While substantial research has demonstrated the poor health status of homeless population s , the health status of vulnerably housed individuals is largely unknown . Furthermore , few longitudinal studies have assessed the impact of housing transitions on health . The health and housing in transition ( HHiT ) study is a prospect i ve cohort study that aims to track the health and housing status of a representative sample of homeless and vulnerably housed single adults in three Canadian cities ( Toronto , Ottawa , and Vancouver ) . This paper discusses
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| IMPLICATION S Smoking prevalence among people with mental illness , substance misuse , homelessness , or criminal justice system involvement remains high .
E-cigarettes could support cessation .
Qualitative thematic synthesis revealed barriers and facilitators mapping to each component of the COM-B ( capability , opportunity , motivation , and behavior ) model , including practical barriers ; perceived effectiveness ; design features contributing to automatic and reflective motivation ; smoking bans facilitating practical opportunity ; and social connectedness increasing social opportunity . |
MS210874 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
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Input: Background and Purpose — Early supported discharge ( ESD ) for stroke has been shown to yield outcomes similar to or better than those of conventional care , but there is less information on the impact on costs and on the caregiver . The purpose of this study is to estimate the costs associated with an ESD program compared with those of usual care . Methods — We conducted a r and omized controlled trial of stroke patients who required rehabilitation services and who had a caregiver at home . Results — Acute-care costs incurred before r and omization when patients were medically ready for discharge averaged $ 3251 per person . The costs for the balance of the acute-care stay , from r and omization to discharge , were $ 1383 for the home group and $ 2220 for the usual care group . The average cost of providing the 4-week home intervention service was $ 943 per person . The total cost generated by persons assigned to the home group averaged $ 7784 per person , significantly lower than the $ 11 065 per person for those assigned to usual care . A large proportion of the cost differential between the 2 groups arose from readmissions , for which the usual care group generated costs more than quadruple those of the home intervention group . Conclusions — Providing care at home was no more ( or less ) expensive for those with greater functional limitation than for those with less . Caregivers in the ESD group scored consistently lower on the Burden Index than caregivers with usual care , even caregivers of persons with major functional limitations . For persons recovering from stroke and their families , ESD provides a cost-effective alternative to usual care Self-efficacy reflects an individual 's perceptions or beliefs about how capable he or she is of performing a specific activity or task and measures self-confidence to perform that specific activity or task . This study investigated the effect of in-patient cardiac rehabilitation on self-efficacy scores for 3 categories of activities : routine physical activities , daily living tasks and levels of concentration and ability to cope . On discharge from the intensive or coronary care unit , patients without contraindications to early ambulation were r and omized to either a ward ambulation program ( n = 26 ) or a dedicated exercise center program ( n = 25 ) with all patients receiving the same st and ardized education/counseling . There were no differences between the groups in self-efficacy at baseline , at hospital discharge or 7 days later . Significant improvements in self-efficacy scores were observed by day 28 in both groups for routine physical activities and daily living tasks with no change in self-efficacy scores for concentration or ability to cope . At that time the exercise center patients had higher self-efficacy scores for walking time ( p = 0.041 ) and overall exertion ( p = 0.024 ) than the ward ambulation patients . For the majority of the self-efficacy variables considered , both in-patient exercise rehabilitation programs were equally effective in improving self-efficacy scores for physical activities and daily living tasks over the first 28 days after return to home . The lower cost associated with ward ambulation programs suggests that they are more cost-effective than developing a program in a dedicated in-patient exercise center OBJECTIVE To estimate the cost-utility and cost-effectiveness of a 3-week intensive exercise training ( IET ) program directly following hospital discharge in patients with rheumatic diseases . METHODS Patients with arthritis who were admitted to the hospital because of a disease activity flare or for elective hip or knee arthroplasty were r and omly assigned to either the IET group or usual care ( UC ) group . Followup lasted 1 year . Quality -adjusted life years ( QALYs ) were derived from Short Form 6D scores and a visual analog scale ( VAS ) rating personal health . Function-related outcome was measured using the Health Assessment Question naire , the McMaster Toronto Arthritis ( MACTAR ) Patient Preference Disability Question naire , and the Escola Paulista de Medicina Range of Motion scale ( EPMROM ) . Costs were reported from a societal perspective . Differences in costs and incremental cost-effectiveness ratios ( ICERs ) were estimated . RESULTS Data from 85 patients ( 50 IET and 35 UC ) could be used for health-economic analysis . VAS personal health-based QALYs were in favor of IET . Function-related outcome showed statistically significant improvements in favor of IET over the first 6 months , according to the MACTAR ( P < 0.05 ) and the EPMROM ( P < 0.01 ) . At 1-year followup , IET was euro718 less per patient . The ICER showed a reduction in mean total costs per QALY . In 70 % of cases the intervention was cost-saving . CONCLUSION IET results in better quality of life at lower costs after 1 year . Thus , IET is the dominant strategy compared with UC . This highlights the need for implementation of IET after hospital discharge in patients with arthritis Objective : To assess the relative cost effectiveness of clinical nurse specialist care , inpatient team care , and day patient team care . Methods : Incremental cost effectiveness analysis and cost utility analysis , alongside a prospect i ve r and omised controlled trial with two year follow up . Included were patients with rheumatoid arthritis ( RA ) with increasing difficulty in performing activities of daily living over the previous six weeks . Quality of life and utility were assessed by the Rheumatoid Arthritis Quality of Life question naire , the Short Form-6D , a transformed rating scale , and the time tradeoff . A cost-price analysis was conducted to estimate the costs of inpatient and day patient hospitalisations . Other healthcare and non-healthcare costs were estimated from cost question naires . Results : 210 patients with RA ( 75 % female , median age 59 years ) were included . Aggregated over the two year follow up period , no significant differences were found on the quality of life and utility instruments . The costs of the initial treatment were estimated at € 200 for clinical nurse specialist care , € 5000 for inpatient team care , and € 4100 for day patient team care . Other healthcare costs and non-healthcare costs were not significantly different . The total societal costs did not differ significantly between in patients and day patients , but were significantly lower for the clinical nurse specialist patients by at least € 5400 . Conclusions : Compared with inpatient and day patient team care , clinical nurse specialist care was shown to provide equivalent quality of life and utility , at lower costs . Therefore , for patients with health conditions that allow for any of the three types of care , the preferred treatment from a health-economic perspective is the care provided by the clinical nurse specialist Objective : To determine whether an early increased-intensity upper limb therapy programme following acute stroke improves outcome . Design : A r and omized controlled trial . Setting : A stroke unit which provides acute care and rehabilitation for all stroke admissions . Subjects : One hundred and twenty-three patients who had had a stroke causing upper limb impairment within the previous 10 days . Intervention : The intervention group received stroke unit care plus enhanced upper limb rehabilitation provided jointly by a physiotherapist and occupational therapist , commencing within 10 days of stroke , and available up to 30 minutes/day , five days/week for six weeks . The control group received stroke unit care . Main outcome measures : The primary outcome measure was the Action Research Arm Test ( ARAT ) three months after stroke . Secondary outcome measures : Motricity Index ; Frenchay Arm Test ; upper limb pain ; Barthel ADL Index ; Nottingham E-ADL Scale ; and costs to health and social services at three and six months after stroke . Results : There were no differences in outcomes between the intervention and control groups three and six months after stroke . During the intervention period the intervention group received a median of 29 minutes of enhanced upper limb therapy per working day as in patients . The total amount of inpatient physiotherapy and occupational therapy received by the intervention group was a median of 52 minutes per working day during the intervention period and 38 minutes per working day for the control group ( p = 0.001 ) . There were no differences in service costs . Conclusions : An early increased-intensity interdisciplinary upper limb therapy programme jointly provided by a physiotherapist and occupational therapist did not improve outcome after stroke . The actual difference in the amount of therapy received by intervention and control groups was less than planned due to a competitive therapy bias BACKGROUND AND PURPOSE In an inner-London teaching hospital , a r and omized trial of " conventional " care versus early discharge to community-based therapy found no significant differences in clinical outcomes between patient groups . This report examines the economic consequences of the alternative strategies . METHODS One hundred sixty-seven patients received the early discharge package , and 164 received conventional care . Patient utilization of health and social services was recorded over a 12-month period , and cost was determined using data from provider departments and other published sources . RESULTS Inpatient stay after r and omization was 12 days ( intervention group ) versus 18 days ( controls ) ( P=0.0001 ) . Average units of therapy per patient were as follows : physiotherapy , 22.4 ( early discharge ) versus 15.0 ( conventional ) ( P=0.0006 ) ; occupational therapy , 29.0 versus 23.8 ( P=0.002 ) ; speech therapy , 13 . 7 versus 5.8 ( P=0.0001 ) . The early discharge group had more annual hospital physician contacts ( P=0.015 ) and general practitioner clinic visits ( P=0.019 ) but fewer incidences of day hospital attendance ( P=0.04 ) . Other differences in utilization were nonsignificant . Average annual costs per patient were pound sterling 6800 ( early discharge ) and pound sterling 7432 ( conventional ) . The early discharge group had lower inpatient costs per patient ( pound sterling 4862 [ 71 % of total cost ] versus pound sterling 6343 [ 85 % ] for controls ) but higher non-inpatient costs ( pound sterling 1938 [ 29 % ] versus pound sterling 1089 [ 15 % ] ) . Further analysis demonstrated that early discharge is unlikely to lead to financial savings ; its main benefit is to release capacity for an expansion in stroke caseload . CONCLUSIONS Overall results of this trial indicate that early discharge to community rehabilitation for stroke is cost-effective . It may provide a means of addressing the predicted increase in need for stroke care within existing hospital capacity & NA ; This study reports a 9–18 month follow‐up of a r and omised controlled trial of pain management programmes for chronic , non‐malignant pain . Twenty‐two in patients , 18 out patients and 12 control subjects completed the follow‐up assessment s. Significant treatment effects were demonstrated by the inpatient group on pain ratings , the Pain Behaviour Checklist , and General Health Question naire , with similar effects demonstrated by the outpatient group on the former 2 measures . The findings were confounded by higher inpatient scores at pretreatment , in comparison with the 2 other conditions . There was a high drop‐out rate of subjects , particularly from the control condition which illustrates the limitations of controlled group design s in this area . Analgesic use , activity levels and pain ratings were also evaluated using the criteria for ‘ success ’ described by Malec et al. ( 1981 ) . Results indicated that 68 % of in patients , 61 % of out patients and 21 % of control subjects met all 3 criteria . Both treatment programmes were effective in returning patients to paid employment , whilst 3 control group patients gave up work . The cost‐benefit implication s of these changes are discussed . We conclude that pain management programmes contribute substantially to the rehabilitation of chronic pain sufferers Background and Purpose The aim of the present study was to examine re source utilization during a 12-month period after acute stroke in elderly patients r and omized to care in an acute stroke unit integrated with a care continuum compared with conventional care in general medical wards . A secondary aim was to describe costs related to the severity of stroke . Methods Two hundred forty-nine consecutive patients aged ≥70 years with acute stroke within 7 days before admission , living in their own homes in Göteborg , Sweden , without recognized need of care were r and omized to 2 groups : 166 patients were assigned to nonintensive stroke unit care with a care continuum , and 83 patients were assigned to conventional care . There was no difference in mortality or the proportion of patients living at home after 1 year . Main outcomes were costs from inpatient care , outpatient care , and informal care . Results Mean annual cost per patient was 170 000 Swedish crowns ( SEK ) ( equivalent to $ 25 373 ) and 191 000 SEK ( $ 28 507 ) in the stroke unit and the general medical ward groups , respectively ( P = NS ) . Seventy percent of the total cost was for inpatient care , and 30 % was for outpatient and informal care . For patients with mild , moderate , and severe stroke , the mean annual costs per patient were 107 000 SEK ( $ 15 970 ) , 263 000 SEK ( $ 39 254 ) , and 220 000 SEK ( $ 32 836 ) , respectively ( P < 0.001 ) . There was no statistical difference in age or nonstroke diagnosis . Conclusions The total costs the first year did not differ significantly between the treatment groups in this prospect i ve study . The total annual cost per patient showed a very large variation , which was related to stroke severity at onset and not to age or nonstroke diagnoses . Costs other than those for hospital care constituted a substantial fraction of total costs and must be taken into account when organizing the management of stroke patients . The high variability in costs necessitates a larger study to assess long-term cost effectiveness STUDY OBJECTIVE We report on the incremental costs associated with improvements in health-related quality of life ( HRQL ) following 6 months of respiratory rehabilitation compared with conventional community care . DESIGN Prospect i ve r and omized controlled trial of rehabilitation . SET
Output:
| Based on this systematic review and meta-analyses , a single rehabilitation service may not provide health economic benefits for all patient groups and situations .
For some patients , inpatient rehabilitation may be the most cost-effective method of providing rehabilitation ; yet , for other patients , rehabilitation in the home or community may be the most cost-effective model of care . |
MS210875 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
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Input: BACKGROUND Warfarin , which requires coagulation monitoring , is associated with relatively high rates of thromboembolism despite providing adequate prophylaxis . This study compared an oral direct thrombin inhibitor , ximelagatran , with warfarin in order to evaluate the safety and efficacy of the medication for the prevention of venous thromboembolism in patients undergoing total knee arthroplasty . METHODS Following surgery , patients were r and omly assigned to fixed-dose oral ximelagatran ( 36 mg twice daily ) or warfarin ( target international normalized ratio , 2.5 ) , both administered for seven to twelve days in a double-blind , double-dummy design . Warfarin was initiated on the evening of the day of surgery , and ximelagatran , on the morning after surgery . The primary efficacy end point was the incidence of asymptomatic deep-vein thrombosis determined by bilateral venography , objective ly confirmed symptomatic deep-vein thrombosis or pulmonary embolism , and death from all causes during treatment . RESULTS Adequate venograms or confirmed symptomatic events ( efficacy population ) were obtained for 1949 patients . Venous thromboembolism and death from all causes occurred in 22.5 % ( 221 ) of 982 ximelagatran-treated patients and in 31.9 % ( 308 ) of 967 warfarin-treated patients ( p < 0.001 ) . Proximal deep-vein thrombosis and pulmonary embolism were observed in 3.1 % ( thirty ) and 0.2 % , respectively , of the patients in the ximelagatran group and in 3.4 % ( thirty-three ) and 0.4 % , respectively , of the patients in the warfarin group . The six deaths from all causes included 0.3 % ( four ) of the ximelagatran-treated patients and 0.2 % ( two ) of the warfarin-treated patients . Major bleeding was noted in 1 % ( twelve ) of the ximelagatran-treated patients and in 0.4 % ( five ) of the warfarin-treated patients ( p = 0.09 ) . CONCLUSIONS Oral ximelagatran ( 36 mg twice daily ) , administered without coagulation monitoring or dose adjustment and started the day after total knee arthroplasty , demonstrates superior efficacy compared with warfarin prophylaxis , with no wound complications and no significant difference with respect to bleeding events , although the rate of major bleeding events was greater with ximelagatran than with warfarin . LEVEL OF EVIDENCE Therapeutic Level One hundred forty-nine consecutive patients requiring lower extremity total joint arthroplasty were r and omized to either coumadin ( 52 patients ) or intermittent pneumatic compression ( 48 patients ) as prophylaxis against deep vein thrombosis ( DVT ) . Forty-nine patients were excluded . When fully ambulatory , the presence or absence of DVT was diagnosed by ascending venography ( 90 % of patients ) , nuclear venography , venous dopplers , or impedence plethysmography . The two groups were similar in average age ( 64 years ) , indication for arthroplasty ( pain because of arthritis in 90 % ) , gender ( 98 % male ) , and average number of risk factors ( 2.4 ) . Twenty-five percent of patients on coumadin and 25 % of patients on intermittent pneumatic compression ( IPC ) developed DVT . IPC was more effective than coumadin following primary total hip arthroplasties ( THAs ) ( 16 % versus 24 % incidence DVT ) ; coumadin was more effective than IPC following primary total knee arthroplasties ( TKAs ) ( 19 % versus 32 % incidence of DVT ) . DVT developed in 36 % of patients following revision arthroplasty . Seventy-five percent of all thrombi were proximal . Both IPC and coumadin were found to be safe ; there was no increased perioperative bleeding in the coumadin group . Of three postoperative deaths , one was possibly due to pulmonary embolism ( PE ) The effect of the pneumatic tourniquet on the incidence of postoperative deep venous thrombosis is uncertain . We carried out a controlled study comparing the incidence of deep venous thrombosis when a tourniquet was used with the incidence when a tourniquet was not used . Thrombosis was detected by radioisotope venography . The results of the study showed no difference in incidence and we concluded that the pneumatic tourniquet has no influence on the formation of a thrombus in a deep vein In a r and omized , prospect i ve trial of 100 patients , we have studied the safety and efficacy of warfarin sodium in comparison with that of dextran 40 in the prevention of venous thrombosis in patients at high risk for deep vein thrombosis after elective total hip or knee replacement . Warfarin was given in a new two-step regimen design ed to avoid bleeding complications while still preventing venous thrombosis . A low dose of warfarin was started ten to 14 days preoperatively , and the prothrombin time was regulated to between 1.5 and 3 seconds longer than control at the time of surgery ; immediately after surgery , the dose was increased to prolong the prothrombin time to 1.5 times control . The overall incidence of venous thrombosis as documented by venography was less in the 53 patients treated with warfarin than in the 37 treated with dextran ( 21 % v 51 % ) , as was the incidence of thrombi in the femoral or popliteal veins ( 2 % v 16 % ) . Objective measures of blood loss showed no difference between patients treated with warfarin or dextran , and excessive postoperative bleeding was infrequent and similar in both treatment groups . This study demonstrates that two-step warfarin therapy provides highly effective prophylaxis of postoperative venous thrombosis after elective hip or knee prosthetic surgery without excessive risk of perioperative bleeding The authors undertook a r and omised prospect i ve study to investigate the contribution of thigh tourniquets to the formation of intra-operative venous emboli during lower limb surgery . Patients were r and omised to have a thigh tourniquet or no tourniquet and transoesophageal echocardiography was used to detect embolic signals in the right heart during and after knee arthroscopy . Three physicians blinded to patient demographics and tourniquet status separately assessed videotapes of the echocardiograms for evidence of emboli . Of the 32 patients r and omised , 18 underwent knee arthroscopy with and 14 without tourniquet . Emboli were seen in 72 % ( 95 % CI 55 to 84 ) of patients , in 14 patients with tourniquet and in 9 patients without tourniquet . There was an estimated 13 % greater incidence of emboli in the tourniquet group compared to the non-tourniquet group , a difference which was not statistically significant ( Fisher 's Exact Test , p = 0.45 ) . No patients suffered symptoms or signs attributable to a pulmonary embolus We assessed the safety and efficacy of the novel low molecular weight heparinoid Lomoparan ( Org 10172 ) for the prevention of deep-vein thrombosis in patients undergoing elective total hip replacement in a r and omized , placebo-controlled , double-blind trial in 197 consecutive patients . The heparinoid ( 750 anti-factor Xa-units , s.c . , b.i.d . ) was administered to 97 patients and 99 patients received placebo . Study medication was started preoperatively and continued for 10 days . Efficacy was assessed by bilateral phlebography at day 10 , postoperatively . The incidence of deep-vein thrombosis was 56.6 % and 15.5 % respectively in the placebo and heparinoid treated patients ( incidence reduction : 74 % ; P less than 0.001 ) . This reduction was observed both for proximal-vein thrombosis ( 25 % to 8 % ; P less than 0.005 ) and isolated calf-vein thrombosis ( 31 % to 7 % ; P less than 0.001 ) . No major hemorrhage was observed . The number of red-cell units transfused and drain-fluid loss were comparable for the two study groups . Six patients in the heparinoid group and none in the control group developed minor wound hematomas ( P less than 0.05 ) . During an 8-week post-discharge follow-up period three patients with a normal venogram at day 10 developed clinical ly apparent venous thromboembolism , which was confirmed by objective testing . All three patients belonged to the heparinoid-treated group . We conclude that 750 anti-factor Xa units Org 10172 s.c . twice daily starting preoperatively is safe and effectively reduces early deep-vein thrombosis following elective total hip replacement . Further studies on the incidence of post-discharge thromboembolism are required The scientific community 's quest for unbiased research received a strong boost from a recent policy amendment on r and omised controlled trials ( RCTs ) in this journal . Henceforth , the status of allocation concealment will be clearly indicated in the abstract s along with that of blinding . Thus , readers will have additional information by which to judge the internal validity of trials . In this editorial I address the background and rationale for these enhancements . R and om allocation to intervention groups remains the only method of ensuring that the groups being compared are on an equivalent footing at the outset of the study , thus eliminating selection and confounding biases . This has allowed RCTs to play a key part in advancing medical science . The success of r and omisation depends on 2 interrelated processes.1 , 2 The first entails generating a sequence by which the participants in a trial are allocated to intervention groups . To ensure unpredictability of that allocation sequence , investigators should generate it by a r and om process . The second process , allocation concealment , shields those involved in a trial from knowing upcoming assignments in advance.3 , 4 Without this protection , investigators and patients have been known to change who gets the next assignment , making the comparison groups less equivalent.5 , 6 For example , suppose that an investigator creates an adequate allocation sequence using a r and om number table . However , the investigator then affixes the list of that sequence to a bulletin board , with no allocation concealment . Those responsible for admitting participants could ascertain the upcoming treatment allocations and then route participants with better prognoses to the experimental group and those with poorer prognoses to the control group , or vice versa . Bias would result . Inadequate allocation concealment also Tourniquet time and its relationship to blood loss and deep vein thrombosis were studied in 80 cases of unilateral total knee arthroplasty . These data were part of a prospect i ve multicenter double-blind study on thromboprophylaxis for knee surgery . This study reports on the cases done at one institution in which the tourniquet was used in three different ways : group 1 , no tourniquet use ; group 2 , limited tourniquet use for cementing time only ; group 3 , tourniquet use throughout the whole case . Blood loss was significantly related to tourniquet time ( P = .0001 ) . The incidence of deep vein thrombosis was not related to the tourniquet group ( P = .9 ) We performed a prospect i ve r and omized clinical study to determine whether use of a thigh tourniquet influences the incidence of deep venous thrombosis . The lower limbs of patients who were scheduled for elective surgery on the fore part of the foot were r and omized and assigned to one of three treatment categories : Group I , no tourniquet ; Group II , exsanguination by an Esmarch b and age before tourniquet application ; and Group III , exsanguination by elevation of the extremity prior to application of a tourniquet . The 117 limbs of seventy-one patients included in this study were evaluated preoperatively and twenty-four and seventy-two hours postoperatively with 125I-labeled fibrinogen , and preoperatively and seventy-two hours postoperatively with Doppler ultrasound studies and phleborheography . The findings in all of the Doppler ultrasound studies and all of the phleborheograms were normal . Two of the 125I-fibrinogen studies were positive , but subsequent contrast venography revealed that these were false-positive findings . We therefore concluded that the use of a thigh tourniquet does not increase the risk of deep venous thrombosis in patients who have had an operation on the fore part of the foot The effects of using a tourniquet during total knee arthroplasty were studied in 80 patients r and omly allocated to two groups , either with or without a tourniquet . The groups were similar in mean age , gender , preoperative knee score and radiographic grading and the patients were all operated on by the same surgeon using one type of prosthesis . There was no significant difference between the two groups in operating time or total blood loss but postoperative pain was less in the patients in whom a tourniquet had not been used . They achieved straight-leg raising and knee flexion earlier and had fewer superficial wound infections and deep-vein thromboses . Total knee arthroplasty can be safely performed without the use of the tourniquet with the benefit that several adverse effects associated with its use can be avoided OBJECTIVE To compare efficacy , safety , and feasibility of adjusted-dose oral anticoagulants ( OAC ) versus fixed-dose subcutaneous low molecular weight heparin ( LMWH ) for the prevention of deep venous thrombosis ( DVT ) in
Output:
| The incidence of DVT in patients undergoing elective TKA appears to have declined in patients receiving warfarin thromboprophylaxis |
MS210876 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Although Post-traumatic Stress Disorder ( PTSD ) is common among patients seeking care at medical clinics , little is known about the performance of screening instruments for this disorder in these setting s. Previous studies of acute trauma population s using the PTSD Checklist ( PCL ) have suggested that scores of 45 - 50 provide the best discrimination between cases and noncases . We gave the PCL to 1,225 r and omly selected women enrolled in an HMO . After interviewing a sample of 261 of these women using a structured , clinician-administered PTSD interview , we compared the results of the PCL to the clinician interviews over a range of possible cut scores using Receiver Operating Characteristic analysis . The optimum balance of sensitivity and specificity for this population was a score of 30 , yielding a sensitivity of.82 and specificity of.76 . The positive and negative likelihood ratios for this cut score were 3.40 and 0.24 , respectively . By comparison , the use of 45 as a cut score would result in very low sensitivity ( .36 ) in this setting . The lower cut score found in this study may indicate that the use of previously published cut scores of 45 - 50 may not optimize the function of the PCL as a screening tool outside of acute trauma setting s due to an unacceptably high number of false negative cases BACKGROUND Patients ' deaths in the ICU have been associated with a high burden of psychologic symptoms in families . This study identifies characteristics associated with psychologic symptoms in family members . METHODS Families of patients dying in the ICU or within 30 h of ICU discharge in 11 hospitals previously participated in a r and omized trial . In the current study , we assessed these families for symptoms of posttraumatic stress disorder ( PTSD ) and depression with follow-up surveys . Outcomes included vali date d measures of PTSD ( PTSD Checklist ) and depressive ( Patient Health Question naire ) symptoms . Predictors included family member mental-health history , involvement in decision making , and demographics . RESULTS Surveys were completed by 226 families . Response rate was 46 % in the original r and omized trial and 82 % in this study . Prevalence ( 95 % CI ) of PTSD and depressive symptoms were 14.0 % ( 9.7%-19.3 % ) and 18.4 % ( 13.5%-24.1 % ) , respectively . Family characteristics associated with increased symptoms included : female gender ( PTSD , P = .020 ; depression , P = .005 ) , knowing the patient for a shorter duration ( PTSD , P = .003 ; depression , P = .040 ) , and discordance between family members ' preferences for decision making and their actual decision-making roles ( PTSD , P = .005 ; depression , P = .049 ) . Depressive symptoms were also associated with lower educational level ( P = .002 ) . Families with psychologic symptoms were more likely to report that access to a counselor ( PTSD , P < .001 ; depression , P = .003 ) and information about spiritual services might have been helpful while the patient was in the ICU ( PTSD , P = .024 ; depression , P = .029 ) . CONCLUSIONS Families demonstrated a high prevalence of psychologic symptoms after a death in the ICU . Characteristics associated with symptoms may help target interventions to reduce these symptoms . TRIAL REGISTRATION clinical trials.gov ; Identifier : NCT00685893 Introduction : Severe traumatic brain injury ( STBI ) can cause psychological stress in proxies in the long-term . This study assessed post-traumatic stress ( PTS ) symptoms in proxies of survivors of STBI in the short-term and investigated stress-associated factors . Methods : Prospect i ve cross-sectional study , conducted at three Swiss trauma centres over 1 year . Patient and proxy demographics , trauma data including Glasgow Coma Scale ( GCS ) and management data were collected . The proxies ’ PTS symptoms were assessed by applying the Impact of Event Scale – Revised ( IES-R ) , once in the first month after the accident ( median : 11 days ) . Results : Sixty-nine proxies were included ; 52 proxies were female ( 77.8 % ) . Mean IES-R sum score for intrusions was 13.38 ( SD = 7.26 ) , for avoidance 8.91 ( SD = 5.94 ) , and for hyperarousal 9.07 ( SD = 6.75 ) . Clinical ly significant PTS symptoms were observed in 36 proxies ( 52.2 % ) ; mean IES-R sum scores were significantly higher in women . IES-R sub-scale values were inversely related with GCS at the scene of the accident and on hospital admission . Conclusions : More than half of proxies had clinical ly significant PTS symptoms shortly after their relative 's accident . More severe PTS symptoms were found in women and in proxies of patients with poorer initial GCS scores . Further research into risk groups in the short- and long-term and the long-term impact on patients of PTS syndrome in proxies is warranted OBJECTIVES To describe the occurrence of delirium in a cohort of older medical intensive care unit ( ICU ) patients and its short-term duration in the hospital and to determine the association between preexisting dementia and the occurrence of delirium . DESIGN Prospect i ve cohort study . SETTING Fourteen-bed medical ICU of an 800-bed university teaching hospital . PARTICIPANTS One hundred eighteen consecutive patients aged 65 and older admitted to the ICU . MEASUREMENTS Baseline characteristics were obtained through surrogate interviews and medical chart review . Dementia was determined using two vali date d surrogate-rated instruments . Delirium was assessed daily in the ICU using the Confusion Assessment Method ( CAM ) for the ICU ( CAM-ICU ) . After discharge from the ICU , patients were followed for up to 7 days using the CAM . RESULTS Delirium was present in 37 of 118 ( 31 % ) patients on admission . Only 45 patients had a normal mental status on admission , of whom 14 ( 31 % ) became delirious during their hospital stay . In the post-ICU period , delirium occurred in 40 % of patients . Almost half of patients with delirium in the ICU had persistent delirium in the post-ICU period . Overall , 83 of 118 ( 70 % ) had delirium during hospitalization . Stupor or coma occurred in 44 % of the patients overall , and 89 % of survivors of stupor/coma progressed to delirium . Patients with dementia were 40 % more likely to be delirious ( relative risk = 1.4 , 95 % confidence interval = 1.1 - 1.7 ) , even after controlling for comorbidity , baseline functional status , severity of illness , and invasive procedures . CONCLUSION Delirium is a frequent complication in older ICU patients and often persists beyond their ICU stay . Delirium in older ICU persons is a dynamic and complex process . Dementia is an important predisposing risk factor for the development of delirium in this population during and after the ICU stay STUDY OBJECTIVES The physical and psychological effects of caregiving have been examined in several population s. To date , no one has examined the effects of caregiving on caregivers of patients receiving long-term mechanical ventilation ( LTV ) [ patients who required > 4 days of continuous in-hospital mechanical ventilation ] who reside in a home or institutional setting after hospital discharge . The purpose of this study was to describe the characteristics and examine depression , burden , overload , and physical health in this caregiver population over a 6-month period after hospital discharge . DESIGN This was a prospect i ve longitudinal descriptive study of posthospital outcomes for patients receiving LTV and their caregivers . SETTING AND PARTICIPANTS Caregivers of 135 patients receiving LTV admitted to the ICUs of a university medical center , a Veterans Administration hospital , and small community hospital were enrolled . MEASUREMENTS AND RESULTS Interviews of caregivers were conducted at hospital discharge and 6 months later . Descriptive statistics , analysis of variance , and multiple regression analyses were used to analyze the data . Established tools were used to assess caregiver depression , burden , overload , and physical health . Caregivers reported a drop in physical health scores from hospital discharge to 6 months after discharge ( p = 0.0001 ) . Caregivers of patients residing in an institution reported higher depression ( p = 0.039 ) and overload scores ( p = 0.002 ) than did caregivers of patients residing at home 6 months after discharge ; 51.2 % of caregivers at discharge and 36.4 % at 6 months after discharge reported symptoms consistent with some degree of depression . In addition , 12.2 % of caregivers at hospital discharge and 15.6 % at 6 months after discharge were classified as having symptoms consistent with severe depression . Caregiver physical health ( p = 0.025 ) and overload ( p = 0.006 ) made statistically significant contributions to explaining caregiver depression . CONCLUSIONS Caregivers of patients receiving LTV in our sample have similar characteristics to other caregiving population s. However , our sample had higher depression scores than those reported for many other caregiver groups We examined the psychometric properties of the PTSD Checklist ( PCL ) , a self-report instrument design ed to assess symptoms of posttraumatic stress disorder . Three hundred ninety-two participants recruited in a university setting completed the PCL in addition to several well-established self-report instruments design ed to assess various forms of psychopathology ( e.g. , depression , general anxiety , PTSD ) . Ninety participants returned for readministration of selected measures . Findings provided support for psychometric properties of the PCL , including internal consistency , test – retest reliability , convergent validity , and discriminant validity . Additional strengths of the PCL are discussed CONTEXT Delirium is a common problem in the intensive care unit ( ICU ) . Accurate diagnosis is limited by the difficulty of communicating with mechanically ventilated patients and by lack of a vali date d delirium instrument for use in the ICU . OBJECTIVES To vali date a delirium assessment instrument that uses st and ardized nonverbal assessment s for mechanically ventilated patients and to determine the occurrence rate of delirium in such patients . DESIGN AND SETTING Prospect i ve cohort study testing the Confusion Assessment Method for ICU Patients ( CAM-ICU ) in the adult medical and coronary ICUs of a US university-based medical center . PARTICIPANTS A total of 111 consecutive patients who were mechanically ventilated were enrolled from February 1 , 2000 , to July 15 , 2000 , of whom 96 ( 86.5 % ) were evaluable for the development of delirium and 15 ( 13.5 % ) were excluded because they remained comatose throughout the investigation . MAIN OUTCOME MEASURES Occurrence rate of delirium and sensitivity , specificity , and interrater reliability of delirium assessment s using the CAM-ICU , made daily by 2 critical care study nurses , compared with assessment s by delirium experts using Diagnostic and Statistical Manual of Mental Disorders , Fourth Edition , criteria . RESULTS A total of 471 daily paired evaluations were completed . Compared with the reference st and ard for diagnosing delirium , 2 study nurses using the CAM-ICU had sensitivities of 100 % and 93 % , specificities of 98 % and 100 % , and high interrater reliability ( kappa = 0.96 ; 95 % confidence interval , 0.92 - 0.99 ) . Interrater reliability measures across subgroup comparisons showed kappa values of 0.92 for those aged 65 years or older , 0.99 for those with suspected dementia , or 0.94 for those with Acute Physiology and Chronic Health Evaluation II scores at or above the median value of 23 ( all P<.001 ) . Comparing sensitivity and specificity between patient subgroups according to age , suspected dementia , or severity of illness showed no significant differences . The mean ( SD ) CAM-ICU administration time was 2 ( 1 ) minutes . Reference st and ard diagnoses of delirium , stupor , and coma occurred in 25.2 % , 21.3 % , and 28.5 % of all observations , respectively . Delirium occurred in 80 ( 83.3 % ) patients during their ICU stay for a mean ( SD ) of 2.4 ( 1.6 ) days . Delirium was even present in 39.5 % of alert or easily aroused patient observations by the reference st and ard and persisted in 10.4 % of patients at hospital discharge . CONCLUSIONS Delirium , a complication not currently monitored in the ICU setting , is extremely common in mechanically ventilated patients . The CAM-ICU appears to be rapid , valid , and reliable for diagnosing delirium in the ICU setting and may be a useful instrument for both clinical and research purpose Objective : To describe the symptom experiences of family members of patients at high risk for dying in the intensive care unit and to assess risk factors associated with higher symptom burden . Design : Prospect i ve , cross-sectional study . Setting : Three intensive care units at a large academic medical center . Participants : A sample of 74 family members of 74 intensive care unit patients who had a grave prognosis and were judged to be at high risk for dying . Patients at high risk for dying were identified as having Acute Physiology and Chronic Health Evaluation II scores > 20 , an intensive care unit length of stay
Output:
| Findings demonstrate a significant prevalence of family PTSD symptoms in the months following ICU hospitalization . |
MS210877 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Contrast-induced nephropathy limits the outcomes of percutaneous coronary intervention ( PCI ) . The present study compared the protective effects of different statin doses on renal function . A total of 228 patients with acute coronary syndrome undergoing selective PCI were r and omly divided into simvastatin 20-mg group ( S20 , n = 115 ) and simvastatin 80-mg group ( S80 , n = 113 ) . Serum creatinine was measured at admission , the day of PCI , and 24 and 48 hours after PCI . The creatinine clearance was calculated using the Cochcroft-Gault formula . High-sensitive C-reactive protein , P-selectin , and intercellular adhesion molecule-1 were also measured before and after the procedure . Contrast-induced nephropathy was defined as a postprocedure increase in serum creatinine of > or = 0.5 mg/dl or > 25 % from baseline . The serum creatinine significantly increased after PCI , with the peak value occurring at 24 hours , and then began to decrease . At 48 hours , the serum creatinine had decreased to the baseline level in the S80 group , but it had failed to do so in the S20 group . At 24 and 48 hours after PCI , the serum creatinine was lower in the S80 group than in the S20 group ( p < 0.05 and p < 0.001 , respectively ) . The creatinine clearance significantly decreased after PCI , with the lowest value occurring at 24 hours , and then it began to increase . In the S80 group , the creatinine clearance recovered to baseline level at 48 hours , but it failed to do so in the S20 group . The creatinine clearance was greater at 24 and 48 hours in the S80 group than that in the S20 group . Although the procedure caused a significant increase in high-sensitive C-reactive protein , P-selectin , and intercellular adhesion molecule-1 levels , the value was lower in the S80 group than in the S20 group ( p < 0.001 ) . In conclusion , pretreatment with simvastatin 80 mg before PCI could further decrease the occurrence of contrast-induced nephropathy compared with simvastatin 20 mg . This benefit was associated with the lowering of high-sensitive C-reactive protein , P-selectin , and intercellular adhesion molecule-1 levels We investigated the efficacy of short-term high-dose atorvastatin in decreasing the risk of contrast-induced nephropathy ( CIN ) in patients with chronic kidney disease ( CKD ) subjected to coronary angiography and /or angioplasty . CIN occurs in up to 15 % of patients with pre-existing CKD and affects clinical outcome . The protective effect of statin therapy against CIN is still controversial . A prospect i ve , single-center study of 304 patients with baseline estimated creatinine clearance < 60 ml/min were r and omized to receive atorvastatin 80 mg/day or placebo for 48 hours before and 48 hours after contrast medium administration . All patients received intravenous saline hydration and oral N-acetylcysteine 1,200 mg 2 times/day . Iso-osmolar contrast medium was used . CIN was defined as an absolute increase of serum creatinine > or = 0.5 mg/dl within 5 days after the procedure . CIN occurred in 31 patients ( 10 % ) , 16 ( 11 % ) in the placebo group and 15 ( 10 % ) in the atorvastatin group ( p = 0.86 ) . Mean increase in creatinine was not significantly different in the 2 groups ( 0.59 + or - 0.17 in placebo group vs 0.72 + or - 0.26 mg/dl in atorvastatin group , p = 0.31 ) . Persistent kidney injury , defined as 1-month increase from baseline creatinine value > or = 25 % , was observed in 30 % in the placebo group and in 31 % in the atorvastatin group ( p = 0.58 ) . In conclusion , a short-term administration of high doses of atorvastatin before and after contrast exposure , in addition to st and ard intravenous hydration and oral N-acetylcysteine , does not decrease CIN occurrence in patients with pre-existing CKD Objectives : To investigate whether preprocedural high-dose atorvastatin decreases the incidence of contrast-induced nephropathy ( CIN ) and protects the renal function after emergency percutaneous coronary intervention ( PCI ) . Methods : Statin-naive patients with acute ST-segment elevation myocardial infa rct ion ( STEMI ) undergoing emergency PCI ( n = 161 ) r and omly received atorvastatin ( 80 mg , n = 78 , ATOR group ) or placebo [ n = 83 , control ( CON ) group ] followed by long-term atorvastatin ( 40 mg/day ) . The primary end point was incidence of CIN . Results : In the ATOR group , 2.6 % of the patients developed CIN versus 15.7 % in the CON group ( p = 0.01 ) . In the ATOR group , postprocedural serum creatinine was significantly lower ( 93.4 ± 17.1 vs. 112.6 ± 23.3 µmol/l at 48 h and 84.2 ± 14.2 vs. 95.3 ± 17.7 µmol/l at 72 h , both p < 0.0001 ) and in the CON group , peak serum cystatin C was lower ( 0.51 ± 0.14 vs. 0.61 ± 0.13 mg/l , p < 0.0001 ) . Atorvastatin pretreatment was independently associated with a decreased risk of CIN ( OR 0.084 , 95 % CI 0.015–0.462 , p = 0.004 ) . The proportion of alanine aminotransferase > 3 × upper limit of the normal value within 1 month was 3.85 versus 1.20 % ( ATOR vs. CON group , p = 0.57 ) . Conclusion : Preprocedural high-dose atorvastatin prevents CIN and protects the renal function in patients with acute STEMI undergoing emergency PCI OBJECTIVE To compare the efficacy of high and low dose atorvastatin on preventing contrast induced nephropathy ( CIN ) in patients underwent diagnostic and therapeutic coronary intervention . METHODS All patients received atorvastatin 10 mg/d on the basis of hydrated therapy ( n = 100 ) and high dose group received additional atorvastatin 80 mg at 12 to 24 hours before procedure ( n = 50 ) . Scr , Ccr , blood beta(2)-M , urine NAG/Cr , and urine osmolality before and after the procedure were compared between the groups . RESULTS Baseline demographic characteristics and nephropathy risk factors were similar between groups . Ccr was significantly reduced while blood beta(2)-M and uric NAG/Cr were significantly increased in low dose group ( all P < 0.05 ) . Blood beta(2)-M in the high dose group was significantly lower than that in the low dose group at day 1 [ ( 2.35 + /- 0.52 ) mg/L vs. ( 2.67 + /- 0.64 ) mg/L , P = 0.008 ] , day 3 [ ( 2.49 + /- 0.55 ) mg/L vs. ( 2.80 + /- 0.64 ) mg/L , P = 0.011 ] and day 5 [ ( 2.29 + /- 0.53 ) mg/L vs. ( 2.56 + /- 0.66 ) mg/L , P = 0.026 ] post-procedure respectively;urine NAG/Cr in the high dose group was also significantly lower than that in the low dose group at day 1 [ ( 1.19 + /- 0.30 ) U/mmol vs. ( 1.46 + /- 0.34 ) U/mmol , P < 0.001 ] , day 3 [ ( 1.30 + /- 0.30 ) U/mmol vs. ( 1.59 + /- 0.33 ) U/mmol , P < 0.001 ] , and day 5 [ ( 1.10 + /- 0.30 ) U/mmol vs. ( 1.34 + /- 0.35 ) U/mmol , P = 0.001 ] post-procedure respectively;Ccr in the high dose group was significantly higher than that in the low dose group at day 1 [ ( 73.69 + /- 20.99 ) ml/min vs. ( 65.19 + /- 18.72 ) ml/min , P = 0.035 ] , day 3 [ ( 64.04 + /- 15.82 ) ml/min vs. ( 56.79 + /- 14.50 ) ml/min , P = 0.019]post-procedure respectively . CONCLUSION High dose atorvastatin use before angiography is superior than low dose atorvastatin on attenuating contrast induced renal dysfunction Background — The role of statins in the prevention of contrast-induced acute kidney injury ( CIAKI ) is controversial . Methods and Results — First , we investigated the in vivo effects of atorvastatin on CIAKI . Patients with chronic kidney disease enrolled in the Novel Approaches for Preventing or Limiting Events ( NAPLES ) II trial were r and omly assigned to ( 1 ) the atorvastatin group ( 80 mg within 24 hours before contrast media [ CM ] exposure ; n=202 ) or ( 2 ) the control group ( n=208 ) . All patients received a high dose of N-acetylcysteine and sodium bicarbonate solution . Second , we investigated the in vitro effects of atorvastatin pretreatment on CM-mediated modifications of intracellular pathways leading to apoptosis or survival in renal tubular cells . CIAKI ( ie , an increase > 10 % of serum cystatin C concentration within 24 hours after CM exposure ) occurred in 9 of 202 patients in the atorvastatin group ( 4.5 % ) and in 37 of 208 patients in the control group ( 17.8 % ) ( P=0.005 ; odds ratio=0.22 ; 95 % confidence interval , 0.07–0.69 ) . CIAKI rate was lower in the atorvastatin group in both diabetics and nondiabetics and in patients with moderate chronic kidney disease ( estimated glomerular filtration rate , 31–60 mL/min per 1.73 m2 ) . In the in vitro model , pretreatment with atorvastatin ( 1 ) prevented CM-induced renal cell apoptosis by reducing stress kinases activation and ( 2 ) restored the survival signals ( mediated by Akt and ERK pathways ) . Conclusions — A single high loading dose of atorvastatin administered within 24 hours before CM exposure is effective in reducing the rate of CIAKI . This beneficial effect is observed only in patients at low to medium risk A decline in kidney function after contrast exposure is associated with a high risk of morbidity and mortality during hospitalization and over long-term periods . Several retrospective and recent prospect i ve clinical trials have shown that statin therapy might prevent contrast-induced nephropathy in patients undergoing percutaneous coronary intervention . In this study , we aim ed to assess the effects of statin therapies on renal function parameters in patients undergoing elective coronary angiography . One hundred and sixty patients undergoing elective coronary angiography were r and omized equally into two groups : atorvastatin 40 mg/day group ( statin started 3 days before coronary angiography ) and an untreated control group . An additional 80 patients were included as a chronic statin therapy group . Serum creatinine , serum cystatin C , and glomerular filtration rate ( GFR ) were measured before and 48 h after coronary angiography . Cockcroft – Gault and Modification of Diet in Renal Disease ( MDRD ) equations were used to determine GFR . After coronary angiography , serum creatinine and GFR determined by MDRD were significantly better in patients using atorvastatin than those in controls ( P = 0.002 and P = 0.004 , respectively ) . Postprocedure serum creatinine , cystatin C , and GFR determined by MDRD were also significantly better in chronic statin therapy group than those in controls ( P = 0.006 , P = 0.003 , and P = 0.004 , respectively ) . There were no differences in renal function parameters between the short-term atorvastatin group and the chronic statin therapy group . Our data demonstrate that the use of short-term atorvastatin and chronic statin therapy may have a role in protecting renal function after elective coronary angiography OBJECTIVE To evaluate the efficacy of atorvastatin in preventing contrast agent-induced nephrop
Output:
| A greater risk reduction in CI-AKI in the statin group significantly correlated with higher estimated glomerular filtration rate ( eGFR ; p=0.003 ) CONCLUSIONS : The present trial sequential analysis provides support for statins in reducing the incidence of CI-AKI in patients undergoing CAG/PCI .
This effect appeared to be greater in patients with higher eGFR |
MS210878 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Although metronidazole ( MNZ ) has been used worldwide for more than 4 decades as a st and ard therapy for trichomoniasis , anaerobic and amebic infections , resistance to MNZ is still low . MNZ is available as oral , intravenous , and vaginal formulations , but the intravenous formulation of MNZ has not been approved in Japan . We conducted a phase 3 study to evaluate the efficacy and safety of intravenous MNZ combined with ceftriaxone ( CTRX ) in Japanese subjects with infectious peritonitis , abdominal abscess or pelvic inflammatory diseases ( PIDs ) to obtain regulatory approval . A combination of MNZ/CTRX at doses of 500 mg 3 or 4 times a day/1 or 2 g twice a day was administered intravenously to a total of 38 hospitalized subjects . MNZ/CTRX was well tolerated and exhibited excellent clinical and bacteriological efficacy with clinical efficacy rates of 100 % ( 20/20 ) in infectious peritonitis or abdominal abscess subjects and 90.0 % ( 9/10 ) in PID subjects , and the eradication rates in infectious peritonitis or abdominal abscess subjects and PID subjects were 100 % ( 16/16 ) and 100 % ( 4/4 ) , respectively , at the test of cure . MNZ/CTRX was effective in 1 subject in whom a metallo-β-lactamase-producing Bacteroides fragilis strain ( MIC of MNZ , 2 μg/ml ) was identified . The most common treatment-related adverse event was diarrhea ( 23.7 % ) , followed by nausea ( 5.3 % ) . No new safety signals were identified . MNZ/CTRX demonstrated excellent efficacy and was well tolerated in Japanese infectious peritonitis , abdominal abscess and PID subjects . This treatment regimen can be useful for anaerobic infections . Clinical registration number : NCT01473836 Tigecycline ( TGC ) has demonstrated clinical efficacy and safety , in comparison with imipenem/cilastatin in phase 3 clinical trials , for complicated intra-abdominal infection ( cIAI ) . The present study comprised a multicentre , open-label , r and omized study of TGC vs. ceftriaxone plus metronidazole ( CTX/MET ) for the treatment of patients with cIAI . Eligible subjects were r and omized ( 1:1 ) to receive either an initial dose of TGC ( 100 mg ) followed by 50 mg every 12 h or CTX ( 2 g once daily ) plus MET ( 1 - 2 g daily ) , for 4 - 14 days . The primary endpoint was the clinical response in the clinical ly evaluable ( CE ) population at the test of cure ( TOC ) assessment . Of 473 r and omized subjects , 376 were CE . Among these , clinical cure rates were 70.4 % ( 133/189 ) with TGC vs. 74.3 % ( 139/187 ) with CTX/MET ( 95 % CI -13.1 to 5.1 ; p 0.009 for non-inferiority ) . Clinical cure rates for subjects with Acute Physiological and Chronic Health Evaluation II scores > or = 10 were 56.8 % ( 21/37 ) with TGC vs. 58.3 % ( 21/36 ) with CTX/MET . The microbiologic response was similar between the two treatment arms , with microbiological eradication at TOC achieved in 68.1 % ( 94/138 ) of TGC-treated subjects and 71.5 % ( 98/137 ) of CTX/MET-treated subjects . ( The most frequently reported adverse events ( AEs ) for both treatment arms were nausea ( TGC , 38.6 % vs CTX/MET , 27.7 % ) and vomiting ( TGC , 23.3 % vs CTX/MET , 17.7 % ) . Overall discontinuation rates as a result of an AE were 8.9 % and 4.8 % in TGC- and comparator-treated subjects , respectively . The results obtained in the present study demonstrate that TGC monotherapy is non-inferior to a combination regimen of CTX/MET with respect to treating subjects with cIAI BACKGROUND Appropriate antimicrobial therapy results in improved clinical outcomes in complicated intra-abdominal infections ( cIAIs ) . Recent in vitro studies have reported increasing moxifloxacin resistance of Bacteroides species , thereby caution ing empiric use in infections with these organisms . METHODS This pooled analysis of 4 r and omized clinical trials ( 2000 - 2010 ) evaluated the comparative efficacy of moxifloxacin in cIAIs , including infection with anaerobic organisms . The intent-to-treat population included 1209 patients who received moxifloxacin ( 745 microbiologically valid cases ) and 1193 patients who received comparator agents ( 741 microbiologically valid cases ) . RESULTS Overall clinical success rates in the per- protocol population were 85.6 % ( 817 of 955 patients ) for moxifloxacin and 87.8 % ( 860 of 979 patients ) for comparators . Of 642 pretherapy anaerobes from moxifloxacin-treated patients , 561 ( 87.4 % ) were susceptible at ≤2 mg/L , 34 ( 5.3 % ) were intermediate at 4 mg/L , and 47 ( 7.3 % ) were resistant at ≥8 mg/L. Moxifloxacin achieved similar clinical success rates against all anaerobes including those isolated from patients infected with Bacteroides fragilis ( 158 [ 82.7 % ] of 191 patients ) , Bacteroides thetaiotaomicron ( 74 [ 82.2 % ] of 90 patients ) and Clostridium species ( 37 [ 80.4 % ] of 46 patients ) . The overall clinical success rate for all anaerobes was 82.3 % . For all anaerobes combined , the clinical success rate was 83.1 % ( 466 of 561 patients ) for a minimum inhibitory concentration ( MIC ) of ≤2 mg/L , 91.2 % ( 31 of 34 patients ) for an MIC of 4 mg/L , 82.4 % ( 14 of 17 patients ) for an MIC of 8 mg/L , 83.3 % ( 5 of 6 patients ) for an MIC of 16 mg/L , and 66.7 % ( 16 of 24 patients ) for an MIC of ≥32 mg/L. CONCLUSIONS Moxifloxacin demonstrated clinical success for intra-abdominal infections caused by both aerobic and anaerobic isolates . More than 87 % of baseline anaerobic isolates from intra-abdominal infections were susceptible to moxifloxacin , and efficacy was maintained beyond the current susceptibility breakpoint MIC of ≤2 mg/L against major anaerobes Summary In an open , r and omised , multicentre trial , the efficacy and tolerability of empirical meropenem monotherapy ( 1 g intravenously every 8 hours ) and cefotaxime ( 2 g every 8 hours ) plus metronidazole ( 0.5 g intravenously every 8 hours ) for 5 to 10 days was compared in 94 patients with serious intra-abdominal infection who required surgery . Eighty-three patients had an evaluable clinical response . Significantly more patients in the meropenem group had a satisfactory clinical response at the end of treatment ( 41/43 [ 95.3 % ] vs 30/40 [ 75.0 % ] ; p=0.008 ) . The bacteriological response was also higher in the meropenem group ( 31/33 vs 26/32 ) . In the bacteriologically evaluable population , a satisfactory clinical response was observed in 31/33 of those who received meropenem compared to 24/32 of the cefotaxime/metronidazole recipients ( p=0.03 ) . Empirical meropenem monotherapy should prove a useful alternative to the currently st and ard combination treatment for serious intraabdominal infections . ZusammenfassungIn einer offenen , r and omisierten Multicenter-Studie wurden die Wirksamkeit und Verträglichkeit einer initialen Monotherapie mit Meropenem ( MEM , 1 g 3 × tägl . i.v . ) mit der etablierten Kombinationstherapie Cefotaxim ( CTX ) plus Metronidazol ( MTR ) ( 2 g CTX+0.5 g MTR 3 × tägl . i.v . ) verglichen . 94 Patienten mit operationspflichtigen schweren intraabdominellen Infektionen wurden einbezogen . Davon waren 83 Patienten bezüglich klinischem Ansprechen auswertbar . Die klinische Wirksamkeit war in der MEM-Gruppe signifikant höher ( 41/43 Pat.=95.3 % vs 30/40 Pat.=75 % ; p=0.008 ) . Das bakteriologische Ansprechen war in der MEM-Gruppe ebenfalls höher i m Vergleich zur Kombinationsgruppe ( 31/33 vs 26/32 ) , der Unterschied war jedoch statistisch nicht signifikant . In der bakteriologisch auswertbaren Population war das klinische Ansprechen in der MEM-Gruppe signifikant höher als i m Vergleichskollektiv ( 31/33 vs 24/32 ; p=0.03 ) . MEM erscheint somit für die initiale empirische Monotherapie bei schweren intraabdominellen Infektionen geeignet OBJECTIVES Avibactam , a novel non-β-lactam β-lactamase inhibitor , restores the in vitro activity of ceftazidime against class A , C and some class D β-lactamase-producing pathogens , including those commonly associated with complicated intra-abdominal infections ( cIAIs ) . This r and omized , active-controlled , double-blind , Phase II trial ( NCT00752219 ) aim ed to evaluate the safety and efficacy of ceftazidime/avibactam plus metronidazole compared with meropenem in hospitalized patients with cIAI . METHODS Adults with confirmed cIAI requiring surgical intervention and antibiotics were r and omized 1 : 1 to receive intravenously either ( i ) 2000 mg of ceftazidime plus 500 mg of avibactam plus a separate infusion of 500 mg of metronidazole or ( ii ) 1000 mg of meropenem plus placebo every 8 h for a minimum of 5 days and a maximum of 14 days . The primary efficacy endpoint was the clinical response in microbiologically evaluable ( ME ) patients at the test-of-cure ( TOC ) visit 2 weeks after the last dose of study therapy . RESULTS Overall , 101 patients received ceftazidime/avibactam plus metronidazole ; 102 received meropenem . The median duration of treatment was 6.0 and 6.5 days , respectively . Favourable clinical response at the TOC visit in the ME population was observed in 91.2 % ( 62/68 ) and 93.4 % ( 71/76 ) of patients in the ceftazidime/avibactam plus metronidazole and meropenem groups , respectively ( observed difference : -2.2 % ; 95 % CI : -20.4 % , 12.2 % ) . The incidence of treatment-emergent adverse events was similar for ceftazidime/avibactam plus metronidazole ( 64.4 % ) and meropenem ( 57.8 % ) . CONCLUSIONS Ceftazidime/avibactam plus metronidazole was effective and generally well tolerated in patients with cIAI , with a favourable clinical response rate in the ME population of > 90 % , similar to that of meropenem In a r and omized , double-blind clinical trial conducted at 13 medical centers , meropenem ( 1,000 mg given iv every 8 hours ) was compared with the combination of clindamycin ( 900 mg every 8 hours ) plus tobramycin ( 5 mg/[kg.d ] in three divided doses ) given iv for the treatment of intra-abdominal infections that required surgery and parenteral antibiotic therapy . At the end of treatment , efficacy data on patients who met study inclusion criteria ( intent-to-treat ) were available for 132 of 215 patients in the meropenem group and 134 of 212 patients in the clindamycin/tobramycin group ; 120 ( 91 % ) of 132 intent-to-treat patients in the meropenem group were cured , 115 ( 86 % ) of 134 intent-to-treat patients in the clindamycin/tobramycin group were cured ( P value , not significant ) . Of the patients treated with mer
Output:
| Combined therapy with metronidazole is as effective and safe as carbapenem in treatment of cIAI .
Therefore , combined therapy with metronidazole offers an effective alternative to carbapenem with low risk of drug resistance |
MS210879 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Objective : The aim of the trial was to compare laparoscopic technique with open technique regarding short-term pain , quality of life ( QoL ) , recovery , and complications . Background : Laparoscopic and open techniques for incisional hernia repair are recognized treatment options with pros and cons . Methods : Patients from 7 centers with a midline incisional hernia of a maximum width of 10 cm were r and omized to either laparoscopic ( LR ) or open sublay ( OR ) mesh repair . Primary end point was pain at 3 weeks , measured as the bodily pain subscale of Short Form-36 ( SF-36 ) . Secondary end points were complications registered by type and severity ( the Clavien-Dindo classification ) , movement restrictions , fatigue , time to full recovery , and QoL up to 8 weeks . Results : Patients were recruited between October 2005 and November 2009 . Of 157 r and omized patients , 133 received intervention : 64 LR and 69 OR . Measurements of pain did not differ , nor did movement restriction and postoperative fatigue . SF-36 subscales favored the LR group : physical function ( P < 0.001 ) , role physical ( P < 0.012 ) , mental health ( P < 0.022 ) , and physical composite score ( P < 0.009 ) . Surgical site infections were 17 in the OR group compared with 1 in the LR group ( P < 0.001 ) . The severity of complications did not differ between the groups ( P < 0.213 ) . Conclusions : Postoperative pain or recovery at 3 weeks after repair of midline incisional hernias does not differ between LR and OR , but the LR results in better physical function and less surgical site infections than the OR does . ( Clinical Trials.gov Identifier : NCT00472537 Background The laparoscopic approach has emerged in the search for a surgical technique to decrease the morbidity associated with conventional repair of ventral hernias . In this study we aim ed to compare the results of our open and laparoscopic ventral hernia repairs prospect ively . Methods Between January 2001 and October 2005 , a total of 46 patients diagnosed with ventral hernias ( primary and incisional ) who were admitted to our surgical unit and accepted to be included in this study group were examined . All patients were divided into laparoscopic repair ( n = 23 ) and open repair ( n = 23 ) subgroups in a r and omized fashion . The patients ’ demographic characteristics , operation times , body mass indices , sizes of fascial defects , hernia locations , duration s of hospital stay , presence and degrees of postoperative pain , and postoperative minor and major complications were analysed and compared . All the data were expressed as means ± SDs . Chi-square and Wilcoxon tests were used for statistical analysis , and P < 0.05 was accepted as a significant statistical value ( SPSS 11.0 for Windows ) . Results The demographic characteristics of both groups were similar . Women predominated , especially in the laparoscopy group ( P < 0.05 ) . The comparison of the results revealed that the major advantage of laparoscopy was the shortened postoperative hospital stay and the reduced incidence of mesh infection ( P < 0.05 , P < 0.05 ) . On the other h and , operation time was significantly longer in the laparoscopy group ( P < 0.05 ) . The major complications encountered in the laparoscopy group were ileus and a missed enterotomy . The most frequent minor complication was seroma , which was significantly more frequent in the laparoscopy group ( P < 0.05 ) . Postoperative pain assessment revealed similar results in both groups ( P > 0.05 ) . Conclusions The laparoscopic approach appears to be as effective as open repairs in the treatment of ventral hernias . Advanced surgical skill , laparoscopic experience and high technology are m and atory factors for successful ventral hernia repair BACKGROUND Incisional hernia is an important complication of abdominal surgery . Procedures for the repair of these hernias with sutures and with mesh have been reported , but there is no consensus about which type of procedure is best . METHODS Between March 1992 and February 1998 , we performed a multicenter trial in which we r and omly assigned to suture repair or mesh repair 200 patients who were scheduled to undergo repair of a primary hernia or a first recurrence of hernia at the site of a vertical midline incision of the abdomen of less than 6 cm in length or width . The patients were followed up by physical examination at 1 , 6 , 12 , 18 , 24 , and 36 months . Recurrence rates and potential risk factors for recurrent incisional hernia were analyzed with the use of life-table methods . RESULTS Among the 154 patients with primary hernias and the 27 patients with first-time recurrent hernias who were eligible for the study , 56 had recurrences during the follow-up period . The three-year cumulative rates of recurrence among patients who had suture repair and those who had mesh repair were 43 percent and 24 percent , respectively , with repair of a primary hernia ( P=0.02 ; difference , 19 percentage points ; 95 percent confidence interval , 3 to 35 percentage points ) . The recurrence rates were 58 percent and 20 percent with repair of a first recurrence of hernia ( P=0.10 ; difference , 38 percentage points ; 95 percent confidence interval , -1 to 78 percentage points ) . The risk factors for recurrence were suture repair , infection , prostatism ( in men ) , and previous surgery for abdominal aortic aneurysm . The size of the hernia did not affect the rate of recurrence . CONCLUSIONS Among patients with midline abdominal incisional hernias , mesh repair is superior to suture repair with regard to the recurrence of hernia , regardless of the size of the hernia IMPORTANCE Incisional hernia is the most frequent surgical complication after laparotomy . Up to 30 % of all patients undergoing laparotomy develop an incisional hernia . OBJECTIVE To compare laparoscopic vs open ventral incisional hernia repair with regard to postoperative pain and nausea , operative results , perioperative and postoperative complications , hospital admission , and recurrence rate . DESIGN Multicenter r and omized controlled trial between May 1999 and December 2006 with a mean follow-up period of 35 months . SETTING All patients were operated on in a clinical setting at 1 of the 2 participating university medical centers or at the other 8 teaching hospitals . PARTICIPANTS Two hundred six patients from 10 hospitals were r and omized equally to laparoscopic or open mesh repair . Patients with an incisional hernia larger than 3 cm and smaller than 15 cm , either primary or recurrent , were included . Patients were excluded if they had an open abdomen treatment in their medical histories . INTERVENTION Laparoscopic or open ventral incisional hernia repair . MAIN OUTCOME MEASURES The primary outcome of the trial was postoperative pain . Secondary outcomes were use of analgesics , perioperative and postoperative complications , operative time , postoperative nausea , length of hospital stay , recurrence , morbidity , and mortality . RESULTS Median blood loss during the operation was significantly less ( 10 mL vs 50 mL ; P = .05 ) as well as the number of patients receiving a wound drain ( 3 % vs. 45 % ; P < .001 ) in the laparoscopic group . Operative time for the laparoscopic group was longer ( 100 minutes vs. 76 minutes ; P = .001 ) . Perioperative complications were significantly higher after laparoscopy ( 9 % vs. 2 % ) . Visual analog scale scores for pain and nausea , completed before surgery and 3 days and 1 and 4 weeks postoperatively , showed no significant differences between the 2 groups . At a mean follow-up period of 35 months , a recurrence rate of 14 % was reported in the open group and 18 % , in the laparoscopic group ( P = .30 ) . The size of the defect was found to be an independent predictor for recurrence ( P < .001 ) . CONCLUSIONS AND RELEVANCE During the operation , there was less blood loss and less need for a wound drain in the laparoscopic group . However , operative time was longer during laparoscopy . Perioperative complications were significantly higher in the laparoscopic group . Visual analog scores for pain and nausea did not differ between groups . The incidence of a recurrence was similar in both groups . The size of the defect was found to be an independent factor for recurrence of an incisional hernia BACKGROUND Laparoscopic repair of ventral incisional hernias has not been proved to be safer than open mesh repair . DESIGN Prospect i ve r and omized trial conducted between February 1 , 2004 , to January 31 , 2007 . SETTING Four Veterans Affairs medical centers . PARTICIPANTS One hundred sixty-two patients with ventral incisional hernias . INTERVENTIONS St and ardized laparoscopic or open repair . MAIN OUTCOME MEASURES Overall complication rates at 8 weeks and the odds of complications , adjusted for study site , body mass index , and hernia type . RESULTS Of the 162 r and omized patients , 146 underwent surgery ( 73 open and 73 laparoscopic repairs ) . Complications were less common in the laparoscopic group ( 23 patients [ 31.5 % ] ) compared with the open repair group ( 35 patients [ 47.9 % ] ; adjusted odds ratio [ AOR ] , 0.45 ; 95 % confidence interval [ CI ] , 0.22 - 0.91 ; P = .03 ) . Surgical site infection through 8 weeks was less common in the laparoscopic group ( 5.6 % vs 23.3 % ; AOR , 0.2 ; 95 % CI , 0.1 - 0.6 ) . The mean worst pain score in the laparoscopic group was 15.2 mm lower on a visual analog scale at 52 weeks ( 95 % CI , 1.0 - 29.3 ; P = .04 ) . Time to resume work activities was shorter for the laparoscopic group than for the open repair group ( median , 23.0 days vs 28.5 days ) , with an adjusted hazard ratio of 0.54 ( 95 % CI , 0.28 - 1.04 ; P = .06 ) . Overall recurrence at 2 years was 12.5 % in the laparoscopic group and 8.2 % in the open repair group ( AOR , 1.6 ; 95 % CI , 0.5 - 4.7 ; adjusted P = .44 ) . CONCLUSIONS Laparoscopic repair was associated with fewer , albeit more severe , complications and improved some patient-centered outcomes . Trial Registration clinical trials.gov Identifier : NCT00240188 Background Incisional hernia is a common complication following abdominal surgery . Although the use of prosthetics has decreased recurrence rates , the st and ard open approach is still unsatisfactory . Laparoscopic techniques are an attempt to provide similar outcomes with the advantages of minimally invasive surgery . Methods Open r and omized controlled clinical trial with follow-up at 1 , 2 , 3 , 7 , and 15 days , and 1 , 3 , and 12 months from hernia repair . The study was carried out in the surgery departments of three general hospitals of the Valencia Health Agency . Objectives To compare laparoscopic with anterior open repair using health-related quality of life outcomes as main endpoints . Results Eighty-four patients with incisional hernia were r and omly allocated to an open group ( OG ) ( n = 39 ) or to a laparoscopic group ( LG ) ( n = 45 ) . Seventy-four patients completed 1-year follow up . Mean length of stay and time to oral intake were similar between groups . Operative time was 32 min longer in the LG ( p < 0.001 ) . Conversion rate was 11 % . The local complication rate was superior in the LG ( 33.3 % versus 5.2 % ) ( p < 0.001 ) . Recurrence rate at 1 year ( 7.9 % versus 9.7 % ) was similar in the two groups . There were no significant differences in the pain scores or the EQ5D tariffs between the two groups during follow-up . Conclusions Laparoscopic incisional hernia repair does not seem to be a better procedure than the open anterior technique in terms of operative time , hospitalization , complications , pain or quality of life To compare the early and intermediate results of the open and laparoscopic tension-free repair of incisional hernia , 24 patients were r and omized prospect ively to undergo laparoscopic or open repair of incisional hernia with retromuscular placement of the prosthesis using transabdominal sutures for mesh fixation . All the procedures were completed as planned . The mean duration of surgery was not significantly different between the 2 groups ( P=0.15 ) . Time to oral solid food intake was longer in the open group ( P=0.002 ) . The analgesic requirement was lower in the laparoscopic group ( P=0.05 ) . One patient after open surgery and 2 in the laparoscopic group suffered postoperative complications ( P=0.71 ) . Postoperative stay was shorter in the laparoscopic group ( P=0.006 ) . No readmission or recurrence
Output:
| Conclusions Laparoscopic incisional and ventral hernia repair is a feasible and effective alternative to the open technique .
It is associated with lower incidences of wound infection and shorter length of hospital stay .
Given the relatively short follow-up duration of trials included in the systematic review , trials with long-term follow-up are needed to compare the durability of laparoscopic and open repair |
MS210880 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
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Input: Abstract Objective : To evaluate the effect of intensive geriatric rehabilitation on demented patients with hip fracture . Design : Preplanned sub analysis of r and omised intervention study . Settting : Jyväskylä Central Hospital , Finl and . Participants : 243 independently living patients aged 65 years or older admitted to hospital with hip fracture . Intervention : After surgery patients in the intervention group ( n=120 ) were referred to the geriatric ward whereas those in the control group were discharged to local hospitals . Main outcome measures : Length of hospital stay , mortality , and place of residence three months and one year after surgery for hip fracture . Results : The median length of hospital stay of hip fracture patients with moderate dementia ( mini mental state examination score 12 - 17 ) was 47 days in the intervention group ( n=24 ) and 147 days in the control group ( n=12 , P=0.04 ) . The corresponding figures for patients with mild dementia ( score 18 - 23 ) were 29 days in the intervention group ( n=35 ) and 46.5 days in the control group ( n=42 , P=0.002 ) . Three months after the operation , in the intervention group 91 % ( 32 ) of the patients with mild dementia and 63 % ( 15 ) of the patients with moderate dementia were living independently . In the control group , the corresponding figures were 67 % ( 28 ) and 17 % ( 2 ) . There were no significant differences in mortality or in the lengths of hospital stay of severely demented patients and patients with normal mini mental state examination scores . Conclusions : Hip fracture patients with mild or moderate dementia can often return to the community if they are provided with active geriatric rehabilitation Background The incidence of hip fracture is expected to increase during the coming years , dem and ing greater re sources and improved effectiveness on this group of patients . The aim of the present study was to evaluate the effectiveness of an integrated care pathway ( ICP ) in patients with an acute fracture of the hip . Methods A nonr and omized prospect i ve study comparing a consecutive series of patients treated by the conventional pathway to a newer intervention . 112 independently living patients aged 65 years or older admitted to the hospital with a hip fracture were consecutively selected . Exclusion criteria were pathological fracture and severe cognitive impairment . An ICP was developed with the intention of creating a care path with rapid pre-operative attention , increased continuity and an accelerated training programme based on the individual patient 's prerequisites and was used as a guidance for each patient 's tailored care in the intervention group ( N = 56 ) The main outcome measure was the length of hospital stay . Secondary outcomes were the amount of time from the emergency room to the ward , to surgery and to first ambulation , as well as in-hospital complications and 30-day readmission rate . Results The intervention group had a significantly shorter length of hospital stay ( 12.2 vs. 26.3 days ; p < 0.000 ) , a shorter time to first ambulation ( 41 vs. 49 h ; p = 0.01 ) , fewer pressure wounds ( 8 vs. 19 ; p = 0.02 ) and medical complications ( 5 vs. 14 ; p = 0.003 ) than the comparison group . No readmissions occurred within 30 days post-intervention in either group . Conclusion Implementing an ICP for patients with a hip fracture was found to significantly reduce the length of hospital stay and improve the quality of care The purpose of the current study was to evaluate the effectiveness of a multidisciplinary Hip Fracture Service in the treatment of hip fractures in elderly patients . Baseline information and hospital outcomes were compared for 510 patients over the age of 65 with hip fracture treated before and after the institution of the Hip Fracture Service . Data included basic demographic data , admission laboratory results , surgical information , number of comorbidities , mortality , medical complications , discharge information , time to surgery , and length of stay in hospital . The demographics of the two groups of patients were similar . Patients treated as part of the Hip Fracture Service had fewer medical complications ( 36 % vs. 51 % ) , more often had surgery within 24 hours ( 63 % vs. 35 % ) , and had shorter hospital stays ( mean , 5.7 days vs. 8.1 days ) than patients treated before the Hip Fracture Service . These findings provide the rationale for a prospect i ve , r and omized trial of the service OBJECTIVES To evaluate the incremental cost in the year after hip fracture . DESIGN Prospect i ve cohort study . SETTING Baltimore , Maryl and . PARTICIPANTS 759 community dwelling older patients who sustained a hip fracture and participated in the Baltimore Hip Fracture Study . MEASUREMENTS Re source use for direct medical care , formal nonmedical care , and informal care in the 6 months before and the year after fracture was estimated from interviews with patients or proxy respondents . Costs in 1993 dollars were estimated by multiplying re sources times national unit cost estimates . RESULTS The annualized costs in the year before the fracture ranged between $ 18,523 and $ 20,928 . The costs in the year after the fracture equaled $ 37,250 . The incremental costs in the year after the fracture , compared with the costs in the year before the fracture , ranged between $ 16,322 and $ 18,727 . The largest cost differences were attributable to hospitalizations , nursing home stays , and rehabilitation services . CONCLUSIONS Because we compared the costs after a fracture with costs before , our estimates of the incremental cost of a hip fracture are lower than others in the literature . These results , obtained from interviews with patients enrolled in a cohort study , or their proxies , provide the best data available to date on the economic cost of hip fractures among community-dwelling older persons In recent years , intense pressures to reduce the costs of health care have led many health care organizations to seek strategies that reduce re source utilization while maintaining the quality of care [ 1 - 5 ] . Among the most popular of the methods intended to meet this challenge are critical pathways . Critical pathways are management plans that display goals for patients and provide the corresponding ideal sequence and timing of staff actions to achieve those goals with optimal efficiency [ 6 - 8 ] . Interest in critical pathways has increased tremendously during the past several years as early anecdotal reports of their cost-saving potential have been disseminated , usually outside the peer- review ed medical literature [ 7 , 9 , 10 ] . The rapid push for critical pathway implementation comes from intense competitive pressures and the persistent evidence of unexplained variation in medical practice [ 11 , 12 ] . Many managed care organizations have added their weight to this process by m and ating certain critical pathways or seeking partner hospitals that are willing to develop their own [ 7 ] . However , no controlled study has shown a critical pathway to reduce the duration of hospital stay or to decrease re source use , nor has any study shown critical pathways to improve patient satisfaction or outcomes [ 13 ] . Nevertheless , like other promising medical technologies , critical pathways are being disseminated before controlled trials have been done to evaluate their effectiveness . Despite the lack of data , an increasing number of physicians will be asked to participate in critical pathway development . Even more will find that their hospitalized patients are already on pathways that they may or may not have endorsed . To enhance the effectiveness of critical pathways and minimize the disruption to the patientphysician relationshipphysicians and other caregivers must underst and the origin , potential benefits , and potential pitfalls of this new method . Critical Pathways : A New Form of Clinical Guideline Critical pathways have varying formats and are known by many names , including critical paths , clinical pathways , and care paths . Interpreted formally , a critical pathway is the sequence of events in a process that takes the greatest length of time . Like the techniques of continuous quality improvement , critical pathway techniques were first developed for use in industry as a tool to identify and manage the rate-limiting steps in production processes [ 14 - 17 ] . First developed in the 1950s , the Critical Path Method was frequently linked with a similar approach , the Program Evaluation and Review Technique , to coordinate multiple contractors or persons in a project by identifying the key sequence of events , or critical path , the requirements of which would drive the timeline of the overall project [ 18 , 19 ] . Critical pathway techniques have subsequently been applied to projects as diverse as construction , civil engineering , town planning , marketing , ship building , product design , and equipment installation [ 6 ] . Critical pathways were first developed and applied to health care in the 1980s , when prospect i ve payment systems focused greater interest on potential methods to improve hospital efficiency [ 6 ] . Most of the first critical pathways in hospitals were developed by nurses for nursing care alone [ 20 , 21 ] , but multidisciplinary teams soon began developing pathways to encompass all aspects of care for hospitalized patients [ 22 - 24 ] . In general , efforts to develop critical pathways in health care have not incorporated the formal techniques used by industrial predecessors to identify the true critical pathway in any care process [ 18 , 25 ] . Instead , when critical pathways are used to plan medical care , the specific goals usually include the following : 1 . Selecting a best practice when practice styles vary unnecessarily . 2 . Defining st and ards for the expected duration of hospital stay and for the use of tests and treatments . 3 . Examining the interrelations among the different steps in the care process to find ways to coordinate or decrease the time spent in the rate-limiting steps . 4 . Giving all hospital staff a common game plan from which to view and underst and their various roles in the overall care process . 5 . Providing a framework for collecting data on the care process so that providers can learn how often and why patients do not follow an expected course during their hospitalization . 6 . Decreasing nursing and physician documentation burdens . 7 . Improving patient satisfaction with care by educating patients and their families about the plan of care and involving them more fully in its implementation . The general format of critical pathway guidelines is the Gantt chart , which outlines the suggested patient care process based on a time-task matrix , listing the components of care in one column and cross-aligning these entries with columns pertaining to time [ 8 ] . Figure 1 is an example of such a chart for a critical pathway for patients who have had coronary artery bypass graft surgery . Categories of multidisciplinary staff actions are listed in the first column of the pathway , with specific actions for each day of hospitalization . As indicated in Figure 1 , a patient 's diet is expected to progress successfully from ice chips to clear liquids on the first day after surgery . For all other categories of patient care , critical pathways likewise explicitly mark the transition points of patient progress and lay out a coordinated map of staff activities to achieve those transitions in the most efficient way possible . Figure 1 . The first 2 days of a simplified critical pathway for patients who have had cardiac surgery . Critical pathways differ from most clinical guidelines , protocol s , and algorithms in several key respects . First , clinical guidelines often address the appropriateness of care by delineating the indications for tests or treatments . Critical pathways , on the other h and , have almost always focused on the quality and efficiency of care after decisions have already been made to admit the patient or perform the procedure . Another way in which critical pathways differ from most clinical guidelines is that they are multidisciplinary in their development and in the scope of their implementation . Critical pathways are also design ed along specific timelines , sometimes even in hour-by-hour detail , for indicated actions , and pathways not only spell out these specific actions but also enumerate expected intermediate patient outcomes that serve as checkpoints for the performance of both the patient and the pathway . Yet another distinguishing feature of critical pathways is that their comprehensive design allows them to be used as a part of the patient record , often replacing other documentation entirely [ 6 , 24 ] . All staff interventions and intermediate clinical outcomes that occur as expected can be simply initialed on the critical pathway document . If staff actions or intermediate patient outcomes do not occur as expected , however , a variance from the pathway is said to have occurred [ 26 ] . Variances , too , can be noted on the document , along with an explanation of their cause or causes , and , if needed , a plan can be described to return the patient to the expected course of treatment and outcomes . Critical Pathway Development Topic Selection Critical pathways are typically developed for the hospital care associated with high-volume , high-cost diagnoses and procedures , particularly those for which inefficient variation in the process of care is thought to exist [ 6 ] . Surgical procedures , such as coronary artery bypass graft surgery and total hip replacement , lend themselves particularly well to critical pathways because the care process differs relatively little from patient to patient . For this same reason , obstetric procedures such as normal vaginal delivery and cesarean section have also been subjects of pathways in many institutions [ 24 ] . For most medical diagnoses , however , patient care has proved more difficult to translate successfully into critical pathways because of the greater heterogeneity among patients and problems [ 6 , 27 ] . Some institutions have reported that pathways fail when used for medical patients who have either multiple problems and therefore multiple relevant pathways or a problem that does not fit neatly within any single st and ardized pathway [ 27 - 29 ] . Despite these concerns , however , pathways have been design ed and implemented at many institutions for medical diagnoses such as myocardial infa rct ion , stroke , and deep venous thrombosis [ 23 ] . Team Composition The group that is organized to develop a critical pathway should be multidisciplinary in order to bring to the table the knowledge and perspectives that are necessary to view the care process in its entirety . Although many institutions have appointed nurses as the leaders of critical pathway teams [ 6 ] , we have found that having a physician-expert lead each team lends credibility to the pathways and builds a foundation of support among all clinicians . Each pathway team should also have a group facilitator from the hospital administration , a housestaff physician , a member of the quality management department who has expertise in critical pathway methods , and a community-based primary care phys
Output:
| There were wide differences among the studies that assessed the effects of CPs on HF patients , with some contrasting clinical outcomes reported .
Secondary studies that were non-specific for CPs and included other multidisciplinary care approaches as well showed , in some cases , a shorter hospital length of stay ( LOS ) compared to usual care ; studies that focused on promoting early mobilization showed better outcomes of mortality , morbidity , function , or service utilization ; CPs mainly based on intensive occupational therapy and /or physical therapy exercises improved functional recovery and reduced LOS , with patients also discharged to a more favorable discharge destination ; CPs principally focused on early mobilization improved functional recovery .
A secondary study specifically design ed for CPs showed lower odds of experiencing common complications of hospitalization after HF . |
MS210881 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
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Input: In our experience , stroke patients discharged straight to their homes sometimes showed marked deterioration . We investigated whether this negative course of events could be prevented by means of follow-up visits entailing extensive testing and result ant measures one month after discharge . The patients in our study included a selection of mild cases with a short length of hospital stay . Forty-six patients returned to the stroke unit on a follow-up visit , and 49 patients made up the control group . The groups were compared after 3 months , by means of question naires . The results did not show any definite difference between the groups . However , after 3 months we detected depressions in 13 patients in the study group and in 11 patients in the control group , most of them untreated . The study points to a need for follow-up aim ed specifically at detecting depression Background and Purpose — Functioning and disability after ischemic stroke are clinical ly meaningful and of major relevance to patients . Despite many instruments available to assess these outcomes , little is known about their interrelation and predictive factors . Methods — We prospect ively identified 4264 patients with acute ischemic stroke from 30 hospitals in Germany during a 1-year period between 1998 and 1999 and registered them in a common data bank . The patients were central ly followed up via telephone interview after 100 days and 1 year to assess various scales such as the Barthel Index ( BI ) , modified Rankin Scale ( MRS ) , extended Barthel Index ( EBI ) , Short Form-36 Physical Functioning ( SF-36 PF ) , and Center for Epidemiologic Studies –Depression short form ( CES-D ) . Results — Outcome status could be assessed in 67.2 % of patients 100 days after hospital admission . Of these , 13.9 % had died , 53.7 % had regained functional independence ( BI < 95 ) , 46.3 % had no or mild residual symptoms ( MRS ≤1 ) , and 44.6 % had no higher cognitive deficits on the EBI . Of the patients who personally answered the follow-up questions , 67 % had no major physical disability ( SF-36 PF < 60 ) , and 32.9 % reported symptoms classified as depression ( CES-D ≥10 ) . The high percentage of patients reaching the maximum score ( ceiling effect ) in the BI was less pronounced in the MRS and SF-36 PF . The predictive factors for dichotomized outcomes on each scale were similar for adverse functioning and disability but varied considerably for depression . Conclusions — To avoid ceiling effects in outcome distribution of patients treated in specialized stroke centers , the MRS and SF-36 PF instruments are preferable to the BI . Parametric use of the SF-36 PF could further improve outcome measurement by considering individual treatment effects BACKGROUND national policy recommends routine re- assessment of disabled patients and their carers at 6 months after stroke onset . The clinical and re source outcomes of this policy were investigated . DESIGN prospect i ve , single-blind , r and omised controlled trial in two centres . PARTICIPANTS a total of 265 patients with a disabling stroke and their carers . INTERVENTIONS a structured re- assessment system for patients and their carers at 6 months post-stroke or existing care . OUTCOME MEASURES primary : patient independence ( Frenchay activities index ) and carer stress ( general health question naire 28 ) . Secondary : activities of daily living , mood state , satisfaction with services , carer strain index , health and social service re source use and costs . RESULTS independence at 12 months post-stroke was similar in both groups ( Frenchay activities index , adjusted mean difference 0.64 ; 95 % confidence interval -0.74 - 2.02 ) . Emotional distress in carers was similar in both groups ( general health question naire 28 , mean difference 0.02 ; 95 % confidence interval -0.95 - 1.00 ) . Results for the secondary outcome measures and total mean costs were similar for both groups . The intervention group patients used 301 fewer hospital bed days and 1,631 fewer care home bed days . CONCLUSIONS the structured , systematic re- assessment for patients and their carers was not associated with any clinical ly significant evidence of benefit at 12 months . Health and social care re source use and mean cost per patient were broadly similar in both groups . TRIAL REGISTRATION International St and ard R and omised Controlled Trial Register ; number : IS RCT N55412871 Objective : To compare intensive with non-intensive home-based rehabilitation provision following stroke or hip fracture in old age ( 65 years ) . Design : Parallel single-blind r and omized control trial . Setting : Domiciliary provided multidisciplinary rehabilitation . Subjects : One hundred and sixty patients aged 65 or over recently discharged from hospital after suffering a stroke or hip fracture . Intervention : Patients assigned to receive six or more face-to-face contacts or three or less face-to-face contacts from members of a multidisciplinary rehabilitation team . Main measures : Patients assessed using the Barthel Index , Therapy Outcome Measure , Euroqol 5D ( EQ-5D ) , Hospital Anxiety and Depression Scale ( HADS ) and Frenchay Activities Index ( FAI ) at three months . All follow-up assessment s were conducted blind to allocation . Results : Subgroup analysis was conducted on the basis of incident condition ( stroke or hip fracture ) . Significant differences were detected for the stroke subgroup at three months [ Therapy Outcome Measure H and icap ( median difference 0.5 ( P < 0.05 ) ) and EQ-5D ( median difference 0.17 ( P < 0.05 ) ) ] and in change at three months [ Therapy Outcome Measure ( mean difference 0.52 ( SD 0.85 ) 95 % CI ( 0.16 , 0.88 ) ) and EQ-5D ( mean difference 0.15 ( SD 0.25 ) 95 % CI ( 0.05 , 0.26 ) ) ] . No significant differences were detected between the two arms of the study for the hip fracture subgroup . Conclusion : Following stroke older people who receive a more intensive communitybased multidisciplinary rehabilitation service may experience short-term benefit in relation to social participation and some aspects of health-related quality of life . A more intensive service after discharge from hospital following a hip fracture is unlikely to result in similar patient benefit OBJECTIVES To compare the effectiveness and costs of a new domiciliary rehabilitation service for elderly stroke patients with geriatric day-hospital care . DESIGN R and omized controlled trial . PARTICIPANTS Stroke patients aged 55 + who required further rehabilitation after hospital discharge or after referral to geriatricians from the community . SETTING Poole area , East Dorset , a mixed urban/rural area on the south coast of Engl and . MAIN OUTCOMES Primary -changes between hospital discharge and 6-month follow-up in physical function as measured by Barthel index . Secondary -changes over this period in Rivermead Mobility Index and mental state ( Philadelphia Geriatric Centre Morale Scale ) and differences in social activity ( Frenchay Activities Index ) and generic health status ( SF-36 ) . Health service and social service cost per patient were compared for the two groups . RESULTS 180 patients were eligible and 140 ( 78 % ) were r and omized . The groups were well balanced for age , sex , social class and initial Barthel index . We achieved follow-up in 88 % of subjects who were alive at 6 months . We detected no significant differences in patient outcomes , although there was a non-significant improvement in measures of physical function and social activity in the domiciliary group . Domiciliary patients had more physiotherapy time per session and more district nurse time , and made greater use of social service day centres and home helps . Total cost per patient did not differ significantly between the two groups , with reduced health service costs in the domiciliary arm offset by higher social service costs . CONCLUSION No significant differences were detected in the effectiveness of the two services . Neither service influenced patients ' mental state , and their social activity remained low . Total costs were similar . A mixed model of day-hospital and domiciliary care may be most cost-effective for community stroke rehabilitation , but this requires further evaluation This study compared the functional ability and perceived health status of stroke patients treated by a domiciliary rehabilitation team or by routine hospital-based services after discharge from hospital . Patients discharged from two acute and three rehabilitation hospitals in Nottingham were r and omly allocated in three strata ( Health Care of the Elderly , General Medical and Stroke Unit ) to receive domiciliary or hospital-based care after discharge . Functional recovery was assessed by the Extended Activities of Daily Living ( ADL ) scale three and six months after discharge and perceived health at six months was measured by the Nottingham Health Profile . A total of 327 eligible patients of 1119 on a register of acute stroke admissions were recruited over 16 months . Overall there were no differences between the groups in their Extended ADL scores at three or six months , or their Nottingham Health Profile scores at six months . In the Stroke Unit stratum , patients treated by the domiciliary team had higher household ( p = 0.02 ) and leisure activity ( p = 0.04 ) scores at six months than those receiving routine care . In the Health Care of the Elderly stratum , death or a move into long-term institutional care at six months occurred less frequently in patients allocated to the routine service , about half of whom attended a geriatric day hospital . Overall there was no difference in the effectiveness of the domiciliary and hospital-based services , although younger stroke unit patients appeared to do better with home therapy while some frail elderly patients might have benefited from day hospital attendance OBJECTIVE To compare a specialized interprofessional team approach to community-based stroke rehabilitation with usual home care for stroke survivors using home care services . METHODS R and omized controlled trial of 101 community-living stroke survivors ( < 18 months post-stroke ) using home care services . Subjects were r and omized to intervention ( n=52 ) or control ( n=49 ) groups . The intervention was a 12-month specialized , evidence -based rehabilitation strategy involving an interprofessional team . The primary outcome was change in health-related quality of life and functioning ( SF-36 ) from baseline to 12 months . Secondary outcomes were number of strokes during the 12-month follow-up , and changes in community reintegration ( RNLI ) , perceived social support ( PRQ85-Part 2 ) , anxiety and depressive symptoms ( Kessler-10 ) , cognitive function ( SPMSQ ) , and costs of use of health services from baseline to 12 months . RESULTS A total of 82 subjects completed the 12-month follow-up . Compared with the usual care group , stroke survivors in the intervention group showed clinical ly important ( although not statistically significant ) greater improvements from baseline in mean SF-36 physical functioning score ( 5.87 , 95 % CI -3.98 to 15.7 ; p=0.24 ) and social functioning score ( 9.03 , CI-7.50 to 25.6 ; p=0.28 ) . The groups did not differ for any of the secondary effectiveness outcomes . There was a higher total per-person costs of use of health services in the intervention group compared to usual home care although the difference was not statistically significant ( p=0.76 ) . CONCLUSIONS A 12-month specialized , interprofessional team is a feasible and acceptable approach to community-based stroke rehabilitation that produced greater improvements in quality of life compared to usual home care . Clinical trials.gov identifier : NCT00463229 BACKGROUND This r and omized controlled trial tested the effectiveness of comprehensive , interdisciplinary postdischarge care management in improving a profile of indicators of health recovery and secondary prevention ( profile of health and prevention ) in stroke and transient ischemic attack ( TIA ) patients . METHODS Ninety-six stroke/TIA patients were r and omized to usual care or intervention at discharge from our acute stroke unit . The intervention group received an in-home biopsychosocial assessment by an advanced practice nurse at 1 month . A care plan was developed by an interdisciplinary team and implemented in collaboration with the patient 's primary care physician . The profile of health and prevention , measured at 3 months , was comprised of 5 domains : ( 1 ) Neuromotor Function , ( 2 ) Severe Complications , ( 3 ) Quality of Life , ( 4 ) Management of Risk for common poststroke complications and recurrent stroke , and ( 5 ) Stroke Knowledge . A single global hypothesis test across multiple end points was used to compare the 2 groups . RESULTS The intervention significantly improved the profile of health and prevention ( P < .0001 ) . In addition , each domain showed a positive effect of the intervention . Effect sizes ( in st and ard deviation units ) of the intervention on domains were .1 for Neuromotor Function ( 90 % confidence interval [ CI ] = -.3 to .5 ) ; .4 for Severe Complications ( 90 % CI = .1 to .8 ) ; .5 for Quality of Life ( 90 % CI = .1 to .9 ) ; .6 for Management of Risk for common poststroke complications and recurrent stroke ( 90 % CI = .3 to 1 . ) ; and 1.0 for Stroke Knowledge ( 90 % CI = .6 to 1.4 ) . CONCLUSIONS This model of care management result ed in a significantly better profile of health and prevention for stroke/TIA patients 3 months postdischarge Objective : To assess the effect of three weeks of rehabilitation in the home setting for younger patients with stroke with the aim of improving activity level . Design : A r and omized controlled study with blinded evaluations at discharge , three weeks , three months and one year after discharge . Setting : Home of the patient or the ordinary day rehabilitation clinic at the university hospital . Subjects : Fifty-
Output:
| DATA SYNTHESIS None of the studies showed favourable effects of the intervention on activities of daily living and none assessed social participation .
CONCLUSION There is little evidence for the effectiveness of multidisciplinary care for stroke patients being discharged home . |
MS210882 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: Introduction Inadequate initial treatment and delayed hemodynamic stabilization ( HDS ) may be associated with increased risk of death in severe sepsis patients . Methods In order to compare the hemodynamic efficacy and safety of 6 % HES 130/0.4 and NaCl 0.9 % for HDS in patients with severe sepsis , we design ed a prospect i ve , multicenter , active-controlled , double-blind , r and omized study in intensive care units . Results 174 out of 196 patients reached HDS ( 88 and 86 patients for HES and NaCl , respectively ) . Significantly less HES was used to reach HDS vs. NaCl ( 1,379 ±886 ml in the HES group and 1,709 ±1,164 ml in the NaCl group ( mean difference = -331± 1,033 , 95 % CI -640 to -21 , P = 0.0185 ) . Time to reach HDS was 11.8 10.1 hours vs. 14.3 ±11.1 hours for HES and NaCl , respectively . Total quantity of study drug infused over four consecutive days , ICU and hospital LOS , and area under the curve of SOFA score were comparable . Acute renal failure occurred in 24 ( 24.5 % ) and 19 ( 20 % ) patients for HES and NaCl , respectively ( P = 0.454 ) . There was no difference between AKIN and RIFLE criteria among groups and no difference in mortality , coagulation , or pruritus up to 90 days after treatment initiation . Conclusion Significantly less volume was required to achieve HDS for HES vs. NaCl in the initial phase of fluid resuscitation in severe sepsis patients without any difference for adverse events in both groups . Clinical Trials.gov To assess the effects of crystalloid and colloid resuscitation on hemodynamic response and on lung water following thermal injury , 79 patients were assigned r and omly to receive lactated Ringer 's solution or 2.5 % albumin-lactated Ringer 's solution . Crystalloid-treated patients required more fluid for successful resuscitation than did those receiving colloid solutions ( 3.81 vs. 2.98 ml/kg body weight/% body surface burn , p < 0.01 ) . In study phase 1 ( 29 patients ) , cardiac index and myocardial contractility ( ejection fraction ' and mean rate of internal fiber shortening , Vcf ) were determined by echocardiography during the first 48 hours postburn . Cardiac index was lower in the 12-to 24-hour postburn interval in the crystalloid group , but this difference between treatment groups had disappeared by 48 hours postburn . Ejection fractions were normal throughout the entire study , while Vcf was supranormal ( p < 0.01 vs. normals ) and equal in the two resuscitation groups . In study phase 2 ( SO patients ) , extravascular lung water and cardiac index were measured by a st and ard rebreathing technique at least daily for the first postburn week . Lung water remained unchanged in the crystalloid-treated patients ( p > 0.10 ) , but progressively increased in the colloid-treated patients over the seven day study ( p < 0.0001 ) . The measured lung water in each treatment group was significantly different from one another ( p < 0.001 ) . Cardiac index increased progressively and identically in both treatment groups over the study period ( p < 0.01 ) . These data refute the existence of myocardial depression during postburn resuscitation and document hypercontractile left ventricular performance . The addition of colloid to crystalloid resuscitation fluids produces no long lasting benefit on total body blood flow , and promotes accumulation of lung water when edema fluid is being reabsorbed from the burn wound Background The use of hypertonic crystalloid solutions , including sodium chloride and bicarbonate , for treating severe sepsis has been much debated in previous investigations . We have investigated the effects of three crystalloid solutions on fluid resuscitation in severe sepsis patients with hypotension . Methods Ninety-four severe sepsis patients with hypotension were r and omly assigned to three groups . The patients received the following injections within 15 min at initial treatment : Ns group ( n = 32 ) , 5 ml/kg normal saline ; Hs group ( n = 30 ) , with 5 ml/kg 3.5 % sodium chloride ; and Sb group ( n = 32 ) , 5 ml/kg 5 % sodium bicarbonate . Cardiac output ( CO ) , systolic blood pressure , mean arterial pressure ( MAP ) , body temperature , heart rate , respiratory rate and blood gases were measured . Results There were no differences among the three groups in CO , MAP , heart rate or respiratory rate during the 120 min trial or the 8 hour follow-up , and no significant differences in observed mortality rate after 28 days . However , improvement of MAP and CO started earlier in the Sb group than in the Ns and Hs groups . Sodium bicarbonate increased the base excess but did not alter blood pH , lactic acid or [HCO3]- values ; and neither 3.5 % hypertonic saline nor 5 % sodium bicarbonate altered the Na+ , K+ , Ca2 + or Cl- levels . Conclusion All three crystalloid solutions may be used for initial volume loading in severe sepsis , and sodium bicarbonate confers a limited benefit on humans with severe sepsis . Trial registration IS RCT N36748319 Abstract . The objective of this study was to compare the cardiac and hemodynamic responses to a rapid infusion of 1000 ml of modified fluid gelatin ( group A ) or 1000 ml of lactated Ringer 's solution ( group B ) in emergency room patients suffering from shock . This prospect i ve , r and omized , open , noncrossover study was performed at a medical center university hospital in a surgical resuscitation room in the emergency department . The subjects were 34 patients with either hypovolemic or neurogenic shock who were admitted to the emergency room . A resuscitation protocol according to Advanced Trauma Life Support ( ATLS ) with an additional central venous line or Swan-Ganz catheters for hemodynamic monitoring was used . Physical parameters and hemodynamic variables were measured at baseline and 15 minutes , 30 minutes , and 1 hour after the infusion of each fluid . In both groups the mean arterial blood pressure ( MAP ) , systolic and diastolic pressure , central venous pressure ( CVP ) , and pulmonary artery occlusion pressure ( PAOP ) increased significantly . The CVP and PAOP increased significantly more in the modified fluid gelatin resuscitation group . In patients with traumatic or neurogenic shock due to acute volume deficiency , there was significantly better hemodynamic improvement , judged by CVP and PAOP measurements using the modified fluid gelatin for volume replacement than with lactated Ringer 's solution during the first hour of resuscitation BACKGROUND Both balanced crystalloids and saline are used for intravenous fluid administration in critically ill adults , but it is not known which results in better clinical outcomes . METHODS In a pragmatic , cluster‐r and omized , multiple‐crossover trial conducted in five intensive care units at an academic center , we assigned 15,802 adults to receive saline ( 0.9 % sodium chloride ) or balanced crystalloids ( lactated Ringer 's solution or Plasma‐Lyte A ) according to the r and omization of the unit to which they were admitted . The primary outcome was a major adverse kidney event within 30 days — a composite of death from any cause , new renal‐replacement therapy , or persistent renal dysfunction ( defined as an elevation of the creatinine level to ≥200 % of baseline ) — all censored at hospital discharge or 30 days , whichever occurred first . RESULTS Among the 7942 patients in the balanced‐crystalloids group , 1139 ( 14.3 % ) had a major adverse kidney event , as compared with 1211 of 7860 patients ( 15.4 % ) in the saline group ( marginal odds ratio , 0.91 ; 95 % confidence interval [ CI ] , 0.84 to 0.99 ; conditional odds ratio , 0.90 ; 95 % CI , 0.82 to 0.99 ; P=0.04 ) . In‐hospital mortality at 30 days was 10.3 % in the balanced‐crystalloids group and 11.1 % in the saline group ( P=0.06 ) . The incidence of new renal‐replacement therapy was 2.5 % and 2.9 % , respectively ( P=0.08 ) , and the incidence of persistent renal dysfunction was 6.4 % and 6.6 % , respectively ( P=0.60 ) . CONCLUSIONS Among critically ill adults , the use of balanced crystalloids for intravenous fluid administration result ed in a lower rate of the composite outcome of death from any cause , new renal‐replacement therapy , or persistent renal dysfunction than the use of saline . ( Funded by the V and erbilt Institute for Clinical and Translational Research and others ; SMART‐MED and SMART‐SURG Clinical Trials.gov numbers , NCT02444988 and NCT02547779 . BACKGROUND Normal saline ( NS ) is the most commonly used crystalloid solution worldwide but contains an excess of chloride and may cause metabolic acidosis and hyperchloraemia . Such abnormalities may be attenuated by the use of a balanced solution such as Plasma-Lyte 148 ( PL-148 ) . OBJECTIVE To assess the feasibility , safety and biochemical and physiological effects of resuscitation with NS versus PL-148 in critically ill patients . DESIGN , SETTING AND PARTICIPANTS An exploratory , multicentre , doubleblind , r and omised controlled trial involving patients aged ≥ 18 years who were prescribed crystalloid fluid resuscitation by the treating clinician between 16 July and 22 October 2015 , in three multidisciplinary intensive care units in Melbourne , Victoria , Australia . METHODS R and om allocation of NS or PL-148 was concealed , and all fluids were delivered in indistinguishable bags . INTERVENTION NS or PL-148 was administered for all fluid resuscitation and for all subsequent crystalloid fluid therapy until Day 4 of ICU admission . The treating intensivist determined the rate and frequency of fluid administration . MAIN OUTCOME MEASURES Primary outcome was daily base excess ( BE ) . Relevant secondary outcomes included the incidence of acute kidney injury ( AKI ) , change in serum creatinine and serum chloride levels , and mortality . RESULTS Seventy patients were recruited , with 34 in the NS group and 33 in the PL-148 group available for analysis . Baseline characteristics of study patients were well balanced ; the mean ages were 64 and 62 years , respectively , and nearly two-thirds of the patients in each group were men . The median Acute Physiology and Chronic Health Evaluation III scores were 64 for the NS group ( interquartile range [ IQR ] , 48 - 73 ) and 55 for the PL-148 group ( IQR , 44 - 81 ) . After treatment , there was no significant difference in the worst ( most negative ) median BE between the NS and PL-148 groups ( -4 mEq/L [ IQR , -7 to -2 mEq/L ] v -3 mEq/L [ IQR , -7 to 2 mEq/L ] ; P = 0.42 ) . Chloride levels were significantly higher with NS therapy ( median , 111 mmol/L [ IQR , 108 - 116 mmol/L ] v 108 mmol/L [ IQR , 106 - 110 mmol/L ] ; P = 0.01 ) . There was no significant difference in the incidence of AKI ( P = 0.48 ) , peak creatinine levels ( P = 0.92 ) or ICU or hospital mortality between the two groups . CONCLUSIONS In our exploratory , double-blind , r and omised controlled trial , when compared with NS , PL-148 did not significantly increase BE values in critically ill patients requiring fluid resuscitation , but decreased peak chloride concentrations Introduction We sought to investigate whether the use of balanced solutions reduces the incidence of hyperchloraemic acidosis without increasing the risk for intracranial hypertension in patients with severe brain injury . Methods We conducted a single-centre , two-arm , r and omised , double-blind , pilot controlled trial in Nantes , France . Patients with severe traumatic brain injury ( Glasgow Coma Scale score ≤8 ) or subarachnoid haemorrhage ( World Federation of Neurosurgical Society grade III or higher ) who were mechanically ventilated were r and omised within the first 12 hours after brain injury to receive either isotonic balanced solutions ( crystalloid and hydroxyethyl starch ; balanced group ) or isotonic sodium chloride solutions ( crystalloid and hydroxyethyl starch ; saline group ) for 48 hours . The primary endpoint was the occurrence of hyperchloraemic metabolic acidosis within 48 hours . Results Forty-two patients were included , of whom one patient in each group was excluded ( one consent withdrawn and one use of forbidden therapy ) . Nineteen patients ( 95 % ) in the saline group and thirteen ( 65 % ) in the balanced group presented with hyperchloraemic acidosis within the first 48 hours ( hazard ratio = 0.28 , 95 % confidence interval
Output:
| Conclusion BCs , especially the Plasma-Lyte , are presumably the best choice for most critically ill patients who need fluid resuscitation .
Meanwhile , the use of H-HES was associated with an increased incidence of AKI and risk of receiving RRT . |
MS210883 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: Background Neonatal respiratory distress syndrome , as a consequence of preterm birth , is a major cause of early mortality and morbidity . The withdrawal of progesterone , either actual or functional , is thought to be an antecedent to the onset of labour . There remains limited information on clinical ly relevant health outcomes as to whether vaginal progesterone may be of benefit for pregnant women with a history of a previous preterm birth , who are at high risk of a recurrence . Our primary aim was to assess whether the use of vaginal progesterone pessaries in women with a history of previous spontaneous preterm birth reduced the risk and severity of respiratory distress syndrome in their infants , with secondary aims of examining the effects on other neonatal morbidities and maternal health and assessing the adverse effects of treatment . Methods Women with a live singleton or twin pregnancy between 18 to < 24 weeks ’ gestation and a history of prior preterm birth at less than 37 weeks ’ gestation in the preceding pregnancy , where labour occurred spontaneously or in association with cervical incompetence or following preterm prelabour rupture of the membranes , were eligible . Women were recruited from 39 Australian , New Zeal and , and Canadian maternity hospitals and assigned by r and omisation to vaginal progesterone pessaries ( equivalent to 100 mg vaginal progesterone ) ( n = 398 ) or placebo ( n = 389 ) . Participants and investigators were masked to the treatment allocation . The primary outcome was respiratory distress syndrome and severity . Secondary outcomes were other respiratory morbidities ; other adverse neonatal outcomes ; adverse outcomes for the woman , especially related to preterm birth ; and side effects of progesterone treatment . Data were analysed for all the 787 women ( 100 % ) r and omised and their 799 infants . Findings Most women used their allocated study treatment ( 740 women , 94.0 % ) , with median use similar for both study groups ( 51.0 days , interquartile range [ IQR ] 28.0–69.0 , in the progesterone group versus 52.0 days , IQR 27.0–76.0 , in the placebo group ) . The incidence of respiratory distress syndrome was similar in both study groups—10.5 % ( 42/402 ) in the progesterone group and 10.6 % ( 41/388 ) in the placebo group ( adjusted relative risk [ RR ] 0.98 , 95 % confidence interval [ CI ] 0.64–1.49 , p = 0.912)—as was the severity of any neonatal respiratory disease ( adjusted treatment effect 1.02 , 95 % CI 0.69–1.53 , p = 0.905 ) . No differences were seen between study groups for other respiratory morbidities and adverse infant outcomes , including serious infant composite outcome ( 155/406 [ 38.2 % ] in the progesterone group and 152/393 [ 38.7 % ] in the placebo group , adjusted RR 0.98 , 95 % CI 0.82–1.17 , p = 0.798 ) . The proportion of infants born before 37 weeks ’ gestation was similar in both study groups ( 148/406 [ 36.5 % ] in the progesterone group and 146/393 [ 37.2 % ] in the placebo group , adjusted RR 0.97 , 95 % CI 0.81–1.17 , p = 0.765 ) . A similar proportion of women in both study groups had maternal morbidities , especially those related to preterm birth , or experienced side effects of treatment . In 9.9 % ( 39/394 ) of the women in the progesterone group and 7.3 % ( 28/382 ) of the women in the placebo group , treatment was stopped because of side effects ( adjusted RR 1.35 , 95 % CI 0.85–2.15 , p = 0.204 ) . The main limitation of the study was that almost 9 % of the women did not start the medication or forgot to use it 3 or more times a week . Conclusions Our results do not support the use of vaginal progesterone pessaries in women with a history of a previous spontaneous preterm birth to reduce the risk of neonatal respiratory distress syndrome or other neonatal and maternal morbidities related to preterm birth . Individual participant data meta- analysis of the relevant trials may identify specific women for whom vaginal progesterone might be of benefit . Trial registration Current Clinical Trials IS RCT N20269066 OBJECTIVE The aim of this study was to compare perinatal outcomes of patients with second-trimester ultrasonographic evidence of preterm dilatation of the internal os treated with cerclage versus those of patients not treated with cerclage . STUDY DESIGN From May 1998 through June 1999 patients with ultrasonographic evidence of preterm dilatation of the internal os between 16 and 24 weeks ' gestation were r and omly assigned to receive a McDonald cerclage or no cerclage . Before r and om assignment all patients underwent amniocentesis and urogenital cultures and then received 48 hours of therapy with indomethacin and antibiotics . After treatment each patient was followed up as an outpatient with bed rest and weekly ultrasonographic evaluation . RESULTS Of the 61 patients 31 were r and omly assigned to cerclage and 30 were r and omly assigned to no cerclage . There were no differences between groups with respect to maternal demographic characteristics , risk factors for preterm birth , cervical measurements , rescue procedures , readmission , chorioamnionitis , and abruptio placentae . The mean gestational age at delivery ( 33.5 + /- 6.3 weeks ) and the perinatal death rate ( 12 . 9 % ) in the cerclage group were similar to the mean gestational age at delivery ( 34.7 + /- 4.7 weeks ; P = .4 ) and the perinatal death rate ( 10.0 % ; P = .9 ) in the no-cerclage group . CONCLUSION Treatment with McDonald cerclage of preterm dilatation of the cervix detected ultrasonographically during the second trimester did not improve perinatal outcomes Objective . To assess efficacy and tolerability of vaginal compared with intramuscular progesterone in reducing the rate of recurrent preterm birth before 34 weeks of gestation . Design . Prospect i ve r and omized study . Setting . Obstetrics and Gynecology Department , Armed Forces Hospital Southern Region , Kingdom of Saudi Arabia . Sample . Five‐hundred and eighteen women with a prior history of preterm birth . Methods . Women were r and omized to receive either 90 mg of vaginal progesterone gel once daily or 250 mg of intramuscular progesterone weekly . Treatment began between 14 and 18 weeks of gestation and continued until 36 complete weeks of gestation , delivery or the occurrence of premature rupture of membranes . Main outcome measures . The primary outcome measure was delivery before 34 weeks of gestation . The secondary outcome measures were PTB between 34 and 37 weeks of gestation and neonatal outcomes including birthweight , neonatal death , and the need for admission to the neonatal intensive care unit . Results . The baseline characteristics of the study participants were similar . Two‐hundred and thirty‐eight ( 94.1 % ) patients in the vaginal group and 226 ( 90.8 % ) patients in the intramuscular group were compliant with their medications . Vaginal progesterone was associated with a lower percentage of deliveries before 34 weeks of gestation than the intramuscular preparation ( p= 0.02 ) . This association was also observed at 28 and 32 weeks of gestation ( p= 0.04 ) . Adverse effects were reported in 14.1 % of patients in the intramuscular group , but in only 7.5 % of patients in the vaginal group ( p= 0.017 ) . Conclusions . Vaginal progesterone was more effective than intramuscular progesterone for the prevention of preterm birth and had fewer adverse effects OBJECTIVE To determine the effectiveness of cerclage pessary in the prevention of preterm birth in asymptomatic Chinese women with a short cervix at 20 to 24 weeks . METHODS Low-risk women carrying singleton pregnancies were screened with transvaginal ultrasound , and those with a cervical length < 25 mm at 20 to 24 weeks were recruited into a r and omized controlled trial , comparing the prophylactic use of cerclage pessary with expectant management . The analysis was by intent-to-treat . The primary outcome measure was preterm delivery before 34 weeks . RESULTS Among 4438 screened women , 203 women ( 4.6 % ) met the inclusion criteria and 108 ( 58 % ) consented for the study . A total of 53 and 55 women were allocated to pessary and control groups , respectively . There was no difference in background demographics , including the mean cervical length ( 19.6 mm versus 20.5 mm ) and the mean gestational age at r and omization ( both 21.9 weeks ) . Delivery before 34 weeks occurred in 9.4 % and 5.5 % ( p = 0.46 ) in the pessary and the control groups , respectively . No differences in major side effects were noted between the groups . CONCLUSION In our population , < 5 % had a cervical length of less than 25 mm at 20 to 24 weeks ' gestation . The prophylactic use of cerclage pessary did not reduce the rate of preterm delivery before 34 weeks Background Preterm birth is a worldwide health concern due to its various negative consequences . Therefore , the prevention of preterm birth is a top priority for healthcare systems in all countries . Objective To compare the effectiveness of vaginal versus intramuscular progesterone in the prevention of preterm delivery . Methods This r and omized clinical trial was conducted at Shahid Sadoughi Hospital in Yazd , Iran , from November 21 , 2012 to January 20 , 2015 . Seventy-eight pregnant women with singleton pregnancy and one risk factor of preterm delivery were included in the study . The subjects were assigned r and omly to two groups , with group one receiving Cyclogest and group two receiving 17-α hydroxyprogesterone caproate . Subsequently , we analyzed drug complications during pregnancy , delivery time , neonatal outcomes , and patients ’ satisfaction among the two groups . The data were analyzed using SPSS version 16 . We used descriptive statistics , chi-squared , t-test , and ANOVA for the analyses of primary and secondary outcomes . Results Among the 39 births in group one , 33.3 % occurred preterm , and , among the 39 births in group two , 30.7 % occurred preterm ( < 37 weeks ) . The mean gestational ages at delivery in groups 1 and 2 were 37.07 ± 2.23 and 36.81 ± 2.77 weeks , respectively ( p = 0.765 ) . Other variables were not significantly different between the two groups , including birth weight ( p = 0.745 ) , Apgar scores for the first and fifth minutes ( p = 0.574 , 0.630 ) , length of stay in the neonatal intensive care unit ( NICU ) when the newborns needed hospitalization ( p = 0.358 ) , and the patients ’ satisfaction with the drugs that were used ( p = 0.615 ) . Conclusions In this study , vaginal progesterone and intramuscular progesterone had the same levels of effectiveness , safety and acceptance by patients in the prevention of preterm delivery . Therefore , both can be used for this purpose in clinical practice s , but more studies are needed Background : Preterm birth is the major cause of neonatal mortality and morbidity . Objective : The aim of this study was to evaluate the effect of prophylactic vaginal progesterone on decreasing preterm birth rate and neonatal complications in a high-risk population . Material s and Methods : A r and omized , double-blind , placebo-controlled study was performed on 100 high-risk singleton pregnancies . Vaginal suppository progesterone ( 400 mg ) or placebo was administered daily between 16 - 22 wks to 36 wks of gestation . Progesterone ( n=50 ) and placebo ( n=50 ) groups were compared for incidence of preterm delivery and neonatal complications . Results : The preterm birth rate was 52 % . Preterm birth rate before the 37 wks of gestation ( 68 % vs. 36 % : RR=1.89 , 95 % CI : 1.25 - 2.86 ) and also before the 34 wks of gestation ( 42 % vs. 18 % : RR=2.33 , 95 % CI : 1.19 - 4.58 ) in placebo group was significantly higher than progesterone group . Our study also showed that the administration of vaginal progesterone was associated with a significant reduction in the risk of birth weight ≤2500 gr , the rates of respiratory distress syndrome ( RDS ) and admission to the Neonatal Intensive Care Unit ( NICU ) in the progesterone group when compared with the placebo group . However , there was no significant difference between the two groups in terms of neonatal death , days of admission in NICU , intra
Output:
| CONCLUSIONS Vaginal progesterone was the only intervention with consistent effectiveness for preventing preterm birth in singleton at-risk pregnancies overall and in those with a previous preterm birth .
TWEETABLE ABSTRACT In up date d NMA , vaginal progesterone consistently reduced PTB in overall at-risk pregnancies and in women with previous PTB |
MS210884 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: Nursing documentation is an important part of clinical documentation . However , documentation of the nursing process is frequently lacking quality . There are high expectations that computer support in nursing documentation will help improve documentation quality . This study aim ed to examine whether the introduction of a computer based nursing documentation system can improve documentation quality . A prospect i ve intervention study was conducted on 4 wards of the University Medical Center Heidelberg over a period of 18 months . Two wards in the Psychiatric University Medical Center Heidelberg were involved in the research study , as well as a dermatological and a pediatric ward . The results of the study show a significant improvement of documentation quantity and quality on three of the four wards . Positive aspects include completeness of documentation on the nursing process , formal aspects and subjective quality improvement by the nurses . Negative aspects were mainly associated with the contents of the care plans At an antenatal clinic in St. Thomas 's Hospital , London , 246 expectant mothers were r and omly allocated to hold either their own maternity case notes or the st and ard co-operation card . Information was collected on three occasions during their care on attitudes and health behaviour . Clinical outcomes were recorded and the effects of the two systems on clinic administration were observed . More of the notes group expressed satisfaction with most aspects of their care and delivery and significantly more of the notes group felt well informed and satisfied with their companion during labour . There were no differences in clinical outcomes between the two groups except that , for no identifiable systematic reason , there were more assisted deliveries among the notes group . A number of administrative advantages result ed from mothers holding their own notes and although initial reservations were found amongst professional staff interviewed at the start of the study , the results proved persuasive and the practice of giving mothers their own notes is now to be extended throughout the department Despite the widespread use of home based child health records of varying complexity in Engl and , there is a notable absence of their evaluation . Such a record booklet developed in the West Lambeth Health Authority has been used by parents , doctors , and community nurses to build up an independent chronological record of a child 's birth statistics , health , growth , immunisation , development checks , and contacts with health services . A r and omised controlled evaluation of the record , analyses of entries in it , and a survey of the views of mothers and health professionals using the record have been carried out . The need for such a record was confirmed by those question ed and analyses of entries in the booklet helped to modify and improve it . The evaluation was unable to show , however , any effect of the record on immunisation and developmental assessment service uptake . Its value in improving communication between the numerous health and other care agencies was dependent on its proper use OBJECTIVE In intensive care units ( ICUs ) , patient outcome depends on quality of nutritional support . We investigated the effect of computerized information systems ( CISs ) on quality of nutritional support by comparing two ICUs with or without CIS and burned patients before and after CIS implementation . METHODS Part 1 was a 2-wk prospect i ve survey in two units of a surgical ICU : unit A ( 11 beds ) without CIS and unit B ( four beds ) with CIS . Part 2 consisted of two 18-mo periods in burn patients before and after CIS implementation . Nurses and doctors belonged to the same team ; procedures were identical . A computer page was configured to retrieve data related to nutritional support . RESULTS A total of 1313 ICU days were analyzed in 109 patients . Patients ' characteristics were similar in parts 1 and 2 . In part 1 , nutritional support was required 38 % of days . Nutritional route was similar but data were more frequently missing in unit A. Energy delivery was higher with CIS but below target values in both units ( 31+/-11 % of target in unit A , 77+/-4 % in unit B ) . Computations were incomplete and time consuming for unit A versus B ( 11+/-2 versus 2+/-1 min/patient , P<0.0001 ) . In part 2 , in the 54 burn patients , use of postpyloric feeding tubes and energy delivery increased with CIS , result ing in less weight loss . CONCLUSION Computerized information systems favored st and ardization of nutritional care and monitoring , thus decreasing time required for writing and computations . Follow-up was improved and nutrient delivery was closer to target values , thus increasing quality of care . In burn patients , the better data visibility was associated with a significant improvement in nutrient delivery A two-month r and omized , controlled trial based on 60 patients has been performed on a ward of the Department of Psychiatry at Heidelberg University Medical Center , Germany , to investigate the influence of computer-based nursing documentation on time investment for documentation , quality of documentation and user acceptance . Time measurements , question naires , documentation analysis and interviews were used to compare patients documented with the computer-based system ( PIK group ) with the control group ( patients documented with the paper-based system ) . The results showed the advantages and disadvantages of computer-based nursing documentation . Time needed for nursing care planning was lower in the PIK group . Some formal aspects of quality were considerably better in the PIK group . On the other h and , time required for documentation of tasks and for report writing was greater in the PIK group . User acceptance increased significantly during the study . The interviews indicated a positive influence of PIK on the cooperation between nurses and physicians Abstract Objective . Nowadays , registration of patient data on paper is gradually being replaced by registration using an intensive care information system ( ICIS ) . The aim of this study was to evaluate the effect of the use of an ICIS on nursing activity . Design . R and omized controlled trial with a crossover design . Setting . An 18-bed medical-surgical ICU in a teaching hospital . Patients , nurses and interventions . During a 6week period 145 consecutive adult patients admitted to the ICU after uncomplicated cardiothoracic surgery were r and omized into two groups : for one group the documentation was carried out using a paper-based registration ( Paper ) , in the second group an ICIS was used for documentation . Measurements and results . The nursing activities for these patients were studied during two separate periods : the admission period and the registration phase ( the period directly following the admission procedure ) . The duration of the admission procedure was measured by time-motion analysis and the nursing activities in the registration phase were studied by work sampling methodology . All nursing activities during the registration phase were grouped in four main categories : patient care , documentation , unit-related and personal time . The duration of the admission procedure was longer in the ICIS group ( 18.1±4.1 versus 16.8±3.1 min , p<0.05 ) . In the registration phase , a 30 % reduction in documentation time ( Paper 20.5 % of total nursing time versus ICIS 14.4 % , p<0.001 ) , corresponding to 29 min ( per 8h nursing shift ) was achieved . This time was completely re-allocated to patient care . Conclusions . The use of the present ICIS in patients after cardiothoracic surgery alters nursing activity ; it reduces the time for documentation and increases the time devoted to patient care . Electronic Supplementary Material is available if you access this article at http://dx.org/10.1007/s00134-002-1542-9 . On that page ( frame on the left side ) , a link takes you directly to the supplementary material The purpose of this study was to determine how use of a st and ardized nomenclature for nursing diagnosis and intervention statements on the computerized nursing care plan in a long-term care ( LTC ) facility would affect patient outcomes , as well as organizational processes and outcomes . An experimental design was used to compare the effects of two methods of documentation : Computer care plan and paper care plan . Twenty participants ( 10 in each group ) were r and omly assigned to either group . No statistically significant differences were found by group for demographic data . Repeated measures ANOVA was computed for each of the study variables with type of care plan , written or computerized , as the independent variable . There were no statistically significant differences between participants , group ( care plan ) , within subjects ( across time ) , or interaction ( group and time ) effects for the dependent variables : Level of care , activities of daily living , perception of pain , cognitive abilities , number of medications , number of bowel medications , number of constipation episodes , weight , percent of meals eaten , and incidence of alteration in skin integrity . There were significantly more nursing interventions and activities on the computerized care plan , although this care plan took longer to develop at each of the three time periods . Results from this study suggest that use of a computerized plan of care increases the number of documented nursing activities and interventions , but further research is warranted to determine if this potential advantage can be translated into improved patient and organizational outcomes in the long-term care setting Abstract Objective To investigate whether a form of advance agreement for people with severe mental illness can reduce the use of inpatient services and compulsory admission or treatment . Design Single blind r and omised controlled trial , with r and omisation of individual patients . The investigator was blind to allocation . Setting Eight community mental health teams in southern Engl and . Participants 160 people with an operational diagnosis of psychotic illness or non-psychotic bipolar disorder who had experienced a hospital admission within the previous two years . Intervention The joint crisis plan was formulated by the patient , care coordinator , psychiatrist , and project worker and contained contact information , details of mental and physical illnesses , treatments , indicators for relapse , and advance statements of preferences for care in the event of future relapse . Main outcome measures Admission to hospital , bed days , and use of the Mental Health Act over 15 month follow up . Results Use of the Mental Health Act was significantly reduced for the intervention group , 13 % ( 10/80 ) of whom experienced compulsory admission or treatment compared with 27 % ( 21/80 ) of the control group ( risk ratio 0.48 , 95 % confidence interval 0.24 to 0.95 , P = 0.028 ) . As a consequence , the mean number of days of detention ( days spent as an inpatient while under a section of the Mental Health Act ) for the whole intervention group was 14 compared with 31 for the control group ( difference 16 , 0 to 36 , P = 0.04 ) . For those admitted under a section of the Mental Health Act , the number of days of detention was similar in the two groups ( means 114 and 117 , difference 3 , −61 to 67 , P = 0.98 ) . The intervention group had fewer admissions ( risk ratio 0.69 , 0.45 to 1.04 , P = 0.07 ) . There was no evidence for differences in bed days ( total number of days spent as an inpatient ) ( means 32 and 36 , difference 4 , −18 to 26 , P = 0.15 for the whole sample ; means 107 and 83 , difference −24 , −72 to 24 , P = 0.39 for those admitted ) . Conclusions Use of joint crisis plans reduced compulsory admissions and treatment in patients with severe mental illness . The reduction in overall admission was less . This is the first structured clinical intervention that seems to reduce compulsory admission and treatment in mental health services AIM To investigate whether a comprehensive strategy involving both patients and professionals , with the introduction of a diabetes passport as a key component , improves diabetes care . METHODS The first 150 consecutive patients who visited their internist for a diabetes check up at the internal medicine outpatient departments at each of nine Dutch general hospitals were included in this 1 year clustered , r and omised , controlled trial . Health care professionals attended an educational meeting about the use and dissemination of the diabetes passport which is a patient held record . They also received aggregated feedback on baseline data and personal feedback . Educational meetings were also organised for patients . Patient files were used in conjunction with question naires to determine adherence rates . Data were analysed using multilevel regression analysis . RESULTS Small but significant changes were found in mean HbA1c levels . In the intervention group , positive health changes for patients were found ( -0.3 % ) when compared to those in the control group ( + 0.2 % ) . Diastolic blood pressure improved slightly , but no changes were found in systolic blood pressure or cholesterol . Improvements were found with regard to levels of examination of patients ' feet and in patient education . CONCLUSIONS Efforts to improve professional practice involving both professionals and patients led to small improvements in HbA1c and diastolic blood pressure levels . Further study is needed to establish whether a better structured health care delivery , operating in a more supportive environment can enhance these effects Physicians were much less likely than other primary care team members to use a Web-based application to counsel patients with diabetes about behavior change To assess a policy of women holding and thus having constant access to their own obstetric records , 290 women attending a peripheral consultant clinic in Newbury , West Berkshire , were r and omly allocated to hold either their full case notes , or the more usual co‐operation card . Women holding their full records were significantly more likely to feel in control of their antenatal care ( rate ratio 1·45 ; 95 % confidence interval 1·08–1·95 ) and to feel it was easier to talk to doctors and midwives ( rate ratio 1·73 ; 95 % confidence interval 1·16‐2·59 ) . No other beneficial effects were detected . Asked about their preferences for any subsequent pregnancies , women holding their own records in the index pregnancy were more likely to say they would prefer to hold the same kind of record again in a subsequent pregnancy than were women holding a co‐operation card ( rate ratio 1·56 ; 95 % confidence interval 1·34–1·81 ) . There was no evidence of negative effects . In particular , women holding their case notes did not feel more anxious than co‐operation card holders . The policy of women holding their notes result ed in savings in elerical time , without evidence of an increase in the rate of lost notes AIM AND OBJECTIVES The aim of this paper is to present a study describing nurses ' adherence to the VIPS model by evaluating the quality of nursing assessment , and the quantity of completed nursing care plans . BACKGROUND N
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| Studies of nursing care planning systems and total nurse records demonstrated uncertain or equivocal results .
We found some limited evidence of effects on practice attributable to changes in record systems .
It is clear from the literature that it is possible to set up the r and omised trials or other quasi-experimental design s needed to produce evidence for practice . |
MS210885 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
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Input: BACKGROUND Despite its effectiveness , methadone maintenance is rarely provided in American correctional facilities . This study is the first r and omized clinical trial in the US to examine the effectiveness of methadone maintenance treatment provided to prisoners with pre-incarceration heroin addiction . METHODS A three-group r and omized controlled trial was conducted between September 2003 and June 2005 . Two hundred eleven Baltimore pre-release inmates who were heroin dependent during the year prior to incarceration were enrolled in this study . Participants were r and omly assigned to the following : counseling only : counseling in prison , with passive referral to treatment upon release ( n=70 ) ; counseling+transfer : counseling in prison with transfer to methadone maintenance treatment upon release ( n=70 ) ; and counseling+methadone : methadone maintenance and counseling in prison , continued in a community-based methadone maintenance program upon release ( n=71 ) . RESULTS Two hundred participants were located for follow-up interviews and included in the current analysis . The percentages of participants in each condition that entered community-based treatment were , respectively , counseling only 7.8 % , counseling+transfer 50.0 % , and counseling+methadone 68.6 % , p<.05 . All pairwise comparisons were statistically significant ( all ps<.05 ) . The percentage of participants in each condition that tested positive for opioids at 1-month post-release were , respectively , counseling only 62.9 % , counseling+transfer 41.0 % , and counseling+methadone 27.6 % , p<.05 , with the counseling only group significantly more likely to test positive than the counseling+methadone group . CONCLUSIONS Methadone maintenance initiated prior to or immediately after release from prison appears to have beneficial short-term impact on community treatment entry and heroin use . This intervention may be able to fill an urgent treatment need for prisoners with heroin addiction histories OBJECTIVE Both methadone and buprenorphine are effective therapy for heroin dependence . Efficacy is best documented for methadone maintenance therapy , but safety concerns limit its use . Buprenorphine offers lower overdose risk and improved access , but efficacy may be lower . The authors compared adaptive , buprenorphine-based stepped care to optimal methadone maintenance treatment . METHOD This r and omized controlled trial was undertaken 2004 - 2006 . It consisted of a 24-day uniform double-blind induction phase followed by single-blind flexible dosing based on structured clinical criteria , for a total of 6 months . Ninety-six self-referred subjects with heroin dependence were r and omly assigned to methadone or to stepped treatment initiated with buprenorphine/naloxone and escalated to methadone if needed . All subjects received intensive behavioral treatment . Primary outcome was retention in treatment . Secondary outcomes were completer analyses of problem severity ( Addiction Severity Index ) and proportion of urine sample s free of illicit drugs . RESULTS Overall , 6-month retention was 78 % . Stepped treatment and methadone maintenance therapy outcomes were virtually identical . Among completers of stepped therapy , 46 % remained on buprenorphine/naloxone . Proportion of urine sample s free of illicit opiates increased over time and ultimately reached approximately 80 % in both arms . Problem severity decreased significantly and uniformly in both arms . CONCLUSIONS A stepped treatment of heroin dependence as described here appears equally efficacious compared to optimally delivered methadone maintenance therapy . Together with prior data on the advantageous safety of buprenorphine , this suggests that broad implementation of strategies using buprenorphine as first-line treatment should be considered OBJECTIVE This study examined whether substance abuse patients self- selecting into one of three aftercare groups ( outpatient treatment only , 12-step groups only , and outpatient treatment and 12-step groups ) and patients who did not participate in aftercare differed on 1-year substance use and psychosocial outcomes . METHOD A total of 3,018 male patients filled out a question naire at intake and 1 year following discharge from treatment . Patients were classified into aftercare groups at follow-up using information from VA data bases and self-reports . RESULTS Patients who participated in both outpatient treatment and 12-step groups fared the best on 1-year outcomes . Patients who did not obtain aftercare had the poorest outcomes . In terms of the amount of intervention received , patients who had more outpatient mental health treatment , who more frequently attended 12-step groups or were more involved in 12-step activities had better 1-year outcomes . In addition , patients who kept regular outpatient appointments over a longer time period fared better than those who did not . CONCLUSIONS Encouraging substance abuse patients to regularly attend both outpatient aftercare and self-help groups may improve long-term outcomes Methadone-maintained cocaine abusers ( N = 78 ) were r and omly assigned to 1 of the following 52-week interventions : ( a ) usual care only ( UC ) , ( b ) take-home methadone doses contingent on cocaine- and opiate-negative results ( THM ) , or ( c ) take-home methadone doses for cocaine- and opiate-negative results and monetary-based vouchers contingent on cocaine-negative urinalysis results ( THM + V ) . Cocaine use was assessed by urinalysis on a thrice-weekly schedule . Frequency and enjoyability of non-drug-related activities were assessed with the Pleasant Events Schedule ( PES ) at baseline , midtreatment , and end of treatment . The THM + V condition achieved the greatest abstinence from cocaine and opiate use , followed by the THM and UC conditions . The THM + V condition had the highest PES frequency ratings at midtreatment and at the end of treatment , followed by the THM and UC conditions . There were significant differences between the THM + V and UC conditions on 10 of 12 PES-derived subscales . Analyses revealed that abstinence mediated the effects of treatment condition on frequency ratings . There were no significant differences in enjoyability ratings . These results suggest that when contingency-management interventions increase abstinence from drug abuse , they also increase engagement in non-drug-related activities in naturalistic setting BACKGROUND Contingency management ( CM ) and significant other involvement ( SO ) were evaluated as strategies to enhance treatment retention , medication compliance , and outcome for naltrexone treatment of opioid dependence . METHODS One hundred twenty-seven recently detoxified opioid-dependent individuals were r and omly assigned to 1 of 3 conditions delivered for 12 weeks : ( 1 ) st and ard naltrexone treatment , given 3 times a week ; ( 2 ) naltrexone treatment plus contingency management ( CM ) , with delivery of vouchers contingent on naltrexone compliance and drug-free urine specimens ; or ( 3 ) naltrexone treatment , CM , plus significant other involvement ( SO ) , where a family member was invited to participate in up to 6 family counseling sessions . Principal outcomes were retention in treatment , compliance with naltrexone therapy , and number of drug-free urine specimens . RESULTS First , CM was associated with significant improvements in treatment retention ( 7.4 vs 5.6 weeks ; P = .05 ) and in reduction in opioid use ( 19 vs 14 opioid-free urine specimens ; P = .04 ) compared with st and ard naltrexone treatment . Second , assignment to SO did not significantly improve retention , compliance , or substance abuse outcomes compared with CM . Significant effects for the SO condition over CM on retention , compliance , and drug use outcomes were seen only for the subgroup who attended at least 1 family counseling session . The SO condition was associated with significant ( P = .02 ) improvements in family functioning . CONCLUSION Behavioral therapies , such as CM , can be targeted to address weaknesses of specific pharmacotherapies , such as noncompliance , and thus can play a substantial role in broadening the utility of available pharmacotherapies We examined the effectiveness of a contingency management program in preventing relapse to illicit opiate use and increasing treatment retention during outpatient methadone detoxification treatment . Twenty male opiate addicts were r and omly assigned to an experimental or control group . Following a 3-week methadone stabilization period , men in both groups received identical gradual methadone dose reductions during Weeks 4 through 9 and were maintained on placebo during Weeks 10 through 13 . Beginning in Week 4 , control patients received $ 5.00 for providing a specimen twice weekly . Experimental patients received $ 10.00 and a take home methadone dose for each opiate-free urine specimen but forfeited the incentives and participated in more intensive clinic procedures when specimens were opiate positive . The contingency management procedure slowed the rate of relapse to illicit opiate use . Experimental patients provided significantly more opiate-free urines during the methadone dose reduction in Weeks 4 through 9 than control patients , although the difference between groups was no longer significant during placebo administration in Weeks 10 through 13 . In addition , the contingency management program improved treatment retention and reduced symptom complaints during the detoxification . The usefulness and limitations of contingency management procedures for outpatient methadone detoxification are discussed The number of drugs targeted may have an important influence on the ability of drug abusers to abstain during motivational incentive procedures . The authors investigated outcomes in methadone maintenance patients ( n = 58 ) , who had evidence of both opiate and cocaine use , when continuous abstinence from cocaine only ( single target ) or from both cocaine and heroin ( dual target ) was required to earn US dollars 200 in voucher incentives over a 4-day period . Study patients were equally likely to initiate and sustain abstinence from cocaine under the single- versus the dual-drug target . They were more likely to initiate opiate abstinence under the dual-target condition , demonstrating sensitivity to reinforcer effects . Results suggest that adding a second drug target does not impede short-term cocaine abstinence initiation This article presents the outcomes of an innovative vocational rehabilitation model design ed for methadone-maintained patients —the Customized Employment Supports ( CES ) model . CES counselors work intensively with a small caseload of patients to overcome the vocational as well as non-vocational barriers that hinder employment , with the goal of attaining rapid job placement . A r and omized clinical trial was implemented at two methadone treatment programs in New York City and was funded by the National Institute on Drug Abuse The study tested the hypothesis that patients assigned to the experimental ( CES ) condition would have better employment outcomes than those assigned to a control condition who received st and ard vocational counseling at the programs . The data were collected from May 2001 through April 2005 . The efficacy sample for the analysis consisted of 168 patients who completed follow-up interviews . The sample was 58 % male , 75 % minority group , average age 45 years , and in methadone treatment for an average of five years . The results supported the hypothesis for two measures of employment ; i.e. , the CES group was significantly more likely than the control group to obtain both any paid employment and informal paid employment . However , there were no significant differences for competitive employment or total earnings . The study 's limitations are noted . Implication s of the findings for the improvement of vocational rehabilitation for addiction patients are discussed Abstract The effect of giving methadone maintenance clients the opportunity to regulate their dosage and of offering take-home doses as an incentive for dose reduction was studied . Subjects ( 116 ) were r and omly assigned to one of three conditions : self-regulation ofdose ( SR-1 ) ; self-regulation of dose with incentive for reduction ( SR-2 ) and st and ard treatment ( control ) . Dependent variables were dosage and use of illicit drugs ( measured by urinalyses ) . Results for the first four months show SR-1 subjects increased dose and maintained themselves at dosages significantly greater than the SR-2 or control groups while having significantly less use of illicit opiates during certain time periods . SR-2 subjects were not different from controls . Findings indicate subjects behaved responsibly under self-regulation and that this regimen is clinical ly feasible . Nevertheless , an increase in take-home privileges was an insufficient incentive to yield major reductions in dosage in SR-2 as a group Abstract Sixty-nine methadone maintenance patients were r and omly assigned to an immediate contingency for take home or the same contingency 2 months later . The contingency required zero rate drug-seeking as measured by r and omly scheduled and monitored urinalyses once per week and full-time production activity , verified every other week . These were examined two months before and after the contingency . Significant decreases in drug-seeking and increases in productivity were associated with the contingency . Control over drug-seeking was evidence d by increased consecutive “ clean urines ” although there was little change in overall percent “ clean urines ” . Although no diversion incidents were observed , experimenters felt unrecorded diversion occurred and discuss implication s of this and other results , concluding take-home methadone can be a powerful reinforcer of rehabilitation behaviors in methadone programs AIMS The aim of this study was to examine the effect of a case management intervention on retention in opiate agonist therapy among injection drug users ( IDUs ) referred from a needle exchange program ( NEP ) . DESIGN , INTERVENTION , PARTICIPANTS , AND SETTING : A r and omized trial of a strengths-based case management intervention versus passive referral ( control ) was conducted among NEP
Output:
| For the considered outcomes , it seems that adding any psychosocial support to st and ard maintenance treatments do not add additional benefits .
Data do not show differences also for contingency approaches , contrary to all expectations . |
MS210886 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Background : In most cases of hyponatremia , arginine vasopressin secretion is inappropriately high . This placebo-controlled , r and omized , double-blind multicenter study evaluated the efficacy and safety of oral conivaptan , a V1A/V2-receptor antagonist , in patients with euvolemic or hypervolemic hyponatremia . Methods : Eighty-three patients with serum [ Na+ ] less than 130 mEq/L were stratified by volume status and r and omly assigned to placebo or conivaptan 40 or 80 mg/d for 5 days . Results : Conivaptan increased the baseline-adjusted area under the serum [Na+]-time curve significantly more than placebo ( P = 0.0001 ) . Patients given either dose of conivaptan demonstrated a serum [ Na+ ] of 4 mEq/L or greater above baseline significantly faster than those given placebo ( P < 0.001 ) and maintained that increase for a greater total time ( P = 0.0001 ) . The least squares mean change in serum [ Na+ ] from baseline to end of treatment was also significantly greater with conivaptan 40 and 80 mg/d ( 6.8 and 8.8 mEq/L , respectively ) ( P = 0.0001 ) than that with placebo ( 1.2 mEq/L ) . The percentage of patients who obtained an increase from baseline in serum [ Na+ ] of 6 mEq/L or greater or normal serum [ Na+ ] was significantly higher among patients given conivaptan 40 and 80 mg/d ( 67 % and 88 % , respectively ) than among those given placebo ( 20 % ; P < 0.001 ) . Conivaptan was well tolerated ; the most frequent adverse events were urinary tract infection , anemia , pyrexia , cardiac failure , hypotension , and hypokalemia . Conclusion : Oral conivaptan was effective in increasing serum [ Na+ ] in patients with euvolemic or hypervolemic hyponatremia and had a favorable safety profile Hyponatremia is the most common electrolyte disorder in clinical practice . Its incidence increases with age and it is associated with increased morbidity and mortality . Recently , the vaptans , antagonists of the arginine vasopressin pathway , have shown promise for safe treatment of hyponatremia . Here we evaluated the efficacy , safety , and tolerability of oral lixivaptan , a selective vasopressin V2-receptor antagonist , for treatment of nonhospitalized individuals with euvolemic hyponatremia ( sodium less than 135 mmol/l ) in a multicenter , r and omized , double-blind , placebo-controlled , phase III study . About half of the 206 patients were elderly in a chronic care setting . Of these patients , 52 were given a placebo and 154 were given 25 - 100 mg per day lixivaptan , titrated based on the daily serum sodium measurements . Compared with placebo ( 0.8 mmol/l ) , the serum sodium concentration significantly increased by 3.2 mmol/l from baseline to day 7 ( primary efficacy endpoint ) with lixivaptan treatment . A significantly greater proportion of patients that received lixivaptan achieved normal serum sodium ( 39.4 % ) by day 7 relative to placebo ( 12.2 % ) . Overall , lixivaptan was considered safe and well-tolerated . Thus , oral lixivaptan can be safely initiated in the outpatient setting and effectively increases serum sodium concentrations in out patients with euvolemic hyponatremia Purpose Tolvaptan may reduce the signs of volume overload in heart failure ( HF ) patients who experience volume overload despite using conventional diuretics . In this study , we evaluated the dose-response effects of tolvaptan on weight loss , urine volume and electrolyte excretion in furosemide-treated Japanese HF patients exhibiting volume overload . Methods In the study , 117 HF patients with volume overload on stable doses of furosemide ( ≥40 mg/day ) were treated with tolvaptan ( 15 , 30 or 45 mg ) or placebo once-daily for 7 days . Results The decrease in body weight from baseline to the day after the final dose with 15 , 30 or 45 mg tolvaptan ( –1.62 ± 1.55 , –1.35 ± 1.54 and –1.85 ± 1.10 kg , respectively ) , was significantly greater compared with that in the placebo group ( –0.53 ± 0.96 kg ) ( p < 0.05 ) . However , the decrease in body weight with tolvaptan was not significantly dose-dependent . Signs of volume overload improved at all doses of tolvaptan . Tolvaptan elicited a dose-dependent increase in urine volume and a decrease in urine osmolality , but did not affect urinary sodium or potassium excretion . Adverse reactions associated with diuresis were most frequently observed at the higher doses of tolvaptan . Conclusions Once-daily tolvaptan ( 15 , 30 or 45 mg ) was effective and tolerable as an add-on treatment to furosemide therapy in Japanese HF patients with volume overload OBJECTIVES Hyponatremia ( serum sodium [ Na+ ] concentration < 136 mmol/L ) is a prevalent and potentially life-threatening medical comorbidity for schizophrenic patients . No definitive pharmacological treatments have been established . Tolvaptan ( OPC-41061 ) , an oral non-peptide V2-receptor antagonist , was recently shown to correct hyponatremia in a diverse population of 448 hyponatremic patients . Efficacy in a sub-set of 19 schizophrenic patients with idiopathic hyponatremia included in that sample is specifically examined . METHODS Nineteen subjects were r and omly assigned to receive placebo ( n = 12 ) or tolvaptan ( n = 7 ) once daily for 30 days . Dosage adjustment was based on serum Na+ changes , initially 15 mg , titratable to 30 or 60 mg . The average daily area under the curve ( AUC ) changes in serum Na+ from baseline to Day 4 and Day 30 were co- primary end points . RESULTS Increases in serum Na+ concentrations were significantly greater with tolvaptan than placebo at Day 4 ( p = .0055 ) and at Day 30 ( p < .0001 ) . Two subjects receiving tolvaptan ( 28.6 % ) became dehydrated and experienced hypotension , and five subjects receiving placebo ( 41.7 % ) experienced symptoms associated with dilutional hyponatremia . CONCLUSIONS These results suggest that tolvaptan effectively normalizes idiopathic hyponatremia in schizophrenic patients . Clinicians are advised to carefully monitor fluid status especially at the beginning of treatment to prevent dehydration The rate of hyponatremia is higher in hospitalized cancer patients than in hospitalized patients without cancer and is associated with poor clinical outcomes . The availability of V2 receptor antagonists has been a major breakthrough in the management of hyponatremia , but its efficacy and safety in treating hyponatremia in patients with cancer is not known Hyponatremia is common and is associated with a poor prognosis . Traditional management with fluid restriction is difficult to maintain , and it is often ineffective . The objective of this study was to determine the effect of tolvaptan versus fluid restriction on serum sodium concentration . The study was a prospect i ve , multicenter , r and omized , active-controlled , open-label trial . Twenty-eight hospitalized subjects with serum sodium < 135 mmol/L were enrolled in the study . After a 2-day run-in period , subjects were r and omized 2:1 to tolvaptan alone ( n = 17 ) or fluid restriction ( 1,200 ml/day ) plus placebo ( n = 11 ) . Oral tolvaptan was started at 10 mg/day and increased to 60 mg/day as needed . Treatment was continued for up to 27 days , and follow-up continued for up to 65 days . The primary end point was the normalization of serum sodium , defined as > 135 mmol/L or a > or = 10 % increase from baseline . At the last inpatient visit , serum sodium had increased by 5.7 + /- 3.2 mmol/L in the tolvaptan group and 1.0 + /- 4.7 mmol/L in the fluid restriction group ( p = 0.0065 ) . No differences in adverse events were observed between the groups . In conclusion , tolvaptan appears to be more effective than fluid restriction at correcting hyponatremia in hospitalized subjects , without an increase in adverse events OBJECTIVE Tolvaptan , an oral antagonist of the vasopressin V(2 ) receptor , has been found to improve hyponatremia in patients with mixed etiologies . This study analyzed a subgroup of patients with the syndrome of inappropriate antidiuretic hormone secretion ( SIADH ) to evaluate the efficacy and safety of tolvaptan in this group . DESIGN AND PATIENTS Hyponatremic patients in the SALT-1 and SALT-2 studies with a diagnosis of SIADH were identified based on clinical diagnosis by individual study investigators . Subjects were r and omized to receive oral placebo ( n=52 ) or tolvaptan 15 mg daily , with further titration to 30 and 60 mg daily , if necessary , based on the response of serum [ Na(+ ) ] ( n=58 ) . RESULTS In patients with SIADH , improvement in serum [ Na(+ ) ] was significantly greater ( P<0.0001 ) with tolvaptan than placebo over the first 4 days of therapy as well as the entire 30-day study , with minimal side effects of increased thirst , dry mouth , and urination . Only 5.9 % of tolvaptan-treated patients had overly rapid correction of hyponatremia as defined by current guidelines . After discontinuation of tolvaptan , serum [ Na(+ ) ] declined to values similar to placebo . A significant positive treatment effect favoring tolvaptan on the physical component , and a near-significant trend on the mental component , was found using the SF-12 Health Survey . Tolvaptan was associated with a significantly reduced incidence of fluid restriction . CONCLUSIONS Results for the SIADH subgroup were analogous to those of the combined SALT population regarding efficacy and safety but demonstrated a greater improvement in the physical component of the SF-12 Health Survey than in the full mixed etiology SALT patient group Water retention and dilutional hyponatremia , mainly attributable to an impairment of free water excretion and increased vasopressin activity , are well-documented complications in cirrhotic patients with ascites . VPA-985 is a selective , nonpeptide , orally active , vasopressin-2-receptor antagonist . The aim of this study was to determine the pharmacodynamics , safety , and pharmacokinetics of ascending single doses ( 25 , 50 , 100 , 200 , and 300 mg ) in cirrhotic patients with ascites in a r and omized , double-blind , placebo-controlled trial . Each dose level was studied in 5 patients ( 4 active and 1 placebo ) . After an overnight fast and fluid restriction ( continued for 4 hours after dose administration ) , all patients were given placebo on baseline day and an oral suspension of VPA or placebo on the following day . VPA produced a significant dose-related increase in daily urine output ( 1,454 + /- 858 mL to 4,568 + /- 4,385 mL with VPA 300 mg ) and a dose-related decrease in urine osmolality . The free water clearance reached greater than 3 mL/min for doses 100 mg or greater . Simultaneously , significant increases in serum osmolality , sodium , and vasopressin levels were found . There was a significant increase in sodium urine excretion . VPA was rapidly absorbed and maximum serum concentrations were achieved within 1 hour after administration . Elimination half-life ranged from 9.0 hours after 100 mg to 22.6 hours after 200 mg . In conclusion , VPA induced a dose-related aquaretic response , suggesting a therapeutic potential in managing water retention in patients with liver cirrhosis with ascites PURPOSE The effect of serum sodium concentration and tolvaptan treatment on length of stay ( LOS ) in patients hospitalized with heart failure ( HF ) was evaluated . METHODS Data for this study were derived from a large , international , Phase III trial of patients hospitalized for HF . Two distinct post hoc analyses were performed , analyzing the association between serum sodium concentration and index hospitalization LOS in normonatremic patients and hyponatremic patients treated with placebo plus st and ard of care versus tolvaptan . Analysis of covariance models were constructed to adjust for potential variation in care delivery and adjusted for hyponatremia status or treatment . RESULTS Patients with a baseline serum sodium concentration of < 135 meq/L who received placebo had an adjusted mean LOS that was 3.06 days longer than did normonatremic patients ( p < 0.001 ) . More severely hyponatremic patients had an adjusted mean LOS 5.18 days longer than did normonatremic patients ( p < 0.
Output:
| Effects were generally consistent across the different agents , suggesting class effect .
In people with chronic hyponatraemia , vasopressin receptor antagonists modestly raise serum sodium concentration at the cost of a 3 % increased risk of it being rapid .
To date there is very low certainty evidence for patient-important outcomes ; the effects on mortality and health-related quality of life are unclear and do not rule out appreciable benefit or harm ; there does not appear to be an important effect on cognitive function , but hospital stay may be slightly shorter , although available data are limited . |
MS210887 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Background Patients with severe aortic stenosis and coexisting non-cardiac conditions may be at high risk for surgical replacement of the aortic valve or even be no c and i date s for surgery . In these patients , transcatheter aortic valve implantation ( TAVI ) is suggested as an alternative . Results of the PARTNER ( Placement of AoRTic TraNscathetER Valve ) trial comparing the clinical effectiveness of TAVI with surgical valve replacement and st and ard therapy were published . The authors assessed the cost-effectiveness of TAVI in Belgium . Methods A Markov model of incremental costs , effects ( survival and quality of life ) and incremental cost-effectiveness of TAVI was developed . The impact on survival , number of events and quality of life was based on the PARTNER trial . Costs per event were context specific . Results In high-risk operable patients , even if the minor differences in 30-day and 1-year mortality are taken into account , the incremental cost-effectiveness ratio ( ICER ) remains on average above € 750 000 per quality -adjusted life-year ( QALY ) gained ( incremental cost : € 20 400 ; incremental effect : 0.03 QALYs ) . In inoperable patients , an ICER of € 44 900 per QALY ( incremental cost : € 33 200 ; incremental effect : 0.74 QALYs ) is calculated , including a life-long extrapolation of the mortality benefit . This result was sensitive to the assumed time horizon . The subgroup of anatomically inoperable patients had better outcomes than medically inoperable patients , with ICERs decreasing more than € 10 000/QALY . Conclusions It is inappropriate to consider reimbursement of TAVI for high-risk operable patients . Reimbursing TAVI in inoperable patients in essence is a political decision . From an economic perspective , it would be prudent to first target patients that are inoperable because of anatomical prohibitive conditions . In the search for evidence , the authors identified non-published negative results from a r and omised controlled TAVI trial . The study sponsor should be more willing to share this information to allow balanced evaluations and policy recommendations . Payers should require these data before taking reimbursement decisions Objective To determine the cost-effectiveness of transcatheter aortic valve implantation ( TAVI ) compared with surgical aortic valve replacement ( SAVR ) in a high-risk aortic stenosis ( AS ) population . Design A cost-utility analysis employing the National Institute of Clinical Excellence ( NICE ) reference case design for technology appraisal s. Setting The perspective of the UK National Health Service . Patients Utility data from a UK high-risk AS population . TAVI and SAVR effectiveness was taken from the PARTNER A r and omised controlled trial . Main outcome measures Costs modelled over a 10 year horizon using a Markov model . Incremental cost-effectiveness ratios and cost-effectiveness acceptability curve were calculated with reference to the NICE willingness to pay per quality adjusted life year ( QALY ) gain threshold . Deterministic and probabilistic sensitivity analyses performed . Results Despite greater procedural costs ( £ 16 500 vs £ 9,256 ) , TAVI was cost-effective compared with SAVR over the 10 year model horizon ( costs £ 52 593 vs £ 53 943 and QALYs 2.81 vs 2.75 ) , indicating that TAVI dominated SAVR . This appeared to be due to greater postsurgical costs , related to the length and cost of hospital stay . The results appeared robust to a number of deterministic sensitivity and probabilistic analyses . The cost-effectiveness acceptability curve indicated that at the NICE £ 20 000 willingness to pay threshold per QALY gained , TAVI had a 64.6 % likelihood of being cost-effective , compared with 35.4 % for SAVR . Conclusions TAVI is likely to be a cost-effective treatment for high-risk patients with AS compared with the reference st and ard of SAVR . However , uncertainty surrounding the long-term outcomes for TAVI patients remains ; this could have a substantive impact on estimates of cost-effectiveness Abstract Objective : The only effective treatment for severe aortic stenosis ( AS ) is valve replacement . However , many patients with co-existing conditions are ineligible for surgical valve replacement , historically leaving medical management ( MM ) as the only option which has a poor prognosis . Transcatheter Aortic Valve Replacement ( TAVR ) is a less invasive replacement method . The objective was to estimate cost-effectiveness of TAVR via transfemoral access vs MM in surgically inoperable patients with severe AS from the Canadian public healthcare system perspective . Methods : A cost-effectiveness analysis of TAVR vs MM was conducted using a deterministic decision analytic model over a 3-year time horizon . The PARTNER r and omized controlled trial results were used to estimate survival , utilities , and some re source utilization . Costs included the valve replacement procedure , complications , hospitalization , outpatient visits/tests , and home/nursing care . Re sources were valued ( 2009 Canadian dollars ) using costs from the Ontario Case Costing Initiative ( OCCI ) , Ontario Ministry of Health and Long-Term Care and Ontario Drug Benefits Formulary , or were estimated using relative costs from a French economic evaluation or clinical experts . Costs and outcomes were discounted 5 % annually . The effect of uncertainty in model parameters was explored in deterministic and probabilistic sensitivity analysis . Results : The incremental cost-effectiveness ratio ( ICER ) was $ 32,170 per quality -adjusted life year ( QALY ) gained for TAVR vs MM . When the time horizon was shortened to 24 and 12 months , the ICER increased to $ 52,848 and $ 157,429 , respectively . All other sensitivity analysis returned an ICER of less than $ 50,000/QALY gained . Limitations : A limitation was lack of availability of Canadian-specific re source and cost data for all re sources , leaving one to rely on clinical experts and data from France to inform certain parameters . Conclusions : Based on the results of this analysis , it can be concluded that TAVR is cost-effective compared to MM for the treatment of severe AS in surgically inoperable patients OBJECTIVE With increased life expectancy and improved technology , valve replacement is being offered to increasing numbers of elderly patients with satisfactory clinical results . By using st and ard econometric techniques , we estimated the relative cost-effectiveness of aortic valve replacement by drawing on a large prospect i ve data base at our institution . By using aortic valve replacement as an example , this introductory report paves the way to more definitive studies of these issues in the future . METHODS From 1961 to 2003 , 4617 adult patients underwent aortic valve replacement at our service . These patients were provided with a prospect i ve lifetime follow-up . As of 2005 , these patients had accumulated 31,671 patient-years of follow-up ( maximum 41 years ) and had returned 22,396 yearly question naires . A statistical model was used to estimate the future life years of patients who are currently alive . In the absence of direct estimates of utility , quality -adjusted life years were estimated from New York Heart Association class . The cost-effectiveness ratio was calculated by the patient 's age at surgery . RESULTS The overall cost-effectiveness ratio was approximately 13,528 dollars per quality -adjusted life year gained . The cost-effectiveness ratio increased according to age at surgery , up to 19,826 dollars per quality -adjusted life year for octogenarians and 27,182 dollars per quality -adjusted life year for nonagenarians . CONCLUSIONS Given the limited scope of this introductory study , aortic valve replacement is cost-effective for all age groups and is very cost-effective for all but the most elderly according to st and ard econometric rules of thumb BACKGROUND Major scores for the evaluation of procedural risk in cardiac surgery are the European system for cardiac operative risk evaluation score ( EuroSCORE ) , the Society of Thoracic Surgeons ( STS ) score , and the Parsonnet score . The aim of our study was to analyze the predictive value of these scores in " high risk " patients undergoing isolated aortic valve replacement ( AVR ) . METHODS Six hundred and fifty-two patients underwent isolated AVR from January 1999 through June 2007 . Emergency and redo operations were included ; acute endocarditis was excluded . Evaluation was performed by logistic regression analysis . Data collection was prospect i ve . RESULTS The mean logistic EuroSCORE of all patients was 8.5 + /- 7.9 % , the mean STS score was 4.4 + /- 3.9 % , and the mean logistic Parsonnet score was 9.8 + /- 8.5 % . In-hospital mortality was 2.5 % ( n = 16 ) . Freedom from all-cause death was 93.4 % at 1 year , 90.2 % at 2 years , and 75.8 % at 5 years , respectively . A total of 182 patients had a logistic EuroSCORE greater than 10 . For the group of patients with a EuroSCORE between 10 % and 20 % ( n = 130 ) the mean EuroSCORE was 13.9 + /- 2.8 % and the STS score was 6.5 + /- 3.8 % . Observed mortality was 4.6 % in this group . For the 52 patients with a logistic EuroSCORE of at least 20 ( mean 28.5 + /- 10.3 % , STS score 10.1 + /- 7.3 % ) the observed mortality was 3.9 % ( n = 2 ) . By stepwise logistic regression , none of the EuroSCORE variables could be identified as an independent predictor in the " high- risk " group . CONCLUSIONS The logistic EuroSCORE was primarily created to allow patient grouping for the total spectrum of cardiac surgery . In patients undergoing isolated AVR , the EuroSCORE highly overestimates mortality , whereas the STS score seems to be actually more suitable in assessing perioperative mortality for these patients BACKGROUND The incremental cost-effectiveness of transapical transcatheter aortic valve implantation ( TAVI ) is ill-defined in high-risk patients where aortic valve replacement ( AVR ) is an option , and has not been ascertained outside a r and omized controlled trial . METHODS We developed a Markov model to examine the progression of patients between health states , defined as peri- and post-procedural , post-complication , and death . The mean and variance of risks , transition probabilities , utilities and cost of transapical TAVI , high-risk AVR , and medical management were derived from analysis of relevant registries . Outcome and cost were derived from 10,000 simulations . Sensitivity analyses further evaluated the impact of mortality , stroke , and other commonly observed outcomes . RESULTS In the reference case , both transapical TAVI and high-risk AVR and TAVI were cost-effective when compared to medical management ( $ 44,384/QALY and $ 42,637/QALY , respectively ) . Transapical TAVI failed to meet accepted criteria for incremental cost-effectiveness relative to AVR , which was the dominant strategy . In sensitivity analyses , the mortality rates related to the two strategies , the utilities post-AVR and post-transapical TAVI , and the cost of transapical TAVI , were the main drivers of model outcome . CONCLUSION Transapical TAVI did not satisfy current metrics of incremental cost-effectiveness relative to high-risk AVR in the reference case . However , it may provide net health benefits at acceptable cost in selected high-risk patients among whom AVR is the st and ard intervention BACKGROUND Many patients with severe aortic stenosis and coexisting conditions are not c and i date s for surgical replacement of the aortic valve . Recently , transcatheter aortic-valve implantation ( TAVI ) has been suggested as a less invasive treatment for high-risk patients with aortic stenosis . METHODS We r and omly assigned patients with severe aortic stenosis , whom surgeons considered not to be suitable c and i date s for surgery , to st and ard therapy ( including balloon aortic valvuloplasty ) or transfemoral transcatheter implantation of a balloon-exp and able bovine pericardial valve . The primary end point was the rate of death from any cause . RESULTS A total of 358 patients with aortic stenosis who were not considered to be suitable c and i date s for surgery underwent r and omization at 21 centers ( 17 in the United States ) . At 1 year , the rate of death from any cause ( Kaplan – Meier analysis ) was 30.7 % with TAVI , as compared with 50.7 % with st and ard therapy ( hazard ratio with TAVI , 0.55 ; 95 % confidence interval [ CI ] , 0.40 to 0.74 ; P<0.001 ) . The rate of the composite end point of death from any cause or repeat hospitalization was 42.5 % with TAVI as compared with 71.6 % with st and ard therapy ( hazard ratio , 0.46 ; 95 % CI , 0.35 to 0.59 ; P<0.001 ) . Among survivors at 1 year , the rate of cardiac symptoms ( New York Heart Association class III or IV ) was lower among patients who had undergone TAVI than among those who had received st and ard therapy ( 25.2 % vs. 58.0 % , P<0.001 ) . At 30 days , TAVI , as compared
Output:
| Mechanical mitral valve replacement ( MVR ) had the lowest costs per success compared to mitral valve repair and biological MVR . |
MS210888 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Abstract In March 2002 The Northern Clinical Research Centre , Epping implemented a six week outpatient based pulmonary rehabilitation program for people with COPD . This paper outlines the establishment , underlying philosophy , marketing , coordination and personnel necessary for a successful program , as identified by the research centre . Barriers to program participation were identified and steps to minimize these were implemented . The longitudinal evaluation of this program in a prospect i ve manner enables the duration of the effect of this adjunctive therapy to be examined in the Australian population . One hundred and thirty six participants have graduated from the research centre 's pulmonary rehabilitation program since the program commenced in 2002 . This paper review s the process of implementing a pulmonary rehabilitation program in the northern corridor of Melbourne Aims : The main objective of this study was to investigate whether a comprehensive self-management programme , including self-treatment guidelines for exacerbations and a fitness programme , is an efficient treatment option for chronic obstructive pulmonary disease ( COPD ) patients . Method : We r and omly allocated 248 COPD patients to either self-management ( 127 ) or usual care ( 121 ) . Data on preference-based utilities ( EuroQol-5D ) , health-related quality of life ( HRQoL ) , health-care re source use and productivity losses associated with exacerbations were prospect ively collected . Quality -adjusted life years ( QALYs ) were calculated . The economic analysis took the societal perspective and the observation period was one year . Results : As we observed that the groups were equally effective in terms of QALYs and HRQoL ( SGRQ ) , we described a cost minimization analysis only . The self-management programme-specific costs amounted to 6642 per patient . In the base-case cost analysis , the incremental cost difference amounted to 838 per patient per year in favour of usual care . When only direct medical costs were included , the incremental annual cost of self-managementrelative to usual care was 179 per person per year . If time costs for the fitness programme were set to zero , the costs for self-management diminished to 542 . Sensitivity analysis showed that these results were robust to changes in the underlying assumptions . Conclusion : We conclude that the COPE self-management programme is not an efficient treatment option for moderate to severe COPD patients who rate their HRQoL relatively high . The programme was twice as expensive as usual care and had no measurable beneficial effects on QALYs or On the basis of the beneficial health effects of self-management in the treatment of other chronic diseases like asthma it might be expected that the active participation of COPD - patients in the management of their disease may reduce the burden of the disease . Self-management of COPD includes sufficient coping behaviour , compliance with inhaled medication , attention to changes in the severity of the disease , adequate inhalation technique , and self adjustment of the medication in case of exacerbations . The results of a pilot study on the effects of self-management in COPD suggest a reduction of morbidity due to COPD . The definite place of self-management in the treatment of COPD has to established by larger , prospect i ve , controlled trials This study tested the hypothesis that severity of respiratory disability may affect the outcome of pulmonary rehabilitation . In this r and omized , controlled study , 126 patients with chronic obstructive pulmonary disease ( COPD ) were stratified for dyspnoea using the Medical Research Council ( MRC ) dyspnoea score into MRC3/4 ( Moderate ) ( n=66 ) and MRC 5 ( Severe ) dyspnoeic ( n=60 ) groups . The patients were r and omly assigned to an eight week programme of either exercise plus education ( Exercise group ) or education ( Control group ) . Education and exercise programmes for the moderately dyspnoeic patients were carried out in a hospital outpatient setting . Severely dyspnoeic patients were all treated at home . Those in the Exercise group received an individualized training programme . There was a significant improvement in shuttle walking distance in the moderate dyspnoeic group , who received exercise training ; baseline ( mean+/-SEM ) 191+/-22 m , post-rehabilitation 279+/-22 m ( p<0.001 ) . There was no improvement in exercise performance in the severely dyspnoeic patients receiving exercise . Neither group of control patients improved . Health status , assessed by the Total Chronic Respiratory Disease Question naire score , increased in the moderately dyspnoeic patients receiving exercise from 80+/-18 to 95+/-17 ( p<0.0001 ) after rehabilitation . Much smaller changes were seen in the other three groups . Improvement in exercise performance and health status in patients with chronic obstructive pulmonary disease after an exercise programme depends on the initial degree of dyspnoea The aim of the present study was to assess the long-term impact on hospitalisation of a self-management programme for chronic obstructive pulmonary disease ( COPD ) patients . A multicentre , r and omised clinical trial was carried out involving 191 COPD patients from seven hospitals . Patients who had one or more hospitalisations in the year preceding study enrolment were assigned to a self-management programme “ Living Well with COPD TM ” or to st and ard care . Hospitalisations from all causes were the primary outcome and were documented from the provincial hospitalisation data base ; emergency visits were recorded from the provincial health insurance data base . Most patients were elderly , not highly educated , had advanced COPD ( reflected by a mean forced expiratory volume in one second of 1 L ) , and almost half reported a dyspnoea score of 5/5 ( modified Medical Research Council ) . At 2 years , there was a statistically significant and clinical ly relevant reduction in all-cause hospitalisations of 26.9 % and in all-cause emergency visits of 21.1 % in the intervention group as compared to the st and ard-care group . After adjustment for the self-management intervention effect , the predictive factors for reduced hospitalisations included younger age , sex ( female ) , higher education , increased health status and exercise capacity . In conclusion , in this study , patients with chronic obstructive pulmonary disease who received educational intervention with supervision and support based on disease-specific self-management maintained a significant reduction in hospitalisations after a 2-year period Abstract Objective : To assess whether sharing the uncertainty of the value of antibiotics for acute bronchitis in the form of written and verbal advice affects the likelihood of patients taking antibiotics . Design : Nested , single blind , r and omised controlled trial . Setting : Three suburban general practice s in Nottingham . Participants : 259 previously well adults presenting with acute bronchitis . Intervention : In group A , 212 patients were judged by their general practitioner not to need antibiotics that day but were given a prescription to use if they got worse and st and ard verbal reassurance . Half of them ( 106 ) were also given an information leaflet . All patients in group B ( 47 ) were judged to need antibiotics and were given a prescription and encouraged to use it . Main outcome measures : Antibiotic use in the next two weeks . Reconsultation for the same symptoms in the next month . Results : In group A fewer patients who received the information leaflet took antibiotics compared with those who did not receive the leaflet ( 49 v 63 , risk ratio 0.76 , 95 % confidence interval 0.59 to 0.97 , P=0.04 ) . Numbers reconsulting were similar ( 11 v 14 ) . In group B , 44 patients took the antibiotics . Conclusion : Most previously well adults with acute bronchitis were judged not to need antibiotics . Reassuring these patients and sharing the uncertainty about prescribing in a information leaflet supported by verbal advice is a safe strategy and reduces antibiotic use . What is already known on this topic Most adults with acute bronchitis who consult their general practitioner will receive antibiotics For most patients antibiotics do not modify the natural course of the symptoms The widespread belief among patients that infection is the problem and antibiotics the solution has considerable influence on prescribing by general practitioners , even when they judge that antibiotics are not definitely indicated What this study adds General practitioners judged that about four in five adults with acute bronchitis did not definitely need antibiotics on the day they consulted Antibiotic use was reduced by a quarter in such patients , who received verbal and written information and reassurance in addition to a prescription for antibiotics Sharing with the patient the uncertainty about the decision to prescribe seems safe and The aim of this study was to assess the effects of a comprehensive self-management intervention on health-related quality of life ( HRQoL ) , symptoms and walking distance in patients with stable moderately severe chronic obstructive pulmonary disease ( COPD ) . This study was part of the overall COPD study of the Dept of Pulmonary Medicine , Enschede , which consisted of an inhaled corticosteroid ( ICS ) trial and a self-management trial . After the ICS trial , all patients were r and omised again to a self-management and a control group . The self-management intervention consisted of askill-oriented patient education programme and a near-home fitness programme , on top of usual care . The control group received usual care by the treating chest physician . HRQoL was measured by the St George ’s Respiratory Question naire ( SGRQ ) and walking distance by the 6‐min walking test . Patients recorded their symptoms in diaries and grade d their health status from 1–10 in a weekly report . Altogether , 248 COPD patients were r and omly allocated to either an intervention ( 127 ) or control ( 121 ) group . No differences in the SGRQ scores within and between both groups were observed over 1 yr . Similarly , no differences in symptom scores and 6‐min walking distance were found within and between groups . The intervention group reported more exacerbations than the control group . The majority ( 69 % ) of the exacerbations in the intervention group were self-treated at home . This study failed to show positive effects of a self-management programme among moderately severe chronic obstructive pulmonary disease patients This study assessed the long-term efficacy of adding self-treatment guidelines to a self-management programme for adults with asthma . In this prospect i ve r and omized controlled trial , 245 patients with stable , moderate to severe asthma were included . They were r and omized into a self-treatment group ( group S ) and a control group ( group C ) . Both groups received self-management education . Additionally , group S received self-treatment guidelines based on peak expiratory flow ( PEF ) and symptoms . Outcome parameters included : asthma symptoms , quality of life , pulmonary function , and exacerbation rate . The 2-yr study was completed by 174 patients . Both groups showed an improvement in the quality of life of 7 % . PEF variability decreased by 32 % and 29 % , and the number of outpatient visits by 25 % and 18 % in groups S and C , respectively . No significant differences in these parameters were found between the two groups . After 1 yr , patients in both groups perceived better control of asthma and had more self-confidence regarding their asthma . The latter improvements were significantly greater in group S as compared to group C. There were no other differences in outcome parameters between the groups . Individual self-treatment guidelines for exacerbations on top of a general self-management programme does not seem to be of additional benefit in terms of improvements in the clinical outcome of asthma . However , patients in the self-treatment group had better scores in subjective outcome measures such as perceived control of asthma and self-confidence than patients in the control group Seventy five patients with chronic respiratory disability were r and omised to a group visited by a respiratory health worker ( 42 ) or control group ( 33 ) . The first group was visited monthly by a respiratory nurse , who gave education and support . The effect of the intervention was assessed in terms of quality of life ( by question naires ) , the number and duration of admissions to hospital , and the number of deaths . The question naires on quality of life showed no changes in either group during the study , but nearly all of the group visited by a respiratory health worker said that they valued the visits and wished them to continue . Their knowledge about their condition also improved compared with that of the controls . The duration of stay in hospital for respiratory reasons in the group visited by a respiratory health worker was longer than that of control patients . This was explained by their being scored as more ill than the controls on admission . Fewer patients died in the group visited by a respiratory health worker than in the control group ( p = 0.11 ) . The patients in the group visited by respiratory health workers may have survived longer because they sought help rather than dying at home . If confirmed this could have implication s for the cost of their care By instructing patients in how to deal with their disease financial dem and s on health services may be reduced . 100 consecutive patients ( aged 48 to 89 ) admitted to a general medical ward in Denmark with chronic obstructive pulmonary disease ( COPD ) were allocated r and omly to receive either " personalized hospital practice " ( PHP ) , which includes training in aspects of their disease , or st and ard hospital practice . Changes in " consumption " of health services per patient from 1 year before until 1 year after the intervention admission were evaluated in 82 ( PHP group 42 , controls 40 ) patients who completed the intervention phase . Each group contained about the same percentage of asthmatics and smokers . The increase in consumption of health services after intervention was on average Kr15,298 per patient per year less in the PHP group than in the control group ( p = 0.048 , Wilcoxon test ) . Consumption of general practitioner services was significantly increased in the control group compared with the PHP group ( mean [ 95 % Cl ] Kr1346 [ 549 to 2143 ] vs -89 [ -423 to 245 ] per patient per year ; p = 0.001 , Wilcoxon test ) . These differences could not be explained by changes in smoking habits
Output:
| It is likely that self-management education is associated with a reduction in hospital admissions with no indications for detrimental effects in other outcome parameters .
This would in itself already be enough reason for recommending self-management education in COPD .
However , because of heterogeneity in interventions , study population s , follow-up time , and outcome measures , data are still insufficient to formulate clear recommendations regarding the form and contents of self-management education programmes in COPD . |
MS210889 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: AIM To establish the extent to which contrast enhancement with SonoVue in combination with quantitative evaluation of contrast-medium dynamics facilitates the detection of hepatic tumors . METHODS One hundred patients with histologically confirmed malignant or benign hepatic tumor ( maximum size 5 cm ) were analyzed . Contrast-enhanced ultrasound ( bolus injection 2.5 mL SonoVue ) was carried out with intermittent breath-holding technique using a multifrequency transducer ( 2.5 - 4 MHz ) . Native vascularization was analyzed with power Doppler . The contrast-enhanced dynamic ultrasound investigation was carried out with contrast harmonic imaging in true detection mode during the arterial , portal venous and late phases . Mechanical index was set at 0.15 . Perfusion analysis was performed by post-processing of the raw data [ time intensity curve ( TIC ) analysis ] . The cut-off of the gray value differences between tumor and normal liver tissue was established using Receiver Operating Characteristic ( ROC ) analysis 64-line multi-slice computed tomography served as reference method in all cases . Magnetic resonance tomography was used additionally in 19 cases . RESULTS One hundred patients with 59 malignant ( 43 colon , 5 breast , 2 endocrine metastases , 7 hepatocellular carcinomas and 2 kidney cancers ) and 41 benign ( 15 hemangiomas , 7 focal nodular hyperplasias , 5 complicated cysts , 2 abscesses and 12 circumscribed fatty changes ) tumors were included . The late venous phase proved to be the most sensitive for classification of the tumor type . Fifty-eight of the 59 malignant tumors were classified as true positive , and one as false negative . This result ed in a sensitivity of 98.3 % . Of the 41 benign tumors , 37 were classified as true negative and 4 as false negative , which corresponds to a specificity of 90.2 % . Altogether , 95.0 % of the diagnoses were classified as correct on the basis of the histological classification . No investigator-dependency ( P = 0.23 ) was noted . CONCLUSION The results show the possibility of accurate prediction of malignancy of hepatic tumors with a positive prognostic value of 93.5 % using advanced contrast-enhanced ultrasound . Contrast enhancement with SonoVue in combination with quantitative evaluation of contrast-medium dynamics is a valuable tool to discriminate hepatic tumors OBJECTIVE To evaluate the tolerability and safety of frovatriptan 2.5 mg in patients with migraine . BACKGROUND Frovatriptan is a new , selective serotonin agonist ( triptan ) developed for the acute treatment of migraine . Dose range-finding studies identified 2.5 mg as the dose that conferred the optimal combination of efficacy and tolerability . METHODS The tolerability and safety of frovatriptan 2.5 mg were assessed during controlled , acute migraine treatment studies , including a study that compared frovatriptan 2.5 mg with sumatriptan 100 mg , as well as a 12-month open-label study during which patients could take up to three doses of frovatriptan 2.5 mg within a 24-hour period . Safety and tolerability were assessed through the collection of adverse events , monitoring of heart rate and blood pressure performance of 12-lead electrocardiogram , hematology screen , and blood chemistry studies . RESULTS In the short-term studies , 1554 patients took frovatriptan 2.5 mg and 838 took placebo . In the 12-month study , 496 patients treated 13 878 migraine attacks . Frovatriptan was well tolerated in the short- and long-term studies with 1 % of patients in the short-term studies and 5 % of patients in the long-term study withdrawing due to lack of tolerability . The incidence of adverse events was higher in the frovatriptan-treated patients than in the patients who took placebo ( 47 % versus 34 % ) and the spectrum of adverse events was similar . When compared to sumatriptan 100 mg , significantly fewer patients taking frovatriptan experienced adverse events ( 43 % versus 36 % ; P=.03 ) and the number of adverse events was lower ( 0.62 versus 0.91 ) , there were also fewer adverse events suggestive of cardiovascular symptoms in the frovatriptan group . Analysis of the entire clinical data base ( n=2392 ) demonstrated that frovatriptan was well tolerated by the patients regardless of their age , gender , race , concomitant medication , or the presence of cardiovascular risk factors . No effects of frovatriptan on heart rate , blood pressure , 12-lead electrocardiogram , hematology screen , or blood chemistry were observed . No patient suffered any treatment-related serious adverse event . CONCLUSIONS Short- and long-term use of frovatriptan 2.5 mg was well tolerated by a wide variety of patients . Frovatriptan treatment produced an adverse events profile similar to that of placebo , and in a direct comparison study was better tolerated than sumatriptan 100 mg
Output:
| However , pathways are still not fully understood as TLR2 up-regulation was also associated to enhanced tumorigenesis .
TLR3 has a well-known protective role influencing crucial processes like angiogenesis , cell growth or proliferation .
TLR4 works as an interesting epithelial-mesenchymal transition 's inducer and a promoter of cell survival probably inducing HCC carcinogenesis even though an anti-cancer role has already been observed .
Genetic polymorphisms in some TLRs have been found and its influence on the risk of HCC has been reported .
In conclusion , TLRs have been shown to be an interesting influence on the HCC 's microenvironment , with TLR3 clearly determining an anti-tumour influence .
TLR4 and TLR9 are considered to have a positive relationship with tumour development even though , in each of them anti-tumorigenic signals have been described .
TLR2 presents a more ambiguous role , possibly depending on the stage of the inflammation-HCC axis |
MS210890 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Guided bone regeneration ( GBR ) is frequently used in oral implantology . It is unclear to what extent GBR affects the periodontium of adjacent teeth . Therefore , the present study quantifies changes in the proximal gingiva and bone levels at these teeth in 30 patients . Staged surgery involved a st and ard GBR treatment , r and omly using resorbable membranes with a bone substitute or non-resorbable membranes with or without a bone substitute , followed by fixture installation at 6 months and abutment connection a further 6 months later . The data were sample d at each surgery and analysed using MANOVA . Twelve months after GBR , there was on average a small but statistically significant amount of proximal gingival recession ( 0.75 mm ) and bone resorption ( 0.34 mm ) observed , of which 50 % was the result of GBR surgery . No significant differences were found between the different GBR treatment modalities . It is concluded that GBR treatment may have a small negative effect on the levels of the free gingival margin and alveolar bone at adjacent teeth , which is in most patients not clinical ly relevant PURPOSE The aim of this study was to report on the rehabilitation of partial edentulism with immediate function implants placed in predominantly soft bone with flap and flapless surgical techniques . MATERIAL S AND METHODS The prospect i ve clinical study comprises 72 implants ( 50 in the maxilla and 22 in the m and ible ) placed in 41 consecutively included patients rehabilitated from partial edentulism , followed for 1 year . An implant specially design ed for immediate function was used . The evaluation included clinical examinations and radiographic assessment of the marginal bone level at 6 months and 1 year . The outcome measure was the implant success , evaluated using the following implant success criteria : clinical stability ( fixed dental prostheses removed and implants individually checked ) ; fulfilled purported function without any discomfort to the patient ; no suppuration or infection present ; no radiolucent areas around the implants at time of evaluation ; and no aesthetic complaints from the patient . RESULTS No dropouts were registered during the follow-up of the study . The overall cumulative survival rate at 1 year was 98.6 % ( 1 implant lost ) , with 100 % for the implants placed with the flap surgical technique , and 96.9 % for the implants placed with the flapless surgical technique . The overall average marginal bone resorption was 1.6 mm ( SD=1.1 mm ) at 1-year follow-up , with 1.4 mm ( SD=0.8 mm ) and 2.0 mm ( SD = 1.4 mm ) for the flap and flapless surgical technique study groups , respectively . The complications registered were : peri-implant pathology ( 3 implants in 3 patients ) ; fracture of the provisional crown/prosthesis ( 2 patients ) ; crown loosening ( 1 patient ) and prosthetic screw loosening ( 1 patient ) . CONCLUSIONS The placement of the specially design ed implant for immediate function in predominantly soft bone is viable , as given by the overall 98.6 % cumulative survival rate , and the rehabilitation using flapless surgery is safe and predictable . However , the flapless technique revealed more marginal bone resorption compared with the flap technique . Extra care should be taken in the flapless approach with respect to the inclusion criteria and difficulty of the surgery Background The association between periodontal conditions , oral yeast colonisation and salivary proteins in subjects with type 2 diabetes ( T2D ) is not yet documented . The present study aim ed to assess the relationship between these variables in type 2 diabetic subjects with reference to gender . Methods Fifty-eight type 2 diabetic subjects ( 23 males and 35 females ) with r and om blood glucose level ≥ 11.1 mmol/L were investigated . Periodontal conditions ( plaque index [ PI ] , bleeding on probing [ BOP ] , probing pocket depth [ PD ] ( 4 to 6 mm and ≥ 6 mm ) , oral yeasts , salivary immunoglobulin ( Ig ) A , IgG and total protein concentrations , and number of present teeth were determined . Results Periodontal conditions ( PI [ p < 0.00001 ] , BOP [ p < 0.01 ] and PD of 4 to 6 mm [ p < 0.001 ] , salivary IgG (μg)/mg protein ( p < 0.001 ) and salivary total protein concentrations ( p < 0.05 ) were higher in type 2 diabetic females with C and ida albicans ( C. albicans ) colonisation compared to males in the same group . Type 2 diabetic females with C. albicans colonisation had more teeth compared to males in the same group ( p < 0.0001 ) . Conclusion Clinical and salivary parameters of periodontal inflammation ( BOP and IgG (μg)/mg protein ) were higher in type 2 diabetic females with oral C. albicans colonisation compared to males in the same group . Further studies are warranted to evaluate the association of gender with these variables in subjects with T2D BACKGROUND The association among periodontal conditions , socioeconomic status ( SES ) , and diabetes has been reported . However , there is a lack of published data comparing periodontal conditions among individuals with poorly controlled type 2 diabetes mellitus ( T2D ) . The aim of the present study was to compare the periodontal conditions and SES between subjects with T2D and non-diabetic controls . METHODS A total of 75 ( 31 males and 44 females ) individuals with T2D ( 62 poorly controlled and 13 well-controlled ) and 99 non-diabetic patients ( healthy controls ; 51 males and 48 females ) participated in the study . Plaque index ( PI ) , bleeding on probing ( BOP ) , and probing depth ( PD ) were investigated . R and om blood glucose level was recorded . Premolar and molar marginal bone loss ( MBL ) was measured digitally on scanned orthopantomograms . RESULTS Individuals with poorly controlled T2D had increased MBL in molars and maxillary premolars ( P<0.05 ) compared to individuals with well-controlled T2D . PI , BOP , and PD of 4 to < 6 mm were increased in individuals with poorly controlled T2D compared to those with well-controlled T2D ( P<0.001 ) . There was no difference between the diabetic groups when PD was > or=6 mm . Individuals with poorly controlled T2D had a lower SES compared to patients with well-controlled T2D ( P<0.05 ) . Illiteracy and the number of missing teeth were not different between the groups . CONCLUSIONS Radiologic and clinical indicators of periodontal destruction were increased in individuals with poorly controlled T2D . Low SES aggravated the periodontal condition in individuals with T2D The purpose of this r and omized controlled clinical study was to compare the survival of a one-piece anodically oxidized surface implant when placed with a flapless or flap protocol . Bone loss measurements on radiographs and changes in clinical probing depths 1 year post-definitive restoration placement were recorded and compared . Fifty-two of 60 patients ( implants ) remained in the study at the 1-year follow-up . At the time of final evaluation , no implant was lost in either group . At the time of placement of the definitive restoration , there was a mean mesial and distal bone gain in both groups compared to bone levels present at the time of implant insertion . There were no significant changes in bone levels between placement of the definitive restoration and those recorded 12 months later , and no significant differences in bone levels between the flap or flapless group at 6 or 12 months were noted . No significant differences were seen either in pocket depth or change in pocket depth at 6 and 12 months in the flapless and flap groups . It was therefore concluded that one-piece anodically oxidized surface implants , 1 year post-definitive restoration insertion , had high survival rates ( 100 % ) and stable marginal bone and probing depth levels whether a flapless or flap protocol was used for implant insertion OBJECTIVES To evaluate and compare the outcome of dental implants placed using a flapless protocol and immediate loading with a conventional protocol and loading after 6 weeks . MATERIAL S AND METHODS Fourteen patients with bilateral maxillary edentulous areas were treated using Straumann SLA-implants . Using a r and omized split-mouth design , implants were placed in one side of the maxilla using a stereolithographic surgical guide for flapless surgery and immediately loaded on temporary abutments with a bridge ( test ) . Implants in the other side were placed using the conventional protocol and loaded after 6 weeks of healing ( control ) . Clinical and radiographic evaluation of peri-implant tissues was performed at time of implant surgery , and after 1 week , 6 weeks , 3 , 6 , 12 and 18 months . RESULTS A total of 70 implants were placed ( 36 test and 34 control ) . One implant ( test ) was lost after 3 months , result ing in a survival rate of 97.3 % for the test implants and 100 % for the control implants . Marginal bone levels were not statistically significantly different between the test and control implants but at baseline the marginal bone level was significantly lower compared to the other evaluation periods ( P < 0.05 ) . The mean bone level for test and control implants was 1.95 mm ± 0.70 and 1.93 mm ± 0.42 after 18 months , respectively . There was a significant change in height of the attached mucosa at implants placed with a conventional flap between post-operative and 1 week and between 1 week and 6 weeks . Statistically significant differences were found between the test side and the control side for opinion about speech , function , aesthetics , self-confidence and overall appreciation the first 6 weeks . CONCLUSION Implants can successfully integrate in the posterior maxilla using a flapless approach with immediate loading similar to a conventional protocol . The mucosal tissues around implants placed with a conventional flap changed significantly compared with flapless placed implants PURPOSE To evaluate and compare the changes in crestal bone height around implants placed with flapless surgery and with-flap surgery . MATERIAL S AND METHODS Ten implants were placed in six patients --five using flapless and five using with-flap techniques . Single-piece root-form implants and a one-stage approach with immediate nonfunctional loading protocol were used . The change in heights of crestal bone was measured on st and ardized digital periapical radiographs taken at 0 , 1 , and 3 months . RESULTS On mesial side , the mean change from months 0 - 1 , months 1 - 3 , and months 0 - 3 for flapless method was significantly lower than with-flap method [ 0.01 - 0.06 mm for flapless and 0.13 - 0.40 mm for with-flap ( P = 0.01 ) ] . On the distal side , the mean change from months 0 - 1 , months 1 - 3 , and months 0 - 3 for flapless method was significantly lower than with-flap method [ 0.02 - 0.05 mm for flapless and 0.09 - 0.30 mm for with-flap ( P = 0.01 ) ] . CONCLUSIONS During the three-month period , reduction of crestal bone height around the implants placed with flapless surgery ( 0.06 mm ) was not statistically significant , while the reduction of crestal bone height around the implants placed using with-flap surgery ( 0.4 mm ) was statistically significant . Comparitively , flapless approach showed lesser crestal bone height reduction , which was statistically significant OBJECTIVE To evaluate how bone-level implants maintain crestal bone stability after thickening of thin mucosal tissues with allogenic membrane . MATERIAL S AND METHODS Ninety-seven bone-level implants of 4.1 mm diameter ( Institute Straumann AG , Switzerl and ) were evaluated in 97 patients ( 28 men and 69 women , mean age 47.3 ± 1.2 years ) . According to vertical gingival thickness , patients were assigned into test T1 ( thin , 2 mm or less , n = 33 ) , test T2 ( thin thickened with allogenic membrane , n = 32 ) and control C groups ( thick , more than 2 mm , n = 32 ) . Implants were placed in posterior m and ible in one-stage approach and after integration were restored with single screw-retained metal-ceramic restorations . Radiographic examination was performed after implant placement , 2 months after healing , after prosthetic restoration and after 1-year follow-up . Crestal bone loss was calculated mesially and distally . Mann-Whitney U-test was applied and significance was set to 0.05 . RESULTS After 2 months , implants in group T1 had 0.75 ± 0.11 mm bone loss mesially and 0.73 ± 0.10 mm distally . Implants in group T2 had 0.16 ± 0.06 mm mesially and 0.20 ± 0.06 mm distally . C group implants lost 0.17 ± 0.05 mm mesially and 0.18 ± 0.03 mm distally . Differences between T1/T2 , and T1/C were statistically significant ( P = 0.000 ) both mesially and distally , while between T2 and C was not significant mesially ( P = 0.861 ) and distally ( P = 0.827 ) .
Output:
| CBL around dental implants placed in healed sites using flapped and flapless techniques is comparable |
MS210891 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: PURPOSE To investigate the effect of the augmentation of levodopa with part-time and full-time occlusion on visual acuity and to determine its late results in amblyopia . METHODS Seventy-two patients with amblyopia were prospect ively studied and r and omly distributed into groups A , B , and C consisting of 24 patients each . Group A patients received levodopa alone , group B received levodopa and part-time ( 3 hours/day ) occlusion , and group C received levodopa and full-time ( during all waking hours ) occlusion of the dominant eye . Levodopa 0.50 mg/kg body weight , with a 25 % fixed dose combination of carbidopa , was administered orally three times a day for 7 weeks . Snellen visual acuity and its logMAR equivalent were recorded before treatment , at weeks 1 , 3 , 5 , and 7 after starting treatment , and every 6 weeks for 1 year after the completion of treatment . RESULTS Fifty-three ( 74 % ) of the 72 patients had an improvement in visual acuity after treatment . Forty-four of the 53 patients with improved visual acuities completed 1-year post-treatment follow-up . Twenty-three ( 52 % ) of the 44 patients had a regression in visual acuity . CONCLUSION The augmentation of levodopa with part-time or full-time occlusion does not enhance the recovery of vision in amblyopia . Improved visual acuity after levodopa administration persists at least 1 year in almost half of patients after cessation of treatment . Addition of full-time occlusion to levodopa helps maintain improved visual acuity for a longer duration compared to levodopa alone or combined with part-time occlusion PURPOSE To determine the effectiveness of weekend atropine for severe amblyopia from strabismus , anisometropia , or both combined among children 3 to 12 years of age . METHODS We enrolled children into 2 prospect i ve , r and omized multicenter clinical trials of amblyopia therapy . Herein we report the results for severe amblyopia , 20/125 to 20/400 . In Trial 1 , 60 children 3 to 6 years of age ( mean , 4.4 years ) were r and omized to weekend atropine plus a plano lens or weekend atropine plus full spectacle correction for the sound eye . In Trial 2 , 40 children 7 to 12 years of age ( mean , 9.3 years ) were r and omized to weekend atropine or 2 hours of daily patching . The visual acuity outcome was assessed at 18 weeks in Trial 1 and 17 weeks in Trial 2 . RESULTS In Trial 1 , visual acuity improved by an average of 4.5 lines in the atropine plus correction group ( 95 % CI , 3.2 - 5.8 lines ) and 5.1 lines in the atropine plus plano lens group ( 95 % CI , 3.7 - 6.4 lines ) . In Trial 2 , visual acuity improved by an average of 1.5 lines in the atropine group ( 95 % CI , 0.5 - 2.5 lines ) and 1.8 lines in the patching group ( 95 % CI , 1.1 - 2.6 lines ) . CONCLUSIONS Weekend atropine can improve visual acuity in children 3 to 12 years of age with severe amblyopia . Improvement may be greater in younger children The authors previously showed that a single dose of levodopa improves the contrast sensitivity and decreases the size of fixation point scotomas in amblyopic patients . In the present study , they investigated the effect of levodopa after 1 wk of daily administration using a cross-over , double masked design . The decrease of fixation point scotomas was confirmed with automatic static perimetry . An improvement of visual acuity occurred in 70 % of the patients after 1 wk of levodopa administration compared to only 22 % in the authors ' previous study using one single dose . The improvements in visual acuities and visual fields persisted even after the levodopa administration was completed BACKGROUND amblyopia is a major cause of visual impairment in children . Our aim is to compare patching and atropine penalization for treatment of moderate amblyopia in 4 - 10 years old children . METHODS During 2004 - 2007 , in a r and omized clinical trial , 120 patients aged 4 - 10 years old with moderate amblyopia in the range of 20/40 -20/100 were enrolled . Subjects r and omized either to patch therapy or twice weekly atropine penalization in equal groups and were followed for 2 years . The success rate was defined as increment of 2 or more lines of visual acuity or final visual acuity of 20/25 or better . RESULTS The visual acuity in amblyopic eye improved from base line to a mean of 3.8 lines in patching group and mean of 3.7 lines in atropine group at the end of follow up . The average visual acuity in both groups was 0.5 Log MAR acuity that increased to 0.18 in patching group and 0.2 in atropine group . CONCLUSION Twice weekly atropine penalization could improve visual acuity of a magnitude like to improvement provided by patching in treatment of moderate amblyopia in patients aged 4 - 10 years The aim of this study was to investigate the effect of laser acupuncture on cerebral activation . Using functional magnetic imaging ( fMRI ) cortical activations during laser acupuncture at the left foot ( Bladder 67 ) and dummy acupuncture , were compared employing a block design in ten healthy male volunteers . All experiments were done on a 1.5 Tesla magnetic resonance scanner equipped with a circular polarized head coil . During laser acupuncture , we found activation in the cuneus corresponding to Brodmann Area ( BA ) 18 and the medial occipital gyrus ( BA 19 ) of the ipsilateral visual cortex . Placebo stimulation did not show any activation . We could demonstrate that laser acupuncture of a specific acupoint , empirically related to ophthalmic disorders , leads to activation of visual brain areas , whereas placebo acupuncture does not . These results indicate that fMRI has the potential to eluci date effects of acupuncture on brain activity OBJECTIVE To determine the visual acuity outcome at age 10 years for children younger than 7 years when enrolled in a treatment trial for moderate amblyopia . METHODS In a multicenter clinical trial , 419 children with amblyopia ( visual acuity , 20/40 - 20/100 ) were r and omized to patching or atropine eyedrops for 6 months . Two years after enrollment , a subgroup of 188 children entered long-term follow-up . Treatment after 6 months was at the discretion of the investigator ; 89 % of children were treated . MAIN OUTCOME MEASURE Visual acuity at age 10 years with the electronic Early Treatment Diabetic Retinopathy Study test . APPLICATION TO CLINICAL PRACTICE Patching and atropine eyedrops produce comparable improvement in visual acuity that is maintained through age 10 years . RESULTS The mean amblyopic eye acuity , measured in 169 patients , at age 10 years was 0.17 logMAR ( logarithm of the minimum angle of resolution ) ( approximately 20/32 ) , and 46 % of amblyopic eyes had an acuity of 20/25 or better . Age younger than 5 years at entry into the r and omized trial was associated with a better visual acuity outcome ( P < .001 ) . Mean amblyopic and sound eye visual acuities at age 10 years were similar in the original treatment groups ( P = .56 and P = .80 , respectively ) . CONCLUSIONS At age 10 years , the improvement of the amblyopic eye is maintained , although residual amblyopia is common after treatment initiated at age 3 years to younger than 7 years . The outcome is similar regardless of initial treatment with atropine or patching BACKGROUND Although amblyopia can be successfully treated with patching or atropine , there have been few prospect i ve studies of amblyopia recurrence once treatment is discontinued . METHODS We enrolled 156 children with successfully treated anisometropic or strabismic amblyopia ( 145 completed follow-up ) , who were younger than 8 years of age and who received continuous amblyopia treatment for the previous 3 months ( prescribed at least 2 hours of daily patching or prescribed at least one drop of atropine per week ) and who had improved at least 3 logMAR levels during the period of continuous treatment . Patients were followed off treatment for 52 weeks to assess recurrence of amblyopia , defined as a 2 or more logMAR level reduction of visual acuity from enrollment , confirmed by a second examination . Recurrence was also considered to have occurred if treatment was restarted because of a nonreplicated 2 or more logMAR level reduction of visual acuity . RESULTS Recurrence occurred in 35 ( 24 % ) of 145 cases ( 95 % confidence interval 17 % to 32 % ) and was similar in patients who stopped patching ( 25 % ) and in patients who stopped atropine ( 21 % ) . In patients treated with moderately intense patching ( 6 to 8 hours per day ) , recurrence was more common ( 11 of 26 ; 42 % ) when treatment was not reduced prior to cessation than when treatment was reduced to 2 hours per day prior to cessation ( 3 of 22 ; 14 % , odds ratio 4.4 , 95 % confidence interval 1.0 to 18.7 ) . CONCLUSIONS Approximately one fourth of successfully treated amblyopic children experience a recurrence within the first year off treatment . For patients treated with 6 or more hours of daily patching , our data suggest that the risk of recurrence is greater when patching is stopped abruptly rather than when it is reduced to 2 hours per day prior to cessation . A r and omized clinical trial of no weaning versus weaning in successfully-treated amblyopia is warranted to confirm these observational findings Background and purpose : To date , much of the research regarding amblyopia has been focused on which therapeutic modality is the most efficacious in amblyopia management . Unfortunately , there is a lack of research into which method of treatment cessation is the most appropriate once therapy has been completed . The purpose of this study is to investigate if the cessation method affects the recurrence rate of amblyopia . Methods : This study was a prospect i ve r and omized clinical trial of 20 subjects who were wearing full-time occlusion and were at the end point of their therapy . The subjects were r and omized into one of two groups : abrupt cessation or therapy tapering . All subjects were followed for 3 consecutive 4-week intervals , for a total of 12 weeks , to assess the short-term recurrence rate of amblyopia . Subjects who were in the tapered group had their occlusion reduced from full-time occlusion ( all waking hours minus one ) to 50 % of waking hours at study enrollment ( i.e. , from 12 hours/day to 6 hours per day ) ; occlusion was reduced by an additional 50 % at the first 4-week study visit ( i.e. , from 6 hours/day to 3 hours ) , with occlusion being discontinued completely at the week 8 visit . All subjects who were in the abrupt cessation group had their full-time occlusion discontinued completely at the start of the study ( i.e. , from 12 hours/day to none ) . Additional assessment s were also conducted at week 26 and week 52 post – therapy cessation to determine the longer term amblyopia regression rate . For the purpose s of this study , recurrence was defined as a 0.2 ( 10 letters ) or more logarithm of the minimum angle of resolution ( logMAR ) loss of visual acuity . Results : A recurrence of amblyopia occurred in 4 of 17 ( 24 % ; CI 9%–47 % ) participants completing the study by the week 52 study end point . There were 2 subjects from each treatment group who demonstrated a study protocol –defined recurrence . Conclusion : There was a 24 % risk of amblyopia recurrence if therapy was discontinued abruptly or tapered in 8 weeks . In this small sample , the assigned cessation method did not affect the rate of amblyopia recurrence . It is recognized that the smaller sample size in our study prevents us from making definitive conclusions on the potential role that abrupt cessation has on the regression rate of amblyopia . The sample size was too small to reach an acceptable level of statistical power ; therefore the generalizability of the findings to the broad population of all patients with amblyopia requires continuing research . This study therefore could be considered as a pilot study Amblyopia is a developmental abnormality that results in physiological alterations in the visual cortex and impairs form vision . It is often successfully treated by patching the sound eye in infants and young children , but is generally considered to be untreatable in adults . However , a number of recent studies suggest that repetitive practice of a visual task using the amblyopic eye results in improved performance in both children and adults with amblyopia . These perceptual learning studies have used relatively brief periods of practice ; however , clinical studies have shown that the time-constant for successful patching is long . The time-constant for perceptual learning in amblyopia is still unknown . Here we show that the time-constant for perceptual learning depends on the degree of amblyopia . Severe amblyopia requires > 50 h ( ≈35,000 trials ) to reach plateau , yielding as much as a five
Output:
| This includes the finding that less intensive occlusion treatments can be successful in treating amblyopia .
A relationship between adherence to treatment and visual acuity has also been established and has been shown to be influenced by the use of intervention material .
In addition , there is growing evidence of that a period of glasses wearing only can significantly improve visual acuity alone without any other modes of treatment . |
MS210892 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: A r and omized , controlled intervention trial of two household-scale drinking water filters was conducted in a rural village in Cambodia . After collecting four weeks of baseline data on household water quality , diarrheal disease , and other data related to water use and h and ling practice s , households were r and omly assigned to one of three groups of 60 households : those receiving a ceramic water purifier ( CWP ) , those receiving a second filter employing an iron-rich ceramic ( CWP-Fe ) , and a control group receiving no intervention . Households were followed for 18 weeks post-baseline with biweekly follow-up . Households using either filter reported significantly less diarrheal disease during the study compared with a control group of households without filters as indicated by longitudinal prevalence ratios CWP : 0.51 ( 95 % confidence interval [ CI ] : 0.41 - 0.63 ) ; CWP-Fe : 0.58 ( 95 % CI : 0.47 - 0.71 ) , an effect that was observed in all age groups and both sexes after controlling for clustering within households and within individuals over time Daniel Maeusezahl and colleagues conducted a cluster-r and omized controlled trial in rural Bolivia of solar drinking water disinfection , and find only moderate compliance with the intervention and no evidence of reduction in diarrhea among children A number of household water treatment and safe storage technologies , such as chlorine disinfection , solar disinfection , and ceramic filtration , have been documented for their ability to reduce diarrheal disease and improve microbial water quality . The bios and filter ( BSF ) is a promising household water treatment technology in use by > 500,000 people globally . The purpose of this research was to document the ability of BSFs to improve water quality and to reduce diarrheal disease in user compared with non-user households in a r and omized controlled trial in Bonao , Dominican Republic , during 2005 - 2006 . During the 6-month intervention period , 75 BSF households had significantly improved drinking water quality on average compared with 79 control households ( P < 0.001 ) . Based on r and om intercepts logistic regression , BSF households had 0.53 times the odds of diarrheal disease as control households , indicating a significant protective effect of the BSF against waterborne diarrheal disease Although the efficacy of chlorine disinfection under controlled laboratory conditions is well known , the effectiveness of chlorine under field point-of-use ( POU ) conditions is still not clearly understood and may be impacted by a variety of factors . This study evaluated the effectiveness of POU chlorine disinfection in rural Ecuador under typical use conditions and compared this effectiveness with the efficacy in controlled laboratory conditions . While reductions of indicator organisms were slightly higher in households that used chlorination , no significant differences were seen between households employing POU chlorination and the households with no chlorination ( 1 - 1.5 log10 median reductions for chlorinating households and 0.31 - 0.55 log10 for nonchlorinating households , depending on the indicator organism ) . In contrast , significant reduction of all test organisms was found when simulating POU conditions in the laboratory . This study demonstrates that POU chlorination can be considerably less effective under actual field conditions than would be predicted based on its laboratory efficacy ( 3 - 5 log10 median reductions for chlorinated and 0 - 0.3 log10 for nonchlorinated sample s ) . Human factors ( including improper storage and chlorine dosing ) and uncontrolled water quality effects are hypothesized to impact significantly the effectiveness of chlorine disinfection Simple , effective and affordable methods are needed to treat and safely store non-piped , gathered household water . This study evaluated point-of-use chlorination and storage in special plastic containers of gathered household water for improving microbial quality and reducing diarrhoeal illness of consumers living under conditions of poor sanitation and hygiene . Community families were recruited and r and omly divided into intervention ( household water chlorination and storage in a special container ) and control ( no intervention ) households . Microbes in stored household water were extensively inactivated by 1 - 5-mg/L doses of hypochlorite . Escherichia coli levels in stored household waters were < 1/100 mL in most intervention households but readily detectable at high levels in control households . Stored water of intervention households was also lower in Clostridium perfringens and heterotrophic plate count bacteria than in control households . The intervention reduced household diarrhoeal illness . In Bolivia , monthly episodes of household diarrhoeal illness were 1.25 and 2.2 in intervention and control families , respectively ( P = < 0.002 ) indicating that 43 % of community diarrhoea was preventable by using the intervention . In Bangladesh , mean episodes of child diarrhoea/1,000 d were 19.6 and 24.8 in intervention and control groups respectively ( P = < 0.03 ) indicating that about 24 % of observed diarrhoea was preventable by using the intervention . Chlorine disinfection and storage in an appropriate container significantly improved the microbiological quality of non-piped household drinking water and reduced community diarrhoeal disease . Widespread use of this simple treatment and storage system for non-piped domestic water has the potential to dramatically reduce the global burden of waterborne diarrhoeal disease To determine the effectiveness of ceramic filters in reducing diarrhea , we conducted a r and omized controlled trial in Zimbabwe and South Africa , in which 61 of 115 households received ceramic filters . Incidence of non-bloody and bloody diarrhea was recorded daily over 6 months using pictorial diaries for children 24 - 36 months of age . Poisson regression was used to compare incidence rates in intervention and control households . Adjusted for source quality , intervention household drinking water showed reduced Escherichia coli counts ( relative risk , 0.67 ; 95 % CI , 0.50 - 0.89 ) . Zero E. coli were obtained for drinking water in 56.9 % of intervention households . The incidence rate ratio for bloody diarrhea was 0.20 ( 95 % CI , 0.09 - 0.43 ; P < 0.001 ) and for non-bloody diarrhea was 0.17 ( 95 % CI , 0.08 - 0.38 ; P < 0.001 ) , indicating much lower diarrhea incidence among filter users . The results suggest that ceramic filters are effective in reducing diarrheal disease incidence
Output:
| Indeed these three interventions are predicted to have the same or less effect than what may be expected due purely to reporting bias in unblinded studies With the currently available evidence ceramic filters are the most effective form of HWT in the longterm , disinfection-only interventions including SODIS appear to have poor if any longterm public health benefit |
MS210893 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Flaws in the design , conduct , analysis , and reporting of r and omised trials can cause the effect of an intervention to be underestimated or overestimated . The Cochrane Collaboration ’s tool for assessing risk of bias aims to make the process clearer and more Severe open fractures of the tibia have a high incidence of complications and a poor outcome . The most usual method of stabilisation is by external fixation , but the advent of small diameter locking intramedullary nails has introduced a new option . We report the early results of a r and omised , prospect i ve study comparing external fixation with non-reamed locked nails in grade -IIIb open tibial fractures . Of 29 patients , 15 were treated by nails and 14 by external fixation . Both groups had the same initial management , soft-tissue procedures , and early bone grafting . All 29 fractures healed within nine months , but the nailed group had slightly better motion and less final angulation . Complications included one deep infection and two pin-track infections in the external fixator group and one deep infection and one vascular problem in the nailed group . Although the differences in healing and range of motion were not statistically significant , we found that the nailed fractures were consistently easier to manage , especially in terms of soft-tissue procedures and bone grafting . It is the treatment preferred by patients and does not require the same high level of patient compliance as external fixation . The only factors against nailing are the longer operating time and the greater need for fluoroscopy . We consider that locked non-reamed nailing is the treatment of choice for grade -IIIb open tibial fractures OBJECTIVE To compare unreamed intramedullary nailing ( IMN ) with external fixation ( EF ) in patients with Type II , IIIA , and IIIB open fractures of the tibial shaft . DESIGN An inception cohort of consecutive patients with Type II , IIIA , and IIIB tibial fractures incurred between January 1988 and March 1993 were systematic ally allocated into one of two treatment groups . Patients were treated and followed with a prospect ively design ed protocol . PATIENTS AND SETTING All patients were skeletally mature and had incurred a fracture of the tibial diaphysis within twenty-four hours of presentation to the tertiary care hospital , a Level I Trauma Center . One hundred seventy-four fractures in 168 patients were stabilized with either IMN ( 104 ) or half-pin EF ( 70 ) . There were 132 men and thirty-six women , with an average age of thirty-three years ( range , 14 to 77 years ) . INTERVENTION Except for the selection of the fixation device , open fracture care was similar in the two treatment groups . All patients underwent emergent irrigation and debridement with concomitant skeletal stabilization . Cephalosporin antibiotics were administered perioperatively for twenty-four to forty-eight hours . No wounds were closed primarily . Delayed primary closure , skin grafting , and /or myoplasty were performed between three and ten days after injury . MAIN OUTCOME MEASURES The main outcome measures were final fracture alignment , presence of infection or inflammation , hardware failure , time to union , and the number of operative procedures . RESULTS The IMN group had significantly fewer incidences of malalignment than did the EF group [ 8 vs. 31 percent ; p = 0.00005 ; confidence interval ( CI ) = 0.18 , 0.76 ] and had significantly fewer subsequent procedures ( mean of 1.7 vs. mean of 2.7 per fracture ; p = 0.001 ; CI = 0.45 , 1.59 ) . IMN result ed in fewer infections/ inflammatory problems than did EF at the injury site ( 13 vs. 21 percent ; p = 0.73 ; CI = -0.63 , 0.45 ) and significantly fewer at surgical interfaces ( i.e. , pin sites , nail and interlocking screw insertion sites ; 2 vs. 50 percent ; p = 0.000 ; CI = 0.39 , 0.60 ) . No significant difference was found in the healing rates for the two implant groups . The more severe Gustilo injury types had longer healing times regardless of the type of fixation . CONCLUSIONS Results suggest that unreamed interlocking intramedullary nails are more efficacious than half-pin external fixators , in particular with regard to maintenance of limb alignment . However , the severity of soft tissue injury rather than the choice of implant appears to be the predominant factor influencing rapidity of bone healing and rate of injury site infection Although the intramedullary nailing is thought to be the method of choice for treatment of closed tibial shaft , there is ongoing debate on the optimal surgical approach in patients with open types of these fractures . In addition , choosing between the reamed and unreamed intramedullary nailing is still an issue for the orthopedic surgeons . In present study , we aim ed to compare the outcome and consequences of OA tubular external fixation vs. unreamed intramedullary nailing in open grade IIIA-IIIB tibial shaft fractures . In a r and omized clinical trial , 50 patients with open tibial shaft fractures ( grade s IIIA-IIIB ) were recruited in Tabriz Shohada teaching centre in a 2-year period of time . They r and omized in two equal groups underwent either AO tubular external fixation or unreamed intramedullary nailing . These 2 groups were matched for sex , age and fracture- grade . The follow-up time was one year . Union time , surgical outcome , postoperative complications and the ambulation time were compared between the two groups . Twenty five patients , 20 males and 5 females with a mean age of 30.80 + /- 5.24 years were allocated in unreamed intramedullary group and 25 other patients , 22 males and 3 females with a mean age of 28.92 + /- 8.88 years were studied in the external fixation group ( p = 0.70 and 0.37 , respectively ) . The two groups were matched for sex ( p = 0.70 ) and age ( p = 0.37 ) . The time of union was 3 , 4 , 5 and 6 < or = weeks after operation in 28 , 12 , 32 and 28 % of the cases in unreamed intramedullary group vs. 4 , 12 , 48 and 36 % of the cases in external fixation group , respectively ( p = 0.14 ) . Post-operative infection , soft tissue injury , malunion and nonunion were documented in 16 , 8 , 0 and 4 % of the cases in unreamed intramedullary group vs. 32 , 12 , 24 and 8 % of the cases in external fixation group , respectively ( p = 0.19 , 0.50 , 0.02 and 0.50 , respectively ) . The mean ambulation time after operation was 2.92 + /- 2.43 weeks in the unreamed intramedullary nailing group vs. 2.68 + /- 2.14 weeks in the external fixation group ( p = 0.71 ) . Our results are in favor of unreamed intramedullary nailing against external fixation in treatment of open tibial shaft fractures In a prospect i ve study , since March 1989 , 55 tibial shaft fractures have been treated with a new , unreamed solid tibial nail ( UTN ) . This nail was initially design ed as a temporary implant . The first 33 cases with second or third degree soft tissue damage were review ed 6 months or more after the operation . Fractures were classified according to Müller : 6 type A ( 18.2 % ) , 15 type B ( 45.5 % ) , and 12 type C ( 36.7 % ) . In 9 cases ( 27.3 % ) , there was GII ( n = 4 ) or GIII ( n = 5 ) closed soft tissue damage according to Tscherne 's classification . The 24 open fractures ( 72.7 % ) comprised 11 OII , 3 OIIIA and 10 OIIIB fractures ( Gustilo classification ) . 24 patients ( 72.7 % ) were polytraumatized , the mean PTS ( Hannover Polytrauma Score ) was 18 points ( range : 8 - 65 points ) . All fractures were stabilized without reaming . The implant diameter was 8 mm ( n = 14 ) or 9 mm ( n = 19 ) . Static locking was performed in 31 cases . Dermatofasciotomy was necessary because of compartment syndrome in 14 cases . In 1 grade IIIB open fracture soft tissue coverage was performed with a latissimus dorsi myocutaneous free flap 4 days after nailing . In 32 of the 33 cases the use of an additional cast or brace was not necessary during the follow-up treatment ; 1 patient had a cast for 8 weeks for the treatment of accompanying injuries . Full weight-bearing was achieved in 5 cases within 3 weeks , in 16 cases within 12 weeks , and in 30 cases within 26 weeks . In 16 cases ( 48.5 % ) the interlocking screws were removed after 5 - 26 weeks ( mean : 10 weeks ) . ( ABSTRACT TRUNCATED AT 250 WORDS Unreamed intramedullary nailing is an alternative to external fixation in the treatment of open tibial fractures . We compared a prospect i ve series of thirty-one patients managed with a solid nail with static interlocking without intramedullary reaming , with a retrospective series of thirty-one patients managed by external fixation . The protocol for soft tissue treatment was the same throughout the study period . Most fractures were caused by high energy trauma and included Grade I to III B injuries . The fracture wound infection rate was equal in both groups ; there were two deep and three superficial infections in the nail group and three deep and two superficial infections in the external fixation group . In addition , eleven patients in the external fixation group had severe pin track infections . The mean time to union was five months in the nail group and eight months in the external fixation group . The incidence of delayed union was twice as high in the external fixation group as in the nail group . The number of surgical procedures performed to promote union was three times higher in the external fixation group . The malunion rate did not differ between the groups . Although the treatment groups are not fully comparable , the results indicate that intramedullary nailing is superior to external fixation in the treatment of most open tibial fractures We undertook a prospect i ve study comparing the unreamed interlocking nail to Hoffmann external skeletal fixation ( ESF ) in the treatment of 36 consecutive patients with open type IIIA and IIIB tibia fractures . The choice of interlocking nail or Hoffmann ESF was r and omized , ultimately producing four different patient groups : group 1 , type IIIA fractures treated by interlocking nail ; group 2 , type IIIA fractures treated by ESF ; group 3 , type IIIB fractures with interlocking nail ; and group 4 , type IIIB fractures with ESF . The average length of follow-up was 20.5 months . The infection rate was highest in group 3 ( 3 of 8) . The malrotation , malunion , and nonunion rates were highest in group 4 and lowest in group 1 . These results suggest the unreamed interlocking nail is a good choice for the treatment of open type IIIA tibia fractures , but not recommended for the treatment of open type IIIB tibia fractures because of the high infection rate We performed a prospect i ve , r and omised study on 50 patients with Tscherne C1 tibial diaphyseal fractures comparing treatment with reamed and unreamed intramedullary nails . Our results show that reamed nailing is associated with a significantly lower time to union and a reduced requirement for a further operation . Unreamed nailing should not be used in the treatment of the common Tscherne C1 tibial fracture In 673 open fractures of long bones ( tibia and fibula , femur , radius and ulna , and humerus ) treated from 1955 to 1968 at Hennepin County Medical Center , Minneapolis , Minnesota , and analyzed retrospectively , the infection rate was 12 per cent from 1955 to 1960 and 5 per cent from 1961 to 1968 . In a prospect i ve study from 1969 to 1973 , 352 patients were managed as follows : débridement and copious irrigation , primary closure for Type I and II fractures and secondary closure for Type III fractures , no primary internal fixation except in the presence of associated vascular injuries , cultures of all wounds , and oxacillin-ampicillin before surgery and for three days postoperatively . In 158 of the patients in the prospect i ve study the initial wound cultures revealed bacterial growth in 70.3 per cent and the infection rate was 2.5 per cent . Sensitivity studies suggested that cephalosporin is currently the prophylactic antibiotic of choice . For the Type III open fractures ( severe soft-tissue injury , segmental fracture , or traumatic amputation ) , the infection rates were 44 per cent in the retrospective study and 9 per cent in the prospect i ve study Grade III open tibial fractures are known for frequent complications and poor clinical results , yet published series are few and cite conflicting results . To address this dilemma , the authors report a prospect i ve study of 202 consecutive Grade III tibial fractures . All injuries were treated under protocol at the authors ' university with primary external fixation and serial debridement . Equinus deformity was prevented with a new tibiometatarsal frame extension . Severe injuries crossing the ankle or knee were temporarily stabilized
Output:
| Data analysis revealed that UTN reduced the incidence rates of superficial infection and malunion after fixation compared with EF .
However , EF led to a significant reduction in hardware failure .
For postoperative deep infection , delayed union and nonunion , the treatment effects were similar between these two groups . |
MS210894 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: BACKGROUND The results of FASTACT , a r and omised , placebo-controlled , phase 2 study , showed that intercalated chemotherapy and erlotinib significantly prolonged progression-free survival ( PFS ) in patients with advanced non-small-cell lung cancer . We undertook FASTACT-2 , a phase 3 study in a similar patient population . METHODS In this phase 3 trial , patients with untreated stage IIIB/IV non-small-cell lung cancer were r and omly assigned in a 1:1 ratio by use of an interactive internet response system with minimisation algorithm ( stratified by disease stage , tumour histology , smoking status , and chemotherapy regimen ) to receive six cycles of gemcitabine ( 1250 mg/m(2 ) on days 1 and 8 , intravenously ) plus platinum ( carboplatin 5 × area under the curve or cisplatin 75 mg/m(2 ) on day 1 , intravenously ) with intercalated erlotinib ( 150 mg/day on days 15 - 28 , orally ; chemotherapy plus erlotinib ) or placebo orally ( chemotherapy plus placebo ) every 4 weeks . With the exception of an independent group responsible for monitoring data and safety monitoring board , everyone outside the interactive internet response system company was masked to treatment allocation . Patients continued to receive erlotinib or placebo until progression or unacceptable toxicity or death , and all patients in the placebo group were offered second-line erlotinib at the time of progression . The primary endpoint was PFS in the intention-to-treat population . This trial is registered with Clinical Trials.gov , number NCT00883779 . FINDINGS From April 29 , 2009 , to Sept 9 , 2010 , 451 patients were r and omly assigned to chemotherapy plus erlotinib ( n=226 ) or chemotherapy plus placebo ( n=225 ) . PFS was significantly prolonged with chemotherapy plus erlotinib versus chemotherapy plus placebo ( median PFS 7·6 months [ 95 % CI 7·2 - 8·3 ] , vs 6·0 months [ 5·6 - 7·1 ] , hazard ratio [ HR ] 0·57 [ 0·47 - 0·69 ] ; p<0·0001 ) . Median overall survival for patients in the chemotherapy plus erlotinib and chemotherapy plus placebo groups was 18·3 months ( 16·3 - 20·8 ) and 15·2 months ( 12·7 - 17·5 ) , respectively ( HR 0·79 [ 0·64 - 0·99 ] ; p=0·0420 ) . Treatment benefit was noted only in patients with an activating EGFR gene mutation ( median PFS 16·8 months [ 12·9 - 20·4 ] vs 6·9 months [ 5·3 - 7·6 ] , HR 0·25 [ 0·16 - 0·39 ] ; p<0·0001 ; median overall survival 31·4 months [ 22·2-undefined ] , vs 20·6 months [ 14·2 - 26·9 ] , HR 0·48 [ 0·27 - 0·84 ] ; p=0·0092 ) . Serious adverse events were reported by 76 ( 34 % ) of 222 patients in the chemotherapy plus placebo group and 69 ( 31 % ) of 226 in the chemotherapy plus erlotinib group . The most common grade 3 or greater adverse events were neutropenia ( 65 [ 29 % ] patients and 55 [ 25 % ] , respectively ) , thrombocytopenia ( 32 [ 14 % ] and 31 [ 14 % ] , respectively ) , and anaemia ( 26 [ 12 % ] and 21 [ 9 % ] , respectively ) . INTERPRETATION Intercalated chemotherapy and erlotinib is a viable first-line option for patients with non-small-cell lung cancer with EGFR mutation-positive disease or selected patients with unknown EGFR mutation status . FUNDING F Hoffmann-La Roche A quantitative systematic review , or meta- analysis , uses statistical methods to combine the results of multiple studies . Meta-analyses have been done for systematic review s of therapeutic trials , diagnostic test evaluations , and epidemiologic studies . Although the statistical methods involved may at first appear to be mathematically complex , their purpose is simple : They are trying to answer four basic questions . Are the results of the different studies similar ? To the extent that they are similar , what is the best overall estimate ? How precise and robust is this estimate ? Finally , can dissimilarities be explained ? This article provides some guidance in underst and ing the key technical aspects of the quantitative approach to these questions . We have avoided using equations and statistical notations ; interested readers will find implementations of the described methods in the listed references . We focus here on the quantitative synthesis of reports of r and omized , controlled , therapeutic trials because far more meta-analyses on therapeutic studies than on other types of studies have been published . For practical reasons , we present a stepwise description of the tasks that are performed when statistical methods are used to combine data . These tasks are 1 ) deciding whether to combine data and defining what to combine , 2 ) evaluating the statistical heterogeneity of the data , 3 ) estimating a common effect , 4 ) exploring and explaining heterogeneity , 5 ) assessing the potential for bias , and 6 ) presenting the results . Deciding Whether To Combine Data and Defining What To Combine By the time one performs a quantitative synthesis , certain decisions should already have been made about the formulation of the question and the selection of included studies . These topics were discussed in two previous articles in this series [ 1 , 2 ] . Statistical tests can not compensate for lack of common sense , clinical acumen , and biological plausibility in the design of the protocol of a meta- analysis . Thus , a reader of a systematic review should always address these issues before evaluating the statistical methods that have been used and the results that have been generated . Combining poor- quality data , overly biased data , or data that do not make sense can easily produce unreliable results . The data to be combined in a meta- analysis are usually either binary or continuous . Binary data involve a yes/no categorization ( for example , death or survival ) . Continuous data take a range of values ( for example , change in diastolic blood pressure after antihypertensive treatment , measured in mm Hg ) . When one is comparing groups of patients , binary data can be summarized by using several measures of treatment effect that were discussed earlier in this series [ 3 ] . These measures include the risk ratio ; the odds ratio ; the risk difference ; and , when study duration is important , the incidence rate . Another useful clinical measure , the number needed to treat ( NNT ) , is derived from the inverse of the risk difference [ 3 ] . Treatment effect measures , such as the risk ratio and the odds ratio , provide an estimate of the relative efficacy of an intervention , whereas the risk difference describes the intervention 's absolute benefit . The various measures of treatment effect offer complementary information , and all should be examined [ 4 ] . Continuous data can be summarized by the raw mean difference between the treatment and control groups when the treatment effect is measured on the same scale ( for example , diastolic blood pressure in mm Hg ) , by the st and ardized mean difference when different scales are used to measure the same treatment effect ( for example , different pain scales being combined ) , or by the correlation coefficients between two continuous variables [ 5 ] . The st and ardized mean difference , also called the effect size , is obtained by dividing the difference between the mean in the treatment group and the mean in the control group by the SD in the control group . Evaluating the Statistical Heterogeneity of the Data This step is intended to answer the question , Are the results of the different studies similar ( homogeneous ) ? It is important to answer this question before combining any data . To do this , one must calculate the magnitude of the statistical diversity ( heterogeneity ) of the treatment effect that exists among the different sets of data . Statistical diversity can be thought of as attributable to one or both of two causes . First , study results can differ because of r and om sampling error . Even if the true effect is the same in each study , the results of different studies would be expected to vary r and omly around the true common fixed effect . This diversity is called the within- study variance . Second , each study may have been drawn from a different population , depending on the particular patients chosen and the interventions and conditions unique to the study . Therefore , even if each study enrolled a large patient sample , the treatment effect would be expected to differ . These differences , called r and om effects , describe the between- study variation with regard to an overall mean of the effects of all of the studies that could be undertaken . The test most commonly used to assess the statistical significance of between- study heterogeneity is based on the chi-square distribution [ 6 ] . It provides a measure of the sum of the squared differences between the results observed and the results expected in each study , under the assumption that each study estimates the same common treatment effect . A large total deviation indicates that a single common treatment effect is unlikely . Any pooled estimate calculated must account for the between- study heterogeneity . In practice , this test has low sensitivity for detecting heterogeneity , and it has been suggested that a liberal significance level , such as 0.1 , should be used [ 6 ] . Estimating a Common Effect The questions that this step tries to answers are , 1 ) To the extent that data are similar , what is their best common point estimate of a therapeutic effect , and 2 ) how precise is this estimate ? The mathematical process involved in this step generally involves combining ( pooling ) the results of different studies into an overall estimate . Compared with the results of individual studies , pooled results can increase statistical power and lead to more precise estimates of treatment effect . Each study is given a weight according to the precision of its results . The rationale is that studies with narrow CIs should be weighted more heavily than studies with greater uncertainty . The precision is generally expressed by the inverse of the variance of the estimate of each study . The variance has two components : the variance of the individual study and the variance between different studies . When the between- study variance is found to be or assumed to be zero , each study is simply weighted by the inverse of its own variance , which is a function of the study size and the number of events in the study . This approach characterizes a fixed-effects model , as exemplified by the Mantel-Haenszel method [ 7 , 8 ] or the Peto method [ 9 ] for dichotomous data . The Peto method has been particularly popular in the past . It has the advantage of simple calculation ; however , although it is appropriate in most cases , it may introduce large biases if the data are unbalanced [ 10 , 11 ] . On the other h and , r and om-effects models also add the between- study variance to the within- study variance of each individual study when the pooled mean of the r and om effects is calculated . The r and om-effects model most commonly used for dichotomous data is the DerSimonian and Laird estimate of the between- study variance [ 12 ] . Fixed- and r and om-effects models for continuous data have also been described [ 13 ] . Pooled results are generally reported as a point estimate and CI , typically a 95 % CI . Other quantitative techniques for combining data , such as the Confidence Profile Method [ 14 ] , use Bayesian methods to calculate posterior probability distributions for effects of interest . Bayesian statistics are based on the principle that each observation or set of observations should be viewed in conjunction with a prior probability describing the prior knowledge about the phenomenon of interest [ 15 ] . The new observations alter this prior probability to generate a posterior probability . Traditional meta- analysis assumes that nothing is known about the magnitude of the treatment effect before r and omized trials are performed . In Bayesian terms , the prior probability distribution is noninformative . Bayesian approaches may also allow the incorporation of indirect evidence in generating prior distributions [ 14 ] and may be particularly helpful in situations in which few data from r and omized studies exist [ 16 ] . Bayesian analyses may also be used to account for the uncertainty introduced by estimating the between- study variance in the r and om-effects model , leading to more appropriate estimates and predictions of treatment efficacy [ 17 ] . Exploring and Explaining Heterogeneity The next important issue is whether the common estimate obtained in the previous step is robust . Sensitivity analyses determine whether the common estimate is influenced by changes in the assumptions and in the protocol for combining the data . A comparison of the results of fixed- and r and om-effects models is one such sensitivity analysis [ 18 ] . Generally , the r and om-effects model produces wider CIs than does the fixed-effects model , and the level of statistical significance may therefore be different depending on the model used . The pooled point estimate per se is less likely to be affected , although exceptions are possible [ 19 ] . Other sensitivity analyses may include the examination of the residuals and the chi-square components [ 13 ] and assessment of the effect of deleting each study in turn . Statistically significant results that depend on a single study may require further exploration . Cumulative Meta- Analysis PURPOSE To determine the proportion of lung adenocarcinomas from East Asian never-smokers who harbor known oncogenic driver mutations . PATIENTS AND METHODS In this surgical series , 52 resected lung adenocarcinomas from never-smokers ( < 100 cigarettes in a lifetime ) at a single institution ( Fudan University , Shanghai , China ) were analyzed concurrently for mutations in EGFR , KRAS , NRAS , HRAS , HER2 , BRAF , ALK , PIK3CA , TP53 and LKB1 . RESULTS Forty-one tumors harbored EGFR mutations , three harbored EML4-ALK fusions , two harbored HER2 insertions , and one harbored a KRAS mutation . All mutations were mutually exclusive . Thus , 90 % ( 47 of 52 ; 95 % CI , 0.7896 to 0.9625 ) of lung adenocarcinomas from never-smokers were found to harbor well-known oncogenic mutations in just four genes . No BRAF , NRAS , HRAS , or LKB1 mutations were detected , while
Output:
| Conclusions This meta- analysis suggests that EGFR mutation is an important predictive factor linked to improved OS for NSCLC patients with brain metastases .
It can serve as a useful index in the prognostic assessment of NSCLC patients with brain metastases |
MS210895 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Background Several studies have recently demonstrated that a post-treatment communication to explain the importance of an oral hygiene can improve the orthodontic patients ’ compliance over a period of 66 days . The main goal of this study is to evaluate the effects of a structured follow-up communication after orthodontic appliance application on oral hygiene compliance after 30–40 days . Methods Eighty-four orthodontic participants enrolled from patients who were beginning fixed orthodontic treatment at the Orthodontic Department , Gaslini Hospital , Genova , between July and October 2014 were r and omly assigned to one of three trial arms . Before the bonding , all patients underwent a session of oral hygiene aim ed at obtaining an plaque index of “ zero . ” At the following orthodontic appointment , the plaque index was calculated for each patient in order to assess oral hygiene compliance . The first group served as control and did not receive any post-procedure communication , the second group received a structured text message giving reassurance , and the third group received a structured telephone call . Participants were blinded to group assignment and were not made aware that the text message or the telephone call was part of the study . ( The research protocol was approved by the Italian Comitato Etico Regionale della Liguria-sezione 3^ c/o IRCCS-Istituto G. Gaslini 845/2014 , and it is not registered in the trial ’s register . ) Results Thirty patients were r and omly assigned to the control group , 28 participants to the text message group , and 26 to the telephone group . Participants who received a post-treatment communication reported higher level of oral hygiene compliance than participants in the control group . The plaque index was 0.3 ( interquartile range ( Iqr ) , 0.60 ) and 0.75 ( Iqr , 1.30 ) , respectively , with a significant difference ( P = 0.0205 ) . Conclusions A follow-up procedure after orthodontic treatment may be an effective tool to increase oral hygiene compliance also over a short period OBJECTIVE Text messaging is useful for promoting numerous health-related behaviors . The Text2Floss Study examines the feasibility and utility of a 7-day text messaging intervention to improve oral health knowledge and behavior in mothers of young children . METHODS Mothers were recruited from a private practice and a community clinic . Of 156 mothers enrolled , 129 r and omized into text ( n = 60 ) and control groups ( n = 69 ) completed the trial . Participants in the text group received text messages for 7 days , asking about flossing and presenting oral health information . Oral health behaviors and knowledge were surveyed pre- and post-intervention . RESULTS At baseline , there were no differences between text and control group mothers in knowledge and behaviors ( P > 0.10 ) . Post-intervention , text group mothers flossed more ( P = 0.01 ) , had higher total ( P = 0.0006 ) and specific ( P < 0.05 ) knowledge , and tried to improve their child 's oral health behaviors ( P = 0.03 ) and decrease their soda and sugary snacks ( P = 0.05 ) more than control mothers . Text messages were accepted and perceived as useful . CONCLUSIONS Mothers receiving text messages improved their own oral health behaviors and knowledge as well as their behaviors regarding their children 's oral health . Text messaging represents a viable method to improve oral health behaviors and knowledge . Its high acceptance may make it useful for preventing oral disease OBJECTIVE To determine if text message reminders regarding oral hygiene compliance have an influence on the level of compliance within an orthodontic population . MATERIAL S AND METHODS In this prospect i ve , r and omized , controlled clinical trial , 42 orthodontic patients were assigned to a text message or control group . Parents of patients assigned to the text message group received a reminder text message one weekday each week . Oral hygiene compliance was measured using bleeding index ( BI ) , modified gingival index ( MGI ) , and plaque index ( PI ) , and visual examination of white spot lesion ( WSL ) development at baseline ( T0 ) , two appointments after baseline ( T1 ) , and four appointments after baseline ( T2 ) . RESULTS BI , MGI , and PI scores were significantly lower in the text message group than in the control group at T2 . CONCLUSION A text message reminder system is effective for improving oral hygiene compliance in orthodontic patients BACKGROUND Rising concern over the poor level of blood-pressure ( BP ) control among hypertensive patients has prompted search es for novel ways of managing hypertension . The objectives of this study were to develop and pilot-test a home BP tele-management system that actively engages patients in the process of care . METHODS Phase 1 involved a series of focus-group meetings with patients and primary care providers to guide the system 's development . In Phase 2 , 33 diabetic patients with uncontrolled ambulatory hypertension were enrolled in a 4-month pilot study , using a before- and -after design to assess its effectiveness in lowering BP , its acceptability to users , and the reliability of home BP measurements . RESULTS The system , developed using commodity hardware , comprised a Bluetooth-enabled home BP monitor , a mobile phone to receive and transmit data , a central server for data processing , a fax-back system to send physicians ' reports , and a BP alerting system . In the pilot study , 24-h ambulatory BP fell by 11/5 ( + /-13/7 SD ) mm Hg ( both P < .001 ) , and BP control improved significantly . Substantially more home readings were received by the server than expected , based on the preset monitoring schedule . Of 42 BP alerts sent to patients , almost half ( n = 20 ) were due to low BP . Physicians received no critical BP alerts . Patients perceived the system as acceptable and effective . CONCLUSIONS The encouraging results of this study provide a strong rationale for a long-term , r and omized , clinical trial to determine whether this home BP tele-management system improves BP control in the community among patients with uncontrolled hypertension Background The grading of recommendation , assessment , development and evaluation ( GRADE ) approach is widely implemented in health technology assessment and guideline development organisations throughout the world . GRADE provides a transparent approach to reaching judgements about the quality of evidence on the effects of a health care intervention , but is complex and therefore challenging to apply in a consistent manner . Methods We developed a checklist to guide the research er to extract the data required to make a GRADE assessment . We applied the checklist to 29 meta-analyses of r and omised controlled trials on the effectiveness of health care interventions . Two review ers used the checklist for each paper and used these data to rate the quality of evidence for a particular outcome . Results For most ( 70 % ) checklist items , there was good agreement between review ers . The main problems were for items relating to indirectness where considerable judgement is required . Conclusions There was consistent agreement between review ers on most items in the checklist . The use of this checklist may be an aid to improving the consistency and reproducibility of GRADE assessment s , particularly for inexperienced users or in rapid review s without the re sources to conduct assessment s by two research ers independently AIM The aims of this study were to discover the knowledge of and attitudes towards dental health of a group of regularly attending mothers of young children at high-risk of caries , and to evaluate their toothbrushing techniques . METHOD As part of the baseline examination of a r and omised controlled trial to test the influence of dental health counselling on the caries increment of at-risk pre-school children , 268 mothers of 334 children completed a question naire enquiring about their dental health knowledge and attitudes , and were also observed brushing their children 's teeth . RESULTS Although most mothers ( 71 % ) knew that they should brush their children 's teeth twice a day using a small toothbrush ( 94 % ) only 52 % knew that they should use only a small pea-sized amount of paste , and only 3 % knew the recommended level of fluoride in toothpaste for these at-risk children . 40 % of the children insisted on brushing their own teeth and 40 % of the mothers brushed their children 's teeth inadequately . Although three-quarters of the mothers knew that sugary foods and drinks should be consumed only at mealtimes , only 7 % knew the four foods and drinks supplying most sugar to a child 's diet . Although three-quarters of mothers thought that dental decay in milk teeth was very important , only half wanted their children 's carious teeth restored . CONCLUSION Knowledge , attitudes and behaviour about dental health among these regularly attending mothers of at-risk , pre-school children were superficial . Their attitudes to dental health of primary teeth were equivocal and their demonstrated brushing behaviour on the part of their children was inadequate INTRODUCTION Fixed orthodontic treatment is frequently associated with increased plaque accumulation leading to gingivitis and white spot lesions ( WSLs ) . AIM This study evaluated the role of text message reminder on oral hygiene of orthodontic patients . MATERIAL S AND METHODS A total of 60 patients under fixed orthodontic treatment were r and omly divided into two equal groups as control group and study ( text message ) group . Text message group received reminders about oral hygiene , while the control group did not receive any messages . Oral hygiene of both the groups was evaluated at baseline , 2 , and 3 months using plaque indices ( PIs ) along with WSL status . Data were statistically analyzed using Statistical Package for the Social Sciences ( SPSS ) statistical software , version 19 , with chi-square test and t-test . RESULTS At the baseline , plaque score was higher in the study group over control group ( p > 0.038 ) , whereas it was decreased after 3 months in the test group ( p > 0.001 ) . For WSL , there was no significant difference at baseline , but it was significantly lower in study group ( p > 0.003 ) . CONCLUSION Oral hygiene status improved with text message reminder Objective To investigate the effect of using mobile applications active reminders to improve oral hygiene in comparison to verbal oral hygiene instructions . Design Two-arm parallel r and omised controlled trial . Setting orthodontic clinics at two branches of a university hospitals of the college of dentistry of Riyadh Colleges of Dentistry and Pharmacy , Riyadh , Saudi Arabia . Participants Forty-four 12-year-old and older subjects . Method Subjects undergoing orthodontic treatment with fixed appliances were r and omly assigned to one of two groups using simple r and omisation . Group I : subjects received a mobile application that sends active reminders of oral hygiene three times a day ( n = 22 ) . Group II : subjects received verbal oral hygiene instructions verbally during their routine orthodontic visits ( n = 22 ) . Two primary outcomes were assessed using plaque index ( PI ) and gingival index ( GI ) for Ramfjord teeth to evaluate the level of oral hygiene at baseline and after 4 weeks . Results Mean differences for PI and GI for group I were reduced from T1 to T2 ( P < 0.05 , P < 0.05 ) but did not significantly change for group II ( P > 0.05 , P > 0.05 ) . Both PI and GI significantly reduced for group I compared to group II between T1 and T2 ( P < 0.05 , P < 0.05 ) . Conclusions PI and GI all significantly decreased after 4 weeks of using active reminders of oral hygiene instructions on mobile application compared to verbal oral hygiene instructions . The study was registered at clinical trials.gov with number : NCT03109769 OBJECTIVE To investigate whether text message reminders regarding oral hygiene have an effect on plaque removal in orthodontic patients . MATERIAL S AND METHODS In this r and omized , controlled clinical trial , 50 orthodontic patients were assigned to either a text message or control group . Patients in the text message group received 12 text messages over the course of 4 weeks and one text message for 8 weeks thereafter . Photos were taken at baseline ( T0 ) , at 4 weeks after baseline ( T1 ) , and at 12 weeks after baseline ( T2 ) . For each subject , photos of eight teeth were taken and then the area of the tooth and amount of plaque were measured using planimetry . RESULTS There was a statistically significant difference in plaque coverage between baseline and both T1 and T2 in the text message group as measured using planimetry . This was demonstrated by comparing the average measurements of the control group and the treatment group . CONCLUSION This study demonstrated that the use of automated text message reminders sent from an orthodontic office was effective in improving oral hygiene compliance in orthodontic patients Objectives This study aims to determine the effectiveness of a messaging app ( WeChat ) in improving patients ’ compliance and reducing the duration of orthodontic treatment ( DOT ) . Material s and methods A r and omized controlled trial was performed in a dental hospital and a clinic from August 2012 to May 2015 . Orthodontic patients were included at the beginning of treatment . Patients with multiphase treatment or braceless technique were excluded . Participants were r and omized to WeChat group ( received regular reminders and educational messages ) or control group ( received conventional management ) and were followed up until the treatment was completed . Primary outcome measure was DOT . Others were late and failed attendance , bracket bond failure , and oral hygiene condition . Results One hundred twelve patients in each group participated and completed the trial . DOT in WeChat group were 7.3 weeks shorter ( P = 0.007 ) . There were less failed attendance ( 3.1 vs. 10.9 % , P < 0.001 )
Output:
| The pooled SMD for the dental plaque index ( n = 10 studies ) was -9.43 ( 95 % CI -14.36 to -4.495 ; I2 = 99 % , p < 0.001 ) , and that of gingival bleeding ( n = 7 studies ) was -8.54 ( 95 % CI -13.16 to -3.91 ; I2 = 99 % , p < 0.001 ) , indicating significant improvement in dental plaque control and gingival bleeding for groups that received the mobile health ( mHealth ) strategy .
CONCLUSION mHealth can be used as an adjunct component in managing gingivitis , acquiring oral health knowledge and improving oral hygiene |
MS210896 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: OBJECTIVES Self-criticism and reassurance are important mechanisms for regulating negative emotions but relatively little attention has been paid to interventions aim ed at improving them . DESIGN This study explored the use of an expressive writing task to increase self-reassurance and reduce self-criticism using a r and omized controlled design . METHOD A total of 46 participants wrote either about life goals ( the expressive writing task , n= 23 ) or a control topic ( a review of a recent book or film , n= 23 ) for 15 min , three times within an hour . Measures of self-criticism/self-reassurance , stress , and positive affect were completed at baseline and at 2-week follow-up . The Linguistic Inquiry and Word Count ( LIWC ) was used to analyse the writing of participants in the ' life goals ' condition to identify psychological processes that might differentiate those who improved and those who did not . RESULTS While there were no significant changes in self-reported stress or positive affect , participants writing about life goals decreased in their levels of self-criticism at 2-week follow-up relative to participants writing about control topics . Text analysis showed that experimental participants using words that imply the possibility of doubt or failure , including use of the subjunctive tense ( e.g. , could , would , should ) , were least likely to decrease their self-criticism . CONCLUSION . Expressive writing shows promise as a means by which people may decrease in their self-criticism . Future research should determine whether such experimentally induced changes in self-criticism lead to the improvements in psychological health that is implied by previous cross-sectional research Growing evidence suggests that well-being interventions can be effective . However , it is unclear whether happiness-increasing practice s are equally effective for individuals from different cultural background s. To investigate this question , Anglo Americans and predominantly foreign-born Asian Americans were r and omly assigned to express optimism , convey gratitude , or list their past experiences ( control group ) . Multilevel analyses indicated that participants in the optimism and gratitude conditions reported enhanced life satisfaction relative to those in the control condition . However , Anglo Americans in the treatment conditions demonstrated larger increases in life satisfaction relative to Asian Americans , while both cultural groups in the control condition showed the least improvement . These results are consistent with the idea that the value individualist cultures place on self-improvement and personal agency bolsters the efforts of Anglo Americans to become more satisfied , whereas collectivist cultures ’ de-emphasis of self-focus and individual goals interferes with the efforts of Asian Americans to pursue enhanced well-being This study examined the influence of expressive writing on working memory capacity ( WMC ) , a component of executive function . Japanese undergraduates ( N=104 ) were individually tested across six separate experimental sessions ( baseline , three writing , and two follow-up sessions at 1 and 5 weeks ) . Participants were r and omly assigned to write about a traumatic experience , their best possible future selves ( BPS ) , or a trivial topic for 20 minutes . WMC tests were completed at baseline and follow-ups . Results indicate that expressive writing about traumatic experience can improve WMC at 5 weeks after writing , but that writing about BPS or trivial topics has no effect on WMC Most systematic review s rely substantially on the assessment of the method ological quality of the individual trials . The aim of this study was to obtain consensus among experts about a set of generic core items for quality assessment of r and omized clinical trials ( RCTs ) . The invited participants were experts in the field of quality assessment of RCTs . The initial item pool contained all items from existing criteria lists . Subsequently , we reduced the number of items by using the Delphi consensus technique . Each Delphi round comprised a question naire , an analysis , and a feedback report . The feedback report included staff team decisions made on the basis of the analysis and their justification . A total of 33 international experts agreed to participate , of whom 21 completed all question naires . The initial item pool of 206 items was reduced to 9 items in three Delphi rounds . The final criteria list ( the Delphi list ) was satisfactory to all participants . It is a starting point on the way to a minimum reference st and ard for RCTs on many different research topics . This list is not intended to replace , but rather to be used alongside , existing criteria lists
Output:
| These results indicate that the BPS can be considered a valuable Positive Psychology Intervention to improve clients ' wellbeing , and it seems that it might be more effective for older participants and with shorter practice s ( measured as total minutes of practice ) |
MS210897 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: BACKGROUND Minimally invasive plate osteo synthesis ( MIPO ) is an established technique for fixation of fractures of the distal third tibia . Our study aim ed to manage intra articular and extraarticular fractures of the distal third tibia by the minimally invasive plate osteo synthesis technique and follow them prospect ively . Clinical and radiological outcomes were studied and clinical indications & efficacy of the procedure review ed . Though many studies on the subject have been done previously , these have been retrospective review s or small series . METHODS From May 2010 to May 2013 , 50 patients of closed distal tibial fractures were operated by MIPO technique with a distal tibial anatomical locking plate having 4.5/5 proximal and 3.5/4 distal screw holes . The follow up duration was for 3 years . RESULTS The mean fracture healing time was 21.4 weeks ( range 16 - 32 weeks ) and average AOFAS score 95.06 was out of a total possible 100 points . At last follow up , superficial infection occurred in 5 patients ( 10 % ) ; deep infection , implant failure and malunion in 1-patient each ( 2 % ) . CONCLUSION MIPO technique provides good , though slightly delayed bone healing and decreases incidence of nonunion and need for bone grafting . This technique should be used in distal tibia fractures where locked nailing can not be done like fractures with small distal metaphyseal fragments , vertical splits , markedly comminuted fractures and in fractures with intra-articular extension BACKGROUND The ideal treatment of distal tibial extra articular fractures remains controversial . Minimally invasive percutaneous plate osteo synthesis and intramedullary nailing are the two most commonly used methods . We did a prospect i ve r and omized controlled study to assess the functional outcome of distal tibial extra articular tibial fractures by comparing these treatment methods . MATERIAL S AND METHODS Sixty patients with distal tibial extra articular fractures were r and omly assigned to an IMN ( intramedullary nailing ) group and a MIPPO ( minimally invasive percutaneous plate osteo synthesis ) group . All patients were followed up for a period of one year . At final follow-up , clinical and radiological outcome was assessed by foot function index . Malunion , infection , implant removal , time to union and secondary interventions were compared between the two groups . The comparison of continuous variables was performed by using the Student t-test or Mann-Whitney U test in accordance with normality testing . A value of p less than 0.05 was considered statistically significant . RESULTS All patients were followed up for a period of one year . Time to callus formation was equal in both groups . There was no non-union in our series . Malunion was more common in the nailing group . The foot function index was similar in both groups . CONCLUSION MIPPO and intramedullary nailing are effective treatment options in the management of distal tibial extra particular fractures , with comparable functional outcomes Objective : To evaluate the clinical , radiographic , and functional outcomes of middle and distal third humeral shaft fractures treated with the minimally invasive percutaneous osteo synthesis ( MIPO ) . Design : Prospect i ve , single-center , nonconsecutive clinical series study . Setting : Skeletal trauma center of a university teaching hospital . Patients : Thirteen patients who were seen from May 2004 to October 2005 with an average age of 38.1 years ( range , 25 to 60 years ) form the basis of this study . Patients were obtained from a surgical data base of 1 surgeon . Intervention : The middle and the distal third humeral shaft fractures were reduced by closed means and fixed with long narrow 4.5-mm dynamic compression plates introduced through 2 small incisions away from the fracture sites and placed on the anterior aspect of the humerus . Main Outcome Measurements : Time to fracture healing and functional assessment s were assessed at an average follow-up of 12.5 months ( range , 7 to 19 months ) for the affected shoulders and elbows using the UCLA and Mayo elbow performance scoring systems , respectively . Results : All fractures united with a mean healing time of 16.2 weeks ( range , 12 to 32 years ) . There were no nonunions , radial nerve palsies , or implant failures . The UCLA scoring system showed excellent results in 7 cases ( 53.8 % ) and good results in 6 cases ( 46.2 % ) . Thirteen patients had excellent results of their elbow function when assessed with the Mayo elbow performance scoring system . Conclusion : Closed reduction and internal fixation of middle or distal third humeral shaft fractures using MIPO is a safe and effective surgical treatment method and an alternative option to open techniques This study compared the results of external fixation combined with limited open reduction and internal fixation ( EF + LORIF ) , minimally invasive percutaneous plate osteo synthesis ( MIPPO ) , and intramedullary nailing ( IMN ) for distal tibia fractures . A total of 84 patients with distal tibia shaft fractures were r and omized to operative stabilization using EF + LORIF ( 28 cases ) , MIPPO ( 28 cases ) , or IMN ( 28 cases ) . The 3 groups were comparable with respect to patient demographics . Data were collected on operative time and radiation time , union time , complications , time of recovery to work , secondary operations , and measured joint function using the American Orthopaedic Foot and Ankle Society ( AOFAS ) score . There was no significant difference in time to union , incidence of union status , time of recovery to work , and AOFAS scores among the 3 groups ( P>.05 ) . Mean operative time and radiation time in the MIPPO group were longer than those in the IMN or EF + LORIF groups ( P<.05 ) . Wound complications after MIPPO were more common compared with IMN or EF + LORIF ( P<.05 ) . Anterior knee pain occurred frequently after IMN ( 32.1 % ) , and irritation symptoms were encountered more frequently after MIPPO ( 46.4 % ) . Although EF + LORIF was associated with fewer secondary procedures vs MIPPO or IMN , it was related with more pin-tract infections ( 14.3 % ) . Findings indicated that EF + LORIF , MIPPO , and IMN all achieved similar good functional results . However , EF + LORIF had some advantages over MIPPO and IMN in reducing operative and radiation times , postoperative complications , and reoperation rate . [ Orthopedics . 2016 ; 39(4):e627-e633 . ] Flaws in the design , conduct , analysis , and reporting of r and omised trials can cause the effect of an intervention to be underestimated or overestimated . The Cochrane Collaboration ’s tool for assessing risk of bias aims to make the process clearer and more Introduction : The treatment of fractures of proximal and distal tibia is challenging , because of the limited soft tissue envelope and poor vascularity . The best treatment remains controversial and it depends on the fracture morphology , displacement and comminution . Treatment options vary from closed reduction and cast to open reduction and internal fixation with plate . Open reduction and internal fixation with plate can result in extensive dissection and tissue devitalization . We conducted a study on management of these fractures by biological osteo synthesis using Minimally Invasive Plate Osteo synthesis ( MIPO ) technique with preservation of osseous and soft tissue vascularity . Methods : We conducted a prospect i ve study on closed reduction and percutaneous plating in 30 cases ( mean age 42.7 years ; 22 males and 8 females ) of closed fractures of tibia . Among them 24 had proximal tibial fractures and 6 had distal tibial fractures . The mean time from injury to surgery was seven days . Results : The mean operative time was 72.6 minutes ( range : 55 - 90 minutes ) . Mean time for radiological union was 17 weeks ( range : 14 - 22 weeks ) . There was one superficial wound infection which resolved with daily dressings and one week of oral antibiotics . One patient developed a nonunion which required a bone grafting procedure . Conclusions : The satisfactory functional results and lack of soft tissue complications suggest that this method should be considered in periarticular fractures . Biological fixation of complex fractures gives stable as well as optimal internal fixation and complete recovery of limb function at an early stage with minimal risk of complications Purpose The purpose of this r and omized clinical trial is to compare intramedullary nailing ( IMN ) versus minimally invasive plate osteo synthesis ( MIPO ) for the treatment of extra-articular distal tibial shaft fractures . Material s and methods Twenty-five consecutive patients with distal extra-articular tibial fractures which were located between 4 and 12 cm from the tibial plafond ( AO 42A1 and 43A1 ) were r and omly assigned into IMN ( n : 10 ) or MIPO ( n : 15 ) treatment groups . All patients were followed for at least 1 year . Foot function index , time to weight bearing , union time , duration of operation , length of incision , intra-operative blood loss , intra-operative fluoroscopy time , rotational and angular malalignment , rate of infection , secondary interventions and complications were compared between groups . Results All patients completed the trial and were followed with a mean of 23.1 ± 9.4 months ( range 12–52 ) . Foot function index , weight bearing time , union time , rate of malunion , rate of infection and rate of secondary interventions were all similar between groups ( p = 0.807 , p = 0.177 , p = 0.402 , p = 0.358 , p = 0.404 , p = 0.404 , respectively ) . Intra-operative blood loss , length of surgical incision , radiation time and rotational malalignment were higher in the IMN group ( p = 0.012 , p = 0.019 , p = 0.004 and p = 0.027 , respectively ) . Conclusions Results of our study showed that both treatment methods have similar therapeutic efficacy regarding functional outcomes and can be used safely for extra-articular distal tibial shaft fractures , and none of the techniques had a major advantage over the other Purpose A few studies focused on the methods of treatment for displaced distal tibial shaft fractures have been published , all of which compared two different methods . In this r and omized , prospect i ve study , we aim ed to compare minimally invasive plate osteo synthesis , locking intramedullary nail stabilization and external fixation combined with limited open reduction and absorbable internal fixation for distal tibial shaft fractures by assessing complications and secondary procedures . Methods From November 2002 to June 2012 , 137 skeletally mature patients with displaced distal tibial shaft fractures with or without fibula fracture were r and omized to be treated by minimally invasive plate osteo synthesis ( group A , n = 46 ) , locking intramedullary nail ( group B , n = 46 ) or external fixation combined with limited open reduction and absorbable internal fixation ( group C , n = 45 ) . Age , gender , mechanism of injury , fracture pattern and presence of open fracture were equally distributed among the three groups . Indexes for evaluation included hospital stay , operative time , time to radiographic union , union status , infection and the incidence of re-operation . Mazur ankle score was introduced for functional evaluation . Statistics Analysis System ( SAS ) 9.2 was used for analysis . Results A total of 121 patients were included in the final analysis ( group A 42 , group B 40 and group C 39 ) and evaluated after a mean of 14.8 months follow-up . There was no significant difference ( P > 0.05 ) in hospital stay , time to radiographic union and the incidence of union status among the three groups . Although group C was associated with less secondary procedures versus groups A and B , it was related with more pin tract infections ( 15.4 % ) . Anterior knee pain occurred frequently after locking intramedullary nailing ( 37.5 % ) and the irritation symptoms were more frequently encountered in group A ( 59.5 % ) . There was no difference in ankle function between the three methods after operation ( P > 0.05 ) . Conclusions We consider that the minimally invasive plate osteo synthesis , locking intramedullary nail stabilization and external fixation combined with limited open reduction and absorbable internal fixation techniques are all efficient methods for treating distal tibia fractures . With its wide indications , external fixation combined with limited open reduction and absorbable internal fixation leads to minimal soft tissue complication , good functional result and no local soft tissue irritation or implant removal Background : Extraarticular distal tibial fractures are among the most challenging fractures encountered by an orthopedician for treatment because of its subcutaneous location , poor blood supply and decreased muscular cover anteriorly , complications such as delayed union , nonunion , wound infection , and wound dehiscence are often seen as a great challenge to the surgeon . Minimally invasive plate osteo synthesis ( MIPO ) and intramedullary interlocking nail ( IMLN ) are two well-accepted and effective methods , but each has been historically related to complications . This study compares clinical and radiological outcome in extraarticular distal tibia fractures treated by intramedullary interlocking nail ( IMLN ) and minimally invasive plate osteo synthesis ( MIPO ) . Material s and Methods : 42 patients included in this study , 21 underwent IMLN and 21 were treated with MIPO who met the inclusion criteria and operated between June 2014 and May 2015 . Patients were followed up for clinical and radiological
Output:
| Conclusions Compared to MIPPO , IMN had a significantly low risk of wound complications and associated with limited time for reunion .
Although the pooled functional outcomes of the two groups were controversial due to different evaluating scores , IMN was the preferred surgical technique than MIPPO for treating distal tibial fractures |
MS210898 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
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Input: Purpose : A new generation of molecularly targeted agents is entering the definitive stage of clinical evaluation . Many of these drugs benefit only a subset of treated patients and may be overlooked by the traditional , broad- eligibility approach to r and omized clinical trials . Thus , there is a need for development of novel statistical methodology for rapid evaluation of these agents . Experimental Design : We propose a new adaptive design for r and omized clinical trials of targeted agents in setting s where an assay or signature that identifies sensitive patients is not available at the outset of the study . The design combines prospect i ve development of a gene expression – based classifier to select sensitive patients with a properly powered test for overall effect . Results : Performance of the adaptive design , relative to the more traditional design , is evaluated in a simulation study . It is shown that when the proportion of patients sensitive to the new drug is low , the adaptive design substantially reduces the chance of false rejection of effective new treatments . When the new treatment is broadly effective , the adaptive design has power to detect the overall effect similar to the traditional design . Formulas are provided to determine the situations in which the new design is advantageous . Conclusion : Development of a gene expression – based classifier to identify the subset of sensitive patients can be prospect ively incorporated into a r and omized phase III design without compromising the ability to detect an overall effect PURPOSE Biomarkers can add substantial value to current medical practice by providing an integrated approach to prediction using the genetic makeup of the tumor and the genotype of the patient to guide patient-specific treatment selection . We discuss and evaluate various clinical trial design s for the validation of biomarker-guided therapy . METHODS Design s for predictive marker validation are broadly classified as retrospective ( ie , using data from previously well-conducted r and omized controlled trials [ RCTs ] ) versus prospect i ve ( enrichment , unselected , hybrid , or adaptive analysis ) . We discuss the salient features of each design in the context of real trials . RESULTS Well- design ed retrospective analysis from well-conducted prospect i ve RCTs can bring forward effective treatments to marker-defined subgroups of patients in a timely manner ( eg , KRAS and colorectal cancer ) . Enrichment design s are appropriate when preliminary evidence suggest that patients with or without that marker profile do not benefit from the treatments in question ; however , this may sometimes leave questions unanswered ( eg , trastuzumab and breast cancer ) . An unselected design is optimal where preliminary evidence regarding treatment benefit and assay reproducibility is uncertain ( eg , epidermal growth factor receptor and lung cancer ) . Hybrid design s are appropriate when preliminary evidence demonstrate the efficacy of certain treatments for a marker-defined subgroup , making it unethical to r and omly assign patients with that marker status to other treatments ( eg , multigene assay and breast cancer ) . Adaptive analysis design s allow for prespecified marker-defined subgroup analyses of data from an RCT . CONCLUSION The implementation of these design strategies will lead to a more rapid clinical validation of biomarker-guided therapy Purpose : Many anticancer therapies benefit only a subset of treated patients and may be overlooked by the traditional broad eligibility approach to design phase III clinical trials . New biotechnologies such as microarrays can be used to identify the patients that are most likely to benefit from anticancer therapies . However , due to the high-dimensional nature of the genomic data , developing a reliable classifier by the time the definitive phase III trail is design ed may not be feasible . Experimental Design : Previously , Freidlin and Simon ( Clinical Cancer Research , 2005 ) introduced the adaptive signature design that combines a prospect i ve development of a sensitive patient classifier and a properly powered test for overall effect in a single pivotal trial . In this article , we propose a cross-validation extension of the adaptive signature design that optimizes the efficiency of both the classifier development and the validation components of the design . Results : The new design is evaluated through simulations and is applied to data from a r and omized breast cancer trial . Conclusion : The cross-validation approach is shown to considerably improve the performance of the adaptive signature design . We also describe approaches to the estimation of the treatment effect for the identified sensitive sub population . Clin Cancer Res ; 16(2 ) ; Background There is currently much interest in pharmacogenetics : determining variation in genes that regulate drug effects , with a particular emphasis on improving drug safety and efficacy . The ability to determine such variation motivates the application of personalized drug therapies that utilize a patient 's genetic makeup to determine a safe and effective drug at the correct dose . To ascertain whether a genotype-guided drug therapy improves patient care , a personalized medicine intervention may be evaluated within the framework of a r and omized controlled trial . The statistical design of this type of personalized medicine intervention requires special considerations : the distribution of relevant allelic variants in the study population ; and whether the pharmacogenetic intervention is equally effective across sub population s defined by allelic variants . Methods The statistical design of the Clarification of Optimal Anticoagulation through Genetics ( COAG ) trial serves as an illustrative example of a personalized medicine intervention that uses each subject 's genotype information . The COAG trial is a multicenter , double blind , r and omized clinical trial that will compare two approaches to initiation of warfarin therapy : genotype-guided dosing , the initiation of warfarin therapy based on algorithms using clinical information and genotypes for polymorphisms in CYP2C9 and VKORC1 ; and clinical -guided dosing , the initiation of warfarin therapy based on algorithms using only clinical information . Results We determine an absolute minimum detectable difference of 5.49 % based on an assumed 60 % population prevalence of zero or multiple genetic variants in either CYP2C9 or VKORC1 and an assumed 15 % relative effectiveness of genotype-guided warfarin initiation for those with zero or multiple genetic variants . Thus we calculate a sample size of 1238 to achieve a power level of 80 % for the primary outcome . We show that reasonable departures from these assumptions may decrease statistical power to 65 % . Conclusions In a personalized medicine intervention , the minimum detectable difference used in sample size calculations is not a known quantity , but rather an unknown quantity that depends on the genetic makeup of the subjects enrolled . Given the possible sensitivity of sample size and power calculations to these key assumptions , we recommend that they be monitored during the conduct of a personalized medicine intervention . Trial Registration clinical trials.gov : The optimal design of phase II studies continues to be the subject of vigorous debate , especially studies of newer molecularly targeted agents . The observations that many new therapeutics “ fail ” in definitive phase III studies , coupled with the numbers of new agents to be tested as well as the increasing costs and complexity of clinical trials , further emphasize the critical importance of robust and efficient phase II design . The Clinical Trial Design Task Force ( CTD-TF ) of the National Cancer Institute ( NCI ) Investigational Drug Steering Committee ( IDSC ) has published a series of discussion papers on phase II trial design in Clinical Cancer Research . The IDSC has developed formal recommendations about aspects of phase II trial design that are the subject of frequent debate , such as endpoints ( response versus progression-free survival ) , r and omization ( single-arm design s versus r and omization ) , inclusion of biomarkers , biomarker-based patient enrichment strategies , and statistical design ( e.g. , two-stage design s versus multiple-group adaptive design s ) . Although these recommendations in general encourage the use of progression-free survival as the primary endpoint , r and omization , inclusion of biomarkers , and incorporation of newer design s , we acknowledge that objective response as an endpoint and single-arm design s remain relevant in certain situations . The design of any clinical trial should always be carefully evaluated and justified based on characteristic specific to the situation . Clin Cancer Res ; 16(6 ) ; Pharmacogenomics is the science of determining how the benefits and adverse effects of a drug vary among a target population of patients based on genomic features of the patient 's germ line and diseased tissue . By identifying those patients who are most likely to respond while eliminating serious adverse effects , the therapeutic index of a drug can be substantially increased . This may facilitate demonstrating the effectiveness of the drug and may avoid subsequent problems due to serious adverse events . Our objective here is to provide clinical trial design s and analysis strategies for the utilization of genomic signatures as classifiers for patient stratification or patient selection in therapeutics development . We review methods for the development of genomic signature classifiers of treatment outcome in high-dimensional setting s , where the number of variables available for prediction far exceeds the number of cases . The split- sample and crossvalidation methods for obtaining estimates of prediction accuracy in developmental studies are described . We present clinical trial design s for utilizing genomic signature classifiers in therapeutics development . The purpose of the classifier is to facilitate the identification of groups of patients with a high probability of benefiting from it and avoiding serious adverse events . We distinguish exploratory analysis during the development of the genomic classifier from prospect i ve planning and rigorous testing of therapeutic hypotheses in studies that utilize the genomic classifier in therapeutics development . We discuss a variety of clinical trial design s including those utilizing specimen collection and assay prospect ively for newly accrued patients and those involving a prospect ively planned analysis of archived specimens from a previously conducted clinical trial . Our discussion of the development and use of classifiers of efficacy is mostly focused on applications in oncology using classifiers based on biomarkers measured in tumors . Some of the same considerations apply , however , to development of efficacy and safety classifiers in nononcologic diseases based on single-nucleotide germline polymorphisms Advancements made in molecularly targeted therapeutics have focussed increasing attention on biomarker-adaptive clinical trial design s as a means of improving the efficiency of drug development and advancing medical care . Here , we focus on r and omized clinical trial ( RCT ) design s aim ed at developing/validating clinical ly relevant pharmacogenomic biomarkers capable of identifying patients sensitive to a given therapy(s ) , and thereby , selecting the best therapy for a given patient . The term ‘ biomarker-adaptive ’ refers to biomarker trials that incorporate adaptive clinical trial method ology to modify the trial according to the accumulating outcome data . While some adaptive methods ( e.g. , interim monitoring ) have been an integral part of traditional clinical trial design for decades , these methods can be particularly advantageous in biomarker studies that evaluate molecularly targeted therapies . Here , we briefly review the main clinical trial methods that are used in design ing adaptive trials . We then discuss how these methods can be used to improve the efficiency of biomarker RCT design The decade since the publication of the Human Genome Project draft has ended with the discovery of hundreds of genomic markers related to diseases and phenotypes . However , the project has not yet delivered on its promise to tailor treatments for individuals . The number of genomic markers in clinical practice is very small . The number of markers to guide treatment decisions is even smaller . In order to speed up discovery and validation of genomic treatment selection markers , we call for considering the brilliant potential of r and omized clinical trials . If biomedical research community can collaborate in organizing large-scale consortium of clinical trials associated with well- design ed biobanks , these studies would soon act as huge laboratories for investigating genomic medicine ; a big step forward towards personalizing medicine BACKGROUND We present the combined results of two trials that compared adjuvant chemotherapy with or without concurrent trastuzumab in women with surgically removed HER2-positive breast cancer . METHODS The National Surgical Adjuvant Breast and Bowel Project trial B-31 compared doxorubicin and cyclophosphamide followed by paclitaxel every 3 weeks ( group 1 ) with the same regimen plus 52 weeks of trastuzumab beginning with the first dose of paclitaxel ( group 2 ) . The North Central Cancer Treatment Group trial N9831 compared three regimens : doxorubicin and cyclophosphamide followed by weekly paclitaxel ( group A ) , the same regimen followed by 52 weeks of trastuzumab after paclitaxel ( group B ) , and the same regimen plus 52 weeks of trastuzumab initiated concomitantly with paclitaxel ( group C ) . The studies were amended to include a joint analysis comparing groups 1 and A ( the control group ) with groups 2 and C ( the trastuzumab group ) . Group B was excluded because trastuzumab was not given concurrently with paclitaxel . RESULTS By March 15 , 2005 , 394 events ( recurrent , second primary cancer , or death before recurrence ) had been reported , triggering the first scheduled interim analysis . Of these , 133 were in the trastuzumab group and 261 in the control group ( hazard ratio , 0.48 ; P<0.0001 ) . This result crossed the early stopping boundary . The absolute difference in disease-free survival between the trastuzumab group and the control group was 12 percent at three years . Trastuzumab therapy was associated with a 33 percent reduction in the risk of death ( P=0.015 ) . The three-year cumulative incidence of class III or IV congestive heart failure or death from cardiac causes in the trastuzumab group was 4.1 percent in trial B-31 and 2.9 percent in trial N9831 . CONCLUSIONS Trastuzumab combined with paclitaxel after doxorubicin and cyclophosphamide improves outcomes among women with surgically removed HER2-positive breast cancer . ( Clinical Trials.gov numbers , NCT00004067 and NCT00005970 . The developmental pathway from discovery to clinical practice for biomarkers and biomarker-directed therapies is complex . While several issues need careful consideration , two critical issues that surround the validation of biomarkers are the choice of clinical trial design ( which is based on the strength of the preliminary evidence and marker prevalence ) and the biomarker assay related issues surrounding the marker assessment methods such as the reliability and reproducibility of the assay . This review focuses on trial design s for marker validation , both in
Output:
| Our review showed that a considerable number of labels has been proposed for trial design s evaluating prognostic and predictive biomarkers which , based on patient flow elements , can be classified into five basic categories . |
MS210899 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: OBJECTIVES Patients with knee osteoarthritis ( OA ) often suffer pain that is not fully controlled by analgesics and often require intra-articular therapies . The aim of this study was to compare the benefits of intra-articular corticosteroid injections ( CSIs ) and tidal irrigation ( TI ) in patients with OA of the knee . METHODS We performed a dual-centre , single blind , r and omised , parallel group trial comparing TI and CSI . Patients with knee OA were r and omised to either irrigation using a 3.2 mm arthroscope under local anaesthesia or an intra-articular injection of 40 mg triamcinolone acetonide and 1 % lidocaine . Patients were followed for 6 months . The primary outcome measure was the Western Ontario and McMaster Universities OA Index total pain score ( visual analogue scale , VAS ) . RESULTS One hundred and fifty patients were recruited of whom 71 received TI and 79 CSI . In both treatment groups , over 80 % of patients reported improvement at 2 and 4 weeks . After this time , the benefit of CSI decreased whereas that of TI was maintained : at 26 weeks the pain relief afforded by TI was significantly greater than that of CSI . At 26 weeks 29 % of the CSI group reported improvement vs 64 % of the TI group ( P<0.001 ) . Patients with a knee effusion responded better to both treatments , however , this was most apparent for CSI . Patients with less severe radiographic OA also obtained the greatest improvement from both treatments . CONCLUSION Both procedures lead to significant short-term pain relief of at least 4 weeks , however , TI displayed a significantly greater duration of benefit . Patients with effusions and milder radiographic change obtained the best response to treatment Osteoarthritis of the knee is the most common cause of chronic disability among older persons in the United States [ 1 ] . In persons with symptomatic osteoarthritis of the knee , quadriceps muscle weakness is common and is widely believed to result from disuse atrophy secondary to joint pain . Although exercises to strengthen the quadriceps may relieve joint pain in persons with osteoarthritis of the knee [ 2 - 6 ] , the role of periarticular muscle weakness in the pathogenesis of joint pain and disability in these persons is poorly understood . The basis for the beneficial effect of strengthening exercises is unclear , and the duration of the improvement has not been studied . Furthermore , the possibility that muscle weakness is an etiologic factor underlying the pathologic changes of osteoarthritis has seldom been considered . Elucidation of the role of muscle weakness in osteoarthritis is particularly important given our growing underst and ing of safe and effective methods for increasing strength in elderly persons [ 7 , 8 ] . A substantial proportion of persons who have radiographic evidence of osteoarthritis of the knee have no joint pain [ 9 ] . Because asymptomatic persons with radiographic changes seldom seek medical attention for osteoarthritis , muscle weakness has not been studied previously in this group . Thus , it is not known whether quadriceps weakness precedes or follows joint pain or ( if it follows joint pain ) whether it is mediated by disuse atrophy or by physiologic mechanisms that may inhibit muscle contraction [ 10 ] . To address this issue , we studied the relation among lower-extremity muscle strength , lower-extremity lean tissue mass , and osteoarthritis of the knee in men and women 65 years of age and older . Methods Study Group To obtain a sample of elderly persons living in the community , we conducted brief telephone interviews with residents of households in central Indiana . Potential participants were selected through modified r and om-digit dialing to increase the sample d proportion of persons 65 years of age and older . Persons were eligible if they met the minimal criteria for participation : They were willing and able to provide informed consent and to undergo the necessary strength assessment s and other evaluations . Persons were excluded if they had had amputations of both lower extremities , had undergone total knee arthroplasty , or had recently had a cerebrovascular accident or myocardial infa rct ion . A total of 462 persons ( approximately 55 % of all who were eligible ) agreed to participate and completed the following evaluations . Evaluations Radiography of the Knee St and ing anteroposterior and lateral radiographs of both knees of each study participant were obtained , and the severity of osteoarthritis in the tibiofemoral compartment was grade d by a musculoskeletal radiologist according to the criteria of Kellgren and Lawrence . Similar criteria , based on the presence of osteophytes and joint space narrowing , were used for the patellofemoral compartment [ 11 ] . The radiologist was blinded to the clinical status and characteristics of all patients . A participant had to have a Kellgren and Lawrence grade of 2 or more in either knee to be classified as having osteoarthritis . Knee Pain and Function The Western Ontario and McMaster Universities Arthritis Index was used to evaluate knee pain and function [ 12 ] . This index assesses the severity of knee pain during 5 activities or situations ( walking on a flat surface , going up or down stairs , at night while in bed , sitting or lying , and st and ing upright ) and the severity of impairment of lower-extremity function during 17 activities . Pain and functional impairment were assessed in each knee separately . Responses to each question about the severity of knee pain and level of impairment were recorded on a categorical scale as none , mild , moderate , severe , or extreme . Each category was assigned a corresponding numeric score from 1 to 5 ( 5 = extreme ) . Hence , the range on the pain scale was 5 to 25 and the range on the physical impairment scale was 17 to 85 ( 85 = greatest functional limitation ) . For the purpose s of analysis , participants who rated the severity of their knee pain as moderate or greater ( 3 ) with any of the 5 activities on more than half of the days in the month preceding the evaluation were considered to have knee pain . Thus , pain in the more distant past that had resolved was not included . Participants were also question ed about current and previous regular ( 5 times per week ) or occasional use of over-the-counter and prescription analgesics and nonsteroidal anti-inflammatory drugs ( NSAIDs ) in the past year . Lower-Extremity Muscle Strength The strength of each leg was evaluated by using an isokinetic dynamometer ( KIN-COM 500H , Chattecx Corp. , Hixson , Tennessee ) . Peak torque was recorded in both the concentric ( contractions during muscle shortening ) and eccentric ( contractions during muscle lengthening ) modes . Participants were allowed several submaximal or maximal practice efforts to familiarize themselves with the operation of the dynamometer . Once formal testing began , the best of three maximal efforts was recorded for flexion and extension at both 60 degrees per second and 120 degrees per second . Aborted efforts were repeated in order to obtain the best possible representation of strength for each participant . Concentric and eccentric testing yielded similar results , but because of greater variability in eccentric testing , only the concentric test results are shown . Lower-Extremity Lean Tissue Mass Total-body dual-energy x-ray absorptiometry was done in all participants by using a Lunar-DPX-L instrument ( Lunar Corp. , Madison , Wisconsin ) . Results were analyzed for total and regional body composition , including body fat , mineral , and lean components ( lean components were components other than fat or mineral ) . The right and left lower extremities were analyzed separately . The lower extremity was defined as all tissue below a diagonal line drawn outward and upward from the groin area through the femoral neck . Statistical Analysis Participants were divided into four groups on the basis of presence or absence of radiographic evidence of osteoarthritis of the knee and presence or absence of knee pain , as defined above . Men and women were compared by using the t-test . Comparisons of Arthritis Index pain and functional impairment scores were done by using nonparametric approaches . For analyses of continuous data involving more than two groups of participants ( for example , osteoarthritis with or without knee pain ) , analysis of variance was used to determine whether an overall difference was present . The Fisher protected least-significant-difference procedure was used for pairwise comparisons . Comparisons within participants ( for example , comparison of the two legs in a person with unilateral osteoarthritis of the knee ) were done by using paired t-tests . Regression models were constructed with the generalized estimating equations approach of Zeger and Liang [ 13 ] . This approach inflates the st and ard errors to adjust for correlations in both independent variables ( such as strength ) and dependent variables ( such as radiographic grade ) within participants . Statistically significant differences ( P < 0.05 ) in the above analyses are specifically noted below . Results The characteristics of the 462 men and women in the cohort are shown in Table 1 . As expected , men were taller , were heavier , and had greater lower-extremity strength and lean tissue mass in the lower extremities compared with women ( P < 0.001 for all comparisons ) . Table 1 . Age , Height , Weight , and Lower-Extremity Strength and Lean Tissue Mass * One hundred forty-five participants ( 31 % ; 33 % of the women and 30 % of the men ) had radiographic evidence of osteoarthritis involving the tibiofemoral compartment , the patellofemoral compartment , or both . In 62 participants ( 43 % ) , the radiographic changes were unilateral . Table 2 shows the association between osteoarthritis and obesity [ 14 - 16 ] . Women in the cohort who had osteoarthritis were approximately 15 % heavier than women with normal radiographs and no knee pain . Men with osteoarthritis were also slightly heavier than men without osteoarthritis . Table 2 . Body Weight and Summed Arthritis Index Scores for Recent Pain and Function in the Left Knee in Participants with and without Radiographic Evidence of Osteoarthritis * Among those with radiographic evidence of tibiofemoral osteoarthritis , women were slightly more likely than men to report knee pain ( P = 0.10 ; Table 3 ) . Table 3 . Radiography and Recent Pain in the Left Knee Table 2 also shows the mean summed and the distribution of scores for left knee pain and functional impairment ( data for the right knee were similar ) . Among men and women with radiographic evidence of osteoarthritis who reported having knee pain , the mean summed pain score for the knee with osteoarthritis was approximately 12 ( median score , 2 of 5 ) . In comparison , the mean pain score of participants who reported knee pain but did not have radiographic evidence of osteoarthritis in the painful knee was approximately 10 ( median score , 2 of 5)-only slightly lower than the mean pain score of participants with radiographic changes . Consistent with their relatively low pain scores , these community-dwelling participants with osteoarthritis reported moderately low use of NSAIDs ( Table 4 ) . Table 4 . Participants Reporting Regular Current or Previous Use of Analgesics and Nonsteroidal Anti-inflammatory Drugs Related to the Presence of Radiographic Evidence of Osteoarthritis of the Knee and Recent Knee Pain * Arthritis Index scores for functional impairment paralleled those for pain ( Table 2 ) . Participants with osteoarthritis had the greatest functional impairment ( P < 0.001 for the comparison with patients who did not have pain or radiographic evidence of osteoarthritis ) . Functional impairment in participants who had pain but no radiographic evidence of OBJECTIVE To determine the relationship between change in body mass and knee-joint moments and forces during walking in overweight and obese older adults with knee osteoarthritis ( OA ) following an 18-month clinical trial of diet and exercise . METHODS Data were obtained from 142 sedentary , overweight , and obese older adults with self-reported disability and radiographic evidence of knee OA who underwent 3-dimensional gait analysis . Gait kinetic outcome variables included peak knee-joint forces and peak internal knee-joint moments . Mixed regression models were created to predict followup kinetic values , using followup body mass as the primary explanatory variable . Baseline body mass was used as a covariate , and thus followup body mass was a surrogate measure for change in body mass ( i.e. , weight loss ) . RESULTS There was a significant direct association between followup body mass and peak followup values of compressive force ( P = 0.001 ) , result ant force ( P = 0.002 ) , abduction moment ( P = 0.03 ) , and medial rotation moment ( P = 0.02 ) . A weight reduction of 9.8 N ( 1 kg ) was associated with reductions of 40.6 N and 38.7 N in compressive and result ant forces , respectively . Thus , each weight-loss unit was associated with an approximately 4-unit reduction in knee-joint forces . In addition , a reduction in body weight of 9.8 N ( 1 kg ) was associated with a 1.4 % reduction ( 0.496 Nm ) in knee abduction moment . CONCLUSION Our results indicate that each pound of weight lost will result in a 4-fold reduction in the load exerted on the knee per step during daily activities . Accumulated over thous and s of steps per day , a reduction of this magnitude would appear to be clinical ly meaningful OBJECTIVE . To compare the safety and efficacy of a topical diclofenac solution versus oral diclofenac in relieving the symptoms of primary osteoarthritis ( OA ) of the knee , in a r and omized , double-blind , double-dummy equivalence trial . METHODS A total of 622 men and women with radiological evidence of primary knee OA and mild to severe symptoms were r and omly assigned to
Output:
| Other noninvasive or less invasive strategies are available that have varying degrees of effect .
Conclusions : Although the evidence supporting many of the clinical management options might be considered modest , those effects are sufficient to permit an active lifestyle and have , given the prevalence of the disease , a public health impact |
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