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MS210600 | ***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 300IR ( index of reactivity ) 5-grass pollen tablet has favorable short-term and sustained clinical efficacy in patients with grass pollen-induced allergic rhinoconjunctivitis ( ARC ) . Here , we report maintenance of efficacy and safety over 2 years following treatment discontinuation . Methods R and omized , double-blind , placebo-controlled , parallel-group , multicenter Phase 3 trial in patients aged 18–50 years with ARC . During study years 1–3 , patients received a daily sublingual tablet containing either 300IR 5-grass pollen extract or placebo , according to a discontinuous pre- and coseasonal protocol . Study years 4 and 5 were treatment-free . In response to health authorities ’ recommendations , the daily combined score ( DCS ) was assessed in a post-hoc analysis as the efficacy endpoint . Components of the DCS were daily rhinoconjunctivitis total symptom score ( DRTSS ) and daily rescue medication score ( DRMS ) . Results 633 patients with ARC were r and omized to placebo ( n = 219 ) or 300IR 5-grass pollen tablet , beginning 4 months ( 4 M , n = 207 ) or 2 months ( 2 M , n = 207 ) prior to the estimated start of the grass pollen season and continuing until season ’s end . During the first post-treatment year , a statistically significant difference versus placebo in least squares ( LS ) mean DCS was noted in patients previously receiving active treatment ( 300IR ( 2 M ) point estimate : −0.16 , 95 % confidence interval ( CI95 % ) : [ −0.26 , −0.06 ] , p = 0.0019 ; −31.1 % ; 300IR ( 4 M ) point estimate : −0.13 , CI95 % : [ −0.23 , −0.03 ] , p = 0.0103 , −25.3 % ) . During the second post-treatment year , patients in the 300IR ( 4 M ) group , but not the 300IR ( 2 M ) group , showed a statistically significant difference in LS mean DCS versus placebo ( point estimate : −0.11 , CI95 % : [ −0.21 ; 0.00 ] , p = 0.0478 , −28.1 % ) . This significant efficacy seen during the post-treatment years in patients previously treated with 5-grass pollen tablet compared favorably with that during the 3 prior years of active treatment . A statistically significant difference versus placebo was also noted in secondary efficacy measures in both post-treatment years ( except for DRTSS in year 5 ) . In the absence of any active treatment , the safety profile was similar in the active groups versus placebo group during either post-treatment year . Conclusions In adults with grass pollen-associated ARC , 5-grass pollen tablet therapy beginning 4 months before the pollen season and continuing to season ’s end demonstrated efficacy across all variables during active treatment , and this effect was prolonged for up to 2 years post-treatment . Trial registration Clinical Trials.gov identifier : NCT00418379 BACKGROUND Sublingual immunotherapy is well tolerated and data suggest its effectiveness for the treatment of allergic rhinitis in adults , but it lacks optimum dose definition . OBJECTIVE To assess the efficacy , safety , and optimal dose of grass pollen tablets for immunotherapy of patients with allergic rhinoconjunctivitis . METHODS In this multinational , r and omized , double-blind , placebo-controlled study , 628 adults with grass pollen rhinoconjunctivitis ( confirmed by positive skin prick test and serum-specific IgE ) received 1 of 3 doses of a st and ardized 5-grass pollen extract , or placebo , administered sublingually using a once-daily tablet formulation . The treatment was initiated 4 months before the estimated pollen season and continued throughout the season . The primary outcome was Rhinoconjunctivitis Total Symptom Score ; secondary outcomes included 6 individual symptom scores , rescue medication use , quality of life , and safety assessment s. RESULTS Both the 300-index of reactivity ( IR ) and 500-IR doses significantly reduced mean Rhinoconjunctivitis Total Symptom Score ( 3.58 + /- 3.0 , P = .0001 ; and 3.74 + /- 3.1 , P = .0006 , respectively ) compared with placebo ( 4.93 + /- 3.2 ) in the intent-to-treat and per- protocol analyses . The 100-IR group ( 4.70 + /- 3.1 ) score was not significantly different from placebo . Analysis of all secondary efficacy variables ( sneezing , runny nose , itchy nose , nasal congestion , watery eyes , itchy eyes , rescue medication usage , and quality of life ) confirmed the efficacy of the 300-IR and 500-IR doses . No serious side effects were reported . CONCLUSION In the first pollen season , the efficacy and safety of sublingual immunotherapy with grass tablets was confirmed . The 300-IR and 500-IR doses both demonstrated significant efficacy compared with placebo . CLINICAL IMPLICATION S The risk-benefit ratio favors the use of 300-IR tablets for clinical practice BACKGROUND Allergen immunotherapy ( AIT ) has been thoroughly documented in r and omized controlled trials ( RCTs ) . It is the only immune-modifying and causal treatment available for patients suffering from IgE-mediated diseases such as allergic rhinoconjunctivitis , allergic asthma and insect sting allergy . However , there is a high degree of clinical and method ological heterogeneity among the endpoints in clinical studies on AIT , for both subcutaneous and sublingual immunotherapy ( SCIT and SLIT ) . At present , there are no commonly accepted st and ards for defining the optimal outcome parameters to be used for both primary and secondary endpoints . METHODS As elaborated by a Task Force ( TF ) of the European Academy of Allergy and Clinical Immunology ( EAACI ) Immunotherapy Interest Group , this Position Paper evaluates the currently used outcome parameters in different RCTs and also aims to provide recommendations for the optimal endpoints in future AIT trials for allergic rhinoconjunctivitis . RESULTS Based on a thorough literature review , the TF members have outlined recommendations for nine domains of clinical outcome measures . As the primary outcome , the TF recommends a homogeneous combined symptom and medication score ( CSMS ) as a simple and st and ardized method that balances both symptoms and the need for antiallergic medication in an equally weighted manner . All outcomes , grouped into nine domains , are review ed . CONCLUSION A st and ardized and globally harmonized method for analysing the clinical efficacy of AIT products in RCTs is required . The EAACI TF highlights the CSMS as the primary endpoint for future RCTs in AIT for allergic rhinoconjunctivitis Background In clinical trials , the efficacy of immunotherapy for allergic rhinoconjunctivitis symptoms is often evaluated with the average Rhinoconjunctivitis Total Symptom Score ( ARTSS ) . Effective treatment is associated with a lower ARTSS vs. placebo but use of rescue medication to alleviate symptoms reduces the RTSS and decreases the mean difference between active treatment and placebo groups BACKGROUND Previous trials have demonstrated the efficacy , safety , and optimal dosage of the 5-grass pollen sublingual tablet for adults and children with grass pollen-induced allergic rhinoconjunctivitis . OBJECTIVES We sought to evaluate the efficacy and safety of 300 index of reactivity ( IR ) 5-grass pollen sublingual tablet in US adults . METHODS Adults with grass pollen allergy and Rhinoconjunctivitis Total Symptom Scores of 12 or greater ( scale , 0 - 18 ) during the previous grass pollen season were r and omized in a double-blind , placebo-controlled study to receive 300IR 5-grass pollen sublingual tablet or placebo starting 4 months before and continuing through the pollen season . The primary efficacy end point was the daily Combined Score ( CS ; scale , 0 - 3 ) , which integrates symptoms and rescue medication use . RESULTS Four hundred seventy-three participants were r and omized . The mean daily CS over the pollen period was significantly lower in the active treatment group versus the placebo group ( least-squares mean difference : -0.13 ; 95 % CI , -0.19 to -0.06 ; P = .0003 ; relative reduction : 28.2 % ; 95 % CI , 13.0 % to 43.4 % ) . In placebo-treated participants , the daily CS least-squares mean was 0.32 in the subgroup with baseline timothy grass-specific serum IgE of less than 0.1 kU/L ( n = 23 ) and 0.46 in those with baseline timothy grass-specific serum IgE of 0.1 kU/L or greater ( n = 204 ) . The most frequent reported adverse events were oral pruritus , throat irritation , and nasopharyngitis . There were no reports of anaphylaxis , and no actively treated participant received epinephrine . CONCLUSION In US adults with grass pollen-induced allergic rhinoconjunctivitis , preseasonal and coseasonal treatment with 300IR 5-grass pollen sublingual tablet demonstrated clinical ly meaningful efficacy , especially in study subjects with measurable timothy grass-specific serum IgE. Use of 300IR 5-grass pollen sublingual tablet was safe and well tolerated . A requirement for a measurable level of allergen-specific serum IgE should be considered in future studies in this field BACKGROUND The main aim of specific immunotherapy is sustained effect due to changes in the immune system that can be demonstrated only in long-term trials . OBJECTIVE To investigate sustained efficacy and disease modification in a 5-year double-blind , placebo-controlled trial , including 2 years of blinded follow-up after completion of a 3-year period of treatment , with the SQ-st and ardized grass allergy immunotherapy tablet , Grazax ( Phleum pratense 75,000 SQ-T/2,800 BAU,(∗ ) ALK , Denmark ) or placebo . METHODS A r and omized , double-blind , placebo-controlled , multinational , phase III trial included adults with a history of moderate-to-severe grass pollen-induced allergic rhinoconjunctivitis , with or without asthma , inadequately controlled by symptomatic medications . Two hundred thirty-eight participants completed the trial . End points included rhinoconjunctivitis symptom and medication scores , combined scores , asthma symptom and medication scores , quality of life , days with severe symptoms , immunologic end points , and safety parameters . RESULTS The mean rhinoconjunctivitis daily symptom score was reduced by 25 % to 36 % ( P ≤ .004 ) in the grass allergy immunotherapy tablet group compared with the placebo group over the 5 grass pollen seasons covered by the trial . The rhinoconjunctivitis DMS was reduced by 20 % to 45 % ( P ≤ .022 for seasons 1 - 4 ; P = .114 for season 5 ) , and the weighted rhinoconjunctivitis combined score was reduced by 27 % to 41 % ( P ≤ .003 ) in favor of active treatment . The percentage of days with severe symptoms during the peak grass pollen exposure was in all seasons lower in the active group than in the placebo group , with relative differences of 49 % to 63 % ( P ≤ .0001 ) . Efficacy was supported by long-lasting significant effects on the allergen-specific antibody response . No safety issues were identified . CONCLUSION The results confirm disease modification by SQ-st and ardized grass allergy immunotherapy tablet in addition to effective symptomatic treatment of allergic rhinoconjunctivitis BACKGROUND Seasonal allergic rhinitis is common and troublesome . Sublingual immunotherapy ( SLIT ) has been proposed as an alternative to injection immunotherapy and might offer some advantages if it were effective and practical in a community setting . OBJECTIVES To assess the efficacy and side-effect profile of SLIT in patients with summer hay fever uncontrolled on current st and ard medication . To assess the feasibility of delivering SLIT in a United Kingdom general practice setting . METHODS Double-blind , placebo-controlled study in 186 patients with severe summer hay fever identified from 16 United Kingdom general practice s. After a baseline year to ensure balanced groups , subjects were r and omized , and SLIT was given for 1 or 2 years and compared with placebo . The principal outcome measure was symptoms as recorded on diary cards . Secondary criteria were skin and conjunctival reactivity , allergen-specific IgE and IgG 4 , and the frequency and severity of adverse effects . RESULTS One hundred thirty-six subjects completed the study . After 1 year , no significant differences were found between actively treated subjects and the placebo group . After the second year of therapy , subjects who had received 2 years treatment were 6.8 times more likely to show a reduction in nose running ( P < .001 ) and 2.4 times more likely to have reduced sneezing ( P < .05 ) compared with subjects in the placebo group . Benefits for nasal blockage were found at the peak pollen season and were similar in both actively treated groups . CONCLUSION Sublingual immunotherapy can be
Output:
| The authors analyzed SSs and MSs separately as the primary outcomes for SLIT , whereas a score combining symptoms and rescue medication use is generally favored as the primary outcome by both regulatory agencies and professional societies . |
MS210601 | ***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 objective of this paper is to summarize current knowledge on the possible advantages of lifestyle interventions , with particular attention to physical fitness , cognitive activity , leisure and social activity as well as nutrition . There is a large amount of published papers providing partial evidence and asserting the need for immediate , appropriate preventive lifestyle measures against dementia and AD development . Nevertheless , there are currently great difficulties in drafting effective guidelines in this field . This depends mainly upon lack of r and omized controlled trials assessing benefits versus risks of particular lifestyle interventions strategies . However , due to the rapid increase of dementia burden , lifestyle factors and their amelioration should be already made part of decision making in light of their health-maintaining effects while awaiting for results of well- design ed large prospect i ve cohort studies in dementia OBJECTIVES To investigate the efficacy of a novel brain plasticity-based computerized cognitive training program in older adults and to evaluate the effect on untrained measures of memory and attention and participant-reported outcomes . DESIGN Multisite r and omized controlled double-blind trial with two treatment groups . SETTING Communities in northern and southern California and Minnesota . PARTICIPANTS Community-dwelling adults aged 65 and older ( N=487 ) without a diagnosis of clinical ly significant cognitive impairment . INTERVENTION Participants were r and omized to receive a broadly-available brain plasticity-based computerized cognitive training program ( intervention ) or a novelty- and intensity-matched general cognitive stimulation program modeling treatment as usual ( active control ) . Duration of training was 1 hour per day , 5 days per week , for 8 weeks , for a total of 40 hours . MEASUREMENTS The primary outcome was a composite score calculated from six subtests of the Repeatable Battery for the Assessment of Neuropsychological Status that use the auditory modality ( RBANS Auditory Memory/Attention ) . Secondary measures were derived from performance on the experimental program , st and ardized neuropsychological assessment s of memory and attention , and participant-reported outcomes . RESULTS RBANS Auditory Memory/Attention improvement was significantly greater ( P=.02 ) in the experimental group ( 3.9 points , 95 % confidence interval (CI)=2.7 - 5.1 ) than in the control group ( 1.8 points , 95 % CI=0.6 - 3.0 ) . Multiple secondary measures of memory and attention showed significantly greater improvements in the experimental group ( word list total score , word list delayed recall , digits backwards , letter-number sequencing ; P<.05 ) , as did the participant-reported outcome measure ( P=.001 ) . No advantage for the experimental group was seen in narrative memory . CONCLUSION The experimental program improved generalized measures of memory and attention more than an active control program BACKGROUND Home-based computerised cognitive training ( CCT ) is ineffective at enhancing global cognition , a key marker of cognitive ageing . OBJECTIVES To test the effectiveness of supervised , group-based , multidomain CCT on global cognition in older adults and to characterise the dose-response relationship during and after training . DESIGN A r and omised , double-blind , longitudinal , active-controlled trial . SETTING Community-based training centre in Sydney , Australia Participants : Eighty nondemented community-dwelling older adults ( mean age = 72.1 , 68.8 % females ) with multiple dementia risk factors but no major neuropsychiatric or sensory disorder . Of the 80 participants admitted to the study , 65 completed post-training assessment and 55 were followed up one year after training cessation . INTERVENTIONS Thirty-six group-based sessions over three months of either CCT targeting memory , speed , attention , language and reasoning tasks , or active control training comprising audiovisual educational exercises . MEASUREMENTS Primary outcome was change from baseline in global cognition as defined by a composite score of memory , speed and executive function . Secondary outcome was 15-month change in Bayer Activities of Daily Living from baseline to one year post-training . RESULTS Intention-to-treat analyses revealed significant effects on global cognition in the cognitive training group compared to active control after three weeks of training ( ES = 0.33 , P=.039 ) that increased after 3 months of training ( ES = 0.49 , P=.003 ) and persisted three months after training cessation ( ES = 0.30 , P=0.023 ) . Significant and durable improvements were also noted in memory and processing speed . Dose-response characteristics differed among cognitive domains . Training effects waned gradually but residual gains were noted twelve months post-training . No significant effects on activities of daily living were noted and there were no adverse effects . CONCLUSIONS In older adults with multiple dementia risk factors , group-based CCT is a safe and effective intervention for enhancing overall cognition , memory and processing speed . Dose-response relationships vary for each cognitive domain , vital information for clinical and community implementation and further trial design The concepts of brain and cognitive reserve capture several elements of common wisdom – that we all differ in the neural re sources we are endowed at birth , that experience and especially complex mental activities then modify how these neural re sources are organized and cultivated , and that after any form of brain injury there is significant individual variation in the degree to which clinical deficits may manifest . Transforming these insights into a formal and refutable working definition , however , has been more challenging . Depending on the scale of analysis , brain and cognitive reserve have been defined from neurocentric , neuropsychological , computational , and behavioral perspectives . In our research , we have focused on the behavioral definition , whereby an individual ’s lifetime exposure to complex mental activities is used for prediction of longitudinal cognitive and neurological change . This approach also benefits from a wealth of epidemiological studies linking heightened complex mental activity with reduced dementia risk . Research in the field of cognitive training is also beginning to indicate that incident cognitive decline can be attenuated , with recent clinical trials addressing the major challenges of transfer of gain and durability of effect . High quality r and omized clinical trials are therefore the most urgent priority in this area so that the promise of brain and cognitive reserve can be harnessed for the purpose of the primary prevention of dementia The ultimate goal of cognitive enhancement as an intervention for age-related cognitive decline is transfer to everyday cognitive functioning . Development of training methods that transfer broadly to untrained cognitive tasks ( far transfer ) requires underst and ing of the neural bases of training and far transfer effects . We used cognitive training to test the hypothesis that far transfer is associated with altered attentional control dem and s mediated by the dorsal attention network and trained sensory cortex . In an exploratory study , we r and omly assigned 42 healthy older adults to six weeks of training on Brain Fitness ( BF-auditory perception ) , Space Fortress ( SF-visuomotor/working memory ) , or Rise of Nations ( RON-strategic reasoning ) . Before and after training , cognitive performance , diffusion-derived white matter integrity , and functional connectivity of the superior parietal cortex ( SPC ) were assessed . We found the strongest effects from BF training , which transferred to everyday problem solving and reasoning and selectively changed integrity of occipito-temporal white matter associated with improvement on untrained everyday problem solving . These results show that cognitive gain from auditory perception training depends on heightened white matter integrity in the ventral attention network . In BF and SF ( which also transferred positively ) , a decrease in functional connectivity between SPC and inferior temporal lobe ( ITL ) was observed compared to RON-which did not transfer to untrained cognitive function . These findings highlight the importance for cognitive training of top-down control of sensory processing by the dorsal attention network . Altered brain connectivity - observed in the two training tasks that showed far transfer effects - may be a marker for training success A r and omized pilot experiment examined the neural substrates of response to cognitive training in participants with mild cognitive impairment ( MCI ) . Participants performed exercises previously demonstrated to improve verbal memory and an active control group performed other computer activities . An auditory-verbal fMRI task was conducted before and after the two-month training program . Verbal memory scores improved significantly and left hippocampal activation increased significantly in the experimental group ( gains in 5 of 6 participants ) relative to the control group ( reductions in all 6 participants ) . Results suggest that the hippocampus in MCI may retain sufficient neuroplasticity to benefit from cognitive training BACKGROUND Modifiable vascular and lifestyle-related risk factors have been associated with dementia risk in observational studies . In the Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability ( FINGER ) , a proof-of-concept r and omised controlled trial , we aim ed to assess a multidomain approach to prevent cognitive decline in at-risk elderly people from the general population . METHODS In a double-blind r and omised controlled trial we enrolled individuals aged 60 - 77 years recruited from previous national surveys . Inclusion criteria were CAIDE ( Cardiovascular Risk Factors , Aging and Dementia ) Dementia Risk Score of at least 6 points and cognition at mean level or slightly lower than expected for age . We r and omly assigned participants in a 1:1 ratio to a 2 year multidomain intervention ( diet , exercise , cognitive training , vascular risk monitoring ) , or a control group ( general health advice ) . Computer-generated allocation was done in blocks of four ( two individuals r and omly allocated to each group ) at each site . Group allocation was not actively disclosed to participants and outcome assessors were masked to group allocation . The primary outcome was change in cognition as measured through comprehensive neuropsychological test battery ( NTB ) Z score . Analysis was by modified intention to treat ( all participants with at least one post-baseline observation ) . This trial is registered at Clinical Trials.gov , number NCT01041989 . FINDINGS Between Sept 7 , 2009 , and Nov 24 , 2011 , we screened 2654 individuals and r and omly assigned 1260 to the intervention group ( n=631 ) or control group ( n=629 ) . 591 ( 94 % ) participants in the intervention group and 599 ( 95 % ) in the control group had at least one post-baseline assessment and were included in the modified intention-to-treat analysis . Estimated mean change in NTB total Z score at 2 years was 0·20 ( SE 0·02 , SD 0·51 ) in the intervention group and 0·16 ( 0·01 , 0·51 ) in the control group . Between-group difference in the change of NTB total score per year was 0·022 ( 95 % CI 0·002 - 0·042 , p=0·030 ) . 153 ( 12 % ) individuals dropped out overall . Adverse events occurred in 46 ( 7 % ) participants in the intervention group compared with six ( 1 % ) participants in the control group ; the most common adverse event was musculoskeletal pain ( 32 [ 5 % ] individuals for intervention vs no individuals for control ) . INTERPRETATION Findings from this large , long-term , r and omised controlled trial suggest that a multidomain intervention could improve or maintain cognitive functioning in at-risk elderly people from the general population . FUNDING Academy of Finl and , La Carita Foundation , Alzheimer Association , Alzheimer 's Research and Prevention Foundation , Juho Vainio Foundation , Novo Nordisk Foundation , Finnish Social Insurance Institution , Ministry of Education and Culture , Salama bint Hamdan Al Nahyan Foundation , Axa Research Fund , EVO funding for University Hospitals of Kuopio , Oulu , and Turku and for Seinäjoki Central Hospital and Oulu City Hospital , Swedish Research Council , Swedish Research Council for Health , Working Life and Welfare , and af Jochnick Foundation Remembering the location of objects , an integral part of everyday life , is known to decline with advancing age and early in the course of neurodegenerative dementia . Here , we aim ed to test if object-location learning and its retention could be modified by noninvasive brain stimulation . In a group of 20 elderly ( mean age 62.1 years ) right-h and ed individuals , we applied transcranial direct current stimulation ( tDCS ; 20 minutes , 1 mA ) over the right temporoparietal cortex , while subjects acquired the correct position of buildings on a street map using an associative learning paradigm . Each subject participated in a r and omized and balanced order in 1 session of anodal tDCS and 1 session of sham stimulation , in a double-blind design with 2 parallel versions of the task . Outcome measures were learning success at the end of each session , and immediate as well as delayed ( 1 week ) free recall . We found that subjects performed comparably in the learning task in the 2 conditions , but showed improved recall 1 week after learning with anodal tDCS compared with learning with sham stimulation . In conclusion , retention of object-location learning in the elderly may be modulated by noninvasive brain stimulation , a finding of potential relevance not only for normal aging but also for memory deficits in pathological aging Background Whether healthy older people can benefit from cognitive training ( CogTr ) remains controversial . This study explored the benefits of CogTr in community dwelling , healthy , older adults and compared the effects of single-domain with multi-domain CogTr interventions . Methods A r and omized , controlled , 3-month trial of CogTr with double-blind assessment s at baseline and immediate , 6-month and 12-month follow-up after training completion was conducted . A total of 270 healthy Chinese older people , 65 to 75 years old , were recruited from the Ganquan-area community in Shanghai . Participants were r and omly assigned to three groups : multi-domain CogTr , single-domain CogTr , and a wait-list control group . Twenty-four sessions of CogTr were administrated to the intervention groups over a three-month period . Six months later , three booster training sessions were offered to 60 % of the initial training participants . The Re
Output:
| Results of this systematic review are mixed : CCT was found to increase and decrease both brain structure and function in older adults .
In addition , depending on region of interest , both increases and decreases in structure and function were associated with behavioural performance .
Conclusions Of all studies included in this systematic review , results from the highest quality studies , which were two r and omized controlled trials , demonstrated that multi-domain CCT could lead to increases in hippocampal functional connectivity . |
MS210602 | ***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 Tinnitus is a common condition in adults ; however , the pathophysiology of tinnitus remains unclear , and no large population -based study has assessed the associated risk factors . The aim of this study was to analyze the prevalence and associated risk factors of tinnitus . Methods We conducted a cross-sectional study using data from the Korea National Health and Nutrition Examination Survey , with 19,290 participants ranging in age from 20 to 98 years old , between 2009 and 2012 . We investigated the prevalence of tinnitus using a question naire and analyzed various possible factors associated with tinnitus using simple and multiple logistic regression analysis with complex sampling . Results The prevalence of tinnitus was 20.7 % , and the rates of tinnitus associated with no discomfort , moderate annoyance , and severe annoyance were 69.2 % , 27.9 % , and 3.0 % , respectively . The prevalence of tinnitus and the rates of annoying tinnitus increased with age . The adjusted odds ratio ( AOR ) of tinnitus was higher for females , those with a smoking history , those reporting less sleep ( ≤ 6 h ) , those with more stress , those in smaller households , those with a history of hyperlipidemia osteoarthritis , rheumatoid arthritis , asthma , depression , thyroid disease , an abnormal tympanic membrane , unilateral hearing loss , bilateral hearing loss , noise exposure from earphones , noise exposure at the workplace , noise exposure outside the workplace , and brief noise exposure . Additionally , unemployed individuals and soldiers had higher AORs for tinnitus . The AOR of annoying tinnitus increased with age , stress , history of hyperlipidemia , unilateral hearing loss , and bilateral hearing loss . Conclusions Tinnitus is very common in the general population and is associated with gender , smoking , stress , sleep , hearing loss , hyperlipidemia , osteoarthritis , rheumatoid arthritis , asthma , depression , and thyroid disease history BACKGROUND Tinnitus is common ; however , few risk factors for tinnitus are known . METHODS We examined cross-sectional relations between several potential risk factors and self-reported tinnitus in 14,178 participants in the 1999 - 2004 National Health and Nutrition Examination Surveys , a nationally representative data base . We calculated the prevalence of any and frequent ( at least daily ) tinnitus in the overall US population and among subgroups . Logistic regression was used to calculate odds ratios ( OR ) and 95 % confidence intervals ( CI ) after adjusting for multiple potential confounders . RESULTS Approximately 50 million US adults reported having any tinnitus , and 16 million US adults reported having frequent tinnitus in the past year . The prevalence of frequent tinnitus increased with increasing age , peaking at 14.3 % between 60 and 69 years of age . Non-Hispanic whites had higher odds of frequent tinnitus compared with other racial/ethnic groups . Hypertension and former smoking were associated with an increase in odds of frequent tinnitus . Loud leisure-time , firearm , and occupational noise exposure also were associated with increased odds of frequent tinnitus . Among participants who had an audiogram , frequent tinnitus was associated with low-mid frequency ( OR 2.37 ; 95 % CI , 1.76 - 3.21 ) and high frequency ( OR 3.00 ; 95 % CI , 1.78 - 5.04 ) hearing impairment . Among participants who were tested for mental health conditions , frequent tinnitus was associated with generalized anxiety disorder ( OR 6.07 ; 95 % CI , 2.33 - 15.78 ) but not major depressive disorder ( OR 1.58 ; 95 % CI , 0.54 - 4.62 ) . CONCLUSIONS The prevalence of frequent tinnitus is highest among older adults , non-Hispanic whites , former smokers , and adults with hypertension , hearing impairment , loud noise exposure , or generalized anxiety disorder . Prospect i ve studies of risk factors for tinnitus are needed Aims : To explore the interaction of smoking and occupational exposure to noise as risk factors for hearing difficulty in the general population . Methods : A question naire was mailed to 21 201 adults of working age , selected at r and om from the age-sex registers of 34 British general practice s , and to 993 members of the armed services , r and omly selected from pay records . Questions were asked about smoking habits , years spent in a noisy occupation , difficulty in hearing conversation , and wearing of a hearing aid . Associations of hearing difficulty with smoking habit were examined by logistic regression and compared across strata of noise exposure , with adjustment for potential confounders . Results : Around half of the respondents had ever smoked , and half of these still smoked . Among 10 418 who provided details on hearing , 348 were classed as having moderate and 311 as having severe hearing difficulty . Risk of hearing difficulty was 3–5-fold higher in those employed for > 5 years in noisy work compared with those never employed in a noisy job . Within strata of noise exposure ( including those who had never worked in a noisy job ) , ex- and current smokers had a higher risk of hearing difficulty than lifetime non-smokers . The additional risks were small compared with those of long term noise exposure , and the combination of effects was more consistent with an additive than a multiplicative interaction . Conclusions : Smoking may adversely affect hearing , and workers should be encouraged to refrain from both smoking and exposure to noise . However , the extra risk to hearing incurred by smoking in high ambient noise levels is small relative to that from the noise itself , which should be the main target for preventive measures This paper is the second in a series of three investigating the role of cholinergic mechanisms in the auditory system by assessing the acute effects of nicotine , an acetylcholinomimetic drug , on aggregate responses within the auditory pathway . In a single-blind procedure , auditory responses were obtained from 20 normal-hearing , non-smokers ( 10 male ) under two conditions ( nicotine , placebo ) . The effects of nicotine on central , mesogenous responses of the auditory system ( middle latency and 40-Hz responses ) are described in this second paper . Results indicated that transdermal administration of nicotine to non-smokers does significantly affect the central , neural transmission of acoustic information . Na-Pa amplitude and Nb latency of the middle latency response and latency measures of the 40-Hz response were acutely altered by the presence of nicotine OBJECTIVE : To test the feasibility of creating a valid and reliable checklist with the following features : appropriate for assessing both r and omised and non-r and omised studies ; provision of both an overall score for study quality and a profile of scores not only for the quality of reporting , internal validity ( bias and confounding ) and power , but also for external validity . DESIGN : A pilot version was first developed , based on epidemiological principles , review s , and existing checklists for r and omised studies . Face and content validity were assessed by three experienced review ers and reliability was determined using two raters assessing 10 r and omised and 10 non-r and omised studies . Using different raters , the checklist was revised and tested for internal consistency ( Kuder-Richardson 20 ) , test-retest and inter-rater reliability ( Spearman correlation coefficient and sign rank test ; kappa statistics ) , criterion validity , and respondent burden . MAIN RESULTS : The performance of the checklist improved considerably after revision of a pilot version . The Quality Index had high internal consistency ( KR-20 : 0.89 ) as did the subscales apart from external validity ( KR-20 : 0.54 ) . Test-retest ( r 0.88 ) and inter-rater ( r 0.75 ) reliability of the Quality Index were good . Reliability of the subscales varied from good ( bias ) to poor ( external validity ) . The Quality Index correlated highly with an existing , established instrument for assessing r and omised studies ( r 0.90 ) . There was little difference between its performance with non-r and omised and with r and omised studies . Raters took about 20 minutes to assess each paper ( range 10 to 45 minutes ) . CONCLUSIONS : This study has shown that it is feasible to develop a checklist that can be used to assess the method ological quality not only of r and omised controlled trials but also non-r and omised studies . It has also shown that it is possible to produce a checklist that provides a profile of the paper , alerting review ers to its particular method ological strengths and weaknesses . Further work is required to improve the checklist and the training of raters in the assessment of external validity Aims : To determine the prevalence of self reported hearing difficulties and tinnitus in working aged people from the general population , and to estimate the risks from occupational exposure to noise and the number of attributable cases nationally . Methods : A question naire was mailed to 22 194 adults of working age selected at r and om from the age – sex registers of 34 British general practice s ( 21 201 subjects ) and from the central pay records of the British armed services ( 993 subjects ) . Information was collected on years of employment in a noisy job ; and whether the respondent wore a hearing aid , had difficulty in hearing conversation , or had experienced persistent tinnitus over the past year . Associations of hearing difficulty and tinnitus with noise exposure were examined by logistic regression , with adjustment for age , sex , smoking habits , and frequent complaints of headaches , tiredness , or stress . The findings were expressed as prevalence ratios ( PRs ) with associated 95 % confidence intervals ( CIs ) . Attributable numbers were calculated from the relevant PRs and an estimate of the prevalence of occupational exposure to noise nationally . Results : Some 2 % of subjects reported severe hearing difficulties ( wearing a hearing aid or having great difficulty in both ears in hearing conversation in a quiet room ) . In men , the prevalence of this outcome rose steeply with age , from below 1 % in those aged 16–24 years to 8 % in those aged 55–64 . The pattern was similar in women , but severe hearing loss was only about half as prevalent in the oldest age b and . Tinnitus was far more common in subjects with hearing difficulties . In both sexes , after adjustment for age , the risk of severe hearing difficulty and persistent tinnitus rose with years spent in a noisy job . In men older than 35 years with 10 or more years of exposure , the PR for severe hearing difficulty was 3.8 ( 95 % CI 2.4 to 6.2 ) and that for persistent tinnitus 2.6 ( 95 % CI 2.0 to 3.4 ) in comparison with those who had never had a noisy job . Nationally , some 153 000 men and 26 000 women aged 35–64 years were estimated to have severe hearing difficulties attributable to noise at work . For persistent tinnitus the corresponding numbers were 266 000 and 84 000 . Conclusions : Significant hearing difficulties and tinnitus are quite common in men from the older working age range . Both are strongly associated with years spent in a noisy occupation — a predominantly male exposure . The national burden of hearing difficulties attributable to noise at work is substantial This paper is the first in a series of three investigating the role of cholinergic mechanisms in the auditory system by assessing the acute effects of nicotine , an acetylcholinomimetic drug , on aggregate responses within the auditory pathway . In a single-blind procedure , auditory responses were obtained from 20 normal-hearing , non-smokers ( 10 male ) under two conditions ( nicotine , placebo ) . After the drug session , plasma tests revealed a subject 's nicotine concentration . The effects of nicotine on early , exogenous responses of the auditory system ( otoacoustic emissions and auditory brainstem potentials ) are described in this first paper . Results indicated that transdermal administration of nicotine to non-smokers does not significantly affect cochlear activity but does acutely affect the neural transmission of acoustic information . Overall , otoacoustic emissions were unaffected by transdermal nicotine while wave I of the auditory brainstem response was significantly increased in latency and decreased in amplitude
Output:
| CONCLUSION There is sufficient evidence that smoking is associated with tinnitus .
As the review mainly consists of cross-sectional studies , the observed correlation does not give evidence of a causal relationship . |
MS210603 | ***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 Moxibustion is an ancient traditional medicine using burning mugworts to stimulate acupuncture points . The aim of this study was to investigate the safety and efficacy of moxibustion for the treatment of constipation using a r and omized , sham-controlled , participant-blinded , pilot trial . Methods Twenty-six participants ( identified with either qi ( vital energy ) deficiency or qi excess syndrome ) were r and omly divided into either a moxibustion or sham group . Participants were treated with real or sham moxibustion at 4 acupuncture points , ST23 and ST27 , bilaterally , 3 times per week for four weeks . The primary outcome was the frequency of defecations ; secondary outcomes were the Bristol stool form scale ( BSS ) and the constipation assessment scale ( CAS ) . Results Of the 26 participants that were r and omized , 24 completed the study . Defecation frequency , BSS , and CAS showed no difference between the moxibustion and sham groups . The differences were -0.25 ( 95 % CI : -2.08 , 1.58 , p = 0.78 ) , -1.22 ( 95 % CI : -2.7 , 0.26 , p = 0.1 ) , 0.91 ( 95 % CI : -1.46 , 3.28 , p = 0.44 ) in defecation frequency , BSS , CAS , respectively . The defecation frequency increased from an average of 3.3 to 4.6 times per week in the moxibustion group ( 1.5[-0.5 , 2 ] , p = 0.06 ) and from 2.7 to 3.7 stools per week in the sham group ( 1[-1 , 2 ] , p = 0.15 ) after four weeks of treatment . The difference between participants with a deficiency or an excess syndrome , determined based on assessment of sweat , facial features , pain , body energy , and pulse type , was significant in only defecation frequency . The difference was 3.3 ( 95 % CI : 0.41 , 6.19 , p = 0.03 ) . Conclusion Moxibustion treatment appears safe , but showed no positive effect on constipation . The effectiveness of moxibustion treatment may depend on the syndrome pattern , and further long-term studies with a larger number of subjects are warranted . Trial registration Clinical Research Information Service , BACKGROUND & AIMS Probiotics is an emerging therapeutic agent which may alleviate the symptoms of constipation . We evaluated the effectiveness of microbial cell preparation ( Hexbio ( ® ) ) containing fructooligosaccharide , Bifidobacterium and Lactobacillus in improving stool frequency and symptoms of chronic constipation . METHODS A total of 120 constipated adults diagnosed using Rome III criteria were r and omized and given either microbial cell preparation or placebo to be consumed twice daily . Follow-up was done after a 7-day intervention based on a question naire which includes an assessment of symptom profile and a stool diary . RESULTS During the intervention period , the stool frequency was higher ( p = 0.001 ) in the treatment group . Subjects experienced less straining ( p = 0.001 ) and sensation of incomplete evacuation ( p < 0.001 ) , as well as improved stool consistency ( p < 0.001 ) compared to the placebo group . While a higher proportion of subjects in the treatment group had a reduction in anorectal blockage sensation and having to defecate by manual maneuvers , the differences were not statistically significant . CONCLUSION The results suggest that microbial cell preparation is effective in improving stool frequency and stool consistency . Furthermore , it could reduce the symptoms of straining and sensation of incomplete evacuation in adults with chronic functional constipation . MREC REG NO 866.59 ( IRB , UMMC , Malaysia ) CONTEXT Constipation is a very common symptom in the general population . One way of non-pharmacological treatment of constipation is through the addition of probiotics to food . OBJECTIVES The aim of this study was to evaluate de effect of the consumption of a fresh cheese , enriched with Bifidobacterium lactis Bi-07 on the symptoms of constipated women . METHODS A r and omized controlled trial , carried out in the Basic Health Units of Guaporé 's City - RS/Brazil , between January and May 2012 , with 30 constipated women . The patients were r and omized into two groups whom received , for 30 days , 30 g of fresh cheese enriched with Bifidobacterium lactis Bi-07 ( n = 15 ) or regular fresh cheese ( n = 15 ) . Constipation symptoms were evaluated according to ROMA III Consensus , before and after the nutritional intervention . Also , data of clinical and anthropometric characteristics of the individuals were collected . Accepted level of significance 5 % ( P≤0,05 ) . RESULTS The medium age of the studied population was 37,5±14,4 years in the intervention group and 40,8±12,8 years in the control group . After 30 days we observed that the ingestion of fresh cheese enriched with Bifidobacterium lactis Bi-07 promoted benefic effects on the symptoms of strength to evacuate . CONCLUSION The consumption of 30g/day of a fresh cheese enriched with Bifidobacterium lactis Bi-07 has beneficial effects on constipation symptoms BACKGROUND & AIMS Although stimulant laxatives have been used for many years to treat patients with constipation , their clinical value has been question ed , and there have been few high- quality trials to assess their efficacy . We tested the efficacy and safety of 4 weeks of treatment with oral bisacodyl tablets in patients with chronic constipation , defined by Rome III criteria . METHODS This r and omized , double-blind , placebo-controlled , parallel-group study was conducted in 27 centers in the United Kingdom . After a 2-week baseline period without study medication , patients were r and omly assigned , in a 2:1 ratio , to groups that were given 10 mg bisacodyl ( n = 247 ) or placebo ( n = 121 ) , once daily , for 4 weeks . Patients used an electronic diary each day to record information relating to their constipation . RESULTS The mean ( ± st and ard error of the mean [ SEM ] ) number of complete spontaneous bowel movements ( CSBMs ) per week during the treatment period increased from 1.1 ± 0.1 in both groups to 5.2 ± 0.3 in the bisacodyl group and 1.9 ± 0.3 in the placebo group ( P < .0001 ) . All secondary end points ( number of complete spontaneous bowel movements for each single week , number of spontaneous bowel movement ( SBMs ) , and constipation-associated symptoms ) differed significantly between groups , demonstrating efficacy for bisacodyl ( P < .0001 ) . Compared with baseline , there was a statistically significant improvement in the overall Patient Assessment of Constipation quality of life ( PAC-QOL ) score and all subscales ( satisfaction , physical discomfort , psychosocial discomfort , worries and concerns ) in the bisacodyl-treated patients , compared with those that received placebo ( P ≤ .0070 ) . Treatment with bisacodyl was well-tolerated . CONCLUSIONS Oral bisacodyl is an effective and well-tolerated treatment for patients with chronic constipation . It improves bowel function , constipation-related symptoms , and disease-related QOL Background and Aim Partially hydrolyzed guar gum ( PHGG ) is a water-soluble , non-gelling dietary fiber with a wide range of uses in clinical nutrition . The aim of this prospect i ve study was to investigate the effect of guar gum on colonic transit time ( CTT ) and symptoms of chronic constipation . Methods We enrolled patients fulfilling Rome III criteria for chronic constipation . CTT was measured before and at the end of treatment . After a 2-week run-in period , patients received 5 mg PHGG daily for 4 weeks . During study period , patients kept daily symptoms , stool and laxative usage diaries . They also recorded their symptom-related satisfaction weekly and treatment adverse events . Results Forty-nine patients received treatment ; 39 ( 80 % ) completed the study . Treatment significantly reduced colon transit time , from 57.28 ± 39.25 to 45.63 ± 37.27 h ( p = 0.026 ) , a reduction more prominent in slow transit patients ( from 85.50 ± 27.75 to 63.65 ± 38.11 h , p = 0.016 ) . Overall , the weekly number of complete spontaneous and spontaneous bowel movements increased significantly ( p < 0.001 ) ; the latter correlated significantly with the acceleration of CTT in the overall population and in slow transit patients ( B = 0.382 ; p = 0.016 and B = 0.483 ; p = 0.023 , respectively ) . In addition , the number of bowel movements with straining decreased ( p < 0.001 ) and stool form improved ( p < 0.001 ) , while days with laxative intake and days with abdominal pain decreased ( p = 0.001 and p = 0.027 , respectively ) . Conclusion Four-week PHGG use accelerates colon transit time in patients with chronic constipation , especially in those with slow transit , and improves many of their symptoms including frequency of bowel movements Background : Treatment of chronic constipation is creating one of the major problems for doctors and patients . Pyridostigmine increases the gastrointestinal motility through the effects on cholinesterase . It seems that this mechanism can reduce chronic constipation . The aim of this study was to compare the effects of pyridostigmine and bisacodyl on chronic constipation . Methods : This study was conducted on 68 patients who suffered from chronic constipation . Patients were r and omly divided into two groups of Pyridostigmine and bisacodyl in which each consisted of 34 patients , respectively . Bristol stool form score , straining defecation , the time of defecation , the number of defecation per week , sense of incomplete evacuation and self-digitation were collected by means of question naires and the data were compared . Results : Sixty-eight patients with the mean age of 68.12±84.49 were studied . The mean difference in the frequency of defecation per week , VAS score , the time to defecation and the Bristol Stool form Scale in pre and post-treatment were 4.33±1.88 , 5.96±2.29 , 12.30±7.95 min and 2.10±0.95 in pyridostigmine group and 2.96±1.81 , 4.06±2.22 , 6.67±5.23 min and 1.41±0.84 in bisacodyl group , respectively . The significant difference was observed in both pyridostigmine and bisacodyl groups ( P=0.005 , P=0.002 , P=0.002 and P=0.005 , respectively ) . 60 % and 32.3 of patients in pyridostigmine and bisacodyl groups recovered from self-digitations , respectively . In pyridostigmine and bisacodyl groups , 66.7 % and 32.3 of them had improvement in the sense of incomplete defecation , respectively . Conclusion : Pyridostigmine and bisacodyl significantly improved the symptoms of chronic constipation similarly 1 . This was an 18-week prospect i ve , r and omised , double-blind , placebo-controlled clinical study on a Chinese herbal medicine -- ma zi ren wan (MZRW)--for the treatment of functional constipation . 2 . 120 subjects with functional constipation ( Rome III criteria ) were r and omised ( 60 per arm ) into the MZRW and placebo groups . Respective responder rates for the two groups were 43.3 % and 8.3 % during treatment , and 30.0 % and 15.0 % in the follow-up period ( p<0.05 ) . The MZRW group was superior to the placebo group in terms of increased complete spontaneous bowel movement as well as reduction in severity of constipation , straining at evacuation , and use of rescue therapy . No serious adverse effects were reported . 3 . The dose of MZRW ( 7.5 g bid ) was determined in a separate clinical trial . This study entailed a dose determination study and then a placebo-controlled clinical trial and can be a good reference for future studies Introduction Constipation may be primary or secondary . Pathophysiologic subtypes of primary constipation are dyssynergic defecation ( DD ) , slow ( STC ) , and normal transit constipation ( NTC ) . Clinical subtypes are functional constipation ( FC ) and constipation predominant IBS ( C-IBS ) . Aims The objectives of this paper are to study the clinical profile , categorize and compare various subtypes of primary constipation , and to assess the success of biofeedback therapy ( BFT ) in a non-r and omized , uncontrolled open-label study among patients with DD . Material and Methods Consecutive constipation patients ( April 2011 to December 2012 ) were evaluated . Patients < 18 years and secondary constipation were excluded . FC and C-IBS were classified by Rome III module . All patients , after excluding secondary constipation
Output:
| We conclude that adults with functional constipation have significant variation in stool frequency and form , explained in part by geography and study design |
MS210604 | ***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 —Accelerated neonatal growth increases the later propensity to cardiovascular disease ( CVD ) in animals , whereas slower growth is thought to have a beneficial effect . To test this hypothesis in humans , we measured flow-mediated endothelium-dependent dilation ( FMD ) in a population subject to slower early growth and in healthy controls . Methods and Results —High-resolution vascular ultrasound was used to measure the change in brachial artery diameter in response to reactive hyperemia in adolescents age 13 to 16 years who were either part of a cohort born preterm and followed up prospect ively ( n=216 ) or controls born at term ( n=61 ) . Greater weight gain or linear growth in the first 2 weeks postnatally was associated with lower FMD at adolescence ( regression coefficient , −0.026-mm change in mean arterial diameter per 100-g increase in weight ; 95 % CI , −0.040 to −0.012 mm ; P = 0.0003 ) independent of birthweight and potential confounding factors . Mean FMD in the half of the preterm population with the lowest rates of early growth was higher than in both the half with the greatest growth ( P = 0.001 ) and subjects born at term ( P = 0.03 ) . Conclusions —FMD was 4 % lower in adolescents with the highest compared with the lowest rate of weight gain in the first 2 weeks after birth , a substantial negative effect similar to that for insulin-dependent diabetes mellitus or smoking in adults . Our findings are consistent with the adverse effects of accelerated neonatal growth on long-term cardiovascular health and suggest that postnatal growth patterns could explain the previously reported association between birthweight and later CVD Background Participant drop-out occurs in all longitudinal studies , and if systematic , may lead to selection biases and erroneous conclusions being drawn from a study . Aims We investigated whether drop out in the Avon Longitudinal Study of Parents And Children ( ALSPAC ) was systematic or r and om , and if systematic , whether it had an impact on the prediction of disruptive behaviour disorders . Method Teacher reports of disruptive behaviour among currently participating , previously participating and never participating children aged 8 years in the ALSPAC longitudinal study were collected . Data on family factors were obtained in pregnancy . Simulations were conducted to explain the impact of selective drop-out on the strength of prediction . Results Drop out from the ALSPAC cohort was systematic and children who dropped out were more likely to suffer from disruptive behaviour disorder . Systematic participant drop-out according to the family variables , however , did not alter the association between family factors obtained in pregnancy and disruptive behaviour disorder at 8 years of age . Conclusions Cohort studies are prone to selective drop-out and are likely to underestimate the prevalence of psychiatric disorder . This empirical study and the simulations confirm that the validity of regression models is only marginally affected despite range restrictions after selective drop-out Background —Low birth weight predisposes to later coronary disease . To further eluci date the mechanisms behind this association and their timing , vascular endothelial function — a key factor in early pathophysiology of atherosclerosis — was studied in 54 infants born either before the third trimester or at term . Methods and Results —All subjects were studied at 3 months of postnatal age . A laser-Doppler technique was used to measure skin perfusion before and after transdermal iontophoresis of acetylcholine ( ACh ; an endothelium-dependent vasodilator ) . In infants born at term ( n=19 ; birth weight range : 2230 to 4205 g ) , maximum perfusion after ACh was 109±8 perfusion units ( PU , mean±SEM ) in normal – birth weight controls compared with 56±13 PU among those who had been small for gestational age at birth ( P < 0.01 ) . In infants born preterm ( n=35 ; birth weight range , 722 to 1868 g ) , ACh induced similar perfusion responses among subjects appropriate for gestational age ( 113±16 PU ) and in those small for gestational age at birth ( 109±19 PU ) . Conclusions —Impairment in human endothelial function associated with low birth weight occurs or emerges late in pregnancy . Very preterm birth attenuates this association . Different gene – environment interactions in the third trimester may contribute to this finding Background — Few population studies addressed the prognostic significance of aortic pulse wave velocity ( APWV ) above and beyond other cardiovascular risk factors . Methods and Results — We studied a sex- and age-stratified r and om sample of 1678 Danes aged 40 to 70 years . We used Cox regression to investigate the prognostic value of APWV , office pulse pressure ( PP ) , and 24-hour ambulatory PP while adjusting for mean arterial pressure ( MAP ) and other covariates . Over a median follow-up of 9.4 years , the incidence of fatal and nonfatal cardiovascular end points , cardiovascular mortality , and fatal and nonfatal coronary heart disease amounted to 154 , 62 , and 101 cases , respectively . We adjusted for sex , age , body mass index , MAP measured in the office ( conventional PP and APWV ) or by ambulatory monitoring ( 24-hour PP ) , smoking , and alcohol intake . With these adjustments , APWV maintained its prognostic significance in relation to each end point ( P<0.05 ) , whereas office and 24-hour PP lost their predictive value ( P>0.19 ) , except for office PP in relation to coronary heart disease ( P=0.02 ) . For each 1-SD increment in APWV ( 3.4 m/s ) , the risk of an event increased by 16 % to 20 % . In sensitivity analyses , APWV still predicted all cardiovascular events after st and ardization to a heart rate of 60 beats per minute , after adjustment for 24-hour MAP instead of office MAP , and /or after additional adjustment for the ratio of total to HDL serum cholesterol and diabetes mellitus at baseline . Conclusions — In a general Danish population , APWV predicted a composite of cardiovascular outcomes above and beyond traditional cardiovascular risk factors , including 24-hour MAP Background — Endothelial dysfunction develops early and has been shown to predict the development of clinical complications of atherosclerosis . However , the relationship between early endothelial dysfunction and the progression of arterial disease in the general population is unknown . We investigated endothelial dysfunction , risk factors , and progression of carotid intima-media thickness ( cIMT ) in late-middle-aged individuals at low to intermediate cardiovascular risk in a prospect i ve study between 1997 and 2005 . Methods and Results — Brachial artery flow-mediated dilatation and cIMT were measured in 213 nonsmoking British civil servants recruited from a prospect i ve cohort ( Whitehall II study ) . Participants ( age , 45 to 66 years ) were free of clinical cardiovascular disease and diabetes mellitus . Risk factors and Framingham Risk Score were determined at baseline . cIMT was repeated 6.2±0.4 years later . At baseline , age , blood pressure , low-density lipoprotein cholesterol , and Framingham Risk Score correlated with cIMT . However , only flow-mediated dilatation , not risk factors or Framingham Risk Score , was associated with average annual progression of cIMT . This relationship remained significant after adjustment for risk factors whether entered as separate variables or as Framingham Risk Score . Further adjustment for waist circumference , triglycerides , and employment grade had no significant effect . Conclusions — Systemic endothelial function was associated with progression of pre clinical carotid arterial disease over a 6-year period and was more closely related to cIMT changes than conventional risk factors . Thus , the relationship between endothelial dysfunction and adverse outcome is likely to be due not only to destabilization of established disease in high-risk population s but also to its impact on the evolution of the atherosclerotic substrate . Flow-mediated dilatation testing provides an integrated vascular measure that may aid the prediction of structural disease evolution and represents a potential short- to intermediate-term outcome measure for evaluation of preventive treatment strategies AIMS To assess the feasibility and reproducibility of non-invasive vascular assessment in a childhood population setting and identify the determinants of vascular phenotype in early life . METHODS AND RESULTS We studied 7557 children ( age 9.8 - 12.3 years ) participating in the Avon Longitudinal Study of Parents and Children ( ALSPAC ) . Six research technicians underwent a 5-month training protocol to enable study of brachial artery endothelial function by flow-mediated dilatation ( FMD ) and arterial stiffness by carotid to radial pulse wave velocity ( PWV ) and brachial distensibility [ distensibility coefficient ( DC ) ] . Reproducibility studies were performed at the beginning , the middle , and the end of the study . A blinded repeat evaluation of a r and om selection of 3 % of the cohort was also undertaken throughout the study . The effect of anthropometric and environmental factors on each measure was examined . Successful measures were obtained in 88 , 95 , and 87 % of the studied children for FMD , PWV , and DC , respectively . The coefficients of variation between technicians for FMD , PWV , and DC were 10.5 , 4.6 , and 6.6 % at the beginning of the study and reached 7.7 , 4.1 , and 10 % at the end . Baseline vessel diameter and gender were important determinants of all the vascular measures , with a small effect of room and skin temperatures on FMD and PWV . Boys consistently had lower FMD and DC and higher PWV measures ( P < 0.01 for all ) . CONCLUSION Reproducible , high- quality assessment s of vascular structure and function in children can be made on a large scale in field studies by suitably trained non-specialist operators . This study provides an invaluable re source for assessing the impact of early influences , genetic , and environmental factors on arterial phenotype The Avon Longitudinal Study of Parents and Children ( ALSPAC ) is a transgenerational prospect i ve observational study investigating influences on health and development across the life course . It considers multiple genetic , epigenetic , biological , psychological , social and other environmental exposures in relation to a similarly diverse range of health , social and developmental outcomes . Recruitment sought to enrol pregnant women in the Bristol area of the UK during 1990–92 ; this was extended to include additional children eligible using the original enrolment definition up to the age of 18 years . The children from 14 541 pregnancies were recruited in 1990–92 , increasing to 15 247 pregnancies by the age of 18 years . This cohort profile describes the index children of these pregnancies . Follow-up includes 59 question naires ( 4 weeks–18 years of age ) and 9 clinical assessment visits ( 7–17 years of age ) . The re source comprises a wide range of phenotypic and environmental measures in addition to biological sample s , genetic ( DNA on 11 343 children , genome-wide data on 8365 children , complete genome sequencing on 2000 children ) and epigenetic ( methylation sampling on 1000 children ) information and linkage to health and administrative records . Data access is described in this article and is currently set up as a supported access re source . To date , over 700 peer- review ed articles have been published using ALSPAC data OBJECTIVE . The purpose of this work was to evaluate the effects of a 42-day tapering course of dexamethasone on blood pressure and anthropometric measurements in school-age children who were born with very low birth weight . METHODS . Sixty-eight children , who as neonates participated in a r and omized placebo-controlled trial of a 42-day tapering course of dexamethasone ( n = 38 , dexamethasone ; n = 30 , placebo ) to facilitate weaning from the ventilator , were seen at a median of 9 years of age . Participants underwent measurements of systolic blood pressure , diastolic blood pressure , mid-arm circumference , triceps skinfold thickness , height , and weight . Mann-Whitney U tests were used to compare groups , and Spearman coefficients were used to examine correlations between variables . RESULTS . Comparing dexamethasone- and placebo-treated children , we found no differences in systolic blood pressure , mid-arm circumference , triceps skinfold thickness , height , weight , or body mass index . Twenty-nine percent of all subjects had systolic blood pressure and /or diastolic blood pressure ≥90th percentile for age and gender . Thirty percent of all subjects had body mass index ≥85th percentile for age and gender . CONCLUSIONS . In a group of preterm very low birth-weight infants at high risk for chronic lung disease , we found no effects of dexamethasone on blood pressure or anthropometric measurements at 8 to 11 years of age . Of concern is that a high proportion in this sample had blood pressure ≥90th percentile and /or body mass index ≥85th percentile
Output:
| Systolic blood pressure was higher in subjects born preterm than term , but there were no differences in endothelial dysfunction or arterial stiffness .
The systematic review revealed no clear association between prematurity and vascular function |
MS210605 | ***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: Recent re-evaluation of preventive health care has result ed in more limited and directed guidelines ; nonetheless , physician compliance has remained poor . This study assessed whether an inexpensive reminder system of preventive care checklists would improve physician implementation of periodic health measures . Residents in internal medicine were r and omly placed into two groups : one received a copy of the appropriate checklist with each patient 's medical record ; the other did not . After one year , 200 r and omly selected records were audited to determine the proportion of recommendations implemented for each patient . Residents who received checklists performed appropriate preventive health measures at a significantly higher rate than those who did not ( 0.56 + /- 0.26 versus 0.39 + /- 0.22 , p less than 0.002 ) . The actual use of the checklist to record the results was associated with an even higher rate of compliance compared with instances in which the checklists were provided but not used and instances in which checklists were not received ( 0.70 + /- 0.21 versus 0.44 + /- 0.24 and 0.39 + /- 0.22 , respectively , p less than 0.002 ) . These data suggest that a physician 's use of simple checklists can provide an inexpensive and effective means of improving implementation of periodic health maintenance OBJECTIVE To study the effect of a computerized medical record and other practice factors on the delivery of preventive health care . DESIGN Prospect i ve , controlled trial . SETTING University general internal medicine teaching clinic . PARTICIPANTS Forty-five internal medicine residents and their 4 supervising attending physicians . INTERVENTION The study group used a computerized ambulatory medical record system that included health care maintenance reminders . The control group used a conventional paper record with a health care maintenance flow sheet . MEASUREMENTS AND MAIN RESULTS The computer reminders significantly increased health care maintenance recommendations made to patients for proctosigmoidoscopy , tetanus vaccination , influenza vaccination , and pneumococcal vaccination , but not for fecal occult blood testing , mammography , Pap smears , or serum thyroxine screening in the elderly . First-year residents were nearly twice as successful as third-year residents in overall health care maintenance . Success scores varied markedly depending on which attending physician was supervising the residents . We found a strong interaction among group assignment , supervising attending , and level of training such that the reminders doubled success scores among first-year residents supervised by two of the attending physicians but had little effect on other subgroups . The time of year and the format of the reminder also had important effects for some of the maneuvers . CONCLUSIONS Although computerized medical records markedly improved the performance of prevention maneuvers by committed physicians , many physicians using computer systems failed to make use of the re source . The reasons for this were complex . Future work in this area should carefully control for personal behaviors and focus upon administrative changes that more effectively implement these potentially powerful tools Abstract Objective : To evaluate the use of a computerised support system for decision making for implementing evidence based clinical guidelines for the management of asthma and angina in adults in primary care . Design : A before and after pragmatic cluster r and omised controlled trial utilising a two by two incomplete block design . Setting : 60 general practice s in north east Engl and . Participants : General practitioners and practice nurses in the study practice s and their patients aged 18 or over with angina or asthma . Main outcome measures : Adherence to the guidelines , based on review of case notes and patient reported generic and condition specific outcome measures . Results : The computerised decision support system had no significant effect on consultation rates , process of care measures ( including prescribing ) , or any patient reported outcomes for either condition . Levels of use of the software were low . Conclusions : No effect was found of computerised evidence based guidelines on the management of asthma or angina in adults in primary care . This was probably due to low levels of use of the software , despite the system being optimised as far as was technically possible . Even if the technical problems of producing a system that fully supports the management of chronic disease were solved , there remains the challenge of integrating the systems into clinical encounters where busy practitioners manage patients with complex , multiple conditions BACKGROUND Complete diagnostic evaluation or CDE ( i.e. , colonoscopy or combined flexible sigmoidoscopy plus barium enema X-ray ) is often not performed for persons with an abnormal screening fecal occult blood test ( FOBT+ ) result . METHOD This study evaluated the impact of a reminder-feedback and educational outreach intervention on primary care practice CDE recommendation and performance rates . Four hundred seventy primary care physicians ( PCPs ) in 318 practice s participated in the study . Patients were mailed an FOBT kit annually as part of a screening program . Practice s were r and omly assigned to a Control Group ( N = 198 ) or an Intervention Group ( N = 120 ) . During an 18-month pre-r and omization period and a 9-month post-r and omization period , 2992 screening FOBT+ patients were identified . Intervention practice s received the screening program and the intervention . Control practice s received only the screening program . Study outcomes were baseline-adjusted CDE recommendation and performance rates . RESULTS At baseline , about two-thirds of FOBT+ patients received a CDE recommendation , and about half had a CDE performed . At endpoint , CDE recommendation and performance rates were both significantly higher for the Intervention as compared to the Control practice s ( OR = 2.28 ; 95 % CI : 1.37 , 3.78 , and OR = 1.63 ; 95 % CI : 1.06 , 2.50 , respectively ) . CONCLUSIONS The reminder-feedback plus educational outreach intervention significantly increased CDE recommendation and performance We developed a computer-stored medical record system containing a limited set of the total clinical data base -- primarily diagnostic studies and treatments . This system responds to its own content according to physician-authored reminder rules . To determine the effect of the reminder messages generated by 1490 rules on physician behavior , we r and omly assigned practitioners in a general medicine clinic to study or control groups . The computer found indications for six different actions per patient in 12 467 patients during a 2-year study : 61 study group residents who received computer reminders responded to 49 % of these indications ; 54 control group residents , to only 29 % ( p less than 0.0001 ) . Preventive care ( occult blood testing , mammographic screening , weight reduction diets , influenza and pneumococcal vaccines ) was affected . The intentions of the study group to use a given action for an indication predicted their response to the indications ( p less than 0.03 , r2 = 0.33 ) . The intentions of the control residents did not Objective The objective was to evaluate the effect of a clinic-based intervention program on mammography use by inner-city women . Design A r and omized controlled trial employing firm system methodology was conducted . Setting The study setting was a general internal medicine clinic in the university-affiliated county hospital serving metropolitan Seattle . Participants Women aged 50 to 74 years with at least one routine clinic appointment ( when they were due for mammography ) during the study period were enrolled in the trial ( n=314 ) . Interventions The intervention program emphasized nursing involvement and included physician education , provider prompts , use of audiovisual an printed patient education material s , transportation assistance in the form of bus passes , preppointment telephone or postcard reminders , and rescheduling assistance . Control firm women received usual care . Measurement and Main Results Mammography completion within 8 weeks of clinic visits was significantly higher among intervention ( 49 % ) than control ( 22 % ) firm women ( p<.001 ) . These effects persisted after adjustment for potential confounding by age , race , medical insurance coverage , and previous mammography experience at the hospital ( odds ratio 3.5 ; 95 % confidence interval 1.9 , 6.5 ) . The intervention effect was modified by type of insurance coverage as well as prior mammography history . Process evaluation indicated that bus passes and rescheduling efforts did not contribute to the observed increases in screening participation . Conclusions A clinic-based program incorporating physician education , provider prompts , patient education material s , and appointment reminders and emphasizing nursing involvement can facilitate adherence to breast cancer screening guidelines among inner-city women To determine whether clinical errors can be reduced by prospect i ve computer suggestions about the management of simple clinical events , I studied the responses of nine physicians to computer suggestions generated by 390 protocol s in a controlled crossover design . These protocol s dealt primarily with conditions managed ( e.g. , elevated blood pressure ) or caused ( e.g. , liver toxicity ) by drugs . Physicians responded to 51 per cent of 327 events when given , and 22 per cent of 385 events when not given computer suggestions . Neither level of postgraduate training ( first-year postgraduate or third-year post-graduate ) nor the order in which physicians served as study and control subjects had statistically significant overall effect on the results . It appears that the prospect i ve reminders do reduce errors , and that many of these errors are probably due to man 's limitations as a data processor rather than to correctable human deficiencies OBJECTIVES To evaluate an encounter-based immunization prompting system on resident performance in administering vaccines and knowledge of immunization guidelines . DESIGN / METHODS Prospect i ve r and omized , controlled trial . Subjects were first- and second-year pediatric residents in a hospital-based continuity clinic . The intervention group received manual prompts of immunizations due . Postclinic chart review compared immunizations due with those administered . Acceptable and unacceptable reasons for not administering vaccines were assigned . Resident knowledge was measured by a 70-item examination . RESULTS The intervention group had significantly less missed opportunities/vaccine administration errors ( 11.4 % vs 21.6 % ) . The most common reason for unacceptable errors in the intervention group : vaccine was given too early ; in the control group : vaccine was postponed to next visit . Pre- and postintervention knowledge scores were similar : intervention group ( 75.5 % vs 80.7 % , control group ; 76.5 % vs 81.3 % ) . CONCLUSION An immunization prompting system in a hospital-based pediatric resident continuity clinic reduced missed opportunities/vaccine administration errors without significantly impacting resident knowledge of immunization guidelines .immunization schedule , vaccination , immunization , prompting systems , resident education In an academic general medicine clinic , we performed a r and omized , controlled trial to compare ( 1 ) the effects of supplying monthly feedback reports of compliance with preventive care protocol s by 135 internal medicine house staff with ( 2 ) the effects of specific reminders given to them at the time of patient visits . The protocol s were r and omly divided into two groups , A and B , and half the house staff were given feedback for Group A and half for Group B. Thus , each group served as a control for the other . Each feedback group was also r and omly assigned to receive reminders for either Group A or B protocol s. House staff receiving feedback more often complied with fecal occult blood testing , mammography , pneumococcal vaccination , use of metronidazole , and combined Group A and B protocol s than did controls ( P < 0.01 ) . There was also significantly more compliance with the same protocol s by house staff receiving reminders , but the increase for fecal occult blood testing , pneumococcal vaccination , and combined Group A protocol s was twice that seen in physicians given feedback alone . In addition , reminders alone increased compliance with oral calcium supplementation . Overall compliance with the preventive care protocol s was low : 10 - 15 % in physicians receiving neither feedback nor reminders , increasing to 15 - 30 % in those receiving reminders . Physician compliance with suggested preventive care protocol s can be increased by both delayed feedback and immediate reminders , but reminders have a greater effect BACKGROUND While the Advisory Committee on Immunization Practice s recommends a st and ing order as the most effective mechanism to increase pneumococcal and influenza vaccination rates , Georgia 's Medical Practice Act does not authorize nurses to screen , order , and administer adult vaccines in inpatient setting s. METHODS The setting was a 1000-bed public teaching hospital in metropolitan Atlanta . A 1-month intervention ( INT1 ) included four wards r and omized to intervention or control . A 5-month hospital-wide intervention ( INT2 ) followed INT1 . The intervention used was provider reminder with in-service training . Chart review was the measure used . The main outcome was pneumococcal vaccination prior to discharge . RESULTS During INT1 , 534 patients ( 296 intervention and 238 control ) were discharged . Of the 534 patients , 475 ( 89.0 % ) were African American , 188 ( 35.2 % ) were uninsured , and the median age was 48 ( range 19 to 96 ) . Of the 205 intervention patients with vaccine indications and no contraindications , 78 of 205 ( 38 % ) were vaccinated compared to 7 of 143 ( 4.9 % ) of the control patients ( p<0.001 ) . During INT2 , 879 patient charts were review ed . Patient demographics were similar to INT1 . However , of 554 eligible patients , 16 % were vaccinated , significantly higher than control floors during INT1 ( p<0.001 ) . Although nurses initiated the form almost 70 % of the time , physicians assessed fewer than 35 % of patients with indications . CONCLUSIONS Significantly higher proportions of high-risk patients were vaccinated through the use of a preprinted nurse screening and physician order form . However , a significant percentage of patients did not receive the vaccine owing to the physician '
Output:
| Computer-generated prompts were the most commonly implemented reminders .
Clinician reminders are a successful approach for increasing the rates of delivering preventive care ; however , their effectiveness remains modest . |
MS210606 | ***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 determine whether the addition of the epidermal growth factor receptor tyrosine kinase inhibitor gefitinib ( Iressa , ZD1839 ; AstraZeneca , Wilmington , DE ) to st and ard first-line gemcitabine and cisplatin provides clinical benefit over gemcitabine and cisplatin alone in patients with advanced or metastatic non-small-cell lung cancer ( NSCLC ) . Gefitinib has demonstrated encouraging efficacy in advanced NSCLC in phase II trials in pretreated patients , and a phase I trial of gefitinib in combination with gemcitabine and cisplatin showed favorable tolerability . PATIENTS AND METHODS This was a phase III r and omized , double-blind , placebo-controlled , multicenter trial in chemotherapy-naive patients with unresectable stage III or IV NSCLC . All patients received up to six cycles of chemotherapy ( cisplatin 80 mg/m(2 ) on day 1 and gemcitabine 1,250 mg/m(2 ) on days 1 and 8 of the 3-week cycle ) plus either gefitinib 500 mg/d , gefitinib 250 mg/d , or placebo . Daily gefitinib or placebo was continued until disease progression . End points included overall survival ( primary ) , time to progression , response rates , and safety evaluation . RESULTS A total of 1,093 patients were enrolled . There was no difference in efficacy end points between the treatment groups : for the gefitinib 500 mg/d , gefitinib 250 mg/d , and placebo groups , respectively , median survival times were 9.9 , 9.9 , and 10.9 months ( global ordered log-rank [ GOLrank ] P = .4560 ) , median times to progression were 5.5 , 5.8 , and 6.0 months ( GOLrank ; P = .7633 ) , and response rates were 49.7 % , 50.3 % , and 44.8 % . No significant unexpected adverse events were seen . CONCLUSION Gefitinib in combination with gemcitabine and cisplatin in chemotherapy-naive patients with advanced NSCLC did not have improved efficacy over gemcitabine and cisplatin alone . The reasons for this remain obscure and require further pre clinical testing Purpose : A phase I clinical trial and molecular correlative studies were conducted to evaluate pre clinical evidence for combinatorial activity of the proteasome inhibitor bortezomib , the epidermal growth factor receptor ( EGFR ) inhibitor cetuximab , and radiation therapy . Experimental Design : Patients with radiotherapy-naive stage IV or recurrent squamous cell carcinoma of the head and neck ( SCCHN ) were studied . Escalating doses of bortezomib ( 0.7 , 1.0 , and 1.3 mg/m2 ) were given intravenously twice weekly on days 1 , 4 , 8 , and 11 , every 21 days , with weekly cetuximab beginning 1 week prior and concurrently with intensity-modulated radiotherapy , delivered in 2 Gy fractions to 70 to 74 Gy . Molecular effects were examined in serial serum and SCCHN tumor specimens and the cell line UMSCC-1 . Results : Seven patients were accrued before the study was terminated when five of six previously untreated patients with favorable prognosis oropharyngeal SCCHN progressed within 1 year ( progression-free survival = 4.8 months ; 95 % CI , 2.6–6.9 ) . Three patients each received bortezomib 0.7 or 1.0 mg/m2 , without dose-limiting toxicities ; one patient treated at 1.3 mg/m2 was taken off study due to recurring cetuximab infusion reaction and progressive disease ( PD ) . Expected grade 3 toxicities included radiation mucositis ( n = 4 ) , dermatitis ( n = 4 ) , and rash ( n = 1 ) . SCCHN-related cytokines increased in serial serum specimens of patients developing PD ( P = 0.029 ) . Bortezomib antagonized cetuximab- and radiation-induced cytotoxicity , degradation of EGFR , and enhanced prosurvival signal pathway activation in SCCHN tumor biopsies and UMSCC-1 . Conclusions : Combining bortezomib with cetuximab and radiation therapy showed unexpected early progression , evidence for EGFR stabilization , increased prosurvival signaling , and SCCHN cytokine expression , warranting avoidance of this combination . Clin Cancer Res ; 17(17 ) ; 5755–64 . © 2011 AACR 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 Non-small-cell lung cancer with sensitive mutations of the epidermal growth factor receptor ( EGFR ) is highly responsive to EGFR tyrosine kinase inhibitors such as gefitinib , but little is known about how its efficacy and safety profile compares with that of st and ard chemotherapy . METHODS We r and omly assigned 230 patients with metastatic , non-small-cell lung cancer and EGFR mutations who had not previously received chemotherapy to receive gefitinib or carboplatin-paclitaxel . The primary end point was progression-free survival ; secondary end points included overall survival , response rate , and toxic effects . RESULTS In the planned interim analysis of data for the first 200 patients , progression-free survival was significantly longer in the gefitinib group than in the st and ard-chemotherapy group ( hazard ratio for death or disease progression with gefitinib , 0.36 ; P<0.001 ) , result ing in early termination of the study . The gefitinib group had a significantly longer median progression-free survival ( 10.8 months , vs. 5.4 months in the chemotherapy group ; hazard ratio , 0.30 ; 95 % confidence interval , 0.22 to 0.41 ; P<0.001 ) , as well as a higher response rate ( 73.7 % vs. 30.7 % , P<0.001 ) . The median overall survival was 30.5 months in the gefitinib group and 23.6 months in the chemotherapy group ( P=0.31 ) . The most common adverse events in the gefitinib group were rash ( 71.1 % ) and elevated aminotransferase levels ( 55.3 % ) , and in the chemotherapy group , neutropenia ( 77.0 % ) , anemia ( 64.6 % ) , appetite loss ( 56.6 % ) , and sensory neuropathy ( 54.9 % ) . One patient receiving gefitinib died from interstitial lung disease . CONCLUSIONS First-line gefitinib for patients with advanced non-small-cell lung cancer who were selected on the basis of EGFR mutations improved progression-free survival , with acceptable toxicity , as compared with st and ard chemotherapy . ( UMIN-CTR number , C000000376 . Background : Tegafur/uracil ( UFT ) is suitable for metronomic chemotherapy because of its underlying antiangiogenesis mechanism . This study aim ed to assess the efficacy of adding daily oral UFT to gefitinib treatment in patients with pulmonary adenocarcinoma who had failed previous chemotherapy . Methods : Taiwanese patients who had adenocarcinoma of the lung and failed previous chemotherapy were r and omized into gefitinib 250 mg daily alone ( G ) or plus daily oral UFT ( GU ) . From November 2005 to August 2009 , 115 patients were enrolled . Results : There were 58 patients in the G arm and 57 in the GU arm . One-year progression-free survival ( PFS ) was 18 % in the G arm and 36.7 % in the GU arm ( p = 0.03 ) . Fifty-four patients had tissue sample s available for tumor epidermal growth factor receptor ( EGFR ) sequence analysis : 16 classical mutations and 8 wild types in the G arm , and 20 classical mutations and 10 wild-types in the GU arm . The addition of UFT significantly improved PFS in patients with EGFR mutations ( 14.4 versus 7.6 months , p = 0.0061 ) . Forty-three patients underwent tumor tissue microvessel density measurement , and a trend favoring the addition of UFT to gefitinib treatment was found in those with low microvessel density ( median PFS : 11.8 versus 2.8 months , p = 0.0536 ) . The median survival time was 18.3 months in the G arm and 23.6 months in the GU arm ( p = 0.381 ) . Conclusion : Gefitinib plus UFT treatment had better PFS than gefitinib alone treatment . Gefitinib is effective in patients with EGFR mutations , and the addition of UFT treatment produced better PFS in these patients with mutations PURPOSE Pre clinical studies indicate that gefitinib ( Iressa , ZD1839 ; AstraZeneca , Wilmington , DE ) , an orally active epidermal growth factor receptor tyrosine kinase inhibitor , may enhance antitumor efficacy of cytotoxics , and combination with paclitaxel and carboplatin had acceptable tolerability in a phase I trial . Gefitinib monotherapy demonstrated unparalleled antitumor activity for a biologic agent , with less toxicity than docetaxel , in phase II trials in refractory , advanced non-small-cell lung cancer ( NSCLC ) . This phase III , r and omized , placebo-controlled , double-blind trial evaluated gefitinib plus paclitaxel and carboplatin in chemotherapy-naive patients with advanced NSCLC . PATIENTS AND METHODS Patients received paclitaxel 225 mg/m(2 ) and carboplatin area under concentration/time curve of 6 mg/min/mL ( day 1 every 3 weeks ) plus gefitinib 500 mg/d , gefitinib 250 mg/d , or placebo . After a maximum of six cycles , daily gefitinib or placebo continued until disease progression . End points included overall survival , time to progression ( TTP ) , response rate ( RR ) , and safety evaluation . Results A total of 1,037 patients were recruited . Baseline demographic characteristics were well balanced . There was no difference in overall survival ( median , 8.7 , 9.8 , and 9.9 months for gefitinib 500 mg/d , 250 mg/d , and placebo , respectively ; P = .64 ) , TTP , or RR between arms . Expected dose-related diarrhea and skin toxicity were observed in gefitinib-treated patients , with no new significant/unexpected safety findings from combination with chemotherapy . Subset analysis of patients with adenocarcinoma who received > or = 90 days ' chemotherapy demonstrated statistically significant prolonged survival , suggesting a gefitinib maintenance effect . CONCLUSION Gefitinib showed no added benefit in survival , TTP , or RR compared with st and ard chemotherapy alone . This large , placebo-controlled trial confirmed the favorable gefitinib safety profile observed in phase I and II monotherapy trials BACKGROUND Patients with non-small-cell lung cancer harbouring mutations in the epidermal growth factor receptor ( EGFR ) gene respond well to the EGFR-specific tyrosine kinase inhibitor gefitinib . However , whether gefitinib is better than st and ard platinum doublet chemotherapy in patients selected by EGFR mutation is uncertain . METHODS We did an open label , phase 3 study ( WJTOG3405 ) with recruitment between March 31 , 2006 , and June 22 , 2009 , at 36 centres in Japan . 177 chemotherapy-naive patients aged 75 years or younger and diagnosed with stage IIIB/IV non-small-cell lung cancer or postoperative recurrence harbouring EGFR mutations ( either the exon 19 deletion or L858R point mutation ) were r and omly assigned , using a minimisation technique , to receive either gefitinib ( 250 mg/day orally ; n=88 ) or cisplatin ( 80 mg/m(2 ) , intravenously ) plus docetaxel ( 60 mg/m(2 ) , intravenously ; n=89 ) , administered every 21 days for three to six cycles . The primary endpoint was progression-free survival . Survival analysis was done with the modified intention-to-treat population . This study is registered with UMIN ( University Hospital Medical Information Network in Japan ) , number 000000539 . FINDINGS Five patients were excluded ( two patients were found to have thyroid and colon cancer after r and omisation , one patient had an exon 18 mutation , one patient had insufficient consent , and one patient showed acute allergic reaction to docetaxel ) . Thus , 172 patients ( 86 in each group ) were included in the survival analyses . The gefitinib group had significantly longer progression-free survival compared with the cisplatin plus docetaxel goup , with a median progression-free survival time of 9.2 months ( 95 % CI 8.0 -
Output:
| The synchronous combination of chemotherapy and TKIs is not superior to chemotherapy or EGFR TKIs alone for the first-line treatment of NSCLC |
MS210607 | ***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 : Routine deep venous thrombosis prophylaxis is controversial in Asian patients , because deep venous thrombosis incidence was considered negligible . Because of recent reports of significantly higher incidences , a r and omized , controlled trial was conducted to assess the effectiveness and complications of enoxaparin prophylaxis ( low molecular weight heparins ) in major colorectal surgery . METHODS : Three hundred twenty consecutive patients were r and omly assigned to control or low molecular weight heparins groups . Patients in the low molecular weight heparins group were given perioperative enoxaparin starting 12 hours before surgery . The surgeon ( blinded ) assessed for difficulties related to possible enoxaparin administration . Independent blinded observers performed daily clinical assessment s and Doppler studies ( at the 3rd and 5th postoperative day ) . Deep venous thrombosis was confirmed by duplex ultrasound , and pulmonary embolism was confirmed by lung scans or postmortem examinations . RESULTS : Deep venous thrombosis developed in 5 of 169 ( 3 percent ) controls and 0 of 134 low molecular weight heparins patients ( P=0.045 ) . Three of the deep venous thrombosis patients had pulmonary embolism , which was fatal in one patient . The surgeons were unable to perceive any increased surgical difficulties in the low molecular weight heparins group . The bleeding-related complications were significantly higher in the low molecular weight heparins patients ( controls , n=3 ( 1.8 percent ) ; low molecular weight heparins , n=9 ( 6.7 percent ) ) . However , apart from one subdural hematoma and two abdominal hemorrhages needing re-exploration , which also occurred in one of the controls , these complications were minor bruises at the wounds , drains , or injection sites . CONCLUSION : Deep venous thrombosis prophylaxis is needed in Asian patients undergoing major colorectal surgery In a prospect i ve , r and omized multicentre trial the efficacy and safety of the low molecular weight heparin ( LMWH ) fraction Fraxiparin ® and unfractionated calcium heparin ( Calciparin ® ) were compared for the prevention of postoperative deep vein thrombosis . Of 1909 patients included in the trial 1896 underwent abdominal surgery and received either one daily subcutaneous injection of 7500 anti‐X a units Fraxiparin or 5000 units calcium heparin three times a day subcutaneously . Elastic compression stockings were worn by both groups of patients in the postoperative period . Before r and omization the patients were stratified in two subgroups with or without malignant disease . To assess the rate of deep vein thrombosis ( DVT ) , 125I‐labelled fibrinogen leg scanning was performed daily for 7 postoperative days . Positive results were confirmed by phlebography whenever possible . Venous thrombosis occurred in 27 of 960 patients ( 2.8 per cent ) given Fraxiparin and in 42 of 936 patients ( 4.5 per cent ) given calcium heparin ( P = 0.034 ) . The rates of proximal vein thrombosis were 0.4 per cent ( 4 patients ) and 1.4 per cent ( 13 patients ) respectively ( P<0.05 ) . Pulmonary embolism occurred in 2 of 960 patients ( 0.2 per cent ) treated with Fraxiparin and in 5 of 936 patients ( 0.5 per cent ) treated with calcium heparin . The two treatments were equally well tolerated . Intra‐ and postoperative blood loss , the number of wound haematomas as well as frequency and volume of transfusions were similar in both groups . The present trial demonstrates that a single daily subcutaneous injection of Fraxiparin is more effective than the established low dose subcutaneous heparin prophylaxis with 5000 units three times per day in preventing postoperative DVT after abdominal surgery in patients wearing compression stockings A r and omized multicentre double-blind study was organized to evaluate the efficacy and the safety of Clivarin ( reviparin-sodium ) ( anti-Xa/anti-IIa ratio : 3 - 5 International units ) for the prevention of post-operative thromboembolism in patients undergoing general surgery . 1,351 patients were r and omly allocated to receive subcutaneously either 5,000 U of unfractionated heparin ( UFH ) twice a day or 1,750 anti-Xa IU of reviparin-sodium once a day ( morning ) followed by a placebo injection ( evening ) for at least 6 days . Deep vein thrombosis ( DVT ) was detected with the 125I-fibrinogen technique confirmed by phlebography if necessary . After r and omization thrombotic risk factors were equally distributed in each group . More than 50 % of the patients had a cancer . The incidence of DVT and of pulmonary embolism was 4.8 % ( CI 95 % : 3.3 - 6.7 % ) in the reviparin-sodium group and 4.4 % ( CI 95 % : 2.9 - 6.2 % ) in the UFH group , a non-significant difference . The number of transfusions required was equivalent in the two groups . However , post-operative bleeding complications , including wound haematomas and internal bleeding , were less frequent in the reviparin-sodium group ( P < 0.01 ) . Therefore , for the first time , this study demonstrates that an unusual low dose of a low molecular weight heparin retains its antithrombotic efficacy by comparison with UFH and that the tolerance of this low dose is better In a prospect i ve , double-blind , r and omized multicenter trial the efficacy and safety of low molecular weight heparin and unfractionated heparin were compared for the prevention of postoperative deep vein thrombosis in patients undergoing abdominal surgery . Six hundred and seventy-three patients were r and omly allocated to the two prophylaxis groups ; 20 of these , however , did not undergo surgery and did not receive any prophylaxis . Of the remaining 653 patients 323 received one subcutaneous injection of 3,000 anti-Xa units of low molecular weight heparin and 330 received subcutaneously 5,000 U heparin three times a day . Treatment was initiated 2 h preoperatively and continued for 7 to 10 days . The occurrence of DVT was determined by the 125I-labelled fibrinogen uptake test and phlebography . Venous thrombosis was diagnosed in 24 of 323 patients ( 7.4 % ) treated with low molecular weight heparin and in 26 of 330 patients ( 7.9 % ) treated with low-dose heparin . DVT of proximal veins was detected in four patients of the low molecular weight heparin group and in three patients of the low-dose heparin group . During the observation period three pulmonary emboli - one fatal and two non-fatal - occurred in patients receiving prophylaxis with low-dose heparin . No pulmonary embolism was found in patients treated with low molecular weight heparin . Both prophylactic schemes were well tolerated . Intra- and postoperative blood loss , incidence of wound hematoma , frequency and volume of intra- and postoperative blood transfusion were similar in both groups with a slight advantage for the low molecular weight heparin group . ( ABSTRACT TRUNCATED AT 250 WORDS The effect of low-dose heparin prophylaxis on venous thrombosis and bleeding after major elective surgery was studied in a prospect i ve controlled study of 820 patients . The total incidence of venous thrombosis detected with leg-scanning using fibrinogen labeled with radioactive iodine ( 125I ) was reduced from 16.0 % in the control group to 4.2 % in treated patients . More important , the incidence of popliteal or femoral vein thrombosis was reduced from 2.9 % to 1.0 % . Prophylaxis result ed in a slight increase in bleeding-minor wound hematoma , mean volume of blood transfused , and a post-operative hematocrit fall in treated patients . However , increased bleeding was clinical ly minor , and prophylaxis was well tolerated Abstract . The efficacy of low-molecular-weight heparins ( LMWH ) alone versus a combination of Daflon 500 mg with LMWH in preventing postoperative symptomatic thromboembolism was investigated . A total of 1372 patients aged 40 years or older undergoing major abdominal , pelvic , or abdominal wall surgery were r and omized into four groups . Group A ( n = 591 ) received enoxoparin 20 mg or fraxiparin 0.3 ml . Group B ( n = 595 ) received the regimens of group A plus Daflon 500 mg . Group C ( n = 93 ) received enoxoparin 40 mg or fraxiparin 0.6 ml . Group D ( n = 93 ) received the regimens of group C plus Daflon 500 mg . Each LMWH was given subcutaneously once a day during the hospitalization and continued in groups C and D for 15 days after discharge ( high risk patients ) . Daflon 500 mg was given as two tablets every 8 hours during the day before surgery , two tablets 6 hours before surgery , and two tablets once a day on postoperative days 4 to 15 . Daily clinical examination was performed ; and phlebography or perfusion lung scanning ( or both ) were used in symptomatic patients to confirm deep vein thrombosis ( DVT ) or pulmonary embolism ( PE ) . The wound was examined on a daily basis for hematomas . The diagnosis of PE was established in two patients of group A and in three patients of group C ; symptomatic DVT was established in one patient in group A and three patients of group C. Neither DVT nor PE were established in Daflon 500 mg groups . These data suggest that the combination of Daflon 500 mg and LMWH is more effective than LMWH alone for preventing symptomatic thromboembolism The prophylactic effect of a semisynthetic heparin analogue ( SSHA ) on deep vein thrombosis was investigated in a prospect i ve double‐blind multicentre trial . 440 major general surgical and gynaecological patients were r and omized to one of three treatment groups : 50 mg SSHA , 37.5 mg SSHA and 5000 units sodium heparin subcutaneously 12‐hourly . Deep venous thrombosis ( DVT ) was diagnosed with the fibrinogen uptake test and verified with phlebography . Bleeding complications and other side‐effects were carefully monitored . There were no significant differences between the three treatment groups of patients in age , sex , type of operation or risk factors . A DVT was diagnosed in 16 patients ( 12 per cent ) in the SSHA 50 mg group , in 21 patients ( 15 per cent ) in the SSHA 37.5 mg group and 21 patients ( 14 per cent ) in the heparin‐treated group . No significant differences were found in the number of patients who bled unexpectedly in the postoperative period , required transfusion or developed wound haematomas . Blood loss at operation was similar in all three groups . Three pulmonary emboli were diagnosed by pulmonary scintigraphy , one in each group Objective To compare the effectiveness and safety of low-dose unfractionated heparin and a low-molecular-weight heparin as prophylaxis against venous thromboembolism after colorectal surgery . Methods In a multicenter , double-blind trial , patients undergoing resection of part or all of the colon or rectum were r and omized to receive , by subcutaneous injection , either calcium heparin 5,000 units every 8 hours or enoxaparin 40 mg once daily ( plus two additional saline injections ) . Deep vein thrombosis was assessed by routine bilateral contrast venography performed between postoperative day 5 and 9 , or earlier if clinical ly suspected . Results Nine hundred thirty-six r and omized patients completed the protocol and had an adequate outcome assessment . The venous thromboembolism rates were the same in both groups . There were no deaths from pulmonary embolism or bleeding complications . Although the proportion of all bleeding events in the enoxaparin group was significantly greater than in the low-dose heparin group , the rates of major bleeding and reoperation for bleeding were not significantly different . Conclusions Both heparin 5,000 units subcutaneously every 8 hours and enoxaparin 40 mg subcutaneously once daily provide highly effective and safe prophylaxis for patients undergoing colorectal surgery . However , given the current differences in cost , prophylaxis with low-dose heparin remains the preferred method at present Deep vein thrombosis and its sequel , pulmonary embolus , are possibly the greatest threats to recovery after surgical operation . In a r and omized , controlled clinical trial in which the 125I-fibrinogen uptake test , Doppler ultrasound , and phlebography were used for diagnosis , it was found that low doses of calcium heparinate administered subcutaneously and sodium pentosan polysulfate intramuscularly were effective in preventing deep vein thrombosis ( DVT ) , postoperatively . The incidence of DVT was as follows : 9 % in the group treated with heparinate ; 15 % in the group treated with sodium pentosan polysulfate ; nad 51 % in the un
Output:
| This level 1 evidence report shows that bleeding complications requiring a change in care occur less than 3 % of the time and seem reduced with lower-dose prophylaxis .
Given these findings , most patients undergoing general surgery could receive pharmacologic prophylaxis safely |
MS210608 | ***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 Following male circumcision for HIV prevention , a high proportion of men fail to return for their scheduled seven-day post-operative visit . We evaluated the effect of short message service ( SMS ) text messages on attendance at this important visit . Methodology We enrolled 1200 participants > 18 years old in a two-arm , parallel , r and omized controlled trial at 12 sites in Nyanza province , Kenya . Participants received daily SMS text messages for seven days ( n = 600 ) or usual care ( n = 600 ) . The primary outcome was attendance at the scheduled seven-day post-operative visit . The primary analysis was by intention-to-treat . Principal Findings Of participants receiving SMS , 387/592 ( 65.4 % ) returned , compared to 356/596 ( 59.7 % ) in the control group ( relative risk [ RR ] = 1.09 , 95 % confidence interval [ CI ] 1.00–1.20 ; p = 0.04 ) . Men who paid more than US$ 1.25 to travel to clinic were at higher risk for failure to return compared to those who spent ≤US$1.25 ( adjusted relative risk [ aRR ] 1.35 , 95 % CI 1.15–1.58 ; p<0.001 ) . Men with secondary or higher education had a lower risk of failure to return compared to those with primary or less education ( aRR 0.87 , 95 % CI 0.74–1.01 ; p = 0.07 ) . Conclusions Text messaging result ed in a modest improvement in attendance at the 7-day post-operative clinic visit following adult male circumcision . Factors associated with failure to return were mainly structural , and included transportation costs and low educational level . Trial Registration Clinical Trials.gov OBJECTIVE Regular follow-up is essential to successful management of childhood cataract . We sought to assess whether a mobile phone short message service ( SMS ) for parents of children with cataract could improve follow-up adherence and the proportion of procedures performed in timely fashion . DESIGN R and omized , controlled trial . This trial is registered with Clinical Trials.gov , NCT01417819 . PARTICIPANTS We included 258 parent-child pairs involved in the Childhood Cataract Program of the Chinese Ministry of Health . METHODS Participants were r and omized ( 1:1 ) to a mobile phone SMS intervention or st and ard follow-up appointments . All participants were scheduled to attend ≥ 4 follow-up appointments according to the protocol . Parents in the intervention group received SMS automated reminders before scheduled appointments . The control group parents did not receive SMSs or any alternative reminder of scheduled appointments . Regular ocular examinations and analyses were performed by investigators masked to group allocation ; however , study participants and the manager in charge of r and omization and sending SMSs were not masked . MAIN OUTCOME MEASURES Number of follow-up appointments attended , additional surgeries , laser treatments , changes in eyeglasses prescription , and occurrence of secondary ocular hypertension . RESULTS Among parent-child participants , 135 were r and omly assigned to the SMS intervention and 123 to st and ard appointments . Attendance rates for the SMS group ( first visit , 97.8 % ; second , 91.9 % ; third , 92.6 % ; fourth , 83 % ) were significantly higher than those for the control group ( first visit , 87.8 % ; second , 69.9 % ; third , 56.9 % ; fourth , 33.3 % ) . The increase in attendance rate for total number of follow-up visits with SMS reminders was 47.2 % ( relative risk [ RR ] for attendance , 1.47 ; 95 % confidence interval [ CI ] , 1.16 - 1.78 ; P = 0.003 ) . The number needed to remind ( NNR ) to gain 1 additional visit by 1 child was 3 ( 95 % CI , 1.8 - 4.2 ) . A total of 247 clinical interventions were carried out in the SMS group and 134 in the control group ( RR , 1.68 ; 95 % CI , 1.37 - 1.99 ; P = 0.007 ) . The NNR to result in 1 additional clinical intervention was 5 ( 95 % CI , 3.5 - 6.5 ) . CONCLUSIONS The SMS reminders significantly improved follow-up adherence in pediatric cataract treatment . Using readily available mobile phone re sources may be an effective and economic strategy to improve management of childhood cataract in China . FINANCIAL DISCLOSURE(S ) The authors have no proprietary or commercial interest in any of the material s discussed in this article Background Missed appointments are known to interfere with appropriate care and to misspend medical and administrative re sources . The aim of this study was to test the effectiveness of a sequential intervention reminding patients of their upcoming appointment and to identify the profile of patients missing their appointments . Methods We conducted a r and omised controlled study in an urban primary care clinic at the Geneva University Hospitals serving a majority of vulnerable patients . All patients booked in a primary care or HIV clinic at the Geneva University Hospitals were sent a reminder 48 hrs prior to their appointment according to the following sequential intervention : 1 . Phone call ( fixed or mobile ) reminder ; 2 . If no phone response : a Short Message Service ( SMS ) reminder ; 3 . If no available mobile phone number : a postal reminder . The rate of missed appointment , the cost of the intervention , and the profile of patients missing their appointment were recorded . Results 2123 patients were included : 1052 in the intervention group , 1071 in the control group . Only 61.7 % patients had a mobile phone recorded at the clinic . The sequential intervention significantly reduced the rate of missed appointments : 11.4 % ( n = 122 ) in the control group and 7.8 % ( n = 82 ) in the intervention group ( p < 0.005 ) , and allowed to reallocate 28 % of cancelled appointments . It also proved to be cost effective in providing a total net benefit of 1846 . - EUR/3 months . A satisfaction survey conducted with 241 patients showed that 93 % of them were not bothered by the reminders and 78 % considered them to be useful . By multivariate analysis , the following characteristics were significant predictors of missed appointments : younger age ( OR per additional decade 0.82 ; CI 0.71 - 0.94 ) , male gender ( OR 1.72 ; CI 1.18 - 2.50 ) , follow-up appointment > 1year ( OR 2.2 ; CI : 1.15 - 4.2 ) , substance abuse ( 2.09 , CI 1.21 - 3.61 ) , and being an asylum seeker ( OR 2.73 : CI 1.22 - 6.09 ) . Conclusion A practical reminder system can significantly increase patient attendance at medical outpatient clinics . An intervention focused on specific patient characteristics could further increase the effectiveness of appointment reminders BACKGROUND Psychiatric clinics have high non-attendance rates and failure to attend may be a sign of deteriorating mental health . AIMS To investigate why psychiatric out- patients fail to attend , and the outcome of attenders and non-attenders . METHOD Prospect i ve cohort study of r and omly selected attenders and non-attenders at general adult psychiatric out-patient clinics . Subjects were interviewed at recruitment and severity of mental disorder and degree of social adjustment were measured . Six and 12 months later their engagement with the clinic and any psychiatric admissions were ascertained . RESULTS Of the 365 patients included in the study , 30 were untraceable and 224 consented to participate . Follow-up patients were more psychiatrically unwell than new patients . For follow-up patients , non-attenders had lower social functioning and more severe mental disorder than those who attended . At 12-month follow-up patients who missed their appointment were more likely to have been admitted than those who attended . CONCLUSIONS Those who miss psychiatric follow-up out-patient appointments are more unwell and more poorly socially functioning than those who attend . They have a greater chance of drop-out from clinic contact and subsequent admission Background Telephone or text-message reminders have been shown to significantly reduce the rate of missed appointments in different medical setting s. Since text-messaging is less re source -dem and ing , we tested the hypothesis that text-message reminders would be as effective as telephone reminders in an academic primary care clinic . Methods A r and omized controlled non-inferiority trial was conducted in the academic primary care division of the Geneva University Hospitals between November 2010 and April 2011 . Patients registered for an appointment at the clinic , and for whom a cell phone number was available , were r and omly selected to receive a text-message or a telephone call reminder 24 hours before the planned appointment . Patients were included each time they had an appointment . The main outcome was the rate of unexplained missed appointments . Appointments were not missed if they were cancelled or re-scheduled before or independently from the intervention . We defined non-inferiority as a difference below 2 % in the rate of missed appointments and powered the study accordingly . A satisfaction survey was conducted among a r and om sample of 900 patients ( response rate 41 % ) . Results 6450 patients were included , 3285 in the text-message group and 3165 in the telephone group . The rate of missed appointments was similar in the text-message group ( 11.7 % , 95 % CI : 10.6 - 12.8 ) and in the telephone group ( 10.2 % , 95 % CI : 9.2 - 11.3 p = 0.07 ) . However , only text message reminders were cost-effective . No patient reported any disturbance by any type of reminder in the satisfaction survey . Three quarters of surveyed patients recommended its regular implementation in the clinic . Conclusions Text-message reminders are equivalent to telephone reminders in reducing the proportion of missed appointments in an academic primary care clinic and are more cost-effective . Both types of reminders are well accepted by patients BACKGROUND Text messaging is a dominant form of communication in our society . However , little research has been conducted to evaluate its effectiveness as an appointment reminder in the dental setting . METHODS From the patient pool of the pediatric dentistry clinic at the University of Washington , Seattle , the authors invited 543 caregiver/child dyads who met eligibility criteria to participate in this study . They r and omly assigned 318 pairs ( 59 percent response ) to receive a short message service ( SMS ) text message ( n = 158 ) or a voice message ( control group ) ( n = 160 ) as an appointment reminder . RESULTS Younger caregivers were more likely to be nonattendees than were older caregivers ( P = .02 ) . Participants in the voice message group had a lower no-show attendance ( 8.2 percent ) than did those in the text message group ( 17.7 percent ) ( P = .01 ) . The unadjusted odds ratio ( OR ) for type of appointment reminder and no-show attendance was 2.41 ( P = .01 ) . After the authors adjusted for the caregiver 's age , the OR was 2.12 ( P = .04 ) . CONCLUSIONS SMS text messages were not as effective as voice reminders for patients in a dental school pediatric dentistry clinic . Future studies should investigate the effect of text message reminders when limited to patients who self-select that type of reminder and in patient population s outside the university setting . CLINICAL IMPLICATION S Text messaging may not be the preferable method of reminding patients about appointments in a university pediatric dental clinic BACKGROUND As healthcare services become progressively more stretched , there is increasing discussion of ways in which technological adjuncts may be used to deliver more cost-efficient services . Before widespread implementation , however , the use of these adjuncts requires proper scrutiny of their effects on psychological practice . AIMS This research examined the effectiveness of SMS reminders on client appointment attendance and dropout in a psychological treatment setting . It was predicted that the reminders would result in increased initial appointment attendance , increased total appointment attendance , and decreased client dropout . METHOD A r and omized controlled trial investigated the impact of SMS appointment reminders ( two levels : present or absent ) on client attendance ( three levels : attended , rescheduled , or did not attend ) and dropout ( two levels : completed treatment or terminate early ) . Participants ( N = 140 ) at an outpatient psychology clinic were r and omly allocated to either receive an SMS appointment reminder one day before their scheduled appointment , or to receive no reminder . RESULTS No significant differences were found between the SMS and no SMS conditions in relation to appointment attendance . There were more client dropouts in the SMS compared to the no SMS condition . CONCLUSIONS The SMS appointment reminders were not effective at increasing appointment attendance . The current research suggests that there is more to client non-attendance in psychological setting s than the simple forgetting of appointments . Technological adjuncts may be useful in increasing the cost-efficiency of current services ; however , this research highlights the importance of underst and ing the effects of technology before widespread implementation BACKGROUND Non-attendance is common in primary care and previous studies have reported that reminders were useful in reducing broken appointments . OBJECTIVE To determine the effectiveness of a text messaging reminder in improving attendance in primary care . DESIGN Multicentre three-arm r and omized controlled trial . SETTING Seven primary care clinics in Malaysia . Participants . Patients ( or their caregivers ) who required follow-up at the clinics between 48 hours and 3 months from the recruitment date
Output:
| OUTCOME MEASURES Primary outcomes were rate of attendance/non-attendance at healthcare appointments .
Multiple notifications were significantly more effective at improving attendance than single notifications .
Voice notifications appeared more effective than text notifications at improving attendance .
CONCLUSIONS Electronic text notifications improve attendance and reduce no shows across healthcare setting s. Sending multiple notifications could improve attendance further |
MS210609 | ***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 — Evidence on economically efficient strategies to lower blood pressure ( BP ) from low- and middle-income countries remains scarce . The Control of Blood Pressure and Risk Attenuation ( COBRA ) trial r and omized 1341 hypertensive subjects in 12 r and omly selected communities in Karachi , Pakistan , to 3 intervention programs : ( 1 ) combined home health education ( HHE ) plus trained general practitioner ( GP ) ; ( 2 ) HHE only ; and ( 3 ) trained GP only . The comparator was no intervention ( or usual care ) . The reduction in BP was most pronounced in the combined group . The present study examined the cost-effectiveness of these strategies . Methods and Results — Total costs were assessed at baseline and 2 years to estimate incremental cost-effectiveness ratios based on ( 1 ) intervention cost ; ( 2 ) cost of physician consultation , medications , diagnostics , changes in lifestyle , and productivity loss ; and ( 3 ) change in systolic BP . Precision of the incremental cost-effectiveness ratio estimates was assessed by 1000 bootstrapping replications . Bayesian probabilistic sensitivity analysis was also performed . The annual costs per participant associated with the combined HHE plus trained GP , HHE alone , and trained GP alone were $ 3.99 , $ 3.34 , and $ 0.65 , respectively . HHE plus trained GP was the most cost-effective intervention , with an incremental cost-effectiveness ratio of $ 23 ( 95 confidence interval , 6–99 ) per mm Hg reduction in systolic BP compared with usual care , and remained so in 97.7 of 1000 bootstrapped replications . Conclusions — The combined intervention of HHE plus trained GP is potentially affordable and more cost-effective for BP control than usual care or either strategy alone in some communities in Pakistan , and possibly other countries in Indochina with similar healthcare infrastructure . Clinical Trial Registration — http://www . clinical trials.gov . Unique identifier : NCT00327574 OBJECTIVE To evaluate a simple cardiovascular risk management package for assessing and managing cardiovascular risk using hypertension as an entry point in primary care facilities in low-re source setting s. METHODS Two geographically distant regions in two countries ( China and Nigeria ) were selected and 10 pairs of primary care facilities in each region were r and omly selected and matched . Regions were then r and omly assigned to a control group , which received usual care , or to an intervention group , which applied the cardiovascular risk management package . Each facility enrolled 60 consecutive patients with hypertension . Intervention sites educated patients about risk factors at baseline and initiated treatment with hydrochlorothiazide at 4 months in patients at medium risk of a cardiovascular event , according to a st and ardized treatment algorithm . Systolic blood pressure change from baseline to 12 months was the primary outcome measure . FINDINGS The study included 2397 patients with baseline hypertension : 1191 in 20 intervention facilities and 1206 in 20 control facilities . Systolic and diastolic blood pressure decreased more in intervention patients than in controls . However , at 12 months more than half of patients still had uncontrolled hypertension ( systolic blood pressure > 140 mmHg and /or diastolic blood pressure > 90 mmHg ) . Behavioural risk factors had improved among intervention patients in Nigeria but not in China . Only about 2 % of hypertensive patients required referral to the next level of care . CONCLUSION Even in low-re source setting s , hypertensive patients can be effectively assessed and managed in primary care facilities Background : Lifestyle factors such as weight , salt intake , and physical activity have shown to be important in treating hypertension . The object of this study was to describe feasibility and to assess the effectiveness of a multicomponent lifestyle intervention on high blood pressure ( BP ) of Iranian women . Material s and Methods : This r and omized controlled trial was conducted in four health centers by recruiting 161 women aged 35 - 65 years with high BP and r and omizing them to a 4-week lifestyle modification ( n = 80 ) or control group ( n = 81 ) . BP level and other health behavioral factors were assessed before and after the 4-week intervention and also after 6 months . Results : The mean systolic BP changed from 158.8 ( ±8.1 ) mmHg to 153.2 ( ±6.4 ) mmHg during 4-week and to 145.5 ( ±4.6 ) ) mmHg after 6 months in the intervention group ( P < 0.001 ) . There was a significant difference between two groups of study after 4-week mean = 5.6 ( confidence interval [ CI ] = 5.1 - 6.6 ) and 6 months follow mean ( CI = 12.3 - 14.6).(P < 0.001 ) A significant correlation was detected between systolic BP ( SBP ) and diastolic BP ( DBP ) with weight , body mass index , waist circumference , salt intake , and physical activity level ( P < 0.001 ) . Stepwise regression analyses indicated that the weight , dietary salt intake , and physical activity level were significant predictors of SBP and DBP . Conclusion : The results of this study suggest that lifestyle modification program is associated with improvements in BP level in Iranian women Background We assessed overall annual and unit cost of delivering package of services and specific services at sub-centre level by CHWs and cost effectiveness of Government of India ’s policy of introducing a second auxiliary nurse midwife ( ANM ) at the sub-centre compared to scenario of single ANM sub-centre . Methods We undertook an economic costing of health services delivered by CHWs , from a health system perspective . Bottom-up costing method was used to collect data on re sources spent in 50 r and omly selected sub-centres selected from 4 districts . Mean unit cost along with its 95 % confidence intervals were estimated using bootstrap method . Multiple linear regression model was used to st and ardize cost and assess its determinants . Results Annually it costs INR 1.03 million ( USD 19,381 ) , or INR 187 ( USD 3.5 ) per capita per year , to provide a package of preventive , curative and promotive services through community health workers . Unit costs for antenatal care , postnatal care , DOTS treatment and immunization were INR 525 ( USD 10 ) per full ANC care , INR 767 ( USD 14 ) per PNC case registered , INR 974 ( USD 18 ) per DOTS treatment completed and INR 97 ( USD 1.8 ) per child immunized in routine immunization respectively . A 10 % increase in human re source costs results in 6 % rise in per capita cost . Similarly , 10 % increment in the ANC case registered per provider through-put results in a decline in unit cost ranging from 2 % in the event of current capacity utilization to 3 % reduction in case of full capacity utilization . Incremental cost of introducing 2nd ANM at sub-centre level per unit percent increase ANC coverage was INR 23,058 ( USD 432 ) . Conclusion Our estimates would be useful in undertaking full economic evaluations or equity analysis of CHW programs . Government of India ’s policy of hiring 2nd ANM at sub-centre level is very cost effective from Indian health system perspective INTRODUCTION Tobacco use in low- to middle-income countries is a major public health concern for both smokers and those exposed to environmental tobacco smoke ( ETS ) . Egypt has made important strides in controlling tobacco use , but smoking and ETS remain highly prevalent . This r and omized intervention sought to improve the target population 's knowledge regarding the hazards of smoking and ETS and to change attitudes and smoking behaviors within the community and the household . METHODS In this 2005 - 2006 study in Egypt 's Qalyubia governorate , trained professionals visited schools , households , mosques , and health care centers in rural villages r and omly selected for the intervention to discuss the adverse effects of smoking and ETS exposure and ways to reduce one 's ETS exposure . Data collected in interviewer-facilitated surveys before and after the intervention period were analyzed in pairwise comparisons with data from control villages to assess the effectiveness of the intervention in achieving its aims . RESULTS The intervention group showed a greater increase in underst and ing the dangers associated with smoking cigarettes and waterpipes and became more proactive in limiting ETS exposure by asking smokers to stop , avoiding areas with ETS , and enacting smoking bans in the home . However , the intervention had little to no impact on the number of smokers and the amount of tobacco smoked . CONCLUSIONS Results are consistent with previous studies showing that changing smokers ' behavior can be difficult , but community-wide efforts to reduce ETS exposure through smoking bans , education , and empowering people to ask smokers to stop are effective . The method can be generalized to other setting Background Cardiovascular disease remains the leading killer of women in most developed areas of the world . Rates of physical inactivity and poor nutrition , which are two of the most important modifiable risk factors for cardiovascular disease in women , are substantial . This study sought to examine the effectiveness of a community-based lifestyle-modification program on increasing women 's physical activity in a r and omized trial guided by community-based participatory research ( CBPR ) methods . Methods A total of 335 healthy , 25–64 years old women who had been selected by a multiple-stage stratified cluster r and om sampling method in Bushehr Port/I.R. Iran , were r and omized into control and intervention groups . The intervention group completed an 8-week lifestyle modification program for increasing their physical activity , based on a revised form of Choose to Move program ; an American Heart Association Physical Activity Program for Women . Audio-taped activity instructions with music and practical usage of the educational package were given to the intervention group in weekly home-visits by 53 volunteers from local non-governmental and community-based organizations . Results Among the participants , the percentage who reported being active ( at lease 30 minutes of moderate intensity physical activity for at least 5 days a week , or at least 20 minutes of vigorous physical activity for at least three days a week ) increased from 3 % and 2.7 % at baseline to 13.4 % and 3 % ( p < 0.0001 ) at the ending of the program in the intervention and control groups , respectively . The participants in the intervention group reported more minutes of physical activity per week ( mean = 139.81 , SE = 23.35 ) than women in the control group ( mean = 40.14 , SE = 12.65 ) at week 8 ( p < 0.0001 ) . The intervention group subjects exhibited a significantly greater decrease in systolic blood pressure ( -10.0 mmHg ) than the control group women ( + 2.0 . mmHg ) . The mean ranks for posttest healthy heart knowledge in the intervention and control groups were 198.91 and 135.77 , respectively ( P < 0.0001 ) . Conclusion An intervention based on CBPR methods can be effective for the short-term adoption of physical activity behavior among women . The development of participatory process to support the adequate delivery of lifestyle-modification programs is feasible and an effective healthcare delivery strategy for cardiovascular community health promotion . Trial Registration Uncontrolled diabetes is a major health problem in Thail and . The objective of this study was to determine the effects of a diabetes self-management program on glycemic control , coronary heart disease ( CHD ) risk , and quality of life in 147 diabetic patients ( aged 56.8 + /- 10.2 years ) . Type 2 diabetic patients who met the research criteria were r and omized into two groups for a period of 6 months : the experimental group received the diabetes self-management program and the control group received the usual nursing care . The findings indicated that the experimental group demonstrated a significant decrease in the hemoglobin A(1c ) level and CHD risk , with an increase in quality of life ( QOL ) compared to the control group . The diabetes self-management program was effective for improving metabolic control and the QOL for individuals with diabetes . Further studies should be replicated using larger groups over a longer time frame Background In Africa hypertension is common and stroke is increasing . Detection , treatment and control of high blood pressure ( BP ) is limited . BP can be lowered by reducing salt intake . In Africa salt is added to the food by the consumer , as processed food is rare . A population -wide approach with programmes based on health education and promotion is thus possible . Methods We carried out a community-based cluster r and omised trial of health promotion in 1,013 participants from 12 villages ( 628 women , 481 rural dwellers ) ; mean age 55 years to reduce salt intake and BP . Average BP was 125/74 mmHg and urinary sodium ( UNa ) 101 mmol/day . A health promotion intervention was provided over 6 months to all villages . Assessment s were made at 3 and 6 months . Primary end-points were urinary sodium excretion and BP levels . Results There was a significant positive relationship between salt intake and both systolic ( 2.17 mmHg [ 95 % CI 0.44 to 3.91 ] per 50 mmol of UNa per day , p < 0.001 ) and diastolic BP ( 1.10 mmHg [ 0.08 to 1.94 ] , p < 0.001 ) at baseline . At six months the intervention group showed a reduction in systolic ( 2.54 mmHg [ -1.45 to 6.54 ] ) and diastolic ( 3.95 mmHg [ 0.78 to 7.11 ] ,
Output:
| Existing evidence suggests that , compared with st and ard care , using CHWs in health programmes have the potential to be effective in LMICs , particularly for tobacco cessation , blood pressure and diabetes control |
MS210610 | ***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: A r and omized controlled trial of tamoxifen ( 60 mg/die ) versus placebo was performed in patients with cirrhosis and advanced inoperable hepatocellular carcinoma . Twenty-two patients were matched and coupled for sex , age , Child-Pugh class and tumour mass and then r and omized to tamoxifen or placebo . Median survival was 74 weeks in the tamoxifen group ( range 27 to 144 weeks ) and 52 weeks in the placebo group ( range 4 to 112 weeks ) . The survival of patients treated with tamoxifen improved significantly compared to the controls ( Logrank-test , p = 0.04 ) . These findings suggest that the effect of the antiestrogen tamoxifen is both statistically and clinical ly significant in increasing survival in patients with advanced hepatocellular carcinoma Clinical and experimental evidence indicates that estrogens are involved in the control of hepatocyte proliferation both in normal and in neoplastic conditions . Thirty-two cirrhotic patients with unresectable or otherwise untreatable hepatocellular carcinoma were allocated to receive either tamoxifen ( 30 mg/day ) or no treatment . The patients in the two groups were matched for age , male/female ratio , Child-Pugh class , approximate tumor volume ( US and CT scan ) , and etiology of the underlying cirrhosis . Survival of the tamoxifen-treated patients ( life-table , Wilcoxon-Breslow ) was significantly prolonged ( P=0.0038 ) , with 35 % ( vs 0 % ) survival at 12 months . No difference was observed between males and females or between alcoholic and nonalcoholic cirrhosis . In 40 % of tamoxifen-treated patients , the levels of α-fetoprotein declined . In conclusion , the antiestrogen tamoxifen appears to be effective in the palliative treatment of hepatocellular carcinoma . An initial decline in α-fetoprotein levels may represent an early favorable prognostic sign Thirty-six consecutive patients with advanced hepatocellular carcinoma and chronic liver disease were r and omly allocated to two groups : group I included 20 patients who were treated with 10 mg bid . tamoxifen and group II with 16 non-treated patients . The two groups were homogeneous according to clinical and analytical data . Survival curves in the tamoxifen-treated patients improved significantly when compared with the non-treated group ( p = 0.01 ) . Cumulative survival at the end of the first year was 48.5 % in the treated patients and 9.1 % in controls . Median survival was 261 days in the treated group vs. 172 in the non-treated group ( p < 0.05 ) . Complications of cirrhosis and worsening of the performance status test occurred less in the treated patients than in the controls , but not significantly so . Tamoxifen was well tolerated and no marked side effects were observed . In this series , tamoxifen improved survival in patients with advanced hepatocellular carcinoma BACKGROUND / AIMS Lipiodol chemoembolization is a widely used method of treatment in patients with unresectable hepatocellular carcinoma , but its efficacy is still debated . The aim of our study was to assess the efficacy of lipiodol chemoembolization in patients with unresectable hepatocellular carcinoma . METHODS Seventy-three patients with unresectable hepatocellular carcinoma , but without severe liver disease or portal vein occlusion , were r and omly assigned to receive either repeated lipiodol chemoembolization ( lipiodol , cisplatin ( 2 mg/kg ) , lecithin , and gelatin sponge injected into the hepatic artery ) plus tamoxifen ( 40 mg ) or tamoxifen alone . The main end-point was survival . RESULTS The 37 patients in the lipiodol chemoembolization group received 104 courses ( median 3 per patient ) . By 1 September 1996 , 58 patients had died : 30 in the lipiodol chemoembolization group and 28 in the tamoxifen group . There was no difference in survival between the two groups ( p=0.77 ) . The relative risk of death in the lipiodol chemoembolization plus tamoxifen group as compared to the tamoxifen group was 0.92 ( 95 % confidence interval 0.55 to 1.56 ) . At 1 year , survival was 51 % and 55 % , respectively . An objective tumoral response was more frequently observed in the lipiodol chemoembolization group than in the tamoxifen group ( 24 versus 5.5 % , respectively , p=0.046 ) . Lipiodol chemoembolization caused two deaths and induced signs of liver failure in 51 % of the patients assigned to this treatment . CONCLUSION In our r and omized study , lipiodol chemoembolization did not improve the survival of patients with unresectable hepatocellular carcinoma treated with tamoxifen UNLABELLED Portal vein thrombosis is a poor prognostic factor in patients with hepatocellular carcinoma ( HCC ) and a contraindication for chemoembolization . Intra-arterial injection of 131I-iodized oil which does not modify arterial flow , is feasible in this condition . The aim of this prospect i ve r and omized controlled trial was to compare the efficacy of treatment with radiolabeled oil ( treated group ) versus medical support ( control group ) in patients with stage I or II HCC ( classification of Okuda ) with portal vein thrombosis . METHODS Twenty-seven HCC patients ( 26 males , 1 female ) , aged 53 - 79 yr , with portal vein thrombosis were r and omly assigned to Lipiocis group ( n = 14 ) or Control group ( n = 13 ) . Additional injections of radiolabeled oil were given 2 , 5 , 8 and 12 mo after initial therapy . Medical support treatment consisted of : tamoxifen ( n = 5 ) , 5 FU intravenously ( n = 1 ) , NSAIDs or corticosteroids ( n = 5 ) . Efficacy was evaluated according to survival rate ( Kaplan-Meier method ; log rank test ) , AFP serum values ( measured at 2 , 5 , 8 and 12 mo ) and angiography . RESULTS The two groups were comparable ( Child 's classification , Okuda 's classification , liver function tests , location of the thrombus ) . Tolerance was excellent in the Treated group . The actuarial survival curves were significantly different ( p < 0.01 ) between the two groups , the survival rates ( Cl 95 % ) at 3 , 6 and 9 mo being 71 % ( 48%-95 % ) , 48 % ( 12%-55 % ) , 7 % ( 1%-31 % ) for the Treated group ; and 10 % ( 1%-33 % ) , 0 % and 0 % for the Control group . CONCLUSION Intra-arterial hepatic injection of 131I-labeled iodized oil is a safe and effective palliative treatment of HCC with portal vein thrombosis The liver is an estrogen responsive organ . Clinical ly , estrogens may play a role in the induction of liver tumors and , experimentally , estrogens are involved in the control of hepatocyte proliferation . The results of a prospect i ve controlled clinical trial using an anti-estrogen , tamoxifen , in patients with unresectable hepatocellular carcinoma ( HCC ) are presented below . Thirty-eight consecutive cirrhotics with HCC were allocated to either 30 mg/day tamoxifen or no treatment . The two groups of patients were matched for mean age , male/female ratio , Child-Pugh risk group , approximate tumor volume ( US and /or CT scan ) and etiology of the underlying cirrhosis . The drug appeared to have no side effects . Survival was significantly prolonged in tamoxifen-treated patients with 22 % ( vs. 5 % ) survival at 12 months . No differences were observed between males and females or alcoholic and non-alcoholic cirrhosis . In 53 % of tamoxifen-treated patients the levels of alpha-fetoprotein dropped and , in this subgroup , survival was further prolonged . Tumor volume , lactate dehydrogenase ( LDH ) and alkaline phosphatase slowly increased , suggesting a slower , but continuous , progression of the disease . In conclusion , anti-estrogen treatment appears effective in the palliation of unresectable or otherwise untreatable HCC . A reduction in alpha-fetoprotein levels appears to be a favorable prognostic index This article reports a prospect i ve r and omized controlled study to investigate the effect of sex hormone therapy combined with intra-arterial chemotherapy for hepatocellular carcinoma ( HCC ) . Thirty patients with unresectable HCC were r and omly divided into two groups . A catheter was inserted into the hepatic artery of all patients . The first group ( group A ) was administered 60 mg/m2 of cisplatin ( CDDP ) on day 15 and 13 mg/m2 of Adriamycin ( ADM ) on day 1 and 8 post-operatively via the hepatic artery cannula ; in addition , a daily dose of 150 mg 5-fluorouracil ( 5-FU ) was administered orally . Tamoxifen ( TAM ) 25 mg/m2 daily and medroxyprogesterone acetate ( MPA ) 400 mg/m2 daily were also administered orally . TAM and MPA administration were alternated every 4 weeks . For the second group ( group B ) the same protocol of anti-cancer drugs administration , without the hormonal agents , was given . At least three courses of the treatments were carried out . Twelve patients in group A and 14 in group B were evaluated . Partial response of the hepatic tumor to the treatments was observed in 33.3 % of group A patients and 21.4 % of group B patients , a difference that was not statistically significant . The 1-year survival rate was 44.5 % in group A and 33.0 % in group B. The performance status of 25 % of the patients in group A was significantly improved compared with 14.3 % in group B ( p < 0.05 ) . TAM- and MPA-combined chemotherapy may not prolong the survival of patients with HCC , although it improves their quality of life We tested the hypothesis that a combination of sex hormone suppression and inhibition of their target receptors might improve survival for patients with hepatocellular carcinoma ( HCC ) . Eighty‐five consequent , previously untreated HCC patients with inoperable disease , were r and omized to receive the luteinizing hormone‐releasing hormone (LR‐RH)‐analogue triptorelin and the antiestrogen tamoxifen ( 33 patients ) or triptorelin plus the anti and rogen flutamide ( 23 patients ) , or only placebo ( 29 patients ) in a double blind fashion . All groups were comparable as to age , sex , tumor extension , underlying cirrhosis and biochemical parameters . The tamoxifen ( TMX ) group had a significantly longer survival ( 282 days ) compared with flutamide ( 112 days ) and with placebo ( 127 days ) groups ( P = 0.0238 , log rank test ) . The upper quartile of patients in the TMX group lived 384 days or longer , and most of them ( 57.1 % ) were women ( P < 0.0005 ) , in contrast to the upper quartile of the placebo ( 170 days , 16.7 % women ) and the flutamide group ( 134 days , 33.3 % women ) . The calculated tumor volume doubling time ( TVDT ) was significantly higher in the TMX group ( 296 days ) than in the other two groups ( 99 and 101 days for placebo and flutamide groups , respectively , P = 0.023 ) . In a Cox proportional hazards model , the TMX treatment , along with the baseline Okuda 's HCC stage , the hepatitis B surface antigen , the portal vein diameter , the carcino embryonic antigen ( CEA ) and a self‐ assessment score of quality of life , were covariates predicting survival . Although the degree of serum sex hormone suppression was not a significant predictor of survival , the interaction of female sex and TMX treatment , it was ( P = 0.0052 ) . We conclude that TMX treatment significantly prolongs survival and the TVDT in unresectable HCC . The effect is most pronounced in female patients and is unrelated to sex hormone suppression BACKGROUND In 1998 , when data of a meta- analysis on tamoxifen in the treatment of hepatocellular carcinoma ( HCC ) had suggested a little advantage for this treatment , we published the results of a multicenter r and omised controlled trial , that showed no survival benefit for tamoxifen vs. control . Here we report an up date d analysis of the study results 4.5 years after the closure of enrollment . METHODS The study had a planned sample size of 480 patients . Patients with any stage HCC were eligible , irrespective of locoregional treatment . Tamoxifen was given orally , 40 mg/die , from r and omisation until death . RESULTS 496 patients were r and omised by 30 Institutions from January 1995 to January 1997 . Information was available for 477 patients . As of July 2001 , 374 deaths ( 78 % ) were recorded , and median survival times were 16 and 15 months ( p=0.54 ) , in the control and tamoxifen arm .
Output:
| Tamoxifen was associated with adverse effects .
REVIEW ERS ' CONCLUSIONS These data do not support the use of tamoxifen for patients with hepatocellular carcinoma . |
MS210611 | ***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: PURPOSE Programmed death-1 ( PD-1 ) , an inhibitory receptor expressed on activated T cells , may suppress antitumor immunity . This phase I study sought to determine the safety and tolerability of anti-PD-1 blockade in patients with treatment-refractory solid tumors and to preliminarily assess antitumor activity , pharmacodynamics , and immunologic correlates . PATIENTS AND METHODS Thirty-nine patients with advanced metastatic melanoma , colorectal cancer ( CRC ) , castrate-resistant prostate cancer , non-small-cell lung cancer ( NSCLC ) , or renal cell carcinoma ( RCC ) received a single intravenous infusion of anti-PD-1 ( MDX-1106 ) in dose-escalating six-patient cohorts at 0.3 , 1 , 3 , or 10 mg/kg , followed by a 15-patient expansion cohort at 10 mg/kg . Patients with evidence of clinical benefit at 3 months were eligible for repeated therapy . RESULTS Anti-PD-1 was well tolerated : one serious adverse event , inflammatory colitis , was observed in a patient with melanoma who received five doses at 1 mg/kg . One durable complete response ( CRC ) and two partial responses ( PRs ; melanoma , RCC ) were seen . Two additional patients ( melanoma , NSCLC ) had significant lesional tumor regressions not meeting PR criteria . The serum half-life of anti-PD-1 was 12 to 20 days . However , pharmacodynamics indicated a sustained mean occupancy of > 70 % of PD-1 molecules on circulating T cells > or = 2 months following infusion , regardless of dose . In nine patients examined , tumor cell surface B7-H1 expression appeared to correlate with the likelihood of response to treatment . CONCLUSION Blocking the PD-1 immune checkpoint with intermittent antibody dosing is well tolerated and associated with evidence of antitumor activity . Exploration of alternative dosing regimens and combinatorial therapies with vaccines , targeted therapies , and /or other checkpoint inhibitors is warranted BACKGROUND Ipilimumab is a human monoclonal antibody that blocks cytotoxic T-lymphocyte antigen 4 and has shown promising activity in advanced melanoma . We aim ed to ascertain the antitumour efficacy of ipilimumab in patients with advanced melanoma . METHODS We undertook a r and omised , double-blind , phase 2 trial in 66 centres from 12 countries . 217 patients with previously treated stage III ( unresectable ) or stage IV melanoma were r and omly assigned a fixed dose of ipilimumab of either 10 mg/kg ( n=73 ) , 3 mg/kg ( n=72 ) , or 0.3 mg/kg ( n=72 ) every 3 weeks for four cycles ( induction ) followed by maintenance therapy every 3 months . R and omisation was done with a permuted block procedure , stratified on the basis of type of previous treatment . The primary endpoint was best overall response rate ( the proportion of patients with a complete or partial response , according to modified WHO criteria ) . Efficacy analyses were done by intention to treat , whereas safety analyses included patients who received at least one dose of ipilimumab . This study is registered with Clinical Trials.gov , number NCT00289640 . FINDINGS The best overall response rate was 11.1 % ( 95 % CI 4.9 - 20.7 ) for 10 mg/kg , 4.2 % ( 0.9 - 11.7 ) for 3 mg/kg , and 0 % ( 0.0 - 4.9 ) for 0.3 mg/kg ( p=0.0015 ; trend test ) . Immune-related adverse events of any grade arose in 50 of 71 , 46 of 71 , and 19 of 72 patients at doses of 10 mg/kg , 3 mg/kg , and 0.3 mg/kg , respectively ; the most common grade 3 - 4 adverse events were gastrointestinal immune-related events ( 11 in the 10 mg/kg group , two in the 3 mg/kg group , none in the 0.3 mg/kg group ) and diarrhoea ( ten in the 10 mg/kg group , one in the 3 mg/kg group , none in the 0.3 mg/kg group ) . INTERPRETATION Ipilimumab elicited a dose-dependent effect on efficacy and safety measures in pretreated patients with advanced melanoma , lending support to further studies at a dose of 10 mg/kg . FUNDING Bristol-Myers Squibb
Output:
| Nivolumab concentrations ranged from 35 to 150 ng/ml in CSF of these patients , which is in the range of the half maximal effective concentration ( EC50 ) of 0.64 nM. Conclusions Ipilimumab and nivolumab are active in melanoma brain metastases .
Nivolumab penetrates into the CSF . |
MS210612 | ***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 assess the efficacy and safety of modafinil for the treatment of fatigue in multiple sclerosis ( MS ) . Methods : Patients aged 18–65 years with a diagnosis of MS , a stable disability level ≤6 on the Kurtzke extended disability status scale ( EDSS ) , and a mean score > 4 on the fatigue severity scale ( FSS ) were eligible for the 9 week , single blind , phase 2 , two centre study . Exclusion criteria included a diagnosis of narcolepsy , sleep apnoea , or clinical ly significant major systemic disease and recent use of medications affecting fatigue . All patients , who remained blinded for the treatment regimen , received placebo during weeks 1–2 , 200 mg/day modafinil during weeks 3–4 , 400 mg/day modafinil during weeks 5–6 , and placebo during weeks 7–9 . Safety was evaluated by unblinded investigators . Efficacy was evaluated by self rating scales , using the FSS , the modified fatigue impact scale ( MFIS ) , a visual analogue scale for fatigue ( VAS-F ) , and the Epworth sleepiness scale ( ESS ) . Adverse events were recorded . Results : Seventy two patients ( MS type : 74 % relapsing-remitting ; 7 % primary progressive ; 19 % secondary progressive ) received treatment . After treatment with 200 mg/day modafinil for 2 weeks , a significant improvement in fatigue versus placebo run in was demonstrated . Mean scores after treatment with 200 mg/day modafinil were : FSS , 4.7 versus 5.5 for placebo ( p<0.001 ) ; MFIS , 37.7 versus 44.7 ( p<0.001 ) ; and VAS-F , 5.4 versus 4.5 ( p=0.003 ) . Fatigue scores for 400 mg/day modafinil were not significantly improved versus placebo run in . Mean ESS scores were significantly improved ( p<0.001 ) with 200 mg/day modafinil ( 7.2 ) and 400 mg/day ( 7.0 ) versus the score at baseline ( 9.5 ) . Serious adverse events were not found at either dose . The most common adverse events were headache , nausea , and aesthenia . Sixty five patients ( 90 % ) completed the study . Conclusions : These data suggest that 200 mg/day modafinil significantly improves fatigue and is well tolerated in patients with MS Ifosfamide and cisplatin cause urinary loss of carnitine , which is a fundamental molecule for energy production in mammalian cells . We investigated whether restoration of the carnitine pool might improve chemotherapy-induced fatigue in non-anaemic cancer patients . Consecutive patients with low plasma carnitine levels who experienced fatigue during chemotherapy were considered eligible for study entry . Patients were excluded if they had anaemia or other conditions thought to be causing asthenia . Fatigue was assessed by the Functional Assessment of Cancer Therapy-Fatigue quality of life question naire . Treatment consisted of oral levocarnitine 4 g daily , for 7 days . Fifty patients were enrolled ; chemotherapy was cisplatin-based in 44 patients and ifosfamide-based in six patients . In the whole group , baseline mean Functional Assessment of Cancer Therapy-Fatigue score was 19.7 ( ±6.4 ; st and ard deviation ) and the mean plasma carnitine value was 20.9 μM ( ±6.8 ; st and ard deviation ) . After 1 week , fatigue ameliorated in 45 patients and the mean Functional Assessment of Cancer Therapy-Fatigue score was 34.9 ( ±5.4 ; st and ard deviation ) ( P<.001 ) . All patients achieved normal plasma carnitine levels . Patients maintained the improved Functional Assessment of Cancer Therapy-Fatigue score until the next cycle of chemotherapy . In selected patients , levocarnitine supplementation may be effective in alleviating chemotherapy-induced fatigue . This compound deserves further investigations in a r and omised , placebo-controlled study In this 12-week study with 29 subjects , the effect of Prokarin ™ ( n=22 ) , a proprietary blend of histamine and caffeine , was compared to placebo group ( n=7 ) for the following outcomes : 1 ) fatigue as measured by the Modified Fatigue Impact Scale ( MFIS ) ; 2 ) lower limb function as measured by timed walk test ; 3 ) upper limb function as measured by the pegboard test ; 4 ) cognitive function as measured by the Paced Auditory Serial Additions Test ( PASAT ) ; 5 ) serum caffeine level ; 6 ) change in brain chemistry as measured by quantitative magnetic resonance spectroscopy assay of N-acetyl aspartate ( NAA ) ; and 7 ) safety as measured by routine blood chemistry , TSH and urinalysis . Data were acquired at baseline , 4 , 8 and 12 weeks . The Prokarin ™ group MFIS mean was significantly different from the mean of the placebo group at 12 weeks ( df=24 , t=2.08 , P=<0.02 ) , with respective means of 37.40 , SD=15.18 , for the Prokarin ™ group and 53.2 , SD=11.39 for the controls . For the secondary endpoints ( PASAT , 25 foot timed walk , peg test , and magnetic resonance spectroscopy [ MRS ] ) , there were no significant differences between the Prokarin ™ -treated group and the placebo group . However , there were significant improvements within the Prokarin ™ group for each of these measures for the pre-versus posttreatment comparison at 12 weeks . Serum caffeine data indicated that caffeine exerted no independent effect on performance . No laboratory abnormalities were seen , and the treatment was well tolerated . Conclusion : There was a modest-size statistical effect of Prokarin ™ on fatigue in multiple sclerosis ( MS ) compared with the placebo group . A larger trial is warranted , based on this pilot study OBJECTIVE Fibromyalgia ( FMS ) is a chronic syndrome characterized by widespread pain , troubled sleep , disturbed mood , and fatigue . Several analgesic strategies have been evaluated but the results are moderate and inconsistent . Antidepressant agents are now considered the treatment of choice in most patients . It has been recently suggested that FMS may be associated with metabolic alterations including a deficit of carnitine . In this multicenter r and omized clinical trial we evaluated the efficacy of acetyl L-carnitine ( LAC ) in patients with overt FMS . METHODS One hundred and two patients meeting the American College of Rheumatology criteria for FMS were r and omized into the study . The treatment consisted of 2 capsules/day of 500 mg LAC or placebo plus one intramuscular ( i.m . ) injection of either 500 mg LAC or placebo for 2 weeks . During the following 8 weeks the patients took 3 capsules daily containing either 500 mg LAC or placebo . The patients were seen during treatment after 2 ( visit 3 ) , 6 ( visit 4 ) and 10 weeks ( visit 5 ) . The patients were also visited 4 weeks after treatment discontinuation ( follow-up visit ) . Outcome measures included the number of positive tender points , the sum of pain threshold ( kg/cm2 or " total myalgic score " ) , the Short Form 36 ( SF36 ) , a 100 mm visual analog scale ( VAS ) for self-perceived stiffness , fatigue , tiredness on awakening , sleep , work status , depression , and muscular-skeletal pain , and the Hamilton depression scale . RESULTS The " total myalgic score " and the number of positive tender points declined significantly and equally in both groups until the 6th week of treatment . At the 10th week both parameters remained unchanged in the placebo group but they continued to improve in the LAC group with a statistically significant between-group difference . Most VAS scores significantly improved in both groups . A statistically significant between-group difference was observed for depression and musculo-skeletal pain . Significantly larger improvements in SF36 question naire were observed in LAC than in placebo group for most parameters . Treatment was well-tolerated . CONCLUSION Although this experience deserves further studies , these results indicate that LAC may be of benefit in patients with FMS , providing improvement in pain as well as the general and mental health of these patients BACKGROUND Centenarians are characterized by weakness , decreasing mental health , impaired mobility , and poor endurance . L-Carnitine is an important contributor to cellular energy metabolism . OBJECTIVE This study evaluated the efficacy of L-carnitine on physical and mental fatigue and on cognitive functions of centenarians . DESIGN This was a placebo-controlled , r and omized , double-blind , 2-phase study . Sixty-six centenarians with onset of fatigue after even slight physical activity were recruited to the study . The 2 groups received either 2 g levocarnitine once daily ( n = 32 ) or placebo ( n = 34 ) . Efficacy measures included changes in total fat mass , total muscle mass , serum triacylglycerol , total cholesterol , HDL cholesterol , LDL cholesterol , Mini-Mental State Examination ( MMSE ) , Activities of Daily Living , and a 6-min walking corridor test . RESULTS At the end of the study period , the levocarnitine-treated centenarians , compared with the placebo group , showed significant improvements in the following markers : total fat mass ( -1.80 compared with 0.6 kg ; P < 0.01 ) , total muscle mass ( 3.80 compared with 0.8 kg ; P < 0.01 ) , plasma concentrations of total carnitine ( 12.60 compared with -1.70 mumol ; P < 0.05 ) , plasma long-chain acylcarnitine ( 1.50 compared with -0.1 micromol ; P < 0.001 ) , and plasma short-chain acylcarnitine ( 6.0 compared with -1.50 micromol ; P < 0.001 ) . Significant differences were also found in physical fatigue ( -4.10 compared with -1.10 ; P < 0.01 ) , mental fatigue ( -2.70 compared with 0.30 ; P < 0.001 ) , fatigue severity ( -23.60 compared with 1.90 ; P < 0.001 ) , and MMSE ( 4.1 compared with 0.6 ; P < 0.001 ) . CONCLUSIONS Our study indicates that oral administration of levocarnitine produces a reduction of total fat mass , increases total muscular mass , and facilitates an increased capacity for physical and cognitive activity by reducing fatigue and improving cognitive functions Treatment with acetyl L-carnitine ( ALCAR ) has been shown to improve fatigue in patients with chronic fatigue syndrome , but there have been no trials on the effect of ALCAR for treating fatigue in multiple sclerosis ( MS ) . To compare the efficacy of ALCAR with that of amantadine , one of the drugs most widely used to treat MS-related fatigue , 36 MS patients presenting fatigue were enrolled in a r and omised , double-blind , crossover study . Patients were treated for 3 months with either amantadine ( 100 mg twice daily ) or ALCAR ( 1 g twice daily ) . After a 3-month washout period , they crossed over to the alternative treatment for 3 months . Patients were rated at baseline and every 3 months according to the Fatigue Severity Scale ( FSS ) , the primary endpoint of the study . Secondary outcome variables were : Fatigue Impact Scale ( FIS ) , Beck Depression Inventory ( BDI ) and Social Experience Checklist ( SEC ) . Six patients withdrew from the study because of adverse reactions ( five on amantadine and one on ALCAR ) . Statistical analysis showed significant effects of ALCAR compared with amantadine for the Fatigue Severity Scale ( p = 0.039 ) . There were no significant effects for any of the secondary outcome variables . The results of this study show that ALCAR is better tolerated and more effective than amantadine for the treatment of MS-related fatigue Nutritional factors and comedications are among the postulated causes of fatigue , a highly prevalent symptom in the multiple sclerosis ( MS ) population , with serious impact on patients ’ quality of life . Deficiency of carnitine may play a role by reducing energy production through fatty acid oxidation and numerous MS therapies can induce fatigue syndrome . The aim of this prospect i ve open-labelled study was to collect and study serum carnitine levels in MS patients with and without disease-modifying treatment-induced fatigue syndrome . We investigated whether restoration of the carnitine pool might improve treatment-induced fatigue in MS patients . In our study , there was no statistical difference in fatigue frequency between treated and untreated patients ( P=0.5 ) . Matched to age , gender and treatments , carnitine levels were lower for MS treated patients compared to untreated MS patients ( P<0.05 ) or controls ( P<0.001 ) . Consecutive patients with low plasma carnitine levels who experienced fatigue were substituted . Treatment consisted of oral levocarnitine , 3 - 6 g daily . All patients achieved normal plasma carnitine levels . For 63 % of patients treated with immunosuppressive or immunomodulatory therapies , oral levocarnitine adjunction decreased fatigue intensity , especially in patients treated with cyclophosphamide and interferon beta Objective To determine the relative efficacy of amantad
Output:
| There is insufficient evidence that carnitine for the treatment of MS-related fatigue offers a therapeutic advantage over placebo or active comparators . |
MS210613 | ***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: Differents protocol es therapeutiques et differents dosages de neuroleptiques chez des 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 Hamilton Anxiety Scale ( HAM-A ) was tested for reliability and validity in two different sample s , one sample ( n = 97 ) defined by anxiety disorders , the other sample ( n = 101 ) defined by depressive disorders . The reliability and the concurrent validity of the HAM-A and its subscales proved to be sufficient . Internal validity tested by latent structure analysis was insufficient . The major problems with the HAM-A are that ( 1 ) anxiolytic and antidepressant effects can not be clearly distinguished ; ( 2 ) the subscale of somatic anxiety is strongly related to somatic side effects . The applicability of the HAM-A in anxiolytic treatment studies is therefore limited . More specific anxiety scales are needed CONTEXT Second-generation ( atypical ) antipsychotics ( SGAs ) are more expensive than first-generation ( typical ) antipsychotics ( FGAs ) but are perceived to be more effective , with fewer adverse effects , and preferable to patients . Most evidence comes from short-term efficacy trials of symptoms . OBJECTIVE To test the hypothesis that in people with schizophrenia requiring a change in treatment , SGAs other than clozapine are associated with improved quality of life across 1 year compared with FGAs . DESIGN A noncommercially funded , pragmatic , multisite , r and omized controlled trial of antipsychotic drug classes , with blind assessment s at 12 , 26 , and 56 weeks using intention-to-treat analysis . SETTING Fourteen community psychiatric services in the English National Health Service . PARTICIPANTS Two hundred twenty-seven people aged 18 to 65 years with DSM-IV schizophrenia and related disorders assessed for medication review because of inadequate response or adverse effects . INTERVENTIONS R and omized prescription of either FGAs or SGAs ( other than clozapine ) , with the choice of individual drug made by the managing psychiatrist . MAIN OUTCOME MEASURES Quality of Life Scale scores , symptoms , adverse effects , participant satisfaction , and costs of care . RESULTS The primary hypothesis of significant improvement in Quality of Life Scale scores during the year after commencement of SGAs vs FGAs was excluded . Participants in the FGA arm showed a trend toward greater improvements in Quality of Life Scale and symptom scores . Participants reported no clear preference for either drug group ; costs were similar . CONCLUSIONS In people with schizophrenia whose medication is changed for clinical reasons , there is no disadvantage across 1 year in terms of quality of life , symptoms , or associated costs of care in using FGAs rather than nonclozapine SGAs . Neither inadequate power nor patterns of drug discontinuation accounted for the result 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 BACKGROUND There are cl aims that the extra costs of atypical ( second-generation ) antipsychotic drugs over conventional ( first-generation ) drugs are offset by improved health-related quality of life . AIMS To determine the relative costs and value of treatment with conventional or atypical antipsychotics in people with schizophrenia . METHOD Cost-effectiveness acceptability analysis integrated clinical and economic r and omised controlled trial data of conventional and atypical antipsychotics in routine practice . RESULTS Conventional antipsychotics had lower costs and higher quality -adjusted life-years ( QALYs ) than atypical antipsychotics and were more than 50 % likely to be cost-effective . CONCLUSIONS The primary and sensitivity analyses indicated that conventional antipsychotics may be cost-saving and associated with a gain in QALYs compared with atypical antipsychotics BACKGROUND The relative effectiveness of second-generation ( atypical ) antipsychotic drugs as compared with that of older agents has been incompletely addressed , though newer agents are currently used far more commonly . We compared a first-generation antipsychotic , perphenazine , with several newer drugs in a double-blind study . METHODS A total of 1493 patients with schizophrenia were recruited at 57 U.S. sites and r and omly assigned to receive olanzapine ( 7.5 to 30 mg per day ) , perphenazine ( 8 to 32 mg per day ) , quetiapine ( 200 to 800 mg per day ) , or risperidone ( 1.5 to 6.0 mg per day ) for up to 18 months . Ziprasidone ( 40 to 160 mg per day ) was included after its approval by the Food and Drug Administration . The primary aim was to delineate differences in the overall effectiveness of these five treatments . RESULTS Overall , 74 percent of patients discontinued the study medication before 18 months ( 1061 of the 1432 patients who received at least one dose ) : 64 percent of those assigned to olanzapine , 75 percent of those assigned to perphenazine , 82 percent of those assigned to quetiapine , 74 percent of those assigned to risperidone , and 79 percent of those assigned to ziprasidone . The time to the discontinuation of treatment for any cause was significantly longer in the olanzapine group than in the quetiapine ( P<0.001 ) or risperidone ( P=0.002 ) group , but not in the perphenazine ( P=0.021 ) or ziprasidone ( P=0.028 ) group . The times to discontinuation because of intolerable side effects were similar among the groups , but the rates differed ( P=0.04 ) ; olanzapine was associated with more discontinuation for weight gain or metabolic effects , and perphenazine was associated with more discontinuation for extrapyramidal effects . CONCLUSIONS The majority of patients in each group discontinued their assigned treatment owing to inefficacy or intolerable side effects or for other reasons . Olanzapine was the most effective in terms of the rates of discontinuation , and the efficacy of the conventional antipsychotic agent perphenazine appeared similar to that of quetiapine , risperidone , and ziprasidone . Olanzapine was associated with greater weight gain and increases in measures of glucose and lipid metabolism BACKGROUND Thyroid dysfunction is relatively common in patients with schizophrenia , possibly related to a genetic linkage of the disorders and to antipsychotic treatment . Quetiapine has been implicated as causing some degree of thyroid function changes , yet it remains unclear as to what extent or why these changes may occur . Furthermore , the need for thyroid function monitoring in patients taking this medication is not definitive . METHOD Thyroid function was assessed in 38 adult DSM-IV-diagnosed schizophrenia patients after 6 weeks of prospect i ve , double-blind , r and omized treatment with quetiapine ( 400 mg/day ) , risperidone ( 4 mg/day ) , or fluphenazine ( 12.5 mg/day ) . Data were collected from 1997 to 2002 . RESULTS At baseline , the percentages of r and omized patients with abnormal values were 18 % ( 4/22 ) for serum T(3 ) resin uptake , 13 % ( 4/30 ) for thyroid-stimulating hormone ( TSH ) , and 9 % ( 2/22 ) for total serum thyroxine ( TT(4 ) ) , representing fairly widespread thyroid abnormalities independent of treatment group . Little change was noted in thyroid function during the 6 weeks of treatment , except for a significant decrease in TT(4 ) values for those taking quetiapine ( p = .01 ) . Clinical ly , however , no patients demonstrated any signs or symptoms of hypothyroidism during the study , nor were any significant changes in the free thyroxine index or TSH levels noted . CONCLUSIONS It is expected that TT(4 ) levels will decrease during quetiapine treatment , and this may possibly be related to competitive metabolism of thyroid hormones and quetiapine by UDP-glucuronosyltransferase . Routine monitoring of thyroid function in quetiapine-treated patients without a history of thyroid disease is not recommended This study was undertaken to evaluate the efficacy and safety of olanzapine compared with fluphenazine in the treatment of patients who met the Diagnostic and Statistical Manual , fourth edition ( DSM-IV ) diagnostic criteria for schizophrenia or schizoaffective disorder . This was a long-term ( 22-week ) , r and omized , double-blind , parallel clinical trial . Sixty patients ( mean age , 35.4 years ) were r and omly assigned to either olanzapine ( n=30 ) or fluphenazine ( n=30 ) . They received treatment at three centers in Croatia during a 22-week study period and were assessed weekly for the first 6 weeks and monthly thereafter . Efficacy was measured using the Brief Psychiatric Rating Scale ( BPRS ) , the Positive and Negative Syndrome Rating Scale ( PANSS ) and the Clinical Global Impression ( CGI ) Severity and Improvement scores . The Hillside Akathisia Scale ( HAS ) , Simpson-Angus Scale ( SAS ) , Abnormal Involuntary Movement Scale ( AIMS ) , vital signs , laboratory tests , and treatment-emergent adverse events were assessed to evaluate safety . The olanzapine group showed significantly greater mean decreases from baseline to endpoint for BPRS total ( -25.8 vs. -16.5 , P=.035 ) , PANSS total ( -45.7 vs. -29.5 , P=.037 ) , PANSS positive ( -13.0 vs. -7.9 , P=.034 ) , and CGI Severity ( -2.2 vs. -1.3 , P=.031 ) scores . The olanzapine group showed greater mean decreases on all measures of extrapyramidal symptoms , significantly so for the SAS ( -2.1 vs. 1.9 , P=.004 ) and HAS ( -3.4 vs. 2.6 , P=.028 ) . Patients in the fluphenazine group experienced a higher incidence of treatment-emergent adverse events ( 76.7 % vs. 50.0 % , P=.032 ) . Weight gain was the most frequently reported adverse event in the olanzapine group ( 16.7 % vs. 0.0 % , P=.020 ) . Akathisia ( 30.0 % vs. 10.0 % , P=.053 ) and insomnia ( 20.0 % vs. 0.0 % , P=.010 ) appeared most frequent in the fluphenazine group . Daily use of anticholinergics and benzodiazepines were both significantly greater for the fluphenazine group ( P=.
Output:
| AUTHORS ' CONCLUSIONS Measures of clinical response and mental state do not highlight differences between fluphenazine and amisulpride , risperidone , quetiapine or olanzapine .
Largely measures of adverse effects are also unconvincing for substantive differences between fluphenazine and the newer drugs .
The four small short included studies do not provide much clear information about the relative merits or disadvantages of oral fluphenazine compared with newer atypical antipsychotics |
MS210614 | ***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 st and ard method used to determine the potency of antihistaminesis to assess the degree of suppression of skin response to histamine challenge . OBJECTIVES The aims of this study were to compare the efficacy of 3 antihistaminesusing a histamine challenge test and the usefulness of on-site evaluation with that of photographic evaluation of skin-test reactions . METHODS In this prospect i ve , double-blind , crossover study , healthy volunteerswere given cetirizine 5 mg ( CTZ-5 ) and 10 mg ( CTZ-10 ) , loratadine 10 mg ( LOR ) , fexofenadine 60 mg BID ( FEX ) , and placebo ( PLC ) , in a r and omly assigned order , with an interval of at least 1 week between treatments . Before and 0.5 to 24 hours after administration , the areas of flare and wheal induced by histamine iontophoresis were measured directly ( on site ) by 1 evaluator and by another evaluator using photographic images on a computer monitor . RESULTS Ten healthy volunteers ( 6 men , 4 women ; mean age , 28.2 years[range , 20 - 39 years ] ; mean weight , 60.7 kg [ range , 41 - 81 kg ] ) were enrolled . The data from 9 subjects were analyzed ; the data from 1 subject were omitted because the subject used an over-the-counter cold medication containing diphenhydramine several times during the study . By both methods , all antihistamines were shown to suppress flare significantly from 4 to 24 hours after administration . CTZ was most potent in suppressing both flare and wheal . For flare , the areas as measured using on-site evaluation were larger overall than those measured using photographic evaluation , but the shapes of the time-course graphs were similar for both . Overall , the flare area measurements started to decrease significantly from baseline values 4 hours after drug administration , reached a nadir at 10.5 hours , and remained significantly lower compared with baseline values at 24 hours . Comparisons between antihistamines showed significant differences in mean flare areas between the 2 doses of CTZ and LOR from 8 to 12 hours after administration in both evaluation methods . The wheal areas were significantly reduced from baseline values by most of the antihistamines 4 to 12 hours after drug administration , reached their lowest values at 10.5 hours , and returned to near-baseline values at 24 hours . Comparisons with PLC values at each time point , however , showed significant differences only for CTZ-5 and CTZ-10 from 4 to 12 hours after administration . Comparison between antihistamines showed significant differences in mean flare areas between the 2 doses of CTZ and LOR from 8 to 12 hours after administration in both evaluation methods . Although the flare areas measured by both methods correlated linearly ( r = 0.90 ; P < 0.001 ) , the correlation for wheal areas was weaker ( r = 0.76 ; P < 0.001 ) . CONCLUSIONS In this study in healthy volunteers , single doses of CTZ 5 mg and CTZ 10 mg were more potent compared with single-dose LOR 10 mg and FEX 60 mg BID in suppressing skin response . Although linear correlations were found between skin-response areas , as measured by on-site and photographic evaluation , it was difficult to differentiate between wheal and flare by photographic evaluation , especially when a typical wheal was suppressed to slightly edematous erythema by antihistamines AIMS To compare the onset and duration of action of the new antihistamine levocetirizine with that of the second-generation antihistamine fexofenadine using the Vienna Challenge Chamber ( VCC ) . The latter is an environment where subjects can be exposed to specific aeroallergens in controlled and reproducible conditions allowing for precise comparisons of anti-allergic drugs . METHODS Ninety-four subjects received a single dose of levocetirizine 5 mg , fexofenadine 120 mg or placebo in a r and om order using a three-way cross-over design . On day 1 , subjects were exposed to grass pollens ( 1500 grains/m(3 ) ) in the VCC over a period of 4 h. Treatment was given 2 h after the start of challenge . On day 2 , 22 h after drug intake , subjects were again exposed to pollens for 6 h. Specified symptoms were assessed by the subjects every 15 min using 5-point scales . The main efficacy parameter was the change from baseline in the Major Symptom Complex Score ( MSCS = sum of rhinorrhea , sneezing , itchy nose and eyes ) . RESULTS Baseline characteristics , including symptoms scores , were similar in the three study groups . During the first 2 h after drug intake both antihistamines achieved clinical ly relevant and significant ( P < 0.001 ) improvements in symptom scores . Twenty-two to 24 h after drug intake , mean ( SEM ) MSCS reductions were : 1.9 ( 0.3 ) after placebo ( baseline of 9.7 ) , 3.8 ( 0.3 ) after fexofenadine ( baseline of 9.9 ) , and 5.1 ( 0.3 ) after levocetirizine ( baseline of 9.8 ) . Levocetirizine was significantly ( P < 0.001 ) more effective than fexofenadine with a score difference of 1.3 ( 95 % CI 0.7 , 1.9 ) . This was maintained until the end of the study ( up to 28 h ) . CONCLUSIONS A rapid onset of action in alleviating seasonal allergic rhinitis ( SAR ) symptoms of subjects exposed to grass pollens in the VCC was observed after levocetirizine and fexofenadine . Levocetirizine was more effective than fexofenadine at and later than 22 h after drug intake , an indication of the longer- duration of action of levocetirizine AIMS To assess whether fexofenadine in a range of doses from 80 to 180 mg has any disruptive effects on aspects of psychomotor and cognitive function in comparison with placebo , loratadine and promethazine , an antihistamine known to produce psychomotor and cognitive impairment . METHODS Twenty-four healthy volunteers received fexofenadine 80 mg , 120 mg and 180 mg , loratadine 10 mg , promethazine 30 mg ( as a positive internal control ) and placebo in a six-way crossover , double-blind study . Following each dose , subjects were required to perform a series of tests of cognitive function and psychomotor performance at 1.5 , 3 , 6 , 9 , 12 and 24 h post dose . The test battery included critical flicker fusion ( CFF ) , choice reaction time ( CRT ) and assessment of subjective sedation ( LARS ) . Overall levels of activity were monitored by means of wrist mounted actigraphs throughout each of the 24 h experimental periods . RESULTS Fexofenadine at all doses tested was not statistically different from placebo in any of the tests used and loratadine did not cause any significant impairment of cognitive function . Significant impairments were found following promethazine . Promethazine caused a significant reduction in CFF threshold and this effect was evident up to 12 h post dose ( P<0.05 ) . There was a significant increase in recognition reaction time at 3 and 6 h post promethazine administration , and the drug caused a significant ( P<0 . 002 ) increase in the percentage of ' sleep-like ' activity from actigraph records during the daytime . CONCLUSIONS Fexofenadine at doses up to 180 mg appears free from disruptive effects on aspects of psychomotor and cognitive function in a study where the psychometric assessment s have been shown to be sensitive to impairment , as evidence d by the effects of the verum control promethazine 30 mg This is the first U.S.-based study to compare efficacy and safety of desloratadine with fexofenadine in subjects with symptomatic seasonal allergic rhinitis ( SAR ) . In this double-blind study , subjects were r and omized to desloratadine , 5 mg ( n = 290),fexofenadine , 180 mg ( n = 288 ) , or placebo ( n = 144 ) once daily for 15 days . Primary end point was mean change from baseline to study end in morning instantaneous total symptom score ( AM NOW TSS ) excluding congestion . Secondary measures included change from baseline in the morning/evening reflective TSS ( AM/PM PRIOR TSS ) excluding congestion , AM NOW individual symptom score ( AM NOW ISS ) including congestion , and the AM/PM PRIOR ISS including congestion . Subjects self-evaluated their symptoms on a five-point scale . Mean AM NOW TSSs were significantly reduced from baseline at day 15 with desloratadine ( p = 0.006 ) and fexofenadine ( p = 0.024 ) versus placebo . Desloratadine and fexofenadine were not statistically different ( p = 0.491 ) ; the upper limit of the 95 % CI for desloratadine to fexofenadine ( 0.259 ) was within the prespecified noninferiority margin of 0.7 U. Decrease in mean AM/PM PRIOR TSS excluding congestion was comparable between desloratadine and fexofenadine ( p = 0.405 ; CI = 0.221 ) but was significantly greater with both active treatments versus placebo ( desloratadine , p < 0.001;fexofenadine , p = 0.003 ) . Desloratadine and fexofenadine provided greater reduction in the AM NOW ISS and AM/PM PRIOR ISS ( both including congestion ) versus placebo ; reductions were comparable between active treatments . All treatments were well tolerated . Desloratadine , 5 mg , and fexofenadine , 180 mg , provide comparable efficacy and tolerability in the treatment of SAR . Both treatments are significantly more effective than placebo BACKGROUND This is the first prospect i ve , r and omized , double-blind , placebo-controlled study showing statistical improvement of an H(1)-antihistamine in children with seasonal allergic rhinitis in all symptoms throughout the entire treatment period . OBJECTIVE This r and omized , placebo-controlled , parallel-group , double-blind study was performed to assess the efficacy and safety of fexofenadine in children with seasonal allergic rhinitis . METHODS This study was conducted at 148 centers in 15 countries . Nine hundred thirty-five children ( aged 6 - 11 years ) were r and omized and treated with either fexofenadine HCl 30 mg ( n = 464 ) or placebo ( n = 471 ) tablets twice a day for 14 days . Individual symptoms ( sneezing ; rhinorrhea ; itchy nose , mouth , throat , and /or ears ; itchy , watery , and /or red eyes ; and nasal congestion ) were assessed at baseline and then daily at 7:00 AM and 7:00 PM ( + /-1 hour ) during the double-blind treatment period . Each total symptom score was the sum of all symptoms , excluding nasal congestion . The primary efficacy variable was the change from baseline in the average of the daily 12-hour evening reflective total symptom scores throughout the double-blind treatment . Safety was evaluated from adverse-event reporting , vital signs , physical examinations , and clinical laboratory data at screening and study end point . RESULTS Fexofenadine was significantly superior to placebo in the primary efficacy analysis ( P < /=.0001 ) . Individual symptom scores showed statistically significant superiority compared with placebo ( P < .05 ) , including nasal congestion in the evening reflective assessment ( P < .05 ) . There was no significant difference in adverse events between fexofenadine and placebo , either overall or by causality . CONCLUSION The efficacy and safety of the H(1)-antihistamine fexofenadine has been confirmed in this multicenter , multinational study of children aged 6 to 11 years with seasonal allergic rhinitis BACKGROUND H1-receptor antagonists are widely used in the treatment of allergic skin disorders . OBJECTIVE We sought to evaluate the extent of fexofenadine and diphenhydramine distribution into the skin concomitantly with their peripheral H1-receptor antagonist activity . METHODS In a prospect i ve , r and omized , double-blind , parallel-group study , 7 men received 120 mg of fexofenadine , and 7 received 50 mg of diphenhydramine . Before dosing ; at 1 , 3 , 6 , 9 , and 24 hours after the first dose ; and at 168 hours ( steady-state ) , 12 hours after the seventh and last daily dose , blood sample s and skin punch biopsy specimens were obtained , and epicutaneous tests with histamine phosphate , 1 mg/mL , were performed . RESULTS Fexofenadine penetrated the skin to a significantly greater extent than diphenhydramine at 6 , 9 , 24 , and 168 hours ( P < or = .05 ) . Maximum skin/plasma ratios of both the H1-antagonists ( 41.3 + /- 7.8 for fexofenadine and 8.1 + /- 4.4 for diphenhydramine ) were obtained at 24
Output:
| When compared with placebo , fexofenadine produced more significant antihistamine effects .
Conclusions Fexofenadine has a positive antihistamine effect , which is probably no worse than the second-generation antihistamines .
Fexofenadine probably has a favorable safety profile , which is more likely better than that of the first-generation antihistamines .
There is lack of data to support that fexofenadine has a better overall safety profile compared to the second-generation antihistamines , however , some presently available evidence on sedative effects and certain aspects of cognitive/psychomotor function favors fexofenadine . |
MS210615 | ***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 most common complications after surgical extraction of the third m and ibular molar are trismus , oedema or swelling , local pain , dysphagia and infection . The aim of this comparative , double-blind , r and omized clinical trial was to evaluate the efficacy of two sustained release amoxicillin/clavulanate regimens in the reduction of infection after third molar extractive surgery . A total of 225 patients were r and omized into three equal groups : placebo , prophylaxis with single pre-surgical dose of two tablets amoxicillin/clavulanate 1000/62.5 mg , and pre-emptive post-surgery therapy with two tablets amoxicillin/clavulanate 1000/62.5 mg BID for 5 days . A higher rate of infection ( P=0.006 ) was found among patients receiving placebo ( 16 % ) than those receiving single-dose prophylaxis ( 5.3 % ) or 5-day pre-emptive therapy ( 2.7 % ) . A relationship between both the duration ( 13.8 % for long versus 7.4 % for medium versus 1.6 % for short ) and difficulty ( 12.7 % with ostectomy versus 3.5 % without ostectomy ; P=0.011 ) of surgical procedure and incidence of subsequent infection was also observed . Both prophylactic and therapeutic regimens versus placebo achieved greater reduction of pain after surgery on day 3 ( P=0.001 ) . Logistic regression analysis revealed a risk of infection of 24 % , 9 % and 4 % for ostectomy with placebo , prophylaxis and pre-emptive treatment , respectively , whereas it was 7 % , 2 % and 1 % if ostectomy was not performed . Pre-emptive therapy with the oral sustained release amoxicillin/clavulanate formulation reduced the rate of subsequent infection in patients undergoing ostectomy . Prophylaxis was beneficial in simpler procedures and may be indicated in cases where ostectomy is not performed Background The aim of this study was to assess the efficacy of a single prophylactic dose of amoxicillin and /or dexamethasone in preventing postoperative complications ( PC ) after a surgical removal of a single m and ibular third molar ( M3 ) . Methods This study is a r and omized , placebo controlled clinical trial . Four groups were included : Group 1 ( G1 ) included a prophylactic dose of 2 g of amoxicillin and 8 mg of dexamethasone ; Group 2 ( G2 ) included a prophylactic dose of 2 g of amoxicillin and 8 mg of placebo ; Group 3 ( G3 ) included a prophylactic dose of 8 mg of dexamethasone and 2 g of placebo and ; Group 4 ( G4 ) placebo . Results Fifty patients were included . It was observed one case of alveolar infection ( 2 % ) and two of alveolar osteitis ( 4 % ) result ing in three PC ( 6 % ) . No statistical differences were observed between therapeutic groups for development of PC , trismus , pain and edema . The use of antibiotics showed an absolute risk reduction ( ARR ) for PC development of 3.52 % and the number needed to treat ( NNT ) was 29 . Conclusion Prophylactic antibiotics and corticoid in a single dose regimen did not bring any benefit on M3 surgeries OBJECTIVE The purpose of this study was to determine the effect of amoxicillin/clavulanic acid to prevent infection following completely bone-impacted lower third molar removal . STUDY DESIGN A r and om , double-blind placebo-controlled clinical trial including 118 adults r and omly allocated to placebo ( 60 patients ) or antibiotic treatment ( 58 patients ): 2 g amoxicillin/125 mg clavulanic acid 2 hours before the surgery and post-operatively twice a day for 4 days . Infection was clinical ly assessed until 8 weeks after surgery . Adverse events , as well as clinical and surgical variables , were recorded . Analysis was by intention to treat . RESULTS Infections developed in five patients in the placebo group , all in the first postoperative week , and in two in the antibiotic group , both after the first week , the difference not being statistically significant ( P = .278 , number needed to treat 19 [ 8-∞ ] ) . There were no relationships between any variables studied and infection . No serious adverse events were reported . CONCLUSION There is insufficient evidence to recommend routine use of this antibiotic treatment Aims and Objectives : To evaluate the role of prophylactic antibiotics , if any , in the removal of m and ibular impacted third molars . Patients and Methods : A total of 89 patients were r and omly allocated in 3 groups ( group 1 , placebo ; group 2 , amoxicillin 1 g orally 1 h before surgery ; and group 3 , metronidazole 800 mg orally 1 h before surgery ) . Results : Of the 89 patients , 5 had surgical wound infection ( 3 [ 10.33 % ] in group 1 , 2 [ 6.45 % ] in group 2 , and none [ 0 % ] in group 3 ) , leading to an overall infection rate of 5.61 % . There was no statistically significant difference found in surgical wound infection between the groups . Conclusions : Our study failed to show any advantage in the routine use of prophylactic antibiotics because we found no statistically significant difference between the groups Introduction : Antibiotic resistance is now a serious problem , although it was not so only a few years ago . The need of the hour is to give clear evidence of the efficacy of antibiotic use , or lack thereof , to the surgeon for a procedure as common as m and ibular third molar surgery . Aim : This study aim ed to evaluate whether postoperative combined amoxicillin and clavulanic acid in m and ibular third molar extraction is effective in preventing inflammatory complications . Study and Design : The study was structured as a prospect i ve r and omized double-blind placebo-controlled clinical trial . Material s and Methods : A study was design ed wherein the 96 units ( two bilaterally similar impacted m and ibular third molars per head in 48 patients ) were r and omly assigned to two treatment groups ( Group I and Group II ) . Each patient served as his/her own control . Each patient received 625 mg of combined amoxicillin and clavulanic acid 1 h before surgery . In the case of third molars belonging to Group I , 625 mg of combined amoxicillin and clavulanic acid TDS was continued for 3 days ; in Group II , placebo in similar-looking packs was continued for 3 days . The patients were evaluated on the third and seventh postoperative days for signs of clinical infection and for microbial load evaluation . Statistical Analysis : The data between the two groups were statistically analyzed by the two-tailed Fisher′s exact test , with a 95 % confidence interval . Results : The difference was not statistically significant between the test group and the control group with regard to erythema , dehiscence , swelling , pain , trismus , and infection based on microbial load . The data were statistically significant for alveolar osteitis , with the occurrence of alveolar osteitis ( 14.58 % ) in the placebo group . Conclusion : Postoperative antibiotics are recommended only for patients undergoing contaminated , long- duration surgery The use of prophylactic antibiotics to reduce postoperative complications in third molar surgery remains controversial . The study was a prospect i ve , r and omized , double blind , placebo-controlled clinical trial . 100 patients were r and omly assigned to two groups . Each patient acted as their own control using the split-mouth technique . Two unilateral impacted third molars were removed under antibiotic cover and the other two were removed without antibiotic cover . The first group received antibiotics on the first surgical visit . On the second surgical visit ( after 3 weeks ) , placebo capsules were given or vice versa . The second group received antibiotics with continued therapy for 2 days on the first surgical visit and on the second surgical visit ( after 3 weeks ) placebo capsules were given or vice versa . Pain , swelling , infection , trismus and temperature were recorded on days 3 , 7 and 14 after surgery . Of 380 impactions , 6 sockets ( 2 % ) became infected . There was no statistically significant difference in the infection rate , pain , swelling , trismus , and temperature between the two groups ( p>0.05 ) . Results of the study showed that prophylactic antibiotics did not have a statistically significant effect on postoperative infections in third molar surgery and should not be routinely administered when third molars are removed in non-immunocompromised patients Postoperative infections in the oral region are usually caused by anaerobic bacteria . While some authors cl aim that routine antibiotic prophylaxis is necessary after third molar surgery , others do not recommend this practice . The major subject of controversy is what constitutes postoperative infection . Previous studies that have examined the benefit of routine antibiotic prophylaxis have used several clinical symptoms ( pain , swelling , and trismus ) as indicators of infection ; however , these clinical symptoms may be vague and unreliable , and can not be evaluated scientifically . As a result , their use has only sparked more debate in this area of research . The present study assessed the value of routine antibiotic prophylaxis in impacted m and ibular third molar surgery using acute-phase protein levels as potential indicators of early and late postoperative infection . Specifically , serum levels of C-reactive protein and alpha-1 antitrypsin were measured preoperatively and postoperatively in patients who received either prophylactic antibiotics or placebos . The results revealed no statistically significant difference between treated and control patients in terms of incidence of postoperative infection Introduction Antimicrobial resistance is a growing problem that is likely to have a major negative impact on healthcare in the future . Dentists have a key role in ensuring that antimicrobials are prescribed correctly to reduce the emergence of resistant strains . Objective To audit how appropriately antimicrobials were prescribed in the oral surgery acute dental department of Guy 's Hospital in London , when compared to the st and ards set within the Faculty of General Dental Practice (UK)1 and Scottish Dental Clinical Effectiveness2 guidelines on antimicrobial prescribing in dentistry . Target 100 % compliance . Method A prospect i ve audit consisting of two cycles ( each including 60 patients ) was carried out . Between each cycle , there was a two-month intervention period , which included extensive training and education of staff and students . Results Cycle 1 showed that only 30 % of prescriptions were appropriate and only 62 % of practitioners were recording a diagnosis . After two months of intervention , cycle 2 was carried out ; this showed a significant improvement , with 80 % of prescriptions being appropriate and 100 % of practitioners recording a diagnosis . The majority of inappropriate prescriptions in both cycles were for acute pulpitis without evidence of systemic involvement . Conclusion This audit has shown that clinical practice for antimicrobial prescribing did not follow the published guidelines . Following targeted interventions , a substantial improvement was made in the prescribing pattern . The target of 100 % has not been reached , necessitating further intervention OBJECTIVE To find out whether the frequency of postoperative infectious and inflammatory complications ( IC ) in subjects treated with placebo ( Pl ) is greater than those treated with antibiotic ( Ab ) after extraction of an impacted m and ibular third molar ( M3 ) . Our hypothesis is there are more IC in Pl than in Ab , with a maximum ratio difference of 0.067 . STUDY DESIGN A double-blind placebo-controlled r and omized clinical trial . The sample was derived from the population of subjects attending Cruces Hospital for evaluation and extraction of 1 M3 under local anesthesia . Patients were treated with postoperative placebo or amoxicillin/clavulanic acid 500/125 mg 3 times a day during 4 days . The outcome variable was infectious and inflammatory complications . Sex , age , smoking , molar depth , angulation , need for sectioning , ostectomy , and operation time were recorded . Analysis was by intention to treat , risk measures , and logistic regression . RESULTS In 490 subjects ( 259 Ab and 231 Pl ) , the frequency of IC was 1.9 % in the Ab and 12.9 % in the Pl group ( OR 7.6 , 95%CI 2.9 - 19.9 ; P < .001 ) . The number needed to treat was 10 ( 7 - 16 ) . Unadjusted relative risk was 0.15 ( 0.06 - 0.38 ) ( P < .001 ) . Absolute reduction risk was 0.11(0.066 - 0.155 ) ] . Therefore , the hypothesis can not be rejected . Multivariate analysis shows treatment with antibiotic ( OR = 8.66 ( 3.17 - 23.67 ) ; P < .001 ) and age ( OR = 1.08 ( 1.00 - 1.16 ) ; P = .029 ) are the only variables to be included in the logistic regression model . CONCLUSION Amoxicillin/clavulanic acid is efficacious in reducing the incidence of IC following third molar extraction but should not be prescribed in all cases PURPOSE The aim of the present study was to evaluate and compare the occurrence of postoperative complications in patients receiving either pre- or postoperative amoxicillin versus placebo after third molar surg
Output:
| Prophylactic use of amoxicillin does not significantly reduce the risk of infection and /or dry socket after third molar extraction .
With amoxicillin/clavulanic acid , the risk decreases significantly .
Nevertheless , considering the number needed to treat , low prevalence of infection , potential adverse reactions to antibiotics and lack of serious complications in placebo groups , the routine prescription of amoxicillin with or without clavulanic acid is not justified |
MS210616 | ***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 Purpose — Endovascular therapy in addition to st and ard care ( EVT+SC ) has been demonstrated to be more effective than SC in acute ischemic large vessel occlusion stroke . Our aim was to determine the cost-effectiveness of EVT+SC depending on patients ’ initial National Institutes of Health Stroke Scale ( NIHSS ) score , time from symptom onset , Alberta Stroke Program Early CT Score ( ASPECTS ) , and occlusion location . Methods — A decision model based on Markov simulations estimated lifetime costs and quality -adjusted life years ( QALYs ) associated with both strategies applied in a US setting . Model input parameters were obtained from the literature , including recently pooled outcome data of 5 r and omized controlled trials ( ESCAPE [ Endovascular Treatment for Small Core and Proximal Occlusion Ischemic Stroke ] , EXTEND-IA [ Extending the Time for Thrombolysis in Emergency Neurological Deficits – Intra-Arterial ] , MR CLEAN [ Multicenter R and omized Clinical Trial of Endovascular Treatment for Acute Ischemic Stroke in the Netherl and s ] , REVASCAT [ R and omized Trial of Revascularization With Solitaire FR Device Versus Best Medical Therapy in the Treatment of Acute Stroke Due to Anterior Circulation Large Vessel Occlusion Presenting Within 8 Hours of Symptom Onset ] , and SWIFT PRIME [ Solitaire With the Intention for Thrombectomy as Primary Endovascular Treatment ] ) . Probabilistic sensitivity analysis was performed to estimate uncertainty of the model results . Net monetary benefits , incremental costs , incremental effectiveness , and incremental cost-effectiveness ratios were derived from the probabilistic sensitivity analysis . The willingness-to-pay was set to $ 50 000/QALY . Results — Overall , EVT+SC was cost-effective compared with SC ( incremental cost : $ 4938 , incremental effectiveness : 1.59 QALYs , and incremental cost-effectiveness ratio : $ 3110/QALY ) in 100 % of simulations . In all patient subgroups , EVT+SC led to gained QALYs ( range : 0.47–2.12 ) , and mean incremental cost-effectiveness ratios were considered cost-effective . However , subgroups with ASPECTS ⩽5 or with M2 occlusions showed considerably higher incremental cost-effectiveness ratios ( $ 14 273/QALY and $ 28 812/QALY , respectively ) and only reached suboptimal acceptability in the probabilistic sensitivity analysis ( 75.5 % and 59.4 % , respectively ) . All other subgroups had acceptability rates of 90 % to 100 % . Conclusions — EVT+SC is cost-effective in most subgroups . In patients with ASPECTS ⩽5 or with M2 occlusions , cost-effectiveness remains uncertain based on current data Background and Purpose — Mechanical thrombectomy has the potential to improve recanalization rates and outcomes for patients with ischemic stroke , but potential gains could be offset by procedural complications and costs . We evaluated the cost and utility of combined intravenous ( IV ) tissue-type plasminogen activator ( tPA ) and mechanical thrombectomy compared to IV tPA alone for acute large-vessel ischemic stroke . Methods — We constructed a decision tree for a hypothetical 68-year-old with a large-vessel ischemic stroke who is eligible for IV tPA . The interventional strategy was IV tPA , a cerebral angiogram , and mechanical thrombectomy and thrombolysis if indicated . Recanalization , hemorrhage complications , and outcomes for the interventional strategy were from the Multi-MERCI study . The medical strategy was IV tPA using inputs from a comprehensive systematic review . Costs were estimated from Medicare reimbursements . We modeled lifetime costs and utilities for disability using a Markov model and Monte-Carlo multivariable sensitivity analysis . Results — For the baseline scenario , the recanalization rate was 72.9 % for the interventional strategy and 46.2 % for the medical strategy . For the interventional strategy , the symptomatic hemorrhage rate was 8.6 % with recanalization and 15.4 % without . For the medical strategy , the corresponding rates were 3.6 % and 13.3 % , respectively . The interventional strategy was cost-effective in 97.6 % of simulations ( incremental cost-effectiveness ratio $ 16 001/ quality -adjusted life year ; 95 % CI , $ 2736–$39 232 ) . Conclusions — Based on observational data , the combination of IV tPA and mechanical thrombectomy for large-vessel ischemic stroke appears to be cost-effective compared to IV tPA alone . These findings require additional validation with r and omized trial data Background and Purpose — The only Food and Drug Administration ( FDA ) -approved treatment for acute ischemic stroke is tissue plasminogen activator ( tPA ) given intravenously within 3 hours of symptom onset . An alternative strategy for opening intracranial vessels during stroke is mechanical embolectomy , especially for patients ineligible for intravenous tPA . Methods — We investigated the safety and efficacy of a novel embolectomy device ( Merci Retriever ) to open occluded intracranial large vessels within 8 hours of the onset of stroke symptoms in a prospect i ve , nonr and omized , multicenter trial . All patients were ineligible for intravenous tPA . Primary outcomes were recanalization and safety , and secondary outcomes were neurological outcome at 90 days in recanalized versus nonrecanalized patients . Results — Recanalization was achieved in 46 % ( 69/151 ) of patients on intention to treat analysis , and in 48 % ( 68/141 ) of patients in whom the device was deployed . This rate is significantly higher than that expected using an historical control of 18 % ( P<0.0001 ) . Clinical ly significant procedural complications occurred in 10 of 141 ( 7.1 % ) patients . Symptomatic intracranial hemorrhages was observed in 11 of 141 ( 7.8 % ) patients . Good neurological outcomes ( modified Rankin score ≤2 ) were more frequent at 90 days in patients with successful recanalization compared with patients with unsuccessful recanalization ( 46 % versus 10 % ; relative risk [ RR ] , 4.4 ; 95 % CI , 2.1 to 9.3 ; P<0.0001 ) , and mortality was less ( 32 % versus 54 % ; RR , 0.59 ; 95 % CI , 0.39 to 0.89 ; P=0.01 ) . Conclusions — A novel endovascular embolectomy device can significantly restore vascular patency during acute ischemic stroke within 8 hours of stroke symptom onset and provides an alternative intervention for patients who are otherwise ineligible for thrombolytics Background and Purpose — Endovascular mechanical thrombectomy may be used during acute ischemic stroke due to large vessel intracranial occlusion . First-generation MERCI devices achieved recanalization rates of 48 % and , when coupled with intraarterial thrombolytic drugs , recanalization rates of 60 % have been reported . Enhancements in embolectomy device design may improve recanalization rates . Methods — Multi MERCI was an international , multicenter , prospect i ve , single-arm trial of thrombectomy in patients with large vessel stroke treated within 8 hours of symptom onset . Patients with persistent large vessel occlusion after IV tissue plasminogen activator treatment were included . Once the newer generation ( L5 Retriever ) device became available , investigators were instructed to use the L5 Retriever to open vessels and could subsequently use older generation devices and /or intraarterial tissue plasminogen activator . Primary outcome was recanalization of the target vessel . Results — One hundred sixty-four patients received thrombectomy and 131 were initially treated with the L5 Retriever . Mean age±SD was 68±16 years , and baseline median ( interquartile range ) National Institutes of Health Stroke Scale score was 19 ( 15 to 23 ) . Treatment with the L5 Retriever result ed in successful recanalization in 75 of 131 ( 57.3 % ) treatable vessels and in 91 of 131 ( 69.5 % ) after adjunctive therapy ( intraarterial tissue plasminogen activator , mechanical ) . Overall , favorable clinical outcomes ( modified Rankin Scale 0 to 2 ) occurred in 36 % and mortality was 34 % ; both outcomes were significantly related to vascular recanalization . Symptomatic intracerebral hemorrhage occurred in 16 patients ( 9.8 % ) ; 4 ( 2.4 % ) of these were parenchymal hematoma type II . Clinical ly significant procedural complications occurred in 9 ( 5.5 % ) patients . Conclusions — Higher rates of recanalization were associated with a newer generation thrombectomy device compared with first-generation devices , but these differences did not achieve statistical significance . Mortality trended lower and the proportion of good clinical outcomes trended higher , consistent with better recanalization BACKGROUND AND PURPOSE We assessed the influence of functional status at 6 months after ischemic stroke on cause of death during long-term follow-up in 3 prospect i ve cohorts . METHODS The cohorts were 7710 patients from the Oxfordshire Community Stroke Project , Lothian Stroke Register , and International Stroke Trial . Functional status was assessed at 6 months after stroke onset . Causes of death were identified from death certificates , and were also classified into " stroke-related " or " other " causes . We calculated the relative risk with 95 % CI to assess the association between dependency level and cause of death . We also performed a multivariable regression analysis to adjust for other relevant factors . RESULTS Six months after stroke onset 5961 ( 78 % ) patients were still alive . At the end of follow-up period , 1620 ( 47 % ) patients who were functionally dependent at 6 months after stroke onset had died vs 711 ( 28 % ) independent patients . Dependent patients had a relative risk of dying from stroke of 1.70 ( 95 % CI , 1.44 - 2.00 ) compared to independent patients . Overall , dependent patients had a relative risk of 1.68 ( 95 % CI , 1.49 - 1.91 ) of dying from stroke-related causes . Dependency remained significantly ( P<0.01 ) associated with stroke-related causes of death in a multivariable regression analysis . CONCLUSIONS Stroke-related deaths continue to be a problem during the years after an ischemic stroke , especially in patients who are functionally dependent at 6 months after onset . Better acute treatments to reduce dependency and adequate secondary prevention remain high priorities BACKGROUND Trials of endovascular therapy for ischemic stroke have produced variable results . We conducted this study to test whether more advanced imaging selection , recently developed devices , and earlier intervention improve outcomes . METHODS We r and omly assigned patients with ischemic stroke who were receiving 0.9 mg of alteplase per kilogram of body weight less than 4.5 hours after the onset of ischemic stroke either to undergo endovascular thrombectomy with the Solitaire FR ( Flow Restoration ) stent retriever or to continue receiving alteplase alone . All the patients had occlusion of the internal carotid or middle cerebral artery and evidence of salvageable brain tissue and ischemic core of less than 70 ml on computed tomographic ( CT ) perfusion imaging . The co primary outcomes were reperfusion at 24 hours and early neurologic improvement ( ≥8-point reduction on the National Institutes of Health Stroke Scale or a score of 0 or 1 at day 3 ) . Secondary outcomes included the functional score on the modified Rankin scale at 90 days . RESULTS The trial was stopped early because of efficacy after 70 patients had undergone r and omization ( 35 patients in each group ) . The percentage of ischemic territory that had undergone reperfusion at 24 hours was greater in the endovascular-therapy group than in the alteplase-only group ( median , 100 % vs. 37 % ; P<0.001 ) . Endovascular therapy , initiated at a median of 210 minutes after the onset of stroke , increased early neurologic improvement at 3 days ( 80 % vs. 37 % , P=0.002 ) and improved the functional outcome at 90 days , with more patients achieving functional independence ( score of 0 to 2 on the modified Rankin scale , 71 % vs. 40 % ; P=0.01 ) . There were no significant differences in rates of death or symptomatic intracerebral hemorrhage . CONCLUSIONS In patients with ischemic stroke with a proximal cerebral arterial occlusion and salvageable tissue on CT perfusion imaging , early thrombectomy with the Solitaire FR stent retriever , as compared with alteplase alone , improved reperfusion , early neurologic recovery , and functional outcome . ( Funded by the Australian National Health and Medical Research Council and others ; EXTEND-IA Clinical Trials.gov number , NCT01492725 , and Australian New Zeal and Clinical Trials Registry number , ACTRN12611000969965 . ) Objective : To evaluate the cost-effectiveness of adding endovascular thrombectomy to st and ard care in patients with acute ischemic stroke . Methods : The cost-effectiveness analysis of endovascular thrombectomy in patients with acute is
Output:
| Conclusions — There is a robust body of evidence for the cost and cost-effectiveness of EVT .
The cost analyses suggested that although EVT was associated with higher costs , it also result ed in improved patient outcomes .
From the cost-effectiveness studies , EVT seems to be good value for money when a threshold of $ 50 000 per quality -adjusted life year gained is adopted |
MS210617 | ***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 Despite evidence of the effectiveness of injectable opioid treatment compared with oral methadone for chronic heroin addiction , the additional cost of injectable treatment is considerable , and cost-effectiveness uncertain . AIMS To compare the cost-effectiveness of supervised injectable heroin and injectable methadone with optimised oral methadone for chronic refractory heroin addiction . METHOD Multisite , open-label , r and omised controlled trial . Outcomes were assessed in terms of quality -adjusted life-years ( QALYs ) . Economic perspective included health , social services and criminal justice re sources . RESULTS Intervention costs over 26 weeks were significantly higher for injectable heroin ( mean £ 8995 v. £ 4674 injectable methadone and £ 2596 oral methadone ; P<0.0001 ) . Costs overall were highest for oral methadone ( mean £ 15 805 v. £ 13 410 injectable methadone and £ 10 945 injectable heroin ; P = n.s . ) due to higher costs of criminal activity . In cost-effectiveness analysis , oral methadone was dominated by injectable heroin and injectable methadone ( more expensive and less effective ) . At willingness to pay of £ 30 000 per QALY , there is a higher probability of injectable methadone being more cost-effective ( 80 % ) than injectable heroin . CONCLUSIONS Injectable opioid treatments are more cost-effective than optimised oral methadone for chronic refractory heroin addiction . The choice between supervised injectable heroin and injectable methadone is less clear . There is currently evidence to suggest superior effectiveness of injectable heroin but at a cost that policy makers may find unacceptable . Future research should consider the use of decision analytic techniques to model expected costs and benefits of the treatments over the longer term Group motivational interviewing ( MI ) interventions that target youth at-risk for alcohol and other drug ( AOD ) use may prevent future negative consequences . Youth in a teen court setting [ n=193 ; 67 % male , 45 % Hispanic ; mean age 16.6 ( SD=1.05 ) ] were r and omized to receive either a group MI intervention , Free Talk , or usual care ( UC ) . We examined client acceptance , and intervention feasibility and conducted a preliminary outcome evaluation . Free Talk teens reported higher quality and satisfaction ratings , and MI integrity scores were higher for Free Talk groups . AOD use and delinquency decreased for both groups at 3 months , and 12-month recidivism rates were lower but not significantly different for the Free Talk group compared to UC . Results contribute to emerging literature on MI in a group setting . A longer term follow-up is warranted Juvenile drug court ( JDC ) programs have exp and ed rapidly over the past 20 years and are an increasingly popular option for rehabilitating juvenile offenders with substance use problems . Given the high cost of crime to society , an important economic question is whether and to what extent JDC programs reduce criminal activity among juvenile offenders . To address this question , the present study added an economic cost analysis to an ongoing r and omized trial of JDC conducted in Charleston , South Carolina . Four treatment conditions were included in the parent study : Family Court with usual community-based treatment ( FC , the comparison group ) , Drug Court with usual community-based treatment ( DC ) , DC with Multisystemic Therapy ( DC/MST ) , and DC/MST enhanced with Contingency Management ( DC/MST/CM ) . The economic study estimated the cost of criminal activity for nine specific crimes at baseline ( pretreatment ) and 4 and 12 months thereafter . A number of method ological challenges were encountered , suggesting that it may be more difficult to economically quantify frequency and type of criminal activity for adolescents than for adults . The present paper addresses method ological approaches and challenges , and proposes guidelines for future economic evaluations of adolescent substance abuse and crime prevention programs This r and omized controlled pilot study compared a cognitive-behavioral therapy ( Seeking Safety ; SS ) plus treatment-as-usual ( TAU ) to TAU-alone in 49 incarcerated women with substance use disorder ( SUD ) and posttraumatic stress disorder ( PTSD ; full or subthreshold ) . Seeking Safety consisted of a voluntary group treatment during incarceration and individual treatment after prison release . TAU was required in the prison and comprised 180 to 240 hours of individual and group treatment over 6 to 8 weeks . Assessment s occurred at intake , 12 weeks after intake , and 3 and 6 months after release from prison . There were no significant differences between conditions on all key domains ( PTSD , SUD , psychopathology , and legal problems ) ; but both conditions showed significant improvements from intake to later time points on all of these outcomes across time . Secondary analyses at follow-up found trends for SS participants improving on clinician-rated PTSD symptoms and TAU participants worsening on self-reported PTSD symptoms . Also , SS demonstrated continued improvement on psychopathology at 3 and 6 months , whereas TAU did not . However , alcohol use improved more for TAU during follow-up . Satisfaction with SS was high , and a greater number of SS sessions was associated with greater improvement on PTSD and drug use . Six months after release from prison , 53 % of the women in both conditions reported a remission in PTSD . Study limitations include lack of assessment of SS outcomes at end of group treatment ; lack of blind assessment ; omission of the SS case management component ; and possible contamination between the two conditions . The complex needs of this population are discussed This experimental pilot study compared postrelease outcomes for 115 women who participated in prison-based substance abuse treatment . Women were r and omized to a gender-responsive treatment ( GRT ) program using manualized curricula ( Helping Women Recover and Beyond Trauma ) or a st and ard prison-based therapeutic community . Data were collected from the participants at prison program entry and 6 and 12 months after release . Bivariate and multivariate analyses were conducted . Results indicate that both groups improved in psychological well-being ; however , GRT participants had greater reductions in drug use , were more likely to remain in residential aftercare longer ( 2.6 vs. 1.8 months , p < .05 ) , and were less likely to have been reincarcerated within 12 months after parole ( 31 % vs. 45 % , respectively ; a 67 % reduction in odds for the experimental group , p < .05 ) . Findings show the beneficial effects of treatment components oriented toward women 's needs and support the integration of GRT in prison programs for women OBJECTIVE Motivational interviewing to reduce alcohol and marijuana use among incarcerated adolescents was evaluated . METHOD Adolescents ( N = 162 , 84 % male ; M = 17.10 years old ) were r and omly assigned to receive motivational interviewing or relaxation training , with follow-up assessment 3 months after release . RESULTS Compared with those who received relaxation training , adolescents who received motivational interviewing had lower rates of alcohol and marijuana use at follow-up , with some evidence for moderating effects of depression . At low levels of depression , adolescents who received motivational interviewing had lower rates of use . Adolescents who received relaxation training and who had high levels of depressive symptoms early in incarceration showed less use at follow-up than those low in depressive symptoms who received relaxation training . CONCLUSIONS This brief motivational interviewing intervention during incarceration reduces alcohol and marijuana use after release . In addition , depressive symptoms early in incarceration should be considered in treating these adolescents , but more work is needed to extend follow-up period and account for the impact of depression on outcomes Jail recidivists with serious mental illness and substance use disorders were treated in an in-custody setting and then r and omly assigned to either a high fidelity Integrated Dual Disorders Treatment program ( 103 participants ) or to service as usual ( 79 participants ) . Outcomes were tracked an average of 18 months from program entry at the termination of the initial incarceration . A reduction in jail days from baseline to study period was significant for both groups . The pre to post reduction for arrests and total convictions was significant in the experimental group but not the control group . However , during the study period , differences between experimental and control groups in arrests , convictions and jail days were not statistically significant . Experimental participants had lower study period psychiatric inpatient and crisis utilization and greater outpatient utilization than did control group participants . The groups did not differ with regard to total institutional days . Experimental group attrition was relatively high Evaluated the effectiveness of juvenile drug court for 161 juvenile offenders meeting diagnostic criteria for substance abuse or dependence and determined whether the integration of evidence -based practice s enhanced the outcomes of juvenile drug court . Over a 1-year period , a four-condition r and omized design evaluated outcomes for family court with usual community services , drug court with usual community services , drug court with multisystemic therapy , and drug court with multisystemic therapy enhanced with contingency management for adolescent substance use , criminal behavior , symptomatology , and days in out-of-home placement . In general , findings supported the view that drug court was more effective than family court services in decreasing rates of adolescent substance use and criminal behavior . Possibly due to the greatly increased surveillance of youths in drug court , however , these relative reductions in antisocial behavior did not translate to corresponding decreases in rearrest or incarceration . In addition , findings supported the view that the use of evidence -based treatments within the drug court context improved youth substance-related outcomes . Clinical and policy implication s of these findings are discussed Correctional systems nationwide have increasingly turned to therapeutic community ( TC ) programs for the treatment of addiction in prisons . TC treatment , with modifications , has shown considerable promise in treating offenders who have co-occurring mental and substance use disorders , a group that has a mounting prevalence in prison population s. This article reports data from a study that r and omly assigned male inmates with mental illness and chemical abuse ( MICA ) disorders ( n = 139 ) to either a Modified TC ( MTC ) or a comparison group . Analyses revealed that the MTC group had significantly greater declines in alcohol and drug use at 12-months post-prison release . Additional analysis related positive substance use outcomes to reduced contact with the justice system and self-reported criminal activity . Implication s for treatment and policy are discussed PURPOSE This study assesses the impact of REAL MEN ( Returning Educated African-American and Latino Men to Enriched Neighborhoods ) , an intervention design ed to reduce drug use , risky sexual behavior and criminal activity among 16 - 18-year-old males leaving New York City jails . METHODS Participants ( N = 552 ) were recruited in city jails and r and omly assigned to receive an intensive 30-hour jail/community-based intervention or a single jail-based discharge planning session . All participants were also referred to optional services at a community-based organization ( CBO ) . One year after release from jail , 397 ( 72 % ) participants completed a follow-up interview . Logistic and ordinary least squares regression was used to evaluate the impact of the intervention on drug use , risky sexual behavior , criminal justice involvement , and school/work involvement post release . RESULTS Assignment to REAL MEN and , independently , use of CBO services , significantly reduced the odds of substance dependence ( odds ratio [ OR ] = .52 , p ≤ .05 ; OR = .41 , p ≤ .05 , respectively ) 1 year after release . Those assigned to the intervention spent 29 fewer days in jail compared with the comparison group ( p ≤ .05 ) . Compared to non-CBO visitors , those who visited the CBO were more likely to have attended school or found work in the year after release ( OR = 2.02 , p ≤ .01 ) . CONCLUSIONS Jail and community services reduced drug dependence 1 year after release and the number of days spent in jail after the index arrest . While these findings suggest that multifaceted interventions can improve outcomes for young men leaving jail , rates of drug use , risky sexual behavior , and recidivism remained high for all participants after release from jail , suggesting the need for additional policy and programmatic interventions This study , the largest r and omized controlled trial of treatment for major depressive disorder ( MDD ) in an incarcerated population to date , wave-r and omized 38 incarcerated women ( 6 waves ) with MDD who were attending prison substance use treatment to adjunctive group interpersonal psychotherapy ( IPT ) for MDD or to an attention-matched control condition . Intent-to-treat analyses found that IPT participants had significantly lower depressive symptoms at the end of 8 weeks of in-prison treatment than did control participants . Control participants improved later , after prison release . IPT 's rapid effect on MDD within prison may reduce serious in-prison consequences of MDD Substantial evidence indicates that drug courts can be superior to traditional probation programs for enhancing treatment retention and reducing substance use and crime among drug offenders . Few studies have isolated the effects of the hypothesized " key components " of drug courts to determine their contributions to outcomes . This article presents outcomes at 6 and 12 months post-admission for misdemeanor drug court clients who were r and omly assigned to different dosages of judicial status hearings . Although earlier work revealed superior during-treatment effects for high-risk participants who were assigned to more frequent bi-weekly hearings , those effects did not extend post-treatment . The results did reveal significant pre-to-post improvements for participants , as a whole , in self-reported drug use , alcohol use , and criminal recidivism ; however , lacking a no-drug court control condition , it is not possible to discern the magnitude of the effect of the drug court program
Output:
| Conclusions : We suggest that therapeutic community interventions have some benefit in reducing subsequent re-arrest . |
MS210618 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
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Input: OBJECTIVE To test the validity of a set of defined and tested rules for decisions on use of radiography for acute ankle injuries . DESIGN Prospect i ve survey . SETTING Community hospital emergency department managing 42000 visits annually . PARTICIPANTS A non-consecutive sample of 318 adults and children presenting during 1 year was evaluated by 25 family physicians in part-time emergency practice . INTERVENTIONS Participating physicians interpreted the Ottawa ankle rules for all enrolled patients and ordered radiographs in 96 % of cases . MAIN OUTCOME MEASURES Sensitivity of the Ottawa ankle rules to predict whether radiography is required for acute ankle injuries . RESULTS Of the 318 cases , 22 incomplete records were excluded , leaving 259 records of adults and 37 records of patients younger than 16 accepted for analysis . Of 34 adult patients with identified fractures , only one was predicted by the rules not to require radiographs . Sensitivity of the rules was 0.971 ( confidence interval [ CI ] 0.914 to 1.00 ) , specificity was 0.302 ( CI 0.242 to 0.362 ) , positive predictive value was 0.174 ( CI 0.120 to 0.228 ) , and negative predictive value was 0.986 ( CI 0.971 to 1.00 ) . Radiography could have been reduced by 26.3 % had the rules been applied . Of the 37 children , seven had fractures . All were properly identified by the rules . Radiography in this group could have been reduced by 22 % . CONCLUSIONS This study vali date s the Ottawa ankle rules and supports their use . Further research on how the rules apply to children is required To help curb excessive radiography , we developed a protocol for selecting patients with injured extremities who need x-ray examination , and we tested the protocol prospect ively in 848 patients to determine its safety and effectiveness . Strict adherence to the protocol would have reduced x-ray usage by 12 per cent for upper extremities and 19 per cent for lower extremities . The actual reductions were 5 per cent and 16 per cent , respectively , since further reductions were limited by patient 's dem and s for x-ray examinations . One fracture in 287 were missed , but the treatment was appropriate and the outcome satisfactory . By eliminating superfluous x-ray procedures , the protocol could reduce charges by $ 79 million to $ 139 million nationwide , without compromising quality of care or increasing mal practice liability . Nevertheless , even the best protocol can not eliminate all negative x-ray studies . These results should serve as a stimulus for judicious use of radiography , but also as a warning to avoid overzealous cost-containment strategies that would reduce x-ray usage to below a safe threshold In a sports medicine center , we prospect ively evaluated the Ottawa Ankle Rules over 1 year for their ability to identify clinical ly significant ankle and midfoot fractures and to reduce the need for radiography . We also developed a modification to improve specificity for malleolar fracture identification . Patients with acute ankle injuries ( 10 days old ) had the rules applied and then had radiographs taken . Sensitivity , specificity , and the potential reduction in the use of radiography were calculated for the Ottawa Ankle Rules in 132 patients and for the new “ Buffalo ” rule in 78 of these patients . There were 11 clinical ly significant fractures ( fracture rate , 8.3 % per year ) . In these 132 patients , the Ottawa Ankle Rules would have reduced the need for radiography by 34 % , without any fractures being missed ( sensitivity 100 % , specificity 37 % ) . In 78 patients , the specificity for malleolar fracture for the new rule was significantly greater than that of the Ottawa Ankle Rules malleolar rule ( 59 % versus 42 % ) , sensitivity remained 100 % , and the potential reduction in the need for radiography ( 54 % ) was significantly greater . The Ottawa Ankle Rules could significantly reduce the need for radiography in patients with acute ankle and midfoot injuries in this setting without missing clinical ly significant fractures . The Buffalo modification could improve specificity for malleolar fractures without sacrificing sensitivity and could significantly reduce the need for radiography OBJECTIVE : To assess whether accident and emergency ( A&E ) nurses using the Ottawa Ankle Rules could detect all ankle fractures . DESIGN : Prospect i ve observational study . SETTING : A&E department of a university teaching hospital . SUBJECTS : All patients who presented with ankle injuries who were initially assessed by a nurse taught the Ottawa Ankle Rules . OUTCOME MEASURES : ( 1 ) The numbers of patients referred by the nurse for ankle radiography ; ( 2 ) of these , the number with ankle fractures ; ( 3 ) of those not sent for radiography initially by the nurse , the number who subsequently had x rays ( ordered by the doctor ) and had a fracture ; ( 4 ) of those having no x rays , the number who reattended later . RESULTS : 324 patients were eligible ; 238 had x rays at the request of the nurse ( 73 % ) ; 48 of these ( 20 % ) were diagnosed as having a fracture . Of those 86 patients not sent for radiography by the nurse , 19 subsequently had x ray examinations at the request of a doctor and no fracture was detected . Of the 67 not sent for radiography , none returned within the subsequent eight weeks . CONCLUSIONS : Nurses can apply the Ottawa Ankle Rules safely without missing acute fractures ; that is , of those who were not sent for radiography by nurses , none subsequently reattended the A&E department or the trauma service of the Bristol Royal Infirmary during the following two months Ankle injuries are a frequent cause of attendance to accident and emergency ( A&E ) departments . Although often classed as ' minor injuries ' , the consequences of mismanagement can be debilitating for patients . In addition , it is not always easy to differentiate those injuries with bony fractures from solely ligamentous injuries , and most patients are radiographed unnecessarily . Clinical prediction rules such as the Ottawa Ankle Rules have been devised to reduce the degree of radiographic requests , thus limiting harmful radiation exposure , and reducing departmental costs . The A&E environment of our centre often includes a variety of clinicians with little pure orthopaedic training or knowledge of these clinical prediction rules , hence , providing a prime atmosphere for their assessing their effectiveness . A prospect i ve study was performed in our centre to investigate the validity of the clinician 's decision in diagnosis of a bony injury in the absence of training with the Ottawa Ankle Rules . The effectiveness of applying the rules was then determined on the same set of patients OBJECTIVE To vali date and refine previously derived clinical decision rules that aid the efficient use of radiography in acute ankle injuries . DESIGN Survey prospect ively administered in two stages : validation and refinement of the original rules ( first stage ) and validation of the refined rules ( second stage ) . SETTING Emergency departments of two university hospitals . PATIENTS Convenience sample of adults with acute ankle injuries : 1032 of 1130 eligible patients in the first stage and 453 of 530 eligible patients in the second stage . MAIN OUTCOME MEASURES Attending emergency physicians assessed each patient for st and ardized clinical variables and classified the need for radiography according to the original ( first stage ) and the refined ( second stage ) decision rules . The decision rules were assessed for their ability to correctly identify the criterion st and ard of fractures on ankle and foot radiographic series . The original decision rules were refined by univariate and recursive partitioning analyses . MAIN RESULTS In the first stage , the original decision rules were found to have sensitivities of 1.0 ( 95 % confidence interval [ CI ] , 0.97 to 1.0 ) for detecting 121 maleolar zone fractures , and 0.98 ( 95 % CI , 0.88 to 1.0 ) for detecting 49 midfoot zone fractures . For interpretation of the rules in 116 patients , kappa values were 0.56 for the ankle series rule and 0.69 for the foot series rule . Recursive partitioning of 20 predictor variables yielded refined decision rules for ankle and foot radiographic series . In the second stage , the refined rules proved to have sensitivities of 1.0 ( 95 % CI , 0.93 to 1.0 ) for 50 malleolar zone fractures , and 1.0 ( 95 % CI , 0.83 to 1.0 ) for 19 midfoot zone fractures . The potential reduction in radiography is estimated to be 34 % for the ankle series and 30 % for the foot series . The probability of fracture , if the corresponding decision rule were " negative , " is estimated to be 0 % ( 95 % CI , 0 % to 0.8 % ) in the ankle series , and 0 % ( 95 % CI , 0 % to 0.4 % ) in the foot series . CONCLUSION Refinement and validation have shown the Ottawa ankle rules to be 100 % sensitive for fractures , to be reliable , and to have the potential to allow physicians to safely reduce the number of radiographs ordered in patients with ankle injuries by one third . Field trials will assess the feasibility of implementing these rules into clinical practice The Ottawa ankle rules ( OAR ) have been vali date d in many Western countries . However , a recent study performed in an accident and emergency department in Singapore failed to vali date the OAR . Therefore , the implementation of the use of OAR in accident and emergency departments in Hong Kong may be treated with skepticism . This prospect i ve study was performed to vali date the ordering of radiographs using OAR in Chinese patients with foot and ankle injuries in Hong Kong . Emergency physicians trained in the use of the OAR assessed 773 eligible patients and one hundred thirty-one fractures were identified . The sensitivity and specificity of the OAR for ankle injuries was 98 % and 40.8 % . For midfoot injuries , the sensitivity and specificity of the OAR was 100 % and 43.8 % . We concluded that the OAR are applicable in our population with potential advantages for reducing the number of unnecessary investigations and shortening the patients ' length of stay in accident and emergency departments STUDY OBJECTIVE To vali date criteria predicting ankle and mid-foot fractures with 100 % sensitivity . DESIGN Prospect i ve validation study SETTING A 929-bed community teaching hospital with an annual census of 76,488 ED visits . PARTICIPANTS Convenience sample of patients older than 18 years with acute ankle or midfoot injury . INTERVENTIONS Radiography was performed in each patient received after pertinent history and physical examination findings were recorded . RESULTS Five hundred seventy radiographs were obtained in 484 patients . Four hundred twenty-one were of the ankle , and 149 were of the foot . There were 93 ankle fractures and 29 midfoot fractures , giving a fracture yield of 22.1 % for ankle films and 19.5 % for foot films . Decision rules had sensitivity of 94.6 % and specificity of 15.5 % for ankle fractures and sensitivity of 93.1 % and specificity of 11.5 % for midfoot fractures . Prospect i ve criteria failed to predict fracture in five of the ankle group and two of the midfoot group . Physicians predicting fracture solely on the basis of clinical suspicion had a sensitivity of 69 % in ankle injuries and 76 % in midfoot injuries . CONCLUSION We were unable to vali date with 100 % sensitivity the Ottawa rules predicting ankle and midfoot fractures . However , the Ottawa rules were more sensitive than clinical suspicion alone OBJECTIVE The Ottawa Ankle Rules ( OAR ) assist emergency physicians in the appropriate use of roentgenography in adults with acute ankle injuries . The OAR state that ankle roentgenograms are needed only if there is pain near the malleoli and one or more of the following exists : ( 1 ) age 55 years or older ; ( 2 ) inability to bear weight ; or ( 3 ) bone tenderness at the posterior edge or tip of either malleolus . This study assessed the utility of the OAR on pediatric patients with acute ankle injuries . DESIGN Prospect i ve , consecutive survey of pediatric patients with acute ankle injuries . SETTING Pediatric emergency department of an urban university hospital . PARTICIPANTS Seventy-one children with acute ankle injuries were enrolled from July 22 , 1993 , to December 1 , 1993 . INTERVENTIONS Twenty-four st and ardized clinical variables were assessed and recorded by physicians in the pediatric emergency department . The OAR were applied to each patient by the investigator to determine which ones would qualify for roentgenography . MAIN OUTCOME MEASURES Sensitivity and specificity of the OAR were calculated , as was percent reduction in roentgenograms ordered . RESULTS Seventy-one of 73 eligible patients were enrolled . The two missed patients had open fractures of the tibia . Sixty-eight of 71 patients had ankle roentgenography during the visit . Fourteen patients ( 21 % ) ( mean age , 11.8 + /- 4.0 years ) had fractures noted on the roentgenograms . Fifty-four patients ( 79 % ) ( mean age ,
Output:
| Evidence supports the Ottawa ankle rules as an accurate instrument for excluding fractures of the ankle and mid-foot . |
MS210619 | ***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: Background The treatment results of external beam radiotherapy for intermediate and high risk prostate cancer patients are insufficient with five-year biochemical relapse rates of approximately 35 % . Several r and omized trials have shown that dose escalation to the entire prostate improves biochemical disease free survival . However , further dose escalation to the whole gl and is limited due to an unacceptable high risk of acute and late toxicity . Moreover , local recurrences often originate at the location of the macroscopic tumor , so boosting the radiation dose at the macroscopic tumor within the prostate might increase local control . A reduction of distant metastases and improved survival can be expected by reducing local failure . The aim of this study is to investigate the benefit of an ablative microboost to the macroscopic tumor within the prostate in patients treated with external beam radiotherapy for prostate cancer . Methods / Design The FLAME-trial ( F ocal L esion A blative M icroboost in prostatE cancer ) is a single blind r and omized controlled phase III trial . We aim to include 566 patients ( 283 per treatment arm ) with intermediate or high risk adenocarcinoma of the prostate who are scheduled for external beam radiotherapy using fiducial markers for position verification . With this number of patients , the expected increase in five-year freedom from biochemical failure rate of 10 % can be detected with a power of 80 % . Patients allocated to the st and ard arm receive a dose of 77 Gy in 35 fractions to the entire prostate and patients in the experimental arm receive 77 Gy to the entire prostate and an additional integrated microboost to the macroscopic tumor of 95 Gy in 35 fractions . The secondary outcome measures include treatment-related toxicity , quality of life and disease-specific survival . Furthermore , by localizing the recurrent tumors within the prostate during follow-up and correlating this with the delivered dose , we can obtain accurate dose-effect information for both the macroscopic tumor and sub clinical disease in prostate cancer . The rationale , study design and the first 50 patients included are described . Trial registration This study is registered at Clinical Trials.gov : Purpose To assess whether an exp and ed ( five level ) risk stratification system can be used to identify the sub-group of intermediate risk patients with prostate cancer who benefit from combining and rogen deprivation therapy ( ADT ) with external beam radiotherapy ( EBRT ) . Material s and methods Using a previously vali date d 5-risk group schema , a prospect i ve non-r and omized data set of 1423 men treated at the British Columbia Cancer Agency was assessed for the primary end point of biochemical control ( bNED ) with the RTOG-ASTRO " Phoenix " definition ( lowest PSA to date + 2 ng/mL ) , both with and without adjuvant ADT . The median follow-up was 5 years . Results There was no bNED benefit for ADT in the low or low intermediate groups but there was a statistically significant bNED benefit in the high intermediate , high and extreme risk groups . The 5-year bNED rates with and without ADT were 70 % and 73 % respectively for the low intermediate group ( p = non-significant ) and 72 % and 58 % respectively for the high intermediate group ( p = 0.002 ) . Conclusion There appears to be no advantage to ADT where the Gleason score is 6 or less and PSA is 15 or less . ADT is beneficial in patients treated to st and ard dose radiation with Gleason 6 disease and a PSA greater than 15 or where the Gleason score is 7 or higher When analysis of results of radiotherapy for nearly 500 patients with oropharyngeal cancer showed evidence for rapid tumor regrowth during extensions of treatment from about 5 weeks to about 8 weeks , we search ed the literature on radiotherapy for head and neck cancer to determine whether it revealed similar evidence of accelerated tumor regrowth . Estimates of doses to achieve local control in 50 % of cases ( TCD50 ) were made from published local control rates , and the dependence of these doses on overall treatment duration was evaluated . In parallel , published scattergrams were analyzed to estimate the rate of tumor regrowth over the period of 4 - 10 weeks from initiation of therapy . Both analyses suggested that , on average , clonogen re population in squamous cell carcinomas of the head and neck accelerates only after a lag period of the order of 4 + /- 1 weeks after initiation of radiotherapy and that a dose increment of about 0.6 Gy per day is required to compensate for this re population . Such a dose increment is consistent with a 4-day clonogen doubling rate , compared with a median of about 60 days in published reports of unperturbed tumor growth rates . The values presented here are average values for a large number of patients : it is necessary , not only to verify the results of these retrospective analyses in prospect i ve studies , but also to develop methods to predict the time of onset and rate of accelerated tumor clonogen re population in the individual patient OBJECTIVES To investigate whether low partial pressure of oxygen ( PO2 ) in prostate cancer ( CaP ) predicts for biochemical outcome after radiotherapy . We previously reported that hypoxic regions exist in human CaP. METHODS Custom-made Eppendorf PO2 microelectrodes were used to obtain approximately 100 PO2 readings from both pathologically involved regions of the prostate ( as determined by sextant biopsies ) and normal muscle ( as an internal control ) . Fifty-seven patients with localized disease were prospect ively studied ; all received brachytherapy implants ( 48 low dose rate and 9 high dose rate ) under spinal anesthesia . Nine patients had received prior hormonal therapy . Biochemical failure was defined as two consecutive rises in prostate-specific antigen level , without a return to baseline . Cox proportional hazards regression analysis was used to evaluate the influence of hypoxia on biochemical control , while adjusting for prostate-specific antigen , Gleason score , stage , implant type ( low dose rate versus high dose rate ) , perineural invasion , hemoglobin level , use of hormonal therapy , average ( mean ) of the median prostate PO2 , average median muscle PO2 , and prostate/muscle PO2 ( P/M ) ratio . RESULTS With a median follow-up of 19 months ( range 4 to 31 ) , 9 patients developed biochemical failure . A threshold analysis of the P/M ratio demonstrated that biochemical control at 2 years differed significantly at a ratio of less than 0.05 versus 0.05 or greater ( 31 % versus 92 % , P < 0.0001 ) . However , the classic prognosticators were similar in these two groups . On multivariate analysis , the P/M ratio was the only predictor of biochemical control ( P = 0.0002 ) . CONCLUSIONS To our knowledge , this is the first study to correlate the degree of hypoxia in CaP with treatment outcome after radiotherapy . The P/M PO2 ratio was the strongest predictor for biochemical control on stepwise multivariate analysis . Longer follow up with more patients is planned to confirm this result BACKGROUND AND PURPOSE Heavy ion radiotherapy is a promising modality because of its excellent dose localization and high biological effect on tumors . Using carbon beams , a dose escalation study was conducted for the treatment of stage I non-small cell lung cancer ( NSCLC ) to determine the optimal dose . MATERIAL S AND METHODS The first stage phase I/II trial using 18 fractions over 6 weeks for 47 patients and the second one using nine fractions over 3 weeks for 34 patients were conducted by the dose escalation method from 59.4 to 95.4 Gray equivalents ( GyE ) in incremental steps of 10 % and from 68.4 to 79.2 GyE in 5 % increments , respectively . The local control and survival rates were obtained using the Kaplan-Meier method . RESULTS Radiation pneumonitis at grade III occurred in three of 81 patients , but they fully recovered . This was not a dose-limiting factor . The local control rates in the first and second trials were 64 % and 84 % , respectively . The total recurrence rate in both trials was 23.2 % . The infield local recurrence in the first trial was significantly dependent on carbon dose . The doses greater than 86.4 GyE at 18 fractions and 72 GyE at nine fractions achieved a local control of 90 % and 95 % , respectively . The 5 year overall and cause-specific survivals in 81 patients were 42 % and 60 % , respectively . CONCLUSIONS With our dose escalation study , the optimum safety and efficacy dose of carbon beams was determined . Carbon beam therapy attained almost the same results as surgery for stage I NSCLC although this was a I/II study PURPOSE Analysis of the results of hypofractionated conformal carbon ion radiotherapy for localized prostate cancer was performed , with special regard to normal tissue morbidity and biochemical relapse-free rate ( bNED ) . METHODS AND MATERIAL S Analysis was performed for 201 patients treated with the dose fractionation regimen established during three clinical trials performed between June 1995 and February 2004 . Outcomes were measured in terms of toxicity , survival , freedom from local recurrence , and bNED . RESULTS No Grade 3 or higher toxicities were observed in either the rectum or genitourinary system , and the incidences of Grade 2 rectum or genitourinary morbidity were only 1.0 % and 6.0 % , respectively . The overall 5-year biochemical relapse-free survival was 83.2 % without any local recurrence . Gleason score , initial PSA , and T stage were all significant prognostic factors for bNED , which was 97.1 % in patients with Gleason score < or = 7 and initial PSA < 20 ng/mL. CONCLUSION Hypofractionated carbon ion radiotherapy with the established dose fractionation regimen yielded satisfactory bNED without local recurrence and with minimal morbidity . Long-term results are necessary to confirm the utility of carbon ion radiotherapy in the treatment of localized prostate cancer BACKGROUND AND PURPOSE The objectives of the current study were to compare genito-urinary ( GU ) and gastro-intestinal ( GI ) toxicities as well as biochemical control ( bRFS ) in prostate cancer , utilizing conventional ( 2.0 Gy daily ) ( STD ) or hyperfractionated ( HFX ) conformal irradiation ( CRT ) . HFX ( 1.2 Gy BID ) was chosen as a radiobiological method to try to reduce long term sequelae without compromising local control . PATIENTS AND METHODS Three-hundred- and -seventy consecutive patients ( pts ) entered this prospect i ve , non-r and omized trial in the period January 1993-January 2003 ; 209 were treated with STD and 161 with HFX CRT . All were evaluable for acute toxicity analysis , 179 ( STD ) and 151 pts ( HFX ) being evaluable for late sequelae and bRFS analyses . Pt characteristics were not statistically different in the two groups . CRT consisted of a 4-field technique for prostate and /or pelvic nodes and a 5-field boost with rectal shielding . Median doses were 74 and 79.2 Gy for STD and HFX patients respectively , the latter dose being isoeffective for tumour control assuming alpha/beta=10 ( EQD(2)=73.9 Gy ) . Median follow-up was 29.4 months ( 25.2 mos for STD ; 37.7 mos for HFX ; P<0.01 ) . The two regimens were compared in terms of acute and late GU and GI toxicities and 5-year bRFS by univariate and multivariate analyses . RESULTS Acute grade > or = 2 GU toxicity was higher in the STD group ( 48.6 % versus 37.3 % in HFX , P=0.03 ) , while no significant difference was found for acute GI toxicity . Late grade > or = 2 GU and GI toxicities were lower in the HFX group ( 5-year actuarial rate : GU : 10.1 % versus 20.3 % , P=0.05 ; GI : 6.0 % versus 10.6 % , P=0.18 ) . Five-year bRFS were 70 % ( + /-13.8 % , 95 % CI ) and 82.6 % ( + /-7.2 % ) for STD and HFX , respectively ( P=0.44 ) ; a trend favouring HFX was found in the subgroup of pts who did not receive hormonal therapy ( 5-year bRFS : 85.9%+/-12.4 % versus 63.9%+/-23.8 % , P=0.15 ) . Multivariate analysis revealed only risk groups and age statistically related to bRFS but not fractionation regimen . Using the Nahum-Chapman TLCP model and prostate parameter set , which includes hypoxia , the TLCPs are approximately equal for the two regimens , whereas assuming alpha/beta=1.5 and no hypoxia we obtain 73 % for the STD group but only 36 % for the HFX group . CONCLUSIONS As expected from radiobiological considerations , HFX reduces GI and GU late toxicities . Concerning early bRFS , our clinical findings suggest that HFX is no less effective than STD when delivering an isoeffective ( alpha/beta=10 ) dose . Despite the relatively short follow-up , this result appears to be inconsistent with a low alpha/beta ratio for prostate cancer Gamma knife treatments are usually planned manually , requiring much expertise and time . We describe a new , fully automatic method of treatment planning . The treatment volume to be planned is first compared with a data base of past treatments to find volumes closely matching
Output:
| This TCP model fitted and vali date d to clinical outcome data , appears to be an appropriate model for the inclusion of all clinical prostate cancer risk categories , and allows evaluation of current EBRT modalities with regard to tumor control prediction |
MS210620 | ***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 shown the efficacy , tolerability , and ease of administration of pemetrexed-an antifolate antineoplastic agent-in patients with advanced non-small-cell lung cancer . We assessed pemetrexed as maintenance therapy in patients with this disease . METHODS This r and omised double-blind study was undertaken in 83 centres in 20 countries . 663 patients with stage IIIB or IV disease who had not progressed on four cycles of platinum-based chemotherapy were r and omly assigned ( 2:1 ratio ) to receive pemetrexed ( 500 mg/m(2 ) , day 1 ) plus best supportive care ( n=441 ) or placebo plus best supportive care ( n=222 ) in 21-day cycles until disease progression . Treatment was r and omised with the Simon and Pocock minimisation method . Patients and investigators were masked to treatment . All patients received vitamin B(12 ) , folic acid , and dexamethasone . The primary endpoint of progression-free survival and the secondary endpoint of overall survival were analysed by intention to treat . This study is registered with Clinical Trials.gov , number NCT00102804 . FINDINGS All r and omly assigned participants were analysed . Pemetrexed significantly improved progression-free survival ( 4.3 months [ 95 % CI 4.1 - 4.7 ] vs 2.6 months [ 1.7 - 2.8 ] ; hazard ratio [ HR ] 0.50 , 95 % CI 0.42 - 0.61 , p<0.0001 ) and overall survival ( 13.4 months [ 11.9 - 15.9 ] vs 10.6 months [ 8.7 - 12.0 ] ; HR 0.79 , 0.65 - 0.95 , p=0.012 ) compared with placebo . Treatment discontinuations due to drug-related toxic effects were higher in the pemetrexed group than in the placebo group ( 21 [ 5 % ] vs three [ 1 % ] ) . Drug-related grade three or higher toxic effects were higher with pemetrexed than with placebo ( 70 [ 16 % ] vs nine [ 4 % ] ; p<0.0001 ) , specifically fatigue ( 22 [ 5 % ] vs one [ 1 % ] , p=0.001 ) and neutropenia ( 13 [ 3 % ] vs 0 , p=0.006 ) . No pemetrexed-related deaths occurred . Relatively fewer patients in the pemetrexed group than in the placebo group received systemic post-discontinuation therapy ( 227 [ 51 % ] vs 149 [ 67 % ] ; p=0.0001 ) . INTERPRETATION Maintenance therapy with pemetrexed is well tolerated and offers improved progression-free and overall survival compared with placebo in patients with advanced non-small-cell lung cancer . FUNDING Eli Lilly BACKGROUND Hypertension ( HTN ) , a recognized adverse effect of angiogenesis inhibitors , may be a potential biomarker of activity of these agents . We conducted a retrospective analysis to examine the incidence and predictors of the development of on-treatment HTN with the vascular endothelial growth factor receptor tyrosine kinase inhibitor cediranib , and the relationship of this adverse event with treatment outcomes . PATIENTS AND METHODS BR24 was a double-blind placebo-controlled phase II trial of carboplatin/paclitaxel chemotherapy with either daily oral cediranib or placebo in patients ( n = 296 ) with advanced non-small-cell lung cancer ( NSCLC ) . Exploratory analyses characterized relationships between HTN , baseline variables , and efficacy outcomes . RESULTS New onset or worsening of preexisting HTN ( treatment-emergent HTN ) was more frequent in patients receiving cediranib ( 68 versus 45 % , P < 0.0001 ) . Factors associated with HTN in all r and omized patients were good performance status and treatment with cediranib . In both arms , treatment-emergent HTN was associated with improved efficacy outcomes , but there was no evidence of a differential treatment effect , with nonsignificant interaction P values . CONCLUSIONS In advanced NSCLC , HTN is frequent in patients receiving chemotherapy , with or without cediranib . The development of HTN was favorably prognostic in these patients , but not predictive of a differential outcome with cediranib BACKGROUND We conducted a r and omized , placebo-controlled , double-blind trial to determine whether the epidermal growth factor receptor inhibitor erlotinib prolongs survival in non-small-cell lung cancer after the failure of first-line or second-line chemotherapy . METHODS Patients with stage IIIB or IV non-small-cell lung cancer , with performance status from 0 to 3 , were eligible if they had received one or two prior chemotherapy regimens . The patients were stratified according to center , performance status , response to prior chemotherapy , number of prior regimens , and prior platinum-based therapy and were r and omly assigned in a 2:1 ratio to receive oral erlotinib , at a dose of 150 mg daily , or placebo . RESULTS The median age of the 731 patients who underwent r and omization was 61.4 years ; 49 percent had received two prior chemotherapy regimens , and 93 percent had received platinum-based chemotherapy . The response rate was 8.9 percent in the erlotinib group and less than 1 percent in the placebo group ( P<0.001 ) ; the median duration of the response was 7.9 months and 3.7 months , respectively . Progression-free survival was 2.2 months and 1.8 months , respectively ( hazard ratio , 0.61 , adjusted for stratification categories ; P<0.001 ) . Overall survival was 6.7 months and 4.7 months , respectively ( hazard ratio , 0.70 ; P<0.001 ) , in favor of erlotinib . Five percent of patients discontinued erlotinib because of toxic effects . CONCLUSIONS Erlotinib can prolong survival in patients with non-small-cell lung cancer after first-line or second-line chemotherapy BACKGROUND Previous , uncontrolled studies have suggested that first-line treatment with gefitinib would be efficacious in selected patients with non-small-cell lung cancer . METHODS In this phase 3 , open-label study , we r and omly assigned previously untreated patients in East Asia who had advanced pulmonary adenocarcinoma and who were nonsmokers or former light smokers to receive gefitinib ( 250 mg per day ) ( 609 patients ) or carboplatin ( at a dose calculated to produce an area under the curve of 5 or 6 mg per milliliter per minute ) plus paclitaxel ( 200 mg per square meter of body-surface area ) ( 608 patients ) . The primary end point was progression-free survival . RESULTS The 12-month rates of progression-free survival were 24.9 % with gefitinib and 6.7 % with carboplatin-paclitaxel . The study met its primary objective of showing the noninferiority of gefitinib and also showed its superiority , as compared with carboplatin-paclitaxel , with respect to progression-free survival in the intention-to-treat population ( hazard ratio for progression or death , 0.74 ; 95 % confidence interval [ CI ] , 0.65 to 0.85 ; P<0.001 ) . In the subgroup of 261 patients who were positive for the epidermal growth factor receptor gene ( EGFR ) mutation , progression-free survival was significantly longer among those who received gefitinib than among those who received carboplatin-paclitaxel ( hazard ratio for progression or death , 0.48 ; 95 % CI , 0.36 to 0.64 ; P<0.001 ) , whereas in the subgroup of 176 patients who were negative for the mutation , progression-free survival was significantly longer among those who received carboplatin-paclitaxel ( hazard ratio for progression or death with gefitinib , 2.85 ; 95 % CI , 2.05 to 3.98 ; P<0.001 ) . The most common adverse events were rash or acne ( in 66.2 % of patients ) and diarrhea ( 46.6 % ) in the gefitinib group and neurotoxic effects ( 69.9 % ) , neutropenia ( 67.1 % ) , and alopecia ( 58.4 % ) in the carboplatin-paclitaxel group . CONCLUSIONS Gefitinib is superior to carboplatin-paclitaxel as an initial treatment for pulmonary adenocarcinoma among nonsmokers or former light smokers in East Asia . The presence in the tumor of a mutation of the EGFR gene is a strong predictor of a better outcome with gefitinib . ( Clinical Trials.gov number , NCT00322452 . PURPOSE Bevacizumab is a monoclonal antibody that targets vascular endothelial growth factor ( VEGF ) with demonstrated efficacy in combination with carboplatin and paclitaxel ( PCB ) for the treatment of advanced non-small-cell lung cancer ( NSCLC ) . Administration of bevacizumab is postulated to decrease nitric oxide synthesis and lead to hypertension , which may be a physiological sign that the VEGF pathway is more actively being blocked and could result in improved outcomes . PATIENTS AND METHODS Eastern Cooperative Oncology Group ( ECOG ) 4599 r and omly assigned patients with nonsquamous NSCLC to carboplatin and paclitaxel ( PC ) versus PCB . Hypertensive patients were compared with nonhypertensive patients with respect to overall survival ( OS ) and progression-free survival ( PFS ) using blood pressure data and adverse event data separately . High blood pressure ( HBP ) by the end of cycle 1 was defined as blood pressure > 150/100 at any previous time or at least a 20-mmHg increase in diastolic blood pressure from baseline . Results In a multivariable Cox model adjusting for HBP as a time-varying covariate , comparing those on PCB with HBP with those on PC gave an OS hazard ratio ( HR ) of 0.60 ( 95 % CI , 0.43 to 0.81 ; P = .001 ) ; comparing those on PCB without HBP with those on PC alone , the OS HR was 0.86 ( 95 % CI , 0.74 to 1.00 ; P = .05 ) . Comparing the PCB HBP group with PC gave an adjusted PFS HR of 0.54 ( 95 % CI , 0.41 to 0.73 ; P < .0001 ) and comparing those on PCB without HBP to those on PC , the HR was 0.72 ( 95 % CI , 0.62 to 0.84 ; P < .0001 ) . The 6-month cumulative incidence of hypertension was 6.2 % ( 95 % CI , 3.9 % to 8.6 % ) . CONCLUSION Data from ECOG 4599 suggest that onset of HBP during treatment with PCB may be associated with improved outcomes , and additional studies of the downstream effects of VEGF suppression and hypertension are needed PURPOSE To evaluate the prognostic and predictive significance of plasma levels of the epidermal growth factor receptor ( EGFR ) lig and s , transforming growth factor α ( TGF-α ) and amphiregulin , in patients with non-small-cell lung cancer ( NSCLC ) enrolled in NCIC Clinical Trials Group BR.21 comparing erlotinib with placebo . PATIENTS AND METHODS TGF-α and amphiregulin were assessed retrospectively by enzyme-linked immunosorbent assay from available prospect ively collected baseline plasma sample s in 565 of 731 BR.21 patients . Cutoff points were determined for both amphiregulin ( low , < 10 pg/mL ; high , ≥10 pg/mL ) and TGF-α ( low , ≤12 pg/mL ; high , > 12 pg/mL ) using a graphical method . Cox regression models were used to correlate biomarker data and baseline characteristics with outcomes including overall ( OS ) and progression-free survival ( PFS ) . RESULTS High TGF-α and amphiregulin were associated with poorer performance status ( P=.06 and P<.0001 , respectively ) and no prior platinum therapy ( P=.06 and P=.02 , respectively ) . High amphiregulin was also associated with anemia ( P=.001 ) , increased lactate dehydrogenase ( P=.03 ) , ever-smokers ( P=.04 ) , and non-Asian ethnicity ( P=.001 ) . Patients on the placebo arm with high amphiregulin had poorer OS than patients with low amphiregulin ( hazard ratio [HR]=1.88 ; 95 % CI , 1.34 to 2.64 ; P=.0002 ) , which remained significant in multivariate analysis . Amphiregulin levels did not predict for benefit from erlotinib ( interaction P=.87 )
Output:
| Evidence from multiple RCTs confirmed that histologic subtype is prognostic for survival and predictive of treatment efficacy and /or toxicity in NSCLC .
No biomarkers to date reliably predict response to anti-Vascular Endothelial Growth Factor ( VEGF ) therapies .
There are inconsistent data on the role of ERCC1 , BRCA , Beta tubulin III , RRM1 , K-RAS , or TP-53 in treatment decisions . |
MS210621 | ***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 This study analyzed whether inadequate functional health literacy is an independent risk factor for hospital admission . METHODS We studied a prospect i ve cohort of 3260 Medicare managed care enrollees . RESULTS Of the participants , 29.5 % were hospitalized . The crude relative risk ( RR ) of hospitalization was higher for individuals with inadequate literacy ( n = 800 ; RR = 1.43 ; 95 % confidence interval [ CI ] = 1.24 , 1.65 ) and marginal literacy ( n = 366 ; RR = 1.33 ; 95 % CI = 1.09 , 1.61 ) than for those with adequate literacy ( n = 2094 ) . In multivariate analysis , the adjusted relative risk of hospital admission was 1.29 ( 95 % CI = 1.07 , 1.55 ) for individuals with inadequate literacy and 1.21 ( 95 % CI = 0.97 , 1.50 ) for those with marginal literacy . CONCLUSIONS Inadequate literacy was an independent risk factor for hospital admission among elderly managed care enrollees Background . This investigation examined factors affecting patient involvement in consultations to decide local treatment for early breast cancer and the effectiveness of two methods of preconsultation education aim ed at increasing patient participation in these discussion CONTEXT As the availability of and dem and for genetic testing for hereditary cancers increases in primary care and other clinical setting s , alternative or adjunct educational methods to traditional genetic counseling will be needed . OBJECTIVE To compare the effectiveness of a computer-based decision aid with st and ard genetic counseling for educating women about BRCA1 and BRCA2 genetic testing . DESIGN R and omized controlled trial conducted from May 2000 to September 2002 . SETTING AND PARTICIPANTS Outpatient clinics offering cancer genetic counseling at 6 US medical centers enrolled 211 women with personal or family histories of breast cancer . INTERVENTIONS St and ard one-on-one genetic counseling ( n = 105 ) or education by a computer program followed by genetic counseling ( n = 106 ) . MAIN OUTCOME MEASURES Participants ' knowledge , risk perception , intention to undergo genetic testing , decisional conflict , satisfaction with decision , anxiety , and satisfaction with the intervention . Counselor group measures were administered at baseline and after counseling . Computer group measures were administered at baseline , after computer use , and after counseling . Testing decisions were assessed at 1 and 6 months . Outcomes were analyzed by high vs low risk of carrying a BRCA1 or BRCA2 mutation . RESULTS Both groups had comparable demographics , prior computer experience , medical literacy , and baseline knowledge of breast cancer and genetic testing , and both counseling and computer use were rated highly . Knowledge scores increased in both groups ( P<.001 ) regardless of risk status , and change in knowledge was greater in the computer group compared with the counselor group ( P = .03 ) among women at low risk of carrying a mutation . Perception of absolute risk of breast cancer decreased significantly after either intervention among all participants . Intention to undergo testing decreased significantly after either intervention among low-risk but not high-risk women . The counselor group had lower mean scores on a decisional conflict scale ( P = .04 ) and , in low-risk women , higher mean scores on a satisfaction-with-decision scale ( P = .001 ) . Mean state anxiety scores were reduced by counseling but were within normal ranges for both groups at baseline and after either intervention , regardless of risk status . CONCLUSIONS An interactive computer program was more effective than st and ard genetic counseling for increasing knowledge of breast cancer and genetic testing among women at low risk of carrying a BRCA1 or BRCA2 mutation . However , genetic counseling was more effective than the computer at reducing women 's anxiety and facilitating more accurate risk perceptions . These results suggest that this computer program has the potential to st and alone as an educational intervention for low-risk women but should be used as a supplement to genetic counseling for those at high risk CONTEXT The long-term results of r and omized trials have demonstrated equivalent survival rates for mastectomy and breast-conserving therapy for the treatment of early stage breast cancer . Consequently , the choice of treatment should be based on a patient 's preferences . OBJECTIVE To evaluate the impact of a decision aid regarding the different surgical treatment options on patient decision making . DESIGN AND SETTING A cluster r and omized trial for which general surgeons in the communities of central -west , and eastern Ontario , Canada , were r and omly assigned to use the decision aid or not in the surgical consultation . Patients received the decision aid or not based on the surgeon seen . PARTICIPANTS Twenty surgeons participated in the study . Of the 208 eligible women with newly diagnosed clinical stage I or II breast cancer seen by study surgeons , 201 agreed to be evaluated : 94 were assigned to the decision board and 107 to usual practice . Patients were recruited from November 1999 to April 2002 . INTERVENTION The decision board is a decision aid design ed to help physicians inform their patients about different treatment options and to enable patients to express a preference for treatment . MAIN OUTCOME MEASURES Patient knowledge about the surgical treatment of breast cancer ; decisional conflict ; satisfaction with decision making ; and the treatment decision following the consultation . RESULTS Patients in the decision board group had higher knowledge scores about their treatment options ( 66.9 vs 58.7 ; P<.001 ) , had less decisional conflict ( 1.40 vs 1.62 , P = .02 ) , and were more satisfied with decision making ( 4.50 vs 4.32 , P = .05 ) following the consultation . Patients who used the decision board were more likely to choose BCT ( 94 % vs 76 % , P = .03 ) . CONCLUSIONS The decision board was helpful in improving communication and enabling women to make a choice regarding treatment . Such instruments should be considered by surgeons when communicating the different surgical options to women with breast cancer BACKGROUND In 1976 , we initiated a r and omized trial to determine whether lumpectomy with or without radiation therapy was as effective as total mastectomy for the treatment of invasive breast cancer . METHODS A total of 1851 women for whom follow-up data were available and nodal status was known underwent r and omly assigned treatment consisting of total mastectomy , lumpectomy alone , or lumpectomy and breast irradiation . Kaplan-Meier and cumulative-incidence estimates of the outcome were obtained . RESULTS The cumulative incidence of recurrent tumor in the ipsilateral breast was 14.3 percent in the women who underwent lumpectomy and breast irradiation , as compared with 39.2 percent in the women who underwent lumpectomy without irradiation ( P<0.001 ) . No significant differences were observed among the three groups of women with respect to disease-free survival , distant-disease-free survival , or overall survival . The hazard ratio for death among the women who underwent lumpectomy alone , as compared with those who underwent total mastectomy , was 1.05 ( 95 percent confidence interval , 0.90 to 1.23 ; P=0.51 ) . The hazard ratio for death among the women who underwent lumpectomy followed by breast irradiation , as compared with those who underwent total mastectomy , was 0.97 ( 95 percent confidence interval , 0.83 to 1.14 ; P=0.74 ) . Among the lumpectomy-treated women whose surgical specimens had tumor-free margins , the hazard ratio for death among the women who underwent postoperative breast irradiation , as compared with those who did not , was 0.91 ( 95 percent confidence interval , 0.77 to 1.06 ; P=0.23 ) . Radiation therapy was associated with a marginally significant decrease in deaths due to breast cancer . This decrease was partially offset by an increase in deaths from other causes . CONCLUSIONS Lumpectomy followed by breast irradiation continues to be appropriate therapy for women with breast cancer , provided that the margins of resected specimens are free of tumor and an acceptable cosmetic result can be obtained Counseling women about breast cancer risks has been found to decrease screening compliance . We investigated whether women 's reactions to risk information are an artifact of requiring women to estimate the risk of breast cancer prior to receiving risk information . Three hundred and fifty-six women were r and omized to either make or not make a risk estimate prior to receiving risk information . Outcome measures were participants ' estimates of the average woman 's breast cancer risk and their emotional response to the risk information . Women overestimated the lifetime risk of breast cancer ( M = 46 % ) . Women who made risk estimates felt more relieved about the risk and perceived the risk as being lower than women who did not make estimates ( p 's < 0.001 ) . Asking people to estimate risks influenced their subsequent perceptions of the risk of breast cancer PURPOSE : A patient decision aid for the surgical treatment of early stage breast cancer was developed and evaluated . The rationale for its development was the knowledge that breast conserving therapy ( lumpectomy followed by breast radiation ) and mastectomy produce equivalent outcomes , and the current general agreement that the decision for the type of surgery should rest with the patient . METHODS : A decision aid was developed and evaluated in sequential pilot studies of 18 and 10 women with newly diagnosed breast cancer who were facing a decision for breast conserving therapy or mastectomy . Both qualitative ( general reaction , self-reported anxiety , clarity , satisfaction ) and quantitative ( knowledge and decisional conflict ) measures were assessed . RESULTS : The decision aid consists of an audiotape and workbook and takes 36 min to complete . Based on qualitative comments and satisfaction ratings , 17 of 18 women reported a positive reaction to the decision aid , and all 18 reported that it helped clarify information given by the surgeon . Women did not report an increase in anxiety and 17 of 18 women were either satisfied or very satisfied with the decision aid . CONCLUSION : This pilot study supports the hypothesis that this decision aid may be a helpful adjunct in the decision for surgical management of early stage breast cancer . We are currently conducting a r and omized trial of the decision aid versus a simple educational pamphlet to evaluate its efficacy as measured by knowledge , decisional conflict , anxiety and post-decisional regret A decision aid for the surgical treatment of early breast cancer was evaluated in a r and omized controlled trial . The decision aid , a tape and workbook , includes explicit presentation of probabilities , photographs and graphics , and a values clarification exercise . Community surgeons were r and omized to use the decision aid or a control pamphlet . Patients completed a question naire prior to using the decision aid , after review ing it but prior to surgery , and 6 months after enrollment . There was no difference in anxiety , knowledge , or decisional regret across the 2 groups . There was a nonsignificant trend toward lower decisional conflict in the decision aid group . A subgroup of women who were initially leaning toward mastectomy or were unsure had lower decisional conflict . Although the decision aid had minimal impact on the main study outcomes , a subgroup may have benefited . Such subgroups should be identified , and appropriate decision support interventions should be developed and evaluated OBJECTIVE Although involving women in breast cancer treatment decisions is advocated , there is little underst and ing of whether women have the information they need to make informed decisions . The objective of the current study was to evaluate women 's knowledge of survival and recurrence rates for mastectomy and breast conserving surgery ( BCS ) and the factors associated with this knowledge . METHODS We used a population -based sample of women diagnosed with breast cancer in metropolitan Los Angeles and Detroit between December 2001 and January 2003 . All women with ductal carcinoma in situ and a r and om sample of women with invasive disease were selected ( N=2382 ) , of which 1844 participated ( 77.4 % ) . All participants were mailed surveys . The main outcome measures were knowledge of survival and recurrence rates by surgical treatment type . RESULTS Only 16 % of women knew that recurrence rates were different for mastectomy and BCS , and 48 % knew that the survival rates were equivalent across treatment . Knowledge about survival and recurrence was improved by exposure to the Internet and health pamphlets ( p<0.01 ) . Women who had a female ( versus male ) surgeon , and /or a surgeon who explained both treatments ( rather than just one treatment ) demonstrated higher survival knowledge ( p<0.01 ) . The majority of women had inadequate knowledge with which to make informed decisions about breast cancer surgical treatment . CONCLUSION Previous explanations for poor knowledge , such as ir relevance of knowledge to decision making and lack of access to information , were not shown to be plausible explanations for the low levels of knowledge observed in this sample . PRACTICE IMPLICATION S These results suggest a need for fundamental changes in patient education to ensure that women are able to make informed decisions about their breast cancer treatment . These changes may include an increase in the use of decision aids and in decreasing the speed at which treatment decisions are made Background : In nonindustrialized nations , illiteracy is independently associated with poor health . The objective of this research was to determine whether such a relation exists in the United States . Methods : One hundred ninety-three persons were r and omly selected from a group of adult students enrolled in a publicly funded literacy training program . Subjects ’ health status was measured with the Sickness Impact Profile ( SIP ) , a behaviorally based measure of sickness-related dysfunction . Subjects ’ literacy skills were also measured . Multivariate statistical techniques were then used to evaluate the relation between health status and literacy level and to adjust for confounding sociodemographic factors . Results : The physical health ( measured by the SIP ) of subjects with extremely low reading levels was poor compared with that of subjects with higher reading levels . The relation between reading level and physical health was statistically significant ( P < 0.002 ) , even after adjusting for confounding sociodemographic variables . Psychosocial health ( measured by the SIP ) was
Output:
| The data also suggested that decision aids decreased decisional conflict and increased satisfaction with the decision-making process .
Decision aids were well received by surgeons and patients , facilitated patients ' desire for shared decision making , and were feasible to implement into practice .
Decision aids are important adjuncts for counseling women with early-stage breast cancer .
Their use increases the likelihood that women will choose breast-conserving surgery , and enhances patient knowledge of treatment options |
MS210622 | ***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: One hundred thirteen community dwelling subjects between the ages of 50 and 75 without dementia were recruited . A blind administrator r and omly assigned 54 subjects to placebo and 59 to active treatment groups . The active treatment consisted of four months treatment with a complex antioxidant blend . Placebo treatment was an identical gel and bottle administered for four months . Forty-eight active subjects and 38 placebo subjects completed the study . Memory testing with a 50 part paired association test and a 20-word immediate recall test were significantly improved , p=0.015 and p=0.005 respectively . A secondary study of serum homocysteine was completed in 25 active treatment subjects and 17 placebo subjects . Significant reduction in serum homocysteine levels was seen in the active treatment subjects ( p=0.005 ) . A complex antioxidant blend taken over four months improves performance on two difficult memory tests in community dwelling elderly subjects . Furthermore , the antioxidant significantly reduced the serum homocysteine level in treatment group Background About one-third of people older than 65 years fall at least once a year . Physical exercise has been previously demonstrated to improve gait , enhance physical fitness , and prevent falls . Nonetheless , the addition of cognitive training components may potentially increase these effects , since cognitive impairment is related to gait irregularities and fall risk . We hypothesized that simultaneous cognitive – physical training would lead to greater improvements in dual-task ( DT ) gait compared to exclusive physical training . Methods Elderly persons older than 70 years and without cognitive impairment were r and omly assigned to the following groups : 1 ) virtual reality video game dancing ( DANCE ) , 2 ) treadmill walking with simultaneous verbal memory training ( MEMORY ) , or 3 ) treadmill walking ( PHYS ) . Each program was complemented with strength and balance exercises . Two 1-hour training sessions per week over 6 months were applied . Gait variables , functional fitness ( Short Physical Performance Battery , 6-minute walk ) , and fall frequencies were assessed at baseline , after 3 months and 6 months , and at 1-year follow-up . Multiple regression analyses with planned comparisons were carried out . Results Eighty-nine participants were r and omized to three groups initially ; 71 completed the training and 47 were available at 1-year follow-up . DANCE/MEMORY showed a significant advantage compared to PHYS in DT costs of step time variability at fast walking ( P=0.044 ) . Training-specific gait adaptations were found on comparing DANCE and MEMORY : DANCE reduced step time at fast walking ( P=0.007 ) and MEMORY reduced gait variability in DT and DT costs at preferred walking speed ( both trend P=0.062 ) . Global linear time effects showed improved gait ( P<0.05 ) , functional fitness ( P<0.05 ) , and reduced fall frequency ( −77 % , P<0.001 ) . Only single-task fast walking , gait variability at preferred walking speed , and Short Physical Performance Battery were reduced at follow-up ( all P<0.05 or trend ) . Conclusion Long-term multicomponent cognitive – physical and exclusive physical training programs demonstrated similar potential to counteract age-related decline in physical functioning BACKGROUND Despite widespread use of multivitamin supplements , their effect on cognitive health-a critical issue with aging-remains inconclusive . To date , no long-term clinical trials have studied multivitamin use and cognitive decline in older persons . OBJECTIVE To evaluate whether long-term multivitamin supplementation affects cognitive health in later life . DESIGN R and omized , double-blind , placebo-controlled trial of a multivitamin from 1997 to 1 June 2011 . The cognitive function sub study began in 1998 . Up to 4 repeated cognitive assessment s by telephone interview were completed over 12 years . ( Clinical Trials.gov : NCT00270647 ) SETTING : The Physicians ' Health Study II . PATIENTS 5947 male physicians aged 65 years or older . INTERVENTION Daily multivitamin or placebo . MEASUREMENTS A global composite score averaging 5 tests of global cognition , verbal memory , and category fluency . The secondary end point was a verbal memory score combining 4 tests of verbal memory , which is a strong predictor of Alzheimer disease . RESULTS No difference was found in mean cognitive change over time between the multivitamin and placebo groups or in the mean level of cognition at any of the 4 assessment s. Specifically , for the global composite score , the mean difference in cognitive change over follow-up was -0.01 SU ( 95 % CI , -0.04 to 0.02 SU ) when treatment was compared with placebo . Similarly , cognitive performance did not differ between the multivitamin and placebo groups on the secondary outcome , verbal memory ( mean difference in cognitive change over follow-up , -0.005 SU [ CI , -0.04 to 0.03 SU ] ) . LIMITATION Doses of vitamins may be too low or the population may be too well-nourished to benefit from a multivitamin . CONCLUSION In male physicians aged 65 years or older , long-term use of a daily multivitamin did not provide cognitive benefits . PRIMARY FUNDING SOURCE National Institutes of Health , BASF , Pfizer , and DSM Nutritional Products Purpose To assess the effects of creatine supplementation , associated or not with strength training , upon emotional and cognitive measures in older woman . Methods This is a 24-week , parallel-group , double-blind , r and omized , placebo-controlled trial . The individuals were r and omly allocated into one of the following groups ( n=14 each ) : 1 ) placebo , 2 ) creatine supplementation , 3 ) placebo associated with strength training or 4 ) creatine supplementation associated with strength training . According to their allocation , the participants were given creatine ( 4 x 5 g/d for 5 days followed by 5 g/d ) or placebo ( dextrose at the same dosage ) and were strength trained or not . Cognitive function , assessed by a comprehensive battery of tests involving memory , selective attention , and inhibitory control , and emotional measures , assessed by the Geriatric Depression Scale , were evaluated at baseline , after 12 and 24 weeks of the intervention . Muscle strength and food intake were evaluated at baseline and after 24 weeks . Results After the 24-week intervention , both training groups ( ingesting creatine supplementation and placebo ) had significant reductions on the Geriatric Depression Scale scores when compared with the non-trained placebo group ( p = 0.001 and p = 0.01 , respectively ) and the non-trained creatine group ( p < 0.001 for both comparison ) . However , no significant differences were observed between the non-trained placebo and creatine ( p = 0.60 ) groups , or between the trained placebo and creatine groups ( p = 0.83 ) . Both trained groups , irrespective of creatine supplementation , had better muscle strength performance than the non-trained groups . Neither strength training nor creatine supplementation altered any parameter of cognitive performance . Food intake remained unchanged . Conclusion Creatine supplementation did not promote any significant change in cognitive function and emotional parameters in apparently healthy older individuals . In addition , strength training per se improved emotional state and muscle strength , but not cognition , with no additive effects of creatine supplementation . Trial Registration Clinical trials.gov BACKGROUND Prior investigations have reported a link between poor status of antioxidants , folate , and cobalamin result ing in elevated total plasma homocysteine ( tHcy ) and methylmalonic acid ( MMA ) concentrations with an increased risk for reduced cognitive performance . The aim of the study was to evaluate the effect of a 6-month multivitamin supplementation on the cognitive performance of female seniors and to assess cognitive functioning in relation to vitamin status , tHcy , and MMA values at baseline . METHODS The study was performed as a r and omized placebo-controlled double-blind trial . 220 healthy , free-living women ( aged 60 - 91 years ) were included . Blood drawings and cognitive tests were performed at the Institute of Food Science of the University of Hanover , Germany . Vitamin and cognitive status have been evaluated prior to and 6 months after supplementation . Plasma ascorbic acid , serum concentrations of alpha-tocopherol , beta-carotene , and coenzyme Q10 , serum and erythrocyte folate as well as serum cobalamin , serum MMA , and plasma tHcy concentrations were measured . Activity coefficient of erythrocyte alpha aspartic aminotransferase was used as functional index for vitamin B(6 ) status . The cognitive performance was assessed by the Symbol Search test , a subtest of the Wechsler Adult Intelligence Scale ( WAIS-III ) and the pattern-recognition test . Intelligence as assessed by the ' Kurztest für Allgemeine Intelligenz ' ( KAI ) was a further variable . RESULTS No significant differences in pattern-recognition and intelligence score were observed between vitamin and placebo group prior to and after multivitamin supplementation . In the Symbol Search test , the vitamin group exhibited better test results than the placebo group at both measure points . One-way ANOVA showed a marginally significant linear trend between the baseline tHcy concentration and the pattern-recognition score ( P = 0.051 ) in the total sample . Multiple backward regression revealed only a significant influence of the school graduation on baseline cognitive function test results . A general linear model showed that the changes in cognitive function scores could not be explained by the type of treatment or blood parameters . CONCLUSIONS Our data indicate that 6 months supplementation of physiological dosages of antioxidants and B vitamins have no effect on cognitive performance in presumedly healthy and well-nourished female seniors . An intervention period of only 6 months may be too short for improving cognitive performance in well-educated elderly women without dementia Background Observational studies have frequently reported an association between cognitive function and nutrition in later life but r and omised trials of B vitamins and antioxidant supplements have mostly found no beneficial effect . We examined the effect of daily supplementation with 11 vitamins and 5 minerals on cognitive function in older adults to assess the possibility that this could help to prevent cognitive decline . Methods The study was carried out as part of a r and omised double blind placebo controlled trial of micronutrient supplementation based in six primary care health centres in North East Scotl and . 910 men and women aged 65 years and over living in the community were recruited and r and omised : 456 to active treatment and 454 to placebo . The active treatment consisted of a single tablet containing eleven vitamins and five minerals in amounts ranging from 50–210 % of the UK Reference Nutrient Intake or matching placebo tablet taken daily for 12 months . Digit span forward and verbal fluency tests , which assess immediate memory and executive functioning respectively , were conducted at the start and end of the intervention period . Risk of micronutrient deficiency at baseline was assessed by a simple risk question naire . Results For digit span forward there was no evidence of an effect of supplements in all participants or in sub-groups defined by age or risk of deficiency . For verbal fluency there was no evidence of a beneficial effect in the whole study population but there was weak evidence for a beneficial effect of supplementation in the two pre-specified subgroups : in those aged 75 years and over ( n 290 ; mean difference between supplemented and placebo groups 2.8 ( 95 % CI -0.6 , 6.2 ) units ) and in those at increased risk of micronutrient deficiency assessed by the risk question naire ( n 260 ; mean difference between supplemented and placebo groups 2.5 ( 95 % CI -1.0 , 6.1 ) units ) . Conclusion The results provide no evidence for a beneficial effect of daily multivitamin and multimineral supplements on these domains of cognitive function in community-living people over 65 years . However , the possibility of beneficial effects in older people and those at greater risk of nutritional deficiency deserves further attention Different types of exercise training have the potential to induce structural and functional brain plasticity in the elderly . Thereby , functional brain adaptations were observed during cognitive tasks in functional magnetic resonance imaging studies that correlated with improved cognitive performance . This study aim ed to investigate if exercise training induces functional brain plasticity during challenging treadmill walking and elicits associated changes in cognitive executive functions . Forty-two elderly participants were recruited and r and omly assigned to either interactive cognitive-motor video game dancing ( DANCE ) or balance and stretching training ( BALANCE ) . The 8-week intervention included three sessions of 30 min per week and was completed by 33 participants ( mean age 74.9 ± 6.9 years ) . Prefrontal cortex ( PFC ) activity during preferred and fast walking speed on a treadmill was assessed applying functional near infrared spectroscopy pre- and post-intervention . Additionally , executive functions comprising shifting , inhibition , and working memory were assessed . The results showed that both interventions significantly reduced left and right hemispheric PFC oxygenation during the acceleration of walking ( p < 0.05 or trend , r = 0.25–0.36 ) , while DANCE showed a larger reduction at the end of the 30-s walking task compared to BALANCE in the left PFC [ F(1 , 31 ) = 3.54 , p = 0.035 , r = 0.32 ] . These exercise training induced modulations in PFC oxygenation correlated with improved executive functions ( p < 0.05 or trend , r = 0.31–0.50 ) . The observed reductions
Output:
| In rodent studies , additive effects were found for docosahexaenoic acid supplementation when combined with physical exercise .
The reason for no clear effects of combinatory approaches in humans might be explained by the misfit between the combinations of nutritional methods with the physical interventions in the sense that they were not selected on sharing of similar neuronal mechanisms . |
MS210623 | ***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: After functional endoscopic sinus surgery ( FESS ) , nasal packing may be necessary and a packing material which has benefits in both cost and efficacy would be required . This study aim ed to determine the efficacy of Gelfoam packing on hemostasis and wound healing after FESS . Patients who underwent bilateral FESS due to chronic bilateral rhinosinusitis were enrolled . R and omly , one side was selected for Gelfoam packing and the other side for no packing . Subjective symptoms and objective findings such as synechia , granulation , pus discharge , edema , stenosis , and crust were evaluated . A total of 21 patients ( 17 men and 4 women ; mean age 39.7 years ranging from 12 to 75 years ) were included . There were no statistical significant differences between two groups regarding both subjective symptoms and objective findings during 4 months after surgery . Three patients had postoperative bleeding in the no packing side . Gelfoam packing may be recommendable in terms of efficacy and cost-benefit after FESS Objective : To determine if a hyaluronic acid/carboxymethylcellulose ( HA/CMC ) sinus dressing reduces the rate of postoperative scarring . Methods : In a r and omized , matched-controlled , single-blinded study , following the completion of surgery , an HA/CMC dressing was r and omly assigned to one side with the opposite unpacked side serving as a control . Results : Fifty-three patients underwent surgery for chronic rhinosinusitis ( CRS ; 39 patients ) or CRS with nasal polyposis ( 14 patients ) . At the 8-week follow-up , there was no difference in synechiae on the HA/CMC side compared to the control ( p = 0.09 ) . HA/CMC-treated sinuses , however , demonstrated fewer synechiae in the first 2 weeks postoperatively compared to the control ( p = 0.01 ) , and were associated with significantly less nasal congestion at the 4-week ( p = 0.02 ) and 8-week follow-up visits ( 0.03 ) . Conclusion : There was no long-term difference in the rate of synechiae in the HA/CMC-treated sinus compared to the control . However , less severe nasal congestion and synechiae in the initial postoperative period may reduce the need for aggressive sinus debridement Aim is to determine the efficacy and pain level associated with the use of dissolvable carboxymethyl cellulose ( CMC ) foam dressing in functional endoscopic sinus surgery ( FESS ) in adult patients . In the present prospect i ve study , 60 patients with bilateral chronic rhinosinusitis were included . All patients underwent bilateral FESS . Thirty patients had both nasal cavities packed with dissolvable CMC foam ( CMCF ) and another 30 patients had their nasal cavities packed with routine nasal packing ( RNP ) in latex glove fingers . The haemostatic effect of the CMCF was assessed during the recovery period , and pain levels were recorded by the patients on a visual analogue scale 24 h after surgery . The prevalence of postoperative middle meatal synechia formation was assessed 1 , 2 , 4 and 8 weeks after the operation . Four ( 13.3 % ) of the patients packed with CMCF had primary postoperative bleeding during the recovery period and required additional dressing . Bleeding appeared in two ( 6.7 % ) patients packed with RNP . The mean level of pain was 0.962 ( range 0–4 ) for patients packed with CMCF but was 5.5 ( range 3–9 ) for patients packed with RNP . Four ( 6.7 % ) of 26 CMCF patients and 10 ( 35.7 % ) of 28 RNP patients developed a synechia in the middle meatus . We found that dissolvable CMC foam dressing is associated with very low levels of localised pain and with low levels of postoperative bleeding and synechia formation OBJECTIVES The aim of the study was to evaluate the effects and morbidities of Meropack , an absorbable hyaluronic acid packing material , placed in the middle meatus after endoscopic sinus surgery in children with chronic sinusitis . METHODS Sixty consecutive children with similar degrees of bilateral chronic sinusitis were enrolled in the study . Meropack was r and omly inserted into one side of the middle meatus , while the opposite sinus was not packed after functional endoscopic sinus surgery . Patients were investigated 3 , 8 , and 12 weeks after surgery . The effects and morbidities of nasal dressings in the middle meatus were evaluated with respect to six distinct parameters : blood loss during surgery , postoperative hemorrhage , synechiae , granulation tissue , infection , and patency of the maxillary sinus ostia . RESULTS Mean blood loss of packed and unpacked sinuses did not significantly differ ( p > 0.05 ) . Twenty-nine ( 15 packed , 14 unpacked ) of the 120 sinuses underwent resection of the lateral wall of concha bullosa . Four of 14 unpacked sinuses had postoperative hemorrhaging , while the 15 packed sinuses did not ( p < 0.05 ) . The mean synechiae scores at the first follow-up visit for the Meropack filled and unpacked sinuses differed significantly ( p < 0.05 ) . For the 8- and 12-week follow-up visits , severity of adhesions , granulation tissue formation , infection rate , and patency of the maxillary sinus ostia did not differ significantly between the Meropack filled sinuses and the unpacked sinuses ( p > 0.05 for all ) . CONCLUSION Meropack dressings effectively prevented postoperative hemorrhage , but did not significantly reduced synechiae after endoscopic sinus surgery . Therefore , we recommend that Meropack packing is not necessary for routine use following pediatric functional endoscopic sinus surgery ( FESS ) . However , it should be reserved for children who are predisposed to develop postoperative hemorrhages or adhesions , such as resection of the concha bullosa , traumatic surgery with the creation of large raw surfaces on the middle turbinate , and revision surgery with preexisting adhesions OBJECTIVE : Mitomycin C ( MMC ) is an antineoplastic agent that has been shown to decrease scar tissue after ophthalmologic surgery . Our goal was to determine whether the application of MMC at the conclusion of sinus surgery decreases the incidence of postoperative adhesion formation . METHODS : At the completion of endoscopic sinus surgery in 55 patients , a cotton pledget saturated with 1 mL of 0.4 mg/mL MMC was placed for 4 minutes in the right or left middle meatus and a similar saline-soaked pledget was placed on the opposite side . Patients were examined postoperatively by a masked observer for the presence of synechiae and mucosal changes . RESULTS : Postoperative adhesions were observed in 16 patients ( 29 % ) with a mean follow-up of 4.1 months . These adhesions were bilateral in 6 patients ( 10.9 % ) and unilateral in 10 patients ( 18 % ) . Unilateral adhesions were observed on only 2 sides ( 3.6 % ) treated with MMC and 8 controls ( 14.5 % ) ( P = 0.058 ) . No adverse effects were observed . CONCLUSIONS : MMC was found to be safe to use during sinus surgery , and it may reduce the incidence of postoperative adhesions at the dosage used in this study . SIGNIFICANCE : Because of the observed trend toward decreased synechiae formation with MMC application , further trials using higher concentrations and application times are warranted Background The aim of this study was to determine whether there was any benefit or detrimental consequences of placing a hyaluronic acid pack ( Merogel ) into the middle meatus after endoscopic sinus surgery ( ESS ) . Methods A r and omized controlled blinded study was performed in 42 patients with chronic sinusitis undergoing ESS . The patients were r and omized to receive Merogel on one side and no packing on the other side . Patients were assessed at 2 , 4 , and 6–8 weeks after surgery and the presence of synechia , edema , and infection was noted with the observer blinded to the side that had received the Merogel . Results At 2 weeks the side packed with Merogel had 35 % synechiae , 83 % edema , and 30 % mucopurulent discharge and on the control side the figures were similar with 22.5 % synechiae , 83 % edema , and 28 % mucopurulent discharge . In both groups these figures improved over the observation period but percentages in the groups remained similar . At no time point was the difference between the packed and unpacked sides statistically significant for any of the measures when assessed with Fisher 's exact test . Conclusion Merogel nasal packing has no significant beneficial or detrimental effect in terms of synechia , edema , or infection when placed in the middle meatus after ESS Nasal packings can aid in control of postoperative bleeding and healing following functional endoscopic sinus surgery ( FESS ) , but traditional non-resorbable stents have several inherent drawbacks . We performed a r and omized , controlled , multicenter clinical trial to assess efficacy of resorbable nasal packing in patients undergoing FESS for chronic rhinosinusitis . A total of 66 patients for 88 nasal cavities were r and omized to receive either hyaluronan resorbable packing ( MeroGel ® ) or st and ard non-resorbable nasal dressing after FESS . All underwent preoperative rhinoscopy , CT of sinuses , and , after surgery , were reassessed by rhinoscopy at 2 , 4 , and 12 weeks in blinded fashion . A total of 44 nasal cavities ( MeroGel ® -group ) received resorbable packing , whereas the remaining 44 were packed with non-resorbable nasal dressing . At follow-up endoscopic visit , the presence of nasal synechia was evaluated as primary outcome . Moreover , the tolerability and surgical h and ling properties of MeroGel ® and its comfort were assessed by surgeons and patients . Preoperative severity of rhinosinusitis was similar in both groups . No significant adverse events were observed in all patients . Follow-up endoscopy showed a lower proportion of nasal adhesions in MeroGel ® -group at both 4 ( P = 0.041 ) and 12 weeks ( P < 0.001 ) . Moreover , an improvement of other endoscopic nasal findings such as re-epithelialization , presence of granulation tissue , and appearance of nasal mucosa of nasal cavities after FESS was observed in the MeroGel ® -group . Tolerability and surgical h and ling properties of MeroGel ® were positively rated by clinicians and the overall patient judged comfort of MeroGel ® was favorable . In conclusion , MeroGel ® can be considered a valid alternative to st and ard non-resorbable nasal dressings . It is safe , well-accepted , well-tolerated , and has significant advantage of being resorbable . Moreover , it may favor improved healing in patients undergoing FESS and reduce formation of adhesions Background Functional endoscopic sinus surgery ( FESS ) has become the treatment of choice for patients with medically resistant chronic rhinosinusitis . Nasal packing is usually placed after the surgery to support wound healing and prevent adhesions . The purpose of this study was to investigate the effect of carboxy-methylated cellulose ( CMC ) nasal packing on wound healing after FESS compared with no nasal packing . Methods Twenty-six patients underwent bilateral FESS . The patients were r and omized to receive CMC mesh or gel packing on one side and no packing on the opposite side . The patients were followed at 2 , 4 , and 12 weeks after surgery . Endoscopically visible CMC , crusting , mucosal integrity , synechia formation , granulation tissue formation , and adverse side effects were assessed and documented . Results No adverse side effects were observed . No significant differences were found between the CMC-packed side and the unpacked side with respect to the outcome measure of wound healing . No difference was found between two different forms of CMC in terms of wound healing . Two weeks after surgery , endoscopically visible CMC was detected in four patients of the CMC mesh group , whereas none of the patients in the CMC gel group had endoscopically visible CMC ( p = 0.040 ) . Conclusion As we were unable to establish an effect , we must question the efficacy of this packing material and the necessity of its use after FESS based on the technique of the Graz University Medical School . The mesh form of CMC could be potentially useful as a vehicle for extended drug delivery owing to its longer retention time in the nose OBJECTIVE : To assess the safety and efficacy of Sepragel sinus , a hylan B gel ( cross-linked hyaluronic acid molecule ) , when used as a postoperative dressing after endoscopic sinus surgery as a facilitator of healing and a preventative for scarring and stenosis . STUDY DESIGN : Ten patients undergoing bilateral endoscopic ethmoidectomy in an outpatient specialty hospital operating room underwent complete filling of a r and omly selected right or left ethmoidectomy cavity with Sepragel sinus . Outcome measures were synechiae , middle meatal stenosis , mucosal status , mucosal regeneration , transparency of Sepragel sinus , and subjective pain and congestion . RESULTS : Sepragel sinus significantly improved all
Output:
| Conclusions This systematic review and meta analysis suggests that use of middle meatal packing does not significantly reduce the risk of synechiae formation after ESS .
Additional prospect i ve r and omized studies on this topic will further eluci date the utility of middle meatal packing |
MS210624 | ***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: To evaluate clinical outcomes of autologous peripheral blood stem cell transplantation ( APBCST ) between opticospinal multiple sclerosis ( OSMS ) and conventional multiple sclerosis ( CMS ) during disease progressive stage in a Chinese population . Thirty-six secondary progressive MS patients , among whom 21 were with OSMS and 15 with CMS , underwent APBSCT and were followed up for an average of 48.92 months ( range , 10–91 months ) . Peripheral blood stem cells were obtained by leukapheresis after mobilization with granulocyte colony-stimulating factor . Modified BEAM conditioning regimen ( Tiniposide , melphalan , carmustin , and cytosine arabinoside ) were administered . Outcomes were evaluated using the exp and ed disability status scale ( EDSS ) . No maintenance treatment was administered if there was no disease progression . No treatment-related mortality occurred . Among the 36 patients , one OSMS patient dropped during the follow-up . Among the 22 relapse-free patients , 20 were with continuous neurological improvement without any relapse events , and two remained in neurologically stable states . Among the 13 relapse patients , seven had experienced of neurological relapse , but with no progression during the follow-up period ; and six experienced neurological deterioration after transplantation and needed further immunosuppressant treatment . The confirmed relapse-free survival rate was 62.9 % and progression-free survival rate was 83.3 % after 91 months according to Kaplan and Meier survival curves . Eleven of the 20 OSMS patients ( 55 % ) and two of the 15 CMS patients ( 13.3 % ) stayed in disease active group ( P = 0.014 ) . For the 20 OSMS patients , the overall EDSS score decreased significantly after transplantation ( P = 0.016 ) , while visual functions had no significant improvement ( P = 0.716 ) . Progressive OSMS has a higher relapse rate than CMS following APBSCT The purpose of the study was to determine the long-term safety and effectiveness of high-dose immunosuppressive therapy ( HDIT ) followed by autologous hematopoietic cell transplantation ( AHCT ) in advanced multiple sclerosis ( MS ) . TBI , CY and antithymocyte globulin were followed by transplantation of autologous , CD34-selected PBSCs . Neurological examinations , brain magnetic resonance imaging and cerebrospinal fluid ( CSF ) for oligoclonal b and s ( OCB ) were serially evaluated . Patients ( n=26 , mean Exp and ed Disability Status Scale (EDSS)=7.0 , 17 secondary progressive , 8 primary progressive , 1 relapsing/remitting ) were followed for a median of 48 months after HDIT followed by AHCT . The 72-month probability of worsening ⩾1.0 EDSS point was 0.52 ( 95 % confidence interval , 0.30–0.75 ) . Five patients had an EDSS at baseline of ⩽6.0 ; four of them had not failed treatment at last study visit . OCB in CSF persisted with minor changes in the b and ing pattern . Four new or enhancing lesions were seen on MRI , all within 13 months of treatment . In this population with high baseline EDSS , a significant proportion of patients with advanced MS remained stable for as long as 7 years after transplant . Non-inflammatory events may have contributed to neurological worsening after treatment . HDIT/AHCT may be more effective in patients with less advanced relapsing/remitting MS BACKGROUND Strong immunosuppression , including chemotherapy and immune-depleting antibodies followed by autologous haemopoietic stem-cell transplantation ( aHSCT ) , has been used to treat patients with multiple sclerosis , improving control of relapsing disease . We addressed whether near-complete immunoablation followed by immune cell depleted aHSCT would result in long-term control of multiple sclerosis . METHODS We did this phase 2 single-arm trial at three hospitals in Canada . We enrolled patients with multiple sclerosis , aged 18 - 50 years with poor prognosis , ongoing disease activity , and an Exp and ed Disability Status Scale of 3.0 - 6.0 . Autologous CD34 selected haemopoietic stem-cell grafts were collected after mobilisation with cyclophosphamide and filgrastim . Immunoablation with busulfan , cyclophosphamide , and rabbit anti-thymocyte globulin was followed by aHSCT . The primary outcome was multiple sclerosis activity-free survival ( events were clinical relapse , appearance of a new or Gd-enhancing lesion on MRI , and sustained progression of Exp and ed Disability Status Scale score ) . This study was registered at Clinical Trials.gov , NCT01099930 . FINDINGS Between diagnosis and aHSCT , 24 patients had 167 clinical relapses over 140 patient-years with 188 Gd-enhancing lesions on 48 pre-aHSCT MRI scans . Median follow-up was 6.7 years ( range 3.9 - 12.7 ) . The primary outcome , multiple sclerosis activity-free survival at 3 years after transplantation was 69.6 % ( 95 % CI 46.6 - 84.2 ) . With up to 13 years of follow-up after aHSCT , no relapses occurred and no Gd enhancing lesions or new T2 lesions were seen on 314 MRI sequential scans . The rate of brain atrophy decreased to that expected for healthy controls . One of 24 patients died of transplantation-related complications . 35 % of patients had a sustained improvement in their Exp and ed Disability Status Scale score . INTERPRETATION We describe the first treatment to fully halt all detectable CNS inflammatory activity in patients with multiple sclerosis for a prolonged period in the absence of any ongoing disease-modifying drugs . Furthermore , many of the patients had substantial recovery of neurological function despite their disease 's aggressive nature . FUNDING Multiple Sclerosis Scientific Research Foundation Objective : To evaluate the safety , efficacy , and durability of multiple sclerosis ( MS ) disease stabilization after high-dose immunosuppressive therapy ( HDIT ) and autologous hematopoietic cell transplantation ( HCT ) . Methods : High-Dose Immunosuppression and Autologous Transplantation for Multiple Sclerosis ( HALT-MS ) is a phase II clinical trial of HDIT/HCT for patients with relapsing-remitting ( RR ) MS who experienced relapses with disability progression ( Exp and ed Disability Status Scale [ EDSS ] 3.0–5.5 ) while on MS disease-modifying therapy . The primary endpoint was event-free survival ( EFS ) , defined as survival without death or disease activity from any one of : disability progression , relapse , or new lesions on MRI . Participants were evaluated through 5 years posttransplant . Toxicities were reported using the National Cancer Institute Common Terminology Criteria for Adverse Events ( AE ) . Results : Twenty-five participants were evaluated for transplant and 24 participants underwent HDIT/HCT . Median follow-up was 62 months ( range 12–72 ) . EFS was 69.2 % ( 90 % confidence interval [ CI ] 50.2–82.1 ) . Progression-free survival , clinical relapse-free survival , and MRI activity-free survival were 91.3 % ( 90 % CI 74.7%–97.2 % ) , 86.9 % ( 90 % CI 69.5%–94.7 % ) , and 86.3 % ( 90 % CI 68.1%–94.5 % ) , respectively . AE due to HDIT/HCT were consistent with expected toxicities and there were no significant late neurologic adverse effects noted . Improvements were noted in neurologic disability with a median change in EDSS of −0.5 ( interquartile range −1.5 to 0.0 ; p = 0.001 ) among participants who survived and completed the study . Conclusion : HDIT/HCT without maintenance therapy was effective for inducing long-term sustained remissions of active RRMS at 5 years . Clinical Trials.gov identifier : NCT00288626 . Classification of evidence : This study provides Class IV evidence that participants with RRMS experienced sustained remissions with toxicities as expected from HDIT/HCT Since the start of the international stem cell transplantation project in 1997 , over 2000 patients have received a haematopoietic stem cell transplant ( HSCT ) , mostly autologous , as treatment for a severe autoimmune disease , the majority being multiple sclerosis ( MS ) , systemic sclerosis ( SSc ) and Crohn 's disease . There was an overall 85 % 5-year survival and 43 % progression-free survival . Around 30 % of patients in all disease subgroups had a complete response , often durable despite full immune reconstitution . In many cases , e.g. systemic sclerosis , morphological improvement such as reduction of skin collagen and normalization of microvasculature was documented , beyond any predicted known effects of intense immunosuppression alone . It is hoped that the results of the three running large prospect i ve r and omized controlled trials will allow modification of the protocol s to reduce the high transplant-related mortality which relates to regimen intensity , age of patient , and comorbidity . Mesenchymal stromal cells ( MSC ) , often incorrectly called stem cells , have been the intense focus of in vitro studies and animal models of rheumatic and other diseases over more than a decade . Despite multiple plausible mechanisms of action and a plethora of positive in vivo animal studies , few r and omised controlled clinical trials have demonstrated meaningful clinical benefit in any condition so far . This could be due to confusion in cell product terminology , complexity of clinical study design and execution or agreement on meaningful outcome measures . Within the rheumatic diseases , SLE and rheumatoid arthritis ( RA ) have received most attention . Uncontrolled multiple trial data from over 300 SLE patients have been published from one centre suggesting a positive outcome ; one single centre comparative study in 172 RA was positive . In addition , small numbers of patients with Crohn 's disease , multiple sclerosis , primary Sjögren 's disease , polymyositis/dermatomyositis and type II diabetes mellitus have received MSC therapeutically . The possible reasons for this apparent mismatch between expectation and clinical reality will be discussed Background Autologous haematopoietic stem cell transplantation ( HSCT ) is a viable option for treatment of aggressive multiple sclerosis ( MS ) . No r and omised controlled trial has been performed , and thus , experiences from systematic and sustained follow-up of treated patients constitute important information about safety and efficacy . In this observational study , we describe the characteristics and outcome of the Swedish patients treated with HSCT for MS . Methods Neurologists from the major hospitals in Sweden filled out a follow-up form with prospect ively collected data . Fifty-two patients were identified in total ; 48 were included in the study and evaluated for safety and side effects ; 41 patients had at least 1 year of follow-up and were further analysed for clinical and radiological outcome . In this cohort , 34 patients ( 83 % ) had relapsing-remitting MS , and mean follow-up time was 47 months . Results At 5 years , relapse-free survival was 87 % ; MRI event-free survival 85 % ; exp and ed disability status scale ( EDSS ) score progression-free survival 77 % ; and disease-free survival ( no relapses , no new MRI lesions and no EDSS progression ) 68 % . Presence of gadolinium-enhancing lesions prior to HSCT was associated with a favourable outcome ( disease-free survival 79 % vs 46 % , p=0.028 ) . There was no mortality . The most common long-term side effects were herpes zoster reactivation ( 15 % ) and thyroid disease ( 8.4 % ) . Conclusions HSCT is a very effective treatment of inflammatory active MS and can be performed with a high degree of safety at experienced centres Based on the good results of experimental transplantation in animal models of multiple sclerosis and of other autoimmune diseases , we have treated 24 patients suffering from chronic progressive multiple sclerosis with high-dose chemotherapy ( BEAM regimen ) followed by autologous blood stem cell rescue and antithymocyte globulin . Blood stem cells were mobilised with cyclophosphamide at 4g/m2 and G- ( or GM- ) CSF . In 9 cases , additional CD34 + cell- selection of the graft was performed . Here we up date previously published results of this novel treatment , mainly with regard to clinical efficacy , as the median follow-up time has reached 40 months ( range , 21–51 ) . Infections were the principal toxicity early after the procedure , with death of a patient from aspergillosis 65 days post stem cell infusion . No serious late events occurred apart from a case of autoimmune thyroiditis that developed 11 months after transplant in a patient who had received a CD34 + cell-depleted graft . Mild and transient neurotoxicity was observed in 10 patients ( 42 % ) , most probably associated with fever and infections . Eighteen patients ( 18/23 ; 78 % ) responded to the treatment , i.e. , they were improved or stabilized , while five patients progressed , of which 4 had primary progressive disease . Of those improved or stabilised ( 18 ) , 9 patients have maintained stable condition whereas 9 developed relapses or they slowly resumed progression , although their disability scores have not
Output:
| Conclusions This meta- analysis provides evidence s that AHSCT can induce long-term remissions for MS patients with a high degree of safety .
We indicate low- and intermediate-intensity regimens and RRMS patients with the presence of Gd+ lesions at baseline MRI can obtain the optimal benefit/risk ratio from AHSCT |
MS210625 | ***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: IMPORTANCE Medical treatment setting s such as emergency departments ( EDs ) present important opportunities to address problematic substance use . Currently , EDs do not typically intervene beyond acute medical stabilization . OBJECTIVE To contrast the effects of a brief intervention with telephone boosters ( BI-B ) with those of screening , assessment , and referral to treatment ( SAR ) and minimal screening only ( MSO ) among drug-using ED patients . DESIGN , SETTING , AND PARTICIPANTS Between October 2010 and February 2012 , 1285 adult ED patients from 6 US academic hospitals , who scored 3 or greater on the 10-item Drug Abuse Screening Test ( indicating moderate to severe problems related to drug use ) and who were currently using drugs , were r and omized to MSO ( n = 431 ) , SAR ( n = 427 ) , or BI-B ( n = 427 ) . Follow-up assessment s were conducted at 3 , 6 , and 12 months by blinded interviewers . INTERVENTIONS Following screening , MSO participants received only an informational pamphlet . The SAR participants received assessment plus referral to addiction treatment if indicated , and the BI-B participants received assessment and referral as in SAR , plus a manual-guided counseling session based on motivational interviewing principles and up to 2 " booster " sessions by telephone during the month following the ED visit . MAIN OUTCOMES AND MEASURES Outcomes evaluated at follow-up visits included self-reported days using the patient-defined primary problem drug , days using any drug , days of heavy drinking , and drug use based on analysis of hair sample s. The primary outcome was self-reported days of use of the patient-defined primary problem drug during the 30-day period preceding the 3-month follow-up . RESULTS Follow-up rates were 89 % , 86 % , and 81 % at 3 , 6 , and 12 months , respectively . For the primary outcome , estimated differences in number of days of use ( 95 % CI ) were as follows : MSO vs BI-B , 0.72 ( -0.80 to 2.24 ) , P ( adjusted ) = .57 ; SAR vs BI-B , 0.70 ( -0.83 to 2.23 ) , P ( adjusted ) = .57 ; SAR vs MSO , -0.02 ( -1.53 to 1.50 ) , P ( adjusted ) = .98 . There were no significant differences between groups in self-reported days using the primary drug , days using any drug , or heavy drinking days at 3 , 6 , or 12 months . At the 3-month follow-up , participants in the SAR group had a higher rate of hair sample s positive for their primary drug of abuse ( 265 of 280 [ 95 % ] ) than did participants in the MSO group ( 253 of 287 [ 88 % ] ) or the BI-B group ( 244 of 275 [ 89 % ] ) . Hair analysis differences between groups at other time points were not significant . CONCLUSIONS AND RELEVANCE In this sample of drug users seeking emergency medical treatment , a relatively robust brief intervention did not improve substance use outcomes . More work is needed to determine how drug use disorders may be addressed effectively in the ED . TRIAL REGISTRATION clinical trials.gov Identifier : NCT01207791 Background Psychostimulants and cannabis are two of the three most commonly used illicit drugs by young Australians . As such , it is important to deliver prevention for these substances to prevent their misuse and to reduce associated harms . The present study aims to evaluate the feasibility and effectiveness of the universal computer-based Climate Schools : Psychostimulant and Cannabis Module . Methods A cluster r and omised controlled trial was conducted with 1734 Year 10 students ( mean age = 15.44 years ; SD = 0.41 ) from 21 secondary schools in Australia . Schools were r and omised to receive either the six lesson computer-based Climate Schools program or their usual health classes , including drug education , over the year . Results The Climate Schools program was shown to increase knowledge of cannabis and psychostimulants and decrease pro-drug attitudes . In the short-term the program was effective in subduing the uptake and plateauing the frequency of ecstasy use , however there were no changes in meth/amphetamine use . In addition , females who received the program used cannabis significantly less frequently than students who received drug education as usual . Finally , the Climate Schools program was related to decreasing students ’ intentions to use meth/amphetamine and ecstasy in the future , however these effects did not last over time . Conclusions These findings provide support for the use of a harm-minimisation approach and computer technology as an innovative platform for the delivery of prevention education for illicit drugs in schools . The current study indicated that teachers and students enjoyed the program and that it is feasible to extend the successful Climate Schools model to the prevention of other drugs , namely cannabis and psychostimulants . Trial registration Australian and New Zeal and Clinical Trials Registry ACTRN12613000492752 OBJECTIVE To compare computer-delivered and therapist-delivered treatments for people with depression and comorbid addictive disorders . DESIGN R and omised controlled clinical trial . SETTING AND PARTICIPANTS Our study was conducted between January 2005 and August 2007 at seven study clinics in rural and urban New South Wales . Participants were 274 people who had a Beck Depression Inventory II ( BDI-II ) score ≥ 17 and were using alcohol and /or cannabis at harmful levels in the month before baseline . They were self-referred or referred from other sources such as outpatient drug treatment clinics , general practice s and non-government support agencies . INTERVENTIONS Participants were r and omly allocated to receive ( 1 ) integrated cognitive behaviour therapy and motivational interviewing ( CBT/MI ) delivered by a therapist ; ( 2 ) integrated CBT/MI delivered by computer , with brief therapist assistance at the end of each session ( clinician-assisted computerised [ CAC ] treatment ) , or ( 3 ) person-centred therapy ( PCT ) , consisting of supportive counselling given by a therapist ( the control group ) . All three treatments were delivered according to a manual developed specifically for the study . MAIN OUTCOME MEASURES Changes in depression , alcohol use and cannabis use at 3 months after baseline ; significant predictors of change in the primary outcome variables . RESULTS Compared with computer- or therapist-delivered CBT/MI , PCT was associated with significantly less reduction in depression and alcohol consumption at 3 months . CAC therapy was associated with improvement at least equivalent to that achieved by therapist-delivered treatment , with superior results as far as reducing alcohol consumption . Change in depression was significantly predicted by change in alcohol use ( in the same direction ) and an ability to determine primacy , irrespective of whether this was for drug use or depression . Change in alcohol use was significantly predicted by changes in cannabis use and depression , and change in cannabis use by change in alcohol use . In the regression model , treatment allocation did not independently predict change , but was associated with significant reduction in depression and alcohol use at 3 months . CONCLUSIONS Over a 3-month period , CBT/MI was associated with a better treatment response than supportive counselling . CAC therapy was associated with greater reduction in alcohol use than therapist-delivered treatment . TRIAL REGISTRATION NUMBER ACTRN12610000274077 Throughout the world , drug and alcohol use has a clear adolescent onset ( Degenhardt et al. , 2008 ) . Alcohol continues to be the most popular drug among teens and emerging adults , with almost a third of 12th grade rs and 40 % of college students reporting recent binge drinking ( Johnston et al. , 2009 , 2010 ) , and marijuana ( MJ ) is the second most popular drug in teens ( Johnston et al. , 2010 ) . The initiation of drug use is consistent with an overall increase in risk-taking behaviors during adolescence that coincides with significant neurodevelopmental changes in both gray and white matter ( Giedd et al. , 1996a ; Paus et al. , 1999 ; Sowell et al. , 1999 , 2002 , 2004 ; Gogtay et al. , 2004 ; Barnea-Goraly et al. , 2005 ; Lenroot and Giedd , 2006 ) . Animal studies have suggested that compared to adults , adolescents may be particularly vulnerable to the neurotoxic effects of drugs , especially alcohol and MJ ( see Schneider and Koch , 2003 ; Barron et al. , 2005 ; Monti et al. , 2005 ; Cha et al. , 2006 ; Rubino et al. , 2009 ; Spear , 2010 ) . In this review , we will provide a detailed overview of studies that examined the impact of early adolescent onset of alcohol and MJ use on neurocognition ( e.g. , Ehrenreich et al. , 1999 ; Wilson et al. , 2000 ; Tapert et al. , 2002a ; Hartley et al. , 2004 ; Fried et al. , 2005 ; Townshend and Duka , 2005 ; Medina et al. , 2007a ; McQueeny et al. , 2009 ; Gruber et al. , 2011 , 2012 ; Hanson et al. , 2011 ; Lisdahl and Price , 2012 ) , with a special emphasis on recent prospect i ve longitudinal studies ( e.g. , White et al. , 2011 ; Hicks et al. , 2012 ; Meier et al. , 2012 ) . Finally , we will explore potential clinical and public health implication s of these findings This pilot study sought to test the feasibility of procedures to screen students for marijuana use in Student Health Services ( SHS ) and test the efficacy of a web-based intervention design ed to reduce marijuana use and consequences . Students were asked to participate in voluntary screening of health behaviors upon arrival at SHS . One hundred and twenty-three students who used marijuana at least monthly completed assessment s and were r and omized to one of four intervention conditions in a 2 ( intervention : Marijuana eCHECKUP TO GO vs. control) × 2 ( site of intervention : on-site vs. off-site ) between-groups design . Follow-up assessment s were conducted online at 3 and 6 months . Latent growth modeling was used to provide effect size estimates for the influence of intervention on outcomes . One thous and and eighty undergraduate students completed screening . The intervention did not influence marijuana use frequency . However , there was evidence of a small overall intervention effect on marijuana-related consequences and a medium effect in stratified analyses in the on-site condition . Analyses of psychological variables showed that the intervention significantly reduced perceived norms regarding peer marijuana use . These findings demonstrate that it is feasible to identify marijuana users in SHS and deliver an automated web-based intervention to these students in different context s. Effect size estimates suggest that the intervention has some promise as a means of correcting misperceptions of marijuana use norms and reducing marijuana-related consequences . Future work should test the efficacy of this intervention in a full scale r and omized controlled trial With the increasing legalization of cannabis , underst and ing the consequences of cannabis use is particularly timely . We examined the association between cannabis use and dependence , prospect ively assessed between ages 18 and 38 , and economic and social problems at age 38 . We studied participants in the Dunedin Longitudinal Study , a cohort ( N = 1,037 ) followed from birth to age 38 . Study members with regular cannabis use and persistent dependence experienced downward socioeconomic mobility , more financial difficulties , workplace problems , and relationship conflict in early midlife . Cannabis dependence was not linked to traffic-related convictions . Associations were not explained by socioeconomic adversity , childhood psychopathology , achievement orientation , or family structure ; cannabis-related criminal convictions ; early onset of cannabis dependence ; or comorbid substance dependence . Cannabis dependence was associated with more financial difficulties than was alcohol dependence ; no difference was found in risks for other economic or social problems . Cannabis dependence is not associated with fewer harmful economic and social problems than alcohol dependence Background The relationship between tobacco and cannabis use is strong . When co-smokers try to quit only one substance , this relationship often leads to a substitution effect , that is , the increased use of the remaining substance . Stopping the use of both substances simultaneously is therefore a reasonable strategy , but co-smokers rarely report feeling ready for simultaneous cessation . Thus , the question of how co-smokers can be motivated to attempt a simultaneous cessation has arisen . To reach as many co-smokers as possible , we developed brief Web-based interventions aim ed at enhancing the readiness to simultaneously quit tobacco and cannabis use . Objective Our aim was to analyze the efficacy of three different Web-based interventions design ed to enhance co-smokers ’ readiness to stop tobacco and cannabis use simultaneously . Methods Within a r and omized trial , three brief Web-based and fully automated interventions were compared . The first intervention combined the assessment of cigarette dependence and problematic cannabis use with personalized , normative feedback . The second intervention was based on principles of motivational interviewing . As an active psychoeducational control group , the third intervention merely provided information on tobacco , cannabis , and the co-use of the two substances . The readiness to quit tobacco and cannabis simultaneously was measured before and after the inter
Output:
| Digital prevention and treatment interventions showed small , significant reduction effects on Cannabis use in diverse target population s at post-treatment compared to controls . |
MS210626 | ***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 / Aims : The ideal end point of treatment for chronic hepatitis B virus ( HBV ) infection is sustained off-therapy hepatitis B surface antigen ( HBsAg ) loss with or even without seroconversion to anti-HBs . We investigated the role of adding PEGylated interferon ( PEG IFN ) to ongoing tenofovir treatment in chronic HBV patients for achieving HBsAg clearance . Patients and Methods : In this r and omized controlled trial , chronic HBV patients who have been receiving tenofovir for > 6 months with HBV viral load < 2000 IU/ml were r and omized into two groups . One group ( add-on therapy ) was given subcutaneous PEG IFN 180 mcg weekly for 12 months in addition to tenofovir . Patients in the other group received only tenofovir 300 mg orally on a daily basis . Patients in both groups were followed up for a total of two years , and patients in both groups were given tenofovir 300 mg daily indefinitely until they developed HBsAg clearance . Results : Twenty-three patients were allocated to the PEG IFN and tenofovir ( add-on therapy ) group , and another 25 patients were recruited to the tenofovir monotherapy group . Before r and omization , patients had received tenofovir for 1135 mean days ( range203 to 1542 days ) . One patient ( 4.3 % ) in add-on therapy lost HBsAg and seroconverted . Within two years , mean HBsAg decreased significantly with add-on therapy ( from 4753 IU/ml to 2402 ; P= 0.03 ) ; and it decreased from 5957 IU/ml to 4198 ; P= 0.09 in tenofovir monotherapy group . More patients in the add-on group developed serious side effects , with treatment discontinuation , and dose reductions ( P = 0.3 ) . Conclusion : PEG IFN and tenofovir add-on therapy was successful in achieving HBsAg clearance and seroconversion in 4.3 % of the patients . Add-on therapy patients had a significant decrease in HBsAg levels in two years ; and no significant decrease in HBsAg levels with the tenofovir monotherapy . With no significant HBsAg clearance , the utility of this combination regimen is question able BACKGROUND AND AIMS Results of studies using lamivudine and interferon combination in the treatment of chronic hepatitis B are not consistent or conclusive . This study aim ed to evaluate the efficacy of interferon plus lamivudine use versus single lamivudine in anti-HBe-positive chronic hepatitis B. METHODS Eighty patients were treated with either lamivudine or lamivudine plus simultaneously started interferon . Patients were assigned in groups according to r and om allocation rule . Lamivudine was given 150 mg/day for 96 weeks in each group ; interferon was administered 10 MU three times a week for 24 weeks in the combination therapy group . RESULTS Alanine aminotransferase ( ALT ) normalization was achieved earlier in patients treated with lamivudine alone . At the end of treatment , there was no difference between the groups with respect to HBV DNA negativity , ALT normalization and breakthrough rate . Histological improvement was remarkable in each group , but fibrosis score and necro-inflammatory activity were much lower in lamivudine-treated patients . CONCLUSIONS Addition of interferon to the lamivudine regimen does not increase the effectiveness of the treatment . Considering the side effects of interferon treatment , this combination seems not to be convenient for anti-HBe-positive chronic hepatitis AIM To compare the efficacy of a combination of a-interferon ( IFN-a ) and lamivudine with IFN-a alone in the treatment of patients with HBeAg-positive chronic hepatitis B ( CHB ) . METHODS Sixty-eight treatment-naove patients with HBeAg-positive CHB were r and omized to receive either 9 MU of IFN-a2a three times a week and lamivudine 100 mg daily ( Group 1 ) , or IFN-a2a alone in the same dosage ( Group 2 ) , for 12 months . Serum ALT , HBeAg , anti-HBe and HBV DNA were tested at the end of treatment and 6 months later . Complete response was defined as normal ALT , negative HBeAg and negative HBV DNA , six months after stopping treatment . RESULTS Of the 68 patients , 64 completed the study . In Group 1 ( n=31 ) , mean ( SD ) ALT levels decreased from 124 ( 59 ) IU/L to 39 ( 18 ) IU/L at 12 months ; corresponding values in Group 2 ( n=33 ) were 128 ( 57 ) and 56 ( 11 ) IU/L ( p < 0.05 ) . Absence of HBV DNA at the end of treatment was more common in Group 1 ( 28/31 ) than in Group 2 ( 22/33 ; p < 0.022 ) . The number of patients with seroconversion to anti-HBe ( 4/31 [ 13 % ] vs. 4/33 [ 12 % ] , respectively ; p>0.05 ) , as also those with complete response ( 4/31 [ 13 % ] and 4/33 [ 12 % ] , respectively ; p>0.05 ) six months after completion of treatment was similar in Group 1 and Group 2 . CONCLUSION Combination treatment with IFN-a and lamivudine was better than IFN-a monotherapy in normalization of ALT and clearance of HBV DNA ; however , it did not have a better sustained response rate than IFN-a alone BACKGROUND Pegylated interferon (PEG-IFN)-alpha monotherapy is the current st and ard of care for short-term antiviral treatment of hepatitis B e antigen (HBeAg)-negative chronic hepatitis B ( CHB ) . We aim ed to assess the safety and efficacy of PEG-IFN-alpha plus adefovir dipivoxil ( ADV ) versus PEG-IFN-alpha monotherapy for compensated HBeAg-negative CHB . METHODS A multicentre r and omized controlled trial was performed in eight outpatient hepatology/infectious disease clinics in central Italy . A total of 60 patients ( 67 % male and median age 48 years ) with biopsy-proven HBeAg-negative compensated CHB ( mean alanine aminotranferase [ ALT ] levels 3.3 + /-3x the upper normal limit and serum hepatitis B virus [ HBV ] DNA 5.8 + /-0.9 log(10 ) IU/ml ) were r and omized at baseline to receive PEG-IFN-alpha2a 180 microg/week plus ADV 10 mg/day or PEG-IFN-alpha2a monotherapy for 48 weeks . Post-treatment follow-up was for 24 additional weeks . The primary end point was sustained HBV DNA suppression defined as serum HBV DNA<2,000 IU/ml after 24 weeks of post-treatment follow-up . The secondary end point was ALT normalization at the end of follow-up . RESULTS At week 48 , HBV DNA was undetectable in 20/30 ( 67 % ) in the combination group versus 11/30 ( 37 % ) patients in the monotherapy group ( P=0.02 ) . ALT normalization was achieved in 17/30 ( 57 % ) versus 10/30 ( 30 % ) patients , respectively ( P=0.03 ) . At week 72 , sustained virological response was achieved in 7/30 ( 23.3 % ) in the combination group versus 6/30 ( 20 % ) patients in the monotherapy group ( P=0.75 ) ; 5 ( 16 % ) patients in each group dropped out because of adverse events or non-compliance . CONCLUSIONS In HBeAg-negative CHB , combination PEG-IFN-alpha2a plus ADV for 48 weeks is safe and result ed in greater on-treatment efficacy than PEG-IFN-alpha2a monotherapy . No difference in sustained virological and biochemical response rates were observed between the two treatment regimens 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 : The aims of this study were to compare the efficacy and safety of the addition of adefovir dipivoxil ( ADV ) ( started at different time points ) to pegylated interferon alpha-2a ( PEG-INF-&agr;2a ) and PEG-INF-&agr;2a monotherapy . This prospect i ve , r and omized study sought to evaluate the safety and efficacy of the combination of PEG-INF-&agr;2a and ADV at different time points.120 patients were r and omized into groups that received PEG-INF-&agr;2a as monotherapy ( group A ) or in combination with ADV started at week 0 ( group B ) , 12 ( group C ) , or 24 ( group D ) . All patients were followed for 48 weeks . Efficacy and safety analyses were performed . Methods : Patients in group a received 135 & mgr;g of PEG-INF-&agr;2a by subcutaneous injection once weekly for 48 weeks . Patients in the ADV add-on group received 135 & mgr;g of PEG-INF-&agr;2a subcutaneously once weekly and received 10 mg of ADV administered once daily for 48 weeks . HBV DNA , HBsAg , HBeAg , and hepatitis B e antibody levels were determined . Responses were determined at week 12 ( ADV add-on ) , the end of treatment for PEG-INF-&agr;2a ( 48weeks ) and ADV ( EOT ) and at the end of 96 weeks of follow-up ( EOF ) . Results : The rate of HBV DNA loss were higher in the combination groups than group A at the week 12 , week 48 , the EOT and EOF ( P < 0.05 ) . The rates of HBeAg seroconversion and HBsAg loss were similar among the treatment groups ( P>0.05 ) . The alanineaminotransferase ( ALT ) normalization rate was higher in the combination group than group A only at the EOT ( P = 0.007 ) . By the EOF , the patients with ADV added at week 12 achieved higher rates of HBV DNA loss ( 71.9 % ) , HBeAg seroconversion ( 50.0 % ) , HBsAg loss ( 15.6 % ) , and ALT normalization ( 78.1 % ) . Conclusions : PEG-INF-&agr;2a plus ADV combination therapy is safe and superior to PEG-INF-&agr;2amonotherapyfor decreasing serum HBV DNA and normalizing the ALT level but has no significant impact on the rate of HBeAg seroconversion and HBsAg loss . Adding ADV at week 12 may be an optimal combination strategy BACKGROUND & AIMS Durable post-treatment response is uncommon in chronic hepatitis B ( CHB ) patients on nucleos(t)ide analogue therapy . Response , response predictors and safety were assessed in patients who switched from long-term entecavir ( ETV ) to peginterferon alfa-2a . METHODS Hepatitis B e antigen (HBeAg)-positive CHB patients who had received ETV for 9 - 36 months , with HBeAg < 100 PEIU/ml and HBV DNA ⩽1000 copies/ml , were r and omised 1:1 to receive peginterferon alfa-2a 180 μg/week or ETV 0.5mg/day for 48 weeks . The primary endpoint was HBeAg seroconversion at week 48 ( Clinical Trials.gov : NCT00940485 ) . RESULTS 200 patients were r and omised ; 197 received ⩾1 study drug dose . Five patients who were anti-HBe-positive at baseline were excluded from the modified intention-to-treat population ( peginterferon alfa-2a , n = 94 ; ETV , n = 98 ) . Patients who switched to peginterferon alfa-2a achieved higher week 48 HBeAg seroconversion rates vs. those who continued ETV ( 14.9 % vs. 6.1 % ; p = 0.0467 ) . Only patients receiving peginterferon alfa-2a achieved HBsAg loss ( 8.5 % ) . Among peginterferon alfa-2a-treated patients with HBeAg loss and HBsAg < 1500 IU/ml at r and omisation , 33.3 % and 22.2 % achieved HBeAg seroconversion and HBsAg loss , respectively . Early on-treatment HBsAg decline predicted response at week 48 ; highest rates were observed in patients with week 12 HBsAg < 200 IU/ml ( HBeAg seroconversion , 66.7 % ; HBsAg loss , 77.8 % ) . Alanine aminotransferase elevations were not associated with viral rebound ( n = 38 ) . Peginterferon alfa-2a was well-tolerated . CONCLUSIONS For patients who achieve viro
Output:
| In conclusion , IFN monotherapy/combination had a small but significant increase in HBsAg loss over NA , associated with st and ard dose of IFN and ≥48weeks of therapy , although this effect faded over time |
MS210627 | ***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: Forty-five adults with primary insomnia received cognitive-behavioral therapy ( CBT ) implemented in a group therapy format , in individual face-to-face therapy or through brief individual telephone consultations . The results indicate that CBT was effective in improving sleep parameters with all 3 methods of treatment implementation , and there was no significant difference across methods of implementation . All 3 treatment modalities produced improvements in sleep that were maintained for 6 months after treatment completion . These results suggest that group therapy and telephone consultations represent cost-effective alternatives to individual therapy for the management of insomnia Insomnia is a major health problem , with significant psychological , health , and economic consequences . Studies have demonstrated that cognitive-behavioural therapy can effectively treat insomnia ; however , treatment availability is limited by many factors , including a lack of trained clinicians . One potential way to overcome these barriers is to use the Internet to deliver treatment . Toward this aim , we developed a self-guided , interactive , tailored Internet intervention for adults with insomnia ( SHUTi : Sleep Healthy Using The Internet ) . The current paper provides a detailed description of SHUTi and examines users ' perceptions of the intervention 's usefulness and effectiveness . The study was part of a larger r and omised controlled trial ( RCT ) to test the efficacy of SHUTi , but findings in this paper are based only on the 21 participants who completed the post- assessment after using SHUTi . The overwhelming majority rated SHUTi as convenient , underst and able , and useful . Nearly all ( 95 % ) indicated that the program had at least somewhat improved their sleep , sleep efficiency , and overall quality of life . Ninety percent perceived the intervention as effective and predicted it would be effective in producing a long-term cure . Although these results were based on a small sample , they provide encouraging evidence of the potential for Internet interventions to be accepted by patients Sleep disturbance is common in patients with advanced cancer , and their family carers also may suffer from sleep problems . The aims of this study were to determine the prevalence of sleep-wake disturbances in patients with advanced cancer and their carers , to monitor the amount of daytime spent in activity and rest , and to examine the relationship between sleep , physical , and psychological symptoms . This was a prospect i ve , descriptive observational study in patients with advanced incurable cancer and their carers attending a regional cancer center , using subjective ( Short Form-36 , Epworth Sleepiness Score , Hospital Anxiety and Depression Scale , Memorial Symptom Assessment Scale , and sleep history and diary ) and objective ( Actiwatch ) assessment s over a seven-day period . Sixty patients with advanced cancer and their family carers completed the study . Poor sleep was a frequent complaint : 47 % of the patients and 42 % of the carers reported that they did not sleep well , yet patients reported sleeping an average of 8.2 hours and carers 7.8 hours per night . The objective assessment s revealed that although sleep efficiency ( SE ) was greater than 90 % for most patients and carers , sleep fragmentation was high in both groups . Patients and carers who complained of poor sleep were significantly more anxious ( P<0.001 and < 0.05 ) compared with patients and carers who reported sleeping well . Patients who complained of poor sleep had significantly more pain ( P<0.05 ) . These results show that a substantial proportion of advanced cancer patients and their carers complained of poor sleep despite reporting " normal " duration of sleep . Objective measurements using Actiwatch revealed good SE but high levels of sleep fragmentation and movement , suggesting that sleep quality may be disturbed . Further work is required to investigate sleep quality and the consequences of poor sleep . In the meantime , health care professionals need to routinely inquire about sleep and consider possible reversible underlying factors , such as pain and anxiety , for those who report sleep disturbance BACKGROUND Chronic sleep-onset insomnia is a prevalent health complaint in adults . Although behavioral and pharmacological therapies have been shown to be effective for insomnia , no placebo-controlled trials have evaluated their separate and combined effects for sleep-onset insomnia . The objective of this study was to evaluate the clinical efficacy of behavioral and pharmacological therapy , singly and in combination , for chronic sleep-onset insomnia . METHODS This was a r and omized , placebo-controlled clinical trial that involved 63 young and middle-aged adults with chronic sleep-onset insomnia . Interventions included cognitive behavior therapy ( CBT ) , pharmacotherapy , or combination therapy compared with placebo . The main outcome measures were sleep-onset latency as measured by sleep diaries ; secondary measures included sleep diary measures of sleep efficiency and total sleep time , objective measures of sleep variables ( Nightcap sleep monitor recorder ) , and measures of daytime functioning . RESULTS In most measures , CBT was the most sleep effective intervention ; it produced the greatest changes in sleep-onset latency and sleep efficiency , yielded the largest number of normal sleepers after treatment , and maintained therapeutic gains at long-term follow-up . The combined treatment provided no advantage over CBT alone , whereas pharmacotherapy produced only moderate improvements during drug administration and returned measures toward baseline after drug use discontinuation . CONCLUSIONS These findings suggest that young and middle-age patients with sleep-onset insomnia can derive significantly greater benefit from CBT than pharmacotherapy and that CBT should be considered a first-line intervention for chronic insomnia . Increased recognition of the efficacy of CBT and more widespread recommendations for its use could improve the quality of life of a large numbers of patients with insomnia Sleep disturbance is a very common problem for cancer patients that has largely not been addressed in the clinical intervention literature . Mindfulness meditation has demonstrated clinical benefits for a variety of patient population s in other areas of functioning . This study examined the effects of an 8-week Mindfulness-Based Stress Reduction ( MBSR ) program on the sleep quality of a heterogeneous sample of 63 cancer patients . Overall sleep disturbance was significantly reduced ( p < .001 ) and participants reported that their sleep quality had improved ( p < .001 ) . There was also a significant reduction in stress ( p < .001 ) , mood disturbance ( p = .001 ) , and fatigue ( p < .001 ) . The associations among these changes and implication s for improving quality of life of cancer patients are discussed OBJECTIVE The aim of this study was to investigate the potential of mindfulness-based stress reduction ( MBSR ) as a treatment for chronic primary insomnia . DESIGN A r and omized controlled trial was conducted . SETTING The study was conducted at a university health center . PATIENTS Thirty adults with primary chronic insomnia based on criteria of the Diagnostic and Statistical Manual of Mental Disorders , Text Revision , 4th Edition were r and omized 2:1 to MBSR or pharmacotherapy ( PCT ) . INTERVENTIONS Mindfulness-based stress reduction , a program of mindfulness meditation training consisting of eight weekly 2.5 hour classes and a daylong retreat , was provided , with ongoing home meditation practice expectations during three-month follow-up ; PCT , consisting of three milligrams of eszopiclone ( LUNESTA ) nightly for eight weeks , followed by three months of use as needed . A 10-minute sleep hygiene presentation was included in both interventions . MAIN OUTCOMES The Insomnia Severity Index ( ISI ) , Pittsburgh Sleep Quality Index ( PSQI ) , sleep diaries , and wrist actigraphy were collected pretreatment , posttreatment ( eight weeks ) , and at five months ( self-reports only ) . RESULTS Between baseline and eight weeks , sleep onset latency ( SOL ) measured by actigraphy decreased 8.9 minutes in the MBSR arm ( P < .05 ) . Large , significant improvements were found on the ISI , PSQI , and diary-measured total sleep time , SOL , and sleep efficiency ( P < .01 , all ) from baseline to five-month follow-up in the MBSR arm . Changes of comparable magnitude were found in the PCT arm . Twenty-seven of 30 patients completed their assigned treatment . This study provides initial evidence for the efficacy of MBSR as a viable treatment for chronic insomnia as measured by sleep diary , actigraphy , well-vali date d sleep scales , and measures of remission and clinical recovery Purpose This study aims to provide recommendations on the optimal strategies and interventions for the prevention , screening , assessment , and management of cancer-related sleep disturbance ( insomnia and insomnia syndrome ) in adult cancer population s. Methods A systematic search of the published health literature was conducted to identify r and omized controlled trials , clinical practice guidelines , systematic review s , and other guidance documents . The Sleep Disturbance Expert Panel [ comprised of nurses , psychologists , primary care physicians , oncologists , physicians specialized in sleep disturbances , research ers , and guideline method ologists ] review ed , discussed , and approved the final version of the guideline . Health care professionals across Canada were asked to provide feedback through an external review process . Results Three clinical practice guidelines and 12 r and omized controlled trials were identified as the evidence base . Overall , despite the paucity of evidence , the evidence and expert consensus suggest that it is important to screen and assess adult cancer patients for sleep disturbances using st and ardized screening tools on a routine basis . While prevention of sleep disturbance is the desired objective , cognitive behavioral therapies are effective in improving sleep outcomes . As part of the external review with 16 health care providers , 81 % indicated that they agreed with the recommendations as written . Conclusions Sleep difficulty is a prevalent problem in cancer population s that needs greater recognition by health professionals . Prevention , screening , assessment , and treatment strategies supported by the best available evidence are critical . Recommendations and care path algorithms for practice are offered CONTEXT Insomnia is a common condition in older adults and is associated with a number of adverse medical , social , and psychological consequences . Previous research has suggested beneficial outcomes of both psychological and pharmacological treatments , but blinded placebo-controlled trials comparing the effects of these treatments are lacking . OBJECTIVE To examine short- and long-term clinical efficacy of cognitive behavioral therapy ( CBT ) and pharmacological treatment in older adults experiencing chronic primary insomnia . DESIGN , SETTING , AND PARTICIPANTS A r and omized , double-blinded , placebo-controlled trial of 46 adults ( mean age , 60.8 y ; 22 women ) with chronic primary insomnia conducted between January 2004 and December 2005 in a single Norwegian university-based outpatient clinic for adults and elderly patients . INTERVENTION CBT ( sleep hygiene , sleep restriction , stimulus control , cognitive therapy , and relaxation ; n = 18 ) , sleep medication ( 7.5-mg zopiclone each night ; n = 16 ) , or placebo medication ( n = 12 ) . All treatment duration was 6 weeks , and the 2 active treatments were followed up at 6 months . MAIN OUTCOME MEASURES Ambulant clinical polysomnographic data and sleep diaries were used to determine total wake time , total sleep time , sleep efficiency , and slow-wave sleep ( only assessed using polysomnography ) on all 3 assessment points . RESULTS CBT result ed in improved short- and long-term outcomes compared with zopiclone on 3 out of 4 outcome measures . For most outcomes , zopiclone did not differ from placebo . Participants receiving CBT improved their sleep efficiency from 81.4 % at pretreatment to 90.1 % at 6-month follow-up compared with a decrease from 82.3 % to 81.9 % in the zopiclone group . Participants in the CBT group spent much more time in slow-wave sleep ( stages 3 and 4 ) compared with those in other groups , and spent less time awake during the night . Total sleep time was similar in all 3 groups ; at 6 months , patients receiving CBT had better sleep efficiency using polysomnography than those taking zopiclone . CONCLUSION These results suggest that interventions based on CBT are superior to zopiclone treatment both in short- and long-term management of insomnia in older adults . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00295386 PURPOSE To determine 1-year outcomes of a four-component behavioral therapy ( BT ) sleep intervention ( Individualized Sleep Promotion Plan [ ISPP ] ) versus a healthy eating control ( HEC ) on cancer-related fatigue in women receiving breast cancer adjuvant chemotherapy treatment ( CTX ) . PATIENTS AND METHODS A total of 219 participants from 12 oncology clinics were r and omly assigned in a clinical trial . Before CTX , research nurses coached intervention participants to develop a BT plan including stimulus control , modified sleep restriction , relaxation therapy , and sleep hygiene . BT plans were revised before each CTX and 30 , 60 , and 90 days after the last CTX and reinforced 7 to 9 days later . HEC participants received nutritional information and equal attention . Pittsburgh Sleep Quality Index ( PSQI ) , Daily Diary , Wrist Actigraph , and Piper Fatigue Scale measures and Repeated Linear Mixed Model analysis following the Intent to Treat paradigm were used . RESULTS Sleep quality differed over 1 years time ( F [ 4,162 ] = 7.7 , P < .001 ; by group , F [ 1,173 ] = 4.8 , P = .029 ; and over time by group , F [ 4,162 ] = 3.3 , P = .013 ) . Pairwise comparisons revealed significant differences between groups at 90 days ( P = .002 ) but not at 1 year ( P = .052 ) . Seven days of diary and actigraphy data did not corroborate with monthly reflections ( PSQI ) . The night awakenings ( Actigraph )
Output:
| Results suggest that CBT-I is associated with statistically and clinical ly significant improvements in subjective sleep outcomes in patients with cancer .
CBT-I may also improve mood , fatigue , and overall quality of life , and can be successfully delivered through a variety of treatment modalities , making it possible to reach a broader range of patients who may not have access to more traditional programs . |
MS210628 | ***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 efficacy of ceritinib in patients with untreated anaplastic lymphoma kinase (ALK)-rearranged non-small-cell lung cancer ( NSCLC ) is not known . We assessed the efficacy and safety of ceritinib versus platinum-based chemotherapy in these patients . METHODS This r and omised , open-label , phase 3 study in untreated patients with stage IIIB/IV ALK-rearranged non-squamous NSCLC was done in 134 centres across 28 countries . Eligible patients were assigned via interactive response technology to oral ceritinib 750 mg/day or platinum-based chemotherapy ( [ cisplatin 75 mg/m2 or carboplatin AUC 5 - 6 plus pemetrexed 500 mg/m2 ] every 3 weeks for four cycles followed by maintenance pemetrexed ) ; r and omisation was stratified by World Health Organization performance status ( 0 vs 1 - 2 ) , previous neoadjuvant or adjuvant chemotherapy , and presence of brain metastases as per investigator 's assessment at screening . Investigators and patients were not masked to treatment assignment . The primary endpoint was blinded independent review committee assessed progression-free survival , based on all r and omly assigned patients ( the full analysis set ) . Efficacy analyses were done based on the full analysis set . All safety analyses were done based on the safety set , which included all patients who received at least one dose of study drug . This trial is registered with Clinical Trials.gov , number NCT01828099 . FINDINGS Between Aug 19 , 2013 , and May 11 , 2015 , 376 patients were r and omly assigned to ceritinib ( n=189 ) or chemotherapy ( n=187 ) . Median progression-free survival ( as assessed by blinded independent review committee ) was 16·6 months ( 95 % CI 12·6 - 27·2 ) in the ceritinib group and 8·1 months ( 5·8 - 11·1 ) in the chemotherapy group ( hazard ratio 0·55 [ 95 % CI 0·42 - 0·73 ] ; p<0·00001 ) . The most common adverse events were diarrhoea ( in 160 [ 85 % ] of 189 patients ) , nausea ( 130 [ 69 % ] ) , vomiting ( 125 [ 66 % ] ) , and an increase in alanine aminotransferase ( 114 [ 60 % ] ) in the ceritinib group and nausea ( in 97 [ 55 % ] of 175 patients ) , vomiting ( 63 [ 36 % ] ) , and anaemia ( 62 [ 35 % ] ) in the chemotherapy group . INTERPRETATION First-line ceritinib showed a statistically significant and clinical ly meaningful improvement in progression-free survival versus chemotherapy in patients with advanced ALK-rearranged NSCLC . FUNDING Novartis Pharmaceuticals Corporation PURPOSE Crizotinib confers improved progression-free survival compared with chemotherapy in anaplastic lymphoma kinase (ALK)-rearranged non-small-cell lung cancer ( NSCLC ) , but progression invariably occurs . We investigated the efficacy and safety of alectinib , a potent and selective ALK inhibitor with excellent CNS penetration , in patients with crizotinib-refractory ALK-positive NSCLC . PATIENTS AND METHODS Alectinib 600 mg was administered orally twice daily . The primary end point was objective response rate ( ORR ) by central independent review committee ( IRC ) . RESULTS Of the 138 patients treated , 84 patients ( 61 % ) had CNS metastases at baseline , and 122 were response evaluable ( RE ) by IRC . ORR by IRC was 50 % ( 95 % CI , 41 % to 59 % ) , and the median duration of response ( DOR ) was 11.2 months ( 95 % CI , 9.6 months to not reached ) . In 96 patients ( 79 % ) previously treated with chemotherapy , the ORR was 45 % ( 95 % CI , 35 % to 55 % ) . Median IRC-assessed progression-free survival for all 138 patients was 8.9 months ( 95 % CI , 5.6 to 11.3 months ) . CNS disease control rate was 83 % ( 95 % CI , 74 % to 91 % ) , and the median CNS DOR was 10.3 months ( 95 % CI , 7.6 to 11.2 months ) . CNS ORR in 35 patients with baseline measurable CNS lesions was 57 % ( 95 % CI , 39 % to 74 % ) . Of the 23 patients with baseline CNS metastases ( measurable or nonmeasurable ) and no prior radiation , 10 ( 43 % ) had a complete CNS response . At 12 months , the cumulative CNS progression rate ( 24.8 % ) was lower than the cumulative non-CNS progression rate ( 33.2 % ) for all patients . Common adverse events were constipation ( 33 % ) , fatigue ( 26 % ) , and peripheral edema ( 25 % ) ; most were grade 1 to 2 . CONCLUSION Alectinib is highly active and well tolerated in patients with advanced , crizotinib-refractory ALK-positive NSCLC , including those with CNS metastases BACKGROUND The efficacy of the ALK inhibitor crizotinib as compared with st and ard chemotherapy as first-line treatment for advanced ALK-positive non-small-cell lung cancer ( NSCLC ) is unknown . METHODS We conducted an open-label , phase 3 trial comparing crizotinib with chemotherapy in 343 patients with advanced ALK-positive nonsquamous NSCLC who had received no previous systemic treatment for advanced disease . Patients were r and omly assigned to receive oral crizotinib at a dose of 250 mg twice daily or to receive intravenous chemotherapy ( pemetrexed , 500 mg per square meter of body-surface area , plus either cisplatin , 75 mg per square meter , or carboplatin , target area under the curve of 5 to 6 mg per milliliter per minute ) every 3 weeks for up to six cycles . Crossover to crizotinib treatment after disease progression was permitted for patients receiving chemotherapy . The primary end point was progression-free survival as assessed by independent radiologic review . RESULTS Progression-free survival was significantly longer with crizotinib than with chemotherapy ( median , 10.9 months vs. 7.0 months ; hazard ratio for progression or death with crizotinib , 0.45 ; 95 % confidence interval [ CI ] , 0.35 to 0.60 ; P<0.001 ) . Objective response rates were 74 % and 45 % , respectively ( P<0.001 ) . Median overall survival was not reached in either group ( hazard ratio for death with crizotinib , 0.82 ; 95 % CI , 0.54 to 1.26 ; P=0.36 ) ; the probability of 1-year survival was 84 % with crizotinib and 79 % with chemotherapy . The most common adverse events with crizotinib were vision disorders , diarrhea , nausea , and edema , and the most common events with chemotherapy were nausea , fatigue , vomiting , and decreased appetite . As compared with chemotherapy , crizotinib was associated with greater reduction in lung cancer symptoms and greater improvement in quality of life . CONCLUSIONS Crizotinib was superior to st and ard first-line pemetrexed-plus-platinum chemotherapy in patients with previously untreated advanced ALK-positive NSCLC . ( Funded by Pfizer ; PROFILE 1014 Clinical Trials.gov number , NCT01154140 . ) In this prospect i ve phase III trial , afatinib combined with paclitaxel improved progression-free survival and objective response , compared with single-agent chemotherapy , in patients with NSCLC who were clinical ly enriched for ErbB dependency having failed platinum-based chemotherapy , gefitinib/erlotinib and afatinib monotherapy after initial benefit on each tyrosine kinase inhibitor BACKGROUND Non-small-cell lung cancer with sensitive mutations of the epidermal growth factor receptor ( EGFR ) is highly responsive to EGFR tyrosine kinase inhibitors such as gefitinib , but little is known about how its efficacy and safety profile compares with that of st and ard chemotherapy . METHODS We r and omly assigned 230 patients with metastatic , non-small-cell lung cancer and EGFR mutations who had not previously received chemotherapy to receive gefitinib or carboplatin-paclitaxel . The primary end point was progression-free survival ; secondary end points included overall survival , response rate , and toxic effects . RESULTS In the planned interim analysis of data for the first 200 patients , progression-free survival was significantly longer in the gefitinib group than in the st and ard-chemotherapy group ( hazard ratio for death or disease progression with gefitinib , 0.36 ; P<0.001 ) , result ing in early termination of the study . The gefitinib group had a significantly longer median progression-free survival ( 10.8 months , vs. 5.4 months in the chemotherapy group ; hazard ratio , 0.30 ; 95 % confidence interval , 0.22 to 0.41 ; P<0.001 ) , as well as a higher response rate ( 73.7 % vs. 30.7 % , P<0.001 ) . The median overall survival was 30.5 months in the gefitinib group and 23.6 months in the chemotherapy group ( P=0.31 ) . The most common adverse events in the gefitinib group were rash ( 71.1 % ) and elevated aminotransferase levels ( 55.3 % ) , and in the chemotherapy group , neutropenia ( 77.0 % ) , anemia ( 64.6 % ) , appetite loss ( 56.6 % ) , and sensory neuropathy ( 54.9 % ) . One patient receiving gefitinib died from interstitial lung disease . CONCLUSIONS First-line gefitinib for patients with advanced non-small-cell lung cancer who were selected on the basis of EGFR mutations improved progression-free survival , with acceptable toxicity , as compared with st and ard chemotherapy . ( UMIN-CTR number , C000000376 . BACKGROUND In single-group studies , chromosomal rearrangements of the anaplastic lymphoma kinase gene ( ALK ) have been associated with marked clinical responses to crizotinib , an oral tyrosine kinase inhibitor targeting ALK . Whether crizotinib is superior to st and ard chemotherapy with respect to efficacy is unknown . METHODS We conducted a phase 3 , open-label trial comparing crizotinib with chemotherapy in 347 patients with locally advanced or metastatic ALK-positive lung cancer who had received one prior platinum-based regimen . Patients were r and omly assigned to receive oral treatment with crizotinib ( 250 mg ) twice daily or intravenous chemotherapy with either pemetrexed ( 500 mg per square meter of body-surface area ) or docetaxel ( 75 mg per square meter ) every 3 weeks . Patients in the chemotherapy group who had disease progression were permitted to cross over to crizotinib as part of a separate study . The primary end point was progression-free survival . RESULTS The median progression-free survival was 7.7 months in the crizotinib group and 3.0 months in the chemotherapy group ( hazard ratio for progression or death with crizotinib , 0.49 ; 95 % confidence interval [ CI ] , 0.37 to 0.64 ; P<0.001 ) . The response rates were 65 % ( 95 % CI , 58 to 72 ) with crizotinib , as compared with 20 % ( 95 % CI , 14 to 26 ) with chemotherapy ( P<0.001 ) . An interim analysis of overall survival showed no significant improvement with crizotinib as compared with chemotherapy ( hazard ratio for death in the crizotinib group , 1.02 ; 95 % CI , 0.68 to 1.54 ; P=0.54 ) . Common adverse events associated with crizotinib were visual disorder , gastrointestinal side effects , and elevated liver aminotransferase levels , whereas common adverse events with chemotherapy were fatigue , alopecia , and dyspnea . Patients reported greater reductions in symptoms of lung cancer and greater improvement in global quality of life with crizotinib than with chemotherapy . CONCLUSIONS Crizotinib is superior to st and ard chemotherapy in patients with previously treated , advanced non-small-cell lung cancer with ALK rearrangement . ( Funded by Pfizer ; Clinical Trials.gov number , NCT00932893 . ) BACKGROUND Oncogenic fusion genes consisting of EML4 and anaplastic lymphoma kinase ( ALK ) are present in a
Output:
| Sub-group analysis according to ALK-TKIs showed that the incidence of liver toxicities associated with ceritinib was higher than that of crizotinib and alectinib .
Conclusions The use of ALK-TKIs significantly increases the risk of developing all- grade and high- grade liver toxicities in lung cancer patients |
MS210629 | ***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 common question in clinical consultations is : “ For this person , what are the likely effects of one treatment compared with another ? ” The central tenet of evidence based medicine is that this task is achieved by using the best evidence combined with consideration of that person 's individual needs.1 A further question then arises : “ What is the best evidence ? ” Two recent studies in the New Engl and Journal of Medicine have caused uproar in the research community by finding no difference in estimates of treatment effects between r and omised controlled trials and non-r and omised trials . The r and omised controlled trial and , especially , systematic review s of several of these trials are traditionally the gold st and ards for judging the benefits of treatments , mainly because it is conceptually easier to attribute any observed effect to the treatments being compared . The role of non-r and omised ( observational ) studies in evaluating treatments is contentious : deliberate choice of the treatment for each person implies that observed outcomes may be caused by differences among people being given the two treatments , rather than the treatments alone . Unrecognised confounding factors can always interfere with attempts to correct for identified differences between groups . These considerations have supported a hierarchy of evidence , with r and omised controlled trials and derivatives at the top , controlled The challenges of providing exemplary undergraduate nursing education can not be underestimated in an era when burnout and negative mood states predictably lead to alarming rates of academic as well as career attrition . While the multi-dimensional nature of this complex issue has been extensively eluci date d , few rational strategies exist to reverse a disheartening trend recognizable early in the educational process that subsequently threatens to undermine the future viability of quality healthcare . This controlled prospect i ve crossover study examined the impact of a 6-session Recreational Music-making ( RMM ) protocol on burnout and mood dimensions as well as Total Mood Disturbance ( TMD ) in first year associate level nursing students . A total of 75 first year associate degree nursing students from Allegany College of Maryl and ( ACM ) participated in a 6-session RMM protocol focusing on group support and stress reduction utilizing a specific group drumming protocol . Burnout and mood dimensions were assessed with the Maslach Burnout Inventory and the Profile of Mood States respectively . Statistically significant reductions of multiple burnout and mood dimensions as well as TMD scores were noted . Potential annual cost savings for the typical associate degree nursing program ( $ 16,800 ) and acute care hospital ( $ 322,000 ) were projected by an independent economic analysis firm . A cost-effective 6-session RMM protocol reduces burnout and mood dimensions as well as TMD in associate degree nursing students RATIONALE Stress is known to increase drug craving , associated physiological arousal and risk of relapse in drug dependent individuals . However , it is unclear whether these responses are altered by recent frequency of drug use . The current study examined whether frequency of cocaine and alcohol abuse alters drug craving and associated arousal with laboratory exposure to stress and to drug related cues . METHODS Fifty-four recently abstinent treatment-seeking cocaine abusers who were part of a study on stress and drug craving were categorized into high- and low-frequency users on the basis of their recent cocaine use . The high use cocaine group also consumed significantly more alcohol than the low use cocaine group . Participants were exposed to a brief 5-min guided imagery procedure that involved imagining a recent personal stressful situation , a personal drug-related situation and a neutral-relaxing situation , one imagery session on separate days presented in r and om order . Subjective ( craving and anxiety ) , cardiovascular ( heart rate , systolic blood pressure ( SBP ) and diastolic blood pressure ( DBP ) ) and biochemical ( adrenocorticotropic hormone ( ACTH ) , cortisol , prolactin ) measures were assessed . RESULTS High-frequency abusers demonstrated a significantly greater drug craving , anxiety and associated cardiovascular and hypothalamic-pituitary-adrenal ( HPA ) response to both stress and drug-cue exposure as compared to low-frequency abusers . CONCLUSIONS Increased frequency of recent cocaine and alcohol use is associated with an enhanced stress and cue-induced drug craving and arousal response that appears to be similar to the effects of cocaine , and one that may increase the vulnerability to drug-seeking behavior and relapse in drug dependent individuals A quasi-experimental pre- , post-test , follow-up and control group design was used to investigate the effect of psychological and educational counselling in reducing anxiety in nursing students . The research study used method ological triangulation , involving the use of structured data collection techniques such as st and ardized question naires and semi-structured focus groups . Focus groups were used to provide greater insight regarding the student 's opinions . The sample consisted of 100 second- and fourth-year baccalaureate nursing students from the Faculty of Nursing at Shiraz University of Medical Sciences , Iran . They were r and omly assigned to either an experimental group ( n = 50 ) or a control group ( n = 50 ) . The experimental group received a 12-week intervention programme . Quantitative analysis of data was undertaken using t-test and analysis of variance for repeated measures to test differences between and within groups . The results indicated that from pre- to post-test there was no statistically significant reduction in anxiety between groups , but there was a statistically significant reduction in anxiety after one semester ( in the follow-up ) . Student self-esteem was increased significantly from pre- to post-test . This increase was statistically significant and remained the same in follow-up . A statistically significant difference was seen in the student grade point average from pre-test to follow-up in the experimental group but not for the control group . The implementation of an intervention programme reduced their anxiety , increased their self-esteem and improved their grade point average over time This study sought to develop a stress management program based on the arousal-attribution stress model and to evaluate the effectiveness of the program in reducing anxiety and depression experienced by nursing students . Forty-two sophomore and 34 senior nursing students in a private , sectarian , liberal arts college were r and omly assigned to experimental and control groups . All subjects were given pre- and posttests consisting of the State form of the State-Trait Anxiety Inventory and the Institute for Personality and Ability Testing Depression Scale . Posttest analysis indicated that the experimental group had significantly lower anxiety and depression than the control group ( p less than .05 ) . These results support the use of the arousal-attribution stress model as a theoretical framework for stress management training The double-blind r and omized controlled trial ( RCT ) is accepted by medicine as objective scientific methodology that , when ideally performed , produces knowledge untainted by bias . The validity of the RCT rests not just on theoretical arguments , but also on the discrepancy between the RCT and less rigorous evidence ( the difference is sometimes considered an objective measure of bias ) . A brief overview of historical and recent developments in " the discrepancy argument " is presented . The article then examines the possibility that some of this " deviation from truth " may be the result of artifacts introduced by the masked RCT itself . Can an " unbiased " method produce bias ? Among the experiments examined are those that augment the method ological stringency of a normal RCT in order to render the experiment less susceptible to subversion by the mind . This methodology , a hypothetical " platinum " st and ard , can be used to judge the " gold " st and ard . The concealment in a placebo-controlled RCT seems capable of generating a " masking bias . " Other potential biases , such as " investigator self- selection , " " preference , " and " consent " are also briefly discussed . Such potential distortions indicate that the double-blind RCT may not be objective in the realist sense , but rather is objective in a " softer " disciplinary sense . Some " facts " may not exist independent of the apparatus of their production This study examined the effectiveness of audiotaped imagery in reducing anxiety and improving test performance among first-year nursing students . Volunteer subjects were r and omly assigned to three groups , imagery-only , imagery/relaxation , and a no-treatment control group . Pottest state anxiety scores in these groups were significantly lower ( p = .001 ) than in the no-treatment control group . Test performance did not differ significantly ( p = .067 ) . Subjects using the audiotaped imagery reported an increased sense of well-being , improved ability to sleep , greater energy , and improved self-confidence This article describes a natural experiment that overcomes a number of method ological problems inherent in previous studies of occupational stress and strengthens evidence for the causal role of the work setting in influencing mental health and well-being . Student nurses ( N = 164 ) were r and omly assigned to one of four possible combinations of ward types such that two factors — type of nursing ( medical/surgical ) and sex of patients (male/female)—were systematic all y varied with counterbalancing of order effects . Self-reported levels of affective symptoms and perceptions of the work environment , together with independent data on sickness/absence , performance , and the objective work environment , were recorded longitudinally over the two ward periods . Within-subjects analyses showed significant differences between medical and surgical wards in affective symptoms and in perceived and objective measures of the work environment . Male and female wards differed primarily in the perceived environment , work satisfaction , and performance . Correlational analyses were used to examine the relationships between different types of measures . Further analysis of the main effects , with control for covariance , indicated that the perceived work environment contributed to the observed differences in affective distress between medical and surgical wards , while mitigating differences between male and female wards . In spite of extensive research , the causal role of the work environment in influencing mental health and well-being has not yet been adequately demonstrated . The difficulties in resolving this important issue are primarily method ological , and several recent papers have emphasized the limitations The view is widely held that experimental methods ( r and omised controlled trials ) are the " gold st and ard " for evaluation and that observational methods ( cohort and case control studies ) have little or no value . This ignores the limitations of r and omised trials , which may prove unnecessary , inappropriate , impossible , or inadequate . Many of the problems of conducting r and omised trials could often , in theory , be overcome , but the practical implication s for research ers and funding bodies mean that this is often not possible . The false conflict between those who advocate r and omised trials in all situations and those who believe observational data provide sufficient evidence needs to be replaced with mutual recognition of the complementary roles of the two approaches . Research ers should be united in their quest for scientific rigour in evaluation , regardless of the method used The purpose of this study was to investigate the effects of a 5-week stress management program for 40 junior baccalaureate nursing students . A quasi-experimental pretest-posttest control group design was used . The stress management group included training sessions using cognitive modification techniques and Stroebel 's Quieting Response ( QR ) augmented with biofeedback techniques for self-relaxation . A significant reduction of state anxiety ( P < .001 ) was reported on the State-Trait Anxiety Inventory ( STAI ) by the experimental groups , while the state anxiety of the control groups remained relatively unchanged . There were no significant changes in trait anxiety scores . Urinary potassium excretion was measured as an index of the adrenal stress response . Findings revealed no statistically significant correlation between potassium excretion and scores on the STAI . These results support the benefits of integrating a stress management program into curricula for nursing students BACKGROUND Nurses ' occupational stress decreases job satisfaction , increases turnover rate , and reduces nursing quality . At different workplaces nurses are confronted with different work tasks , working conditions and hence different sources of stress . OBJECTIVES The purpose of this study was to explore what factors contribute to work-related stress among Icel and ic nurses working within and outside the hospital environment . DESIGN The study used a cross-sectional survey design . SETTING S AND PARTICIPANTS The study population was composed of all working nurses registered at the Icel and ic Nurses ' Association ( INA ) . Approximately 95 % ( N=2,234 ) of Icel and ic nurses are members of the INA . Question naires were posted to 522 ( 23.4 % ) r and omly selected participants . The response rate was 42 % ( N=219 ) , representing 9.8 % of the population . Data was analyzed from 206 nurses ; 35 % worked outside the hospital setting and 65 % were hospital based . METHODS Data was gathered on demographic information and indicators of working conditions , occupational stress , workload , and job satisfaction . A stepwise , multiple linear regression model was employed to calculate significant predictors of occupational stress . RESULTS The findings suggest that the strenuous conditions of Icel and ic nurses are felt more severely among hospital nurses than among nurses working outside hospital setting s. The study identified which sources of occupational stress are specific to each of the two groups . CONCLUSIONS The study found several factors that contribute to work-related stress . These findings can be used to guide preventive measures to diminish occupational stress among Icel and ic nurses BACKGROUND It is well-established that stress is likely to contribute to attrition in nursing students . Attrition from nursing programmes and retention of nurses in the profession are international concerns and steps are currently being taken in the United Kingdom to tackle these issues . AIM The aim of this study was to investigate prospect ively the determinants of , and relationships among , stress , burnout and attrition in nursing students . METHOD A longitudinal design involving a complete cohort of nursing students was employed , using a battery of instruments to measure personality , intelligence , psychological morbidity , stress , coping and burnout . Data were gathered on entry , at 12 and 24 months , and at the end of the nursing programme . FINDINGS Students experienced increasing levels of stress and use of negative coping mechanisms as the programme progressed and psychological morbidity increased . Positive aspects of personality were more likely to lead to aspects of burnout , and personality was a more important indicator of attrition than cognitive ability . CONCLUSIONS Stress , burnout and attrition may not be directly linked . Personality factors at
Output:
| RESULTS The most effective interventions provided skills for coping with stressful situations ( typically relaxation ) and skills for changing maladaptive cognitions .
Interventions which promoted skills to reduce the intensity or number of stressors were also successful .
In most cases , stress interventions did not improve academic performance . |
MS210630 | ***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 To study the efficacy of alfuzosin compared with tamsulosin in the management of lower ureteral stones . METHODS A total of 102 patients with stones < 1 cm size and located in the lower ureter were enrolled in the present study and r and omized into 3 equal groups . Group 1 patients ( n = 34 ) received 0.4 mg tamsulosin daily , group 2 patients ( n = 34 ) received 10 mg alfuzosin daily , and group 3 patients ( n = 34 ) received placebo ( control group ) . The patients were given 75 mg diclofenac injection intramuscularly on dem and and were followed up for 4 weeks . RESULTS The average stone size for groups 1 , 2 , and 3 was comparable ( 6.17 , 6.70 , and 6.35 mm , respectively ) . Stone expulsion was observed in 28 of 34 patients ( 82.3 % ) in group 1 , 24 of 34 patients ( 70.5 % ) in group 2 , and 12 of 34 patients ( 35.2 % ) in group 3 . The average expulsion time for groups 1 , 2 , and 3 was 12.3 , 14.5 , and 24.5 days , respectively . The results of both study groups ( groups 1 and 2 ) were superior to those in the placebo group ( P = .003 and P = .001 , respectively ) , but the study failed to show any statistically significant differences between tamsulosin and alfuzosin ( P = .25 ) . Alfuzosin was associated with fewer side effects than tamsulosin , especially in terms of retro grade ejaculation . CONCLUSIONS Medical treatment of lower ureteral calculi with tamsulosin and alfuzosin result ed in a significantly increased stone expulsion rate , decreased expulsion time , and a reduced need for analgesic therapy BACKGROUND Using a selective α-blocker for medical expulsive therapy ( MET ) is a cost-effective treatment approach widely used for ureteral stones . OBJECTIVE To evaluate the efficacy of silodosin , a selective α-1a receptor antagonist , in this setting . DESIGN , SETTING , AND PARTICIPANTS This was a multicenter , phase 2 study conducted in adult patients with a unilateral ureteral calculus of 4 - 10 mm . Of 239 patients in the safety population , six discontinued due to adverse events . INTERVENTION Patients were r and omized 1:1 to receive silodosin 8 mg or placebo for up to 4 wk . OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS The primary outcome was spontaneous stone passage , analyzed using logistic regression . Secondary outcomes included time to stone passage , emergency room ( ER ) visits , hospital admissions , analgesic use , and incidence and severity of pain . RESULTS AND LIMITATIONS No significant differences between the silodosin and placebo groups were observed for passage rate of all stones ( 52 % vs 44 % , respectively ; p=0.2 ) . However , silodosin achieved a significantly greater rate of distal ureter stone passage than placebo ( p=0.01 ) . Significant differences were not observed for ER visits , hospital admission , or use of analgesics . The number of patients in the intent-to-treat population was slightly below the calculated sample size ( 232 vs 240 ) and sample sizes were not calculated for subgroup analyses . CONCLUSIONS This is among the first prospect i ve , r and omized , multi-institutional trials to examine the efficacy of a selective α-1a antagonist as MET in patients with ureteral calculi and did not demonstrate a benefit to the entire ureter . However , silodosin was found to be well tolerated and beneficial in facilitating the passage of distal ureteral stones , warranting additional future studies on distal stone elimination . PATIENT SUMMARY In this report , we looked at the efficacy of silodosin for the treatment of ureteral stones . We found that silodosin increased passage of distal ureteral stones BACKGROUND Urolithiasis is a chronic disease of mankind , which has enormous public health importance and it accounts for a substantial economic burden on our society . Hence , it becomes all the more important to formulate cheaper and easier means for treating this condition . The past few years have seen a number of drugs being introduced and successfully used in the medical expulsion therapy of small , uncomplicated ureteral calculi , with each drug cl aim ing to provide better results than the others . Ours is perhaps the first study which has compared the efficacy of tamsulosin and silodosin in the medical expulsion therapy for ureteral calculi . AIMS To compare the efficacy of tamsulosin ( 0.4 mg ) vs silodosin ( 8 mg ) , both in terms of the stone expulsion rate and the time to stone expulsion . SETTING S AND DESIGN A prospect i ve and a r and omized controlled study was conducted in the Department of Urology , Regional Institute of Medical Sciences ( RIMS ) , Imphal , Manipur , India . MATERIAL AND METHODS From February to August 2012 , 100 patients who were between the age group of 18 - 50 years , who had unilateral , uncomplicated middle or lower ureteral stones < /= 1 cm were enrolled and they were divided into two groups . Group 1 received tamsulosin ( 0.4 mg ) daily , whereas Group 2 received silodosin ( 8 mg ) daily for a maximum period of 4 weeks . The patients were followed up weekly or biweekly with imaging studies . The primary endpoint was the stone expulsion rate and the secondary endpoints were the stone expulsion time , the rate of the interventions and the side effects . STATISTICAL ANALYSIS The statistical analysis was performed by using the Student 's t-test and the Chi-squared test . A p value of < 0.05 was considered to be statistically significant . The SPSS-16 software was used for the statistical analysis of the data . RESULTS A spontaneous stone expulsion was observed in 58 % of the patients in group 1 and in 82 % of the patients in Group 2 , which was statistically significant . There was also a significant difference between the groups with regards to the mean stone expulsion time . A lower analgesic use was found in Group 2 . CONCLUSION In our study , silodosin was found to be clinical ly superior to tamsulosin , both in terms of the stone expulsion rate and the stone expulsion time Purpose We evaluated and compared the efficacy of tamsulosin and alfuzosin in the medical treatment of symptomatic , uncomplicated distal ureteral stones . Material s and Methods A total of 87 patients with distal ureteral stones of ≤10 mm were r and omly divided into 3 groups . Group I patients ( n=29 ) received 0.4 mg tamsulosin daily , group II patients ( n=30 ) received 10 mg alfuzosin daily , and group III patients ( n=28 ) were not given tamsulosin or alfuzosin . Patients in all groups received Diclofenac sodium regularly for 1 week and then on dem and . Follow-up was done on a weekly basis for 30 days . Results The mean stone size was comparable in the 3 groups ( 4.97±2.24 , 5.47±2.13 , and 5.39±1.81 mm , respectively ) . The stone expulsion rate was 86.2 % , 76.6 % , and 50 % in groups I , II , and III , respectively . The difference in groups I and II with respect to group III was significant ( p=0.0028 and 0.035 ) . The mean expulsion time for groups I to III was 7.52±7.06 , 8.26±7.34 , and 13.90±6.99 days , respectively . The expulsion time was significantly shorter in groups I and II than in group III ( p=0.0097 and 0.026 ) . Patients taking tamsulosin and alfuzosin had fewer pain attacks than did group III patients ( 1.24±0.57 vs. 1.43±0.67 vs. 1.75±1.17 ) . Only 3 cases of drug side effects , 2 in group I and 1 in group II , were recorded . Conclusions The use of tamsulosin or alfuzosin for the medical treatment of lower ureteric stones proved to be safe and effective . Moreover , tamsulosin did not have any significant benefits over alfuzosin Background : Alpha – 1 blockers decrease the tension and release the spasm of smooth muscles and thus lessen the obstruction and irritation symptoms in the lower urinary tract ( LUTS ) . They make a faster passing of calculi from the terminal part of the ureters possible . Objectives : The goal of this study was to objective ly assess the improvement of difficulties caused by obstructions in ureterolithiasis localized in the lower part of the ureters of 104 r and omly chosen patients ( pts . ) in a double-blind study . Methods : During a period of 2 and half years ( June 1999–January 2002 ) 104 pts . suffering from ureterolithiasis of the lower urinary tract were treated and observed . Patients were divided into two groups : A ( n:53 ; later only 51 were evaluated ) which was subjected to st and ard treatment and group B ( n:51 ) where the st and ard treatment was supplemented by the alpha – 1 blocker . As alpha – 1 blocker one capsule of Tamsulosin /OMNIC 0.4 / was administered daily . Results : With alpha – 1 blocker , we have registered a more speedy passing of calculi from the terminal parts of ureters in 17.6 % of pts . Recurrence of renal colics was less frequent and occurred in one of eight pts . as compared with group A ( without the alpha – 1 blocker ) where a recurrence of the renal colic was observed in about every fifth pts . In group A ( n:51 ) , 62.8 % of the pts . passed the calculi , whereas in group B ( n:51 ) , where st and ard treatment was supplemented by the administration of the alpha – 1 blocker Tamsulosin , this percentage increased to 80.4 % . Conclusion : The treatment by alpha – 1 blockers considerably decreased not only LUTS but also helped to accelerate the passing of minor calculi from the terminal parts of the ureters of 80.4 % of pts . It seems that alpha – 1 blockers potentiate the spasmoanalgetic action of drugs used in st and ard methods of treatment PURPOSE We evaluated the efficacy of alfuzosin as medical expulsive therapy for distal ureteral stone passage . MATERIAL S AND METHODS A total of 76 patients with a distal ureteral calculus provided consent for the study . Patients were r and omized between placebo and study medication , and investigators and patients were blinded to the r and omization scheme . Followup was done on a weekly basis and continued until the patient was rendered stone-free . The patient blood pressure , discomfort level , stone position on imaging , number of remaining pills and any adverse events were assessed . Statistical analysis was performed with the Student t test with p < 0.05 considered significant . RESULTS The overall spontaneous stone passage rate was 75 % , including 77.1 % for placebo and 73.5 % for alfuzosin ( p = 0.83 ) . Mean + /- SD time needed to pass the stone was 8.54 + /- 6.99 days for placebo vs 5.19 + /- 4.82 days for alfuzosin . ( p = 0.003 ) . There was no difference in the size or volume of stones that passed spontaneously between the placebo and alfuzosin arms , as measured on baseline computerized tomography ( 4.08 + /- 1.17 and 3.83 + /- 0.95 mm , p = 0.46 ) and by a digital caliper after stone expulsion ( 3.86 + /- 1.76 and 3.91 + /- 1.06 mm , respectively , p = 0.57 ) . When comparing the improvement from the baseline pain score , the alfuzosin arm experienced a greater decrease in pain score in the days after the initial emergency department visit to the date of stone passage ( p = 0.0005 ) . CONCLUSIONS Alfuzosin improves the patient discomfort associated with stone passage and decreases the time to distal ureteral stone passage but it does not increase the rate of spontaneous stone passage PURPOSE Recent studies show the interesting efficacy of different drug combinations for the spontaneous expulsion of distal ureteral stones . We performed a r and omized , prospect i ve study to assess and compare the efficacy of 3 drugs as medical expulsive therapy for distal ureteral calculi . MATERIAL S AND METHODS A total of 210 symptomatic patients with distal ureteral calculi greater than 4 mm were r and omly allocated to home treatment with phloroglucinol , tamsulosin or nifedipine ( groups 1 to 3 , respectively ) . Each group was given a corticosteroid drug and antibiotic prophylaxis with an injectable nonsteroidal anti-inflammatory drug was also used on dem and . The primary end point was the expulsion rate and the secondary end points were expulsion time , analgesic use , need for hospitalization and endoscopic treatment as well as the number of workdays lost , quality of life and drug side effects RESULTS The expulsion rate was significantly higher in group 2 ( 97.1 % ) than in groups 1 ( 64.3 % , p < 0.0001 ) or 3 ( 77.1 % , p < 0.0001 ) . Group
Output:
| The expulsion rate of all ureteral stones ( OR 1.59 , 95 % CI 1.08 , 2.36 , P = 0.02 ) , the expulsion rate of distal ureteral stones ( OR 2.82 , 95 % CI 1.70 , 4.67 , P < 0.0001 ) and the expulsion time ( days ) of distal ureteral stones ( st and ard mean difference ( SMD ) -4.71 , 95 % CI -6.60 , -2.83 , P < 0.00001 ) indicated that silodosin was more effective than the placebo .
This meta- analysis indicated that silodosin was superior to placebo or tamsulosin in the efficacy for distal ureteral calculi with better control of pain .
The safety profile of silodosin was similar to tamsulosin though retro grade ejaculation was worse for silodosin use .
We conclude that silodosin might have potential as a MET for ureteral stones |
MS210631 | ***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 : Both Nordic walking and Exercise on Prescription have potential as elements in the management of type 2 diabetes mellitus . These programs are recommended , but their effectiveness has not yet been established . The aim was to evaluate the efficacy of these 2 interventions compared with st and ard information on physical activity . Design : Single-blinded , r and omized , controlled intervention study . Setting : Sixty-eight patients ( 37 men and 31 women ) were r and omized into 3 groups : Nordic walking ( NW ; n = 22 ) , Exercise on Prescription ( EP ; n = 24 ) , and control ( CG ; n = 22 ) . Patients : Patients were recruited from a diabetes outpatient clinic and via newspaper advertisement . Interventions : Consisted of a 4-month intervention period followed by an 8-month follow-up , during which the participants were recommended to train on their own . Main Outcome Measures : HbA1c . Results : There was no difference in HbA1c when comparing the intervention groups relative to the control group : ΔNW = −0.4 % [ 95 % confidence intervals ( CI ) , −0.9 % to 0.1 % ] and ΔEP = −0.2 % ( 95 % CI , −0.6 % to 0.2 % ) after 4 months ; ΔNW = 0.0 % ( 95 % CI , −0.6 % to 0.5 % ) and ΔEP = 0.3 % ( 95 % CI , −0.3 % to 0.9 % ) after 12 months . However , fat mass assessed by dual energy X-ray absorptiometry ( DXA ) decreased significantly in the NW group after 4 months [ −1.0 kg ( 95 % CI , −1.7 to 0.1 ) ] and after 12 months in both NW [ −1.8 kg ( 95 % CI , −3.2 to −0.4 ) ] and EP [ −1.5 kg ( 95 % CI , −2.9 to −0.05 ) ] groups . No significant changes in other variables . Conclusions : Four-month exercise programs at moderate intensity of either Nordic walking or Exercise on Prescription did not significantly improve HbA1c in patients with type 2 diabetes either at the end of the program or at the follow-up Background —The Dietary Approaches to Stop Hypertension ( DASH ) diet is recommended in the 2005 US Dietary Guidelines . To underst and the potential benefits of DASH on coronary heart disease ( CHD ) , we applied the Framingham risk equations to calculate 10-year risk of developing CHD using data from the DASH trial . Methods and Results —In the DASH trial , 459 individuals with prehypertension or stage-1 hypertension not taking antihypertensive medication were r and omly assigned to 1 of 3 diets : control , fruits and vegetables ( F/V ) , or DASH ( rich in fruits , vegetables , low-fat dairy , and reduced in fats and cholesterol ) . Weight was held constant . Estimated 10-year CHD risk was the primary outcome of this secondary analysis . Among 436 participants with complete data , mean ( SD ) age was 44.7 ( 10.7 ) years , 51 % were male , and 60 % were African-American . Median 10-year CHD risk was 0.98 % at baseline and decreased in all groups . Compared with control , the relative risk ratio comparing 8-week with baseline 10-year CHD risk was 0.93 ( 95 % confidence interval , 0.85 to 1.02 ; P=0.12 ) for F/V and 0.82 ( 95 % confidence interval , 0.75 to 0.90 ; P<0.001 ) for DASH . Comparing DASH with F/V , the relative risk ratio was 0.89 ( 95 % confidence interval , 0.81 to 0.97 ; P=0.012 ) . With the exception of an interaction between dietary pattern and race suggesting a greater risk reduction in blacks than whites ( P for interaction=0.038 ) , results were similar across subgroups . Conclusions —Compared with control and F/V , the DASH diet reduced estimated 10-year CHD risk by 18 % and 11 % , respectively . In addition to reducing blood pressure , the DASH diet should substantially reduce the risk of CHD . Clinical Trial Registration —URL : http:// clinical trials.gov . Unique identifier : NCT00000544 Thirty insulin-treated adult diabetic out patients , within normal weight for at least 5 years , were instructed either on an unmeasured diet with the single restriction of simple sugars , or on a weight maintenance , caloric defined , exchange type American Diabetes Association diet . During the next 2 years , both groups reported similar caloric intakes , food composition , and distribution , which were remarkably close to the calculated ideals . Both groups kept body weights within normal limits . There was no difference in insulin doses or serum cholesterol . Fasting glycemia was higher , triglycerides lower , and hypoglycemic reactions less frequent in the group on the unmeasured diet . These differences were not significant . It is suggested that normal weight diabetics spontaneously regulate their intake to maintain a constant weight regardless of precise degree of glycemia control or insulin dosage OBJECTIVE —The effectiveness of intentional weight loss in reducing cardiovascular disease ( CVD ) events in type 2 diabetes is unknown . This report describes 1-year changes in CVD risk factors in a trial design ed to examine the long-term effects of an intensive lifestyle intervention on the incidence of major CVD events . RESEARCH DESIGN AND METHODS —This study consisted of a multicentered , r and omized , controlled trial of 5,145 individuals with type 2 diabetes , aged 45–74 years , with BMI > 25 kg/m2 ( > 27 kg/m2 if taking insulin ) . An intensive lifestyle intervention ( ILI ) involving group and individual meetings to achieve and maintain weight loss through decreased caloric intake and increased physical activity was compared with a diabetes support and education ( DSE ) condition . RESULTS — Participants assigned to ILI lost an average 8.6 % of their initial weight vs. 0.7 % in DSE group ( P < 0.001 ) . Mean fitness increased in ILI by 20.9 vs. 5.8 % in DSE ( P < 0.001 ) . A greater proportion of ILI participants had reductions in diabetes , hypertension , and lipid-lowering medicines . Mean A1C dropped from 7.3 to 6.6 % in ILI ( P < 0.001 ) vs. from 7.3 to 7.2 % in DSE . Systolic and diastolic pressure , triglycerides , HDL cholesterol , and urine albumin-to-creatinine ratio improved significantly more in ILI than DSE participants ( all P < 0.01 ) . CONCLUSIONS —At 1 year , ILI result ed in clinical ly significant weight loss in people with type 2 diabetes . This was associated with improved diabetes control and CVD risk factors and reduced medicine use in ILI versus DSE . Continued intervention and follow-up will determine whether these changes are maintained and will reduce CVD risk OBJECTIVES The aim of the present study was to develop , implement and evaluate a brief intervention to improve adherence to the recommended lifestyle changes for patients with Type 2 diabetes , in particular to help patients to reduce the total amount of fat consumed and to increase lifestyle physical activity levels . DESIGN AND METHOD A brief , tailored lifestyle self-management intervention for patients with Type 2 diabetes was evaluated in a r and omized controlled trial . One hundred participants ( aged 40 - 70 yrs ) completed assessment s at three time points- baseline , three months and one year . Participants were allocated to either an intervention group who received the brief tailored intervention including follow-up telephone calls , or a usual care control group . RESULTS Results indicate that the intervention was successful in helping patients to reduce fat intake and , to a lesser extent , increase lifestyle physical activity levels . These self-reported changes in behaviour were reflected in the objective data with weight maintenance in the intervention group compared to the control group , together with a significant reduction ( 2 cm ) in waist circumference . CONCLUSIONS These results provide further evidence of the effectiveness of tailored interventions for lifestyle change BACKGROUND Physical activity ( PA ) is a cornerstone in the management of type 2 diabetes ( T2DM ) . This pilot investigation explores the effects of a st and ard diabetes education program compared with a supplemental PA intervention on diabetes-related health outcomes . METHODS Using a prospect i ve 2-armed design , 96 adults with T2DM were r and omly assigned to either st and ard care ( diabetes education program ; n = 49 ) or st and ard care supplemented with an 8-week , individualized-counseling and community-based PA component ( n = 47 ) . Measurements were taken at baseline , 3 , 6 , and 12 months . Primary outcomes were changes in PA ( self-report ) and HbA1c . Between group changes were compared using analysis of covariance ( ANCOVA ) and changes over time using repeated- measures ANOVA . RESULTS In comparison with st and ard care , the supplemental group demonstrated an increase in PA ( Ps < 0.01 ) and cardiorespiratory fitness ( Ps < 0.05 ) from baseline to all follow-up time-points . HbA1c levels declined ( P < .05 ) from baseline to all time points in the st and ard care group . Reduction in cholesterol-ratio ( P < .01 ) , increase in HDL ( P < .05 ) , and reductions in blood pressure , resting heart rate and BMI ( approaching statistical significance Ps < 0.10 ) were also reported for both groups . CONCLUSIONS PA counseling in addition to st and ard care is effective for promoting PA behavior change and positive health-related outcomes among individuals with T2DM Background — Although trials of lifestyle interventions generally focus on cardiovascular disease risk factors rather than hard clinical outcomes , 10-year coronary heart disease ( CHD ) risk can be estimated from the Framingham risk equations . Our objectives were to study the effect of 2 multicomponent lifestyle interventions on estimated CHD risk relative to advice alone and to evaluate whether differences can be observed in the effects of the lifestyle interventions among subgroups defined by baseline variables . Methods and Results — A total of 810 healthy adults with untreated prehypertension or stage I hypertension were r and omized to 1 of 3 intervention groups : An “ advice-only ” group , an “ established ” group that used established lifestyle recommendations for blood pressure control ( sodium reduction , weight loss , and increased physical activity ) , or an “ established-plus-DASH ” group that combined established lifestyle recommendations with the DASH ( Dietary Approaches to Stop Hypertension ) diet . The primary outcome was 10-year CHD risk , estimated from follow-up data collected at 6 months . A secondary outcome was 10-year CHD risk at 18 months . Of the 810 participants , 62 % were women and 34 % were black . Mean age was 50 years , mean systolic/diastolic blood pressure was 135/85 mm Hg , and median baseline Framingham risk was 1.9 % . The relative risk ratio comparing 6-month to baseline Framingham risk was 0.86 ( 95 % confidence interval 0.81 to 0.91 , P<0.001 ) in the established group and 0.88 ( 95 % confidence interval 0.83 to 0.94 , P<0.001 ) in the established-plus-DASH group relative to advice alone . Results were virtually identical in sensitivity analyses , in each major subgroup , and at 18 months . Conclusions — The observed reductions of 12 % to 14 % in estimated CHD risk are substantial and , if achieved , should have important public health benefits Background Given the recognized health effects of visceral fat , the underst and ing of how diet can modulate changes in the phenotype “ waist circumference for a given body mass index ( WC BMI ) ” , a proxy measure of visceral adiposity , is deemed necessary . Hence , the objective of the present study was to assess the association between dietary factors and prospect i ve changes in visceral adiposity as measured by changes in the phenotype WC BMI . Methods and Findings We analyzed data from 48,631 men and women from 5 countries participating in the European Prospect i ve Investigation into Cancer and Nutrition ( EPIC ) study . Anthropometric measurements were obtained at baseline and after a median follow-up time of 5.5 years . WC BMI was defined as the residuals of waist circumference regressed on body mass index , and annual change in WC BMI ( ΔWC BMI , cm/y ) was defined as the difference between residuals at follow-up and baseline , divided by follow-up time . The association between energy , energy density ( ED ) , macronutrients , alcohol , glycemic index ( GI ) , glycemic load ( GL ) , fibre and ΔWC BMI was modelled using centre-specific adjusted linear regression , and r and om-effects meta-analyses to obtain pooled estimates . Men and women with higher ED and GI diets showed significant increases in their WC BMI , compared to those with lower ED and GI [ 1 kcal/g greater ED predicted a ΔWC BMI of 0.09 cm ( 95 % CI 0.05 to 0.13 ) in men and 0.15 cm ( 95 % CI 0.09 to 0.21 ) in women ; 10 units greater GI predicted a
Output:
| In patients with cardiometabolic disease , self-management plus exercise may prevent weight and BMI increases and self-management and /or exercise may prevent waist circumference increases versus minimal/no intervention . |
MS210632 | ***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 the context of chronic physical illness , such as breast cancer , depression is associated with increased morbidity , longer periods of hospitalization , and greater overall disability . Prompt diagnosis and effective treatment is , therefore , essential . Several small studies have established the efficacy of tricyclic antidepressants ( TCAs ) in this setting , and the selective serotonin reuptake inhibitors ( SSRIs ) would appear to be an alternative therapeutic option because of their established efficacy and better tolerability profile . This was a multicenter , double-blind , parallel-group study in which 179 women with breast cancer were r and omized to treatment with either the SSRI paroxetine ( 20–40mg/day ) , or the TCA , amitriptyline ( 75–150mg/day ) . After 8-weeks treatment , depressive symptomatology had improved markedly and to a similar extent in both groups on the Montgomery Asberg Depression Rating Scale . Clinical global impression ( CGI ) Global improvement and Patient global evaluation scales indicated that patients were minimally to much improved at study endpoint ; a change from moderately/mildly ill to borderline ill on the CGI severity of Illness scale . A steady improvement in quality of life was also observed in both groups . There were no clinical ly significant differences between the groups . In total , 47 ( 53.4 % ) patients in the paroxetine group and 53 ( 59.6 % ) patients in the amitriptyline group had adverse experiences , the most common of which were the well-recognized side-effects of the antidepressant medications or chemotherapy . Anticholinergic effects were almost twice as frequent in the amitriptyline group ( 19.1 % ) compared with paroxetine ( 11.4 % ) . This study has demonstrated that paroxetine is a suitable alternative to amitriptyline for the treatment of depression in patients with breast cancer In a study lasting 12 weeks , relaxation training was evaluated as a coping re source for cancer patients . 80 patients of both sexes were r and omised to relaxation training and to a control ( no training ) group ( 40 in each ) . Scores for anxiety , depression and psychiatric morbidity were obtained at 0 , 6 and 12 weeks with well-known question naires and a new anxiety and depression scale , the effects of serious illness ( ESI ) scale . 71 patients ( 32 men and 39 women ) successfully completed the study . Results showed that relaxation training and control group scores were similar at 0 weeks . Higher anxiety , depression and psychiatric morbidity scores were reported by all patients at 6 and , to a lesser extent , at 12 weeks with greater differences in women . Female controls invariably reported significantly higher scores at 6 and 12 weeks on all indices . Male controls reported significantly higher anxiety scores only at 6 and 12 weeks Background Studies have shown that there is a high prevalence of depression in cancer patients . Women with breast cancer may have an even higher risk of depression particularly in a postmenopausal or estrogen deficiency state . A small number of r and omized controlled trials have examined the efficacy of antidepressants compared to that of a placebo in cancer patients , but some results have been difficult to interpret due to a heterogeneous patient group . In the current investigation , we screened newly diagnosed early stage breast cancer patients for depressive symptoms prior to the initiation of adjuvant therapy and investigated whether the oral antidepressant fluoxetine affected depressive symptoms , completion of adjuvant treatment , and quality of life . Methods Patients with newly diagnosed early stage breast cancer were screened for depressive symptoms prior to the initiation of adjuvant therapy . Patients with depressive symptoms were r and omized to a daily oral fluoxetine or a placebo . Patients were then followed for 6 months and evaluated for quality of life , completion of adjuvant treatment , and depressive symptoms . Results A high percentage of patients with newly diagnosed early stage breast cancer were found to have depressive symptoms prior to the initiation of adjuvant therapy . The use of fluoxetine for 6 months result ed in an improvement in quality of life , a higher completion of adjuvant treatment ( chemotherapy , hormonal therapy , chemotherapy plus hormonal therapy ) , and a reduction in depressive symptoms compared to patients who received placebo . Conclusions An antidepressant should be considered for early stage breast cancer patients with depressive symptoms who are receiving adjuvant treatment Goals of workCancer is often burdened by psychological comorbidity , mainly represented by depression , anxiety and adjustment disorders . Efficacy and tolerability of sertraline in the treatment of depressive disorders is well known ; however , its efficacy and safety in patients with cancer has been poorly studied . This study was aim ed to provide evidence s of effectiveness , safety , tolerability and rapidity of action of sertraline in a population of oncological out patients affected by mood disorders and its effects on quality of life . Material s and methods Thirty-five adult cancer out patients with mood depression , during chemotherapy , were enrolled to a 12-week trial with a flexible dose regime of sertraline . The treatment response was assessed at baseline , week 4 and week 12 , with hospital anxiety and depression scale ( HADS ) and Montgomery Asberg depression rating scale ( MADRS ) , to rate depression and anxiety ; mini mental adjustment to cancer scale ( Mini-MAC ) , to assess the psychological response to the diagnosis of cancer ; clinical global impression ( CGI ) to evaluate severity of illness ; dosage record and treatment emergent symptom scale ( DOTES ) , to assess the adverse effects of the clinical treatments and their possible relation with the drug used ; and QL index to rate quality of life . Main results Both mean depression scores , analysed by HADS and MADRS scales , and HADS anxiety scores significantly decreased during the 12 weeks of study . Mean MINI-MAC scores show that hopelessness and anxious preoccupation decreased significantly at T2 compared with T0 . No severe adverse effects were observed . Conclusion In this preliminary study , sertraline was found to be effective and well tolerated in the treatment of depressed out patients with cancer Little has been done to study the effectiveness of antidepressants in controlling anxiety/depression in a population of cancer patients . A double‐blind placebo‐controlled study was therefore design ed to assess the effectiveness of 20 mg fluoxetine . Of 115 cancer patients who fulfilled entry criteria for levels of distress , 45 patients were r and omized to a fluoxetine treatment group ( FA ) and 46 patients to a placebo group ( PA ) after a 1‐week placebo period design ed to exclude placebo responders . The Montgomery and Asberg Depression Scale ( MADRS ) , the Hamilton Anxiety Scale ( HAS ) , the Hospital Anxiety and Depression Scale ( HADS ) , the Revised Symptom Checklist ( SCL90‐R ) and the Spitzer Quality of Life Index ( SQOLI ) were used to assess the efficacy of fluoxetine . The response rate , defined by a HADS score lower than 8 after 5 weeks of treatment , was not significantly higher in the FA group ( 11 % ) compared to the PA group ( 7 % ) . Compared to the PA group , patients in the FA group showed a significantly greater decrease in SCL90‐R mean total score after 5 weeks , but not a greater decrease in HADS mean score . No difference between the two groups was found in observer‐reported assessment s ( MADRS , HAS and SQOLI ) . Significantly more drop‐outs were observed in the FA group ( n=15 ) than in the PA group ( n=7 ) , although the frequencies of side‐effects were not significantly different The purpose of this study was to test a brief orientation program for reducing anxiety , depressive symptoms , and overall distress in cancer patients at their initial clinic visit . One hundred and fifty consecutively referred patients seen in an oncology outpatient clinic were r and omly assigned to an intervention or usual care control group . The intervention group received a clinic tour , general information about clinic operations , and a question and answer session with an oncology counselor . Outcome measures included the State-Trait Anxiety Inventory ( STAI ) , the Brief Profile of Mood States ( POMS ) , the Center for Epidemiologic Studies -Depression ( CES-D ) Scale , and an oncology clinic question naire which were administered at the initial clinic visit and follow-up . There were no statistically significant clinical or demographic differences between groups at initial assessment . At follow-up , the intervention group had lower state anxiety , lower overall distress , and fewer patients reporting depressive symptoms . Patients in the intervention group demonstrated significantly more knowledge about clinic operations and greater satisfaction with care . These data provide evidence that anxiety , distress and depressive symptoms can be reduced with an orientation program . This finding has particular relevance in the early stages of diagnosis where patients may suffer symptoms of anxiety and depression BACKGROUND Depression is a common disorder in cancer patients , and it is associated with reduced quality of life , abnormal illness behavior , pain , and suicide risk . A few studies have investigated the effects of tricyclic antidepressants and serotonin reuptake inhibitors in cancer patients . No data are available regarding the use of reboxetine , a norepinephrine reuptake inhibitor that has been shown to be safe ( e.g. , absence of clinical ly significant drug-drug interactions and cytochrome P450 metabolism ) and effective in the treatment of depressed patients , including those with medical illness ( e.g. , Parkinson 's disease , human immunodeficiency virus infection ) . METHOD The effects of reboxetine were investigated in 20 breast cancer patients with a DSM-IV diagnosis of major depressive disorder in an open , prospect i ve 8-week trial . Severity of depression was assessed with the 17-item Hamilton Rating Scale for Depression ( HAM-D ) . Psychiatric symptoms ( Brief Symptom Inventory [ BSI ] ) , styles of coping with cancer ( Mini-Mental Adjustment to Cancer [ Mini-MAC ] ) , quality of life ( European Organization for Research and Treatment of Cancer Quality -of-Life Question naire C30 [ EORTC-QLQ-C30 ] ) , and Clinical Global Impressions scale scores were also monitored . RESULTS At 8 weeks , a significant ( p < .01 ) reduction was observed in HAM-D scores , several BSI dimension scores , and Mini-MAC hopelessness and anxious preoccupation scores . A significant ( p < .05 ) improvement from baseline to endpoint was found on the EORTC-QLQ-C30 subfactors emotional , cognitive , dyspnea , sleep , and global . Discontinuation was necessary in 1 subject because of hypomanic switch and in another because of side effects ( tachycardia , tension ) . Seven patients experienced transient side effects ( e.g. , mild anxiety , insomnia , sweating ) . CONCLUSION In this open trial , reboxetine appeared to be well tolerated and promising in reducing depressive symptoms and maladjusted coping styles and in improving scores on quality -of-life parameters Abstract A behavioural programme to treat psychological distress following mastectomy for breast cancer is described . The first 10 patients to be treated were r and omly allocated to two treatment groups : Behavioural Programme Only or Behavioural Programme + Drugs ( antidepressant medication ) . Both groups showed improvement over treatment , but the Behavioural Programme + Drugs group appeared to maintain their improvement better Summary Background . Fatigue can significantly interfere with a cancer patient ’s ability to fulfill daily responsibilities and enjoy life . It commonly co-exists with depression in patients undergoing chemotherapy , suggesting that administration of an antidepressant that alleviates symptoms of depression could also reduce fatigue . Methods . We report on a double-blind clinical trial of 94 female breast cancer patients receiving at least four cycles of chemotherapy r and omly assigned to receive either 20 mg of the selective serotonin re-uptake inhibitor ( SSRI ) paroxetine ( Paxil ® , SmithKline Beecham Pharmaceuticals ) or an identical-appearing placebo . Patients began their study medication seven days following their first on- study treatment and continued until seven days following their fourth on- study treatment . Seven days after each treatment , participants completed question naires measuring fatigue ( Multidimensional Assessment of Fatigue , Profile of Mood States-Fatigue/Inertia subscale and Fatigue Symptom Checklist ) and depression ( Profile of Mood States-Depression subscale [ POMS-DD ] and Center for Epidemiologic Studies -Depression [ CES-D ] ) . Results . Repeated- measures ANOVAs , after controlling for baseline measures , showed that paroxetine was more effective than placebo in reducing depression during chemotherapy as measured by the CES-D ( p=0.006 ) and the POMS-DD ( p=0.07 ) but not in reducing fatigue ( all measures , ps > 0.27 ) . Conclusions . Although depression was significantly reduced in the 44 patients receiving paroxetine compared to the 50 patients receiving placebo , indicating that a biologically active dose was used , no significant differences between groups on any of the measures of fatigued were observed . Results suggest that modulation of serotonin may not be a primary mechanism of fatigue related to cancer treatment Cognitive impairment seems to be highly prevalent in patients with advanced cancer . Modafinil , a novel vigilance and wake-promoting agent , may be an alternative treatment . We wanted to investigate this treatment on attentional and psychomotor dysfunction in cancer patients . 28 cancer patients with a tiredness score of 50 mm or more on a scale of 0 to 10 ( 0=no tiredness , 10=worst possible tiredness ) and Karnofsky Performance Status 40—70 were included . All medications were kept stable during the trial despite short acting opioids for breakthrough pain . On day 1 the patients were r and omly assigned to receive 200 mg Modafinil orally or placebo and on day 4 they crossed
Output:
| RESULTS Recent evidence from r and omized controlled trials has demonstrated the efficacy of psychosocial and pharmacologic treatments to alleviate depression in patients with cancer . |
MS210633 | ***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: STUDY OBJECTIVE We determined whether a simple emergency department intervention improves the likelihood of primary care provider ( PCP ) follow-up after ED discharge for an acute asthma exacerbation . METHODS This r and omized , controlled clinical trial was conducted in an urban university-based ED . Participants were patients with asthma between the ages of 16 and 45 years who were treated and discharged from the ED . The study intervention was usual care or an intervention that consisted of a free 5-day course of prednisone , vouchers for transportation to and from their PCP , and a 48-hour telephone reminder to make an appointment with their PCP . The main outcome was whether the patient received follow-up care as determined by PCP contact at 4 weeks . RESULTS One hundred ninety-two patients with asthma were enrolled over 8 months ; 178 ( 93 % ) had complete follow-up . The intervention and control groups were similar with regard to age , sex , ethnicity , or years of education . The 2 groups were also comparable with respect to multiple measures of baseline access/barriers to care and severity of ED exacerbation . Patients receiving the intervention were significantly more likely to follow up with their PCP than control patients ( relative risk 1.6 ; 95 % confidence interval [ CI ] 1.1 , 2.4 ) . When adjusted for other factors influencing PCP follow-up care ( ethnicity , prior PCP relationship , insurance status , regular car access ) , intervention patients were more likely to follow up with their PCP ( odds ratio 3.1 ; 95 % CI 1.5 , 6.3 ) . CONCLUSION Providing medication , transportation vouchers , and a telephone reminder to make an appointment increased the likelihood that discharged patients with asthma obtained PCP follow-up BACKGROUND Whether asthma morbidity in minority groups can be reduced by preventative health care measures delivered in the relevant ethnic dialects requires further evaluation . This study reports clinical outcomes and quality of life from a community based project investigating white European ( W/E ) and Indian subcontinent ( ISC ) ethnic groups with asthma living in deprived inner city areas of Birmingham , UK . METHODS Six hundred and eighty nine asthmatic subjects ( 345 W/E , 344 ISC ) of mean ( SD ) age 34.5 ( 15 ) years ( range 11–59 ) and mean forced expiratory volume in one second ( FEV1 ) of 80 % predicted were interviewed in English , Punjabi , Hindi , or Urdu . Subjects r and omised to the active limb of a prospect i ve , open , r and omised , controlled , parallel group , 12 month follow up study underwent individually based asthma education and optimisation of drug therapy with four monthly follow up ( active intervention ) . Control groups were seen only at the beginning and end of the study . Urgent or emergency interactions with primary and secondary health care ( clinical outcomes ) and both cross sectional and longitudinal data from an Asthma Quality of Life Question naire ( AQLQ ) were analysed . RESULTS Clinical outcomes were available for 593 subjects . Fewer of the active intervention group consulted their GP ( 41.8 % versus 57.8 % , odds ratio ( OR ) 0.52 ( 95 % CI 0.37 to 0.74 ) ) or were prescribed antibiotics ( 34.9 % versus 51.2 % , OR 0.51 ( 95 % CI 0.36 to 0.72 ) ) , but by ethnicity statistically significant changes occurred only in the W/E group with fewer also attending A&E departments and requiring urgent home visits . Active intervention reduced the number of hospital admissions ( 10 versus 30 ) , GP consultations ( 341 versus 476 ) , prescriptions of rescue oral steroids ( 92 versus 177 ) , and antibiotics ( 220 versus 340 ) , but again significant improvements by ethnicity only occurred in the active W/E group . AQLQ scores were negatively skewed to the higher values ; regression analysis showed that lower values were associated with ISC ethnicity . Longitudinal changes ( for 522 subjects ) in the mean AQLQ scores were small but statistically significant for both ethnic groups , with scores improving in the active and worsening in the control groups . CONCLUSIONS Active intervention only improved clinical outcomes in the W/E group . AQLQ scores , although lower in the ISC group , were improved by active intervention in both ethnic groups BACKGROUND Isl and and mainl and Puerto Rican children have the highest rates of asthma and asthma morbidity of any ethnic group in the United States . OBJECTIVE We evaluated the effectiveness of a culturally adapted family asthma management intervention called CALMA ( an acronym of the Spanish for " Take Control , Empower Yourself and Achieve Management of Asthma " ) in reducing asthma morbidity in poor Puerto Rican children with asthma . METHODS Low-income children with persistent asthma were selected from a national health plan insurance cl aims data base by using a computerized algorithm . After baseline , families were r and omly assigned to either the intervention or a control group . RESULTS No significant differences between control and intervention group were found for the primary outcome of symptom-free days . However , children in the CALMA intervention group had 6.5 % more symptom-free nights , were 3 times more likely to have their asthma under control , and were less likely to visit the emergency department and be hospitalized as compared to the control group . Caregivers receiving CALMA were significantly less likely to feel helpless , frustrated , or upset because of their child 's asthma and more likely to feel confident to manage their child 's asthma . CONCLUSION A home-based asthma intervention program tailored to the cultural needs of low income Puerto Rican families is a promising intervention for reducing asthma morbidity BACKGROUND AND OBJECTIVE There are significant health disparities between Māori and non-Māori with asthma , a pattern seen between other ethnic population s. This study investigates outcomes for Māori in a r and omized controlled trial ( RCT ) of combination budesonide/formoterol inhaler therapy in asthma . METHODS This 24-week multicentre RCT recruited 303 adult asthma patients , 44 of whom were Māori . Participants were r and omized to the single combination budesonide/formoterol inhaler as maintenance and reliever therapy ( ' SMART ' ) regimen or ' st and ard ' regimen ( combination budesonide/formoterol inhaler for maintenance and salbutamol as reliever ) . Outcomes included patterns of beta-agonist inhaler use including ' high use ' of reliever therapy ( > 8 actuations of budesonide/formoterol in excess of four maintenance doses per day for SMART and > 16 actuations per day of salbutamol for st and ard ) . Differences in outcomes for Māori versus non-Māori were assessed using an interaction term between ethnicity and treatment . RESULTS With adjustment for ethnicity , the SMART group had fewer days of high use ( relative rate ( RR ) 0.57 ( 95 % confidence interval ( CI ) : 0.38 - 0.85 ) ) , days of high use without medical review within 48 h ( RR 0.49 ( 95 % CI : 0.32 - 0.75 ) ) and severe exacerbations ( RR 0.54 ( 95 % CI : 0.36 - 0.81 ) ) compared with st and ard . The magnitude of the benefit from the SMART regimen was similar in Māori and non-Māori . Regardless of treatment regimen , Māori demonstrated more days of high use , high use without medical review and underuse of maintenance therapy . CONCLUSIONS The SMART regimen has a favourable risk/benefit profile in Māori . Days of high use , days of high use without medical review and underuse of maintenance treatment were greater in Māori , regardless of treatment regimen BACKGROUND Few interventions have focused on the difficulties that African American women face when managing asthma . OBJECTIVE To evaluate a telephone-based self-regulation intervention that emphasized African American women 's management of asthma in a series of 6 sessions . METHODS A total of 422 African American women with persistent asthma were r and omly assigned to either an intervention or control group receiving usual care . Behavioral factors , symptoms and asthma control , asthma-related quality of life , and health care use at baseline and 2 years after baseline were assessed . Generalized estimating equations were used to assess the long-term effect of the intervention on outcomes . RESULTS Compared with the control group , those who completed the full intervention ( 6 sessions ) had significant gains in self-regulation of their asthma ( B estimate , 0.73 ; 95 % CI , 0.17 - 1.30 ; P < .01 ) , noticing changes to their asthma during their menstrual cycle ( B estimate , 1.42 ; 95 % CI , 0.69 - 2.15 ; P < .001 ) , and when having premenstrual syndrome ( B estimate , 1.70 ; 95 % CI , 0.67 - 2.72 ; P < .001 ) . They also had significant reductions in daytime symptoms ( B estimate , -0.15 ; 95 % CI , -0.27 to -0.03 ; P < .01 ) , asthma-related hospitalization ( B estimate , 0.51 ; 95 % CI , 0.00 - 1.02 ; P < .05 ) , and improved asthma control ( B estimate , 1.34 ; 95 % CI , 0.57 - 2.12 ; P < .001 ) . However , neither grouped changed over time in outcomes . CONCLUSION Despite high comorbidity , African American women who completed a culturally responsive self-management program had improvements in asthma outcomes compared with the control group . Future work should address significant comorbidities and psychosocial issues alongside asthma management to improve asthma outcomes in the long term . TRIAL REGISTRATION clinical trials.gov Identifier NCT01117805 OBJECTIVE To assess the outcomes of an education intervention for childhood asthma conducted by Australian Indigenous health care workers ( IHCWs ) . DESIGN AND SETTING R and omised controlled trial in a primary health care setting on Thursday Isl and and Horn Isl and , and in Bamaga , Torres Strait region of northern Australia , April 2005 to March 2007 . PARTICIPANTS 88 children , aged 1 - 17 years , with asthma diagnosed by a respiratory physician ( intervention group , 35 ; control group , 53 ; 98 % Indigenous children ) . INTERVENTIONS Children were r and omly allocated to : ( i ) three additional asthma education sessions with a trained IHCW , or ( ii ) no additional asthma education . Both groups were re-assessed at 12 months . MAIN OUTCOME MEASURES Primary endpoint : number of unscheduled visits to hospital or a doctor caused by asthma exacerbation . SECONDARY OUTCOMES measures of quality of life ( QoL ) and functional severity index ; asthma knowledge and underst and ing of asthma action plans ( AAPs ) ; and school days missed because of wheezing . RESULTS The groups were comparable at baseline ( except for asthma severity , which was adjusted for in the analysis ) . There were no significant differences in the primary outcome ( number of unscheduled medical visits for asthma ) . School children in the intervention group missed fewer school days because of wheezing ( 100 % < 7 days v 21 % of those in the control group missed 7 - 14 days ) . Significantly more carers in the intervention group could answer questions about asthma medication , knew where their AAP was kept ( 84 % v 56 % ) , and were able to describe the plan ( 67 % v 40 % ) . In both the intervention and control groups ( before- and -after comparison ) , there was a significantly reduced frequency of asthma exacerbations , as well as an improved QoL score and functional severity index , with no significant differences between the groups . CONCLUSIONS A community-based asthma education program conducted by trained IHCWs improves some important asthma outcomes in Indigenous children with asthma . TRIAL REGISTRATION Australian Clinical Trials Registry ACTRN012605000718640 OBJECTIVE To determine the effectiveness of a home-based asthma education intervention in increasing appropriate nebulizer use and reducing symptom frequency , emergency department ( ED ) visits , and hospitalizations over 12 months . DESIGN A r and omized clinical trial . Setting s Pediatric primary care , pulmonary/allergy , and ED practice s associated with the University of Maryl and Medical System and The Johns Hopkins Hospital , Baltimore . PARTICIPANTS Children with persistent asthma , aged 2 to 9 years , with regular nebulizer use and an ED visit or hospitalization within the past 12 months . Children were r and omized into the intervention ( n = 110 ) or control ( n = 111 ) group . Follow-up data were available for 95 intervention and 86 control children . INTERVENTION Home-based asthma education , including symptom recognition , home treatment of acute symptoms , appropriate asthma medication , and nebulizer practice . MAIN OUTCOME MEASURES Estimates of mean differences in asthma symptom frequency , number of ED visits and hospitalizations and appropriate quick relief , controller medication , and nebulizer practice over 12 months . RESULTS Of the 221 children , 181 ( 81.9 % ) completed the study . There were no
Output:
| The available evidence showed that culture-specific education programmes for adults and children from minority groups are likely effective in improving asthma-related outcomes .
Not all asthma-related outcomes improved with culture-specific programs for both adults and children .
Nevertheless , while modified culture-specific education programs are usually more time intensive , the findings of this review suggest using culture-specific asthma education programmes for children and adults from minority groups . |
MS210634 | ***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: Developing an evidence base for making public health decisions will require using data from evaluation studies with r and omized and nonr and omized design s. Assessing individual studies and using studies in quantitative research syntheses require transparent reporting of the study , with sufficient detail and clarity to readily see differences and similarities among studies in the same area . The Consoli date d St and ards of Reporting Trials ( CONSORT ) statement provides guidelines for transparent reporting of r and omized clinical trials . We present the initial version of the Transparent Reporting of Evaluations with Nonr and omized Design s ( TREND ) statement . These guidelines emphasize the reporting of theories used and descriptions of intervention and comparison conditions , research design , and methods of adjusting for possible biases in evaluation studies that use nonr and omized design The goal of evidence -based medicine is ultimately to improve patient outcomes and quality of care . Systematic review s of the available published evidence are required to identify interventions that lead to improvements in behavior , health , and well-being . Authoritative literature review s depend on the quality of published research and research reports . The Consoli date d St and ards for Reporting Trials ( CONSORT ) Statement ( www.consort-statement.org ) was developed to improve the design and reporting of interventions involving r and omized clinical trials ( RCTs ) in medical journals . We describe the 22 CONSORT guidelines and explain their application to behavioral medicine research and to evidence -based practice . Additional behavioral medicine-specific guidelines ( e.g. , treatment adherence ) are also presented . Use of these guidelines by clinicians , educators , policymakers , and research ers who design , report , and evaluate or review RCTs will strengthen the research itself and accelerate efforts to apply behavioral medicine research to improve the processes and outcomes of behavioral medicine practice Allergic occupational asthma is frequent in farming population s. As educational interventions can improve disease management , the short-term effect of an educational intervention in asthmatic farmers was evaluated on the basis of spirometric indices and exhaled nitric oxide fraction ( FeNO ) . Farmers with occupational asthma ( n = 81 ) , mostly sensitised against cow d and er and storage mites , participated in a 1-day educational programme . Outcome measures were assessed at baseline and after 4–6 weeks , using FeNO , lung function and a question naire . Results were compared with those of a control group without intervention ( n = 24 ) . In the educational group , the proportion of subjects reporting work-related symptoms was reduced after the intervention . The FeNO decreased from a geometric mean of 28.2 to 25.7 ppb , and , in subjects with an elevated ( > 35 ppb ) baseline FeNO ( n = 32 ) , from 59.7 to 49.2 ppb . The corresponding changes in the control group were 25.6 versus 27.7 ppb and 49.5 versus 48.1 ppb . Spirometric results were unaltered in the two groups . Thus exhaled nitric oxide fraction , a marker of allergic airway inflammation , indicated a beneficial effect of a short-term educational intervention in farmers with occupational asthma . This suggests a potential for exhaled nitric oxide fraction in assessing the efficacy of preventive measures within a short time with higher sensitivity than spirometry BACKGROUND In response to the multiple health risks that farm pesticide applicators experience and the need for controlled trials to evaluate prevention programs , this study tested the effects of a small-group educational intervention design ed to increase personal protective equipment ( PPE ) use and to reduce direct pesticide exposure . DESIGN A r and omized controlled design was used with r and om selection of participants , r and om assignment to intervention and control groups , and baseline and postintervention assessment s. SETTING / PARTICIPANTS Four hundred Wisconsin dairy farmers certified to apply pesticides to field crops were recruited to participate over a 1-year evaluation period . INTERVENTION Three-hour educational sessions were conducted with approximately 100 r and omly assigned participants . Sessions targeted four educational messages : ( 1 ) existing evidence of excess cancers among farmers , ( 2 ) simulation of pesticide exposure presented through slide show and description , ( 3 ) feedback of self-reported data collected from the farmers reporting on frequency of exposure and gear use , and ( 4 ) cognitive behavioral strategies that can be adopted to reduce pesticide hazards . MAIN OUTCOME MEASURES A change in use of required protective equipment use during application and self-reported dermal exposure were evaluated in the control and intervention groups postintervention . RESULTS Six-month postintervention analyses showed that an educational intervention had significant effects on the use of gloves and gear during the most recent application and an actual reduction in the total number of pesticides used . However , the intervention did not have a significant impact on achieving full PPE compliance nor in reducing the amount of self-reported dermal pesticide exposure during the most recent application reported by applicators . CONCLUSIONS ; This one-time educational intervention successfully increased protective equipment use . However , more-intensive programs are needed to achieve greater reductions in personal pesticide exposure The present study was design ed as an intervention study to investigate whether an educational programme was efficient in preventing work‐related skin problems on the h and s. 107 student auxiliary nurses ( 61 in the intervention group and 46 in the control group ) were followed during the first 10 weeks of their initial practical training in county hospitals . The intervention group was given an educational programme before the practical training started . For evaluation the participants had question naires , clinical examination of the h and s , measurement of transepidermal water loss ( TEWL ) and patch testing . The use of h and disinfectants , which was discouraged in the educational programme , was significantly lower in the intervention group as compared to the control group ( p=0.002 ) . 48 % of the intervention group and 58 % of the control group had aggravation of skin problems during practical training ( p>0.05 ) . Use of h and disinfectant agents was significantly associated with aggravation of skin problems ( p=0.016 ) . A significant increase in TEWL for the control group ( p<0.005 ) , but not for the intervention group , was seen after 10 weeks of practical training . In conclusion , the present intervention study shows promising results from the use of an educational programme In food occupations , like in many other skin risk occupations , the regular use of personal protection equipment , i.e. of skin protection ointments and protective gloves , is recommended as well as regular skin care for the prevention of occupational h and dermatitis . We investigated the uptake and maintenance of different prevention strategies ( instructions for skin protection and skin care , prevocational skin hardening with UV light ) in food occupations and their efficacy in the primary prevention of vocationally caused h and dermatitis . We could show that the acceptance and regular use of skin protection and care measures could be significantly increased by theoretical and practical instructions in food industry trainees . The highest acceptance was seen with skin protection ointment ( 100 % ) and skin care ( 90 % ) . Protective gloves ( 43.3 % ) were used to a lesser extent . The h and dermatitis point prevalence in the groups after 6 months was 13.3 % ( skin protection ) , 19.4 % ( UV hardening ) and 29.1 % ( controls ) . These clinical trends were supported by statistically significant differences in the basal TEWL values . Adequate skin protection and regular skin care seem to be promising for the prevention of occupationally caused h and dermatitis . The experimental approach using UV hardening prevocationally did not fulfil the expectations BACKGROUND New measures of exposure prevention ( EP ) activity were used to evaluate the effectiveness of a 16-month management-focused intervention addressing hazardous substance exposures in manufacturing work setting s. METHODS EP efforts were assessed using a rating scheme developed for this study . The rating scheme yields a set of measures of exposure potential and protection , which are combined into an overall EP summary rating . A r and omized , controlled design was used to assess intervention effectiveness . Fifteen large manufacturing worksites completed the 16-month intervention and follow-up assessment s. Analyses were conducted on the 107 production processes assessed at both baseline and final . RESULTS Patterns of improvement within the intervention condition were consistent with the intervention emphasis on upstream or source -focused intervention ; whereas patterns in controls were consistent with prevalent practice ( more downstream , worker-focused ) . A mixed model analysis of variance showed greater improvement in EP ratings in intervention versus controls , but the difference in improvement was moderate and statistically non-significant . CONCLUSIONS This study has demonstrated that EP efforts in the manufacturing sector can be systematic ally assessed across the full range of hazardous substances in use , and that such assessment s can serve both needs assessment and effectiveness evaluation functions . Findings suggest that more sustained or intense management-focused intervention would significantly improve EP activity in manufacturing setting
Output:
| We conclude that future interventions could enhance their effectiveness through improving design quality , reporting and basing their content upon evidence -based behavioural change approaches .
Using a comprehensive range of evidence -informed behaviour change ingredients should improve occupational health professional 's ability to reliably reduce occupational ill-health where exposure can not totally be design ed out of the workplace |
MS210635 | ***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: OBJECTIVE Cognitive behavioral therapy ( CBT ) is an empirically supported treatment for social phobia . However , not all individuals respond to treatment and many who show improvement do not maintain their gains over the long-term . Thus , alternative treatments are needed . METHOD The current study ( N = 87 ) was a 3-arm r and omized clinical trial comparing CBT , acceptance and commitment therapy ( ACT ) , and a wait-list control group ( WL ) in participants with a diagnosis of social phobia based on criteria of the Diagnostic and Statistical Manual of Mental Disorders ( 4th ed . ; American Psychiatric Association , 1994 ) . Participants completed 12 sessions of CBT or ACT or a 12-week waiting period . All participants completed assessment s at baseline and posttreatment , and participants assigned to CBT and ACT also completed assessment s 6 and 12 months following baseline . Assessment s consisted of self-report measures , a public-speaking task , and clinician ratings . RESULTS Multilevel modeling was used to examine between-group differences on outcomes measures . Both treatment groups outperformed WL , with no differences observed between CBT and ACT on self-report , independent clinician , or public-speaking outcomes . Lower self-reported psychological flexibility at baseline was associated with greater improvement by the 12-month follow-up in CBT compared with ACT . Self-reported fear of negative evaluation significantly moderated outcomes as well , with trends for both extremes to be associated with superior outcomes from CBT and inferior outcomes from ACT . Across treatment groups , higher perceived control and extraversion were associated with greater improvement , whereas comorbid depression was associated with poorer outcomes . CONCLUSIONS Implication s for clinical practice and future research are discussed Comm and hallucinations represent a special problem for the clinical management of psychosis . While compliance with both non-harmful and harmful comm and s can be problematic , sometimes in the extreme , active efforts to resist comm and s may also contribute to their malignancy . Previous research suggests Cognitive Behaviour Therapy ( CBT ) to be a useful treatment for reducing compliance with harmful comm and hallucinations . The purpose of this trial was to evaluate whether CBT augmented with acceptance-based strategies from Acceptance and Commitment Therapy could more broadly reduce the negative impact of comm and hallucinations . Forty-three participants with problematic comm and hallucinations were r and omized to receive 15 sessions of the intervention " TORCH " ( Treatment of Resistant Comm and Hallucinations ) or the control , Befriending , then followed up for 6 months . A sub- sample of 17 participants was r and omized to a waitlist control before being allocated to TORCH or Befriending . Participants engaged equally well with both treatments . Despite TORCH participants subjectively reporting greater improvement in comm and hallucinations compared to Befriending participants , the study found no significant group differences in primary and secondary outcome measures based on blinded assessment data . Within-group analyses and comparisons between the combined treatments and waitlist suggested , however , that both treatments were beneficial with a differential pattern of outcomes observed across the two conditions The development and well-being assessment ( DAWBA ) has been used in various epidemiological studies , whereas the clinical value of the instrument needs support from further studies . In particular , it is important to document how the use of the DAWBA influences clinical decision-making . The present study employed the DAWBA in a consecutive series of 270 new referrals to a large public child and adolescent psychiatric service in Zurich , Switzerl and . ICD-10 based diagnoses were obtained from clinicians for all patients and reliability of DAWBA expert raters was calculated . The DAWBA diagnoses were r and omly disclosed ( n = 144 ) or not disclosed ( n = 126 ) before clinical decision-making . The reliability of DAWBA expert diagnoses was very satisfactory and the agreement under the disclosed versus the non-disclosed condition amounted to 77 versus 68 % for internalizing disorders and to 63 versus 71 % for externalizing disorders . The increment in agreement due to disclosure of the DAWBA diagnosis was significant for internalizing disorders . Access to DAWBA information was more likely to prompt clinicians to add an extra diagnosis . Professional background and degree of clinical experience did not affect diagnostic agreement . Overall , diagnostic agreements between DAWBA expert diagnoses and clinical diagnoses were in the fair to moderate range and comparable to previous studies with other structured diagnostic interviews . The inclusion of the DAWBA into the clinical assessment process had an impact on diagnostic decision-making regarding internalizing disorders but not regarding externalizing disorders Objective The aim of this study was to compare 2 self-help-based interventions ; a coping-oriented approach , applied relaxation ( AR ) and an acceptance-oriented approach , acceptance and commitment therapy ( ACT ) , for persons with chronic pain . Method This study is a r and omized control trial ( N=90 ) with a mixed between-within participants design with repeated measures . Interventions in both conditions comprised an initial face-to-face session , a 7-week manual-based self-help intervention including weekly therapist telephone support and a concluding face-to-face session . Outcome measures included satisfaction with life , depression , anxiety , acceptance of chronic pain , level of function , and pain intensity . Effects were measured at preintervention and postintervention and at 6 and 12 months after the end of intervention . Results The results show that the ACT condition increased their level of acceptance significantly compared with the AR condition . There was also a marginally significant interaction effect regarding satisfaction with life in which the ACT condition had improved in comparison to the AR condition . Further , the ACT condition reported a higher level of function and decreased pain intensity compared with the AR condition . Both conditions improved significantly regarding depression and anxiety . Conclusions A manual-based self-help intervention with weekly therapist support in an ACT format adds value to the treatment repertoire for persons suffering with chronic pain OBJECTIVE We conducted a pilot r and omized trial of telephone-delivered acceptance and commitment therapy ( ACT ) versus cognitive behavioral therapy ( CBT ) for smoking cessation . METHOD Participants were 121 uninsured South Carolina State Quitline callers who were adult smokers ( at least 10 cigarettes/day ) and who wanted to quit within the next 30 days . Participants were r and omized to 5 sessions of either ACT or CBT telephone counseling and were offered 2 weeks of nicotine replacement therapy ( NRT ) . RESULTS ACT participants completed more calls than CBT participants ( M = 3.25 in ACT vs. 2.23 in CBT ; p = .001 ) . Regarding satisfaction , 100 % of ACT participants reported their treatment was useful for quitting smoking ( vs. 87 % for CBT ; p = .03 ) , and 97 % of ACT participants would recommend their treatment to a friend ( vs. 83 % for CBT ; p = .06 ) . On the primary outcome of intent-to-treat 30-day point prevalence abstinence at 6 months postr and omization , the quit rates were 31 % in ACT versus 22 % in CBT ( odds ratio [ OR ] = 1.5 , 95 % confidence interval [ CI ] = 0.7 - 3.4 ) . Among participants depressed at baseline ( n = 47 ) , the quit rates were 33 % in ACT versus 13 % in CBT ( OR = 1.2 , 95 % CI = 1.0 - 1.6 ) . Consistent with ACT 's theory , among participants scoring low on acceptance of cravings at baseline ( n = 57 ) , the quit rates were 37 % in ACT versus 10 % in CBT ( OR = 5.3 , 95 % CI = 1.3 - 22.0 ) . CONCLUSIONS ACT is feasible to deliver by phone , is highly acceptable to quitline callers , and shows highly promising quit rates compared with st and ard CBT quitline counseling . As results were limited by the pilot design ( e.g. , small sample ) , a full-scale efficacy trial is now needed Acceptance and Commitment Therapy ( ACT ) has a growing empirical base in the treatment of anxiety among adults and children with other concerns . This study reports on the main outcomes of a r and omized controlled trial of ACT and traditional cognitive behavioral therapy ( CBT ) in children with a Diagnostic and Statistical Manual of Mental Disorders ( 4th ed . ) anxiety disorder . Participants were 193 children from urban Sydney , Australia , who were block-r and omized to a 10-week group-based program of ACT or CBT or a 10-week waitlist control ( WLC ) . Completers included 157 children ( ACT = 54 , CBT = 57 , WLC = 46 ; M = 11 years , SD = 2.76 ; 78 % Caucasian , 58 % female ) . Pretreatment , posttreatment , and 3 months posttreatment assessment s included clinician/self/parent-reported measures of anxiety , quality of life ( QOL ; anxiety interference , psychosocial and physical health-related QOL ) , and acceptance/defusion outcomes . Completer and intention-to-treat analyses revealed that ACT and CBT were both superior to WLC across outcomes , reflecting statistically and clinical ly significant differences , with gains maintained at 3 months posttreatment . Both completer and intention-to-treat analyses found ACT and CBT to produce similar outcomes . There was some support for ACT having greater effect sizes for QOL outcomes but not for avoidance/fusion . Although this study does not suggest that ACT is equivalent to CBT or should be adopted in its place , it does provide evidence that ACT might be another empirically supported treatment option for anxious youth . Further research is needed to replicate these findings Background Obesity is a growing epidemic . Weight control interventions can achieve weight loss , but most is regained over time . Stigma and low quality of life are significant problems that are rarely targeted . Purpose A new model aim ed at reducing avoidant behavior and increasing psychological flexibility , has shown to be relevant in the treatment of other chronic health problems and is worth examining for improving the lives of obese persons . Methods Patients who had completed at least 6 months of a weight loss program ( N = 84 ) were r and omly assigned to receive a 1-day , mindfulness and acceptance-based workshop targeting obesity-related stigma and psychological distress or be placed on a waiting list . Results At a 3-month follow-up , workshop participants showed greater improvements in obesity-related stigma , quality of life , psychological distress , and body mass , as well as improvements in distress tolerance , and both general and weight-specific acceptance and psychological flexibility . Effects on distress , stigma , and quality of life were above and beyond the effects due to improved weight control . Mediational analyses indicated that changes in weight-specific acceptance coping and psychological flexibility mediated changes in outcomes . Conclusion Results provide preliminary support for the role of acceptance and mindfulness in improving the quality of life of obese individuals while simultaneously augmenting their weight control efforts BACKGROUND Depression is a highly prevalent disorder , causing a large burden of disease and substantial economic costs . Web-based self-help interventions seem promising in promoting mental health . AIMS To compare the efficacy of a guided web-based intervention based on acceptance and commitment therapy ( ACT ) with an active control ( expressive writing ) and a waiting-list control condition ( Netherl and s Trial Register NTR1296 ) . METHOD Adults with depressive symptoms from the general population were r and omised to ACT ( n = 82 ) , expressive writing ( n = 67 ) or waiting-list control ( n = 87 ) . The main outcome was reduction in depressive symptoms assessed with the Center for Epidemiological Studies - Depression scale . RESULTS Significant reductions in depressive symptoms were found following the ACT intervention , compared with the control group ( Cohen 's d = 0.56 ) and the expressive writing intervention ( d = 0.36 ) . The effects were sustained at 6-month and 12-month follow-up . CONCLUSIONS Acceptance and commitment therapy as a web-based public mental health intervention for adults with depressive symptoms can be effective and applicable Objective To assess the relationship between session-by-session mediators and treatment outcomes in traditional cognitive-behavioral therapy ( CBT ) and acceptance and commitment therapy ( ACT ) for social anxiety disorder . Method Session-by-session changes in negative cognitions ( a theorized mediator of CBT ) and experiential avoidance ( a theorized mediator of ACT ) were assessed in 50 adult out patients r and omized to CBT ( n = 25 ) or ACT ( n = 25 ) for DSM-IV social anxiety disorder . Results Multilevel modeling analyses revealed significant nonlinear decreases in the proposed mediators in both treatments , with ACT showing steeper decline than CBT at the beginning of treatment and CBT showing steeper decline than ACT at the end of treatment . Curvature ( or the nonlinear effect ) of experiential avoidance during treatment significantly mediated posttreatment social anxiety symptoms and anhedonic depression in ACT , but not in CBT , with steeper decline of the Acceptance and Action Question naire at the beginning of treatment predicting fewer symptoms in ACT only . Curvature of negative cognitions during both treatments predicted outcome , with steeper decline of negative cognitions at the beginning of treatment predicting lower posttreatment social anxiety and depressive symptoms . Conclusions Rate of change in negative cognitions at the beginning of treatment is an important predictor of change across both ACT and CBT , whereas rate of change in experiential avoidance at the beginning of treatment is a mechanism specific to ACT Existing strategies for coping with food cravings are of unknown efficacy and rely on principles that have been shown to have par
Output:
| Comparisons of Öst 's quality ratings with independent teams rating the same studies with the same scale suggest that Ost 's ratings were unreliable .
In all of these areas ( factual errors ; interpretive errors ; quality ratings ) mistakes and differences were not r and om : Ost 's data were dominantly more negative toward ACT . |
MS210636 | ***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: Three techniques for treatment of chronic venous incompetence on an out patients basis were compared in a r and omised study . One hundred thirty eight limbs ( 107 patients ) with superficial venous incompetence were r and omly treated with the dentist 's technique ( DT ) [ Group A , 44 limbs ] , compression sclerotherapy ( CS ) [ Group B , 45 limbs ] or the SAVAS ( section en Ambulatoire des Varices avec Sclérothérapie ) technique [ Group C , 49 limbs ] . Patients were evaluated and followed up ( every year for 4 years ) with ambulatory venous pressure ( AVP ) measurements and Quantum angiodynography ( colour duplex scanning ) . DT consisted in the section under local anesthesia of incompetent veins . CS was done injecting polidocanol 3 % with compression applied for 4 weeks . The SAVAS was done with a combination of DT and CS with section of the incompetent veins under local anesthesia and retro grade injection in the distal vein of polidocanol 3 % . With this type of injection only incompetent veins were perfused . After 4 years there was a significantly lower refilling time ( RT ) with AVP in the SAVAS group ( 21 sec ) . RT was 13 sec in group B and 16 in A. The number of significantly incompetent residual veins was in average 0.5 in the SAVAS group , significantly lower than in the other two groups . Also the average cost per treated limb was significantly lower in the SAVAS group ( 917 francs in comparison with 1100 in group A and 1211 in group B ) . In conclusion considering the four year follow up , the SAVAS technique is a more effective treatment of superficial venous incompetence , its hemodynamic value is superior to sclerotherapy alone and its costs are lower BACKGROUND Ultrasound-guided foam sclerotherapy and endovenous laser ablation are widely used alternatives to surgery for the treatment of varicose veins , but their comparative effectiveness and safety remain uncertain . METHODS In a r and omized trial involving 798 participants with primary varicose veins at 11 centers in the United Kingdom , we compared the outcomes of foam , laser , and surgical treatments . Primary outcomes at 6 months were disease-specific quality of life and generic quality of life , as measured on several scales . Secondary outcomes included complications and measures of clinical success . RESULTS After adjustment for baseline scores and other covariates , the mean disease-specific quality of life was slightly worse after treatment with foam than after surgery ( P=0.006 ) but was similar in the laser and surgery groups . There were no significant differences between the surgery group and the foam or the laser group in measures of generic quality of life . The frequency of procedural complications was similar in the foam group ( 6 % ) and the surgery group ( 7 % ) but was lower in the laser group ( 1 % ) than in the surgery group ( P<0.001 ) ; the frequency of serious adverse events ( approximately 3 % ) was similar among the groups . Measures of clinical success were similar among the groups , but successful ablation of the main trunks of the saphenous vein was less common in the foam group than in the surgery group ( P<0.001 ) . CONCLUSIONS Quality -of-life measures were generally similar among the study groups , with the exception of a slightly worse disease-specific quality of life in the foam group than in the surgery group . All treatments had similar clinical efficacy , but complications were less frequent after laser treatment and ablation rates were lower after foam treatment . ( Funded by the Health Technology Assessment Programme of the National Institute for Health Research ; Current Controlled Trials number , IS RCT N51995477 . ) Since thrombotic complications , such as superficial thrombophlebitis and subsequent skin pigmentation , are common after sclerotherapy , we conducted a study to evaluate whether combining sclerotherapy with ligation of varicose veins minimizes complications and what timing for sclerotherapy would be most beneficial-accompanying surgery or several weeks postsurgery . Surgical intervention and compression sclerotherapy were performed consecutively on 111 limbs ( group A ) , and sclerotherapy was performed 28 days after surgical intervention on 87 limbs ( group B ) . The volume of sclerosant used and the frequency of complications ( thrombus formation and pigmentation ) were analyzed . Plasma levels of thrombin-antithrombin III complex ( TAT ) and D-dimer ( DD ) , as markers for activation of coagulation , were compared . In group A , the total volume of sclerosant used in patients with complications was significantly higher than that in patients without complications . The frequency of thrombus formation and of pigmentation was significantly lower ( p < 0.01 ) in group B ( 10 % and 18 % , respectively ) than in group A ( 21 % and 37 % , respectively ) . The plasma levels of TAT 7 days after treatment were significantly lower in group B ( 3.4 + /- 1.2 mg/L ) than in group A ( 4.9 + /- 1.1 mg/L ) . Performing compression sclerotherapy 28 days after surgical intervention is effective for reducing complications and a good alternative for patients with an underlying hypercoagulable state Background Minimally invasive endothermal techniques , for example , radiofrequency ablation ( RFA ) , have revolutionized the treatment of insufficient truncal veins and are associated with an excellent outcome . The use of thermal energy requires the instillation of tumescent anesthesia around the vein . Mechanochemical endovenous ablation ( MOCA ™ ) combines mechanical endothelial damage , using a rotating wire , with simultaneous infusion of a liquid sclerosans . Tumescent anesthesia is not required as no heat is used . Prospect i ve studies using MOCA ™ in both great and small saphenous veins showed good anatomical and clinical results with fast postoperative recovery . Methods / Design The MESSI trial ( Mechanochemical Endovenous ablation versus radiofrequency ablation in the treatment of primary Small Saphenous vein Insufficiency ) is a multicenter r and omized controlled trial in which a total of 160 patients will be r and omized ( 1:1 ) to MOCA ™ or RFA . Consecutive patients with primary small saphenous vein incompetence , who meet the eligibility criteria , will be invited to participate in this trial . The primary endpoint is anatomic success , defined as occlusion of the treated veins objectified with duplex ultrasonography at 1 year follow-up . Secondary endpoints are post-procedural pain , initial technical success , clinical success , complications and the duration of the procedure . Initial technical success is defined as the ability to position the device adequately , treat the veins as planned and occlude the treated vein directly after the procedure has been proven by duplex ultrasonography . Clinical success is defined as an objective improvement of clinical outcome after treatment , measured with the Venous Clinical Severity Score ( VCSS ) . Power analyses are conducted for anatomical success and post-procedural pain . Both groups will be evaluated on an intention-to-treat principle . Discussion The hypothesis of the MESSI trial is that the anatomic success rate of MOCA ™ is not inferior to RFA . The second hypothesis is that post-procedural pain is significantly less after MOCA compared to RFA.Trial registration Trial registration : NTR4613 Date of trial registration : 28 May 2014 The study was planned to evaluate efficacy and costs of endovascular sclerotherapy ( ES ) in comparison with surgery and surgery associated with sclerotherapy in a prospect i ve ( 10-year follow-up ) , good- clinical - practice study . Patients with varicose veins and pure , superficial venous incompetence were included . Of the patients r and omized into the three groups 39 ( group A ) were treated with ES , 40 ( B ) with surgery + sclerotherapy , and 42 with surgery only ( C ) . Surgery consisted of ligation of the SFJ ( saphenofemoral junction ) and of incompetent veins detected with color duplex . Of the preselected 150 patients , 121 subjects entered the study ; 96 completed the 10-year follow-up ( mean age 52.6 ±6 years ; 51 men , 45 women ) . Dropouts were due to nonmedical problems . At 10 years no incompetence was observed in subjects treated with SPJ ligation ( B and C ) . In the ES group 18.8 % of the SFJs were patent and incompetent and in 43.8 % of limbs the distal ( below-knee ) venous system was still incompetent [ 16.1 % in the surgery + scle rotherapy group ( p < 0.05 ) and 36 % in the group treated with surgery only ( p < 0.05 vs B and 0.05 vs A ) ] . Color duplex of the long saphenous vein indicated atrophy or obstruc tion of a segment ( average 6.7 cm ) after SFJ ligation ( 4.2 cm after ES ) . The cost of ES was 68 % of surgery while the cost of surgery and sclerotherapy was 122 % of surgery only . Endovascular sclerotherapy is an effective , cheaper treatment option , but surgery after 10 years is superior OBJECTIVE To compare the long-term value of different forms of treatment for primary varicose veins with saphenous vein insufficiency . EXPERIMENTAL DESIGN A prospect i ve , partially r and omized study with 5-year follow-up . SETTING Ambulatory day-case care . PATIENTS AND INTERVENTIONS The study includes 211 patients ( 214 lower limbs ) , who received compression sclerotherapy ( CST ; n = 78 ) , radical operation ( OP ; n = 74 ) or CST combined with high tie under local anesthesia ( HT + CST ; n = 63 ) . MEASURES The patient 's subjective opinion , objective finding by the surgeon and functional ( foot-volumetric ) assessment were obtained just after treatment and 6 months , 1 , 3 and 5 years later . RESULTS Subjectively the result started to deteriorate in both the CST and HT + CST groups after one year . The patient satisfaction was greatest in the OP group throughout the study period . Objective ly the CST group cure rate fell markedly after 6 months and at 5 year follow-up the failure rate reached 51 % , while the OP group still had a high rate of cured ( 60 % ) and improved ( 35 % ) patients . The HT + CST treatment seemed to hold well for three years followed by increasing failure rate with only 16 % objective ly cured after 5 years . The foot-volumetric parameters expelled volume (= calf pump function ) and refilling flow ratio (= venous reflux ) increased 51 - 79 % respectively decreased 8 - 29 % post-treatment in all groups . After 5 years these parameters had returned to pre-treatment levels in the CST and HT + CST groups , while the OP group was still significantly improved . CONCLUSIONS Radical surgery is superior to compression sclerotherapy alone or in combination with high tie in the treatment of varicose veins with saphenous vein incompetence . The foot-volumetric assessment correlated well with and supported objective findings as a whole but could not replace the clinical examination of each individual patient BACKGROUND To compare polidocanol foam sclerotherapy with surgical treatment of patients with primary chronic venous insufficiency and active ulcer treated at a single vascular center . METHODS Fifty-eight limbs of 56 patients with active ulcers were prospect ively r and omized to undergo either surgical treatment or foam sclerotherapy . Patients completed the Aberdeen Varicose Veins Question naire ( AVVQ ) , the Venous Clinical Severity Score ( VCSS ) , and Venous Disability Score ( VDS ) . The follow-up was 502 ± 220 days . RESULTS The ulcer healed in 100 % and 91.3 % of patients treated with surgery or foam sclerotherapy , respectively ( P > 0.05 ) . There were no significant differences in AVVQ , VCSS , and VDS between the 2 groups after the procedures ( P = 0.45 , 0.58 , and 0.66 , respectively ; Mann-Whitney U test ) . Complications occurred in 14.2 % and 13.0 % in the surgical and foam sclerotherapy groups , respectively . CONCLUSIONS Surgical treatment and foam sclerotherapy achieved high rates of ulcer healing , without a statistically significant difference . Both treatments led to significant improvements in VCSS , VDS , AVVQ scores , demonstrating improvements in clinical outcomes and quality of life BACKGROUND The long-term results of a prospect i ve , r and omized controlled trial in patients with primary varicose veins are reported . METHODS Saphenofemoral ligation ( SFL ) was done in 73 patients ( 82 legs ) . In addition , 43 ( 23 women ; age , 47 ) underwent stripping and multiple phlebectomies under general anesthesia ( group S ) , and 39 ( 32 women ; age , 49 ) had concurrent sclerotherapy under local anesthesia ( group F ) . Assessment s included CEAP C status , Venous Clinical Severity Score ( VCSS ) , Venous Segmental Disease Score ( VSDS ) , Aberdeen Varicose Vein Question naire ( AVVQ ) , and 36-Item Short-Form ( SF-36 ) scores . RESULTS CEAP C was similar between groups ( C(2 - 6 ) ) . In group S , 40 % of legs required 25 additional foam sessions ( mean volume , 11 mL ) . In group F , 47.5 % of legs required
Output:
| Moderate- to low- quality evidence exists to suggest that recanalisation or persistence of reflux at six weeks and recurrence of reflux at one year are less frequent when EVLA is performed , compared with conventional surgery .
For the UGFS versus conventional surgery comparison , the quality of evidence is assessed to be low ; consequently , the effectiveness of UGFS compared with conventional surgery in the treatment of SSV varices is uncertain . |
MS210637 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
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Input: To analyze the clinical characteristics and prognostic factors in patients with glioma in an academic institute in China . From October 2004 to August 2010 , total 1,285 patients were diagnosed as glioma at the Glioma Center of Beijing Tiantan Hospital . Clinical and molecular pathology features and survival rates were analyzed . The median overall survival ( OS ) times were 78.1 , 37.6 and 14.4 months for low- grade glioma ( WHO grade II ) , anaplastic glioma ( WHO grade III ) and glioblastoma ( WHO grade IV ) , respectively . In patients with low- grade glioma , age , preoperative Karnofsky performance scale ( KPS ) , pathological type , radiotherapy , O6-methylguanine-DNA methyltransferase ( MGMT ) expression and Ki-67 expression , were significantly associated with OS in multivariate analyses ; and preoperative KPS and radiotherapy were significantly associated with progression-free survival ( PFS ) . For anaplastic gliomas , age , preoperative KPS , pathological type , extent of resection , radiotherapy , p53 expression and phosphatase and tensin homolog ( PTEN ) expression were associated with OS . For glioblastomas , age , preoperative KPS , pathology type , extent of resection , radiotherapy and chemotherapy were associated with OS ; and age , gender , preoperative KPS , extent of resection , radiotherapy and chemotherapy were associated with PFS . This is the largest survey for glioma management in China to date . We found significant differences in age , presenting symptoms and the expression of p53 , MGMT , PTEN , and Ki-67 among patients with different types of glioma . Age , preoperative KPS , tumor grade s , radiotherapy , chemotherapy and Ki-67 expression were significantly associated with clinical prognosis Background Vascular endothelial growth factor is well known for its angiogenesis potential . The study was performed to determine the possible pro-angiogenic role of magnetic nanoparticles coupled to VEGF in vitro and their capacity to cross an endothelial monolayer . This novel treatment technique for angiogenesis could be potentially useful for therapeutic purpose s using magnetic nanoparticles . Methods Magnetic nanoparticles ( MN ) were synthesized and were conjugated with the vascular endothelial growth factor . The particles were tested in vitro in a 2D to 3D culture system . MN was seeded in different positions in relation to an HUVEC spheroid to assess a preferential migration . To evaluate the MN capacity to cross the endothelial barrier , a confluent monolayer of HUVEC cells was seeded on top of a collagen gel . MN was placed in dissolution on the cell culture media , and the MN position was determined by confocal microscopy for 24 h. Results HUVEC spheroids were able to generate a preferential sprouting depending on the MN position . Meanwhile , there was r and om migration when the MN ’s were placed all over the collagen gel and no sprouting when no MN was added . The trans-endothelial migration capacity of the MN was observed after 20 h in culture in the absence of external stimuli . Conclusion Here we show in vitro angiogenesis following the distribution of the MN conjugated with growth factors . These nanoparticles could be controlled with a magnet to place them in the ischemic area of interest and speed up vascular recovery . Also , MN has potentials to cross endothelium , opening the doors to a possible intravascular and extravascular treatment BACKGROUND Patients with advanced squamous-cell non-small-cell lung cancer ( NSCLC ) who have disease progression during or after first-line chemotherapy have limited treatment options . This r and omized , open-label , international , phase 3 study evaluated the efficacy and safety of nivolumab , a fully human IgG4 programmed death 1 ( PD-1 ) immune-checkpoint-inhibitor antibody , as compared with docetaxel in this patient population . METHODS We r and omly assigned 272 patients to receive nivolumab , at a dose of 3 mg per kilogram of body weight every 2 weeks , or docetaxel , at a dose of 75 mg per square meter of body-surface area every 3 weeks . The primary end point was overall survival . RESULTS The median overall survival was 9.2 months ( 95 % confidence interval [ CI ] , 7.3 to 13.3 ) with nivolumab versus 6.0 months ( 95 % CI , 5.1 to 7.3 ) with docetaxel . The risk of death was 41 % lower with nivolumab than with docetaxel ( hazard ratio , 0.59 ; 95 % CI , 0.44 to 0.79 ; P<0.001 ) . At 1 year , the overall survival rate was 42 % ( 95 % CI , 34 to 50 ) with nivolumab versus 24 % ( 95 % CI , 17 to 31 ) with docetaxel . The response rate was 20 % with nivolumab versus 9 % with docetaxel ( P=0.008 ) . The median progression-free survival was 3.5 months with nivolumab versus 2.8 months with docetaxel ( hazard ratio for death or disease progression , 0.62 ; 95 % CI , 0.47 to 0.81 ; P<0.001 ) . The expression of the PD-1 lig and ( PD-L1 ) was neither prognostic nor predictive of benefit . Treatment-related adverse events of grade 3 or 4 were reported in 7 % of the patients in the nivolumab group as compared with 55 % of those in the docetaxel group . CONCLUSIONS Among patients with advanced , previously treated squamous-cell NSCLC , overall survival , response rate , and progression-free survival were significantly better with nivolumab than with docetaxel , regardless of PD-L1 expression level . ( Funded by Bristol-Myers Squibb ; CheckMate 017 Clinical Trials.gov number , NCT01642004 . ) BACKGROUND Nivolumab was associated with higher rates of objective response than chemotherapy in a phase 3 study involving patients with ipilimumab-refractory metastatic melanoma . The use of nivolumab in previously untreated patients with advanced melanoma has not been tested in a phase 3 controlled study . METHODS We r and omly assigned 418 previously untreated patients who had metastatic melanoma without a BRAF mutation to receive nivolumab ( at a dose of 3 mg per kilogram of body weight every 2 weeks and dacarbazine-matched placebo every 3 weeks ) or dacarbazine ( at a dose of 1000 mg per square meter of body-surface area every 3 weeks and nivolumab-matched placebo every 2 weeks ) . The primary end point was overall survival . RESULTS At 1 year , the overall rate of survival was 72.9 % ( 95 % confidence interval [ CI ] , 65.5 to 78.9 ) in the nivolumab group , as compared with 42.1 % ( 95 % CI , 33.0 to 50.9 ) in the dacarbazine group ( hazard ratio for death , 0.42 ; 99.79 % CI , 0.25 to 0.73 ; P<0.001 ) . The median progression-free survival was 5.1 months in the nivolumab group versus 2.2 months in the dacarbazine group ( hazard ratio for death or progression of disease , 0.43 ; 95 % CI , 0.34 to 0.56 ; P<0.001 ) . The objective response rate was 40.0 % ( 95 % CI , 33.3 to 47.0 ) in the nivolumab group versus 13.9 % ( 95 % CI , 9.5 to 19.4 ) in the dacarbazine group ( odds ratio , 4.06 ; P<0.001 ) . The survival benefit with nivolumab versus dacarbazine was observed across prespecified subgroups , including subgroups defined by status regarding the programmed death lig and 1 ( PD-L1 ) . Common adverse events associated with nivolumab included fatigue , pruritus , and nausea . Drug-related adverse events of grade 3 or 4 occurred in 11.7 % of the patients treated with nivolumab and 17.6 % of those treated with dacarbazine . CONCLUSIONS Nivolumab was associated with significant improvements in overall survival and progression-free survival , as compared with dacarbazine , among previously untreated patients who had metastatic melanoma without a BRAF mutation . ( Funded by Bristol-Myers Squibb ; CheckMate 066 Clinical Trials.gov number , NCT01721772 . ) Background This study evaluated the safety and immune responses to an autologous dendritic cell vaccine pulsed with class I peptides from tumor-associated antigens ( TAA ) expressed on gliomas and overexpressed in their cancer stem cell population ( ICT-107 ) . Methods TAA epitopes included HER2 , TRP-2 , gp100 , MAGE-1 , IL13Rα2 , and AIM -2 . HLA-A1- and /or HLA-A2-positive patients with glioblastoma ( GBM ) were eligible . Mononuclear cells from leukapheresis were differentiated into dendritic cells , pulsed with TAA peptides , and administered intradermally three times at two-week intervals . Results Twenty-one patients were enrolled with 17 newly diagnosed ( ND-GBM ) and three recurrent GBM patients and one brainstem glioma . Immune response data on 15 newly diagnosed patients showed 33 % responders . TAA expression by qRT-PCR from fresh-frozen tumor sample s showed all patient tumors expressed at least three TAA , with 75 % expressing all six . Correlations of increased PFS and OS with quantitative expression of MAGE1 and AIM -2 were observed , and a trend for longer survival was observed with gp100 and HER2 antigens . Target antigens gp100 , HER1 , and IL13Rα2 were downregulated in recurrent tumors from 4 HLA-A2 + patients . A decrease in or absence of CD133 expression was seen in five patients who underwent a second resection . At a median follow-up of 40.1 months , six of 16 ND-GBM patients showed no evidence of tumor recurrence . Median PFS in newly diagnosed patients was 16.9 months , and median OS was 38.4 months . Conclusions Expression of four ICT-107 targeted antigens in the pre-vaccine tumors correlated with prolonged overall survival and PFS in ND-GBM patients . The goal of targeting tumor antigens highly expressed on glioblastoma cancer stem cells is supported by the observation of decreased or absent CD133 expression in the recurrent areas of gadolinium-enhanced tumors Glioblastoma multiforme ( GBM ) is one of the most aggressive human brain malignancies . Even with optimal treatment , median survival is less than 6 months for patients with recurrent GBM . Immune-based therapies have the potential to improve patient outcome by supplementing st and ard treatment . Expression of human cytomegalovirus ( CMV ) antigens in GBM tissues provides the unique opportunity to target viral antigens for GBM therapy . Here , we report findings of a formal clinical assessment of safety and potential clinical efficacy of autologous CMV-specific T-cell therapy as a consolidative treatment for recurrent GBM . From a total of 19 patients with recurrent GBM , CMV-specific T cells were successfully exp and ed from 13 patients ( 68.4 % ) , 11 of whom received up to four T-cell infusions . Combination therapy based on T-cell infusion and chemotherapy was well tolerated , and we detected only minor adverse events . The overall survival of these patients since first recurrence ranged from 133 to 2,428 days , with a median overall survival of 403 days . Most importantly , 4 of 10 patients that completed the treatment remained progression free during the study period . Furthermore , molecular profiling of CMV-specific T-cell therapy from these patients revealed distinct gene expression signatures , which correlated with their clinical response . Our study suggests that a combination therapy with autologous CMV-specific T cells and chemotherapy is a safe novel treatment option and may offer clinical benefit for patients with recurrent GBM Background The growth and recurrence of several cancers appear to be driven by a population of cancer stem cells ( CSCs ) . Glioblastoma , the most common primary brain tumor , is invariably fatal , with a median survival of approximately 1 year . Although experimental data have suggested the importance of CSCs , few data exist regarding the potential relevance and importance of these cells in a clinical setting . Methods We here present the first seven patients treated with a dendritic cell (DC)-based vaccine targeting CSCs in a solid tumor . Brain tumor biopsies were dissociated into single-cell suspensions , and autologous CSCs were exp and ed in vitro as tumorspheres . From these , CSC-mRNA was amplified and transfected into monocyte-derived autologous DCs . The DCs were aliquoted to 9–18 vaccines containing 107 cells each . These vaccines were injected intradermally at specified intervals after the patients had received a st and ard 6-week course of post-operative radio-chemotherapy .
Output:
| The results revealed that the expression levels of HHLA2 were significantly lower in high‑ grade glioma , as well as glioma with wild‑type isocitrate dehydrogenase , no deletion of 1p/19q and telomerase reverse transcriptase promoter mutation .
Receiver operating characteristic analysis revealed that HHLA2 was a predictor of the neural subtype .
The tumor‑infiltrating immune cell model indicated that HHLA2 was negatively associated with tumor‑associated macrophages .
GO analysis and pathway enrichment analysis revealed that HHLA2‑associated genes were functionally involved in inhibition of neoplasia‑associated processes .
HHLA2 was significantly negatively correlated with certain genes , including interleukin‑10 , transforming growth factor‑β , vascular endothelial growth factor and δ‑like canonical Notch lig and 4 , and other immune checkpoint molecules , including programmed cell death 1 , lymphocyte activating 3 and CD276 .
Survival analysis indicated that high expression of HHLA2 predicted a favorable prognosis .
In conclusion , the present study revealed that upregulation of HHLA2 is significantly associated with a favorable outcome for patients with glioma .
Targeting HHLA2 as an immune stimulator may become a valuable approach for the treatment of glioma in clinical practice |
MS210638 | ***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 We explored the differential effect of cessation interventions ( behavioral support sessions with [ BSS+ ] and without [ BSS ] bupropion ) between hookah and cigarette smokers . METHODS We reanalyzed the data from a major cluster-r and omized controlled trial , ASSIST ( Action to Stop Smoking In Suspected Tuberculosis ) , which consisted of 3 conditions : ( a ) behavioral support sessions ( BSS ) , ( b ) behavioral support sessions plus 7 weeks of bupropion therapy ( BSS+ ) , and ( c ) controls receiving usual care . The trial originally recruited 1,955 adult smokers with suspected tuberculosis from 33 health centers in the Jhang and Sargodha districts of Pakistan between 2010 and 2011 . The primary endpoint was continuous 6-month smoking abstinence , which was determined by carbon monoxide levels . Subgroup-specific relative risks ( RRs ) of smoking abstinence were computed and tested for differential intervention effect using log binomial regression ( generalized linear model ) between 3 subgroups ( cigarette-only : 1,255 ; mixed : 485 ; and hookah-only : 215 ) . RESULTS The test result for homogeneity of intervention effects between the smoking forms was statistically significant ( p-value for BSS+ : .04 and for BSS : .02 ) . Compared to the control , both interventions appeared to be effective among hookah smokers ( RR = 2.5 ; 95 % CI = 1.3 - 4.7 and RR = 2.2 ; 95 % CI = 1.3 - 3.8 , respectively ) but less effective among cigarette smokers ( RR = 6.6 ; 95 % CI = 4.6 - 9.6 and RR = 5.8 ; 95 % CI = 4.0 - 8.5 ) , respectively . CONCLUSIONS The differential intervention effects on hookah and cigarette smokers were seen ( a ) because the behavioral support intervention was design ed primarily for cigarette smokers ; ( b ) because of differences in demographic characteristics , behavioral , and sociocultural determinants ; or ( c ) because of differences in nicotine dependency levels between the 2 groups INTRODUCTION Tobacco use in low- to middle-income countries is a major public health concern for both smokers and those exposed to environmental tobacco smoke ( ETS ) . Egypt has made important strides in controlling tobacco use , but smoking and ETS remain highly prevalent . This r and omized intervention sought to improve the target population 's knowledge regarding the hazards of smoking and ETS and to change attitudes and smoking behaviors within the community and the household . METHODS In this 2005 - 2006 study in Egypt 's Qalyubia governorate , trained professionals visited schools , households , mosques , and health care centers in rural villages r and omly selected for the intervention to discuss the adverse effects of smoking and ETS exposure and ways to reduce one 's ETS exposure . Data collected in interviewer-facilitated surveys before and after the intervention period were analyzed in pairwise comparisons with data from control villages to assess the effectiveness of the intervention in achieving its aims . RESULTS The intervention group showed a greater increase in underst and ing the dangers associated with smoking cigarettes and waterpipes and became more proactive in limiting ETS exposure by asking smokers to stop , avoiding areas with ETS , and enacting smoking bans in the home . However , the intervention had little to no impact on the number of smokers and the amount of tobacco smoked . CONCLUSIONS Results are consistent with previous studies showing that changing smokers ' behavior can be difficult , but community-wide efforts to reduce ETS exposure through smoking bans , education , and empowering people to ask smokers to stop are effective . The method can be generalized to other setting A nonr and om sampIe of 2972 Kuwaitis answered a question naire about smoking behaviour and beliefs . More than one-third ( 35 % ) were nonsmokers , 45 % smoked only the waterpipe , 12 % only cigarettes and 8 % both waterpipe and cigarettes . Compared with cigarette smokers , waterpipe smokers were more likely to be female and to be unskilled manual workers than professionals or students . Waterpipe smokers started the habit at an older age on average than cigarette smokers . Most waterpipe smokers smoked only 1 bowl per day , and smoked mostly at coffee houses . Factor analysis of beliefs about waterpipe smoking result ed in 4 groups of beliefs which explained 50 % of the variance . The results are discussed in terms of public health policy and possible risk reduction strategies Cigarette smoking was measured in a naive tenth grade population under conditions expected to influence the student 's willingness to admit smoking . All students were tested for smoking both by question naire and by expired-air carbon monoxide assessment . The carbon monoxide data were used to test the equivalence of the study groups and to partition the sample into smokers and nonsmokers . Of the smokers those who were advised in advance of the biological test were twice as likely to admit cigarette use in the past week compared to those who were advised of the testing procedure only after they had completed their question naire . A live explanation and demonstration of the biological testing procedure proved as effective as a videotaped message . These data support earlier reports of the ' bogus pipeline ' effect . Several method ological issues are discussed which may explain previous failures to replicate this finding BACKGROUND Tobacco use is responsible for a large proportion of the total disease burden from tuberculosis . Pakistan is one of the 10 high-burden countries for both tuberculosis and tobacco use . OBJECTIVE To assess the effectiveness of a behavioral support intervention and bupropion in achieving 6-month continuous abstinence in adult smokers with suspected pulmonary tuberculosis . DESIGN Cluster r and omized , controlled trial . ( Current Controlled Trials : IS RCT N08829879 ) SETTING Health centers in the Jhang and Sargodha districts in Pakistan . PATIENTS 1955 adult smokers with suspected tuberculosis . INTERVENTION Health centers were r and omly assigned to provide 2 brief behavioral support sessions ( BSS ) , BSS plus 7 weeks of bupropion therapy ( BSS+ ) , or usual care . MEASUREMENTS The primary end point was continuous abstinence at 6 months after the quit date and was determined by carbon monoxide levels in patients . Secondary end points were point abstinence at 1 and 6 months . RESULTS Both treatments led to statistically significant relative risks ( RRs ) for abstinence compared with usual care ( RR for BSS+ , 8.2 [ 95 % CI , 3.7 to 18.2 ] ; RR for BSS , 7.4 [ CI , 3.4 to 16.4 ] ) . Equivalence between the treatments could not be established . In the BSS+ group , 275 of 606 patients ( 45.4 % [ CI , 41.4 % to 49.4 % ] ) achieved continuous abstinence compared with 254 of 620 ( 41.0 % [ CI , 37.1 % to 45.0 % ] ) in the BSS group and 52 of 615 ( 8.5 % [ CI , 6.4 % to 10.9 % ] ) in the usual care group . There was substantial heterogeneity of program effects across clusters . LIMITATIONS Imbalances in the urban and rural proportions and smoking habits among treatment groups , and inability to confirm adherence to bupropion treatment and vali date longer-term abstinence or the effect of smoking cessation on tuberculosis outcomes . CONCLUSION Behavioral support alone or in combination with bupropion is effective in promoting cessation in smokers with suspected tuberculosis . PRIMARY FUNDING SOURCE International Development Research Centre BACKGROUND Waterpipe use has increased dramatically in the Middle East and other parts of the world . Many users exhibit signs of dependence , including withdrawal and difficulty quitting , but there is no evidence base to guide cessation efforts . METHODS We developed a behavioral cessation program for willing-to-quit waterpipe users , and evaluated its feasibility and efficacy in a pilot , two arm , parallel group , r and omized , open label trial in Aleppo , Syria . Fifty adults who smoked waterpipe ≥3 times per week in the last year , did not smoke cigarettes , and were interested in quitting were r and omized to receive either brief ( 1 in-person session and 3 phone calls ) or intensive ( 3 in-person sessions and 5 phone calls ) behavioral cessation treatment delivered by a trained physician in a clinical setting . The primary efficacy end point of the developed interventions was prolonged abstinence at three months post-quit day , assessed by self-report and exhaled carbon monoxide levels of < 10 ppm . Secondary end points were 7 day point-prevalent abstinence and adherence to treatment . RESULTS Thirty percent of participants were fully adherent to treatment , which did not vary by treatment group . The proportions of participants in the brief and intensive interventions with prolonged abstinence at the 3-month assessment were 30.4 % and 44.4 % , respectively . Previous success in quitting ( OR=3.57 ; 95 % CI=1.03 - 12.43 ) predicted cessation . Higher baseline readiness to quit , more confidence in quitting , and being unemployed predicted a better adherence to treatment ( all p-values < 0.05 ) . CONCLUSIONS Brief behavioral cessation treatment for waterpipe users appears to be feasible and effective INTRODUCTION There is a rising prevalence of waterpipe smoking worldwide , but still a paucity of information on perceptions toward quitting waterpipe use . We set out to establish the beliefs and perceptions of café waterpipe smokers toward quitting waterpipe smoking in the Kingdom of Bahrain . METHODS A cross-sectional study . A r and om sample of 20 of 91 cafés serving waterpipe tobacco in Bahrain was taken . A question naire was administered in each café to 20 participants aged 18 and above . RESULTS Three hundred eighty participants completed question naires from waterpipe smokers . Eighty-four percent of participants were Bahraini and 71 % had a university degree . Mean age was 28.9 years . Average age of waterpipe smoking initiation was 20.3 years . The majority of waterpipe users chose flavored tobacco . Sixty-one percent smoked waterpipe tobacco daily with a mean smoking time of 2.6hr/day . Seventy-two percent considered waterpipe tobacco as harmful as or more harmful than cigarettes , but 67 % considered cigarettes as more addictive . Eighty-two percent stated that they could quit waterpipe at any time , but only 40 % were interested in quitting . Interest in quitting smoking was related to 4 variables : a physician mentioning the need to quit smoking , being non-Bahraini , having a family with a hostile attitude toward waterpipe smoking , and not considering oneself " hooked " on waterpipe tobacco . CONCLUSIONS Waterpipe smokers in Bahrain cafés are frequent and high users . Health professionals must consider waterpipe smoking in all consultations and health promotion messages . A partnership between health professionals and disapproving members of families may be an effective strategy in encouraging waterpipe smokers to quit A pilot study of narghile water-pipe smokers in a cafe in the Hamra neighborhood of Beirut , Lebanon , was conducted to develop a preliminary model of narghile water-pipe smoking behavior for use in laboratory smoking machine studies . The model is based on data gathered from smoking sessions of 30 min or longer duration from 52 smoker volunteers using a differential pressure puff topography instrument , as well as anonymous visual observations of 56 smokers in the same cafe . Results showed that the " average " water-pipe cafe smoking session consists of one hundred seventy-one 530-ml puffs of 2.6-s duration at a frequency of 2.8 puffs/min . The implication s of this comparatively high-intensity puffing regimen on the production of toxic smoke constituents are discussed OBJECTIVES To determine the prevalence and predictors of smoking nargileh and /or cigarettes among school students in Greater Beirut , Lebanon . METHODS A proportionate r and om sample of 2443 students from 13 public and private schools was selected and asked to complete self-administered anonymous question naires . RESULTS The prevalence of smoking cigarettes only , nargileh only , and both was 2.5 % , 25.6 % , and 6.3 % , respectively . Stepwise regression analyses revealed that the predictors of smoking for either type are different , whereby nargileh smoking is more culturally accepted than cigarette smoking . CONCLUSIONS Design interventions to increase awareness towards the hazards of the misconceived harmless effects of nargileh smoking UNLABELLED The aim of this study is to analyse the acute effect of water-pipe smoking on heart rate , blood pressure and the baroreflex control of heart rate . SUBJECTS AND METHODS Non-invasive continuous methods were used for investigating inter-beat interval ( IBI ; ms ) , systolic blood pressure ( SBP ; mm Hg ) , diastolic blood pressure ( DBP ; mm Hg ) , pulse pressure ( PP ; mm Hg ) , mean blood pressure ( MBP ; mm Hg ) ; baroreflex sensitivity in ms/mm Hg ( BRS ) and baroreflex sensitivity in Hz/mm Hg ( BRSf ) , were determined by spectral analysis , in 20 normotensive volunteers age of 27+/-6 years ( mean+/-S.D. ) who served as their own control . The measurements
Output:
| Although the literature on waterpipe cessation interventions remains sparse , the review ed studies provide a basis for developing interventions in this area . |
MS210639 | ***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 This study was conducted to determine the criteria for unresectability of major peripancreatic vessels in patients with pancreatic carcinoma as revealed by optimally enhanced , pancreatic-phase thin-section helical CT . SUBJECTS AND METHODS Twenty-five patients with pancreatic adenocarcinoma who underwent local dissection during curative or palliative surgery also underwent preoperative pancreatic-phase thin-section helical CT ( 40- to 70-sec delay , 2.5- to 3-mm collimation ) . Tumor involvement of the portal and superior mesenteric veins and the celiac , hepatic , and superior mesenteric arteries was prospect ively grade d on a 0 - 4 scale based on circumferential contiguity of tumor to vessel . Subsequent surgical results were then correlated with the CT grade s. RESULTS At surgery , definitive evaluation was possible for 80 vessels . Forty-eight of 48 vessels grade d 0 and three of three vessels grade d 1 were resectable . Four of seven vessels grade d 2 , seven of eight vessels grade d 3 , and 14 of 14 vessels grade d 4 were unresectable . A threshold of between grade s 2 and 3 , which corresponded to tumor involvement of one-half circumference of the vessel , yielded the lowest number of false-negatives and an acceptable number of false-positives for unresectability . Such a threshold would have yielded a sensitivity of 84 % , a specificity of 98 % , a positive predictive value of 95 % , and a negative predictive value of 93 % for unresectability of the vessels studied . CONCLUSION A grading system for tumor involvement of the major vessels in patients with pancreatic adenocarcinoma can be based on the degree of circumferential contiguity of tumor to vessel . Involvement of vessel to tumor that exceeds one-half circumference of the vessel is highly specific for unresectable tumor BACKGROUND Complex , highly variable , anatomic relationships in the portal hilum complicate the surgical management at hilar cholangiocarcinoma . Preoperative three-dimensional ( 3D ) imaging to stage the tumor and define anatomy may help in planning for curative resection . METHODS Between 2003 and 2006 , 20 consecutive patients with hilar cholangiocarcinoma underwent preoperative multidetector row computed tomography ( MDCT ) cholangiography ; 3D images of the portal vein , hepatic artery , and bile ducts were created and viewed simultaneously . Longitudinal tumor extension was evaluated by direct cholangiography and 3D cholangiography , and contiguous spread by 2D computed tomography ( CT ) . Of 20 patients , 15 underwent surgical resection . Liver resection was planned based on 3D imaging that allowed visualization of the relationship between the tumor and the umbilical portion of the left portal vein , or the bifurcation of the anterior and posterior branch of the right portal vein . Preoperative and operative findings were compared . RESULTS All patients tolerated 3D CT without serious complication . The accuracy rates of longitudinal tumor extension , using the Bismuth-Corlette classification system , were 85 % ( 11/13 ) and 87 % ( 13/15 ) with direct cholangiography and 3D cholangiography , respectively . The sensitivity , specificity , and accuracy rates were 100 % , 80 % , and 87 % for portal invasion and 75 % , 91 % , and 87 % for hepatic arterial invasion . The number of bile duct orifices in the cut end of the hilar plate was estimated correctly in 13 of 15 patients . There were no operative deaths . Potentially curative resection was achieved in 14 of 15 patients . CONCLUSIONS 3D images provide accurate information about the relationship between hilar cholangiocarcinoma and adjacent vessels . This technique is a powerful new tool for improving the proportion of potentially curative resection The pre-operative radiological assessment of proximal bile duct tumours is clinical ly important as resection may be limited by tumour extension along the bile ducts , into hepatic parenchyma or the adjacent vascular structures . Demonstration of the extent of biliary and vascular involvement can direct additional investigations and definitive treatment . 22 patients with hilar cholangiocarcinoma were studied pre-operatively by conventional ultrasound ( US ) and duplex sonography ( DS ) . The extent of tumour infiltration and vascular involvement was compared with arteriography and operative findings . Bile duct dilatation and the level of obstruction was documented by US in 22 ( 100 % ) , and the tumour was shown by US in 19 ( 86 % ) . In these 19 patients , the extent of extraductal extension compared with operative findings was correct in 13 , underestimated in two , and in four infiltration was massed . Vascular patency or involvement was correctly determined by DS in 19 ( 86 % ) , and by arteriography in 18 ( 82 % ) . In two of the three incorrect DS interpretations , lobar atrophy and contralateral hypertrophy distorted the hilar anatomy . US with DS is valuable in the pre-operative staging of proximal bile duct tumours in predicting ductal and vascular involvement BACKGROUND / AIMS To evaluate prospect ively the preoperative use of 16-multidetector computed tomography ( MDCT ) with cholangiography and angiography in determining the resectability of hilar cholangiocarcinoma . METHODOLOGY From January 2002 to January 2008 , 75 consecutive patients with hilar cholangiocarcinoma underwent preoperative MDCT with cholangiography and angiography . 3D images of the portal vein , hepatic artery , and bile ducts were created and viewed simultaneously . The accuracy of MDCT with cholangiography and angiography was determined by comparison with intraoperative and pathologic findings . RESULTS All patients tolerated the CT imaging well and without serious complication . The sensitivity , specificity , and accuracy rates were 92.9 % , 100 % , and 96 % for portal vein invasion and 83.3 % , 100 % , and 93.3 % for hepatic arterial invasion . The accuracy rate of longitudinal tumor extension , using the modified Bismuth-Corlette classification , was 96 % . The sensitivity , specificity , and accuracy of prediction of resectability were 95.7 % , 82.1 % , and 90.7 % , respectively . CONCLUSIONS Preoperative MDCT with cholangiography and angiography gave a good assessment of the degree of biliary and vascular involvement of hilar cholangiocarcinoma . It also accurately predicted resectability BACKGROUND The purpose of the current study was to evaluate the accuracy of (18)F-FDG PET/CT in staging hilar cholangiocarcinoma . MATERIAL S AND METHODS From June 2004 to December 2007 , patients evaluated for surgical treatment of hilar cholangiocarcinoma were entered into a prospect i ve data base . Dual modality (18)F-FDG PET/CT was performed before surgery . The report was review ed with comparison to the operative and pathological results in each case for tumour-node-metastasis staging . RESULTS Seventeen patients ( 6 women , 11 men ) of a median age of 62 years were included in the study . Radical tumour resection was performed on seven patients . Ten patients underwent surgical exploration . The sensitivity of PET/CT in detecting primary tumour was found to be 58.8 % ( 25 % in T2 tumour , 70 % in T3 tumour , 66.7 % in T4 tumour ) . The sensitivity/specificity of PET/CT in detecting lymph node metastasis and distant metastasis were 41.7%/80 % and 55.6%/87.5 % , respectively . Positive (18)F-FDG uptake in the bile duct was found to be associated with surgical non-resectability ( P = 0.05 ) . CONCLUSION Dual-modality PET/CT imaging was found to have a high specificity in detection of lymph node and distant metastasis in hilar cholangiocarcinoma , with a limited value in correct judgement of surgical resectability for tumours in stadium UICC I-III
Output:
| Data primarily concern CT , which has an acceptable accuracy for assessment of ductal extent , portal vein and hepatic artery involvement , but low sensitivity for nodal status |
MS210640 | ***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 fatigue induced by marathon races was observed in terms of inflammatory and immunological outcomes . Neutrophil survival and activation are essential for inflammation resolution and contributes directly to the pathogenesis of many infectious and inflammatory conditions . The aim of this study was to investigate the effect of marathon races on surface molecules related to neutrophil adhesion and extrinsic apoptosis pathway and its association with inflammatory markers . We evaluated 23 trained male runners at the São Paulo International Marathon 2013 . The following components were measured : hematological and inflammatory mediators , muscle damage markers , and neutrophil function . The marathon race induced an increased leukocyte and neutrophil counts ; creatine kinase ( CK ) , lactate dehydrogenase ( LDH ) , CK-MB , interleukin (IL)-6 , IL-10 , and IL-8 levels . C-reactive protein ( CRP ) , IL-12 , and tumor necrosis factor (TNF)-α plasma concentrations were significantly higher 24 h and 72 h after the marathon race . Hemoglobin and hematocrit levels decreased 72 h after the marathon race . We also observed an increased intercellular adhesion molecule-1 ( ICAM-1 ) expression and decreasedTNF receptor-1 ( TNFR1 ) expression immediately after and 24 h after the marathon race . We observed an increased DNA fragmentation and L-selectin and Fas receptor expressions in the recovery period , indicating a possible slow rolling phase and delayed neutrophil activation and apoptosis . Marathon racing affects neutrophils adhesion and survival in the course of inflammation , supporting the “ open-window ” post-exercise hypothesis The aim of this study was to investigate the effect of two different tapering period lengths on the concentration of plasma interleukin- 6 ( IL-6 ) , interleukin ( IL-1β ) and tumor necrosis factor-α ( TNF-α ) and performance in elite male cyclists . To this end , after completing 8 weeks progressive endurance exercise , twenty four high-level endurance cyclists were r and omly assigned to one of two groups : a control group of cyclists ( n = 12 ) continued performing progressive weekly training volume for 3 weeks while a taper group of cyclists ( n = 12 ) proceeded with a 50 % reduction in weekly training volume relative to the control group . A simulated 40 min time trial ( 40TT ) performance ride was used as the criterion index of performance before and after the tapering period to evaluate the physiological and performance effects of each protocol . Blood sample s were collected immediately post-40TT from all participants at the beginning of week 1 , and the end of weeks 4 , 8 , 9 and 11 . IL-1β , IL-6 and TNFα were assayed using a st and ard commercial ELISA kits ( Quantikine ; R & D Systems , Minneapolis , MN ) . The mean time to complete the 40TT in the taper group decreased significantly ( p < 0.01 ) after both 1 and 3 weeks with reduced training volume relative to the control group . There were significant reductions in ( p < 0.001 ) IL-1β , IL-6 and TNFα concentrations in the taper group relative to the control group at the end of the 3 week tapering period , but not at the end of the 1 week tapering period . These results demonstrate that both a 1 and a 3 week taper period will result in improved physical performance in trained cyclists but only a 3 week taper period will result in attenuation of post-exercise pro- inflammatory cytokines when compared to those continuing a more intense training regimen . Key pointsThe excessive endurance exercise-induced elevations in pro-inflammatory cytokines would , in turn , stimulate the release of anti-inflammatory cytokines . Elevations in pro-inflammatory cytokines indicate athletes are highly susceptible to infections.1 and 3-week taper periods will reduce circulating pro-inflammatory cytokine levels thereby possibly limiting the chances of infection and potentially reducing the effects of these cytokines in inducing fatigue-like symptoms in athletes 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 Abstract To study the effects of exercise on circulating leukocytes and leukocyte subsets , physically active ( n = 32 ) and sedentary ( n = 32 ) male and female subjects were r and omly assigned to an exercise or control condition . Exercise involved a continuous incremental protocol consisting of cycling for three periods of 6 min at power outputs corresponding to 55 % , 70 % and 85 % maximal oxygen uptake ( $ $ \dot V{\text{O}}_{{\text{2max}}}$$ . Blood sample s were drawn from a venous catheter at baseline , and at 6 min , 12 min , and 18 min after beginning the exercise and 2 h following completion of exercise . Resting- and exercise-induced alterations in total leukocytes were independent of gender and subject fitness level . Relative to baseline , each increment in workload result ed in a rapid increase in the number of circulating leukocytes . Increases in neutrophils , lymphocytes and monocytes accounted for the exercise-induced leukocytosis . With regard to lymphocytes , exercise result ed in a significant increase in the number of T cells ( CD3 + ) , T helper cells ( CD4 + ) , T suppresser ( CD8 + ) and natural killer ( NK ) cells ( CD3−/CD16+/CD56 + ) . The largest percentage increase occurred in the NK cell population . The CD4 + : CD8 + ratio decreased ( P < 0.001 ) throughout exercise due to a larger increase in the number of CD8 + cells relative to CD4 + cells . An exercise-induced neutrophilia , lymphocytopenia , and eosinophelia was observed 2 h into recovery . Exercise result ed in significant increases in plasma epinephrine and norepinephrine levels . There was no indication of a hypothalamic-pituitarty-adrenal response during exercise . The results indicate that the rapid , albeit transient , alteration in the number of circulating leukocytes during and following an acute progressive incremental exercise test are independent of gender and fitness This study determined the influence of gender , menstrual phase ( MP ) , and oral contraceptive ( OC ) use on immunological changes in response to endurance exercise . Twelve women and 11 men similar in age , aerobic power , and activity level cycled for 90 min at 65 % maximal aerobic power . Women were OC users ( n = 6 ) or nonusers ( NOC ) and cycled during the follicular ( Fol ) and the luteal ( Lut ) phases . Venous blood was collected before and after exercise to determine leukocyte counts , IL-6 concentrations , and cortisol . Higher resting levels of neutrophils ( approximately 1.5-fold ) and cortisol ( approximately 2.5-fold ) were found in OC vs. NOC and men . Exercise-induced immune cell count and IL-6 changes were similar between men and NOC , except for an approximately 38 % greater lymphocyte response in NOC vs. men ( P = 0.07 ) . Neutrophil , monocyte , and lymphocyte responses to exercise during Lut in OC were greater than during Fol and also greater than the responses in men ( P < or = 0.003 ) . Changes in immune cell counts were consistently greater during Lut in OC vs. NOC , regardless of MP , but only neutrophil responses reached statistical significance ( P = 0.01 ) . The exercise-induced change in IL-6 was approximately 80 % greater in NOC vs. OC during Fol ( P = 0.06 ) , but it was similar between these groups during Lut . Cortisol changes with exercise were not different between groups or MP . These results highlight the necessity to control for gender , and in particular OC use , when design ing studies evaluating exercise and immunology Cell-cell and cell-matrix contacts are dependent on cell surface density , localization , and avidity state of adhesion molecules . These adhesion molecules are involved in all steps of the leukocyte 's adhesion process . Selectins , molecules of the immunoglobulin superfamily , and integrins are necessary for an initial tethering , triggering , firm attachment , and transendothelial migration of leukocytes . Hormones , cytokines , other pro-inflammatory agents , and shedded receptors like the LPS-receptor significantly alter the adhesion process . Infectious and noninfectious inflammatory processes are capable of inducing an altered adhesion of leukocytes to endothelial cells . The result is a preferential homing of leukocytes to sites of inflammation . Acute bouts of exercise may induce a release or secretion of many of the aforementioned substances involved in the adhesion process . The acute immune response to exercise is strongly influenced by the activation of the sympathetic nervous system and the hypothalamo-pituitary-adrenal axis . During the first 10 - 30 min of exercise an almost maximal increase of T and B lymphocytes , monocytes , and NK cells from the marginal pool into the blood circulation is induced . This demargination of cells is likely an effect mediated by beta 2 adrenergic receptors and probably due to a change of the avidity state of adhesion molecules . Strenuous exercise is associated with an increase of serum cortisol result ing in a delayed neutrocytosis and lymphocytopenia . Both phenomena are due to altered circulation patterns . It will be discussed how far adhesion molecules might contribute to this effect . Furthermore an evaluation of contradicting experimental results about surface expression of selectins and integrins will be provided Apoptosis or programmed cell death is a process of fundamental importance for regulation of the immune response . Several reasons suggest that apoptosis is involved in exercise-induced alterations of the immune system such as postexercise lymphocytopenia . Healthy volunteers performed two treadmill exercise tests ; the first was performed at 80 % maximal oxygen uptake until exhaustion ( exhaustive exercise ) and the second 2 wk later at 60 % maximal oxygen uptake with the identical running time ( moderate exercise ) . Blood sample s were taken before , immediately after , and 1 h after the test . Lymphocytes were analyzed for apoptotic and necrotic cells by using FITC-labeled annexin V-antibodies and nuclear propidium iodide uptake , respectively . In addition , apoptotic/necrotic cells were measured after a 24-h incubation of lymphocytes in the presence of camptothecin or phytohemagglutinin . Finally , plasma membrane expression of CD95-receptor and CD95-receptor lig and was investigated . Immediately after the exhaustive exercise , the percentage of apoptotic cells increased significantly , whereas it remained unchanged after the moderate exercise . Similar results were obtained after 24-h incubation of lymphocytes in medium alone or in the presence of camptothecin , but not with phytohemagglutinin . We found an upregulation of CD95-receptor expression after both exercise tests . However , only after exhaustive exercise a characteristic shift in CD95 expression profile toward cells with a high receptor density was observed . Expression of the CD95-receptor lig and remained unchanged after both exhaustive and moderate exercise . These results suggest that apoptosis may contribute to the regulation of the immune response after exhaustive exercise . Whether this mechanism can be regarded either as beneficial , i.e. , deletion of autoreactive cells , or harmful , i.e. , suppression of the immune response , awaits further investigations This study was conducted to determine the effects of an aerobic exercise training program on sub population s of lymphocyte phenotypes . Fourteen healthy but sedentary males , 18 - 40 years of age , were r and omly assigned to either an aerobic exercise training or control condition . Aerobic exercise training consisted of three 45-minute sessions of cycle ergometry exercise per week at 70 - 80 % of age-predicted maximum heart rate for ten weeks . The aerobic exercise training result ed in a significant decrease in submaximal heart rate from 176 to 150 beats per minute to a fixed work rate of 150 watts ( p < .01 ) . This training effect was accompanied by increases in the resting level of the following lymphocyte sub population s : CD2 ( 1717 vs 2183 mm3 ; p < .01 ) , CD4 ( 942 vs 1280 mm3 ; p < .01 ) , CD45RA+CD4 + ( 312 vs 595 mm3 ; p < .01 ) , CD8 ( 655 vs 816 mm3 ; p < .05 ) , and CD20 ( 162 vs 244 mm3 ; p < .01 ) cell counts . These findings indicate that several lymphocyte sub population s are increased following a 10-week program of aerobic exercise training Abstract To study the effects of exercise on natural killer ( NK ) cell number and activity ( NKCA ) healthy male ( n = 32 ) and female ( n = 32 ) subjects were r and omly assigned to an exercise or control condition . Exercise involved a continuous incremental protocol consisting of cycling for three periods of 6 min at work rates corresponding to 55 % , 70 % and 85 % peak oxygen uptake ( $ $ \dot V{\text{O}}_{2{\text{peak}}}$$ ) . Blood sample s were drawn at baseline , at 6 min , 12 min and 18 min during exercise , and at 2 h following completion of exercise . Relative to both baseline and control conditions , exercise result ed in an increase in the number of circulating lymphocytes . The proportion of T cells ( CD3 + ) and B cells ( CD19 + ) significantly decreased , and NK cells ( CD3−CD16+
Output:
| Conclusion : Thus , it can be concluded that the evidence indicates that acute and chronic interventions may modify most immune markers , but aspects such as gender , contraceptive pill use in women , physical capacity of the investigated individuals , environment , and type and intensity of the exercises may interfere with these markers as well as the data analysis . |
MS210641 | ***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 : To evaluate the effect on the process of care of an active strategy to implement clinical guidelines on physiotherapy for low back pain . Design : A cluster r and omised controlled trial comparing an active strategy with st and ard dissemination . Setting : Primary care physiotherapy practice s. Participants : 113 physiotherapists were r and omly allocated to receive the guidelines by mail ( control group ) or to receive an additional active strategy ( intervention group ) which consisted of a multifaceted programme including education , discussion , role playing , feedback , and reminders . Main outcome measures : Adherence to the guidelines was measured by means of individual patients ’ forms recording the treatment completed by the physiotherapist . The forms were assessed using an algorithm based on the number of treatment sessions , treatment goals , interventions , and patient education . Results : Physiotherapists in the intervention group more often correctly limited the number of treatment sessions for patients with a normal course of back pain ( OR 2.39 ; 95 % CI 1.12 to 5.12 ) , more often set functional treatment goals ( OR 1.99 ; 95 % CI 1.06 to 3.72 ) , more often used mainly active interventions ( OR 2.79 ; 95 % CI 1.19 to 6.55 ) , and more often gave adequate patient education ( OR 3.59 ; 95 % CI 1.35 to 9.55 ) . They also adhered more to all four criteria ( OR 2.05 ; 95 % CI 1.15 to 3.65 ) . Conclusions : The active strategy moderately improved adherence to the guidelines . Active strategies are recommended to implement the clinical guidelines on physiotherapy for low back pain Abstract Objective To examine the extent and nature of outcome reporting bias in a broad cohort of published r and omised trials . Design Retrospective review of publications and follow up survey of authors . Cohort All journal articles of r and omised trials indexed in PubMed whose primary publication appeared in December 2000 . Main outcome measures Prevalence of incompletely reported outcomes per trial ; reasons for not reporting outcomes ; association between completeness of reporting and statistical significance . Results 519 trials with 553 publications and 10 557 outcomes were identified . Survey responders ( response rate 69 % ) provided information on unreported outcomes but were often unreliable — for 32 % of those who denied the existence of such outcomes there was evidence to the contrary in their publications . On average , over 20 % of the outcomes measured in a parallel group trial were incompletely reported . Within a trial , such outcomes had a higher odds of being statistically non-significant compared with fully reported outcomes ( odds ratio 2.0 ( 95 % confidence interval 1.6 to 2.7 ) for efficacy outcomes ; 1.9 ( 1.1 to 3.5 ) for harm outcomes ) . The most commonly reported reasons for omitting efficacy outcomes included space constraints , lack of clinical importance , and lack of statistical significance . Conclusions Incomplete reporting of outcomes within published articles of r and omised trials is common and is associated with statistical non- significance . The medical literature therefore represents a selective and biased subset of study outcomes , and trial protocol s should be made publicly available BACKGROUND AND PURPOSE An active strategy was developed for the implementation of the clinical guidelines on physical therapy for patients with low back pain . The effect of this strategy on patients ' physical functioning , coping strategy , and beliefs regarding their low back pain was studied . SUBJECTS One hundred thirteen primary care physical therapists treated a total of 500 patients . METHODS The physical therapists were r and omly assigned to 1 of 2 groups . The control group received the guidelines by mail ( st and ard passive method of dissemination ) . The intervention group , in contrast , received an additional active training strategy consisting of 2 sessions with education , group discussion , role playing , feedback , and reminders . Patients with low back pain , treated by the participating therapists , completed question naires on physical functioning , pain , sick leave , coping , and beliefs . RESULTS Physical functioning and pain in the 2 groups improved substantially in the first 12 weeks . Multilevel longitudinal analysis showed no differences between the 2 groups on any outcome measure during follow-up . DISCUSSION AND CONCLUSION The authors found no additional benefit to applying an active strategy to implement the physical therapy guidelines for patients with low back pain . Active implementation strategies are not recommended if patient outcomes are to be improved Objectives To provide information on the frequency and reasons for outcome reporting bias in clinical trials . Design Trial protocol s were compared with subsequent publication(s ) to identify any discrepancies in the outcomes reported , and telephone interviews were conducted with the respective trialists to investigate more extensively the reporting of the research and the issue of unreported outcomes . Participants Chief investigators , or lead or co authors of trials , were identified from two sources : trials published since 2002 covered in Cochrane systematic review s where at least one trial analysed was suspected of being at risk of outcome reporting bias ( issue 4 , 2006 ; issue 1 , 2007 , and issue 2 , 2007 of the Cochrane library ) ; and a r and om sample of trial reports indexed on PubMed between August 2007 and July 2008 . Setting Australia , Canada , Germany , the Netherl and s , New Zeal and , the United Kingdom , and the United States . Main outcome measures Frequency of incomplete outcome reporting — signified by outcomes that were specified in a trial ’s protocol but not fully reported in subsequent publications— and trialists ’ reasons for incomplete reporting of outcomes . Results 268 trials were identified for inclusion ( 183 from the cohort of Cochrane systematic review s and 85 from PubMed ) . Initially , 161 respective investigators responded to our requests for interview , 130 ( 81 % ) of whom agreed to be interviewed . However , failure to achieve subsequent contact , obtain a copy of the study protocol , or both meant that final interviews were conducted with 59 ( 37 % ) of the 161 trialists . Sixteen trial investigators failed to report analysed outcomes at the time of the primary publication , 17 trialists collected outcome data that were subsequently not analysed , and five trialists did not measure a prespecified outcome over the course of the trial . In almost all trials in which prespecified outcomes had been analysed but not reported ( 15/16 , 94 % ) , this under-reporting result ed in bias . In nearly a quarter of trials in which prespecified outcomes had been measured but not analysed ( 4/17 , 24 % ) , the “ direction ” of the main findings influenced the investigators ’ decision not to analyse the remaining data collected . In 14 ( 67 % ) of the 21 r and omly selected PubMed trials , there was at least one unreported efficacy or harm outcome . More than a quarter ( 6/21 , 29 % ) of these trials were found to have displayed outcome reporting bias . Conclusion The prevalence of incomplete outcome reporting is high . Trialists seemed generally unaware of the implication s for the evidence base of not reporting all outcomes and protocol changes . A general lack of consensus regarding the choice of outcomes in particular clinical setting s was evident and affects trial design , conduct , analysis , and reporting OBJECTIVE To test if basic training for dietitians in motivational interviewing ( MI ) result ed in changes in dietitians ' counseling style and improvements in their patients ' diet and risk parameters . DESIGN A r and omized controlled trial . SETTING 9 home-care organizations in the Netherl and s. PARTICIPANTS 37 dietitians , 209 baseline patients , and 142 follow-up diabetes patients . INTERVENTION Dietitians were r and omly allocated to receive basic training in motivational interviewing ( MI dietitians , n=18 ) or not ( control dietitians , n=19 ) . MAIN OUTCOME MEASURES Counseling style of dietitians ; total self-reported saturated fat , fruit , and vegetable intake , measured body mass index ( BMI ) , waist circumference , and glycated hemoglobin ( Hemoglobin A(1c ) , HbA(1c ) ) of patients . ANALYSIS Analyses of variance and multiple linear regression analyses . Alpha = .05 RESULTS MI dietitians were significantly more empathetic , more often showed reflection during consultations , and were more likely than control dietitians to let their patients talk for the majority of the consultation . Patients of MI dietitians had significantly lower saturated fat intake levels at posttest compared to patients of control dietitians . No effects on HbA(1c ) , BMI , and waist circumference were found . CONCLUSIONS AND IMPLICATION S Basic training in MI changed the dietitians ' counseling style and result ed in lower saturated fat intakes in their patients INTRODUCTION Online data bases can support the implementation of evidence -based practice by providing easy access to research . OTseeker ( http://www.otseeker.com ) , an electronic evidence data base , was introduced in 2003 to assist occupational therapists to locate and interpret research . OBJECTIVES This study explored Australian occupational therapists ' use and perceptions of OTseeker and its impact on their knowledge and practice . METHODS A postal survey question naire was distributed to two sample s : ( i ) a proportionate r and om sample of 400 occupational therapists from all states and territories of Australia , and ( ii ) a r and om sample of occupational therapists working in 95 facilities in two Australian states ( Queensl and and New South Wales ) . RESULTS The question naire was completed by 213 participants . While most participants ( 85.9 % ) had heard of OTseeker , only 103 ( 56.6 % ) had accessed it , with lack of time being the main reason for non-use . Of the 103 participants who had accessed OTseeker , 68.9 % had done so infrequently , 63.1 % agreed that it had increased their knowledge and 13.6 % had changed their practice after accessing information on OTseeker . CONCLUSION Despite OTseeker being developed to provide occupational therapists with easy access to research , lack of time was the main reason why over half of the participants in this study had not accessed it . This exploratory research suggests , however , that there is potential for the data base to influence occupational therapists ' knowledge and practice about treatment efficacy through access to the research literature Objective The aim of this research was to assess the effects of a series of four training courses comprised of 13 synchronous videoconferences on the implementation of cognitive services in Spanish community pharmacies . Setting A phone survey to continuing training course attendants . Methods A r and om sample of 225 pharmacists registered in a 2004 videoconference course was selected . The phone-survey question naire included quality perception elements rated on a 5-point Likert scale , and a series of questions used to identify position in the Rogers 5-step innovation – decision model . An algorithm was used to translate the questions into Rogers ’ categories . To discover determinants of attendants position in these categories , bivariate analysis , simple correspondence analysis , and logistic regressions were performed . Main outcome measure Position in Rogers ’ diffusion of innovation steps regarding the adoption of pharmacotherapy follow-up . Results The perception of the course quality rated between good and very good for the majority of respondents . A significant association between having attended two or more of these four courses and the Persuasion/Decision step in Rogers ’s model appeared . No association was found between course attendance and the Implementation/Confirmation step of patient follow-up . Fifty percent of those who indicated they implemented the service reported following-up with less than 10 patients , and only 25 % reported following up with more than 20 patients . Conclusions Although participation in these courses was associated with higher steps in Rogers ’ model , significant association appeared only with Persuasion/Decision steps and not with the Implementation/Confirmation step , reflecting an attitude but not a performance change QUESTION Are implementation strategies involving education any more effective than mere dissemination of clinical practice guidelines in changing physiotherapy practice and reducing patient disability after acute whiplash ? DESIGN Cluster-r and omised trial . PARTICIPANTS Twenty-seven physiotherapists from different private physiotherapy clinics and the 103 patients ( 4 dropouts ) who presented to them with acute whiplash . INTERVENTION The implementation group of physiotherapists underwent education by opinion leaders about whiplash guidelines and the dissemination group had the guidelines mailed to them . OUTCOME MEASURES The primary outcome was patient disability , measured using the Functional Rating Index , collected on admission to the trial and at 1.5 , 3 , 6 and 12 months . Physiotherapist knowledge about the guidelines was measured using a custom-made question naire . Physiotherapist practice and cost of care were measured by audit of patient notes . RESULTS There were no significant differences between groups for any of the patient outcomes at any time . The implementation patients had 0.6 points ( 95 % CI -7.8 to 6.6 ) less disability than the dissemination patients at 12 months ; 44 % more physiotherapists in the implementation group reported that they prescribed two out of the five guideline -recommended treatments ; and 32 % more physiotherapists actually prescribed them . The cost of care for patients in the implementation group was $ 255 ( 95 % CI -1505 to 996 ) less than for patients in the dissemination group . CONCLUSION Although the active implementation program increased guideline -consistent practice , patient outcomes and cost of care were not affected Summary .¶ Objectives : The periconceptional intake of 0.4 mg folic acid is recommended in many countries to prevent neural tube defects . This paper describes the poor implementation of corresponding guidelines in Germany , the effectiveness of an intervention-based on providing adequate information and the problems associated with the implementation.¶ Methods : Two cross sectional studies investigated knowledge , attitude , and behaviour of
Output:
| Conclusions Across five allied health professions , equivocal results , low method ological quality , and outcome reporting bias limited our ability to recommend one KT strategy over another . |
MS210642 | ***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 examine whether peanut consumption is associated with a reduced risk of colorectal cancer in a prospect i ve cohort with a 10-year follow-up . METHODS In 1990 - 1992 , residents ( 12026 men and 11917 women aged 30 to 65 years ) in 7 townships , Taiwan , were interviewed and recruited into a cancer-screening cohort and annually followed up . Colorectal cancer cases in this cohort were identified from cancer registry and death certificates . Incidence rates of this disease by the end of 2001 were calculated by gender for the primary study variable and covariates . The dietary intake was assessed by means of weekly food frequency measures , including frequently consumed food groups and folk dishes including sweet potato , bean products , peanut products , pickled foodstuffs , nitrated or smoked foodstuffs . RESULTS During the study period , 107 new colorectal cancer cases ( 68 men and 39 women ) were confirmed . The multivariate Cox 's proportional hazard model showed that the relative risk ( RR ) of peanut consumption was 0.73 [ 95 % confidence interval ( CI ) = 0.44 - 1.21 ] for men and 0.42 ( 95 % CI = 0.21 - 0.84 ) for women . However , frequent intake of pickled foodstuffs was harmful for women ( RR = 2.15 , 95 % CI = 0.99 - 4.65 ) . The risk of colorectal cancer was also elevated among cigarette smokers but not significant ( P<0.05 ) . CONCLUSION This study suggests that frequent intake of peanut and its products may reduce colorectal cancer risk in women , demonstrating the anti-proliferating effect of peanut intake Background : Increasing nut intake has been associated with reduced risk of diabetes mellitus , which is a risk factor for pancreatic cancer . Methods : We prospect ively followed 75 680 women in the Nurses ’ Health Study , and examined the association between nut consumption and pancreatic cancer risk . Participants with a previous history of cancer were excluded . Nut consumption was assessed at baseline and up date d every 2 to 4 years . Relative risks ( RRs ) and 95 % confidence intervals ( 95 % CIs ) were estimated using Cox proportional hazards models . Results : We documented 466 incident cases of pancreatic cancer . After adjusting for age , height , smoking , physical activity , and total energy intake , women who consumed a 28-g ( 1 oz ) serving size of nuts ⩾2 times per week experienced a significantly lower risk of pancreatic cancer ( RR , 0.65 ; 95 % CI , 0.47–0.92 ; P for trend=0.007 ) when compared with those who largely abstained from nuts . The results did not appreciably change after further adjustment for body mass index ( BMI ) and history of diabetes mellitus ( RR , 0.68 ; 95 % CI , 0.48–0.95 ; P for trend=0.01 ) . The inverse association persisted within strata defined by BMI , physical activity , smoking , and intakes of red meat , fruits , and vegetables . Conclusion : Frequent nut consumption is inversely associated with risk of pancreatic cancer in this large prospect i ve cohort of women , independent of other potential risk factors for pancreatic cancer OBJECTIVE Fat intake , especially monounsaturated fatty acid ( MUFA ) , has been liberalized in diabetic diets to preserve HDL cholesterol and improve glycemic control , yet the exact sources have not been clearly defined . Therefore , we assessed the effect of mixed nut consumption as a source of vegetable fat on serum lipids and HbA1c in type 2 diabetes . RESEARCH DESIGN AND METHODS A total of 117 type 2 diabetic subjects were r and omized to one of three treatments for 3 months . Supplements were provided at 475 kcal per 2,000-kcal diet as mixed nuts ( 75 g/day ) , muffins , or half portions of both . The primary outcome was change in HbA1c . RESULTS The relative increase in MUFAs was 8.7 % energy on the full-nut dose compared with muffins . Using an intention-to-treat analysis ( n = 117 ) , full-nut dose ( mean intake 73 g/day ) reduced HbA1c ( −0.21 % absolute HbA1c units , 95 % CI −0.30 to −0.11 , P < 0.001 ) with no change after half-nut dose or muffin . Full-nut dose was significantly different from half-nut dose ( P = 0.004 ) and muffin ( P = 0.001 ) , but no difference was seen between half-nut dose and muffins . LDL cholesterol also decreased significantly after full-nut dose compared with muffin . The LDL cholesterol reduction after half-nut dose was intermediate and not significantly different from the other treatments . Apolipoprotein ( apo ) B and the apoB : apoA1 ratio behaved similarly . Nut intake related negatively to changes in HbA1c ( r = −0.20 , P = 0.033 ) and LDL cholesterol ( r = −0.24 , P = 0.011 ) . CONCLUSIONS Two ounces of nuts daily as a replacement for carbohydrate foods improved both glycemic control and serum lipids in type 2 diabetes BACKGROUND Although dietary factors are suspected to be important determinants of coronary heart disease ( CHD ) risk , the direct evidence is relatively sparse . METHODS The Adventist Health Study is a prospect i ve cohort investigation of 31,208 non-Hispanic white California Seventh-Day Adventists . Extensive dietary information was obtained at baseline , along with the values of traditional coronary risk factors . These were related to risk of definite fatal CHD or definite nonfatal myocardial infa rct ion . RESULTS Subjects who consumed nuts frequently ( more than four times per week ) experienced substantially fewer definite fatal CHD events ( relative risk , 0.52 ; 95 % confidence interval [ CI ] , 0.36 to 0.76 ) and definite nonfatal myocardial infa rct ions ( relative risk , 0.49 ; 95 % CI , 0.28 to 0.85 ) , when compared with those who consumed nuts less than once per week . These findings persisted on covariate adjustment and were seen in almost all of 16 different subgroups of the population . Subjects who usually consumed whole wheat bread also experienced lower rates of definite nonfatal myocardial infa rct ion ( relative risk , 0.56 ; 95 % CI , 0.35 to 0.89 ) and definite fatal CHD ( relative risk , 0.89 ; 95 % CI , 0.60 to 1.33 ) when compared with those who usually ate white bread . Men who ate beef at least three times each week had a higher risk of definite fatal CHD ( relative risk , 2.31 ; 95 % CI , 1.11 to 4.78 ) , but this effect was not seen in women or for the nonfatal myocardial infa rct ion end point . CONCLUSION Our data strongly suggest that the frequent consumption of nuts may protect against risk of CHD events . The favorable fatty acid profile of many nuts is one possible explanation for such an effect Background Prospect i ve studies in non-Mediterranean population s have consistently related increasing nut consumption to lower coronary heart disease mortality . A small protective effect on all-cause and cancer mortality has also been suggested . To examine the association between frequency of nut consumption and mortality in individuals at high cardiovascular risk from Spain , a Mediterranean country with a relatively high average nut intake per person . Methods We evaluated 7,216 men and women aged 55 to 80 years r and omized to 1 of 3 interventions ( Mediterranean diets supplemented with nuts or olive oil and control diet ) in the PREDIMED ( ‘ PREvención con DIeta MEDiterránea ’ ) study . Nut consumption was assessed at baseline and mortality was ascertained by medical records and linkage to the National Death Index . Multivariable-adjusted Cox regression and multivariable analyses with generalized estimating equation models were used to assess the association between yearly repeated measurements of nut consumption and mortality . Results During a median follow-up of 4.8 years , 323 total deaths , 81 cardiovascular deaths and 130 cancer deaths occurred . Nut consumption was associated with a significantly reduced risk of all-cause mortality ( P for trend < 0.05 , all ) . Compared to non-consumers , subjects consuming nuts > 3 servings/week ( 32 % of the cohort ) had a 39 % lower mortality risk ( hazard ratio ( HR ) 0.61 ; 95 % CI 0.45 to 0.83 ) . A similar protective effect against cardiovascular and cancer mortality was observed . Participants allocated to the Mediterranean diet with nuts group who consumed nuts > 3 servings/week at baseline had the lowest total mortality risk ( HR 0.37 ; 95 % CI 0.22 to 0.66 ) . Conclusions Increased frequency of nut consumption was associated with a significantly reduced risk of mortality in a Mediterranean population at high cardiovascular risk . Please see related commentary : http://www.biomed central .com/1741 - 7015/11/165.Trial registration Clinical trials.gov . International St and ard R and omized Controlled Trial Number ( IS RCT N ) : 35739639 . Registration date : 5 October 2005 Epidemiological data on most cancer sites suggest that consumption of plant foods , which contain high levels of antioxidants , might slow or prevent the appearance of cancer . We used data from three case-control studies to test this hypothesis . The total study population consisted of 617 incident cases of prostate cancer and 636 population controls from Ontario , Quebec , and British Columbia . Dietary information was collected by an in-person interview with a detailed quantitative dietary history . Unconditional logistic regression analyses were performed to estimate odds ratios ( ORs ) and 95 % confidence intervals ( CIs ) . A decreasing , statistically significant association was found with increasing intakes of green vegetables ( OR = 0.54 , 95 % CI = 0.40 - 0.71 for 4th quartile ) , tomatoes ( OR = 0.64 , 95 % CI = 0.45 - 0.91 ) , beans/lentils/nuts ( OR = 0.69 , 95 % CI = 0.53 - 0.91 ) , and cruciferous vegetables ( OR = 0.69 , 95 % CI = 0.52 - 0.91 for 3rd quartile ) . Higher intakes of fruit were associated with higher ORs ( OR = 1.51 , 95 % CI = 1.14 - 2.01 for 4th quartile ) , an effect that was seen for total fruit and citrus fruit , as well as for all other noncitrus fruits . Among the grains , refined-grain bread intake was associated with a decrease in risk ( OR = 0.65 for 4th quartile ) , whereas whole-grain breakfast cereals were associated with a higher risk for prostate cancer . Of all the antioxidant nutrients studied , the ORs were higher with higher intakes of cryptoxanthin ( OR = 1.44 , 95 % CI = 1.09 - 1.89 for 4th quartile ) . Exposure to certain dietary components of plant origin , which are potentially modifiable , indicates the theoretical scope for reducing the risk from prostate cancer . Future experimental studies or trials are warranted for further underst and ing BACKGROUND Dietary nut intake has been associated with a reduced risk of coronary heart disease mortality ; however , the mechanism is unclear . Since components of nuts may have antiarrhythmic properties , part of the benefit may be due to a reduction in sudden cardiac death . METHODS We prospect ively assessed whether increasing frequency of nut consumption , as ascertained by an abbreviated food frequency question naire at 12 months of follow-up , was associated with a lower risk of sudden cardiac death and other coronary heart disease end points among 21 454 male participants enrolled in the US Physicians ' Health Study . Participants were followed up for an average of 17 years . RESULTS Dietary nut intake was associated with a significantly reduced risk of sudden cardiac death after controlling for known cardiac risk factors and other dietary habits ( P for trend,.01 ) . Compared with men who rarely or never consumed nuts , those who consumed nuts 2 or more times per week had reduced risks of sudden cardiac death ( relative risk , 0.53 ; 95 % confidence interval , 0.30 - 0.92 ) and total coronary heart disease death ( relative risk , 0.70 ; 95 % confidence interval , 0.50 - 0.98 ) . In contrast , nut intake was not associated with significantly reduced risks of nonsudden coronary heart disease death or nonfatal myocardial infa rct ion . CONCLUSION These prospect i ve data in US male physicians suggest that the inverse association between nut consumption and total coronary heart disease death is primarily due to a reduction in the risk of sudden cardiac death A link between unsaturated fatty acids or phytonutrients and reduced risk of colorectal cancer has been suggested . However , the effects of higher intake of dietary sources of these nutrients , such as the nuts and seeds food group , are less
Output:
| Effects were primarily driven by decreased coronary artery disease deaths rather than stroke deaths . |
MS210643 | ***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 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 BACKGROUND Genital warts are a common sexually transmitted disease caused by human papillomavirus . Imiquimod is a novel immune-response modifier capable of inducing a variety of cytokines , including interferon alfa , tumor necrosis factor-alpha , as well as interleukins 1 , 6 , and 8 . In animal models imiquimod has demonstrated antiviral , antitumor , and adjuvant activity . In vitro , imiquimod has no antiviral or antitumor activity . OBJECTIVE Our purpose was to determine the safety and efficacy of topical imiquimod for the treatment of external genital warts . METHODS This prospect i ve double-blind , placebo-controlled , parallel design clinical trial was performed in three outpatient centers , a public health clinic , a university-based clinic , and a private practice . One hundred eight patients with external genital warts ( predominantly white men ) were entered into the trial . Fifty-one patients were r and omly selected to receive 5 % imiquimod cream ; 57 patients were r and omly chosen to receive placebo cream . Study medication was applied three times weekly for up to 8 weeks . Patients whose warts cleared completely were observed for up to 10 weeks to determine recurrence rates . RESULTS In the intent-to-treat analysis , the warts of 37 % ( 19 of 51 ) of the imiquimod-treated patients and 0 % ( 0 of 57 ) of the placebo group cleared completely ( p < 0.001 ) . In addition , many patients experienced a partial response . A reduction in baseline wart area of 80 % or more was observed in 62 % of imiquimod-treated patients ( 28 of 45 ) and 4 % of the placebo group ( 2 of 50 ) ( p < 0.001 ) ; a 50 % reduction or more in wart area was noted in 76 % of imiquimod-treated patients ( 34 of 45 ) and 8 % of placebo recipients ( 4 of 50 ) ( p < 0.001 ) . Of imiquimod-treated patients whose warts cleared completely and who finished the 10-week follow-up period , 19 % ( 3 of 16 ) experienced recurrences of warts . Imiquimod-treated patients experienced a significantly greater number of local inflammatory reactions than the placebo group . Symptoms and signs associated with the local inflammatory reactions included itching ( 54.2 % ) , erythema ( 33.3 % ) , burning ( 31.3 % ) , irritation ( 16.7 % ) , tenderness ( 12.5 % ) , ulceration ( 10.4 % ) , erosion ( 10.4 % ) , and pain ( 8.3 % ) . There were no differences in systemic reactions or laboratory abnormalities between treatment groups . CONCLUSION Topical 5 % imiquimod cream appears to have a significant therapeutic effect in the treatment of external genital warts BACKGROUND Traditional and largely qualitative review s of evidence are now giving way to much more structured systematic overviews that use a quantitative method to calculate the overall effect of treatment . The latter approach is dependent on the quality of primary studies , which may introduce bias if they are of poor method ologic quality . OBJECTIVE To test the hypothesis that the inclusion of poor- quality trials in meta-analyses would bias the conclusions and produce incorrect estimates of treatment effect . METHODS An overview of r and omized trials of antiestrogen therapy in subfertile men with oligospermia was performed to test the hypothesis . Data sources included online search ing of MEDLINE and Science Citation Index data bases between 1966 and 1994 , scanning the bibliography of known primary studies and review articles , and contacting experts in the field . After independent , blind assessment , nine of 149 originally identified studies met the inclusion criteria and were selected . We assessed study quality independently . Outcome data from each study were pooled and statistically summarized . RESULTS There was a marginal improvement in pregnancy rate with antiestrogen treatment ( odds ratio , 1.6 ; 95 % confidence interval , 0.9 to 2.6 ) . Sensitivity analyses on the basis of method ologic quality demonstrated that poor- quality studies produced a positive effect with treatment , whereas no benefit was observed with high- quality studies . CONCLUSION The results of a meta- analysis are influenced by the quality of the primary studies included . Method ologically , poor studies tend to exaggerate the overall estimate of treatment effect and may lead to incorrect inferences OBJECTIVE To compare the safety and effectiveness of 5 % and 1 % imiquimod cream with vehicle cream in the treatment of external anogenital warts . DESIGN R and omized , double-blind , placebo-controlled comparison that evaluated patients for total clearance of their warts . Patients who experienced total clearance were evaluated for recurrence in a 12-week follow-up . SETTING Eleven ambulatory offices , including both private physician offices and referral medical centers . PATIENTS Three hundred eleven healthy men and women aged 18 years or older with 2 to 50 external anogenital warts were recruited from the practice s of investigators , referring physicians , and advertisements . Eighty-two additional patients were screened but did not qualify . Four patients discontinued use of the medication because of adverse effects . INTERVENTIONS Five percent imiquimod ( Aldara ) cream , 1 % imiquimod cream , or vehicle cream was applied to all external warts overnight 3 times each week for 16 weeks , or until all treated warts disappeared , whichever occurred first . MAIN OUTCOME MEASUREMENTS The number of patients experiencing the elimination of all baseline warts and the recurrence rate of these warts . In addition , the reduction in baseline wart area the duration of therapy required to eliminate warts , and the frequency and severity of adverse reactions were principal measurements . RESULTS In the intent-to-treat analysis , 54 ( 50 % ) of 109 patients who received 5 % imiquimod cream , 21 ( 21 % ) of 102 of those who received 1 % imiquimod cream , and 11 ( 11 % ) of 100 patients treated with vehicle cream experienced eradication of all treated baseline warts . The difference between the effectiveness of 5 % imiquimod cream and the vehicle cream was statistically significant ( P < .001 ) . Of those patients whose warts cleared during therapy , 13 % of patients who received 5 % imiquimod experienced a recurrence of at least 1 wart . Recurrences occurred in none of the patients who used 1 % imiquimod cream and in 10 % of patients who used the vehicle cream . Local erythema was the most common adverse reaction , but the majority of patients in each group experienced no or only mild local inflammatory reactions . There were no differences in incidences of flulike symptoms among treatment groups . CONCLUSIONS Five percent imiquimod cream is an effective and safe self-administered therapy for external anogenital warts when applied 3 times a week overnight for up to 16 weeks . The recurrence rate is low This dose-escalation study was performed to evaluate safety and efficacy of imiquimod 5 % cream in the treatment of uncircumcised men with penile warts associated with the foreskin . The cream was applied 3 times/week ( n=34 ) or once per day ( n=30 ) over 8 ± 2h . Imiquimod 5 % cream was safe in both treatment groups . However , the 3 times/week regimen was better tolerated with a lower incidence of local skin reactions . In both groups , the 2 most frequently reported local skin reactions were erythema and erosion ; they were more severe with the once-daily dosing . The most frequently reported application site reactions were burning , pruritus and irritation or pain ( once-daily patients only ) . Total clearance was achieved in 62 % of the patients in the 3 times/week group and by 57 % in the once-daily group . Thus , imiquimod 5 % cream administered 3 times/week was the optimal dosing regimen in the treatment of penile warts in uncircumcised men As professionals , we want to use the best treatments ; as patients , we want to be given them . Knowing whether an intervention works ( or does not work ) is fundamental to clinical decision making . However , clinical decision making involves more than simply taking published results of research directly to the bedside . Physicians need to consider how similar their patients are to those in the published studies , to take the values and preferences of their patients into account , and to consider their own experience with a given test or treatment . Evidence from clinical research is becoming increasingly important in medical- practice decisions as more and better evidence is published . But when is the evidence strong enough to justify changing a practice ? Individual studies that involve only small numbers of patients may have results that are distorted by the r and om play of chance and thus lead to less than optimal decisions . As is clear from other papers in this series , systematic review s identify , critically appraise , and review all the relevant studies on a clinical question and are more likely to give a valid answer . They use explicit methods and quality st and ards to reduce bias . Their results are the closest we can come to reaching the truth given our current state of knowledge . The questions about an intervention that a systematic review should answer are the following : 1 . Does it work ? 2 . If it works , how well does it work in general and compared with placebo , no treatment , or other interventions that are currently in use ? 3 . Is it safe ? 4 . Will it be safe and effective for my patients ? Whereas the critical appraisal and qualitative synthesis provided by review articles can be interpreted directly , the numerical products of quantitative review s can be more difficult to underst and and apply in daily clinical practice . This paper provides guidance on how to interpret the numerical and statistical results of systematic review s , translate these results into more underst and able terms , and apply them directly to individual patients . Many of these principles can also be used to interpret the numerical results of individual clinical studies . They are particularly relevant to systematic review s , however , because such review s contain more information than do primary studies and often exert greater influence than do individual studies . Making Sense of the Numerical Results of Clinical Studies Although the results of clinical studies can be expressed in intuitively meaningful ways , such results do not always easily translate into clinical decision making . For example , results are frequently expressed in terms of risk , which is an expression of the frequency of a given outcome . ( Risks are probabilities , which can vary between 0.0 and 1.0 . A probability of 0.0 means that the event will never happen , and a probability of 1.0 means that it always happens . ) Consider a hypothetical study of the recurrence of migraine headaches in a control group receiving placebo and a treatment group receiving a new antimigraine preparation , drug M ( a secondary prevention trial ) . Suppose that at the end of the trial , migraines recurred in 30 % of the control group ( the risk for recurrence was 0.30 ) but in only 5 % of the drug M group ( risk of 0.05 ) ( Table 1 ) . Table 1 . Numerical Expression of Hypothetical Clinical Trial Results The outcomes of the study are clear enough for the two groups when they are examined separately . But clinicians and patients are more interested in the comparative results , that is , the outcome in one group relative to the outcome in the other group . This overall ( comparative ) result can be expressed in various ways . For example , the relative risk , which is the risk in the treatment group relative to that in the control group , is simply the ratio of the risks in the two groups . In other words , relative risk is the risk in the treatment group divided by that in the control group , 0.05 0.30 , or 0.17 . The comparison can also be expressed as the reduction in relative risk , which is the ratio between the decrease in risk ( in the treatment group ) and the risk in the control group , 0.25 0.30 , or 0.83 ( Table 1 ) . ( The relative risk reduction can also be calculated as
Output:
| Imiquimod is effective in home application , though not in patients with HIV infection with the evidence presently available |
MS210644 | ***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: A r and omized , double-blind , placebo-controlled study was conducted to evaluate the efficacy of OciBest , an extract of Ocimum tenuiflorum Linn . in symptomatic control of general stress . The participants received either placebo ( n = 79 ) or OciBest ( n = 71 ; 1200 mg of actives per day ) for six weeks . The severity of stress-related symptoms was self-evaluated by patients at weeks 0 , 2 , 4 and 6 of the trial period using a symptom rating scale . After six weeks of intervention , scores of symptoms such as forgetfulness , sexual problems of recent origin , frequent feeling of exhaustion , and frequent sleep problems of recent origin decreased significantly ( P ≤ 0.05 ) in OciBest group as compared with placebo group . Also , the total symptom scores of OciBest group revealed significant reduction ( P ≤ 0.05 ) as compared to placebo group . The overall improvement in OciBest group was found to be 1.6 times or 39 % more in the control of general stress symptoms with respect to placebo . No adverse events were reported during the study . The findings revealed that OciBest was found to be effective and well tolerated by all the patients over the six weeks of study period The existing review s of massage therapy ( MT ) research are either limited to infants , adults , or were conducted prior to the publication of the most recent studies using pediatric sample s. R and omized controlled trials ( RCTs ) of pediatric MT are review ed . A literature search yielded 24 RCTs of pediatric MT , defined as the manual manipulation of soft tissue intended to promote health and well-being in recipients between 2 and 19 years of age . Because RCTs of pediatric MT varied considerably in the amount and types of data reported , quantitative and narrative review methods were both used . Singledose and multiple-dose effects were examined separately . Among single-dose effects , significant reductions of state anxiety were observed at the first session ( g 1⁄4 0.59 , P < 0.05 ) and the last session ( g 1⁄4 1.10 , P < 0.01 ) of a course of treatment . Effects for salivary cortisol ( g 1⁄4 0.28 ) , negative mood ( g 1⁄4 0.52 ) and behavior ( g 1⁄4 0.37 ) were non-significant . Three of eleven multiple-dose effects were statistically significant . These were trait anxiety ( g 1⁄4 0.94 , P < 0.05 ) , muscle tone ( g 1⁄4 0.90 , P < 0.01 ) and arthritis pain ( g1⁄4 1.33 , P < 0.01 ) . Results of studies not permitting effect size calculation were judged to be generally consistent with quantitative results . MT benefits pediatric recipients , though not as universally as sometimes reported . Numerous weaknesses endemic to MT research ( e.g. low statistical power , frequent failure to report basic descriptive statistics ) are identified , and recommendations for future pediatric MT research are discussed Ocimumn sanctum , an Indian medicinal plant , has been on trial for its role in generalized anxiety disorder ( GAD ) in hospital based clinical set-up . Hamilton 's brief psychiatric rating scale ( BPRS ) and thorough clinical investigations were used to screen the subjects . Thirty-five subjects ( 21 male and 14 female ; average age 38.4 years ) were medicated with the plant extract in a fixed dose regime ( 500 mg/capsule , twice daily , p.o . after meal ) . They were thoroughly investigated clinical ly and using st and ard question naires based on different psychological rating scale at baseline ( day 0 ) , mid-term ( day 30 ) and final ( day 60 ) . The observations exhibited that , O. sanctum significantly ( p<0.001 ) attenuated generalized anxiety disorders and also attenuated its correlated stress and depression . It further significantly ( p<0.001 ) improved the willingness to adjustment and attention in human . Therefore , it may be concluded that O. sanctum may be useful in the treatment of GAD in human and may be a promising anxiolytic agent in near future The study was aim ed to examine if oral administration of the aqueous extract of the whole plant OCIMUM SANCTUM ( OS ) protects against the development of insulin resistance in fructose fed rats . Male Wister rats were r and omly divided into four groups of eight animals each : group-S ( starch diet ) , group-F ( fructose diet ) , group-F+OS ( fructose diet along with OCIMUM SANCTUM extract at a dose of 200 mg/kg ) , group-S+OS ( starch diet along with OCIMUM SANCTUM ) . During the experimental period of 60 days body weight , plasma glucose , insulin , and triglycerides were measured at an interval of 15 days . Insulin sensitivity was assessed at the end of experimental period by measuring glucose-insulin index , which is the product of the areas under the curve of glucose and insulin during oral glucose tolerance test . The nontoxic nature of OS was revealed by unaltered body weight , plasma glucose , insulin , and triglyceride levels in group-S+OS when compared with group-S. A significant gain in body weight , hyperglycemia , hyperinsulinemia , hypertriglyceridemia , and insulin resistance were observed in group-F when compared with group-S. OS treatment prevented the observed fructose induced alterations in group-F+OS . In conclusion , our results suggests that oral administration of OS aqueous extract could delay the development of insulin resistance in rats and may be used as an adjuvant therapy for treating diabetic patients with insulin resistance ETHNOPHARMACOLOGICAL RELEVANCE Tulsi ( Ocimum sanctum Linn . ) is considered as a sacred herb and traditionally it is believed that consumption of Tulsi leaf on empty stomach increases immunity . Experimental studies have shown that alcoholic extract of Tulsi modulates immunity . MATERIAL S AND METHODS The present study was design ed to evaluate the immunomodulatory effects of ethanolic extract of Tulsi leaves through a double-blinded r and omized controlled cross-over trial on healthy volunteers . Three hundred milligrams capsules of ethanolic extracts of leaves of Tulsi or placebo were administered to 24 healthy volunteers on empty stomach and the results of 22 subjects who completed the study were analyzed . The primary objective was to study the levels of Th1 and Th2 cytokines ( interferon-γ and interleukin-4 ) during both pre and post intervention period in blood culture supernatants following stimulation with lipopolysaccharide and phytohaemagglutinin . Other immunological parameters such as T-helper and T-cytotoxic cells , B-cells and NK-cells also were analyzed using Flowcytometry . RESULTS Statistically significant increase in the levels of IFN-γ ( p=0.039 ) , IL-4 ( p=0.001 ) and percentages of T-helper cells ( p=0.001 ) and NK-cells ( p=0.017 ) were observed after 4 weeks in the Tulsi extract intervention group in contrast to the placebo group . CONCLUSIONS These observations clearly ascertain the immunomodulatory role of Tulsi leaves extract on healthy volunteers Immunotherapeutic potential of aqueous extract of Ocimum sanctum ( O. sanctum ) leaf in bovine sub- clinical mastitis ( SCM ) was investigated . Somatic cell count ( SCC ) , total bacterial count ( TBC ) , milk differential leukocyte count ( DLC ) , phagocytic activity and Phagocytic index and leukocyte lysosomal enzymes like myeloperoxidase and acid phosphatase content were evaluated after intramammary infusion of aqueous leaf extract of O. sanctum . The results revealed that the aqueous extract of O. sanctum treatment reduced the TBC and increased neutrophil and lymphocyte counts with enhanced phagocytic activity and phagocytic index . Similarly , the lysosomal enzymes contents of the milk polymorphonuclear cells ( PMNs ) were also enhanced significantly in animals treated with the extract . The results suggest that the crude aqueous extract of O. sanctum ( leaf ) possesses some biologically active principles that are antibacterial and immunomodulatory in nature . As such , the present wok substantiates the therapeutic use of medicinal herb and also emphasizes on the potential of the commonly available non-toxic substances to enhance the mammary immunity In this present study , we have described the diversity of nine Ocimum genotypes naturally grown in the Dakshin Dinajpur district of West Bengal , India . Their diversity was determined on the basis of morphological , chemical and r and omly amplified polymorphic DNA ( RAPD ) to determine the level of variation present in the genus Ocimum . Among nine Ocimum genotypes six ( O. americanum , O. × africanum , O. basilicum , O. gratissimum , O. kilim and scharicum and O. tenuiflorum ) are found to be different Ocimum species and the rest are as varieties . A total of 18 qualitative and 17 quantitative morphological traits and chemical compositions were evaluated . Significant variations were observed in the morphological traits except O. × africanum and O. basilicum species . Cluster generated from the morphological data showed two different groups viz . basilicum group and sanctum group . Chemical analysis did not show much variation between morphologically similar species viz . O. × africanum and O. basilicum . However , RAPD analyses clearly showed that O. × africanum and O. basilicum are different species . Thus the combined analyses of morphological traits , chemical and molecular markers represent the best possible approach to confirm taxonomic delineation . Moreover , we are reporting O. × africanum for the first time from this region as well as from West Bengal , India
Output:
| The review ed studies reinforce traditional uses and suggest tulsi is an effective treatment for lifestyle-related chronic diseases including diabetes , metabolic syndrome , and psychological stress . |
MS210645 | ***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 / AIMS Two main systems have been utilized for measuring transepidermal water loss ( TEWL ) : open chamber and closed chamber . Yet , further validation and st and ardization studies may be necessary to reveal the sensitivity , precision , and robustness of these instruments . METHODS Three instruments are compared for their applicability to assess TEWL : unventilated chamber , open chamber and condenser chamber . The comparative study was performed on human forearm skin ( n=6 ) , in the normal condition ( baseline ) , and after ( 1 ) 10 tape strippings on both arms , ( 2 ) moisturizer cream ( Eucerin ) and petrolatum application for 1 h , and ( 3 ) 1 % sodium lauryl sulfate ( SLS ) aqueous solution and distilled water ( as control ) application for 20 min . RESULTS The condenser-chamber system , was the only device among these three that could show the effect of tape stripping on TEWL values as compared with baseline ( P<0.001 ) . The effect of moisturization , in terms of % change of TEWL values after application of cream and petrolatum , did not show significant difference between devices ( P>0.05 ) . However , only the values obtained from condenser-chamber device revealed a highly significant change as compared with baseline ( P<0.001 ) . Condenser-chamber system could also discriminate between the effect of moisturizer and petrolatum on TEWL values ( P<0.05 ) . The change of TEWL values after SLS application was shown to be significant by unventilated and condenser-chamber systems ( P<0.05 ) . However , none of the devices differentiated between the effect of water and 1 % SLS solution applied for 20 min . The values obtained from all three instruments correlate well with each other ( P<0.001 ) . CONCLUSION Our results highlight the differences between two closed-chamber TEWL measurement instruments , which are design ed based on different measurement principles . This may provide insights to find the best practice to improve the quality , precision and sensitivity of the measurements Stratum corneum lipids play a predominant role in maintaining the water barrier of the skin . In order to underst and the biological variation in the levels and composition of ceramides , ceramide 1 subtypes , cholesterol and fatty acids , stratum corneum lipids collected from tape strippings from three body sites ( face , h and , leg ) of female Caucasians of different age groups were analysed . In addition , we studied the influence of seasonal variation on the lipid composition of stratum corneum from the same body sites . The main lipid species were quantified using high-performance thin-layer chromatography and individual fatty acids using gas chromatography . Our findings demonstrated significantly decreased levels of all major lipid species , in particular ceramides , with increasing age . Similarly , the stratum corneum lipid levels of all the body sites examined were dramatically depleted in winter compared with spring and summer . The relative levels of ceramide 1 linoleate were also depleted in winter and in aged skin whereas ceramide 1 oleate levels increased . The other fatty acid levels remained fairly constant with both season and age , apart from lignoceric and heptadecanoic acid which showed a decrease in winter compared with summer . The decrease in the mass levels of intercellular lipids and the altered ratios of fatty acids esterified to ceramide 1 , are likely to contribute to the increased susceptibility of aged skin to perturbation of barrier function and xerosis , particularly during the winter months BACKGROUND The measurement of transepidermal water loss ( TEWL ) is used to monitor changes in the stratum corneum 's permeability to water vapor . This measurement is widely used in the cosmetics industry and in dermatology research . However , only limited work has been undertaken to assess the comparability of results from different TEWL meters over an extended range of measurements . METHODS This study compared the results of TEWL measurements between two commonly used open-chamber and closed-chamber TEWL devices . Five hundred and forty measurements were taken in 17 participants on the dorsum and palm of both h and s on two different days and the order of the devices was r and omized . RESULTS The results showed that the open TEWL meter 's capacity for measuring high values of TEWL was restricted , and that the closed-chamber TEWL meter was less sensitive to differences in the lower range of measurements . CONCLUSION Both devices have their strengths for different applications , but their results can not be directly compared . We were unable to find a statistical model that would allow us to transform the measurements made on one device for a comparison with the results generated by the other device Overwhelming evidence shows the quality of reporting of r and omised controlled trials ( RCTs ) is not optimal . Without transparent reporting , readers can not judge the reliability and validity of trial findings nor extract information for systematic review s. Recent method ological analyses indicate that inadequate reporting and design are associated with biased estimates of treatment effects . Such systematic error is seriously damaging to RCTs , which are considered the gold st and ard for evaluating interventions because of their ability to minimise or avoid bias . A group of scientists and editors developed the CONSORT ( Consoli date d St and ards of Reporting Trials ) statement to improve the quality of reporting of RCTs . It was first published in 1996 and up date d in 2001 . The statement consists of a checklist and flow diagram that authors can use for reporting an RCT . Many leading medical journals and major international editorial groups have endorsed the CONSORT statement . The statement facilitates critical appraisal and interpretation of RCTs . During the 2001 CONSORT revision , it became clear that explanation and elaboration of the principles underlying the CONSORT statement would help investigators and others to write or appraise trial reports . A CONSORT explanation and elaboration article was published in 2001 alongside the 2001 version of the CONSORT statement . After an expert meeting in January 2007 , the CONSORT statement has been further revised and is published as the CONSORT 2010 Statement . This up date improves the wording and clarity of the previous checklist and incorporates recommendations related to topics that have only recently received recognition , such as selective outcome reporting bias . This explanatory and elaboration document-intended to enhance the use , underst and ing , and dissemination of the CONSORT statement-has also been extensively revised . It presents the meaning and rationale for each new and up date d checklist item providing examples of good reporting and , where possible , references to relevant empirical studies . Several examples of flow diagrams are included . The CONSORT 2010 Statement , this revised explanatory and elaboration document , and the associated website ( www.consort-statement.org ) should be helpful re sources to improve reporting of r and omised trials BACKGROUND / AIM Transepidermal water loss ( TEWL ) is one of the most important biophysical parameters for evaluating the efficiency of the human skin water barrier . Different approaches exist to measure TEWL . The most commonly used methodology consists of the open chamber diffusion technique in which the water vapor pressure gradient is measured in g/h m2 according to Fick 's law . A typical apparatus is the Tewameter . Recently , a portable device -- the VapoMeter -- became available with a humidity sensor in a closed chamber . METHODS In the present work , the closed chamber VapoMeter is compared with the open chamber Tewameter for its applicability to assess TEWL . A comparative study --including parallel in vivo measurements with both devices -- was carried out on human forearm skin . RESULTS It could be concluded that both instruments are reliable tools . A good correlation between recordings ( r=0.503 - 0.966 ) was found with a consistent feature of measuring higher TEWL values for the Tewameter than for the VapoMeter . Probe pressure , probe temperature and relative humidity were revealed to be important parameters inducing significant differences in data outcome . CONCLUSIONS From skin barrier damage experiments it became clear that the Tewameter is able to detect significantly smaller differences than the VapoMeter . In addition , the closed chamber device is currently not sensitive enough to discriminate for the effects induced by diurnal rhythm and fluctuations as a function of time . On the other h and , the small and h and y VapoMeter allows more flexibility in measuring protocol s and in in-use performance OBJECTIVE The goal of the described study was complex assessment of age-specific morphofunctional features of skin of different anatomic localization using optical coherence tomography ( OCT ) . METHODS Forty-three healthy volunteers aging from 4 to 74 years were enrolled in the study . Optical and functional skin parameters were studied in 18 areas of the human body . All the studied areas were classified as open and closed , depending on external impact . Structural parameters of skin were determined by means of the OCT device equipped with a removable , flexible probe with microscanner ( registration certificate no. 022a2035/2213 - 05 ) design ed and fabricated at the IAP RAS ( Nizhny Novgorod , Russia ) with longitudinal and transverse resolution of about 20 μm . RESULTS Age-specific morphofunctional features of skin most evident in areas exposed to external action were found . Statistically significant difference in elasticity ( -0.57 , P = 0.00012 ) in areas closed to external action ( further referred to as closed areas ) and in useful signal depth , hydration and elasticity in areas exposed to external action ( further referred to as open areas ) was assessed for different age groups . Analysis of the dependence of parameters on age showed statistically significant correlations between age and thickness of cellular layers of the epidermis ( -0.33 , P = 0.035 ) , pigmentation level ( -0.22 , P = 0.044 ) and elasticity in closed areas and highly significant correlations between age and hydration and elasticity in open areas . CONCLUSION The current work is concerned with investigation of age-specific morpho-functional parameters of skin of different localizations The measurement of transepidermal water loss ( TEWL ) is an important noninvasive method in order to assess the barrier function of the stratum corneum . As a consequence , TEWL has been found to be a very useful technique for study ing skin irritation induced by various physical and chemical effects . Exposure of the skin to chemicals ( detergents ) and physical conditions ( occlusion and stripping ) generally results in an increase of TEWL . Until recently the only commercially available TEWL instrument was the Evaporimeter developed by ServoMed ( Sweden ) . The instrument is based on the open chamber system with two humidity and temperature sensors which measure the water evaporation gradient at the surface of the skin . Recently a new commercially available instrument based on the same physical principle of measurement was developed by Courage and Khazaka ( Tewameter , FRG ) . Our aim in this study has been to compare the measuring capacities of both instruments . The accuracy , sensitivity , variability and reproducibility of both instruments were compared in vivo under identical conditions on normal skin and skin damaged by external conditions . The influence of external and environmental factors such as air and probe temperature , relative humidity , air turbulence and pressure of application was evaluated for both instruments . Finally , the two instruments were compared in practice when following the increase in TEWL of the skin after stripping , occlusion and exposure to irritant household detergents . A very good correlation ( r = + 0.97 ) was found between the results of the two instruments over a wide range of TEWL values According to the European Society of Contact Dermatitis ( ESCD ) guidelines on the sodium lauryl sulfate ( SLS ) exposure test ‘ the flexor side of forearm skin with cubital fossa and wrist excluded is the preferred study site ’ . In this study we analysed the exact anatomic region within the suggested test area in respect to the outcome of the SLS exposure test . 3 test areas at the volar forearm were chosen : ‘ distal ’ with a 5‐cm distance to the wrist , exact ‘ midvolar ’ and ‘ proximal ’ with a 5‐cm distance to the cubital fossa . 25 healthy volunteers were irritated for 24 hr with 1 % SLS . Transepidermal water loss ( TEWL ) measurements were taken before and 1 and 24 hr after removal of Finn Chambers ® . Median baseline TEWL showed no significant differences in the 3 test sites . However , postexposure TEWL proximal was significantly ( P < 0.01 ) higher than midvolar and distal . The distal volar forearm showed the lowest TEWL 24 h after the irritation . The differences were in comparison to midvolar ( P < 0.01 ) and proximal ( P < 0.001 ) significant . The results show that it is essential to point out the exact position of the test area at the volar forearm in study reports and to r and omize the irritation areas at the volar forearm if different treatments are to be compared BACKGROUND / AIM The measurement of transepidermal water loss ( TEWL ) is frequently used to evaluate the barrier function of the stratum corneum ( SC ) of diseased skin in vivo , as well as normal skin damaged by external injurious agents . For this purpose , most people use biophysical instruments , based on an open chamber system , measuring the water vapor pressure gradient produced above the skin surface by vapor passing through the SC barrier . Recently , we tested a new portable device ( Model H4300 NIKKISO-YSI CO . , LTD . , Tokyo , Japan ) based on a closed chamber system . Its measuring principle is based on a computed TEWL estimation , from the progressive increase in relative humidity inside a closed chamber , due to continuous water evaporation from the skin surface on which the chamber is placed . METHODS We conducted an in vivo comparative study between the new portable device and a conventional method , using the DermaLab ( Cortex Technology , Hadsund , Denmark ) , on both healthy and diseased skin surfaces , under well-controlled , st and ardized , experimental conditions ( 21 degrees C and 50 % relative humidity ) . RESULTS We found that the sensitivity of the new device was similar to that of the DermaLab . For example , the poor SC
Output:
| TEWL in individuals being 65 years and above was consistently lower compared to the group of 18- to 64-year-old individuals . |
MS210646 | ***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: PURPOSE Individuals experiencing myocardial infa rct ion ( MI ) report anxiety , depression , diminished quality of life ( QOL ) , and reduced sexual activity . DESIGN AND METHODS We examined return to sexual activity post-MI , and pilot tested a comprehensive sexual counseling intervention based on social-cognitive theory . The intervention in this pretest/posttest preexperimental study used an informational video , newsletters , and telephone counseling , with cardiac patients ( N = 10 ) and partners ( N = 3 ) . Measures included QOL ; knowledge ; sexual anxiety , depression , self-efficacy , and satisfaction . FINDINGS At 8 weeks , only 60 % had returned to sexual activity , with low QOL and sexual satisfaction for patients and partners . PRACTICE IMPLICATION S Supportive interventions by nurses are needed to assist MI patients and partners return to sexual activity Twenty-eight male cardiac patients who had either experienced myocardial infa rct ion or undergone coronary bypass surgery were assigned to a treatment condition and participated in a 3-month , exercise-based Cardiac Rehabilitation Program , whereas 20 other cardiac patients were assigned to a routine-care condition and did not participate in the rehabilitation program . Cardiovascular , psychological , and psychosocial functioning were assessed before treatment or routine care was begun , after 3 months of treatment or routine care , and 4 months later . Results indicated that patients in the treatment condition evidence d reliably more efficient cardiovascular functioning ( resting heart rate , resting diastolic blood pressure , treadmill exercise performance , exercise heart rate , exercise systolic blood pressure ) , better underst and ing of heart disease , better underst and ing of and reported compliance with treatment recommendations , more positive self-perceptions ( health , body concept , self-concept , progress toward goals ) , and better psychosocial functioning ( e.g. , decreased employmentrelated stress , more active use and enjoyment of leisure time , more physical and sexual activity ) . Chronic patients benefited as much from the treatment as did acute patients , and the beneficial effects for all treated patients were evident not only just after rehabilitation , but also 4 months later . This investigation appears to be the first such test of effects of this type of treatment , and the results have wide generalizability and applicability Background Sexual problems are common among people with coronary heart disease and can adversely affect patients ' quality of life . GPs are ideally placed to deal with these problems . Research suggests that GPs are reluctant to address sexual problems but little is known about what currently takes place in practice . The aim of this study was to examine GPs ' self-reported behaviour and attitudes to discussing sexual problems with people with coronary heart disease . Method Design : A cross-sectional survey which administered 230 postal question naires to a nationally representative , stratified r and om sample of GPs in the Republic of Irel and . GPs were asked about current practice , knowledge , awareness and confidence in dealing with sexual problems , barriers to addressing sexual problems , and about improving services in this area . Results Responses were available for 61 GPs ( 27 % response rate ) . Seventy percent of GPs reported that they rarely or never discussed sexual problems with coronary patients . While all GPs believed addressing sexual problems was important , many GPs reported lacking awareness , knowledge and confidence in addressing sexual problems . The main barriers were lack of time , feeling the patient was n't ready and lack of training in the area . GPs wanted more training and guidelines for practice . Conclusions There is currently no st and ardised protocol for GPs for dealing with sexual problems among coronary patients . Awareness of these issues appears to be low among GPs . Services could be improved by developing practice guidelines for brief , effective actions or assessment s , providing training in the area and improving information re sources and support services for referral This study prospect ively examined the role of cognitive behavioral therapy ( CBT ) in ( 1 ) alleviating psychological and somatic distress , and ( 2 ) lowering arrhythmic events requiring shocks . Forty-nine of 61 consecutive patients were r and omized into therapy ( CBT , n = 25 ) or no therapy ( NT , n = 24 ) and completed a battery of self-report question naires at baseline and at 9-month follow-up . CBT was administered at preimplant , predischarge , and at seven routine follow-up visits . Patients were 65 + /- 10 years old , 65 % were men , and 92 % Caucasian . Eighteen ( 72 % ) CBT patients and 18 ( 75 % ) NT patients were retained at follow-up . Compared to CBT patients , NT patients reported higher levels of depression ( P = 0.046 ) , more anxiety ( P = 0.013 ) , more psychological distress ( P = 0.015 ) , poorer overall adjustment ( P = 0.009 ) , and poorer sexual functioning ( P = 0.003 ) . Mean number of shocks did not differ between the CBT and NT groups ( 2.85 vs 2.30 , respectively ) ; however , more patients in the CBT group ( 61 % ) than the NT group ( 33 % ) received shocks ( P = 0.070 ) . At follow-up , a subgroup analysis revealed that the significant differences observed between the CBT and NT groups were attributable to the patients who received shocks in both groups . In conclusion , CBT was associated with decreased depression , decreased anxiety , and increased adjustment for ICD recipients , particularly among those patients receiving shocks . CBT can be administered effectively at routine follow-up visits or transtelephonically with little added inconvenience to the ICD recipient Background Growing evidence exists that living with an ICD can lead to fear and avoidance behaviour including the avoidance of physical activity . It has been suggested that psychological stress can increase the risk of shock and predict death . Small studies have indicated a beneficial effect arising from exercise training and psychological intervention , therefore a large-scale rehabilitation programme was set up . Methods / Design A mixed methods embedded experimental design was chosen to include both quantitative and qualitative measures . A r and omised clinical trial is its primary component . 196 patients ( power-calculated ) were block r and omised to either a control group or intervention group at a single centre . The intervention consists of a 1-year psycho-educational component provided by two nurses and a 12-week exercise training component provided by two physiotherapists . Our hypothesis is that the COPE-ICD programme will reduce avoidance behaviour , sexual dysfunction and increase quality of life , increase physical capability , reduce the number of treatment-dem and ing arrhythmias , reduce mortality and acute re-hospitalisation , reduce sickness leading to absence from work and be cost-effective . A blinded investigator will perform all physical tests and data collection . Discussion Most participants are men ( 79 % ) with a mean age of 58 ( range 20 - 85 ) . Most ICD implantations are on primary prophylactic indication ( 66 % ) . 44 % is NYHA II . Mean walk capacity ( 6MWT ) is 417 m. Mean perception of General Health ( SF-36 ) is PCS 42.6 and MCS 47.1.A large-scale ICD rehabilitation trial including psycho-educational intervention and exercise training has been initiated and will report findings starting in 2011.Trial Registration Clinical Trials.gov : A two-group r and omized clinical trial was used to test the hypothesis that patients with myocardial infa rct ion ( MI ) who receive both written instructions and a videotape to view at home will have greater knowledge , better quality of life , less anxiety , greater sexual satisfaction , and will resume sexual activity more quickly than will those who receive written instructions alone . The participants , 115 patients diagnosed with an MI , were pretested in the hospital and followed at home at 1 , 3 , and 5 months . The intervention was an educational videotape on return to sexual activity . Significant improvements in knowledge were found for the experimental group at 1 month . The videotape intervention provides an alternative method for education to facilitate recovery post-MI For this study a r and omized clinical trial was design ed to test the effects of an early home recovery information intervention on physical functioning , psychological distress , and symptom frequency 1 month following coronary artery bypass graft surgery ( CABG ) . Recovery outcomes were compared between two groups : those receiving an audiotape of information on expected physical sensations and their management ( Cardiac Home Information Program [ CHIP ] ) in addition to the usual care , and those receiving the usual cardiac discharge information protocol . A nonprobability sample of 180 patients ( 84 women and 96 men ; mean age = 62 years ) was equally distributed between the two study groups . When controlling for age , comorbidity , and cardiac functional status , the results showed positive effects on physical functioning in women and psychological distress , vigor and fatigue in men . Consistent with other studies , women had worse physical functioning and more symptom frequency than men . These findings indicate that the CHIP intervention is an effective method to prepare CABG patients for home recovery Introduction Sexuality is an important part of people ’s physical and mental health . Patients with heart disease often suffer from sexual dysfunction . Sexual dysfunction has a negative impact on quality of life and well-being in persons with heart disease , and sexual dysfunction is associated with anxiety and depression . Treatment and care possibilities seem to be lacking . Studies indicate that non-pharmacological interventions such as exercise training and psychoeducation possess the potential of reducing sexual dysfunction in patients with heart disease . The CopenHeartSF trial will investigate the effect of a comprehensive sexual rehabilitation programme versus usual care . Methods and analysis CopenHeartSF is an investigator-initiated r and omised clinical superiority trial with blinded outcome assessment , with 1:1 central r and omisation to sexual rehabilitation plus usual care versus usual care alone . Based on sample size calculations , 154 male patients with impaired sexual function due to implantable cardioverter defibrillator or ischaemic heart disease will be included from two university hospitals in Denmark . All patients receive usual care and patients allocated to the experimental intervention group follow a 12-week sexual rehabilitation programme consisting of an individualised exercise programme and psychoeducative consultation with a specially trained nurse . The primary outcome is sexual function measured by the International Index of Erectile Function . The secondary outcome measure is psychosocial adjustment to illness by the Psychosocial Adjustment to Illness Scale , sexual domain . A number of explorative analyses will also be conducted . Ethics and dissemination CopenHeartSF is approved by the regional ethics committee ( no H-4 - 2012 - 168 ) and the Danish Data Protection Agency ( no 2007 - 58 - 0015 ) and is performed in accordance with good clinical practice and the Declaration of Helsinki in its latest form . Registration Clinical trials.gov identifier : NCT01796353 The present study was conducted to examine whether a sexual rehabilitation intervention program , which was developed during the present study and design ed for stroke patients and their spouses , was effective in terms of sexual knowledge and satisfaction and frequency of sexual activity at 1 month after intervention . The study subjects were conveniently selected from stroke patients admitted to the neurology department at a university hospital located in Incheon , South Korea . A total of 46 subjects ( 12 couples for the experimental group and 11 couples for the control group ) were included . Sexual knowledge , sexual satisfaction , frequency of sexual activity , level of cognitive function , and performance with respect to daily living activities were measured . The results obtained demonstrated that the devised sexual rehabilitation intervention program significantly increased sexual satisfaction and frequency of sexual activity , but that it did not promote sexual knowledge . The present study has meaning because the intervention program could be used as a practical guideline for post-stroke sexual rehabilitation . In addition , the findings of this study provide evidence regarding the usefulness of sexual education and counseling on the sexual health of post-stroke patients and their spouses The British Heart Foundation and the Chest , Heart and Stroke Association have allocated funds to develop cardiac rehabilitation programmes . We have recently completed and now evaluate an exercise-based rehabilitation course reinforced with advice about return to normal activity for 110 patients who had suffered acute myocardial infa rct ion . Patients admitted to the Plymouth cardiac care unit were r and omised into groups : a control group to receive st and ard hospital care , and a rehabilitation group who , in addition , received an exercise programme reinforced with advice . Patients were assessed at entry to the study and at intervals thereafter . Assessment was by question naire and objective tests consisting of a 12-minute walking test and weekly outpatient pedometry . In the rehabilitation group patients were able to walk further and faster , return to work earlier , undertake more housework , and resume normal sexual activity ; they were less short of breath and did not experience more angina . However , the rehabilitation course brought little benefit to the patients ' perception of well-being and their anxiety about health or their outlook on life . Exercise and advice are important components of a rehabilitation programme , but more attention needs to be given to the psychological aspects of recovery from a heart attack Sexual dysfunction is a common problem of increasing incidence that is associated with multiple co-morbid conditions and chronic diseases . In heart failure , however , exact numbers are unknown , in part secondary to under-reporting and under-interrogating by health care providers . A gender-specific question naire was modified from established sexual dysfunction question naires to correspond to a non-r and omized outpatient heart failure population , to assess the prevalence and demographic distribution of sexual dysfunction and potential treatments expectations . One-hundred patients in a stable hemodynamic condition in New York Heart Association classes I – III participated . Eighty-seven percent of women were diagnosed with female sexual dysfunction compared to 84 % of men with erectile dysfunction . Eighty percent of women reported reduced lubrication , which result ed in frequent unsuccessful intercourse in 76 % . Thirty-six percent of patients thought that sexual activity could harm their current cardiac condition ;
Output:
| We found no high quality evidence to support the effectiveness of sexual counselling for sexual problems in patients with cardiovascular disease . |
MS210647 | ***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 In the treatment of severe malaria , intravenous artesunate is more rapidly acting than intravenous quinine in terms of parasite clearance , is safer , and is simpler to administer , but whether it can reduce mortality is uncertain . METHODS We did an open-label r and omised controlled trial in patients admitted to hospital with severe falciparum malaria in Bangladesh , India , Indonesia , and Myanmar . We assigned individuals intravenous artesunate 2.4 mg/kg bodyweight given as a bolus ( n=730 ) at 0 , 12 , and 24 h , and then daily , or intravenous quinine ( 20 mg salt per kg loading dose infused over 4 h then 10 mg/kg infused over 2 - 8 h three times a day ; n=731 ) . Oral medication was substituted when possible to complete treatment . Our primary endpoint was death from severe malaria , and analysis was by intention to treat . FINDINGS We assessed all patients r and omised for the primary endpoint . Mortality in artesunate recipients was 15 % ( 107 of 730 ) compared with 22 % ( 164 of 731 ) in quinine recipients ; an absolute reduction of 34.7 % ( 95 % CI 18.5 - 47.6 % ; p=0.0002 ) . Treatment with artesunate was well tolerated , whereas quinine was associated with hypoglycaemia ( relative risk 3.2 , 1.3 - 7.8 ; p=0.009 ) . INTERPRETATION Artesunate should become the treatment of choice for severe falciparum malaria in adults From June 1993 to June 1994 , a study was carried out to compare artemether and quinine for management of severe falciparum malaria in adults and adolescents in Cameroon . Artemether was administered intramuscularly at a dose of 3.6 mg/kg on the first day and 1.6 mg/kg for the following 4 days . Quinine was administered intravenously at a dose of 1.6 mg/kg for the first 4 hours and 8 mg every 8 hours for the next 3 days . The files of 84 of the 95 patients recruited were vali date d for inclusion in the final study . There were 40 patients in the artemether group and 44 in the quinine group . The two groups were comparable with regard to all factors at the time of inclusion . Findings showed that artemether was more effective than quinine with regard to total clearance of parasitemia , 90 p. 100 clearance , and fever control and that it was as effective with regard to 50 p. 100 clearance and recovery of consciousness . In view of its good performance and of the simplicity of its administration by intramuscular injection , artemether would appear to be an excellent alternative for treatment of severe malaria and cerebral malaria in areas with poor medical facilities We have compared the efficacy of artemether versus quinine as treatment for cerebral malaria in children in an open r and omized clinical trial in Kenya . Children admitted to hospital with coma and Plasmodium falciparum parasitaemia were treated with either intramuscular artemether ( 3.2 mg/kg loading dose followed by 1.6 mg/kg daily ) or intravenous quinine ( 20 mg/kg loading dose followed by 10 mg/kg every 8 h ) . Both drugs were well tolerated and no significant adverse effect was observed . Parasite clearance times ( 50 % and 90 % ) were shorter in patients treated with artemether ( median times [ h ] , with interquartile ranges in brackets , were : 50 % , 7.3 [ 4.2 - 12.4 ] vs. 15.5 [ 9 - 22 ] ; 90 % , 16.9 [ 13.2 - 25 ] vs. 28.5 [ 22 - 35 ] ; P < 0.0001 ) . The total mortality in 160 children with cerebral malaria was 16.25 % , with no overall significant difference between the 2 treatment groups . In a subgroup of children with respiratory distress , mortality was higher in those treated with artemether ( 43.7 % vs. 11.1 % , P < 0.05 ) . The frequency of neurological sequelae and clinical recovery times were similar in both treatment groups . We conclude that there would currently be no advantage in replacing quinine with artemether for the treatment of cerebral malaria in African children Severe malaria remains a major cause of mortality and morbidity for children living in many tropical regions . With the emergence of strains of Plasmodium falciparum resistant to both chloroquine and quinine , alternative antimalarial agents are required . The artemisinin group of compounds are rapidly effective in severe disease when given by intramuscular or intravenous injection . However , these routes of administration are not always available in rural areas . In an open , r and omized comparison 109 Vietnamese children , aged between 3 months and 14 years , with severe P.falciparum malaria , were allocated at r and om to receive artemisinin suppositories followed by mefloquine ( n = 37 ) , intramuscular artesunate followed by mefloquine ( n = 37 ) , or intravenous quinine followed by pyrimethamine/sulfadoxine ( n = 35 ) . There were 9 deaths : 2 artemisinin , 4 artesunate and 5 quinine-treated children . There was no difference in fever clearance time , coma recovery , or length of hospital stay among the 3 groups . However , parasite clearance times were significantly faster in artemisinin and artesunate-treated patients than in those who received quinine ( P < 0.0001 ) . Both artemisinin and artesunate were very well tolerated , but children receiving these drugs had lower peripheral reticulocyte counts by day 5 of treatment than those in the quinine group ( P = 0.011 ) . No other adverse effect or toxicity was found . There was no treatment failure in these 2 groups , but 4 patients in the quinine group failed to clear their parasites within 7 d of starting treatment and required alternative antimalarial therapy . Artemisinin suppositories are easy to administer , cheap , and very effective for treating children with severe malaria . In rural areas where medical facilities are lacking these drugs will allow antimalarial therapy to be instituted earlier in the course of the disease and may therefore save lives The efficacy of a 5-day treatment with intramuscular artemether ( 3.2-mg/kg loading dose followed by 1.6 mg/kg daily ) was compared to that of the st and ard 7-day treatment with quinine ( 20-mg/kg loading dose followed by 10 mg/kg every 8 h ) in a r and omised clinical trial including 103 children aged 12 - 60 months with cerebral malaria between 1994 and 1996 . No statistical difference of immediate efficacy was found between the two treatments . There were 11 ( 20 % ) deaths in the artemether group and 14 ( 28 % ) in the children who received quinine . The respective artemether versus quinine median fever clearance times ( h ) were 39 ( interquartile ranges [ IQ ] 30 - 54 ) vs. 48 ( IQ 30 - 60 ) , and parasite clearance 42 ( IQ 24 - 60 ) vs. 36 ( IQ 30 - 48 ) . However , one patient who received artemether had a recrudescence on day 14 , which was successfully treated with sulphadoxine-pyrimethamine . Times to recovery from coma were 24 h ( IQ 18 - 45 ) and 33 h ( IQ 19 - 57 ) , respectively . The occurrence of transient neurological sequelae including motor disabilities , cortical blindness , and afebrile seizures was also similar in the two groups . No adverse reactions to the two drugs were recorded during the study period . Artemether represents an important option in the management of cerebral malaria in Nigeria especially in rural areas where facilities for intravenous administration may not yet be optimal OBJECTIVE To compare the clinical efficacy and safety of rectal dihydroartemisinin ( DATM -- Cotecxin ) and intravenous quinine in the treatment of severe malaria in children and adults . SETTING Moi Teaching and Referral Hospital , Eldoret , Kenya between July and November 1998 . PATIENTS A total of sixty seven patients aged two to sixty years with severe malaria were studied . DESIGN This was an open r and omised comparative clinical trial . OUTCOME MEASURES These were parasite clearance time , fever clearance time , efficacy and the side effect profile of the two drugs . RESULTS The two groups were comparable on admission on the clinical and laboratory parameters . The parasite clearance time was shorter in the rectal DATM group than quinine group . There was no statistical difference on the fever clearance time and cure rates in the two groups . The adverse reaction profile was better with rectal DATM than with quinine , tinnitus observed more in the quinine group . CONCLUSION Rectal DATM is faster in parasite clearance than quinine and is a safe and convenient alternative to quinine in the treatment of severe malaria OBJECTIVE To compare the efficacy of artemether and quinine in the treatment of severe malaria in hospitalized children . STUDY DESIGN Open r and omized trial . SETTING Pediatric ward of a tertiary care center . METHODS All children admitted with clinical manifestations of severe malaria ( as per WHO criteria ) and asexual forms of Plasmodium falciparum demonstrated on peripheral smear were r and omized to receive either artemether or quinine . Their clinical status and smears for parasite count were assessed every 12 hours until two successive blood films were negative . The primary end point of the study was death in the hospital and residual damage to the organ involved . The secondary end points were clearance of parasites and fever , length of time of recovery from coma and normal functions of the involved system . RESULTS Forty-six cases completed the study protocol , 23 assigned to each drug group . Cerebral malaria was the commonest manifestation ( 76.1 % ) . Mean age in artemether versus quinine group ( 6.6 + /- 3.5 and 5.8 + /- 2.4 years ) as well as degree of parasitemia at admission ( 55,800 and 60,300 per microlitre ) were comparable . The overall mortality rate was 23.9 % with no significant difference between the two groups . Twenty six cases ( 56.5 % ) presented with more than one manifestations of severe malaria . The mortality rate was 100 % with four coexisting manifestations of severe malaria . Fever clearance time in artemether and quinine group was 44.5 and 45.9 hours respectively ( P > 0.05 ) . Parasite clearance time was significantly shorter in artemether group ( 40.9 vs. 51.9 hours ; P<0.001 ) . Recovery from coma was shorter in artemether group ( 34.8 vs. 38.1 hours ; P<0.05 ) . CONCLUSION Cerebral malaria is the most common manifestation of severe malaria in children . Artemether is a good alternative drug to quinine for P. falciparum malaria . Mortality rate is directly proportional to the number of coexisting manifestations of severe malaria One hundred and two children aged 0 - 10 years with cerebral malaria ( Blantyre coma score of 2 or less ) were r and omly treated either with intramuscular arteether ( 3.2 mg/kg on Day 0 , followed by 1.6 mg/kg on Days 1 to 4 ) or intravenous ( i.v . ) quinine dihydrochloride ( 20 mg of the salt/kg , followed by 10 mg of the salt/kg every 8 hr up to Day 6 ) . Treatment with oral quinine sulfate ( 10 mg/kg every 8 hr ) was substituted for i.v . quinine when the patient was able to take oral medicine . All patients were followed up in the hospital for 7 days ; thereafter , they were treated as out patients on Days 14 , 21 , and 28 . Mortality rate , the main efficacy parameter , was 11.8 % lower in the arteether treatment group than in the quinine group ( 15.7 % versus 27.4 % ) ; however , the difference was not significant ( P = 0.25 ) . Means for fever clearance time , coma resolution time , and parasite clearance time were similar in the 2 treatment groups ( 42.2 + /- 34.9 hr ; 34.8 + /- 18.8 hr , and 46.3 + /- 28.5 hr , respectively for arteether , versus 45.0 + /- 26.7 hr ; 30.3 + /- 18.9 hr , and 40.7 + /- 18.9 hr , respectively , for quinine ) . At 28 days , the cure rates were 73.2 % and 64.9 % for the arteether and quinine treatment groups , respectively . Arteether is safe and therapeutically at least as effective as quinine for the treatment of cerebral malaria in children in Cameroon . Because of its ease of administration , arteether appears to be suited for use in the rural zones where
Output:
| The WHO ’s 2010 Guideline ( 1 ) strongly recommends aresunate in adults with severe malaria , positioning quinine only as an alternative ; however , it cites lack of evidence to frame a similar recommendation for children |
MS210648 | ***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 Although the Pneumonia Severity Index ( PSI ) has been extensively vali date d , little is known of the impact of its routine use as an aid to site-of-treatment decisions for patients with pneumonia who present to emergency departments ( EDs ) . METHODS A prospect i ve , observational , controlled cohort study of patients with pneumonia was conducted in 8 EDs that used the PSI ( PSI-user EDs ) and 8 EDs that did not use the PSI ( PSI-nonuser EDs ) in France . The outcomes examined included the proportion of " low-risk " patients ( PSI risk classes I-III ) treated as out patients , all-cause 28-day mortality , admission of in patients to the intensive care unit , and subsequent hospitalization of out patients . RESULTS Of the 925 patients enrolled in the study , 472 ( 51.0 % ) were treated at PSI-user EDs , and 453 ( 49.0 % ) were treated at PSI-nonuser EDs ; 449 ( 48.5 % ) of all patients were considered to be at low risk . In PSI-user EDs , 92 ( 42.8 % ) of 215 patients at low risk were treated as out patients , compared with 56 ( 23.9 % ) of 234 patients at low risk in PSI-nonuser EDs . The adjusted odds ratios for outpatient treatment were higher for patients in PSI risk classes I and II who were treated in PSI-user EDs , compared with PSI-nonuser EDs ( adjusted odds ratio , 7.0 [ 95 % confidence interval , 2.0 - 25.0 ] and 4.6 [ 95 % confidence interval , 1.3 - 16.2 ] , respectively ) , whereas the adjusted odds ratio did not differ by PSI-user status among patients in risk class III or among patients at high risk . After adjusting for pneumonia severity , mortality was lower in patients who were treated in PSI-user EDs ; other safety outcomes did not differ between patients treated in PSI-user and PSI-nonuser EDs . CONCLUSIONS The routine use of the PSI was associated with a larger proportion of patients in PSI risk classes I and II who had pneumonia and who were treated in the outpatient environment without compromising their safety Prognosis studies are investigations of future events or the evaluation of associations between risk factors and health outcomes in population s of patients ( 1 ) . The results of such studies improve our underst and ing of the clinical course of a disease and assist clinicians in making informed decisions about how best to manage patients . Prognostic research also informs the design of intervention studies by helping define subgroups of patients who may benefit from a new treatment and by providing necessary information about the natural history of a disorder ( 2 ) . There has recently been a rapid increase in the use of systematic review methods to synthesize the evidence on research questions related to prognosis . It is essential that investigators conducting systematic review s thoroughly appraise the method ologic quality of included studies to be confident that a study 's design , conduct , analysis , and interpretation have adequately reduced the opportunity for bias ( 3 , 4 ) . Caution is warranted , however , because inclusion of method ologically weak studies can threaten the internal validity of a systematic review ( 4 ) . This follows abundant empirical evidence that inadequate attention to biases can cause invalid results and inferences ( 5 - 9 ) . However , there is limited consensus on how to appraise the quality of prognosis studies ( 1 ) . A useful framework to assess bias in such studies follows the basic principles of epidemiologic research ( 10 , 11 ) . We focus on 6 areas of potential bias : study participation , study attrition , prognostic factor measurement , confounding measurement and account , outcome measurement , and analysis . The main objectives of our review of review s are to describe methods used to assess the quality of prognosis studies and to describe how well current practice s assess potential biases . Our secondary objective is to develop recommendations to guide future quality appraisal , both within single studies of prognostic factors and within systematic review s of the evidence . We hope this work facilitates future discussion and research on biases in prognosis studies and systematic review s. Methods Literature Search and Study Selection We identified systematic review s of prognosis studies by search ing MEDLINE ( 1966 to October 2005 ) using the search strategy recommended by McKibbon and colleagues ( 12 ) . This strategy combines broad search terms for systematic review s ( systematic review .mp ; meta- analysis .mp ) and a sensitive search strategy for prognosis studies ( cohort , incidence , mortality , follow-up studies , prognos * , predict * , or course ) . We also search ed the reference lists of included review s and method ologic papers to identify other relevant publications . We restricted our search to English- language publications . One review er conducted the search and selected the studies . Systematic review s , defined as review s of published studies with a comprehensive search and systematic selection , were included if they assessed the method ologic quality of the included studies by using 1 or more explicit criteria . We excluded studies if they were meta-analyses of independent patient data only , if their primary goal was to investigate the effectiveness of an intervention or specific diagnostic or screening tests , or if they included studies that were not done on humans . Data Extraction and Synthesis Individual items included in the quality assessment of the systematic review s were recorded as they were reported in the publication ( that is , the information that would be available to readers and future review ers ) . We review ed journal Web sites and contacted the authors of the systematic review s for additional information when authors made such an offer in their original papers . When review s assessed different study design s by using different sets of quality items , we extracted only those items used to assess cohort studies . We constructed a comprehensive list of distinct items that the review s used to assess the quality of their included studies . The full text of each review was screened . All items used by the review authors to assess the quality of studies were extracted into a computerized spreadsheet by 1 review er . Two experienced review ers , a clinical epidemiologist and an epidemiologist , independently synthesized the quality items extracted from the prognosis review s to determine how well the systematic review s assessed potential biases . We did this in 3 steps : 1 ) identified distinct concepts or domains addressed by the quality items ; 2 ) grouped each extracted quality item into the appropriate domain or domains ; and 3 ) identified the domains necessary to assess potential biases in prognosis studies . We then used this information to assess how well the review s ' quality assessment included items from the domains necessary to assess potential biases . After completing each of the first 3 steps , the review ers met to attempt to reach a consensus . The consensus process involved each review er presenting his or her observations and results , followed by discussion and debate . A third review er was available in cases of persistent disagreement or uncertainty . In the first step , all domains addressed by the quality items were identified . The first review er iteratively and progressively defined the domains as items were extracted from the included review s. The second review er defined domains from a r and om list of all extracted quality items . Limited guidance was provided to the review ers so that their assessment s and definitions of domains would be independent . The review ers agreed on a final set of domains that adequately and completely defined all of the extracted items . In the second step , review ers independently grouped each extracted item into the appropriate domains . Review ers considered each extracted item by asking , What is each particular quality item addressing ? or What are the review 's authors getting at with the particular quality assessment item ? . Items were grouped into the domain or domains that best represented the concepts being addressed . For example , the extracted items at least 80 % of the group originally identified was located for follow-up and follow-up was sufficiently complete or does n't jeopardize validity were each independently classified by both review ers as assessing the domain completeness of follow-up adequate , whereas the extracted item quantification and description of all subjects lost to follow-up was classified as assessing the domain completeness of follow-up described . In the third step , we identified the domains necessary to assess potential biases . Each review er considered the ability of the identified domains to adequately address , at least in part , 1 of the following 6 potential biases : 1 ) study participation , 2 ) study attrition , 3 ) prognostic factor measurement , 4 ) confounding measurement and account , 5 ) outcome measurement , and 6 ) analysis . Domains were considered to adequately address part of the framework if information garnered from that domain would inform the assessment of potential bias . For example , both review ers judged that the identified domain study population represents source population or population of interest assessed potential bias in a prognosis study , whereas the domain research question definition did not , although the latter is an important consideration in assessing the inclusion of studies in a systematic review . Finally , on the basis of our previous ratings , we looked at whether each review included items from the domains necessary to assess the 6 potential biases . We calculated the frequency of systematic review s by assessing each potential bias and the number of review s that adequately assessed bias overall . From this systematic synthesis , we developed recommendations for improving quality appraisal in future systematic review s of prognosis studies . We used Microsoft Access and Excel 2002 ( Microsoft Corp. , Redmond , Washington ) for data management and SAS for Windows , version 9.1 ( SAS Institute , Inc. , Cary , North Carolina ) for descriptive statistics . Role of the Funding Sources The funding sources , the Canadian Institutes of Health Research , the Canadian Chiropractic Research Foundation , the Ontario Chiropractic Association , and the Ontario Ministry of Health and Long Term Care , did not have a role in the collection , analysis , or interpretation of the data or in the decision to su bmi t the manuscript for publication . Results We identified 1384 potentially relevant articles . Figure 1 shows a flow chart of studies that were included and excluded . Figure 2 shows the number of review s identified by year of publication . We excluded 131 systematic review s of prognosis studies that did not seem to include any quality assessment of the included studies ; this represented 44 % of prognosis review s. We included 163 review s of prognosis studies in our analysis ( 13 - 175 ) . The most common topics were cancer ( 15 % ) , musculoskeletal disorders and rheumatology ( 13 % ) , cardiovascular ( 10 % ) , neurology ( 10 % ) , and obstetrics ( 10 % ) . Other review s included a wide range of health and health care topics . Sixty-three percent of the review s investigated the association between a specific prognostic factor and a particular outcome ; the remainder investigated multiple prognostic factors or models . The number of primary studies included in each systematic review ranged from 3 to 167 ( median , 18 [ interquartile range , 12 to 31 ] ) . A complete description of the included review s is available from the authors on request . Figure 1 . Flow diagram of inclusion and exclusion criteria of systematic review s. Figure 2 . Number of systematic review s of prognosis studies identified over time . Quality Items One hundred fifty-three review s provided adequate detail to allow extraction of quality items . Eight hundred eighty-two distinct quality items were extracted from the review s. Most review s developed their own set of quality items , with only a few applying criteria from previous review s. Most quality items Background : Several severity scores have been proposed to predict patient outcome and to guide initial management of patients with community acquired pneumonia ( CAP ) . Most have been derived as predictors of mortality . A study was undertaken to compare the predictive value of these tools using different clinical ly meaningful outcomes as constructs for “ severe pneumonia ” . Methods : A prospect i ve cohort study was performed of all patients presenting to the emergency department with an admission diagnosis of CAP from March 2003 to March 2004 . Clinical and laboratory features at presentation were used to calculate severity scores using the pneumonia severity index ( PSI ) , the revised American Thoracic Society score ( rATS ) , and the British Thoracic Society ( BTS ) severity scores CURB , modified BTS severity score , and CURB-65 . The sensitivity , specificity , positive and negative predictive values were compared for four different outcomes ( death , need for ICU admission , and combined outcomes of death and /or need for ventilatory or inotropic support ) . Results : 392 patients were included in the analysis ; 37 ( 9.4 % ) died and 26 ( 6.6 % ) required ventilatory and /or inotropic support . The modified BTS severity score performed best for all four outcomes . The PSI ( classes IV+V ) and CURB had a very similar performance as predictive tools for each outcome . The rATS identified the need for ICU admission well but not mortality . The CURB-65 score predicted mortality well but performed less well when requirement for ICU was included in the outcome of interest . When the combined outcome was evaluated ( excluding patients aged > 90 years and those from nursing homes ) , the best predictors were the modified BTS severity score ( sensitivity 94.3 % ) and the PSI and CURB score ( sensitivity 83.3 % for both ) . Conclusions : Different severity scores have different strengths and weaknesses as prediction tools . Validation should be done in the most relevant clinical setting , using more appropriate constructs of “ severe pneumonia ” to ensure that these potentially useful tools truly deliver what clinicians expect of them Background : A study was undertaken to vali date the modified American Thoracic Society ( ATS ) rule and two British Thoracic Society ( BTS ) rules for the prediction of ICU admission and mortality of community acquired pneumonia and to provide a validation of these predictions on the basis of the pneumonia severity index ( PSI ) . Method : Six hundred and ninety six consecutive patients ( 457 men ( 66 % ) , mean ( SD ) age 67.8 ( 17.1 ) years , range 18–101 ) admitted to a tertiary care hospital were studied prospect ively . Of these , 116 ( 16.7 % ) were admitted to the ICU . Results : The modified ATS rule achieved a sensitivity of 69 % ( 95 % CI 50.7 to 77.2 ) , specificity of 97 % ( 95 % CI 96.4 to 98.9 ) , positive predictive value of 87 % ( 95 % CI 78.3 to 93.1
Output:
| Conclusions New severity scores for predicting the need for ICU or intensive treatment in patients with CAP , such as ATS/IDSA 2007 minor criteria , SCAP score , and SMART-COP , have better discriminative performances compared with PSI and CURB-65 .
High negative predictive value is the most consistent finding among the different prediction rules . |
MS210649 | ***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 if cognitive behavior therapy ( CBT ) based on exposure and mindfulness exercises delivered via the Internet would be effective in treating participants with irritable bowel syndrome ( IBS ) . Participants were recruited through self-referral . Eighty-six participants were included in the study and r and omized to treatment or control condition ( an online discussion forum ) . One participant was excluded after r and omization . The main outcome measure was IBS-symptom severity and secondary measures included IBS-related quality of life , GI-specific anxiety , depression and general functioning . Participants were assessed at pre-treatment , post-treatment and 3 month follow-up ( treatment condition only ) . Four participants ( 5 % of total sample ) in the treatment condition did not participate in post-treatment assessment . Participants in the treatment condition reported a 42 % decrease and participants in the control group reported a 12 % increase in primary IBS-symptoms . Compared to the control condition , participants in the treatment group improved on all secondary outcome measures with a large between group effect size on quality of life ( Cohen 's d = 1.21 ) . We conclude that CBT-based on exposure and mindfulness delivered via the Internet can be effective in treating IBS- patients , alleviating the total burden of symptoms and increasing quality of life With limited efficacy of medications for symptom relief , non-medication treatments may play an important role in the treatment of irritable bowel syndrome ( IBS ) , the most common functional gastrointestinal ( GI ) disorder . This study aim ed to evaluate the efficacy of two self-regulation strategies for symptom relief and mood management in IBS patients . Thirty-five adult participants meeting ROME III criteria for IBS were enrolled , 27 of the 35 participants ( 77 % ) completed treatment and pre- and post-treatment visits ( 89 % women , 11 % men ; M ( SD ) age = 36 ( 13 ) ) , and 20 of the 27 ( 74 % ) completed a 6-month follow-up . Participants were r and omly assigned to 16 biweekly group sessions of Iyengar yoga or a walking program . Results indicated a significant group by time interaction on negative affect with the walking treatment showing improvement from pre- to post-treatment when compared to yoga ( p < .05 ) . There was no significant group by time effect on IBS severity . Exploratory analyses of secondary outcomes examined change separately for each treatment condition . From pre- to post-treatment , yoga showed significant decreases in IBS severity measures ( p < .05 ) , visceral sensitivity ( p < .05 ) , and severity of somatic symptoms ( p < .05 ) . Walking showed significant decreases in overall GI symptoms ( p < .05 ) , negative affect ( p < .05 ) , and state anxiety ( p < .05 ) . At 6-month follow-up , overall GI symptoms for walking continued to significantly decline , while for yoga , GI symptoms rebounded toward baseline levels ( p < .05 ) . When asked about self-regulated home practice at 6 months , significantly more participants in walking than in yoga practice d at least weekly ( p < .05 ) . In sum , results suggest that yoga and walking as movement-based self-regulatory behavioral treatments have some differential effects but are both beneficial for IBS patients , though maintenance of a self-regulated walking program may be more feasible and therefore more effective long term Irritable bowel syndrome ( IBS ) is a chronic disease that needs special self-care strategies . The current study aim ed at determining the effects of a self-care program on the severity of symptoms and quality of life of patients with IBS . In this r and omized controlled clinical trial , 119 patients were r and omly assigned to the experimental ( n = 60 ) and control ( n = 59 ) groups . Patients in both groups received the usual treatment of IBS by a gastroenterologist . The control group did not receive any intervention , whereas the experimental group was trained in the self-care program . The process of implementing the self-care program included design ing and determining the content validity of the self-care training package , individual training , the first follow-up call , group training , and the second follow-up call . The instruments for collecting data were IBS- Quality of Life and IBS-Symptom Severity Scale . Two sets of evaluations ( before and 2 months after the intervention ) were done for both groups . The data were analyzed using SPSS software , Version 16 . The results showed that there was not a significant difference between the two groups in the severity of symptoms and quality of life before the intervention ( p > .05 ) ; however , the 2 groups were significantly different after the intervention ( p < .0001 ) . Implementation of the self-care program result ed in the improvement of quality of life and reduction in the symptom severity in the experimental group after the intervention ( p < .0001 ) , whereas no significant changes were observed in the control group ( p > .05 ) . Hence , the data supports that self-care program was effective in improving the quality of life and reducing the severity of symptoms in patients with IBS OBJECTIVE : This study was design ed to develop and to test a home-based , guided imagery treatment protocol , using audio and video recordings , that is easy for health care professionals and patients to use , is inexpensive , and is applicable to a wide range of health care setting s. METHODS : Thirty-four children , 6 to 15 years of age , with a physician diagnosis of functional abdominal pain were assigned r and omly to receive 2 months of st and ard medical care with or without home-based , guided imagery treatment . Children who received only st and ard medical care initially received guided imagery treatment after 2 months . Children were monitored for 6 months after completion of guided imagery treatment . RESULTS : All treatment material s were reported to be self-explanatory , enjoyable , and easy to underst and and to use . The compliance rate was 98.5 % . In an intention-to-treat analysis , 63.1 % of children in the guided imagery treatment group were treatment responders , compared with 26.7 % in the st and ard medical care – only group ( P = .03 ; number needed to treat : 3 ) . Per- protocol analysis showed similar results ( 73.3 % vs 28.6 % responders ) . When the children in the st and ard medical care group also received guided imagery treatment , 61.5 % became treatment responders . Treatment effects were maintained for 6 months ( 62.5 % responders ) . CONCLUSION : Guided imagery treatment plus medical care was superior to st and ard medical care only for the treatment of abdominal pain , and treatment effects were sustained over a long period BACKGROUND Recent guidelines for the treatment of irritable bowel syndrome ( IBS ) emphasize the need for research to facilitate home-based self-management for these patients in primary care . The aim of the current study was to test the efficacy of a manualized cognitive behavioural therapy (CBT)-based self-management programme for IBS in a pilot r and omized controlled trial ( RCT ) . METHOD Sixty-four primary -care patients meeting Rome criteria for IBS were r and omized into either self-management plus treatment as usual ( TAU ) ( n=31 ) or a TAU control condition ( n=33 ) . The self-management condition included a structured 7-week manualized programme that was self-administered in conjunction with a 1-hour face-to-face therapy session and two 1-hour telephone sessions . The primary outcome measures were the Subject 's Global Assessment ( SGA ) of Relief and the Irritable Bowel Syndrome Severity Scoring System ( IBS-SSS ) assessed at baseline , end of treatment ( 2 months ) , and 3 and 6 months post-treatment . RESULTS Analysis was by intention-to-treat . Twenty-three ( 76.7 % ) of the self-management group rated themselves as experiencing symptom relief across all three time periods compared to seven ( 21.2 % ) of the TAU controls [ odds ratio ( OR ) 12.2 , 95 % confidence interval ( CI ) 3.72 - 40.1 ] . At 8 months , 25 ( 83 % ) of the self-management group showed a clinical ly significant change on the IBS-SSS compared to 16 ( 49 % ) of the control group ( OR 5.3 , 95 % CI 1.64 - 17.26 ) . CONCLUSIONS This study provides preliminary evidence that CBT-based self-management in the form of a structured manual and minimal therapist contact is an effective and acceptable form of treatment for primary -care IBS patients Background / Aims This study was conducted with objectives of assessing subtypes of irritable bowel syndrome ( IBS ) in children aged 10 - 16 years , their symptomatology and gender differences . Methods For this survey , 107 children who fulfilled Rome III criteria for IBS and 1,610 healthy controls were recruited from 8 r and omly selected schools , in 4 provinces in Sri Lanka . Data was collected using a previously vali date d , self administered question naire . Results Constipation predominant , diarrhea predominant and mixed type IBS were almost equally distributed ( 27%-28 % ) , while unsubtyped IBS had a lower prevalence ( 17.8 % ) . IBS was more common in girls ( 59.8 % vs 40.2 % in boys , P = 0.001 ) . Bloating , flatulence , burping , headache and limb pain were significantly higher in affected children ( P < 0.05 ) . Conclusions This study highlights the distribution of IBS subtypes among Sri Lankan children and adolescents and its female preponderance . This study also shows a higher prevalence of other intestinal-related and extraintestinal somatic symptoms among affected children Background Women with irritable bowel syndrome ( IBS ) report sexual dysfunction . Comprehensive self-management ( CSM ) intervention has been shown to reduce gastrointestinal , psychological , and somatic symptoms in IBS women . Whether this intervention also reduces sexual dysfunction is not known . Aims We sought to compare demographic and clinical factors in IBS women with and without sexual dysfunction as defined by the Arizona sexual experiences scale ( ASEX ) and to test the effects of CSM treatment on sexual dysfunction scores and on the sexual relations subscale of an IBS quality of life ( IBSQOL ) scale which measures the effect of IBS on sexual QOL . Methods IBS ( Rome II ) women enrolled in a r and omized clinical trial of CSM treatment were characterized as having sexual dysfunction ( N = 89 ) or not ( N = 86 ) at baseline based on ASEX criteria . Baseline characteristics and symptoms were compared between the two groups . Post-intervention changes were compared between the CSM and the usual care arms of the r and omized trial . Results Women meeting ASEX criteria for sexual dysfunction were older , had higher lifetime depression and antidepressant use , more primary care/MD visits , fewer mental healthcare visits , and greater sleep disturbance than those without sexual dysfunction . No significant group differences in gastrointestinal or somatic symptoms were observed . Compared with usual care treatment , CSM increased sexual QOL scores and had a weaker effect on ASEX scores . Conclusions Severity of IBS symptoms at baseline did not differ between IBS women with or without sexual dysfunction . The CSM intervention can reduce the effect of IBS on sexual QOL Background Many patients with IBS suffer on-going symptoms . The evidence base is poor for IBS drugs but they are widely prescribed and advised in Guidelines . Cognitive Behavioural Therapy ( CBT ) can be helpful , but availability is poor in the NHS . We developed a web-based CBT self-management programme ( Regul8 ) in partnership with patients and trialled it and common IBS medications in an exploratory factorial RCT to test trial procedures and provide information for a larger trial . Methods Patients , 16 to 60 years , with IBS symptoms fulfilling Rome III criteria were recruited via GP practice s and r and omised to over-encapsulated mebeverine , methylcellulose or placebo for 6 weeks and to 1 of 3 website conditions : Regul8 with a nurse telephone session and email support , Regul8 with minimal email support , or no website . Results 135 patients recruited from 26 GP practice s. Mean IBS SSS score 241.9 ( sd 87.7 ) , IBS-QOL 64 ( sd 20 ) at baseline . 91 % follow-up at 12 weeks . Mean IBS SSS decreased by 35 points from baseline to 12 weeks . There was no significant difference in IBS SSS or IBS-QOL score between medication or website groups at 12 weeks , or in medication groups at 6 weeks , or IBS-QOL in website groups at 6 weeks . However , IBS SSS at 6 weeks was lower in the No website group than the website groups ( IBS SSS no website = 162.8 ( 95 % CI 137.4 - 188.3 ) , website 197.0 ( 172.4 - 221.7 ) , Website + telephone support 208.0 ( 183.1 - 233.0 ) p = 0.037).Enablement and Subjects Global Assessment of relief ( SGA ) were significantly improved in the Regul8 groups compared to the non-website group at 12 weeks ( Enablement = 0 in 56.8 % of No website group , 18.4 % website , 10.5 % Website + support , p = 0.001 ) ( SGA ; 32.4 % responders in No website group , 45.7 % website group , 63.2 % website + support group , p = 0.035 ) . Conclusions This exploratory study demonstrates feasibility and high follow-up rates and provides information for a larger trial . Primary outcomes ( IBS SS and IBS
Output:
| Overall , there is robust evidence supporting self-management interventions for improving short-term symptom management and improving quality of life , whereas longer term outcomes are variable . |
MS210650 | ***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 a r and omized study , we have evaluated the treatment of cervical human papillomavirus ( HPV ) lesions by CO2 laser vaporization . Fifty patients with abnormal Papanicolaou smears and histological evidence of cervical HPV infection associated or not with cervical intraepithelial neoplasia ( CIN ) grade I were r and omized to either a treatment or a control group . The cervical swabs were obtained every 3 months in both groups and examined for HPV type 16 DNA by the polymerase chain reaction . After a follow-up period of 12 months no significant differences were found between the laser treatment and the control groups in relation to the disappearance of the abnormal Papanicolaou smear . Two patients in the treatment group and 3 in the control group had a conization because of development of CIN I or aggravation of the concomitant CIN found at the initial visit . The percentage of women who demonstrated HPV in their cervical smears at 12 months ' follow-up was identical in the two groups , supporting the hypothesis that HPV is a persistent infection during which the virus is widespread in the vaginal epithelium OBJECTIVE To evaluate the effect of alpha-interferon as an adjuvant to laser or fluorouracil treatment in patients with recurrent genital human papillomavirus ( HPV ) infection . METHODS Sixty-two females and 21 males were treated for recurrent HPV infection , with either fluorouracil ( Efudex 5 % ) cream or laser ablation of the lesions . Half of the patients were then r and omly treated with adjuvant alpha-interferon , to the lesions for patients treated with fluorouracil , or beneath areas previously treated by laser , once a week , for 8 weeks . The other half of the patients did not receive interferon adjuvant . Evaluation of both groups was done using colposcopy and acetic acid , to assess recurrence rates up to 1 year after treatment . RESULTS Of the 83 patients followed for 1 year , colposcopy revealed recurrent anogenital lesions in 3 of 45 receiving interferon , compared with 9 of 38 patients treated without adjuvant interferon . CONCLUSION Interferon is effective as adjuvant treatment in controlling the recurrence of genital HPV A series of 119 women with Human papillomavirus ( HPV ) infections of the uterine cervix and /or vagina were included in the present study , where the efficacy of cryotherapy and CO2‐laser vaporization was assessed after a mean follow‐up of 14 months ( SD 6 months ) after treatment , as related to the natural history of the disease . Routine Papanicolaou ( PAP ) smears with HPV‐induced changes were the basis for patient recruitment . Patients with cervical HPV lesions ( HPV‐NCIN , HPV‐CIN l or II ) were r and omly allocated into laser ( 55 women ) and cryotherapy ( 42 women ) groups . Women with combined lesions ( HPV‐CIN & HPV‐VAIN ) were treated by laser ( 22 patients ) . The cure rate after laser vaporization was practically identical to that of cryotherapy , 64 % and 54 % , respectively ( difference not statistically significant ) . The success rate was significantly lower ( 40 % ) for the combined lesions ( HPV‐CIN & HPV‐VAIN)(p<0.05 ) . The residual disease encountered in patients after the first treatment with cryotherapy and laser was classified as HPV‐NCIN in 78.9 % and 37.0 % , respectively . The number of patients is still too small to draw reliable conclusions on the effects of these therapy modes , as related to HPV type of lesion ( HPV 6 , 11 , 16 , 18 , 31 and 33 ) . The cure rates for both cryotherapy and laser in our treatment groups were significantly higher than the spontaneous regression rate ( p < 0.001 ) , suggesting that treatment by either cryotherapy or CO2,‐laser vaporization significantly changes the natural history of genital HPV infections . More patients and longer follow‐up are still needed , however , to fully establish the efficacy of the current treatment modalities in gynecological HPV infections The efficacy of systemic interferon-alpha ( IFN-alpha n1 ; Wellferon ) treatment on genital human papillomavirus ( HPV ) infections was studied in a double-blind , placebo-controlled trial . A total of 120 women were r and omly allocated to receive either interferon ( IFN , n = 60 ) or placebo ( n = 60 ) . In both treatment groups , 15 patients with lesions induced by each of the four HPV types ( HPV 6 , 11 , 16 , and 18 ) were included . The dose of IFN was 1.5 x 10(6 ) IU subcutaneously three times for the first week followed by 3 x 10(6 ) IU three times weekly for a further 6 weeks . The control patients received matching placebo injections . Ten patients ( three IFN-treated and seven placebo-treated ) were lost to follow-up . As determined by colposcopy , cytological and histological examinations , and HPV typing ( in situ hybridization , ISH ) , 8 IFN-treated patients ( 14 % ) and 11 placebo-treated patients ( 18 % ) showed complete response ( CR ) at the 8th week . The corresponding figures were 22 ( 37 % ) and 25 ( 43 % ) at the 24th week and 28 ( 49 % ) and 25 ( 49 % ) at the 52nd week , respectively . The total number of HPV DNA negative patients at Week 8 was 29 ( 49 % ) in the IFN group and 24 ( 40 % ) in the placebo group ( statistically nonsignificant ) . At Week 24 , 37 ( 63 % ) of the IFN-treated patients and 39 ( 67 % ) of the placebo-treated patients were HPV DNA negative . In 2 placebo-treated cases , cervical lesions progressed to CIN III and were treated by conization after the 24th week . There were 4 recurrences ( 7 % ) in the IFN group and no recurrences in the placebo group at the 24th week , corresponding figures at the 52nd week being 6 ( 11 % ) and 4 ( 7 % ) , respectively . When the clinical efficacy was evaluated in relation to the histological grade of lesion and four different HPV types , there were no differences in CR or in the number of HPV DNA negative patients between the two study groups . In conclusion , systemic IFN-alpha therapy did not show any significant therapeutic effect on genital HPV infections ( by HPV types 6 , 11 , 16 , and 18 ) compared to placebo Forty-six patients with biopsy-proven cervical koilocytosis , which in 19 cases was associated with CIN I , were r and omized to treatment by cervical laser vaporization or to follow-up without therapy . The polymerase chain reaction was used to examine the paraffin-embedded cervical biopsies for human papillomavirus ( HPV ) types 6 , 11 , 16 , 18 and 33 by polymerase chain reaction and molecular hybridization technique . Twenty biopsies contained HPV DNA , in 17 cases of the putatively oncogenic types HPV 16 and HPV 18 . During a mean follow-up of 28 months , the lesions resolved in 37 women , 5 women had progression to CIN III lesions , and 4 women had persisting disease . Lesions not harboring any of the 5 HPV types showed a high spontaneous regression rate of 88 % , which was not improved by the laser therapy . In the HPV-positive lesions , resolution occurred in only 29 % of untreated lesions , but in 92 % of those treated by laser . The difference is significant ( P = 0.007 ) . It is concluded that in patients with cervical koilocytosis , the HPV diagnosis could be of practical value in identifying patients who might benefit from treatment OBJECTIVE --To determine the efficacy and morbidity of fine loop diathermy excision of the cervical transformation zone as applied to the management of out patients with abnormal cervical smears . DESIGN -- Prospect i ve programme trial with six month follow up . SETTING --Two hospital based colposcopy clinics . PATIENTS --616 Patients aged 16 - 60 with abnormal cervical smears . INTERVENTIONS --After colposcopic and cytological assessment excision of the cervical transformation zone by fine loop diathermy under local anaesthesia in the outpatient department . MAIN OUTCOME MEASURES --Time to complete the treatment , immediate morbidity in terms of discomfort and bleeding , and cytological and colposcopic findings at six months . RESULTS --Treatment was completed in a mean of 3.47 minutes ( SD 1.99 ) . Immediate morbidity was minimal , and histological specimens were adequate in over 90 % of cases . Almost two thirds of patients were treated at their first visit to the clinic . 58 Patients ( 9.4 % ) failed to attend for follow up at six months and one had had a hysterectomy . Of the 557 patients who attended for colposcopic and cytological follow up at six months , 506 ( 91 % ) were normal cytologically and 19 ( 3.4 % ) had histologically confirmed persistence of cervical intraepithelial neoplasia . The overall confirmed failure rate of the technique was 4.4 % . CONCLUSION --Loop diathermy excision is an effective treatment with low morbidity and is an appropriate modality for patients with abnormal cervical smears OBJECTIVE To assess whether cold coagulation to the cervix eliminates sub clinical wart virus infection and to determine the effectiveness of treatment for CIN I and II , using cold coagulation , by genitourinary physicians . DESIGN Prospect i ve study . SETTING Department of Genitourinary medicine in a large teaching hospital . PARTICIPANTS All patients who received cold coagulation to the cervix in a 1 year period , who had not had previous treatment . RESULTS 261 patients were enrolled into this study ; of these , 138 ( 53 % ) patients attended for repeat colposcopy and cytology at one year . Cure rates for lesions were 66 % for initial wart virus infection , 80 % for CIN I and 94 % for CIN II and III . Four ( 5 % ) cases in whom repeat cytology was normal had CIN which would have been missed if repeat colposcopy had not been performed at one year . CONCLUSIONS Cold coagulation is inappropriate treatment for sub clinical wart virus infection of the cervix but is useful for the management of patients with CIN . Repeat colposcopy following treatment to the cervix is not necessary if cervical cytology is normal Fifty women with human papillomavirus (HPV)-induced abnormal cervical smears were r and omly allocated to either CO2-laser vaporization or routine control . The success rate at the 6 months check was 100 % after laser treatment compared to that of 72 % in the control group ( p less than 0.05 ) . Although longer follow-up is needed to fully establish the efficacy of the treatment , the method seems appropriate to this large group of women at risk of developing cervical intraepithelial neoplasia Summary : Between February , 1988 , and January , 1991,222 women with histologically proven cervical wart virus infection without dysplasia were r and omized to be managed by 1 of 4 protocol s. Group 1 acted as control , Group 2 were asked to use condoms for 6 months , Group 3 underwent local ablative therapy and Group 4 were asked to use condoms after ablative therapy . Assessment at 2 and 3 years of follow‐up showed no statistically significant superiority for treatment over observation . Defaulters from follow‐up were over 50 % by the completion of the study Background and Objectives Treatment of genital warts is problematic . Numerous treatment modalities are available , but response to any therapy often is unsatisfactory . Recently , studies have suggested that interferons would be effective in the treatment of some genital warts . Goal of this Study To compare carbon dioxide laser with or without adjuvant subcutaneously administered interferon alpha-2b in the treatment of genital human papillomavirus infection . Study Design One hundred r and omized women with genital HPV infection were treated with carbon dioxide laser and adjuvant systemic interferon alpha-2b or carbon dioxide laser and placebo . Patients were followed colposcopically , cytologically , and by HPV DNA testing for 6 months . Results Complete response was seen in 62 % patients who received adjuvant interferon , and in 68 % patients who received placebo . However , recurrence was less common in patients treated with interferon who were infected with HPV 16/18 . Conclusion Only a subgroup of patients , women infected with HPV DNA 16/18 , benefited from adjuvant systemic interferon treatment Consensus interferon and interferon alfa-2a were used to treat patients with persistent human papillomavirus disease . Thirty-one patients were treated with either consensus interferon or a placebo ( 25 received active drug and 6 received placebo ) , and 24 patients were treated with interferon alfa-2a . Of the 25 patients who received consensus interferon , 19 ( 76 % ) showed either complete or partial clearing of condyloma 10 and 16
Output:
| CONCLUSION The evidence we found in the medical literature regarding the efficacy of any therapy for sub clinical HPV infection without intraepithelial neoplasia of the uterine cervix was unsatisfactory |
MS210651 | ***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 In modern sprint cross-country skiing , strength and maximal speed are major determinants of performance . The aims of this study were to ascertain the anthropometric characteristics of world-class sprint skiers and to evaluate whether a specific body composition and /or body dimension characterizes a successful sprint skier . Our hypothesis was that body height and lean body mass are related to peak speed in double poling and diagonal stride . Fourteen male national and international elite skiers performed two peak speed tests in double poling and diagonal stride roller skiing on a treadmill and were analysed using dual-energy X-ray absorptiometry to determine body composition and body dimensions . Relative pole length was positively correlated with both techniques ( double poling : r = 0.77 , P < 0.01 ; diagonal stride : r = 0.60 , P < 0.05 ) and was the only variable that was part of the multiple regression model for both double poling and diagonal stride peak speed . Body height was not correlated with any technique , whereas lean trunk mass ( r = 0.75 , P < 0.01 ) , body mass index ( r = 0.66 , P < 0.01 ) , total lean mass ( r = 0.69 , P < 0.01 ) , and body mass ( r = 0.57 , P < 0.05 ) were positively related to double poling peak speed . Total lean mass ( absolute : r = 0.58 , P < 0.05 ; relative : r = 0.76 , P < 0.001 ) and relative lean mass of the trunk , arms ( both r = 0.72 , P < 0.01 ) , and legs ( r = 0.54 , P < 0.05 ) were positively related to diagonal stride peak speed . In conclusion , skiers should aim to achieve a body composition with a high percentage of lean mass and low fat mass . A focus on trunk mass through increased muscle mass appears to be important , especially for double poling . The use of longer poles ( percent body height ) seems to be advantageous for both double poling and diagonal stride peak speed , whereas body dimensions do not appear to be a predictive factor There is still considerable debate and some confusion as to the most appropriate method of scaling or normalizing maximum oxygen uptake ( V̇O2max ) for differences in body mass ( m ) in both adults and children . Previous studies on adult population s have demonstrated that although the traditional ratio st and ard V̇O2max ( ml kg−1 min−1 ) fails to render V̇O2max independent of body mass , the ratio st and ard is still the best predictor of running performance . However , no such evidence exists in children . Hence , the purpose of the present study was to investigate whether the ratio st and ard is still the most appropriate method of normalising V̇O2max to predict 1-mile run speed in a group of 12-year-old children ( n=36 ) . Using a power function model and log-linear regression , the best predictor of 1-mile run speed was given by : speed ( m s−1)=55.1V̇O2max0.986m−0.96 . With both the V̇O2max and body mass exponents being close to unity but with opposite signs , the model suggest the best predictor of 1-mile run speed is almost exactly the traditional ratio st and ard recorded in the units ( ml kg−1 min−1 ) . Clearly , reporting the traditional ratio st and ard V̇O2max , recorded in the units ( ml kg−1 min−1 ) , still has an important place in publishing the results of studies investigating cardiovascular fitness of both children and adults Little is known about the relationship among training , energy expenditure , muscle volume , and fitness in prepubertal girls . Because physical activity is high in prepubertal children , we hypothesized that there would be no effect of training . Forty pre- and early pubertal ( mean age 9.1 + /- 0.1 yr ) nonobese girls enrolled in a 5 day/wk summer school program for 5 wk and were r and omized to control ( n = 20 ) or training groups ( n = 20 ; 1.5 h/day , endurance-type exercise ) . Total energy expenditure ( TEE ) was measured using doubly labeled water , thigh muscle volume using magnetic resonance imaging , and peak O(2 ) uptake ( VO(2 peak ) ) using cycle ergometry . TEE was significantly greater ( 17 % , P < 0.02 ) in the training girls . Training increased thigh muscle volume ( + 4.3 + /- 0.9 % , P < 0.005 ) and VO(2 peak ) ( + 9.5 + /- 6 % , P < 0.05 ) , effects surprisingly similar to those observed in adolescent girls using the same protocol ( Eliakim A , Barstow TJ , Brasel JA , Ajie H , Lee W-NP , Renslo R , Berman N , and Cooper DM , J Pediatr 129 : 537 - 543 , 1996 ) . We further compared these two sample population s : thigh muscle volume per weight was much lower in adolescent compared with prepubertal girls ( 17.0 + /- 0.3 vs. 27.8 + /- 0.6 ml/kg body mass ; P < 0.001 ) , and allometric analysis revealed remarkably low scaling factors relating muscle volume ( 0.34 + /- 0.05 , P < 0.0001 ) , TEE ( 0.24 + /- 0 . 06 , P < 0.0004 ) , and VO(2 peak ) ( 0.28 + /- 0.07 , P < 0.0001 ) to body mass in all subjects . Muscle and cardiorespiratory functions were quite responsive to brief training in prepubertal girls . Moreover , a retrospective , cross-sectional analysis suggests that increases in muscle mass and VO(2 peak ) may be depressed in nonobese American girls as they mature Maximal oxygen uptake ( VO2max ) in females , expressed as ml x kg(-1 ) x min(-1 ) , declines steadily during the first three decades of life . The contribution of diminished cardiovascular function to this apparent fall in aerobic fitness is unknown . Cardiac responses to maximal cycle exercise were compared in 24 premenarcheal females ( mean age 11.7 years ) and 17 young adult women ( mean age 27.4 years ) using Doppler echocardiography . Mean VO2max was 40 ml x kg(-1 ) x min(-1 ) and 34.7 ml x kg(-1 ) x min(-1 ) in the girls and women , respectively ( p < 0.05 ) . When VO2max was expressed relative to allometrically-derived mass(0.52 ) , however , no significant difference was observed in aerobic fitness between the two groups . Similar allometric analyses revealed no significant differences in average maximal cardiac output ( 10.50 vs 10.07 L x min(-1 ) BSA(-1.11 ) for girls and women , respectively ) nor maximal stroke volume ( 53 vs 56 ml BSA(-1.13 ) respectively ) . These findings suggest that 1 ) allometric scaling is important in eliminating the effects of body size on VO2max , 2 ) body dimension differences can account for variations in VO2 in young females , and 3 ) cardiac functional reserve is similar in premenarcheal girls and young adult women PURPOSE Anthropometric ( ANTHRO ) and dual-energy x-ray absorptiometric ( DEXA ) estimates of total body and leg fat-free masses ( FFM ) were obtained in 77 r and omly selected sedentary men and women , aged 20 - 80 : inter method limits of agreement and their clinical significance , as inferred from the differences on peak VO2 corrected for FFMANTHRO and FFMDEXA , were determined . METHODS Limits of agreement were calculated as mean bias + /- 95 % confidence intervals : peak VO2 at maximum cycle ergometry was related to FFMANTHRO and FFMDEXA by using both st and ard ( y x x(-1 ) ) and power function ratios ( allometry ) . RESULTS Data distribution of the ANTHRO-DEXA differences presented significant heteroscedasticity in both sexes , i.e. , differences were proportional to the mean ( P < 0.05 ) . After logarithmic transformation , the mean bias + /- 95 % limits of agreement were expressed as ratios ( ANTHRO x DEXA(-1 ) x// error ratio ) : these corresponded to 0.95 x// 1.11 or 0.99 x// 1.15 for total body FFM and 0.90 x// 1.10 or 1.02 x// 1.07 for leg FFM in men and women , respectively . In addition , we found different allometric exponents for FFMANTHRO and FFMDEXA : the inter method differences , therefore , increased after power function expression ( P < 0.05 ) . CONCLUSION Discrepancies between ANTHRO and DEXA measurements of FFM depend on the magnitude of the estimate : differences are typically within 10 to 15 % . Importantly , FFM-corrected peak VO2 values can vary according to the method chosen for body composition assessment , especially when allometry is used for peak VO2 correction . These results demonstrate that ANTHRO-DEXA differences in FFM estimation do have relevant practical consequences for the analysis of maximum aerobic capacity in nontrained humans The method of removing the confounding effect of body mass on peak oxygen uptake simply by dividing the measured values by body mass has been question ed . The aim of the study was to find an expression of body mass for compensating for differences in body mass so as to achieve the best correlation to running performance . In a cross-sectional study , design peak oxygen uptake ( VO2peak ) was measured in 107 boys in the age range 8 - 17 years and 88 girls in the age range 8 - 16 years . The present study indicates that VO2peak do not increase in proportion to body mass during running , rather that VO2peak is inversely related to body mass . When using allometric regression st and ards with the sexes separated in gender groups , there was a tendency that boys achieved scaling factors closer to unity than did the girls . The increase in subcutaneous fat in the girls throughout the pubertal years is the most likely reason why body mass increased proportionally more than VO2peak in girls . The present study indicates that VO2peak when expressed as milliliters per kilogram per minute ( ml kg(-1 ) min(-1 ) ) is a poor denominator for VO2peak as a function of running performance in children and adolescents Background Statistical methods for inferring the true magnitude of an effect from a sample should have acceptable error rates when the true effect is trivial ( type I rates ) or substantial ( type II rates ) . Objective The objective of this study was to quantify the error rates , rates of decisive ( publishable ) outcomes and publication bias of five inferential methods commonly used in sports medicine and science . The methods were conventional null-hypothesis significance testing [ NHST ] ( significant and non-significant imply substantial and trivial true effects , respectively ) ; conservative NHST ( the observed magnitude is interpreted as the true magnitude only for significant effects ) ; non- clinical magnitude-based inference [ MBI ] ( the true magnitude is interpreted as the magnitude range of the 90 % confidence interval only for intervals not spanning substantial values of the opposite sign ) ; clinical MBI ( a possibly beneficial effect is recommended for implementation only if it is most unlikely to be harmful ) ; and odds-ratio clinical MBI ( implementation is also recommended when the odds of benefit outweigh the odds of harm , with an odds ratio > 66 ) . Methods Simulation was used to quantify st and ardized mean effects in 500,000 r and omized , controlled trials each for true st and ardized magnitudes ranging from null through marginally moderate with three sample sizes : suboptimal ( 10 + 10 ) , optimal for MBI ( 50 + 50 ) and optimal for NHST ( 144 + 144 ) . Results Type I rates for non- clinical MBI were always lower than for NHST . When type I rates for clinical MBI were higher , most errors were debatable , given the probabilistic qualification of those inferences ( unlikely or possibly beneficial ) . NHST often had unacceptable rates for either type II errors or decisive outcomes , and it had substantial publication bias with the smallest sample size , whereas MBI had no such problems . Conclusion MBI is a trustworthy , nuanced alternative to NHST , which it outperforms in terms of the sample size , error rates , decision rates and publication bias Objective : The present study analysed the allometric relationship ( MR = a · Mb ) between human metabolic rate ( MR ) , ranging from resting to maximal metabolic conditions , and body mass ( M ) , both in athletes of different specialization and untrained individuals . Subjects and methods : Two hundred and seventy male athletes and 43 untrained men performed a continuous incremental test to volitional exhaustion on a motorized treadmill . Metabolic rate ( i.e. ) was measured during resting ( ) , sub-maximal ( walking at 5 km h−1 ; running at 7.5 km h−1 ; ventilatory anaerobic threshold ) and maximal exercise conditions ( maximum oxygen uptake ) . Results : A significant difference ( p < 0.001 ) in the MR – body mass relationships between athletes and controls was found . For the control group , the mass exponent b exhibited a non-significant ( p = 0.37 ) increase with increasing metabolic dem and ( b = 0.69 , 0.76 , 0.76 , 0.84 , and 0.89 , for , , , , and , respectively ) . In contrast , the corresponding mass exponent for the athletic group significantly ( p < 0.01 ) decreased when moving from resting to maximal metabolic conditions ( b = 0.98 , 0.88 , 0.80 , 0.69 , and 0.67 ) . Conclusion : These results indicate that the recently proposed allometric cascade model may be valid in describing the scaling behaviour of MR in untrained individuals , but
Output:
| We conclude that the scaling of $ $ { \dot{\text{V}}\text{O}}$$V˙O2max in humans is consistent with the allometric cascade model with an estimated prediction interval for the fat-free mass exponent not likely to be consistent with the $ $ \frac{2}{3}\text { and } \frac{3}{4}$$23 and 34 power laws |
MS210652 | ***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 the aim of this r and omized-controlled clinical trial was to compare the objective and subjective esthetic outcomes of two types of screwed-retained single-implant crowns . MATERIAL S AND METHODS participants were r and omly assigned to the test ( all-ceramic ) and control [ porcelain-fused-to-ceramic ( PFM ) ] groups and were seen under investigation at baseline ( B ) , crown insertion ( CI ) , 1-year follow-up ( 1Y ) , and 2-year follow-up ( 2Y ) . Objective parameters were assessed by an intra-oral digital photograph ( 1:1 ratio ) , a study cast , a st and ardized radiograph , periodontal/peri-implant measurements , and question naires were obtained for the subjective parameters . In addition , pink esthetic score ( PES ) and white esthetic score ( WES ) were calculated for both groups . For the subjective evaluation , a visual analogue scale ( VAS ) question naire was used to assess the level of patient satisfaction regarding the esthetic outcome . Then , nine expert clinicians visually inspected and assessed subjective evaluation at the professional level . Statistical analysis was used to compare between groups and investigational appointments . RESULTS twenty patients were included in the study , 10 allocated to the all-ceramic group and 10 to the PFM group . No statistically significant differences were observed for the objective measurements comparing the test and control groups . Minor chipping of the ceramic veneering material was observed in the two patients of control group . The mean difference for all groups comparing objective parameters revealed an increase of papilla height between time points . A slight recession ( 0.26 mm ) of the peri-implant mucosal margin at the implant site was observed between 1Y and 2Y . Mean values for PES and WES were 13.9 and 13.1 for the PFM group and for the all-ceramic group , respectively . These values were not statistically significant . Implant crown volume , outline , translucency , and characterization showed major discrepancies with the contra-lateral natural teeth . As for subjective parameters , VAS patients ' responses regarding their perceptions of the esthetic outcome showed no statistical differences between groups and clinicians ' accuracy scores were 50 % and 47 % for PFM and all-ceramic crowns , respectively . CONCLUSION PFM and all-ceramic single-implant restorations may be indistinguishable from each other regarding the objective /subjective assessment of esthetic integration . The material chosen for fabricating an implant crown per se does not ensure an optimal esthetic outcome if other esthetic parameters are not present OBJECTIVE The aim of this uncontrolled prospect i ve multicenter study was to determine the success and survival rate of posterior single crowns composed of zirconia frameworks h and -layered with a leucite-reinforced feldspathic ceramic supported by one-piece zirconia oral implants . MATERIAL AND METHODS In two centers , sixty patients received 71 zirconia oral implants . To obtain a clear indication of posterior implant-supported single crowns ( ISSCs ) , 14 patients ( 25 implants ) were excluded from the analysis ( 11 bridges , three anterior crowns ) . The remaining patients were provided with single implants in posterior regions . As one patient lost his implant and another refused further participation after final prosthesis insertion , 44 ISSCs/ patients ( 19 females , 25 males ) were available for evaluation . Of these patients , all were seen at prosthetic delivery and the 6- and 12-month follow-up appointments . Evaluations were performed using modified United States Public Health Service ( USPHS ) criteria . Restorations within Alpha and Bravo ratings were regarded as success . This included minor chippings , a slight roughness , slightly soundable restoration margins and minimal contour deficiencies . In case of more distinct defects that could , however , be repaired to a clinical ly acceptable level , restorations were regarded as surviving . Kaplan-Meier plots and log-rank tests were used for the success/survival analyses and the calculation of potential group differences ( gender , jaw and center ) . RESULTS After a mean observation period of 12.5 months ( SD : 0.8 months ) , no ISSC had to be replaced , result ing in a Kaplan-Meier survival rate of 100 % . The Kaplan-Meier success rate was 90.9 % ( one major chipping , one obvious roughness , one significant crevice and one pronounced over-contouring ) . Minor chippings and occlusal roughness were frequent complications . No significantly different survival/success rates could be observed between the mentioned groups . CONCLUSION The frequent incidence of minor chippings suggests a high technique sensitivity when providing zirconia implants with veneered zirconia-based crowns question ing its suitability for this indication OBJECTIVES To prospect ively evaluate the clinical long-term outcome of tooth-supported crowns ( SCs ) , implant-supported crowns ( ISCs ) , and fixed dental prostheses ( FDPs ) made of a lithium-disilicate glass-ceramic framework material ( IPS Empress 2 ) . MATERIAL S AND METHODS Between 1997 and 1999 , a total of 184 restorations ( 106 SCs , 32 ISCs , 33 FDPs , and 13 diverse restorations ) were placed in 73 patients . Kaplan-Meier estimation was applied for survival and chipping-free rates . Inter-group comparison of both rates was realized by a log rank test and a 2 × 2 contingency table . Also , SCs and FDPs were compared regarding adhesive vs. conventional cementation , and anterior vs. posterior positioning , for impact on survival . RESULTS Due to 14 dropouts ( 34 restorations ) and reasonable exclusion of 19 other restorations , the final data set included : i ) 87 SCs [ 37 patients , mean observation time 11.4 (±3.8)years ] ; ii ) 17 ISCs [ 12 patients , mean observation time 13.3 (±2.3)years ; and iii ) 27 FDPs [ 19 patients , mean observation time 8.9 (±5.4)years ] . The 10-year survival rate/chipping-free rate for SCs were 86.1%/83.4 % , for ISCs 93.8%/94.1 % , and for FDPs were 51.9%/90.8 % . Both ISCs and SCs had a significantly higher survival than FDPs ( ISCs vs. FDPs : both tests p=0.001 ; SCs vs. FDPs : p=0.001 and p=0.005 ) . Differences in the chipping-free rates did not reach significance . Also , neither the cementation mode nor positioning of the restoration had an impact on survival . CONCLUSIONS SCs had a slightly lower outcome than can generally be expected from single crowns . In contrast , ICSs had a favorable outcome and the FDPs predominantly failed . CLINICAL SIGNIFICANCE The practitioner 's choice of dental material s is based ( at best ) on long-term experience . The present 10-year results are based on comprehensive data analyses and show the high potential of lithium-disilicate as a reliable material , especially for single-unit restoration In aesthetic sites , the integrity of the facial bone wall dimension in the anterior maxilla is jeopardized by physiologic and structural changes post extraction . An effective regenerative protocol is key to reestablish and maintain the hard and soft tissue dimensions over time . The present prospect i ve case series study examined the effectiveness of early implant placement with simultaneous contour augmentation through guided bone regeneration with a 2-layer composite graft in post extraction single-tooth sites over an observation period of 10 y among 20 patients . The median peri-implant bone loss was 0.35 mm between the 1- and 10-y examination . A success rate of 95 % was obtained , with pleasing aesthetic outcomes and a high median Pink Esthetic Score ( 8) . Implant crowns ( ICs ) revealed significant median facial recession between IC10y and IC1y ( 0.17 mm ) . The facial bone wall dimensions were assessed by preoperative cone beam computed tomography and 2 subsequent scans taken at 6 and 10 y. The median facial bone wall thickness increased significantly from 0 mm at surgery to 1.67 mm at the 10-y examination . The facial vertical bone wall peak ( DIC ) was located at a median distance of 0.16 mm coronal to the implant shoulder . The facial vertical bone loss of DIC amounted to 0.02 mm between 6 and 10 y. Equivalence testing was performed for the null hypothesis of a difference of > 0.2 mm per year between 2 respective time points , showing stable bone conditions . Modulating factors influencing the regenerative outcomes at 10 y were the preoperative proximal crest width and soft tissue thickness . In conclusion , the present study confirmed the long-term effectiveness of early implant placement with simultaneous contour augmentation through guided bone regeneration with a 2-layer composite graft in post extraction single-tooth sites offering stable bone conditions with low risks of mucosal recessions over an observation period of 10 y ( Clinical Trials.gov NCT03252106 ) Patients ’ esthetic expectations are increasing , and the options of the prosthetic pathways are currently evolving . The objective of this r and omized multicenter clinical trial was to assess and compare the esthetic outcome and clinical performance of anterior maxillary all-ceramic implant crowns ( ICs ) based either on prefabricated zirconia abutments veneered with pressed ceramics or on CAD/CAM zirconia abutments veneered with h and buildup technique . The null hypothesis was that there is no statistically significant difference between the 2 groups . Forty implants were inserted in sites 14 to 24 ( FDI ) in 40 patients in 2 centers , the Universities of Bern and Geneva , Switzerl and . After final impression , 20 patients were r and omized into group A , restored with a 1-piece screw-retained single crown made of a prefabricated zirconia abutment with pressed ceramic as the veneering material using the cut-back technique , or group B using an individualized CAD/CAM zirconia abutment ( CARES abutment ; Institut Straumann AG ) with a h and buildup technique . At baseline , 6 mo , and 1 y clinical , esthetic and radiographic parameters were assessed . Group A exhibited 1 dropout patient and 1 failure , result ing in a survival rate of 94.7 % after 1 y , in comparison to 100 % for group B. No other complications occurred . Clinical parameters presented stable and healthy peri-implant soft tissues . Overall , no or only minimal crestal bone changes were observed with a mean DIB ( distance from the implant shoulder to the first bone-to-implant contact ) of −0.15 mm ( group A ) and 0.12 mm ( group B ) at 1 y. There were no significant differences at baseline , 6 mo , and 1 y for DIB values between the 2 groups . Pink esthetic score ( PES ) and white esthetic score ( WES ) values at all 3 examinations indicated stability over time for both groups and pleasing esthetic outcomes . Both implant-supported prosthetic pathways represent a valuable treatment option for the restoration of single ICs in the anterior maxilla ( Clinical Trials.gov NCT02905838 ) Background Supporting 21st century health care and the practice of evidence -based medicine ( EBM ) requires ubiquitous access to clinical information and to knowledge-based re sources to answer clinical questions . Many questions go unanswered , however , due to lack of skills in formulating questions , crafting effective search strategies , and accessing data bases to identify best levels of evidence . Methods This r and omized trial was design ed as a pilot study to measure the relevancy of search results using three different interfaces for the PubMed search system . Two of the search interfaces utilized a specific framework called PICO , which was design ed to focus clinical questions and to prompt for publication type or type of question asked . The third interface was the st and ard PubMed interface readily available on the Web . Study subjects were recruited from interns and residents on an inpatient general medicine rotation at an academic medical center in the US . Thirty-one subjects were r and omized to one of the three interfaces , given 3 clinical questions , and asked to search PubMed for a set of relevant articles that would provide an answer for each question . The success of the search results was determined by a precision score , which compared the number of relevant or gold st and ard articles retrieved in a result set to the total number of articles retrieved in that set . Results Participants using the PICO templates ( Protocol A or Protocol B ) had higher precision scores for each question than the participants who used Protocol C , the st and ard PubMed Web interface . ( Question 1 : A = 35 % , B = 28 % , C = 20 % ; Question 2 : A = 5 % , B = 6 % , C = 4 % ; Question 3 : A = 1 % , B = 0 % , C = 0 % ) 95 % confidence intervals were calculated for the precision for each question using a lower boundary of zero . However , the 95 % confidence limits were overlapping , suggesting no statistical difference between the groups . Conclusion Due to the small number of search es for each arm , this pilot study could not demonstrate a statistically significant difference between the search protocol s. However there was a trend towards higher precision that needs to be investigated in a larger study to determine if PICO can improve the relevancy of search results BACKGROUND New dental material s are introduced and promoted in the field without extensive clinical testing . Using those material s in a clinical setting might result in unacceptable early failure rates . PURPOSE The purpose of this paper was to
Output:
| CONCLUSIONS All-ceramic implant-supported SCs showed-with the exception of a RNC material -high survival rates . |
MS210653 | ***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 Central venous access devices ( CVADs ) are a mainstay of current medical therapy but often become occluded by thrombus . Tissue plasminogen activator ( alteplase ) , at a dose of 2 mg per 2 mL , has been shown to be effective in restoring flow to catheters proven by radiographic contrast injection to be occluded by thrombus . The purpose of this double-blind placebo-controlled multicenter trial was to determine the efficacy of alteplase in occluded catheters without earlier contrast injections or radiographic examinations . MATERIAL S AND METHODS Patients were eligible for inclusion if blood could not be withdrawn from their catheter after a period of normal function of at least 48 hours . Single or multiple catheters , peripherally inserted central catheters , catheters with valves , and implanted ports were eligible ; catheters used for hemodialysis were not included . Patients were r and omly assigned to one of two groups . In one group , patients received a first dose of 2 mg alteplase followed , if needed , by a second dose of 2 mg alteplase and a third dose of placebo . The other group received placebo first followed by one 2-mg dose of alteplase and then a second , if needed . Each dose was allowed to dwell for 2 hours and ability to withdraw blood from the catheter was reassessed . The endpoint was restoration of the ability to withdraw and infuse through the catheter . One hundred forty-nine patients were r and omized : 74 received placebo first , 75 received alteplase first . RESULTS After the first 2-hour treatment , function was restored to 74 % in the alteplase arm and 17 % in the placebo arm ( P < .0001 compared to placebo ) . After one or two treatments , function was restored in 90 % of patients . There were no serious study -drug-related adverse events , no intracranial hemorrhage , no major hemorrhage , and no embolic events . CONCLUSION Infusion of alteplase appeared to be safe and effective in restoring flow to occluded catheters without need for pretreatment radiographic evaluation The function of long term indwelling venous access devices is commonly perturbed by postinsertion catheter‐related complications ( CRC ) . In an effort to assess the patterns of CRC in our community accurately , a prospect i ve analysis of Groshong catheters in adult cancer patients was undertaken PURPOSE To evaluate , in a phase III , single-arm study , the safety and efficacy of the thrombolytic agent tenecteplase in restoring function to dysfunctional central venous catheters ( CVCs ) . MATERIAL S AND METHODS Pediatric and adult patients with dysfunctional CVCs were eligible to receive as much as 2 mL ( 2 mg ) of intraluminal tenecteplase , which was left to dwell in the CVC lumen for a maximum of 120 minutes . If CVC function was not restored at 120 minutes , a second dose was instilled for an additional 120 minutes . RESULTS Tenecteplase was administered to 246 patients . Mean patient age was 44 years ( range , 0 - 92 y ) ; 72 patients ( 29 % ) were younger than 17 years of age . Chemotherapy was the most common reason for catheter insertion . Restoration of CVC function was achieved in 177 patients ( 72 % ) within 120 minutes after the first dose . After instillation of a maximum of two doses of tenecteplase , CVC function was restored in 200 patients ( 81 % ) , with similar frequencies in pediatric ( 83 % ) and adult ( 80 % ) patients . Adverse events ( AEs ) were reported in 31 patients ( 13 % ) ; fever ( 2 % ) , neutropenia ( 1 % ) , and nausea ( 0.8 % ) were most common . One serious AE , an allergic hypersensitivity reaction , was judged to be related to tenecteplase and /or a chemotherapeutic agent that the patient was receiving concurrently . CONCLUSIONS Consecutive administration of one or two doses of tenecteplase into CVCs showed efficacy in the restoration of catheter function in patients with dysfunctional CVCs PURPOSE This study was undertaken to determine the role of low-dose urokinase infusions in treating fibrinous occlusions of venous access devices ( VADs ) in cancer patients . PATIENTS AND METHODS Forty-two patients with VAD occlusions refractory to routine urokinase instillations were documented by x-ray ( cathetergram ) to have fibrin sleeves at the catheter tips . They were r and omized to receive infusions of either urokinase ( 40,000 U/h ) or urokinase with heparin ( 320 U/h ) through their catheters . After 1 , 3 , 6 , and 12 hours of treatment , the function of the VADs was reassessed . Whenever the obstruction had been relieved , the infusion was stopped and a repeat cathetergram was performed . The status of the unoccluded catheters was followed to determine the longevity of the restored function . RESULTS Twenty-one catheters were treated with urokinase alone and 21 with the combination of urokinase and heparin . In each group , 16 VADs opened within 12 hours of treatment and five did not . By actuarial analysis , the probability was only 0.28 that a reopened catheter would reocclude within 6 months . CONCLUSION Low-dose urokinase infusions can restore function to the majority of catheters occluded by fibrin sleeves . Adding heparin to the urokinase does not enhance the efficacy of the infusions . The restored function often persists until the VADs are removed PURPOSE Recombinant urokinase ( r-UK ) is a high-molecular-weight urokinase produced in transfected , non-human , mammalian cells . A Phase II , r and omized , double-blind , parallel , placebo-controlled , dose-ranging study was performed to compare the safety and efficacy of one or two instillations of three intraluminal concentrations of r-UK ( 5,000 ; 15,000 ; and 25,000 IU/mL ) with a placebo for reestablishment of total function to occluded central venous access devices ( CVADs ) . MATERIAL S AND METHODS One-hundred eight patients with CVAD withdrawal or total occlusion were enrolled and r and omized to treatment ; 104 patients received at least one instillation of study drug and 101 patients completed treatment . All but one patient had cancer . RESULTS All three concentrations of r-UK were significantly superior to placebo in restoring total CVAD function ( patency of all occluded lumens ) after one or two instillations of study medication ( 25,000 IU/mL r-UK , 68 % vs. placebo , 28 % [ P = .007 ] ; 15,000 IU/mL r-UK , 69 % vs. placebo , 24 % [ P = .004 ] ; 5,000 IU/mL r-UK , 70 % vs. placebo , 28 % [ P = .003 ] ) . Comparisons of the three r-UK concentrations indicated no difference after one or two instillations with regards to patency restoration . Treatment-emergent hemorrhagic events occurring within 72 hours after study drug exposure were experienced by four patients ( 17 % ) in the 25,000 IU/mL r-UK group , two patients ( 7 % ) in the 15,000 IU/mL r-UK group , no patients in the 5,000 IU/mL r-UK group , and no patients in the placebo group . CONCLUSIONS Efficacy and safety results of this study support further evaluation of a 5,000 IU/mL concentration of r-UK for treatment of occluded CVADs in adult and pediatric patients from 1 year of age PURPOSE To evaluate the incidence and management of catheter occlusion in implantable arm ports . MATERIAL S AND METHODS Findings were prospect ively examined in 391 patients in whom 393 arm ports were placed . The indications for port placement included chemotherapy ( n = 347 ) , antibiotic administration ( n = 35 ) , combination chemotherapy/antibiotic use ( n = 7 ) , transfusion ( n = 3 ) , and phlebotomy ( n = 1 ) . Of the total catheters , 323 ( 82.2 % ) underwent tip modification prior to placement . Malfunctioning catheters were usually treated with urokinase instillation . RESULTS Three hundred ninety-three devices were implanted with 247 mean days of catheter use ( total , 97,256 days ; range , 1 - 694 days ) . The overall incidence of catheter occlusion was 0.14 per 100 catheter days . A single catheter occlusion occurred in 90 ( 22.9 % ) catheters , with a mean of 90.1 days before the event . A second occlusion occurred in 36 ( 9.2 % ) of the above catheters , with a mean of 60.1 catheter days before the second event . Eighty-five ( 24.0 % ) of the 347 cancer patients had at least one occlusive event , yielding a complication rate of 0.098 per 100 catheter days at risk ( 95 % confidence interval [ CI ] ; 0.079 - 0.114 ) . Of the 35 patients receiving antibiotics , three ( 8.6 % ) had at least one occlusive event . This represented a complication rate of 0.032 per 100 catheter days at risk ( 95 % CI ; 0.010 - 0.061 ) . Seventeen ( 24.3 % ) of the nonmodified catheters developed an occlusion versus 72 ( 22.3 % ) of the modified ( P > .05 ; Fisher exact test ) . Of the catheters with a first occlusive event , 75 ( 98.7 % ) were treated successfully with urokinase instillation . Four ( 1.0 % ) patients developed symptomatic subclavian vein thrombosis . No bleeding complications occurred . CONCLUSION Catheter occlusion is a common complication of long-term arm port placement , with a significantly higher incidence in the cancer patients in our series ( P < . 05 , Fisher exact test ) . Catheter tip modification , however , does not considerably affect the incidence of occlusion . Low-dose urokinase therapy is a safe and efficacious treatment of catheter occlusion , obviating the need for catheter removal PURPOSE Alfimeprase is a recombinantly produced , genetically modified variant of the metalloproteinase , fibrolase . Alfimeprase proteolytically cleaves fibrin , independent of plasminogen activation to plasmin , and directly dissolves thrombi . Based on the direct fibrin degradation effect of alfimeprase , rapid activity in patients with occluded central venous access devices ( CVADs ) was hypothesized . PATIENTS AND METHODS We performed a phase II , r and omized , double-blind , active-control , multicenter , dose-ranging study to compare the safety and efficacy of one or two instillations of three intraluminal doses of alfimeprase ( 0.3 , 1.0 , and 3.0 mg ) and alteplase 2.0 mg in re-establishing patency to occluded CVADs in 55 adult patients . RESULTS All three alfimeprase doses were more successful than alteplase during the first 15 and 30 minutes of treatment . The alfimeprase 3.0-mg dose result ed in 40 % , 50 % , and 60 % patency restoration rates at 5 , 15 , and 30 minutes , respectively , compared with 0 % , 0 % , and 23 % for alteplase . The difference at 15 minutes was highly significant ( P = .0075 ) . Alfimeprase 3.0 mg produced the highest patency rate at 120 minutes after the first ( 60 % ) and second ( 80 % ) doses . No major hemorrhagic or embolic events were reported . CONCLUSION A single 1- or 3-mg dose of alfimeprase has the potential to restore function to occluded CVADs rapidly and safely , and to facilitate on-time infusion of vital therapies PURPOSE To evaluate the efficacy and safety of reteplase for central venous catheter ( CVC ) occlusion in patients with cancer . MATERIAL S AND METHODS An open-label , single-arm , prospect i ve study was conducted . Reteplase ( 0.4 U ) was instilled into each catheter lumen with a dwell time of 30 minutes in patients with cancer with a dysfunctional CVC . If the function of the catheter was not restored in 30 minutes , an additional dwell time of 30 minutes was allowed ( a total of 60 minutes possible dwell time for the first dose ) . A second dose was repeated at 60 minutes after the first dose if catheter function was not restored ( a total of 120 minutes for up to two doses ) . The primary efficacy outcome was the restoration of CVC function . RESULTS Of 139 patients who received reteplase , the first-attempt success rate after a 30-minute dwell time was 66.9 %
Output:
| Conclusion The most common interventions used to treat thrombotic catheter occlusion in cancer patients were urokinase and alteplase . |
MS210654 | ***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 objective of this research was to evaluate the anticaries effectiveness of a low-dose ( 500 ppm F , low-NaF ) sodium fluoride dentifrice , a high-dose ( 2,800 ppm F , high-NaF ) sodium fluoride dentifrice and an experimental 0.454 % stabilized stannous fluoride ( 1,100 ppm F ) with sodium hexametaphosphate ( SnF2-HMP ) dentifrice , each relative to a st and ard 1,100 ppm F sodium fluoride positive control dentifrice . Subjects ( n = 955 , with ∼239 per group ) with a mean age of 10.6 ( ∼9–12 years ) were r and omly assigned to one of four dentifrice treatments . Two calibrated examiners independently measured visual-tactile caries as DMFS that was supplemented with a radiographic examination at baseline , 12 months and 24 months for each subject . Generally similar results were independently observed by both examiners at the conclusion of the 2-year study period . Considering all subjects that attended at least 60 % of the supervised brushing sessions , statistically significantly less caries was observed in the high-NaF group compared to the control group . Similarly , statistically significantly less caries was observed in the SnF2-HMP group as compared to the control group . Differences in caries increments between the low-NaF and control groups were not statistically significant . One of the examiners observed these same statistically significant differences after 1 year . In conclusion , the results of this clinical trial indicated that while no difference in caries increments was observed between the low-NaF and control groups , both the high-NaF and the SnF2-HMP groups experienced significantly fewer lesions than the control group PURPOSE To assess whether the anti-caries effectiveness of three concentrations of fluoride dentifrice ( placebo , 500 ppm F- and 1450 ppm F- ) could be differentiated with small sample sizes in short time frames . MATERIAL S AND METHODS A controlled fluoride ( F ) dose-response study was conducted in concurrence with a supervised school oral hygiene regimen to assess whether dentifrices with increasing fluoride levels could be differentiated with small sample sizes in short time frames . The study was a r and omized , double-blind study conducted for a period of 21 months . Subjects ( N = 657 with approximately 219 per group ) were r and omized to placebo dentifrice , 500 ppm F- dentifrice or 1450 ppm F- dentifrice treatments for the first 9 months of the study . Subjects in the placebo group were then switched to either 500 ppm F- or 1450 ppm F- dentifrice for the remainder of the study , while subjects in the fluoride groups continued with their original treatment assignments . A calibrated examiner measured visual-tactile caries as DMFS that was supplemented with a radiographic examination at baseline , 9 months and 21 months for each subject . RESULTS The mean caries increments at 9 months were 0.35 surfaces , 0.34 surfaces , and 1.28 surfaces for the 1450 ppm F- , 500 ppm F- , and placebo groups , respectively . The mean caries increments at 21 months were 0.21 surfaces , 0.26 surfaces , 1.75 surfaces and 1.90 surfaces for the 1450 ppm F- , 500 ppm F- , placebo/1450 ppm F- , and placebo/500 ppm F- groups , respectively . The 500 ppm F- and 1450 ppm F- fluoride dentifrices delivered statistically significantly ( P < 0.05 ) lower DMFS scores than the placebo control dentifrice at 9 months , while at 21 months the 500 ppm F- and 1450 ppm F- fluoride dentifrices delivered statistically significantly lower DMFS scores as compared to the both the placebo/500 ppm F- and the placebo/1450 ppm F- dentifrice groups . There was no evidence of a dose response ( 1450 ppm F- < 500 ppm F- ) at 9 months or at 21 months . In this study , the effectiveness of the two fluoride dentifrices was observed at 9 months and these outcomes were still present at 21 months , confirming that caries benefits can be observed in time frames as short as 9 months with approximately 200 subjects per treatment group Since there is no consensus on the anticaries effectiveness of low-fluoride ( F ) dentifrice , this r and omized clinical trial evaluated its effect in children at different caries activity status . One hundred and twenty 2- to 4-year-old children , half with and half without active caries lesions , were r and omly divided into 2 groups which used 500- or 1,100-µg F/g ( NaF ) dentifrices during 1 year . Caries progression or regression were evaluated as the number of lesions becoming active/cavities or inactive , respectively . The anticaries effect of the low-F dentifrice was similar to the conventional F dentifrice when used by caries-inactive children . However , in children with active caries lesions the low-F dentifrice was less effective than the 1,100-µg F/g dentifrice in controlling the progression of lesions . The data suggest that the child caries activity may be taken into account to recommend a low-F dentifrice The purpose of the present study was to evaluate the effect of fluoride upon the stain-inducing capacity of chlorhexidine . Ninety-one children , 13 years of age , volunteered for the experiment . Three test dentifrices were used , containing 0.1 % NaF , 0.1 % NaF + 2 % chlorhexidine , and 2 % chlorhexidine respectively . The experiment was carried out as a double-blind test , and the degree of staining was recorded after 1 and 2 years . Four methods were used for stain scoring . The results after 1 year showed that chlorhexidine induced less stain when applied together with fluoride than when applied alone . After 2 years this difference disappeared , indicating that fluoride only retarded chlorhexidine-induced staining of teeth Background In the literature we find many indices of size of treatment effect ( effect size : ES ) . The preferred index of treatment effect in evidence -based medicine is the number needed to treat ( NNT ) , while the most common one in the medical literature is Cohen 's d when the outcome is continuous . There is confusion about how to convert Cohen 's d into NNT . Methods We conducted meta-analyses of individual patient data from 10 r and omized controlled trials of second generation antipsychotics for schizophrenia ( n = 4278 ) to produce Cohen 's d and NNTs for various definitions of response , using cutoffs of 10 % through 90 % reduction on the symptom severity scale . These actual NNTs were compared with NNTs calculated from Cohen 's d according to two proposed methods in the literature ( Kraemer , et al. , Biological Psychiatry , 2006 ; Furukawa , Lancet , 1999 ) . Results NNTs from Kraemer 's method overlapped with the actual NNTs in 56 % , while those based on Furukawa 's method fell within the observed ranges of NNTs in 97 % of the examined instances . For various definitions of response corresponding with 10 % through 70 % symptom reduction where we observed a non-small number of responders , the degree of agreement for the former method was at a chance level ( ANOVA ICC of 0.12 , p = 0.22 ) but that for the latter method was ANOVA ICC of 0.86 ( 95%CI : 0.55 to 0.95 , p<0.01 ) . Conclusions Furukawa 's method allows more accurate prediction of NNTs from Cohen 's d. Kraemer 's method gives a wrong impression that NNT is constant for a given d even when the event rate differs A double-blind , clinical trial involving 923 children and extending over 4 years was carried out on the Isle of Wight . It investigated the additional protection against dental caries result ing when The 2-year caries increments of fifth to seventh grade students ( mean age 11.7 years ) residing in two fluoride-deficient communities ( A 3-year , double-blind caries trial was conducted to evaluate the caries-reducing effect of a modified technique to use toothpaste . At the outset , 369 children , 4 years of age , were r and omly assigned to four groups . At the end of the study , when the children were 7 years old , 281 ( 76 % ) had completed the trial . Two of the groups ( test groups , n = 131 ) were given the following instructions regarding ' toothpaste technique ' : ( 1 ) to spread the paste evenly on the teeth prior to brushing , ( 2 ) not to expectorate more than necessary during brushing , ( 3 ) to filter the remaining dentifrice foam in the dentition , together with a sip of water , by active cheek movements for 1 min before expectorating , and ( 4 ) not to carry out any further water rinsings afterwards , and not to eat or drink for 2 h after brushing . The children in the other two groups ( control groups , n = 150 ) were not given any instruction how to use the dentifrice and how to rinse after the brushing , but were , as the children in the test groups , encouraged to use the test dentifrice and to brush their teeth twice daily . Two commercial fluoride dentifrices ( A and B ) were compared : one of the test groups and one of the control groups used each product . Approximal carious lesions were scored on bite-wing radiographs at baseline and at the end of the study on the distal surface of the first and on the mesial surface of the second primary molars . No difference in caries increment was found between toothpastes A and B. The children in the two test groups developed a mean of 1.14 new dfs during the 3 years compared to 1.55 in the two control groups ( p < 0.05 ) . Thus , the results indicate that the modified toothpaste technique reduced approximal caries in preschool children by an average of 26 % In the present study , 2,087 fifth- grade rs ( mean age : 12 years ) from two cohorts entered a 3-year clinical toothpaste trial . The study subjects were r and omly allocated to two groups : one group was a positive control using a 0.83 % NaFPO3 toothpaste , while the other group brushed with a test toothpaste containing 1.77 % KAl(SO4 ) . Both toothpastes were used unsupervised at home . One set of bite-wing radiographs was obtained at the beginning of the trial and another at the 3-year follow-up . Clinical registration s of caries were performed by the municipal dentists responsible for the child 's dental care . After 3 years , the mean caries increment was significantly higher in the group using the aluminum-containing toothpaste measured both clinical ly and radiographically A 3-year , double-blind , r and omized caries trial was conducted to evaluate the relative anticaries efficacy of four sodium fluoride dentifrices containing 250 ppm fluoride , 1,000 ppm fluoride in combination with 1 % disodium 1-hydroxyethylidene-1.1-bisphosphonate ( HEBP ) , and 1,000 ppm fluoride in combination with 1 % disodium azacycloheptylidene-2.2-bisphosphonate ( AHBP ) . As a positive control , a monofluorophosphate dentifrice ( 1,000 ppm fluoride ) was used . At outset 1,161 Icel and ic children , 11 and 12 years of age , were r and omly assigned to one of the five treatment groups and 1,035 subjects completed the trial . After 3 years of unsupervised brushing , the dentifrice containing 250 ppm fluoride was significantly less effective in controlling the caries increment . The combination of sodium fluoride and AHBP was significantly more effective than the positive control UNLABELLED Low-fluoride dentifrices ( LFD ) have been recommended for young children aim ing to minimize excessive fluoride intake during tooth brushing . Given the uncertainties surrounding the clinical efficacy of such formulations , alternatives to increase their anticaries effect have been investigated . OBJECTIVES This double-blind , r and omized controlled trial assessed the clinical efficacy of LFDs supplemented with Calcium Glycerophosphate ( CaGP ) or Sodium Trimetaphosphate ( TMP ) on the progression of dental caries in the deciduous dentition . METHODS Children ( average age 48 months old ) from two Brazilian cities ( Araçatuba and Fern and ópolis ) were r and omly assigned into 3 groups , according to the dentifrice to be used : 500ppm F plus 1 % TMP ( " 500TMP " , n=206 ) , 500ppm F plus 0.25 % CaGP ( " 500CaGP , n=201 ) and 1100ppm F ( ' 1100F ' , n=193 ) . Clinical exams ( dmfs ) were performed at baseline and 18 months after dentifrices started to be used , and the increment in the number of carious lesions ( final dmfs - initial dmfs ) was calculated . Data were analyzed by multivariate linear regression analysis to verify the influence of city , gender , previous caries experience and type of dentifrice on dmfs increment ( p<0.05 ) . RESULTS Mean caries increment observed for 500TMP ( 0.26 ) was significantly lower when compared with 1100F ( 0.74 ) , while values found for 500CaGP ( 0.5
Output:
| Only a minority of studies assessed adverse effects of toothpaste .
When reported , effects such as soft tissue damage and tooth staining were minimal .
This Cochrane Review supports the benefits of using fluoride toothpaste in preventing caries when compared to non-fluoride toothpaste .
Evidence for the effects of different fluoride concentrations is more limited , but a dose-response effect was observed for D(M)FS in children and adolescents . |
MS210655 | ***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 Supporting 21st century health care and the practice of evidence -based medicine ( EBM ) requires ubiquitous access to clinical information and to knowledge-based re sources to answer clinical questions . Many questions go unanswered , however , due to lack of skills in formulating questions , crafting effective search strategies , and accessing data bases to identify best levels of evidence . Methods This r and omized trial was design ed as a pilot study to measure the relevancy of search results using three different interfaces for the PubMed search system . Two of the search interfaces utilized a specific framework called PICO , which was design ed to focus clinical questions and to prompt for publication type or type of question asked . The third interface was the st and ard PubMed interface readily available on the Web . Study subjects were recruited from interns and residents on an inpatient general medicine rotation at an academic medical center in the US . Thirty-one subjects were r and omized to one of the three interfaces , given 3 clinical questions , and asked to search PubMed for a set of relevant articles that would provide an answer for each question . The success of the search results was determined by a precision score , which compared the number of relevant or gold st and ard articles retrieved in a result set to the total number of articles retrieved in that set . Results Participants using the PICO templates ( Protocol A or Protocol B ) had higher precision scores for each question than the participants who used Protocol C , the st and ard PubMed Web interface . ( Question 1 : A = 35 % , B = 28 % , C = 20 % ; Question 2 : A = 5 % , B = 6 % , C = 4 % ; Question 3 : A = 1 % , B = 0 % , C = 0 % ) 95 % confidence intervals were calculated for the precision for each question using a lower boundary of zero . However , the 95 % confidence limits were overlapping , suggesting no statistical difference between the groups . Conclusion Due to the small number of search es for each arm , this pilot study could not demonstrate a statistically significant difference between the search protocol s. However there was a trend towards higher precision that needs to be investigated in a larger study to determine if PICO can improve the relevancy of search results This study evaluated individual differences in levels of C-reactive protein ( CRP ) measured in saliva , cross-sectionally and prospect ively , in relation to systemic inflammation and risk for cardiovascular disease ( CVD ) . Plasma and saliva sample s , later assayed for CRP , were collected multiple times from an ethnically diverse group of women seeking help from domestic violence crisis shelters-agencies ( N=107 ; mean age at study start=34 years ) . Plasma and saliva CRP levels were moderately associated cross-sectionally and across two years . There were indications that saliva CRP levels were , on average , higher in the morning than evening . Higher levels of saliva and plasma CRP were associated with a higher body mass index , but did not differ between women who did and did not smoke . Salivary CRP reliably discriminated between high and low levels of plasma CRP , using a clinical ly relevant cutoff point of 3mg/L , recommended by the American Heart Association . Results build upon an emerging literature suggesting that under specific conditions levels of CRP in saliva may reflect low- grade inflammation and have the potential to serve as a screen for CVD risk status Non-r and omised studies of the effects of interventions are critical to many areas of healthcare evaluation , but their results may be biased . It is therefore important to underst and and appraise their strengths and weaknesses . We developed ROBINS-I ( “ Risk Of Bias In Non-r and omised Studies - of Interventions ” ) , a new tool for evaluating risk of bias in estimates of the comparative effectiveness ( harm or benefit ) of interventions from studies that did not use r and omisation to allocate units ( individuals or clusters of individuals ) to comparison groups . The tool will be particularly useful to those undertaking systematic review s that include non-r and omised studies Aging is associated with an increased susceptibility to infections and chronic inflammatory diseases . This might be caused by dysregulations of the endocrine system with increased activity of the hypothalamus-pituitary-adrenal ( HPA ) axis and decreased levels of sex steroids . Therefore , we investigated the stress-response of the HPA axis and glucocorticoid ( GC ) sensitivity of pro-inflammatory cytokine production in elderly men , compared to testosterone-treated elderly men and young controls . Stress-induced increases in cortisol did not differ significantly between experimental groups ( F=2.10 ; p>0.10 ) , but GC sensitivity increased significantly in young controls and testosterone-treated elderly men , while a decrease was found in untreated elderly men ( F=5.28 ; p<0.01 ) . We conclude that the increase in GC sensitivity after stress serves to protect the individual from detrimental increases of pro-inflammatory cytokines , a mechanism that is disturbed in elderly men and partly restored by testosterone treatment Psychosocial factors and interleukin-6 ( IL-6 ) levels are both related to risk of morbidity and mortality . The aim of this study was to investigate how a broad range of psychosocial factors related to levels of IL-6 in different media . Fifty-nine men and women aged 30 - 65 were recruited from a larger study and selected to cover a broad range of psychosocial status . IL-6 levels were analyzed in serum , in saliva collected at home at three different time points during a day , and in the supernatant of cell cultures stimulated in vitro with lipopolysaccharide . After adjustments for age , gender , self-reported health problems , and lifestyle factors , IL-6-levels in serum were negatively correlated with coping and self-esteem , and positively correlated with cynicism , hostile affect , hopelessness , depression , and vital exhaustion . In saliva sample s , at all time points , IL-6 levels were positively correlated to cynicism , and IL-6 levels 30 min after awakening were also positively correlated with hopelessness , depression , and vital exhaustion . After adjustment for age and gender , cynicism , depression , and vital exhaustion were negatively correlated to IL-6 levels in the supernatant of cell cultures stimulated in vitro with lipopolysaccharide , but this effect was lost after control for self-reported health problems and lifestyle factors . In conclusion , we found that IL-6 levels in serum and saliva were negatively related to psychosocial re sources and positively related to psychosocial risk factors . These data strengthen the argument that IL-6 is involved in mediating the risk for disease development that has been associated with psychosocial factors
Output:
| Discussion This systematic review will synthesize the evidence regarding salivary markers of inflammation in response to acute stress .
We anticipate variation across studies but hypothesize that salivary markers of inflammation will increase in response to acute stress . |
MS210656 | ***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 For patients with acute-on-chronic liver failure ( ACLF ) , artificial liver support system ( ALSS ) may help prolong lifespan and function as a bridge to liver transplantation ( LT ) , but data on its long-term benefit are lacking . We conducted this prospect i ve , controlled study to determine the efficacy of ALSS and the predictors of mortality in patients with hepatitis B virus (HBV)-associated ACLF.From January 2003 to December 2007 , a total of 234 patients with HBV-associated ACLF not eligible for LT were enrolled in our study . They were allocated to receive either plasma exchange centered ALSS plus st and ard medical therapy ( SMT ) ( ALSS group , n = 104 ) or SMT alone ( control group , n = 130 ) . All the patients were followed-up for at least 5 years , or until death . At 90 days , the survival rate of ALSS group was higher than that of the control group ( 62/104 [ 60 % ] vs 61/130 [ 47 % ] , respectively ; P < 0.05 ) . Median survival was 879 days in the ALSS group ( 43 % survival at 5 years ) and 649 days in the control group ( 31 % survival at 5 years , log-rank P < 0.05 ) . ALSS was found to be associated with favorable outcome of these patients by both univariate and multivariate analysis . Multivariate Cox regression analysis also revealed that lower serum sodium levels , higher grade s of encephalopathy , presence of cirrhosis , hepatorenal syndrome , and higher model for end-stage liver disease scores were independent predictors for both 90-day and 5-year mortality due to ACLF.Our findings suggest that ALSS is safe and may improve the short- and long-term prognosis of patients with HBV-associated ACLF 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 Patients with liver cirrhosis and a superimposed acute injury with progressive hyperbilirubinemia have a high mortality . A prospect i ve , controlled study was performed to test whether hyperbilirubinemia , 30‐day survival , and encephalopathy would be improved by extracorporeal albumin dialysis ( ECAD ) . Twenty‐four patients were studied ; 23 patients had cirrhosis ; 1 had a prolonged cholestatic drug reaction and was excluded from per protocol ( PP ) analysis . Patients had a plasma bilirubin greater than 20 mg/dL and had not responded to prior st and ard medical therapy ( SMT ) . Patients were r and omized to receive SMT with ECAD or without ( control ) . ECAD was performed with an extracorporeal device that dialyzes blood in a hollow fiber dialyzer ( MW cutoff < 60 kd ) against 15 % albumin . Albumin‐bound molecules transfer to dialysate albumin that is regenerated continuously by passage through a charcoal and anion exchange column and a conventional dialyzer . ECAD was associated with improved 30‐day survival ( PP , 11 of 12 ECAD , 6 of 11 controls ; log rank P < .05 ) . Plasma bile acids and bilirubin decreased on average by 43 % and 29 % , respectively , in the ECAD group after 1 week of treatment , but not in the control group . Renal dysfunction and hepatic encephalopathy improved in the ECAD group , but worsened significantly in the control group . ECAD was safe , with adverse events being rare and identical in both groups . In conclusion , ECAD appears to be effective and safe for the short‐term treatment of patients with cirrhosis and superimposed acute injury associated with progressive hyperbilirubinemia and may be useful for increasing survival in such patients awaiting liver transplantation The Molecular Adsorbent Recirculating System ( MARS ) has been proven to prolong survival in patients with hepatorenal syndrome . MARS is a modified dialysis that uses an albumin containing dialysate , which is recirculated and perfused online through charcoal and anion exchanger columns . It allows the selective removal of albumin bound substances . Despite advances in medical therapy and technology , the prognosis of patients with cardiogenic shock remains poor . Mortality rates are as high as 80 % , often because of persistent multiple organ failure . To determine whether patients with hypoxic liver failure after cardiogenic shock after cardiac surgery might benefit from MARS , we performed a prospect i ve , r and omized , controlled , single center study . The primary objective was to prove that MARS improves survival . This article is a report on the interim analysis of the first 27 patients included between August 2000 and December 2001 ; 14 patients were in the MARS group , and 13 patients were in the non-MARS group . All had bilirubin levels greater than 8 mg/ml . Both groups had a similar risk profile . The MARS group received MARS for 3 consecutive days — if bilirubin was still greater than 6 mg/dl afterward , MARS was continued . The non-MARS group received conventional therapy . We had seven survivors in the MARS group ( 50 % ) compared with four ( 32 % ; p = ns ) in the non-MARS group . We conclude that despite the limited number of patients included in this analysis , MARS can be recommended for patients with acute , hypoxic liver failure because it might prolong survival . Further studies in similar patient cohorts are needed to verify our results BACKGROUND Albumin dialysis with the Molecular Adsorbent Recirculating System ( MARS ) ( Gambro , Lund , Sweden ) , a noncell artificial liver support device , may be beneficial in acute liver failure ( ALF ) . OBJECTIVE To determine whether MARS improves survival in ALF . DESIGN R and omized , controlled trial . ( Clinical Trials.gov : NCT00224705 ) . SETTING 16 French liver transplantation centers . PATIENTS 102 patients with ALF . INTERVENTION Conventional treatment ( n = 49 ) or MARS with conventional treatment ( n = 53 ) , stratified according to whether paracetamol caused ALF . MEASUREMENTS 6-month survival and secondary end points , including adverse events . RESULTS 102 patients ( mean age , 40.4 years [ SD , 13 ] ) were in the modified intention-to-treat ( mITT ) population . The per- protocol analysis ( 49 conventional , 39 MARS ) included patients with at least 1 session of MARS of 5 hours or more . Six-month survival was 75.5 % ( 95 % CI , 60.8 % to 86.2 % ) with conventional treatment and 84.9 % ( CI , 71.9 % to 92.8 % ) with MARS ( P = 0.28 ) in the mITT population and 75.5 % ( CI , 60.8 % to 86.2 % ) with conventional treatment and 82.9 % ( CI , 65.9 % to 91.9 % ) with MARS ( P = 0.50 ) in the per- protocol population . In patients with paracetamol-related ALF , the 6-month survival rate was 68.4 % ( CI , 43.5 % to 86.4 % ) with conventional treatment and 85.0 % ( CI , 61.1 % to 96.0 % ) with MARS ( P = 0.46 ) in the mITT population . Sixty-six of 102 patients had transplantation ( 41.0 % among paracetamol-induced ALF ; 79.4 % among non-paracetamol-induced ALF ) ( P < 0.001 ) . Adverse events did not significantly differ between groups . LIMITATION The short delay from r and omization to liver transplantation ( median , 16.2 hours ) precludes definitive efficacy or safety evaluations . CONCLUSION This r and omized trial of MARS in patients with ALF was unable to provide definitive efficacy or safety conclusions because many patients had transplantation before administration of the intervention . Acute liver failure not caused by paracetamol was associated with greater 6-month patient survival . PRIMARY FUNDING SOURCE Assistance Publique-Hôpitaux de Paris Background For patients with an acute exacerbation of chronic liver failure ( ACLF ) , the molecular adsorbent recirculating system ( MARS ) can result in a prolongation of life , but data on costs and cost-effectiveness are lacking . Methods A health economic evaluation of a prospect i ve controlled cohort trial in patients with ACLF not eligible for liver transplantation with 3 years follow-up and consecutive modelling of long-term costs , outcomes and cost-effectiveness was conducted . Costs were calculated from the perspective of the German health-care system . Results One hundred and forty-nine patients with ACLF were included of which 67 ( 44.9 % ) were treated with MARS and 82 ( 55.1 % ) assigned to the control group . Mean survival was 692 days in MARS-treated patients ( 33 % survival after 3 years ) and 453 days in control patients ( 15 % after 3 years , logrank P = 0.022 ) . MARS patients gained 0.66 [ 95 % confidence interval ( CI ) : −0.12 to 1.46 ] life years ( LYs ) , determined by the bootstrap method . The mean cost difference was 19.835 & U20AC ; ( 95 % CI : 13.308–25.429 ) with 35639 & U20AC ; for MARS-treated patients and 15804 & U20AC ; for controls . Incremental costs per LY gained were 29.985 & U20AC ; ( 95 % CI : 9.441–321.761 ) and 43.040 & U20AC ; ( 95 % CI : 13.551–461.856 ) per quality -adjusted LY gained . Conclusion There is an acceptable cost-effectiveness of MARS , compared with other medical technologies presently reimbursed . R and omized controlled trials with sufficient sample size are necessary before a final recommendation for MARS can be given The objective of this pilot controlled study was to evaluate the extracorporeal liver assist device ( ELAD ) in patients with acute liver failure who were judged to still have a significant chance of survival ( approximately 50 % ) and in those who had already fulfilled criteria for transplantation . Twenty-four patients were divided into two groups , 17 with a potentially recoverable lesion ( group I ) and 7 listed for transplantation ( group II ) , and then r and omly allocated to ELAD haemoperfusion or control . The median period of ELAD haemoperfusion was 72 hours ( range 3 - 168 h ) . Biocompatibility of the device was good , with no acceleration in platelet consumption , and haemodynamic stability was maintained . Two patients were withdrawn from the study because of worsening of preexisting disseminated intravascular coagulation in one case and a hypersensitivity reaction in the other . Deterioration with respect to encephalopathy grade was more frequent in the control patients , 7 of 12 ( 58 % ) , than in the ELAD-treated patients , 3 of 12 ( 25 % ) . In group I where survival for the ELAD cases was 7 of 9 ( 78 % ) , there was a higher than expected survival in the controls , 6 of 8 ( 75 % ) . For group II cases , survival was 1 of 3 ( 33 % ) for the ELAD-treated patients , and 1 of 4 ( 25 % ) for the controls . Both of the survivors underwent transplantation . Assessment of additive function for the device revealed an improvement in galactose elimination capacity after 6 hours of haemoperfusion . Based on the results of this pilot-controlled trial , better indices of prognosis will be required , in addition to those used to select for transplantation , if patients at an earlier stage of clinical deterioration are to be included in future studies Patients with acute-on-chronic liver failure ( ACLF ) are known to have a very high mortality rate as the majority of these patients succumb to multiorgan failure . Liver transplant remains the only option for these patients ; however , there are problems with its availability , cost and also the complications and side effects associated with immunosuppression . Unlike advanced decompensated liver disease , there is a potential for hepatic regeneration and recovery in patients with ACLF . A liver support system , cell or non-cell based , logically is likely to provide temporary functional support until the donor liver becomes available or the failing liver survives the onslaught of the acute insult and spontaneously regenerates . Underst and ing the pathogenesis of liver failure and regeneration is essential to define the needs for a support system . Removal of hepatotoxic metabolites and inhibitors of hepatic regeneration by liver dialysis , a non-cell-based hepatic support , could help to provide a suitable microenvironment and support the failing liver . The current systems , i.e. , MARS and Prometheus , have failed to show survival benefits in patients with ACLF based on which newer devices with improved functionality are currently under development . However , larger r and omized trials are needed to prove whether these devices can enable restoration of the complex dysregulated immune system and impact organ failure and mortality in these patients To investigate the role of extracorporeal detoxification in cirrhotic patients with advanced hepatic encephalopathy not responding to medical
Output:
| Conclusions ECLS may reduce mortality and improve HE in patients with ALF and ACLF .
The effect on other outcomes is uncertain . |
MS210657 | ***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 purpose of this prospect i ve clinical study was to evaluate peri-implant soft-tissue conditions and esthetic fulfillment during a 3-year follow-up period following prosthetic rehabilitation . MATERIAL AND METHODS As part of a prospect i ve multi-center study , 152 ITI dental implants were placed in 80 patients in the maxillary anterior region . Fifty-nine crowns ( 38.82 % ) were cement retained , while 93 ( 61.18 % ) crowns were screw retained . At loading and 3 , 6 , 12 and 36 months post-loading , modified plaque index ( MPI ) , sulcus bleeding index ( SBI ) , keratinized mucosa ( KM ) , gingival level ( GL ) , and esthetic fulfillment were recorded . RESULTS All patients completed the study and no complications were reported . While statistically not significant at all time points , cement-retained crowns seemed to present a worsening trend in MPI and SBI scores . Interestingly , screw-retained crowns seemed to present an opposite picture , their MPI and SBI scores improved over time . While plaque accumulation , prophylaxis and depth of crown margin significantly affected levels of sulcus bleeding , prophylaxis alone played a key role in reducing plaque accumulation . No soft tissue recession was observed in either cement- or screw-retained crowns up to 3 years post-loading . Esthetic fulfillment survey revealed that patients did not have a preference for crown types ; however , dentists favored cement-retained over screw-retained crowns . CONCLUSIONS Peri-implant soft tissues responded more favorably to screw-retained crowns when compared with cement-retained crowns . However , no soft-tissue recession was observed in either type of crowns . Cement-retained crowns were preferred by dentists , while patients were equally satisfied with either type of crowns they received PROBLEM The Ankylos endosseous dental implant is a new implant design that will be available in the United States in early 2004 . It features an internal tapered abutment connection , a smooth polished collar without threads at the coronal part of the implant body , and a roughened surface with variable threads on the body of the implant fixture . A precise , tapered , conical abutment connection eliminates the microgap often found in 2-stage implant systems . This microgap may allow the accumulation of food debris and bacteria , as well as micromovement between the parts during clinical function , both of which can lead to a localized inflammation and crestal bone loss . PURPOSE The purpose of this section of the study was to assess any crestal bone loss associated with this new implant . METHOD The clinical performance of this new implant design was studied under well-controlled clinical conditions . Over 1500 implants were placed and restored . The vertical crestal bone loss was measured " directly " between the time of implant placement and uncovering , using a periodontal probe . Serial dental radiographs were taken between loading , and the 12- , 24- , and 36-month follow-up visits to determine " indirect " crestal bone loss within a specific period . RESULTS Bone loss varied among the participating centers from less than 0.5 mm to 2.0 mm . The largest amount of bone loss occurred between the time of placement and uncovering . Following loading , the mean bone loss for all implants for a period of 3 years was about 0.2 mm/y . CONCLUSIONS The extent of the crestal bone loss after loading was minimal for patients regardless of age , gender , prosthetic applications , bone density , and remote or crestal incisions , as well as for smokers or nonsmokers . Bone loss per year is well within the guidelines of 0.2 mm/y proposed by others OBJECTIVE To evaluate marginal bone loss over 3 years around immediate microthreaded implants placed in the maxillary anterior/esthetic zone and immediately restored with single crowns . MATERIAL AND METHODS Seventy-one implants ( with microthreads up to the platform -- rough surface body and neck , internal connection and platform switching ) were placed in fresh extraction sockets in the maxillary arches of 30 men and 23 women ( mean age 37.85 ± 7.09 years , range 27 - 60 ) . All subjects had at least 3 mm of soft tissue to allow the establishment of adequate biologic width and to reduce bone resorption . Each patient received a provisional restoration immediately after implant placement with slight occlusal contact . Mesial and distal bone height was evaluated using digital radiography on the day following implant placement ( baseline ) and after 1 , 2 , and 3 years . Primary stability was measured with resonance frequency analysis . RESULTS No implants failed , result ing in a cumulative survival rate of 100 % after 3 years . Marginal bone loss from implant collar to bone crest measured at baseline ( peri-implant bone defect at the fresh extraction socket ) and after 3 years was 0.86 mm ± 0.29 mm . Mesial and distal site crestal bone loss ranged from 3.42 mm ± 1.2 mm at baseline to 3.51 mm ± 1.5 mm after 3 years ( P = 0.063 ) and from 3.38 mm ± 0.9 mm at baseline to 3.49 mm ± 0.9 mm after 3 years , respectively ( P = 0.086 ) . CONCLUSIONS This prospect i ve study found minimal marginal bone loss and a 100 % implant survival rate over the 3-year follow-up for microthreaded immediate implants subjected to immediate non-occlusal loading OBJECTIVES This r and omised , controlled multicentre trial aim ed at comparing two versions of a variable-thread dental implant design to a st and ard tapered dental implant design in cases of immediate functional loading for 36 months after loading . MATERIAL S AND METHODS 177 patients ( 325 implants ) were included at 12 study centres and r and omly allocated into one of three treatment groups : NAI ( variable-thread design , NobelActive internal connection ) , NAE ( variable-thread design , NobelActive external connection ) and , as control , NR ( st and ard tapered design , NobelReplace tapered groovy ) . Inclusion criteria concerned healed bony implant sites and feasibility for immediate loading . Clinical and radiographic examinations were performed at implant placement and after 3 , 6 , 12 , 24 and 36 months . The outcome measures were marginal bone remodelling ( primary outcome ) , implant survival and success , papilla score , plaque accumulation , and bleeding on probing . RESULTS 127 patients ( NAI : 45 , NAE : 41 , NR : 41 ) were followed-up and evaluated after 36 months . No significant differences in cumulative survival rates were seen for the groups ( NAI : 95.7 % ; NAE : 96.3 % ; NR : 96.6 % ) . In all groups , bone remodelling occurred during the first 3 months , with stable or even increasing bone levels after the initial remodelling period . The bone remodelling from insertion to 36 months for the NAI group ( -0.89 ± 1.65 mm ) was comparable ( P = 0.98 ) to that of the NR group ( -0.85 ± 1.32 mm ) . The NAE group showed comparable bone remodelling during the first year , with an increase in following years result ing in significantly less overall bone loss ( -0.16 ± 1.06 mm ) ( P = 0.041 ) . Overall improvement in papilla size was observed in all treatment groups . CONCLUSIONS Over 36 months , the results show stable or improving bone levels for all treatment groups after the initial bone remodelling seen during the first 3 months after placement . The variable- thread implants showed results comparable to those of st and ard tapered implants in cases of immediate function , and therefore can be considered as a treatment option for immediate loading PURPOSE The present study was design ed to compare the long-term outcome and complications of cemented versus screw-retained implant restorations in partially edentulous patients . MATERIAL S AND METHODS Consecutive patients with bilateral partial posterior edentulism comprised the study group . Implants were placed , and cemented or screw-retained restorations were r and omly assigned to the patients in a split-mouth design . Follow-up ( up to 15 years ) examinations were performed every 6 months in the first year and every 12 months in subsequent years . The following parameters were evaluated and recorded at each recall appointment : ceramic fracture , abutment screw loosening , metal frame fracture , Gingival Index , and marginal bone loss . RESULTS Thirty-eight patients were treated with 221 implants to support partial prostheses . No implants during the follow-up period ( mean follow-up , 66 ± 47 months for screw-retained restorations [ range , 18 to 180 months ] and 61 ± 40 months for cemented restorations [ range , 18 to 159 months ] ) . Ceramic fracture occurred significantly more frequently ( P < .001 ) in screw-retained ( 38 % ± 0.3 % ) than in cemented ( 4 % ± 0.1 % ) restorations . Abutment screw loosening occurred statistically significantly more often ( P = .001 ) in screw-retained ( 32 % ± 0.3 % ) than in cement-retained ( 9 % ± 0.2 % ) restorations . There were no metal frame fractures in either type of restoration . The mean Gingival Index scores were statistically significantly higher ( P < .001 ) for screw-retained ( 0.48 ± 0.5 ) than for cemented ( 0.09 ± 0.3 ) restorations . The mean marginal bone loss was statistically significantly higher ( P < .001 ) for screw-retained ( 1.4 ± 0.6 mm ) than for cemented ( 0.69 ± 0.5 mm ) restorations . CONCLUSION The long-term outcome of cemented implant-supported restorations was superior to that of screw-retained restorations , both clinical ly and biologically PURPOSE To compare the clinical and radiological outcomes of two implant design s with different prosthetic interfaces and neck configurations . MATERIAL S AND METHODS Thirty-four partially edentate patients r and omly received at least one NobelActive implant ( Nobel Biocare , Göteborg , Sweden ) with back-tapered collar , internal conical connection and platform shifting design , and one NobelSpeedy implant ( Nobel Biocare ) with external hexagon and flat-to-flat implant-abutment interface according to a split-mouth design . Follow-up continued to 3 years post-loading . The primary outcome measures were the success rates of the implants and prostheses , and the occurrence of any surgical and prosthetic complications during the entire follow-up . Secondary outcome measures were : horizontal and vertical peri-implant marginal bone level ( MBL ) changes , resonance frequency analysis values at implant placement and loading ( 4 months ) , sulcus bleeding index ( SBI ) and plaque score ( PS ) . RESULTS No drop-out occurred . No implants and prostheses failures were observed to the 3-year follow-up . MBL changes were statistically significant different with better results for the NobelActive implants for both horizontal and vertical measurements ( P = 0.000 ) . After 3 years post-loading , the NobelActive implants underwent a mean vertical bone resorption of 0.66 mm , compared with 1.25 mm for the NobelSpeedy Groovy implants ( P = 0.000 ) ; the mean horizontal bone resorption was 0.19 mm for the NobelActive implants and 0.60 mm for the NobelSpeedy Groovy implants ( P = 0.000 ) . A high ISQ value was found for both implants , and no statistically significant difference was found for ISQ mean values between interventions ( P = 0.941 at baseline ; P = 0.454 at implantabutment connection ; P = 0.120 at prosthesis delivery ) . All implants showed good periodontal health at the 3-year-in-function visit , with no significant differences between groups . CONCLUSION The results of this research suggest that in well-maintained patients , the MBL changes could be affected by the different implant design . After 4 months of unloaded healing , as well as after 3 years in function , both implants provided good results , however vertical and horizontal bone loss had statistically significant differences between the two groups ( difference of 0.58 ± 0.10 mm for the vertical MBL , and 0.4 ± 0.05 mm for the horizontal MBL ) , with lower values in the Nobel Active implants , compared to the NobelSpeedy Groovy implants PURPOSE To evaluate whether platform switching could preserve marginal bone around implants up to 6 months after loading . MATERIAL S AND METHODS 15 patients were selected for a r and omised controlled trial . Each patient received one customised wide body implant , with the external hex connection located eccentrically , allowing an extra 1 mm switch on one side . The hex was positioned at r and om at the mesial or distal side and the implant was loaded after 6 months of non-submerged healing . Patients were examined at 3 , 6 and 12 months after surgery , during which a radiograph was taken to evaluate bone levels . At 12 months , the mucosal thickness was measured using a perio-probe . RESULTS All implants survived and the mean overall bone loss , calculated from both the switched and non-switched side , was 0.39 mm ( SD 0.33
Output:
| Osseointegrated dental implants with internal connections exhibited lower marginal bone loss than implants with external connections . |
MS210658 | ***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 aetiology of nasal polyps remains obscure . Although clinical ly associated with asthma , notably in women , there is a marked male preponderance of polyposis . This study aim ed to explore environmental pollutant triggers and gender differences in risk factors for nasal polyps . In total , 900 patients having surgery for polyposis and 120 new patients with nasal polyps completed a question naire with regard to occupational dust and chemical exposure . The male to female ratio was 2:1 , and 52 % were smokers , although only 37 % of women smoked compared with 66 % of men . Exposure to occupational dusts and chemicals was noted in 45 % ( retrospective ) and 53 % ( prospect i ve ) of respondents . Women were 1.6 times more likely to be asthmatic and 2.7 times more likely to have allergic rhinitis than men . Men were 2.25 times more likely to be smokers and 2.48 times more likely to have been exposed to chemicals and dusts than women ( all statistically significant differences ) . No significant gender associations were found for hayfever , eczema , aspirin intolerance , alcohol intake or hobby dust exposure Background The cause of nonallergic rhinitis ( NAR ) and its relation to lower airway disease remains unclear . The purpose of this study was to perform a descriptive analysis of the occurrence of rhinitis in a Danish general population with focus on NAR and its association with smoking and lower airway disease . Methods A population -based , cross-sectional study conducted in Copenhagen , Denmark was performed . A r and om sample from the general population ( n = 7931 ; age , 18–69 years ) was invited to a general health examination including measurements of serum-specific immunoglobulin E ( IgE ) to common aeroallergens ; 3471 ( 44 % ) persons were accepted . For further analysis , we divided the population into the following groups : ( I ) negative specific IgE and no rhinitis ( controls ) ; ( II ) negative specific IgE and rhinitis ( NAR ) ; ( III ) positive specific IgE and rhinitis ( allergic rhinitis [ AR ] ) ; and ( IV ) positive specific IgE but no rhinitis ( sensitized ) . Results We found that NAR was associated with asthma ( odds ratio [ OR ] = 2.51 [ 1.87–3.37 ] ) ; chronic bronchitis ( OR = 2.27 [ 1.85–2.79 ] ) ; current smoking ( > 15 g/day ; OR = 1.57 [ 1.18–2.08 ] ) ; lower forced expiratory volume in 1 second/forced vital capacity ( FEV1/FVC ) ratios and reduced FEV1 values . The association with chronic bronchitis was stronger in NAR than in AR , whereas the opposite was true for asthma . FEV1/FVC of < 70 % was not significantly associated to any group . Conclusion This epidemiological study indicates that both asthma and chronic bronchitis are important comorbidities in NAR confirming the “ united airway ” hypothesis , and that smoking might be a significant modulator of disease . Although NAR was significantly associated with poor lung function , no significant association with chronic obstructive pulmonary disease was shown OBJECTIVES To compare total nasal resistance ( TNR ) in upright and supine positions in patients who did and did not complain of nocturnal ( supine ) nasal congestion symptoms without daytime ( upright ) congestion , and to determine what other conditions were associated with nocturnal nasal congestion ( NNC ) symptoms . STUDY DESIGN A prospect i ve study comparing objective ly measured nasal airflow in different positions ( upright and reclining ) with subjective patient symptoms . METHODS Subjects completed a question naire about nasal symptoms . Anterior rhinomanometry was performed with patients upright , reclined 45 degrees , and supine . TNR in subject subsets was compared using the Student t test . RESULTS TNR did not differ between upright patients with ( n = 27 ) and without ( n = 20 ) NNC . Supine TNR ( P < .04 ) and increase in TNR ( P < .02 ) between upright and supine was greater in patients with NNC . Smokers ( n = 15 , 10 with NNC , 5 without ) had greater TNR increases when supine versus nonsmokers ( P < .02 ) . Patients with rhinitis symptoms ( n = 29 , 18 with NNC , 11 without ) had greater TNR increases when supine than patients without rhinitis ( P < .01 ) . Patients who both smoked and had rhinitis ( n = 11 , 7 with NNC , 4 without ) had a greater supine TNR than patients who smoked or had rhinitis alone ( P < .02 ) . CONCLUSIONS Some patients without daytime nasal congestion experience NNC . They have a significantly greater TNR increase when supine versus patients without NNC . Smokers and patients with rhinitis , with or without NNC , have a significantly greater TNR increase when supine versus nonsmokers or patients without rhinitis . Smoking cessation and treatment of rhinitis may improve the patients ' NNC Objective --To estimate the prevalence of isolated self-reported allergic and non-allergic rhinitis symptoms in an adult population and to explore the relations to age , gender , olfaction and smoking habits . Material and methods --Self-judged health and environmental exposures were investigated by means of a question naire survey administered to a stratified r and om sample of 15,000 adults in Stockholm County . Results --A total of 10,670 individuals were included in the analysis , corresponding to a response rate of 73 % . The results revealed a high prevalence of self-reported non-allergic rhinitis , 19 % , almost as high as the prevalence of self-reported allergic rhinoconjunctivitis , 24 % . In contrast to current clinical opinion , we did not find a significant increase in the prevalence of non-allergic symptoms with increased age . There were no statistically significant gender differences in the prevalence of either allergic or non-allergic symptoms . A reduced sense of smell was twice as common in the non-allergic group , 23 % , as in the healthy population . The prevalence of rhinitis symptoms differed according to smoking habits . Conclusion --Both self-reported allergic rhinitis symptoms and non-allergic nasal symptoms are frequent in the population sample . Self-reported non-allergic nasal symptoms seem to occur independent of age and reduced olfactory sense is a common complaint among these subjects . The prevalence of self-reported allergic and non-allergic nasal symptoms did not differ much between men and women or between individuals with different smoking habits STUDY OBJECTIVE The upper and lower airways are continuous . While upper airway symptoms are common in COPD patients , with accumulating evidence to suggest increased nasal inflammation , the relationships among upper airway , lower airway , and systemic inflammatory indexes have not been studied . We aim ed to confirm that there is heightened nasal inflammation in COPD patients , to test the hypothesis that the degree of upper airway inflammation relates to the degree of lower airway inflammation , and to investigate the underlying associations with bacterial carriage and the systemic inflammatory response . DESIGN Prospect i ve cohort study . SETTING Outpatient Department , London Chest Hospital , London , UK . PARTICIPANTS Forty-seven patients with COPD and 12 control subjects of similar age , sex , and smoking status . MEASUREMENTS Serum , nasal wash fluid , and sputum sample s were obtained from 47 stable patients with COPD for the analysis of inflammatory indexes and bacterial colonization . Nasal wash fluid specimens were obtained from 12 control subjects . RESULTS COPD patients had an increased nasal interleukin (IL)-8 concentration compared to control subjects ( difference , 97.2 pg/mL ; p = 0.009 ) . The nasal IL-8 concentration in COPD patients correlated with that in sputum ( r = 0.30 ; p = 0.039 ) . In both the upper and lower airways of patients with COPD , the IL-8 concentration was associated with indexes of bacterial colonization . Patients colonized with a sputum potentially pathogenic microorganism had a higher total nasal bacterial load ( difference , 1.5 log cfu/mL ; p = 0.016 ) . We did not find significant relationships between the degree of upper or lower airway inflammation , or bacterial carriage , and the systemic inflammatory response . CONCLUSIONS COPD is associated with an increased nasal concentration of the neutrophil chemoattractant protein IL-8 , the degree of which reflects that present in the lower airway . A relationship between lower airway bacterial colonization , postnasal drip , and higher nasal bacterial load may suggest a mechanism underlying this finding . This study is the first to report a correlation between the degree of upper and lower airway inflammation in COPD Conclusion . There is high prevalence of lower airway diseases in patients with chronic rhinosinusitis and frequently co-existing lower airway diseases have not been diagnosed before . Objectives . To examine the prevalence of lower airway diseases in patients with chronic rhinosinusitis . Methods . Seventy-three consecutive patients with chronic rhinosinusitis were enrolled in this prospect i ve study . With routine physical examination , spirometry and methacholine bronchial provocation test were performed and chest simple radiograph or chest computed tomography was taken . Results . Thirty patients ( 41.1 % ) had lower airway diseases . There were 8 patients with asthma , 5 with asymptomatic bronchial hyperresponsiveness , 11 with small airway disease , 2 with chronic obstructive pulmonary disease and 4 with bronchiectasis . Of these 30 patients , 21 patients ( 70.0 % ) were first diagnosed as having lower airway diseases in this study The effect of tobacco smoking on chronic rhinosinusitis ( CRS ) is not yet well‐delineated . The purpose of this investigation was to evaluate the overall effect of smoking on postoperative outcomes ( endoscopic score and health‐related quality ‐of‐life [ HRQoL ] ) after endoscopic sinus surgery ( ESS ) for CRS and to determine if volume of daily smoking impacts outcomes Background When associated with lower airway involvement , the morbidity and the cost of chronic rhinosinusitis ( CRS ) can increase . The aim of this prospect i ve study was to assess the clinical and radiological characteristics of the upper airways in CRS patients scheduled for functional endoscopic sinus surgery and to correlate these findings with the functional changes of the lower airways . Methods Twenty-five adult patients with CRS were subjected to clinical and endoscopic assessment s , computed tomography scan , and allergic assessment s using vali date d scoring systems . Lower airways were assessed by clinical history , pulmonary function test , histamine bronchial provocation test , and chest x rays . Results Sixty percent of CRS patients were shown to have associated lower airway involvement , i.e. , 24 % had asthma and 36 % had small airway disease ( SAD ) . Nasal congestion and nasal polyps were the most common clinical findings in both of these subgroups of patients . In addition , there was a negative correlation between computed tomography scan findings of the sinuses and the obstructive parameters on pulmonary function test in SAD but not in the asthma subgroup . Conclusion These results showed that different kinds of lower airway involvement frequently could be associated with CRS . Some are manifest such as asthma and some are hidden such as SAD and histamine bronchial hyperresponsiveness The relation between chronic rhinosinusitis ( CRS ) and the associated lower airways involvement is not clear yet . In this context , the aim of this prospect i ve study was to evaluate the correlation between middle meatal lavage ( MML ) and bronchoalveolar lavage ( BAL ) cytology in adult CRS patients . Based on clinical history and pulmonary function changes , CRS patients were divided into three subgroups : asthma , small airway disease ( SAD ) and normal lower airway ( NLA ) subgroups . Preoperatively , 50 MMLs and 25 BALs were performed in 25 CRS patients scheduled for FESS . At 1000X power microscopic magnifications , 48 MML and 24 BAL cytospin slides were examined for total and differential cell counts ( DCC ) . This study showed that eosinophils were the dominant inflammatory cells in MMLs of the asthma subgroup and were significantly correlated to FEVI ( p = 0.042 ) and Tiffineau index ( p = 0.037 ) . On the other h and , neutrophils were the dominant inflammatory cells in MMLs of the SAD subgroup and significantly correlated to FEF75 % and Tiffinau index ( p = 0.013 and p = 0.012 respectively ) . There was no significant correlation between MML and BAL cell differential counts in CRS patients ( p > 0.05 ) . The data showed that the lower airways involvement in CRS patients could be related to the dominant type of inflammatory cells in the upper airways OBJECTIVES /HYPOTHESIS The purpose of this study is to report on long-term outcomes in a prospect i ve study comparing the quality -of-life outcomes in smokers and nonsmokers undergoing functional endoscopic sinus surgery . STUDY DESIGN : Prospect i ve clinical trial . METHODS A total of 235 patients were prospect ively enrolled at a single tertiary academic center . Preoperative Sino-Nasal Outcomes Test (SNOT)-20 scores and comprehensive demographic and smoking data were obtained . Preoperative SNOT-20 scores were compared to postoperative SNOT-20 scores . RESULTS Long-term follow-up results were available
Output:
| Furthermore , we present evidence that smoking on its own can cause nasal disease and that , in COPD patients , nasal inflammation mimics that of the bronchi .
All this evidence suggests that COPD -related sinonasal disease does exist and that smoking on its own rather than systemic inflammation triggers the condition . |
MS210659 | ***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 Youth in war-affected regions are at risk for poor psychological , social , and educational outcomes . Effective interventions are needed to improve mental health , social behavior , and school functioning . This r and omized controlled trial tested the effectiveness of a 10-session cognitive-behavioral therapy (CBT)-based group mental health intervention for multisymptomatic war-affected youth ( aged 15 - 24 years ) in Sierra Leone . METHOD War-affected youth identified by elevated distress and impairment via community screening were r and omized ( stratified by sex and age ) to the Youth Readiness Intervention ( YRI ) ( n = 222 ) or to a control condition ( n = 214 ) . After treatment , youth were again r and omized and offered an education subsidy immediately ( n = 220 ) or waitlisted ( n = 216 ) . Emotion regulation , psychological distress , prosocial attitudes/behaviors , social support , functional impairment , and posttraumatic stress disorder ( PTSD ) symptoms were assessed at pre- and postintervention and at 6-month follow-up . For youth in school , enrollment , attendance , and classroom performance were assessed after 8 months . Linear mixed-effects regressions evaluated outcomes . RESULTS The YRI showed significant postintervention effects on emotion regulation , prosocial attitudes/behaviors , social support , and reduced functional impairment , and significant follow-up effects on school enrollment , school attendance , and classroom behavior . In contrast , education subsidy was associated with better attendance but had no effect on mental health or functioning , school retention , or classroom behavior . Interactions between education subsidy and YRI were not significant . CONCLUSION YRI produced acute improvements in mental health and functioning as well as longer-term effects on school engagement and behavior , suggesting potential to prepare war-affected youth for educational and other opportunities . Clinical trial registration information-Trial of the Youth Readiness Intervention ( YRI ) ; http:// clinical trials.gov ; NCT01684488 This study evaluated the effects of Group Triple P with Chinese parents on parenting and child outcomes as well as outcomes relating to child academic learning in Mainl and China . Participants were 81 Chinese parents and their children in Shanghai , who were r and omly allocated to an intervention group or wait-list control group . Parents in the intervention condition received Group Triple P training , and parents and children were assessed at three/two time points . Compared with the control group , parents in the intervention group reported significant improvements in child adjustment problems , parenting practice s , parental adjustment , and parenting self-efficacy at post- assessment . Moreover , there was a significant increase in parents ’ satisfaction with children ’s academic achievement and a reduction in children ’s academic problem behaviors at post-intervention . All these effects were maintained at 6-month follow-up . There was also a significant increase in the child report of positive parenting at post-intervention OBJECTIVE To assess the efficacy of trauma-focused cognitive behavioral therapy ( TF-CBT ) delivered by non clinical facilitators in reducing posttraumatic stress , depression , and anxiety and conduct problems and increasing prosocial behavior in a group of war-affected , sexually exploited girls in a single-blind , parallel- design , r and omized,+ controlled trial . METHOD Fifty-two 12- to 17-year-old , war-affected girls exposed to rape and inappropriate sexual touch in the Democratic Republic of Congo were screened for trauma , depression and anxiety , conduct problems , and prosocial behavior . They were then r and omized to a 15 session , group-based , culturally modified TF-CBT ( n = 24 ) group or a wait-list control group ( n = 28 ) . Primary analysis , by intention-to-treat , involving all r and omly assigned participants occurred at pre- and postintervention and at 3-month follow-up ( intervention group only ) . RESULTS Compared to the wait list control , the TF-CBT group experienced significantly greater reductions in trauma symptoms ( F(1,49 ) = 52.708 , p<0·001 , χ(p)2 = 0.518 ) . In addition , the TF-CBT group showed a highly significant improvement in symptoms of depression and anxiety , conduct problems , and prosocial behavior . At 3-months follow-up the effect size ( Cohen 's d ) for the TF-CBT group was 2.04 ( trauma symptoms ) , 2.45 ( depression and anxiety ) , 0.95 ( conduct problems ) , and -1.57 ( prosocial behavior ) . CONCLUSIONS A group-based , culturally modified , TF-CBT intervention delivered by non clinical ly trained Congolese facilitators result ed in a large , statistically significant reduction in posttraumatic stress symptoms and psychosocial difficulties among war-affected girls exposed to rape or sexual violence . Clinical trial registration information-An RCT of TF-CBT with sexually-exploited , war-affected girls in the DRC ; http:// clinical trials.gov/ ; NCT01483261 BACKGROUND The Democratic Republic of Congo ( DRC ) has been home to the world 's deadliest conflict since World War II and is reported to have the largest number of child soldiers in the world . Despite evidence of the debilitating impact of war , no group-based mental health or psychosocial intervention has been evaluated in a r and omised controlled trial for psychologically distressed former child soldiers . METHOD A r and omised controlled trial involving 50 boys , aged 13 - 17 , including former child soldiers ( n = 39 ) and other war-affected boys ( n = 11 ) . They were r and omly assigned to an intervention group , or wait-list control group . The intervention group received a 15-session , group-based , culturally adapted Trauma-Focused Cognitive-Behavioural Therapy ( TF-CBT ) intervention . Assessment interviews were completed at baseline , postintervention and 3-month follow-up ( intervention group ) . RESULTS Analysis of Covariance ( ANCOVA ) demonstrated that , in comparison to the wait-list control group , the TF-CBT intervention group had highly significant reductions in posttraumatic stress symptoms , overall psychosocial distress , depression or anxiety-like symptoms , conduct problems and a significant increase in prosocial behaviour ( p < .001 for all ) . Effect sizes were higher when former child soldier scores were separated for sub- analysis . Three-month follow-up of the intervention group found that treatment gains were maintained . CONCLUSIONS A culturally modified , group-based TF-CBT intervention was effective in reducing posttraumatic stress and psychosocial distress in former child soldiers and other war-affected boys Objective : The objective of this study is to assess the efficacy of an intervention design ed to promote resilience in young children living with their HIV-positive mothers . Design / methods : HIV-positive women attending clinics in Tshwane , South Africa , and their children , aged 6–10 years , were r and omized to the intervention ( I ) or st and ard care ( S ) . The intervention consisted of 24 weekly group sessions led by community care workers . Mothers and children were in separate groups for 14 sessions , followed by 10 interactive sessions . The primary focus was on parent – child communication and parenting . Assessment s were completed by mothers and children at baseline and 6 , 12 and 18 months . Repeated mixed linear analyses were used to assess change over time . Results : Of 390 mother – child pairs , 84.6 % ( I : 161 and S : 169 ) completed at least two interviews and were included in the analyses . Children 's mean age was 8.4 years and 42 % of mothers had been ill in the prior 3 months . Attendance in groups was variable : only 45.7 % attended more than 16 sessions . Intervention mothers reported significant improvements in children 's externalizing behaviours ( ß = –2.8 , P = 0.002 ) , communication ( ß = 4.3 , P = 0.025 ) and daily living skills ( ß = 5.9 , P = 0.024 ) , although improvement in internalizing behaviours and socialization was not significant ( P = 0.061 and 0.052 , respectively ) . Intervention children reported a temporary increase in anxiety but did not report differences in depression or emotional intelligence . Conclusion : This is the first study demonstrating benefits of an intervention design ed to promote resilience among young children of HIV-positive mothers . The intervention was specifically design ed for an African context and has the potential to benefit large numbers of children , if it can be widely implemented Background There is an urgent need for effective , affordable interventions to prevent child mental health problems in low- and middle-income countries . Aims To determine the effects of a universal pre-school-based intervention on child conduct problems and social skills at school and at home . Method In a cluster r and omised design , 24 community pre-schools in inner-city areas of Kingston , Jamaica , were r and omly assigned to receive the Incredible Years Teacher Training intervention ( n = 12 ) or to a control group ( n = 12 ) . Three children from each class with the highest levels of teacher-reported conduct problems were selected for evaluation , giving 225 children aged 3–6 years . The primary outcome was observed child behaviour at school . Secondary outcomes were child behaviour by parent and teacher report , child attendance and parents ’ attitude to school . The study is registered as IS RCT N35476268 . Results Children in intervention schools showed significantly reduced conduct problems ( effect size ( ES ) = 0.42 ) and increased friendship skills ( ES = 0.74 ) through observation , significant reductions to teacher-reported ( ES = 0.47 ) and parent-reported ( ES = 0.22 ) behaviour difficulties and increases in teacher-reported social skills ( ES = 0.59 ) and child attendance ( ES = 0.30 ) . Benefits to parents ’ attitude to school were not significant . Conclusions A low-cost , school-based intervention in a middle-income country substantially reduces child conduct problems and increases child social skills at home and at school 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 OBJECTIVE To evaluate the effect of a preventative intervention in Jamaican basic schools on child behaviour and parent-teacher contacts . DESIGN AND METHODS Five basic schools in Kingston , Jamaica , were r and omly assigned to an intervention ( n = 3 ) or control ( n = 2 ) condition . Intervention involved seven whole-day teacher workshops using the Incredible Years Teacher Training Programme supplemented by fourteen lessons on social and emotional skills in each class . Within each classroom ( n = 27 ) , children were screened for behaviour difficulties through teacher report and children with the greatest difficulties were selected for evaluation of outcomes ( 135 children ) . Teachers'reports of child behaviour using the Strengths and Difficulties Question naire and of the quality of teacher-parent contacts were collected at the beginning and end of the school year Multilevel regression analyses controlling for school and classroom were used to evaluate the effects of intervention on child behaviour . RESULTS Significant benefits of intervention were found for children 's conduct problems ( regression coefficient ( b ) = -0.62 , 95 % confidence interval ( CI ) : -0.01 , -1.23 ) , hyperactivity ( b = -0.84 , 95 % CI : -1.57 , -0.11 ) and peer problems ( b = -1.24 , 95 % CI : -1.89 , -0.59 ) . The effect sizes were 0.26 for conduct problems , 0.36 for hyperactivity and 0.71 for peer problems . No significant benefits were found for the prosocial and emotional problems subscales . The intervention also result ed in increases in the number of positive teacher-parent contacts ( p < 0.0001 ) . No benefits were found for the number of negative teacher-parent contacts . CONCLUSION This is a promising approach for reducing children 's externalizing behaviour and peer problems and for improving the quality of teachers ' contacts with parents of children with behaviour problems CONTEXT Prior qualitative work with internally displaced persons in war-affected northern Ug and a showed significant mental health and psychosocial problems . OBJECTIVE To assess effect of locally feasible interventions on depression , anxiety , and conduct problem symptoms among adolescent survivors of war and displacement in northern Ug and a. DESIGN , SETTING , AND PARTICIPANTS A r and omized controlled trial from May 2005 through December 2005 of 314 adolescents ( aged 14 - 17 years ) in 2 camps for internally displaced persons in northern Ug and a. INTERVENTIONS Locally developed screening tools assessed the effectiveness of interventions in reducing symptoms of depression and anxiety , ameliorating conduct problems , and improving function among those who met study criteria and were r and omly allocated ( 105 , psychotherapy-based intervention [ group interpersonal psychotherapy ] ; 105 , activity-based intervention [ creative play ] ; 104 , wait-control group [ individuals wait listed to receive treatment at study end ] ) . Intervention groups met weekly for 16 weeks . Participants and controls were reassessed at end of study . MAIN OUTCOME MEASURES Primary measure was a decrease in score ( denoting improvement ) on a depression symptom scale . Secondary measures were improvements in scores on anxiety , conduct problem symptoms , and function scales . Depression , anxiety , and conduct problems were assessed using the Acholi Psychosocial Assessment Instrument with a minimum score of 32 as the lower limit for clinical ly significant symptoms ( maximum scale score , 105 ) . RESULTS Difference in change in adjusted mean score for depression symptoms between group interpersonal psychotherapy and control
Output:
| Our meta- analysis supports the use of psychosocial interventions as a feasible and effective way to reduce disruptive behaviour problems among children in LMIC .
Our study provides strong evidence for child-focused and behavioural parenting interventions , interventions across age ranges and interventions delivered in groups . |
MS210660 | ***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: OBJECTIVE To evaluate whether simultaneous initial treatment of both insulin resistance and impaired beta-cell insulin secretion with glyburide/metformin tablets is superior to monotherapy with each component agent . RESEARCH DESIGN AND METHODS In this r and omized , parallel-group , placebo-controlled , multicentre study , 806 patients with type 2 diabetes ( mean duration , 3 years ) who had failed diet and exercise were r and omly assigned to 4 weeks of therapy with placebo , glyburide 2.5 mg , metformin 500 mg , glyburide/metformin 1.25/250 mg , or glyburide/metformin 2.5/500 mg once daily . Doses were then titrated over 8 weeks based on glycaemic response . The primary outcome measure was change from baseline in mean HbA1c after 20 weeks . Changes in fasting plasma glucose , lipids and body weight were also assessed along with 2-h postpr and ial glucose and insulin values after a st and ardized meal . RESULTS At week 20 , patients taking glyburide/metformin 1.25/250 mg or 2.5/500 mg tablets had greater reductions in HbA1c levels ( -1.48 % and -1.53 % respectively ) compared with placebo ( -0.21 % ; both p < 0.001 ) , glyburide ( -1.24 % ; p = 0.016 and p = 0.004 respectively ) or metformin ( -1.03 % ; both p < 0.001 ) . Fasting plasma glucose concentrations were reduced more in both glyburide/metformin groups compared with placebo and metformin ( p < 0.001 ) ; patients in both combination therapy groups also had significantly lower postpr and ial glucose concentrations compared with placebo , glyburide and metformin . CONCLUSIONS Initial combination treatment with glyburide/metformin tablets produces greater improvements in glycaemic control than either glyburide or metformin monotherapy . The superiority of initial therapy with glyburide/metformin tablets may arise from simultaneous treatment of both pathophysiological defects of type 2 diabetes OBJECTIVE Study the effects of exenatide ( EXE ) plus rosiglitazone ( ROSI ) on β-cell function and insulin sensitivity using hyperglycemic and euglycemic insulin clamp techniques in participants with type 2 diabetes on metformin . RESEARCH DESIGN AND METHODS In this 20-week , r and omized , open-label , multicenter study , participants ( mean age , 56 ± 10 years ; weight , 93 ± 16 kg ; A1C , 7.8 ± 0.7 % ) continued their metformin regimen and received either EXE 10 μg b.i.d . ( n = 45 ) , ROSI 4 mg b.i.d . ( n = 45 ) , or EXE 10 μg b.i.d . + ROSI 4 mg b.i.d . ( n = 47 ) . Seventy-three participants underwent clamp procedures to quantitate insulin secretion and insulin sensitivity . RESULTS A1C declined in all groups ( P < 0.05 ) , but decreased most with EXE+ROSI ( EXE+ROSI , −1.3 ± 0.1 % ; ROSI , −1.0 ± 0.1 % , EXE , −0.9 ± 0.1 % ; EXE+ROSI vs. EXE or ROSI , P < 0.05 ) . ROSI result ed in weight gain , while EXE and EXE+ROSI result ed in weight loss ( EXE , −2.8 ± 0.5 kg ; EXE+ROSI , −1.2 ± 0.5 kg ; ROSI , + 1.5 ± 0.5 kg ; P < 0.05 between and within all groups ) . At week 20 , 1st and 2nd phase insulin secretion was significantly higher in EXE and EXE+ROSI versus ROSI ( both P < 0.05 ) . Insulin sensitivity ( M value ) was significantly higher in EXE+ROSI versus EXE ( P = 0.014 ) . CONCLUSIONS Therapy with EXE+ROSI offset the weight gain observed with ROSI and elicited an additive effect on glycemic control with significant improvements in β-cell function and insulin sensitivity BACKGROUND Management of type 2 diabetes mellitus ( DM ) that involves uptitration of monotherapy to the maximum dose has been associated with delays in achieving glycemic control and an increased number of adverse events ( AEs ) . Studies have reported the benefits of adding a thiazolidinedione to metformin ( MET ) , but none has compared the effect of adding a thiazolidinedione to MET versus increasing the daily dose of MET to 3 g. OBJECTIVE The goal of this study was to investigate the benefits of fixed-dose combination rosiglitazone and MET ( RSG/MET ) compared with high-dose MET monotherapy in patients with type 2 DM . METHODS This was a 24-week , multicenter , r and omized , double-blind , parallel-group study . Patients previously treated with MET entered a 4-week , single-blind , run-in period with MET 2 g/d and were then r and omized to RSG/MET 4 mg/2 g per day or MET 2.5 g/d . At week 8 , medication was escalated to RSG/MET 8 mg/2 g per day or MET 3 g/d . The primary efficacy end point was change in glycosylated hemoglobin ( HbA1c ) at week 24 . Tolerability was assessed , including the frequency and severity of AEs . RESULTS A total of 568 patients comprised the safety population ( MET , 280 ; RSG/MET , 288 ) and 551 formed the intent-to-treat group ( MET , 272 ; RSG/MET , 279 ) . Baseline characteristics of the safety population were comparable in the 2 groups ; body mass index ( mean [ SD ] ) was 32.2 ( 4.8 ) kg/m(2 ) and 32.1 ( 4.9 ) kg/m(2 ) in the RSG/MET and MET groups , respectively . RSG/MET reduced HbA(1c ) ( mean [ SD ] ) from 7.4 % ( 1.0 % ) to 7.1 % ( 1.1 % ) at week 24 , compared with a reduction from 7.5 % ( 1.0 % ) to 7.4 % ( 1.1 % ) with MET ( treatment difference , -0.22 % ; P = 0.001 ) . Fasting plasma glucose ( mean [ SD ] ) was reduced from 166.2 ( 29 ) to 144.1 ( 33 ) mg/dL with RSG/MET and from 169.3 ( 33 ) to 164.0 ( 37 ) mg/dL with MET ( treatment difference , -18.3 mg/dL ; P < 0.001 ) . In addition , 54 % of patients treated with RSG/MET achieved HbA(1c ) levels < 7.0 % , compared with 36 % with MET ( odds ratio , 2.42 ; P < 0.001 ) . RSG/MET increased homeostasis model assessment ( HOMA ) estimates of insulin sensitivity by 34.4 % versus 6.5 % with MET ( treatment difference , 24.8 % ; P < 0.001 ) . HOMA beta-cell function increased by 15.9 % with RSG/MET versus 2.5 % with MET ( treatment difference , 14.0 % ; P < 0.001 ) . RSG/MET decreased C-reactive protein by a mean of 39.4 % versus 16.0 % with MET ( treatment difference , -33.8 % ; P < 0.001 ) . RSG/MET was generally well tolerated , with the majority of AEs mild to moderate in nature . Serious AEs were reported in 3 % of patients receiving RSG/MET and 2 % with MET . Overall rates of gastrointestinal AEs were 23 % with RSG/MET and 26 % with MET ; however , there was an increased incidence of diarrhea ( 14 % vs 6 % ) and abdominal pain ( 9 % vs 6 % ) with MET . There was a mean ( SE ) increase in weight with RSG/MET ( 1.3 [ 0.22 ] kg ) and a mean decrease ( -0.9 [ 0.26 ] kg ) with MET . Patients receiving RSG/MET reported improvements in treatment satisfaction compared with MET . CONCLUSIONS In this study , the RSG/MET fixed-dose combination ( 8 mg/2 g per day ) was an effective and well-tolerated treatment for type 2 DM and enabled more patients to reach glycemic targets than high-dose MET ( 3 g/d ) Metformin and glibenclamide were compared in a r and omized , double-blind trial in patients with non-insulin-dependent diabetes mellitus ( NIDDM ) using a parallel group design . The study was performed in primary health care , and the main purpose was to assess combination therapy with the two drugs as primary treatment versus conventional oral therapy . After a 2 months diet period patients were r and omized to commence treatment with either metformin , glibenclamide or the combination of both . Patients r and omized to monotherapy received the alternative drug in addition if the maximal dose i.e. 3 g metformin or 14 mg glibenclamide was insufficient to normalize the fasting blood glucose concentration ( FBG ) . R and omization and dose escalation occurred at FBG greater than or equal to 6.7 mmol/l . The titrated dose was continued for 6 months , whereafter placebo was given for 2 weeks . Seventy-two patients were r and omized to either the metformin group ( n = 38 ) or the glibenclamide group ( n = 34 ) . Fifty-six completed 6 months treatment , twenty-eight in each r and omized group . Glycaemic control was unchanged after diet alone in all groups . The improvement during drug treatment was highly significant ( p less than 0.001 ) , mean FBG difference ( + /- SEM ) 3.2 + /- 0.4 mmol/l and mean HbA1c difference ( + /- SEM ) 1.5 + /- 0.2 % ( n = 56 ) . There were no significant differences between patients treated solely with metformin ( n = 16 ) and glibenclamide ( n = 17 ) or between patients treated with a combination of glibenclamide added to metformin ( n = 12 ) and metformin added to glibenclamide ( n = 11 ) . ( ABSTRACT TRUNCATED AT 250 WORDS Aims To compare glucose control over 18 months between rosiglitazone oral combination therapy and combination metformin and sulphonylurea in people with Type 2 diabetes . Methods RECORD , a multicentre , parallel-group study of cardiovascular outcomes , enrolled people with an HbA1c of 7.1–9.0 % on maximum doses of metformin or sulphonylurea . If on metformin they were r and omized to add-on rosiglitazone or sulphonylurea ( open label ) and if on sulphonylurea to rosiglitazone or metformin . HbA1c was managed to ≤ 7.0 % by dose titration . A prospect ively defined analysis of glycaemic control on the first 1122 participants is reported here , with a primary outcome assessed against a non-inferiority margin for HbA1c of 0.4 % . Results At 18 months , HbA1c reduction on background metformin was similar with rosiglitazone and sulphonylurea [ difference 0.07 ( 95 % CI −0.09 , 0.23)% ] , as was the change when rosiglitazone or metformin was added to sulphonylurea [ 0.06 ( −0.09 , 0.20)% ] . At 6 months , the effect on HbA1c was greater with add-on sulphonylurea , but was similar whether sulphonylurea was added to rosiglitazone or metformin . Differences in fasting plasma glucose were not statistically significant at 18 months [ rosiglitazone vs. sulphonylurea −0.36 ( −0.74 , 0.02 ) mmol/l , rosiglitazone vs. metformin −0.34 ( −0.73 , 0.05 ) mmol/l ] . Increased homeostasis model assessment insulin sensitivity and reduced C-reactive protein were greater with rosiglitazone than metformin or sulphonylurea ( all P ≤ 0.001 ) . Body weight was significantly increased with rosiglitazone compared with sulphonylurea [ difference 1.2 ( 0.4 , 2.0 ) kg , P = 0.003 ] and metformin [ difference 4.3 ( 3.6 , 5.1 ) kg , P < 0.001 ] . Conclusions In people with diabetes , rosiglitazone in combination with metformin or sulphonylurea was demonstrated to be non-inferior
Output:
| A high strength of evidence showed that most medications were similarly efficacious at lowering hemoglobin A1c by about 1 absolute percentage point compared with baseline values .
The addition of most oral medications to initial monotherapy further improved glycemiccontrol by lowering A1c by another 1 percentage point .
The only exception was the DPP-4 inhibitor class , which did not lower A1c to the same extent as metformin when used as monotherapy .
Overall , metformin was found to have a more favorable effect on body weight when compared with other medications .
Two-drug combinations compared with each other demonstrated similar reductions in A1c levels .
Metformin decreased low-density lipoprotein cholesterol ( LDL-C ) relative to pioglitazone , sulfonylureas , and DPP-4 inhibitors .
Sulfonylureas had a 4-fold higher risk of mild-to-moderate hypoglycemia compared with metformin alone , and , in combination with metformin , had more than a 5-fold increased risk compared with metformin plus a thiazolidinedione .
Thiazolidinediones had an increased risk of congestive heart failure relative to sulfonylureas , and an increased risk for bone fractures relative to metformin .
Diarrhea occurred more often for metformin users compared with thiazolidinedione users . |
MS210661 | ***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: OBJECTIVES : Host genetic factors , including the IL1 gene cluster , play a key role in determining the long-term outcome of Helicobacter pylori infection . The aim of the study was to investigate the relationship between selected IL1 loci polymorphisms and gastric cancer risk in an Italian population . METHODS : In a case-control study we compared the IL1B−31 and IL1B+3954 biallelic and IL1RN pentaallelic variable number of t and em repeats ( VNTR ) polymorphisms in 185 gastric cancer patients and 546 controls r and omly sample d from the general population of an area at high gastric cancer risk ( Tuscany , Central Italy ) . RESULTS : Genotype frequencies of the IL1B−31 T/C , IL1B+3954 C/T , and IL1RN polymorphisms among our population controls were in Hardy-Weinberg equilibrium . In multivariate analyses , no increase in gastric cancer risk was observed for the IL1B−31*C− and IL1B+3954*T− carriers ; a significant 50 % increase emerged for IL1RN*2 allele carriers ( OR = 1.49 ; 95 % CI : 1.01–2.21).Analyses based on combined genotypes showed also that the association with IL1RN*2 allele was limited to two-variant allele carriers who were also homozygous for the IL1B−31*T allele ( OR = 2.23 ; 95 % CI : 1.18–4.23 ) with a statistically significant interaction between these two genotypes ( p= 0.043 ) . Haplotype analysis showed an increased risk for the haplotype IL1RN*2/IL1B−31*T. CONCLUSIONS : Our results suggest that host genetic factors ( such as the IL1RN and the IL1B−31 polymorphisms ) interact in the complex process of gastric carcinogenesis in this high-risk Italian population . Overall , this effect appears more modest than previously reported in other population s , supporting the hypothesis that other still-to-be-defined factors are important in gastric carcinogenesis . These findings might be due to a haplotype effect Chronic inflammation is thought to contribute to the development of cancer ( [1][1 ] ) . Progressive inflammation leads to activation of inflammatory cytokines , recruitment of inflammatory cells , generation of free radical species , and subsequent malignant transformation . Individual responses to The proinflammatory cytokine interleukin-1 has been implicated in host susceptibility to Helicobacter pylori-associated disease . Recent studies suggest that this susceptibility may be under genetic control . It remains to be determined whether the relationship between IL-1 gene polymorphism and gastrointestinal disease in patients with H. pylori infection is due to the role of IL-1 in determining susceptibility to H. pylori infection per se or to the development of distinct pathological lesions . The aim of this study was to prospect ively investigate the relationship between selected polymorphisms in three of the major IL-1 gene family members , seeking associations with H. pylori infection and /or gastric cancer . A total of 559 individuals were studied : 191 patients attending for gastroscopy , 98 with current or previous H. pylori , an additional 79 patients with gastric cancer , and 289 healthy controls . The major novel finding of the study was a marked difference in the genotype frequencies for the IL1R1 HinfI SNP in those with current or previous evidence of H. pylori compared to those without . ( GG , 53 vs 75 % ; GA , 40 vs 19 % ; AA , 7 vs 6 % ; P = 0.0079 ) . The association indicates an increased risk of H. pylori infection or persistence in those with the IL1R1 Hinf1 A allele ( 0.27 vs 0.156 ; P = 0.009 ; OR = 2.01 ) . Our results suggest that the relationship among IL-1 gene polymorphism , H. pylori , and disease is more complex than initially proposed . More detailed studies of the IL-1 gene cluster are needed
Output:
| Results consistently supported increased cancer risk for IL1RN2 carriers ; the increased risk was specific to non-Asian population s and was seen for intestinal and diffuse cancers , distal cancers , and , to a lesser extent , cardia cancers .
Analyses restricted to high- quality studies or H. pylori-positive cases and controls also showed significant associations with both carrier status and homozygosity status .
In Asian population s , reduced risk was observed in association with IL1B-31C carrier status .
This effect was also observed in analyses restricted to high- quality studies .
These results indicate the importance of stratification by anatomic site , histologic type , H. pylori infection , and country of origin . |
MS210662 | ***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 this study was to evaluate the association of the insulin resistance syndrome with both blood pressure and target organ damage in blacks and whites with essential hypertension . Eighty-two black and 63 white French Canadian patients were studied . None had diabetes , and antihypertensive medications had been discontinued for ≥1 week . Measurements included 24-hour blood pressure monitoring , fasting plasma lipids , insulin sensitivity determined with the Bergman minimal model , echocardiogram , microalbumin excretion , and inulin and lithium clearances . Compared with the white French Canadians , black patients had an attenuated nighttime reduction in blood pressure ( P < 0.02 ) , increased cardiac dimensions ( P < 0.001 ) , greater microalbumin excretion ( P < 0.05 ) , increased inulin clearance ( indicative of glomerular hyperfiltration;P < 0.001 ) , and decreased lithium clearance ( indicative of increased sodium reabsorption in the proximal tubule;P < 0.001 ) . Blood pressure levels were not related to insulin resistance ; although in blacks , the nighttime reduction in systolic blood pressure was inversely related to fasting plasma insulin ( r = −0.18 , P < 0.04 ) . In a stepwise multivariate analysis ( including blood pressure levels and components of the insulin resistance syndrome as independent variables ) , race was the strongest predictor of left ventricular mass ( r = 0.53 , P < 0.000 ) , relative wall thickness ( r = 0.49 , P < 0.000 ) , and both inulin ( r = 0.53 , P < 0.000 ) and lithium ( r = 0.41 , P < 0.000 ) clearances . Nighttime systolic blood pressure was also a significant determinant of concentric left ventricular hypertrophy ( r = 0.37 , P < 0.000 ) . In blacks , microalbumin excretion was related to insulin resistance . These observations are consistent with the hypothesis that there is a genetic contribution to cardiac hypertrophy , glomerular hyperfiltration , and sodium retention in blacks with essential hypertension In 38 hospitalized patients with uncomplicated essential hypertension intra-arterial pressure was recorded continuously for 24 hours with the Oxford technique . On the basis of beat by beat analysis , hourly and 24-hour means of mean arterial pressure ( MAP ) and heart rate ( HR ) were obtained . The st and ard deviations and variation coefficients of the hourly means were used as a measure of absolute and relative blood pressure variability respectively . By r and omization patients were ambulant during the day ( group A ; n = 19 ) or they were restricted to bed ( group B ) . The patients of group B were sensory deprived during the first 4 hours of the blood pressure recording . During the night MAP , HR , and their respective variabilities were similar for both groups . During bed rest MAP was reduced as compared to ambulant values ( P less than 0.05 ) , but bed rest had no effect on HR , or on the variability of HR and MAP . During concomitant sensory deprivation HR and the variability of MAP and HR all declined to nightly values , though MAP did not change . In group B , HR-variability ( absolute and relative ) was inversely correlated to age , but no relationship between these two parameters was observed in group A. During concomitant sensory deprivation , but not during bed rest alone or during night rest , relative MAP-variability was also inversely correlated to age . It is concluded that sensory stimuli have an important effect on HR and on the variability of MAP and HR , but not on MAP itself , indicating that to some extent blood pressure and its variability are regulated independently A number of studies have shown that a smaller than normal nocturnal blood pressure ( BP ) decrease is associated with cardiovascular disease . However , no large prospect i ve studies have examined the reliability of nocturnal dipping within individuals . The aim of our study was to investigate the short-term variability of nocturnal BP fall in a large cohort of patients with recently diagnosed essential hypertension . In all , 414 uncomplicated never treated hypertensive patients referred to our outpatient hypertension hospital clinic ( mean age 46±12 years ; 257 M , 157 F ) prospect ively underwent : ( 1 ) repeated clinic BP measurements ; ( 2 ) routine examinations recommended by WHO/ISH guidelines ; and ( 3 ) ambulatory BP monitoring ( ABPM ) twice within a 4-week period . Dipping pattern was defined as a reduction in the average systolic and diastolic BP at night greater than 10 % compared to average daytime values . Overall , 311 patients ( 75.1 % ) showed no change in their diurnal variations in BP . Of the 278 patients who had a dipping pattern on the first ABPM , 219 ( 78.7 % ) confirmed this type of profile on the second ABPM , while 59 ( 21.3 % ) showed a nondipping pattern . Among 37 dipper patients with > 20 % of nocturnal systolic BP decrease ( extreme dippers ) , only 16 ( 43.2 % ) had this marked fall in BP on the second ABPM . Of the 136 patients who had a nondipping pattern on the first ABPM , 92 ( 67.6 % ) confirmed their initial profile on the second ABPM , while 44 ( 32.4 % ) did not . Patients with reproducible nondipping profile were older ( 48±12 years ) than those with reproducible dipping profile ( 44±12 years , P<0.05 ) . These findings indicate that : ( 1 ) short-term reproducibility of nocturnal fall in BP in untreated middle-aged hypertensives is rather limited : overall , one-fourth of patients changed their initial dipping patterns when they were studied again after a few weeks ; ( 2 ) this was particularly true for extreme dipping and nondipping patterns ; ( 3 ) abnormalities in nocturnal BP fall , assessed by a single ABPM , can not be taken as independent predictors of increased cardiovascular risk We examined the racial differences in left ventricular ( LV ) geometric pattern in relation to 24-hour ambulatory blood pressure ( BP ) monitoring and the presence or absence of a nocturnal BP dip . Our study confirms the blunting of nocturnal BP dip among black hypertensives . Body mass index , rather than race , was a major determinant of left ventricular hypertrophy . We did not observe a difference in prevalence of left ventricular hypertrophy by race . However , left ventricular adaptation to hypertension differed in hypertensive black and white individuals ; whereas most of the white patients with Stage 1 - 2 hypertension had a normal ventricular pattern , LV concentric remodeling and concentric hypertrophy were the most common adaptive ventricular patterns in blacks with Stage 1 - 2 hypertension . A six-fold higher prevalence of concentric remodeling was observed in blacks as compared with whites . The impaired nocturnal BP dip in blacks may contribute to the different hemodynamic pattern . Determinants of myocardial oxygen consumption were significantly higher in black hypertensives
Output:
| Smaller nocturnal blood pressure falls and a higher prevalence of non-dipping may contribute to the higher levels of hypertension complications seen in Black people . |
MS210663 | ***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: Serum norethindrone ( NET ) , estradiol-17 beta ( E ) , progesterone ( P ) , and luteinizing hormone ( LH ) and follicle-stimulating hormone ( FSH ) levels were radioimmunoassayed in 15 women after injection of 300 mg norethindrone enanthate ( NET-EN ) in 2 ml of oil ( 5 women ) , 200 mg NET-EN in 2 ml of oil ( 5 women ) , and 200 mg NET-EN in 1 ml of oil ( 5 women ) . These values were measured twice a week for 4 - 6 months to determine 1 ) the effect of various serum NET concentrations upon hypothalamic/pituitary-ovarian function ; 2 ) intersubject variability of this effect ; 3 ) between-subject variability of serum NET values ; 4 ) the effect of an increase in NET-EN dosage or in the volume of the vehicle ; and 5 ) the correlation between uterine bleeding and serum NET , E and P patterns . Peak serum NET levels were reached 4 - 15 days ( median 7 days ) postinjection . These high levels lasted about 20 days postinjection and then decreased , quickly at first and then gradually . Serum NET averaged 1.0 and .38 ng/ml 60 and 120 days postinjection and continued to be measurable in some of the subjects for up to a year . Calculations of day levels of serum NET revealed 63 % in the 1st 20 days , 26 % in the 2nd , and 11 % in the 3rd . Follicle development occurred between 33 - 116 days postinjection ( median 43 days ) and was followed by ovulation in only 1 subject ( 45 days postinjection ) with the 2nd earliest ovulation at 80 days postinjection . Uterine bleeding patterns were independent of dosage of NET-EN . The higher dose of NET-EN provides no contraceptive advantage , and the larger vehicle has no effect . A variability of positive feedback inhibition among subjects is thought to be responsible for differing patterns of return to ovulation , suggesting that for contraceptive purpose s a regimen of 150 mg or less NET-EN every 6 weeks may be appropriate A comparative study was undertaken in twenty-four Mexican women who discontinued the use of depo-medroxyprogesterone acetate ( DMPA ) or norethisterone enanthate ( NET-EN ) to assess the time required for the return to menses and ovulation . All subjects were exposed to long-acting injectable contraceptives for at least one year , and were followed prospect ively . Serum progesterone levels were determined weekly in all subjects beginning 3 months after the last progestogen injection . Mean time to return to ovulation occurred significantly earlier ( p less than 0.001 ) after NET-EN ( 2.6 months ) as compared with DMPA ( 5.5 months ) . No correlation between the return to ovarian function and the duration of steroid exposure was found . The overall data was interpreted as demonstrating a clear-cut difference between the two long-acting progestogens in terms of ovulation suppression The return of fertility following discontinuation of norethisterone oenanthate ( NET EN ) 200 mg injectable contraceptive after use for a minimum period of six months or more was studied in 69 women who discontinued the method for planning pregnancy . Former users of copper intra-uterine device ( CuT 200 ) were enrolled as a control group . Another 161 women who had discontinued NET EN due to other reasons ( e.g. amenorrohea , excessive bleeding or personal reasons ) were also studied for return of fertility after ensuring that they were not using any other method of contraception and were exposed to the risk of pregnancy . The subjects from both groups were followed for a period of one year . The cumulative conception rates at one year were 72.5 and 83.6 per 100 subjects for ex-NET EN and ex-CuT 200 users who had discontinued the method for planning pregnancy and this difference was not statistically significant ( P greater than 0.05 ) . The median time for conception for ex-NET EN users was 7.8 months as compared to 3.7 months in ex-CuT 200 users but the cumulative conception rates at the end of one year show that future return of fertility in NET EN users does not appear to be adversely affected . In 51 subjects who had discontinued NET EN due to amenorrhoea , the return of fertility was predictably slower and less . The return of fertility in subjects who discontinued NET EN for other reasons ( e.g. excessive bleeding and other personal reasons ) was similar to ex-NET EN and ex-CuT 200 users Depo-Provera is a highly effective contraceptive , given intramuscularly ( 150 mg/mL ) once every 3 months . It has been in use in the United States for over 10 years . A new lower-dose formulation of Depo-Provera ( 104 mg/0.65 mL ) , has been developed that allows subcutaneous injection , potentially increasing the convenience , ease of administration and tolerability of this contraceptive . This prospect i ve , r and omized , single-center , single-dose trial evaluates the pharmacokinetics of the lower-dose formulation of Depo-Provera and compares the lower-dose formulation to the original formulation with regard to efficacy and duration of ovulation suppression and the return to ovulation at 12 months . While delivering a 30 % lower total dose than the intramuscular formulation , the lower-dose formulation of Depo-Provera suppressed ovulation for more than 13 weeks in all subjects and was not affected by body mass index or race . Median time for return to ovulation was 30 weeks , with a 97.4 % cumulative rate of return to ovulation at 12 months BACKGROUND Progestin-only injectable contraceptives continue to gain in popularity , but uncertainty remains about pregnancy risk among women late for reinjection . The World Health Organization ( WHO ) recommends a " grace period " of 2 weeks after the scheduled 13-week reinjection . Beyond 2 weeks , however , many providers send late clients home to await menses . STUDY DESIGN A prospect i ve cohort study in Ug and a , Zimbabwe and Thail and followed users of depot-medroxyprogesterone acetate ( DMPA ) for up to 24 months . Users were tested for pregnancy at every reinjection , allowing analysis of pregnancy risk among late comers . RESULTS The analysis consists of 2290 participants contributing 13,608 DMPA intervals . The pregnancy risks per 100 women-years for " on time " [ 0.6 ; 95 % confidence interval ( CI ) , 0.33 - 0.92 ] , " 2-week grace " ( 0.0 ; 95 % CI , 0.0 - 1.88 ) and " 4-week grace " ( 0.4 ; 95 % CI , 0.01 - 2.29 ) injections were low and virtually identical . CONCLUSION Extending the current WHO grace period for DMPA reinjection from 2 to 4 weeks does not increase pregnancy risk and could increase contraceptive continuation A total of 2388 subjects , 1181 for 60 + /- 5-day and 1207 for 90 + /- 5-day treatment regimen with norethisterone oenanthate ( NET OEN ) 200 mg injection , were observed for 24 months , constituting 28,513 woman-months . This clinical trial represents the largest clinical trial undertaken on NET OEN . The observations indicated that NET OEN given at 60 + /- 5-day intervals provides adequate contraceptive protection . However , as compared to the published studies elsewhere , higher method failures were seen during the first six months of NET OEN usage , when all women were receiving the drug at 60 + /- 5-day intervals . The reasons for this discrepant observation in the present study can not be explained . The higher method failures reported with 90 + /- 5-day regimen were mainly during the third month following the injection , suggesting reduced contraceptive efficacy of the drug during this period . Thin build women ( body weight less than or equal to 40 kg ) were at higher risk of involuntary pregnancy . Disrupted menstrual pattern was the major reason for discontinuation ranging between 42 - 43 per 100 users at the end of 24 months . Amongst these , amenorrhoea was the commonest reason for discontinuation . No change in blood pressure was observed during contraceptive usage . The majority of NET OEN users did not show any change in body weight . The overall continuation rates with NET OEN were lower than those observed in similar conditions with Cu-T 200 mm2 IUCD BACKGROUND A new progestin-only , nondaily depot medroxyprogesterone acetate ( DMPA ) SC injectable contraceptive suspension ( 104 mg/0.65 mL ) has been developed . Clinical trials ( including dose-ranging , pharmacokinetic/pharmacodynamic , and contraceptive efficacy studies ) indicating the effectiveness of this new formulation were conducted primarily in white women . However , results of an early study by the World Health Organization suggested that in Thai women , medroxyprogesterone acetate ( MPA ) may be metabolized in < 91 + /- 7 days ( the range for effective suppression of ovulation established in clinical trials ) , result ing in a faster return to ovulation in this population . OBJECTIVES This study was design ed to determine the duration of ovulation suppression and investigate the pharmacokinetic profile of MPA after a single SC injection of DMPA 104 mg/0.65 mL in Asian women . It also assessed the effect of ethnicity and injection site on the duration of ovulation suppression . METHODS : This was a single-center , single-dose , open-label outpatient trial conducted in Singapore in Asian women aged 18 to 40 years . After 1 control cycle , women with confirmed ovulation were r and omized in a 1:1 ratio to receive an SC injection of DMPA 104 mg/0.65 mL in either the anterior thigh or the abdomen . Serum concentrations of MPA , progesterone , estradiol , luteinizing hormone , and follicle-stimulating hormone were measured during the 91-day dosing interval and for an additional 15 days thereafter . RESULTS Twenty-four Asian women ( mean [ SD ] age , 33.8 [ 43 ] years ; range , 22.7 - 40.1 years ; mean [ SD ] body mass index , 22.4 [ 3.0 ] kg/m(2 ) ) belonging to 5 ethnic groups ( Chinese , Filipino , Indian , Malaysian , and Thai ) were included in the study Ovulation suppression was maintained throughout the 91-day dosing interval , regardless of ethnicity or injection site . Ovulation was suppressed for at least 112 days after injection in 23 ( 95.8 % ) women , as evidence d by maintenance of serum progesterone concentrations < 4.7 ng/mL. The pharmacokinetic parameters for MPA in these Asian women were similar to those previously reported in white women . The most frequently reported adverse events were flulike symptoms and headache , all of mild to moderate intensity . No serious adverse events were reported . CONCLUSIONS In this study , SC DMPA 104 mg/0.65 mL provided effective suppression of ovulation for at least 91 days in Asian women . Ethnicity and injection site had no effect on MPA profiles Doses of DepoProvera of 25 , 50 , 100 and 150 mg were administered to four groups of women . The mean time for the return of follicular and luteal activity increased with increasing dose of DepoProvera . Luteal activity was suppressed for a longer period than follicular activity . None of the women receiving the two higher doses of DepoProvera showed a return of luteal function within 100 days of injection . The period for which medroxyprogesterone acetate ( MPA ) was detectable in serum increased with increasing dose but the values for the 100 and 150 mg doses were not significantly different . There was a significant correlation between the concentration of MPA in blood and the return of follicular and luteal function . It is suggested that in the population studied , 100 mg DepoProvera would be as effective as the usual 150 mg dose and that injection of 50 mg DepoProvera would provide a contraceptive effect for two months . The dose of MPA in the monthly injectable CycloProvera could be substantially reduced without loss of effectiveness
Output:
| Studies of return to ovulation after last injection of DMPA generally found that the earliest ovulation did not occur until several months after the last injection while studies of NET-EN reported ovulations around ( or even before ) the time for reinjection |
MS210664 | ***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 monoclonal anti-CD20 antibody rituximab , combined with chemotherapeutic agents , has been shown to prolong overall survival in physically fit patients with previously untreated chronic lymphocytic leukemia ( CLL ) but not in those with coexisting conditions . We investigated the benefit of the type 2 , glycoengineered antibody obinutuzumab ( also known as GA101 ) as compared with that of rituximab , each combined with chlorambucil , in patients with previously untreated CLL and coexisting conditions . METHODS We r and omly assigned 781 patients with previously untreated CLL and a score higher than 6 on the Cumulative Illness Rating Scale ( CIRS ) ( range , 0 to 56 , with higher scores indicating worse health status ) or an estimated creatinine clearance of 30 to 69 ml per minute to receive chlorambucil , obinutuzumab plus chlorambucil , or rituximab plus chlorambucil . The primary end point was investigator-assessed progression-free survival . RESULTS The patients had a median age of 73 years , creatinine clearance of 62 ml per minute , and CIRS score of 8 at baseline . Treatment with obinutuzumab-chlorambucil or rituximab-chlorambucil , as compared with chlorambucil monotherapy , increased response rates and prolonged progression-free survival ( median progression-free survival , 26.7 months with obinutuzumab-chlorambucil vs. 11.1 months with chlorambucil alone ; hazard ratio for progression or death , 0.18 ; 95 % confidence interval [ CI ] , 0.13 to 0.24 ; P<0.001 ; and 16.3 months with rituximab-chlorambucil vs. 11.1 months with chlorambucil alone ; hazard ratio , 0.44 ; 95 % CI , 0.34 to 0.57 ; P<0.001 ) . Treatment with obinutuzumab-chlorambucil , as compared with chlorambucil alone , prolonged overall survival ( hazard ratio for death , 0.41 ; 95 % CI , 0.23 to 0.74 ; P=0.002 ) . Treatment with obinutuzumab-chlorambucil , as compared with rituximab-chlorambucil , result ed in prolongation of progression-free survival ( hazard ratio , 0.39 ; 95 % CI , 0.31 to 0.49 ; P<0.001 ) and higher rates of complete response ( 20.7 % vs. 7.0 % ) and molecular response . Infusion-related reactions and neutropenia were more common with obinutuzumab-chlorambucil than with rituximab-chlorambucil , but the risk of infection was not increased . CONCLUSIONS Combining an anti-CD20 antibody with chemotherapy improved outcomes in patients with CLL and coexisting conditions . In this patient population , obinutuzumab was superior to rituximab when each was combined with chlorambucil . ( Funded by F. Hoffmann-La Roche ; Clinical Trials.gov number , NCT01010061 . ) PURPOSE Genomic features including unmutated immunoglobulin variable region heavy chain ( IgVH ) genes , del(11q22.3 ) , del(17p13.1 ) , and p53 mutations have been reported to predict the clinical course and overall survival of patients with chronic lymphocytic leukemia ( CLL ) . In addition , ZAP-70 and Bcl-2 family proteins have been explored as predictors of outcome . PATIENTS AND METHODS We prospect ively evaluated the prognostic significance of a comprehensive panel of laboratory factors on both response and progression-free survival ( PFS ) using sample s and data from 235 patients enrolled onto a therapeutic trial . Patients received either fludarabine ( FL ; n = 113 ) or fludarabine plus cyclophosphamide ( FC ; n = 122 ) as part of a US Intergroup r and omized trial for previously untreated CLL patients . RESULTS Complete response ( CR ) rates were 24.6 % for patients receiving FC and 5.3 % for patients receiving FL ( P = .00004 ) . PFS was statistically significantly longer in patients receiving FC ( median , 33.5 months for patients receiving FC and 19.9 months for patients receiving FL ; P < .0001 ) . The occurrence of del(17p13.1 ) ( hazard ratio , 3.428 ; P = .0002 ) or del(11q22.3 ) ( hazard ratio , 1.904 ; P = .006 ) was associated with reduced PFS . CR and overall response rates were not significantly different based on cytogenetics , IgVH mutational status , CD38 expression , or p53 mutational status . Expression of ZAP-70 , Bcl-2 , Bax , Mcl-1 , XIAP , Caspase-3 , and Traf-1 was not associated with either clinical response or PFS . CONCLUSION These results support the use of interphase cytogenetic analysis , but not IgVH , CD38 expression , or ZAP-70 status , to predict outcome of FL-based chemotherapy . Patients with high-risk cytogenetic features should be considered for alternative therapies BACKGROUND On the basis of promising results that were reported in several phase 2 trials , we investigated whether the addition of the monoclonal antibody rituximab to first-line chemotherapy with fludarabine and cyclophosphamide would improve the outcome of patients with chronic lymphocytic leukaemia . METHODS Treatment-naive , physically fit patients ( aged 30 - 81 years ) with CD20-positive chronic lymphocytic leukaemia were r and omly assigned in a one-to-one ratio to receive six courses of intravenous fludarabine ( 25 mg/m(2 ) per day ) and cyclophosphamide ( 250 mg/m(2 ) per day ) for the first 3 days of each 28-day treatment course with or without rituximab ( 375 mg/m(2 ) on day 0 of first course , and 500 mg/m(2 ) on day 1 of second to sixth courses ) in 190 centres in 11 countries . Investigators and patients were not masked to the computer-generated treatment assignment . The primary endpoint was progression-free survival ( PFS ) . Analysis was by intention to treat . This study is registered with Clinical Trials.gov , number NCT00281918 . FINDINGS 408 patients were assigned to fludarabine , cyclophosphamide , and rituximab ( chemoimmunotherapy group ) and 409 to fludarabine and cyclophosphamide ( chemotherapy group ) ; all patients were analysed . At 3 years after r and omisation , 65 % of patients in the chemoimmunotherapy group were free of progression compared with 45 % in the chemotherapy group ( hazard ratio 0·56 [ 95 % CI 0·46 - 0·69 ] , p<0·0001 ) ; 87 % were alive versus 83 % , respectively ( 0·67 [ 0·48 - 0·92 ] ; p=0·01 ) . Chemoimmunotherapy was more frequently associated with grade 3 and 4 neutropenia ( 136 [ 34 % ] of 404 vs 83 [ 21 % ] of 396 ; p<0·0001 ) and leucocytopenia ( 97 [ 24 % ] vs 48 [ 12 % ] ; p<0·0001 ) . Other side-effects , including severe infections , were not increased . There were eight ( 2 % ) treatment-related deaths in the chemoimmunotherapy group compared with ten ( 3 % ) in the chemotherapy group . INTERPRETATION Chemoimmunotherapy with fludarabine , cyclophosphamide , and rituximab improves progression-free survival and overall survival in patients with chronic lymphocytic leukaemia . Moreover , the results suggest that the choice of a specific first-line treatment changes the natural course of chronic lymphocytic leukaemia . FUNDING F Hoffmann-La Roche PURPOSE CAMPATH-1H is a human immunoglobulin G1 ( IgG1 ) anti-CD52 monoclonal antibody ( MAb ) that binds to nearly all B- and T-cell lymphomas and leukemias . We report the results of a multicenter phase II trial that used CAMPATH-1H in previously chemotherapy-treated patients with chronic lymphocytic leukemia ( CLL ) . MATERIAL S AND METHODS Twenty-nine patients who had relapsed after an initial response ( n = 8) or were refractory ( n = 21 ) to chemotherapy were treated with CAMPATH-1H administered as a 30-mg 2-hour intravenous ( IV ) infusion thrice weekly for a maximum period of 12 weeks . RESULTS Eleven patients ( 38 % ) achieved a partial remission ( PR ) and one ( 4 % ) a complete remission ( CR ) ( response rate , 42 % ; 95 % confidence interval [ CI ] , 23 % to 61 % ) . Three of eight patients ( 38 % ) with a relapse and nine of 21 refractory patients ( 43 % ) responded to CAMPATH-1H therapy . CLL cells were rapidly eliminated from blood in 28 of 29 patients ( 97 % ) . CR in the bone marrow was obtained in 36 % and splenomegaly resolved completely in 32 % . Lymphadenopathy was normalized in only two patients ( 7 % ) . The median response duration was 12 months ( range , 6 to 25 + ) . World Health Organization ( WHO ) grade IV neutropenia and thrombocytopenia developed in three ( 10 % ) and two patients ( 7 % ) , respectively . Neutropenia and thrombocytopenia recovered in most responding patients during continued CAMPATH-1H treatment . Lymphopenia ( < 0.5 x 10(9)/L ) occurred in all patients . Two patients had opportunistic infections and four had bacterial septicemia . CONCLUSION CAMPATH-1H had significant activity in patients with advanced and chemotherapy-resistant CLL . The most pronounced effects were noted in blood , bone marrow , and spleen . Preferential clearance of blood may allow harvesting of uncontaminated blood stem cells for use in high-dose chemotherapy protocol PURPOSE This phase II pilot study determined the efficacy and safety of alemtuzumab ( Campath-1H ; Burroughs Wellcome , United Kingdom ) in patients with chronic lymphocytic leukemia ( CLL ) , all of whom had previously received fludarabine and other chemotherapy regimens . PATIENTS AND METHODS Twenty-four patients were treated with intravenous alemtuzumab at six centers in the United States . The target dose of 30 mg over 2 hours , three times weekly , was administered for up to 16 weeks . Responses were evaluated by an independent panel of experts using 1996 National Cancer Institute-sponsored Working Group criteria . Safety assessment s included analysis of lymphocyte sub population s. Antimicrobial prophylaxis was not m and atory . RESULTS Eight patients ( 33 % ) achieved a major response ( all partial remissions ) , with a median time to response of 3.9 months ( range , 1.6 to 5.3 months ) . The median duration of response was 15.4 months ( range , 4.6 to > or= 38.0 months ) , the median time to disease progression was 19.6 months ( range , 7.7 to > or= 42.0 months ) , and the median survival time was 35.8 months ( range , 8.8 to > or= 47.1 months ) . Acute infusion-related events , mainly grade s 1 and 2 , were most common and most severe in the first week . Ten patients ( eight nonresponders and two responders ) experienced major infections on- study . Pneumocystis carinii pneumonia was reported in two patients on- study ; neither had received prophylaxis . Median CD4 + and CD8 + counts decreased and then began to increase by the end of the study , with further recovery by 1-month follow-up . One of 53 sample s obtained from 10 patients had a low titer of alemtuzumab antibodies . CONCLUSION Alemtuzumab has significant activity in poor-prognosis , fludarabine-treated CLL patients . However , because of a relatively high incidence of opportunistic infections accompanying profound lymphopenia , future protocol s should include m and atory prophylaxis BACKGROUND Rituximab has been successfully used as an experimental therapy in different autoimmune diseases . Recently , a double-blind placebo-controlled phase-2 study in early onset type 1 diabetes showed that rituximab delayed progression of the disease . However , like with any immunosuppressive therapy , there is a concern of opportunistic viral reactivations with the use of rituximab , including herpes and polyomaviruses . OBJECTIVES To study the incidence of new infections and reactivations with BK , JC , Epstein-Barr and cytomegalovirus ( B
Output:
| Patients treated with FCR showed significantly higher neutropenia and serious adverse reactions . |
MS210665 | ***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 Current efforts to improve clinical effectiveness and utility of repetitive transcranial magnetic stimulation ( rTMS ) in the treatment of major depression ( MD ) include theta burst stimulation ( TBS ) , a patterned form of rTMS . Here , we investigated the efficacy of bilateral TBS to the dorsolateral prefrontal cortex ( dlPFC ) in patients with MD in additon to ongoing medication and psychotherapy . METHODS In this r and omized-controlled trial , thirty-two patients with MD were treated for six weeks ( thirty sessions ) with either successively intermittent , activity enhancing TBS ( iTBS ) to the left and continuous , inhibiting TBS ( cTBS ) to the right dlPFC or with bilateral sham stimulation . Primary outcome measure was the proportion of treatment response defined as a Montgomery-Åsberg Depression Rating Scale (MADRS)≤50 % compared to baseline . Secondary outcomes comprised response and remission rates of the Hamilton Depression Rating Scale ( HAMD ) and the Beck Depression Inventory ( BDI ) . RESULTS A larger number of responders were found in the cTBS ( n=9 ) compared to the sham-stimulation ( n=4 ) group ( odds ratio : 3.86 ; Wald χ(2)=3.9 , p=0.048 ) . On secondary endpoint analysis , patient-reported outcome as assessed by the BDI , pointed towards a higher rate of remitters in the cTBS ( n=6 ) than in the sham ( n=1 ) group ( odds ratio : 9 ; Wald χ(2)=3.5 , p=0.061 ) . LIMITATIONS With regard to the pilot character of the study and the small sample size , the results have to be considered as preliminary . CONCLUSIONS These findings provide first evidence that six weeks treatment of MDD with iTBS to the left and cTBS to the right dlPFC for six weeks is safe , feasible and superior to sham stimulation applied add-on to pharmacological and psychotherapeutic treatment BACKGROUND Carefully design ed controlled studies are essential in further evaluating the therapeutic efficacy of transcranial magnetic stimulation ( TMS ) in psychiatric disorders . A major method ological concern is the design of the " sham " control for TMS . An ideal sham would produce negligible cortical stimulation in conjunction with a scalp sensation akin to real treatment . Strategies employed so far include alterations in the position of the stimulating coil , but there has been little systematic study of their validity . In this study , we investigated the effects of different coil positions on cortical activation and scalp sensation . METHODS In nine normal subjects , single TMS pulses were administered at a range of intensities with a " figure eight " coil held in various positions over the left primary motor cortex . Responses were measured as motor-evoked potentials in the right first dorsal interosseus muscle . Scalp sensation to TMS with the coil in various positions over the prefrontal area was also assessed . RESULTS None of the coil positions studied met the criteria for an ideal sham . Arrangements associated with a higher likelihood of scalp sensation were also more likely to stimulate the cortex . CONCLUSIONS The choice of a sham for TMS involves a trade-off between effective blinding and truly inactive " stimulation . " Further research is needed to develop the best sham condition for a range of applications This 5-week , r and omized , double-blind , placebo-controlled trial investigated the efficacy and tolerability of high frequency repetitive transcranial magnetic stimulation ( rTMS ) directed to the left prefrontal cortex in drug-resistant depressed patients . Fifty-four patients were r and omly assigned to receive 10 daily applications of either real or sham rTMS . Subjects assigned to receive active stimulation were divided into two further subgroups according to the intensity of stimulation : 80 % vs. 100 % of motor threshold ( MT ) . At study completion , the response rates were 61.1 % ( n=11 ) , 27.8 % ( n=5 ) and 6.2 % ( n=1 ) for the 100 % MT group , 80 % MT group and sham group , respectively . A significant difference ( Pearson chi(2 ) test ) was found between the 100 % MT and sham groups , while the 80 % MT group did not differ significantly from the sham group . Between the two active groups , a marginally significant difference was observed . Analysis of variance with repeated measures on Hamilton Depression Rating Scale scores revealed a significantly different decrease over time of depressive symptomatology among the three treatment groups . Treatment response appeared to be unrelated to the demographic and clinical characteristics recorded , and on the whole the technique was well tolerated . The results of this double-blind trial showed that rTMS may be a useful and safe adjunctive treatment for drug-resistant depressed patients BACKGROUND Major depression is a worldwide severe mental health problem . Unfortunately , not all depressed patients respond to pharmacotherapy or psychotherapy , even when adhering to treatment guidelines . Even though current guidelines do not in particular advocate repetitive Transcranial Magnetic Stimulation ( rTMS ) in refractory treatment resistant depression ( TRD ) , using more intensive stimulation parameters might hold promise as a valuable alternative . OBJECTIVE Consequently , in this r and omized sham-controlled crossover study , we wanted to evaluate clinical outcome of intensive HF-rTMS treatment in TRD when applied to the left dorsolateral prefrontal cortex ( DLPFC ) . METHODS After a 2-week antidepressant washout , 20 unipolar TRD patients , at least stage III , received 20 sham-controlled high-frequency (HF)-rTMS sessions , in a crossover design . Five daily suprathreshold HF-rTMS sessions were spread over four successive days delivering in total 31,200 stimuli . RESULTS Overall , the procedure result ed in immediate statistical significant decreases in depressive symptoms regardless of order/type of stimulation ( real/sham ) , suggesting possible placebo responses . On the other h and , albeit only 35 % ( 7/20 ) of the patients showed a 50 % reduction of their initial Hamilton Depression rating score at the end of the two-week procedure , all these patients showed a prompt clinical response after real HF-rTMS treatment , not after sham . Furthermore , a shorter duration of the current depressive episode was a predictor for beneficial clinical outcome . Unresponsiveness to former ECT could be indicative for negative clinical outcome in these kinds of patients . LIMITATIONS Single center setup with relatively small sample size and no follow-up . CONCLUSIONS Our findings indicate that intensive HF-rTMS treatment might have the potential to result in fast clinical response when confronted with a refractory TRD patient BACKGROUND Multiple groups have reported on the use of repetitive transcranial magnetic stimulation ( rTMS ) in treatment-resistant major depression . The purpose of this study is to assess the efficacy of rTMS in unmedicated , treatment-resistant patients who meet criteria for major depression . METHODS Depressed subjects , who had failed to respond to a median of four treatment trials , were assigned in a r and omized double-blind manner to receive either active ( n = 10 ; 20 2-sec trains of 20 Hz stimulation with 58-sec intervals ; delivered at 80 % motor threshold with the figure-of-eight coil positioned over the left dorsolateral prefrontal cortex ) or sham ( n = 10 ; similar conditions with the coil elevated and angled 45 degrees tangentially to the scalp ) rTMS . These sequences were applied during 10 consecutive weekdays . Continuous electroencephalogram sampling and daily motor threshold determinations were also obtained . RESULTS The group mean 25-item Hamilton Depression Rating Scale ( HDRS ) score was 37.2 ( + /- 2.0 SEM ) points . Adjusted mean decreases in HDRS scores were 14.0 ( + /- 3.7 ) and 0.2 ( + /- 4.1 ) points for the active and control groups , respectively ( p < .05 ) . One of 10 subjects receiving active treatment demonstrated a robust response ( i.e. , HDRS decreased from 47 to 7 points ) ; three other patients demonstrated 40 - 45 % decreases in HDRS scores . No patients receiving sham treatment demonstrated partial or full responses . CONCLUSIONS A 2-week course of active rTMS result ed in statistically significant but clinical ly modest reductions of depressive symptoms , as compared to sham rTMS in a population characterized by treatment resistance BACKGROUND Theta-burst transcranial magnetic stimulation ( TBS ) has been shown to induce potent and long lasting effects on cortical excitability . In a previous open study , we demonstrated safety , tolerability and antidepressant properties of continuous TBS ( cTBS ) in major depression ( MD ) . The present study was aim ed to evaluate the therapeutic efficacy of cTBS in depressed patients using a double-blind , sham-controlled design . METHODS Twenty nine patients with MD were r and omized to receive either active cTBS to the right dorsolateral prefrontal cortex ( n=15 ) or sham cTBS ( n=14 ) for 10 consecutive work days . After the 10th session , patients who received sham TBS were crossed over to active cTBS which consisted of 10 daily sessions . Patients who received active cTBS continued with the same treatment protocol for additional 10 treatments . Each treatment session consisted of 3600 stimuli at an intensity of 100 % of the active motor threshold . Severity of depression was assessed weekly . RESULTS Overall , there was no significant difference in the degree of clinical improvement between active and sham cTBS groups . However , in patients whose medication status remained unchanged before the trial ( n=8 ) and in those who were medication-free ( n=3 ) , active cTBS result ed in a significantly greater reduction of Hamilton depression scores as compared to sham cTBS . LIMITATIONS A small sample size , confounding effect of medication and short treatment period . CONCLUSIONS Our results suggest that the antidepressant effect of cTBS is modest , yet it might be beneficial to patients nonresponsive to ongoing pharmacological treatment . A direct comparison between cTBS and conventional rTMS protocol s is warranted Major depressive disorder ( MDD ) is a prevalent and disabling condition , and many patients do not respond to available treatments . Deep transcranial magnetic stimulation ( dTMS ) is a new technology allowing non-surgical stimulation of relatively deep brain areas . This is the first double-blind r and omized controlled multicenter study evaluating the efficacy and safety of dTMS in MDD . We recruited 212 MDD out patients , aged 22 - 68 years , who had either failed one to four antidepressant trials or not tolerated at least two antidepressant treatments during the current episode . They were r and omly assigned to monotherapy with active or sham dTMS . Twenty sessions of dTMS ( 18 Hz over the prefrontal cortex ) were applied during 4 weeks acutely , and then biweekly for 12 weeks . Primary and secondary efficacy endpoints were the change in the Hamilton Depression Rating Scale ( HDRS-21 ) score and response/remission rates at week 5 , respectively . dTMS induced a 6.39 point improvement in HDRS-21 scores , while a 3.28 point improvement was observed in the sham group ( p=0.008 ) , result ing in a 0.76 effect size . Response and remission rates were higher in the dTMS than in the sham group ( response : 38.4 vs. 21.4 % , p=0.013 ; remission : 32.6 vs. 14.6 % , p=0.005 ) . These differences between active and sham treatment were stable during the 12-week maintenance phase . dTMS was associated with few and minor side effects apart from one seizure in a patient where a protocol violation occurred . These results suggest that dTMS constitutes a novel intervention in MDD , which is efficacious and safe in patients not responding to antidepressant medications , and whose effect remains stable over 3 months of maintenance treatment BACKGROUND Several factors may mitigate the efficacy of repetitive transcranial magnetic stimulation ( rTMS ) over sham rTMS in patients with treatment-resistant depression ( TRD ) . These factors include unilateral stimulation ( i.e. , treatment of only the left dorsolateral prefrontal cortex [ DLPFC ] ) , suboptimal methods of targeting the DLPFC and insufficient stimulation intensity ( based on coil-to-cortex distance ) . METHODS We recruited patients with TRD between the ages of 18 and 85 years from a university hospital , and participants were r and omized to receive sequential bilateral rTMS ( 600 pulses at 1 Hz followed by 1500 pulses at 10 Hz ) , unilateral high-frequency left (HFL)-rTMS ( 2100 pulses at 10 Hz ) or sham rTMS for 3 or 6 weeks depending on treatment response . Stimulation was targeted with MRI localization over the junction of the middle and anterior thirds of the middle frontal gyrus , using 120 % of the coil-to-cortex adjusted motor threshold . Our primary outcome of interest was the remission rate . RESULTS A total of 121 patients participated in this study . The remission rate was significantly higher in the bilateral group than the sham group . The remission rate in the HFL-rTMS group was intermediate and did not differ statistically from the rate in the 2 other groups . There were no significant differences in reduction of depression scores among the 3 groups . LIMITATIONS The number of pulses used per session in the unilateral group was somewhat lower in our trial than in more recent trials , and the sham condition did not involve active stimulation . CONCLUSION Our findings suggest
Output:
| Placebo response was directly associated with publication year and depression improvement of the active group , and inversely associated with higher levels of treatment‐resistant depression .
Conclusion : Placebo response in rTMS depression trials was large and associated with depression improvement of the active treatment group .
Such result suggests that excluding placebo responders with a run‐in phase may not confer advantage since response to ‘ active ’ rTMS may decrease as well .
Moreover , placebo response may be a component of therapeutic response to rTMS in MDD .
Placebo response may be a component of the therapeutic response to rTMS depression trials |
MS210666 | ***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 effect of torasemide and furosemide therapy was compared in 50 patients who had chronic heart failure and symptoms [ NYHA class II-III ] despite long-term therapy with both low-dose furosemide and angiotensin-converting enzyme inhibitors . In this r and omized 6-month , open-label trial , baseline and follow-up echocardiograms and neurohumoral assays were obtained in 25 group F patients ( continued same dose of oral furosemide at 20 - 40 mg/day ) and in 25 group T patients ( received torasemide at 4 - 8 mg/day in place of furosemide ) . At 6 months , parameters were unchanged in group F whereas the group T patients had a lower left ventricular end-diastolic diameter ( p<0.005 ) and left ventricular mass index ( p<0.005 ) with improved Doppler filling parameters , decreased plasma B-type natriuretic concentration ( p<0.001 ) and increased plasma concentrations of active renin ( p<0.005 ) and aldosterone ( p<0.001 ) . The magnitude of these changes appeared dose dependent and it is suggested these favorable effects of switching from furosemide to torasemide may be related to aldosterone receptor blockade Plasma pharmacokinetics of oral furosemide have been shown to be influenced by degree of decompensation in patients with congestive heart failure ( CHF ) . This open-label , sequential comparison trial was conducted to determine whether CHF decompensation also alters the pharmacokinetics and pharmacodynamics of torsemide . Twelve patients with CHF , defined by either hemodynamic parameters or clinical signs and symptoms , were enrolled . On admission for treatment of their CHF , the patients were given 100 mg oral torsemide ( phase A ) . A second dose of oral torsemide 100 mg was administered after hemodynamic parameters and clinical signs and symptoms of decompensated CHF resolved ( phase B ) . Plasma and urine sample s were collected over a 24-hour period for determination of torsemide concentrations and urine sodium . Hemodynamic measurements and physical signs and symptoms also were evaluated . During phase A , patients had significantly greater urine output and fractional sodium excretion compared with phase B. A significant increase in the area under the plasma concentration-time curve ( AUC ) was observed during phase B compared with phase A. However , no significant differences in maximal excretion rate of torsemide were noted between phase A and phase B. Heart failure status slightly affects the plasma pharmacokinetics of torsemide ; however , this does not significantly alter the maximal urinary excretion rate of torsemide The effect of potassium supplements was studied in 28 patients taking long term frusemide ( 40 - 80 mg daily ) . Plasma potassium fell when supplements were stopped , and rose towards prior values on the potassium/frusemide combination , Diumide K. In a crossover study in 14 of these patients comparing equivalent doses of frusemide , Diumide K ( frusemide 40 mg , potassium 8 mmol ) , bumetanide , and Burinex K ( bumetanide 0.5 mg , potassium 7.7 mmol ) plasma potassium was lower on frusemide than on bumetanide . On Diumide K and Burinex K plasma potassium rose significantly but did not reach the levels on prior therapy . Small doses of potassium in combined formulations seem to be effective in countering the mild hypokalaemia caused by loop diuretics PURPOSE Because the bioavailability of oral furosemide is erratic and often incomplete , we tested the hypothesis that patients with heart failure who were treated with torsemide , a predictably absorbed diuretic , would have more favorable clinical outcomes than would those treated with furosemide . PATIENTS AND METHODS We conducted an open-label trial of 234 patients with chronic heart failure ( mean [ + /- SD ] age , 64 + /- 11 years ) from an urban public health care system . Patients received oral torsemide ( n = 113 ) or furosemide ( n = 121 ) for 1 year . The primary endpoint was readmission to the hospital for heart failure . Secondary endpoints included readmission for all cardiovascular causes and for all causes , numbers of hospital days , and health-related quality of life . RESULTS Compared with furosemide-treated patients , torsemide-treated patients were less likely to need readmission for heart failure ( 39 [ 32 % ] vs. 19 [ 17 % ] , P < 0.01 ) or for all cardiovascular causes ( 71 [ 59 % ] vs. 50 [ 44 % ] , P = 0.03 ) . There was no difference in the rate of admissions for all causes ( 92 [ 76 % ] vs. 80 [ 71 % ] , P = 0.36 ) . Patients treated with torsemide had significantly fewer hospital days for heart failure ( 106 vs. 296 days , P = 0.02 ) . Improvements in dyspnea and fatigue scores from baseline were greater among patients treated with torsemide , but the differences were statistically significant only for fatigue scores at months 2 , 8 , and 12 . CONCLUSIONS Compared with furosemide-treated patients , torsemide-treated patients were less likely to be readmitted for heart failure and for all cardiovascular causes , and were less fatigued . If our results are confirmed by blinded trials , torsemide may be the preferred loop diuretic for patients with chronic heart failure The ulcer crater disappeared completely in 81 % of the cases after six weeks and in 92 % after 12 weeks of carbenoxolone . The dose used in the trial was 100 mg . thrice daily for the first week and 50 mg . thrice daily for the second and subsequent weeks . Treatment should be continued until the ulcer has been shown radiologically to have healed . After complete healing a maintenance dose should be prescribed to prevent recurrence . Attention is also drawn to the drug 's side-effects , which occurred in 35 % of patients , and of which salt- and -water retention is the most important . The side-effects led to the introduction of a fiveor six-day regime in which carbenoxolone was omitted on one or both days at the week-end in those at risk . Since the introduction of this regime side-effects have been much less marked and less frequent . Carbenoxolone has a specific effect , facilitating the healing of gastric ulcer , and is not merely yet another symptomatic measure Summary The effects of slow-release furosemide and bendroflumethiazide in the ambulatory treatment of mild to moderate congestive heart failure were compared in a controlled multicentre study using a r and omized , double-blind procedure . In the first trial , slow-release furosemide 60 mg daily was compared with 2.5 mg bendroflumethiazide ; in the second trial the daily doses were 30 mg and 2.5 mg , respectively . There were 47 patients in Trial I and 39 in Trial II . The r and omised allocation to the treatment regimen was made after a four-week period on bendroflumethiazide 2.5 mg daily , and treatment was continued for 12 weeks . Clinical and laboratory data were recorded before , during and at the end of the trial . Adverse effects were few and minor in both medication groups , and there were no significant intergroup differences . It was concluded slow-release furosemide 30 mg or 60 mg daily was as effective as bendroflumethiazide 2.5 mg daily for maintenance treatment in mild to moderate congestive heart failure OBJECTIVES We sought to determine whether non-potassium-sparing diuretics ( PSDs ) in the absence of a PSD may result in progressive heart failure ( HF ) . BACKGROUND Angiotensin-converting enzyme ( ACE ) inhibitors incompletely suppress ACE activity in HF patients . Furthermore , non-PSDs are activators of aldosterone secretion . We reasoned that non-PSDs , in the absence of a PSD , might result in progressive HF . METHODS In the 6,797 patients in the Studies Of Left Ventricular Dysfunction ( SOLVD ) , we compared the risk of hospitalization for , or death from , HF between those taking a PSD and those who were not , adjusting for known covariates . RESULTS The risk of hospitalization from worsening HF in those taking a PSD relative to those taking only a non-PSD was 0.74 ( 95 % confidence interval [ CI ] 0.55 to 0.99 ; p = 0.047 ) . The relative risk for cardiovascular death was 0.74 ( 95 % CI 0.59 to 0.93 ; p = 0.011 ) , for death from all causes 0.73 ( 95 % CI 0.59 to 0.90 ; p = 0.004 ) , and for hospitalization for , or death from , HF 0.75 ( 95 % CI 0.58 to 0.97 ; p = 0.030 ) . Compared with patients not taking any diuretic , the risk of hospitalization or death due to worsening HF in patients taking non-PSDs alone was significantly increased ( risk ratio [ RR ] = 1.31 , 95 % CI 1.09 to 1.57 ; p = 0.0004 ) ; this was not observed in patients taking PSDs with or without a non-PSD ( RR = 0.99 , 95 % CI 0.76 to 1.30 ; p = 0.95 ) . CONCLUSIONS The use of PSDs in HF patients is associated with a reduced risk of death from , or hospitalization for , progressive HF or all-cause or cardiovascular death , compared with patients taking only a non-PSD Systematic review s have become very popular . A recent estimate suggests that 22 new systematic review s are published daily [ 1 ] . One reason for this interest is that they serve many purpose s. For example , the influential Institute of Medicine has indicated that a systematic review is an essential component when developing clinical practice guidelines within the USA [ 2 ] . Some granting agencies are now advocating for the use of systematic review s as an evidence -based rationale for the conduct of a proposed r and omized trial [ 3 ] . And journals are now dem and ing the use of systematic review s to provide readers with context of the results of a clinical trial [ 4 ] . For systematic review s to be useful , they need to be reported in the highest possible quality thus facilitating their accurate use across a wide spectrum of stakeholders , including patients . Unfortunately , surveys of the published literature indicate that the quality of reporting is not optimal . For example , there is evidence indicating that reporting biases , particularly selective outcome reporting , is prevalent . An early example of differences between outcomes reported in protocol s and the paired completed review was an examination of 47 Cochrane review s in which 43 ( 91 % ) contained a major change , such as the addition or deletion of outcomes , between the protocol and the full publication [ 5 ] . More recently , in an examination of 485 Cochrane protocol - review pairs , 38 % ( 95 % CI 23 to 54 % ) were found to have discrepant outcomes ( i.e. , added , omitted , or changed the priority ) between the protocol and completed review [ 6 ] . The vast majority of these discrepancies were without attribution with more significant outcomes being up grade d or added . Whether or not , and to what extent , these examples reflect reporting biases is not clear . However , they represent inconsistencies that should be avoided by authors . The gold st and ard for identifying reporting biases is a comparison of the completed review with its paired protocol . Such an examination is difficult with systematic review s as too few of them report working from a protocol , although a growing number of funders are now requiring them . Perhaps , systematic review ers do not report or use protocol s because there has been little guidance on how to report them until recently . To help facilitate the use of reporting systematic review protocol s , the three of us and several colleagues developed Preferred Reporting Items for Systematic Review and Meta- Analysis Protocol s ( PRISMA -P ) [ 7 ] . This is a reporting guideline consisting of a 17-item checklist , to help prospect i ve authors in the preparation and reporting of a scientifically rigorous systematic review protocol . We also prepared a pedagogical explanation and elaboration document to facilitate its use [ 8 ] . Readers appear interested in the guidance . Since its publication a little more than a year ago , it has been downloaded about 45,000 times and cited ( Google scholar ) nearly 100 times . This journal and others have endorsed PRISMA -P. Here , we describe how the journal intends to implement it . All protocol su bmi ssions to the journal should use continuous line numbering in their manuscript . Authors should also include a completed PRISMA -P checklist indicating whether or not the requested item information is reported ( by completing the check mark ) . If the item is checked , authors should then specify the line number ( or range of line numbers ) where this information is described . Manuscripts accepted for publication will have the completed PRIMSA-P checklist ( on su bmi ssion ) included as an Appendix to their publication , which must be referenced within the main text ( Additional file 1 ) . Prospect i ve authors can download a Word version of the PRISMA -P checklist , which includes the two added columns , from the journal ’s website ( URL to be added)or the PRISMA website ( ttp://www . prisma -statement.org/Extensions/ Protocol s.aspx ) . If PRISMA -P was used to help report the protocol , it should be cited or the PRISMA -
Output:
| NMA demonstrated no significant differences between loop diuretics with respect to all-cause mortality , cardiovascular mortality or hypokalaemia .
In contrast , torasemide ranked best in terms of HF hospitalisation , and there was a trend towards benefits with torasemide with regard to occurrence of acute renal failure .
We found no significant superiority of either loop diuretic with respect to mortality and safety endpoints .
However , clinicians may prefer torasemide , as it was associated with fewer HF-related hospitalisations |
MS210667 | ***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 compare the one-shot dilation ( OSD ) technique with three other dilation techniques namely telescopic Alken , fascial Amplatz and balloon dilation ( BD ) in terms of safety efficacy and cost effectiveness . Methods During a 3½ year enrollment period , 480 patients who required PCNL surgery were equally r and omized into four groups . All the cases were assessed preoperatively , intraoperatively as well as postoperatively till a period of 3 months . Access time , X-ray exposure time , hemoglobin drop , complications , success rate , etc . , were all assessed and recorded . Results Similar preoperative characteristics were observed in all the four study arms . X-ray exposure time during dilation was significantly reduced for both OSD and BD when compared to sequential Amplatz and telescopic Alken dilation ( Group ALD = 62.1 + 13 , Group AMD = 67.0 + 10 , Group OSD = 36.8 + 7 , Group BD = 38.1 + 6 , p value = 0.01 , post hoc : G4 = G3 < G2 = G1 ) . There was no significant difference between the access time , hemoglobin drop , complication and success rates among the groups . BD was the most expensive dilation method when compared to the other three dilation techniques . Conclusion All the four methods of dilation are equally safe and effective but both OSD and BD are advantageous in terms of lesser fluoroscopy time during dilation . OSD is much cheaper option when compared to BD , and therefore with more experience , it can become the preferable dilation method , especially in the developing countries Abstract Objective : To perform an economical single-step renal dilatation ( RD ) during percutaneous nephrolithotomy ( PCNL ) , using directly a 30-F Amplatz dilator over the central Alken dilator , in a trial to reduce the operative duration and radiation exposure during RD while avoiding an exchange of dilators that might increase the risk of blood loss . Patients and methods : In a prospect i ve r and omised study including 49 patients divided into two groups , the first had RD before PCNL using the st and ard metallic telescopic dilators ( Alken ) , and the second had RD using the 30-F Amplatz dilator over the central Alken dilator . The operative duration , with X-ray exposure , was calculated . The procedure outcome in terms of complications , stone-free rates and hospital stay was evaluated statistically . Results : The tract was dilated correctly in all cases . The operative duration and X-ray exposure was shorter in patients undergoing single-step RD ( P < 0.05 ) . There were perioperative complications , according to the Clavien grading system , in 17 ( 34 % ) patients but there was no statistically significant difference between the groups . The stone-free rates were comparable in both groups . Conclusion : A single-step RD during PCNL is feasible , with a shorter operative duration and X-ray exposure . The outcomes were comparable with those of a st and ard metallic telescopic RD Objective : To evaluate the safety and feasibility of percutaneous tract dilation by the one-stage method in preschool children . Methods : Between April 2009 and February 2013 , all preschool ( < 6 years ) children who were c and i date s for percutaneous nephrolithotomy were enrolled in this prospect i ve study . Patients were r and omly assigned to dilation by serial metallic dilators ( group I , 31 patients ) or dilation by one-stage Amplatz according to Frattini et al. [ J Endourol 2001;15:919 - 923 ] ( group II , 31 patients ) . The primary endpoint of interest was fluoroscopy time . Secondary endpoints included tract creation and dilation time , success rate and complications . Stone-free status was defined as residuals ≤3 mm . Results : Age , stone size , operation success and operation time were not significantly different between the studied groups . The most common stone composition was calcium oxalate in both groups . The mean ± st and ard deviation of access and fluoroscopy times in groups I and II were 7.3 ± 1.2 min vs. 5.9 ± 1.5 min ( p > 0.05 ) and 70.0 ± 8.9 s vs. 22.0 ± 5.6 s ( p < 0.001 ) , respectively . Postoperative complications included one case of postoperative fever lasting less than 48 h in group I. Conclusions : Percutaneous tract dilation by the one-stage method is safe and effective . Also , it is associated with considerably less radiation exposure in preschool children BACKGROUND AND PURPOSE Percutaneous nephrolithotomy ( PCNL ) can be done in patients who have previously had open nephrolithotomy . Currently , dilatation of the nephrostomy tract is achieved using an Amplatz renal dilator or telescopic metal dilators in these patients . The aim of this study was to compare the safety and efficacy of the " one-shot " procedure in patients with previous open nephrolithotomy with those of the current telescopic technique . PATIENTS AND METHODS Thirty-one patients with past history of open surgery for kidney stone disease underwent PCNL at our institution from February 2006 to March 2007 . Patients were r and omly divided into two groups according to dilation technique used : group A ( telescopic procedure ) and group B ( one-shot procedure ) . X-ray exposure , blood loss , and complications were evaluated . RESULTS No significant difference in hemoglobin decrease was seen in the two groups . The stone-free and complication rates were the same in the two groups . Fluoroscopy time during the one-shot procedure was significantly shorter than that of the telescopic procedure ( P < 0.000 ) . CONCLUSION Our experience indicated that the one-shot procedure is feasible in patients with previous open nephrolithotomy . It is as safe and effective as the telescopic procedure , with significant reduction in x-ray exposure PURPOSE To assess the feasibility of one-stage acute dilation of the nephrostomy tract with a 30F Amplatz dilator in patients who are c and i date for percutaneous nephrolithotomy ( PCNL ) regardless of whether there is a previous renal scar to make the procedure less time consuming and more cost effective . PATIENTS AND METHODS The outcomes of one-stage tract dilation for PCNL in 100 consecutive patients with and without a history of ipsilateral open stone surgery ( OSS ) , treated by one surgeon , were examined prospect ively . Forty-six patients ( group 1 ) had a history of ipsilateral OSS , and 54 patients ( group 2 ) did not have this history . Demographic data as well as intraoperative information , such as access time and radiation exposure time during access , were recorded . The success of the access technique and its bleeding complications were analyzed between the two groups . RESULTS By applying a " one-stage " technique , the targeted calix could be entered with a success rate of 93 % . There was no difference in the procedural success rate between groups 1 and 2 ( 93.5 % v 92.6 % , respectively ) . All seven failed attempts ( 7 % ; three with previous OSS ) were managed successfully using an Alken dilator to gain access to the proposed calix in the same session . Previous OSS did not impact access time , radiation exposure time during access , postoperative hemoglobin drop , and bleeding complications . There were no visceral and vascular injuries . CONCLUSIONS One-stage tract dilation for PCNL is a safe and effective method in almost every adult patient PURPOSE To compare the effects of one-stage vs gradual dilation techniques during percutaneous nephrolithotomy ( PCNL ) on postoperative renal scar formation and overall renal function . PATIENTS AND METHODS Of 152 adult patients who underwent surgery during the study period , 48 were r and omized into two groups . In group 1 ( n=19 ) , gradual tract dilation with Alken metallic dilators was used , and in group 2 ( n=29 ) , one-stage tract dilation was used . We compared patient demographics , intraoperative and preoperative parameters , postoperative overall renal function , and renal scar formation on the target renal pole . RESULTS Access time ( P=0.001 ; 95 % confidence interval [ CI ] : 3.19 - 6.30 ) and radiation exposure during access ( P=0.03 ; 95 % CI : 0.03 - 0.66 ) were significantly shorter in group 2 . In group 1 , the decrease in mean technetium-99 m dimercaptosuccinic acid ( 99m-Tc DMSA ) uptake from 44.1±20.1 % to 43.4±19.6 % 4 weeks postoperatively ( -0.7%±0.5 % ; P=0.27 ; 95 % CI : -0.56 - 1.93 ) was not significant . In group 2 , however , there was a significant decrease in post-PCNL 99m-Tc DMSA uptake 2 ( -2.4±0.3 % , from 50.1±13.5 % to 47.7±13.8 % ; P=0.001 ; 95 % CI : 1.13 - 3.66 ) . Four weeks after surgery , new scar formation or progression of the preoperative scar at the site of access were seen in 14 of 29 ( 48.3 % ) patients who were treated with one-stage dilation whereas only 2 of 19 ( 11.0 % ) patients who were treated with gradual dilation developed new scarring at the access site ( P=0.007 ) . CONCLUSION Although the one-stage tract dilation technique reduced radiation exposure and access time , in the short term , it may cause more parenchymal damage than the gradual dilation technique
Output:
| Conclusion OSD is a safe and efficacious tract dilation technique that can reduce the access time , fluoroscopy time and postoperative decrease in haemoglobin level .
No difference was found in the successful dilation rate , stone-free rate , transfusion rate or rate of complications between the OSD and serial dilation groups .
The difference in the length of postoperative hospital stay was uncertain .
OSD may be a better method of tract creation for PCNL |
MS210668 | ***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 : We conducted a cluster-r and omized trial aim ed at assessing the effect of the type of faecal occult blood , guaiac or immunochemical test on screening compliance . Methods : We sample d 130 general practitioners ( GPs ) who consented to participate in the trial . We r and omly allocated half of them to the guaiac ( Hemo-Fec ) and half to the immunochemical test ( OC-Hemodia ) . We sample d 2/10 of the GPs ' 50–75-year-old patients ( n=7332 ) and r and omly divided this population into half . One half was invited to be screened at the GP 's office and the other to the nearest gastroenterology ward . The principal outcome was the percentage of returned tests . Results : The immunochemical test had a compliance of 35.8 % and the guaiac of 30.4 % ( relative risk [ RR ] 1.20 ; 95 % confidence interval [ CI ] 1.02–1.44 ) . The difference was mostly due to a higher probability of returning the sample : 93.8 % and 88.6 % for immunochemical and guaiac , respectively ( RR 1.06 ; 95 % CI 1.02–1.10 ) . The guaiac test had a higher prevalence of positives ( 10.3 % versus 6.3 % , RR 0.603 ; 95 % CI 0.433–0.837 ) . There was a higher variability in the results obtained with the guaiac test compared with the immunochemical ( F[1 , 12 ] = 16.25 ; P=0.0017 ) . Conclusions : Compliance is more likely with the immunochemical than the guaiac test , independent of the provider . Guaiac tests show a higher variability of the results among centres . The successful implementation of a screening programme requires a period of st and ardization of the test reading in order to avoid unexpected work overload for colonscopy services Immunochemical fecal occult blood test ( FIT ) is a new colorectal cancer ( CRC ) screening method already recommended by the American screening guidelines . We aim ed to test the feasibility of FIT as compared to guaiac fecal occult blood test ( G‐FOBT ) in a large urban population of Tel Aviv . Average‐risk persons , aged 50–75 years , were offered FIT or G‐FOBT after r and omization according to the socioeconomic status of their clinics . Participants with positive tests underwent colonoscopy . Participants were followed through the Cancer Registry 2 years after the study . Hemoccult SENSA ™ and OC‐MICRO ™ ( three sample s , 70 ng/ml threshold ) were used . FIT was offered to 4,657 persons ( Group A ) and G‐FOBT to 7,880 persons ( Group B ) . Participation rate was 25.9 % and 28.8 % in Group A and B , respectively ( p < 0.001 ) . Positivity rate in Group A and B was 12.7 % and 3.9 % , respectively ( p < 0.001 ) . Cancer found in six ( 0.49 % ) and eight ( 0.35 % ) patients of Group A and B , respectively ( NS ) . Cancer registry follow‐up found missed cancer in five ( 0.22 % ) cases of Group B and none in Group A ( NS ) . The sensitivity , specificity , negative and positive predictive value for cancer in Group A and B were 100 % , 85.9 % , 100 % , 3.9 % and 61.5 % , 96.4 % , 99.8 % , 9.1 % , respectively . There was increased detection of advanced adenomatous polyp ( AAP ) by FIT , irrespective of age , gender , and socioeconomic status ( Per Protocol : odds ratio 2.69 , 95 % confidence interval 1.6–4.5 ; Intention to Screen : odds ratio 3.16 , 95 % confidence interval 1.8–5.4 ) . FIT is feasible in urban , average‐risk population , which significantly improved performance for detection of AAP and CRC , despite reduced participation OBJECTIVES Determine whether colorectal cancer screening adherence is greater with fecal immunochemical tests ( FIT ) or guaiac-based fecal occult blood tests ( gFOBT ) . METHODS We used electronic health records to identify 3869 New Mexico Veterans Affairs Health Care System primary care patients due for screening in 2008 for whom fecal blood testing was appropriate . We invited r and omly selected patients by mail to participate in a study comparing FIT and gFOBT . We r and omly allocated 404 subjects to receive FIT ( n=202 ) or gFOBT ( n=202 ) by mail . We determined the proportion of subjects completing testing within 90days of agreeing to participate in the study . We also used multivariate logistic regression to evaluate screening completion , adjusting for age , gender , race/ethnicity , clinic site , previous gFOBT testing , and co-morbidity . RESULTS Screening adherence was higher with FIT than gFOBT ( 61.4 % vs. 50.5 % , P=0.03 ) . The adjusted odds ratio for completing FIT vs. gFOBT was 1.56 , 95 % CI 1.04 , 2.32 . CONCLUSION In a clinic setting of patients who were due for colorectal cancer screening , adherence was significantly higher with FIT than gFOBT Immunochemical faecal occult blood testing ( FIT ) provides quantitative test results , which allows optimisation of the cut-off value for follow-up colonoscopy . We conducted a r and omised population -based trial to determine test characteristics of FIT ( OC-Sensor micro , Eiken , Japan ) screening at different cut-off levels and compare these with guaiac-based faecal occult blood test ( gFOBT ) screening in an average risk population . A representative sample of the Dutch population ( n=10 011 ) , aged 50–74 years , was 1 : 1 r and omised before invitation to gFOBT and FIT screening . Colonoscopy was offered to screenees with a positive gFOBT or FIT ( cut-off 50 ng haemoglobin/ml ) . When varying the cut-off level between 50 and 200 ng ml−1 , the positivity rate of FIT ranged between 8.1 % ( 95 % CI : 7.2–9.1 % ) and 3.5 % ( 95 % CI : 2.9–4.2 % ) , the detection rate of advanced neoplasia ranged between 3.2 % ( 95 % CI : 2.6–3.9 % ) and 2.1 % ( 95 % CI : 1.6–2.6 % ) , and the specificity ranged between 95.5 % ( 95 % CI : 94.5–96.3 % ) and 98.8 % ( 95 % CI : 98.4–99.0 % ) . At a cut-off value of 75 ng ml−1 , the detection rate was two times higher than with gFOBT screening ( gFOBT : 1.2 % ; FIT : 2.5 % ; P<0.001 ) , whereas the number needed to scope ( NNscope ) to find one screenee with advanced neoplasia was similar ( 2.2 vs 1.9 ; P=0.69 ) . Immunochemical faecal occult blood testing is considerably more effective than gFOBT screening within the range of tested cut-off values . From our experience , a cut-off value of 75 ng ml−1 provided an adequate positivity rate and an acceptable trade-off between detection rate and NNscope OBJECTIVES To investigate the effect on participation in colorectal cancer screening of testing for blood products in faeces using technologies that remove dietary restrictions ( i.e. immunochemical tests ) and simplify faecal sampling ( i.e. tests that use brush sampling ) . METHODS SETTING Urban residents ( n=1818 ) of Adelaide , Australia , aged between 50 and 69 years , r and omly selected from the electoral roll . DESIGN Three r and omised cohorts of 606 invitees were offered a screening test by mail in 2001 . The Hemoccult SENSA and FlexSure OBT cohorts were instructed to sample three stools using a spatula while the InSureTM cohort sample d two stools using a brush . The Hemoccult SENSA cohort was asked to restrict certain ( high-peroxidase ) foods and drugs . MAIN OUTCOME MEASURES Participation ( i.e. return of completed sample kits within 12 weeks ) and generalised linear modelling ( GLM ) of relationships between participation , test technologies and demographic variables . RESULTS Participation was 23.4 % , 30.5 % and 39.6 % for the Hemoccult , FlexSure and InSure cohorts , respectively ( chi(2)=37.1 , p<0.00001 ) . GLM demonstrated that participation was increased by 28 % by removal of restrictions ( p=0.01 ) and by 30 % by simplification of sampling ( p=0.001 ) ; both together increased participation by 66 % ( p<0.001 ) . The differences in participation between tests occurred in the first three weeks . Socio-economic status , gender or age did not significantly influence technology-based improvements in participation . CONCLUSIONS The brush-sampling faecal immunochemical test for haemoglobin ( InSure ) achieves the best participation rates by simplifying sampling and removing the need for restrictions of diet and drugs . Because participation in screening is vital to detection , this new technology should contribute to better detection of neoplasia at the population level OBJECTIVES : To investigate the influence of general practitioner ( GP ) endorsement on participation in screening for colorectal cancer based on a faecal occult blood test ( FOBT ) . SETTING : South Australian residents ( n=2400 ) , in 1999 , aged > 50 years . METHODS : R and om selection of three groups ( GP1 , GP2 , GP3 ) from two general practice s and of one group ( ER ) from the federal electoral roll ; n=600 per group . Without previous communication or publicity , subjects were posted an offer of screening by immunochemical FOBT . The GP1 and ER groups were invited without indication that their GP was involved ; GP2 received an invitation indicating support from the practice ; and GP3 received an invitation on practice letterhead and signed by a practice partner . A reminder was posted at 6 weeks . Participation was defined as return of correctly completed FOBT sample cards within 12 weeks . RESULTS : Participation rates were : GP1 192/600 ( 32.0 % ) , GP2 228/600 ( 38.0 % ) , and GP3 244/600 ( 40.7 % ) ; & khgr;2=10.2 , p=0.006 . Both GP2 and GP3 differed significantly from GP1 ( odds ratio ( OR ) 0.77 , 95 % confidence interval ( 95 % CI ) 0.60 to 0.98 and relative risk (RR)=0.69 , 95 % CI 0.54 to 0.87 respectively ) . ER ( 193/600 ( 32.2 % ) ) and GP1 were not significantly different . Age but not sex was significantly associated with participation . Overall test positivity rate was 4.6 % ; five malignancies were found in the 918 who performed FOBT . CONCLUSIONS : Association of a GP of recent contact with a screening offer in the form of a personalised letter of invitation achieves better participation than does the same letter from a central ised screening unit that does not mention the GP . Thus , GP enhanced participation is achievable without their actual involvement . Additional strategies are needed to further improve participation
Output:
| Colorectal cancer screening programmes currently using guaiac faecal occult blood tests could improve participation rates by converting to faecal immunochemical tests . |
MS210669 | ***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 Pakistan has high maternal mortality , particularly in the rural areas . The delay in decision making to seek medical care during obstetric emergencies remains a significant factor in maternal mortality . Methods We present results from an experimental study in rural Pakistan . Village clusters were r and omly assigned to intervention and control arms ( 16 clusters each ) . In the intervention clusters , women were provided information on safe motherhood through pictorial booklets and audiocassettes ; traditional birth attendants were trained in clean delivery and recognition of obstetric and newborn complications ; and emergency transportation systems were set up . In eight of the 16 intervention clusters , husb and s also received specially design ed education material s on safe motherhood and family planning . Pre- and post-intervention surveys on selected maternal and neonatal health indicators were conducted in all 32 clusters . A district-wide survey was conducted two years after project completion to measure any residual impact of the interventions . Results Pregnant women in intervention clusters received prenatal care and prophylactic iron therapy more frequently than pregnant women in control clusters . Providing safe motherhood education to husb and s result ed in further improvement of some indicators . There was a small but significant increase in percent of hospital deliveries but no impact on the use of skilled birth attendants . Perinatal mortality reduced significantly in clusters where only wives received information and education in safe motherhood . The survey to assess residual impact showed similar results . Conclusions We conclude that providing safe motherhood education increased the probability of pregnant women having prenatal care and utilization of health services for obstetric complications Background As a result of inappropriate feeding , poor health and hygiene , and poor caring practice s , the nutritional status of many young infants deteriorates with advancing age . Objective To explore the effectiveness of a nutrition education package to prevent malnutrition among young children . Methods A community-based , r and omized , controlled trial was conducted among 605 normal and mildly malnourished children aged 6 to 9 months in 121 Community Nutrition Centers ( CNCs ) of the Bangladesh Integrated Nutrition Project ( BINP ) in four regions of Bangladesh from 2000 to 2002 . The intervention group received weekly nutrition education based on the nutrition triangle concept of UNICEF for 6 months , whereas the control group received regular BINP services . Both groups were observed for a further 6 months to assess the sustainability of the effects . Information on socio-economic status , feeding patterns , morbidity , and anthropometric features was collected . Results A significant increase in the frequency of complementary feeding was observed in the intervention group as compared with the control group , and the increase was sustained throughout the observation period . The intervention group had a higher weight gain than the control group after the end of the intervention ( 0.86 vs. 0.77 kg , p = 0.053 ) and after the end of the observation period ( 1.81 vs. 1.39 kg , p < .001 ) . The proportion of normal and mildly malnourished children was greater in the intervention group than in the control group after the end of the observations ( 88.9 % vs. 61.5 % , p < .001 ) . Nutrition education successfully prevented malnutrition in all the areas . Variation in the outcome of nutrition education among the regions was observed . Conclusions This culturally appropriate nutrition education package based on the nutrition triangle model effectively prevented growth faltering and malnutrition among young children Background In Sub-Saharan Africa over one million newborns die annually . We developed a sustainable and scalable home-based counselling intervention for delivery by community volunteers in rural southern Tanzania to improve newborn care practice s and survival . Here we report the effect on newborn care practice s one year after full implementation . Methods All 132 wards in the 6-district study area were r and omised to intervention or comparison groups . Starting in 2010 , in intervention areas trained volunteers made home visits during pregnancy and after childbirth to promote recommended newborn care practice s including hygiene , breastfeeding and identification and extra care for low birth weight babies . In 2011 , in a representative sample of 5,240 households , we asked women who had given birth in the previous year both about counselling visits and their childbirth and newborn care practice s. Results Four of 14 newborn care practice s were more commonly reported in intervention than comparison areas : delaying the baby ’s first bath by at least six hours ( 81 % versus 68 % , OR 2.0 ( 95 % CI 1.2 - 3.4 ) ) , exclusive breastfeeding in the three days after birth ( 83 % versus 71 % , OR 1.9 ( 95 % CI 1.3 - 2.9 ) ) , putting nothing on the cord ( 87 % versus 70 % , OR 2.8 ( 95 % CI 1.7 - 4.6 ) ) , and , for home births , tying the cord with a clean thread ( 69 % versus 39 % , OR 3.4 ( 95 % CI 1.5 - 7.5 ) ) . For other behaviours there was little evidence of differences in reported practice s between intervention and comparison areas including childbirth in a health facility or with a skilled attendant , thermal care practice s , breastfeeding within an hour of birth and , for home births , the birth attendant having clean h and s , cutting the cord with a clean blade and birth preparedness activities . Conclusions A home-based counselling strategy using volunteers and design ed for scale-up can improve newborn care behaviours in rural communities of southern Tanzania . Further research is needed to evaluate if , and at what cost , these gains will lead to improved newborn survival . Trial registration Trial Registration Number NCT01022788 ( http://www . clinical trials.gov , 2009 David Osrin and colleagues report findings from a cluster-r and omized trial conducted in Mumbai slums ; the trial aim ed to evaluate whether facilitator-supported women 's groups could improve perinatal outcomes Breastfeeding rates among low-income women in the east-south- central United States are among the lowest in the country . This study examined the effect of a peer counseling program on breastfeeding initiation and duration in a low-income rural population in West Tennessee . A postpartum survey and chart review were conducted with WIC clients at nine health departments . Response rate was 99 % ( 291/293 ) . Breastfeeding initiation and duration at 6 weeks were increased in the peer counselor group ( n= 156 ) compared with women in the no-peer counselor group ( n= 135 ) ( 53 % vs. 33%,p<0.001 , and 26 % vs. 13%,p=0.006 , respectively ) . Multivariate analysis revealed that women in the peer counselor group were significantly more likely to initiate breastfeeding ( OR=2.43 , 95 % CI=1.23 - 4.67 ) and to be breastfeeding at 6 weeks ( OR=2.78 , 95 % CI=2.08 - 9.5 1 ) , than those in the no-peer counselor group Background Maternal and newborn mortality rates remain unacceptably high , especially where the majority of births occur in home setting s or in facilities with inadequate re sources . The introduction of emergency obstetric and newborn care services has been proposed by several organizations in order to improve pregnancy outcomes . However , the effectiveness of emergency obstetric and neonatal care services has never been proven . Also unproven is the effectiveness of community mobilization and community birth attendant training to improve pregnancy outcomes . Methods / Design We have developed a cluster-r and omized controlled trial to evaluate the impact of a comprehensive intervention of community mobilization , birth attendant training and improvement of quality of care in health facilities on perinatal mortality in low and middle-income countries where the majority of births take place in homes or first level care facilities . This trial will take place in 106 clusters ( 300 - 500 deliveries per year each ) across 7 sites of the Global Network for Women 's and Children 's Health Research in Argentina , Guatemala , India , Kenya , Pakistan and Zambia . The trial intervention has three key elements , community mobilization , home-based life saving skills for communities and birth attendants , and training of providers at obstetric facilities to improve quality of care . The primary outcome of the trial is perinatal mortality . Secondary outcomes include rates of stillbirth , 7-day neonatal mortality , maternal death or severe morbidity ( including obstetric fistula , eclampsia and obstetrical sepsis ) and 28-day neonatal mortality . Discussion In this trial , we are evaluating a combination of interventions including community mobilization and facility training in an attempt to improve pregnancy outcomes . If successful , the results of this trial will provide important information for policy makers and clinicians as they attempt to improve delivery services for pregnant women and newborns in low-income countries . Trial Registration Clinical Trials.gov We sought to determine if a simple educational intervention initiated at the first wellchild care visit , with reinforcement at subsequent visits , can improve inner-city infant immunization rates . We conducted a controlled trial involving 315 newborn infants and their primary caregivers in 3 inner-city primary care centers . Child health care providers gave caregivers in the intervention group an interactive graphic card with verbal reinforcement . At later visits , stickers were applied to the card when immunizations were given . Routine information was given to controls . After the trial , age-appropriate immunization rates at 7 months were 58 % in each group . Intervention infants had 50 % fewer missed opportunities to immunize ( p=0.01 ) but cancelled 77 % more appointments ( p=0.04 ) than controls . We conclude that a brief educational intervention at the first well-child care visit did not boost 7-month immunization rates , although it was associated with fewer missed opportunities to immunize Background A community-based r and omized control prenatal care trial was performed in a rural county of China during 2000 - 2003 . The purpose of this paper is to describe the trial implementation and the impact of the trial on the utilization of prenatal care and perinatal outcomes . Material s and methods In the study county , 10 townships ( from a total of 55 ) were each paired with a control ( 20 study townships in total ) , with the criteria for pairing being the township 's socioeconomic development , perinatal health , and maternal care utilization and provision . One of each township pair was r and omly allocated to the intervention or control groups . The trial interventions were : 1 ) training township hospital midwives and instructing them in how to provide systematic maternal care , 2 ) informing women in the community of the importance of prenatal care , 3 ) if needed , providing basic medical instruments to the hospitals . A variety of data sources were used to describe the trial implementation ( observations , group discussion s , field notes , survey to women ) . The data on pregnancy and perinatal outcomes were from the original h and -written work-records in the village family planning centers of the study townships . Results Implementation of the intervention was deficient . The factors hindering the trial implementation included poor coordination between midwives and family planning officers , broader policy changes implemented by the provincial government during the trial , the de central ization of county governance , and the lack of government funding for maternal care . There was only little difference in the use of maternal care , in women 's opinions related to maternal care or content of prenatal care , and no difference in the perinatal outcomes between the intervention and control townships . Conclusions A community based r and omized controlled trial could not be fully carried out in rural China as planned due to the changing political l and scape , the complexity of the socio-economic situation and a lengthy planning stage . The study could not answer if perinatal outcomes could be improved by increased use of prenatal care . Trial registration NCT Abstract Background Neonatal mortality remains high in rural Nepal . Previous work suggests that local women 's groups can effect significant improvement through community mobilisation . The possibility of identification and management of newborn infections by community-based workers has also arisen . Methods / Design The objective of this trial is to evaluate the effects on newborn health of two community-based interventions involving Female Community Health Volunteers . MIRA Dhanusha community groups : a participatory intervention with women 's groups . MIRA Dhanusha sepsis management : training of community volunteers in the recognition and management of neonatal sepsis . The study design is a cluster r and omized controlled trial involving 60 village development committee clusters allocated 1:1 to two interventions in a factorial design . MIRA Dhanusha community groups : Female Community Health Volunteers ( FCHVs ) are supported in convening monthly women 's groups . Nine groups per cluster ( 270 in total ) work through two action research cycles in which they ( i ) identify local issues around maternity , newborn health and nutrition , ( ii ) prioritise key problems , ( iii ) develop strategies to address them , ( iv ) implement the strategies , and ( v ) evaluate their success . Cycle 1 focuses on maternal and newborn health and cycle 2 on nutrition in pregnancy and infancy and associated postpartum care practice s. MIRA Dhanusha sepsis management : FCHVs are trained to care for vulnerable newborn infants . They ( i ) identify local births , ( ii ) identify low birth weight infants , ( iii ) identify possible newborn infection , ( iv ) manage the process of treatment with oral antibiotics and referral to a health facility to receive parenteral gentamicin , and ( v ) follow up infants and support families . Primary outcome : neonatal mortality rates . Secondary outcomes : MIRA Dhanusha community group : stillbirth , infant and under-two mortality rates , care practice s and health care seeking behaviour , maternal diet , breastfeeding and complementary feeding practice s , maternal and under-2 anthropometric status . MIRA Dhanusha sepsis management : identification and treatment of neonatal sepsis by community health volunteers ,
Output:
| This review offers encouraging evidence on the value of integrating packages of interventions with educational components delivered by a range of community workers in group setting s in LMICs , with groups consisting of mothers , and additional education for family members , for improved neonatal survival , especially early and late neonatal survival |
MS210670 | ***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: Physical exercise has a favorable impact on bones , but optimum training strategies are still under discussion . In this study , we compared the effect of slow and fast resistance exercises on various osteodensitometric parameters . Fifty-three postmenopausal women were r and omly assigned to a strength training ( ST ) or a power training group ( PT ) . Both groups carried out a progressive resistance training , a gymnastics session , and a home training over a period of 12 mo . During the resistance training , the ST group used slow and the PT group fast movements ; otherwise there were no training differences . All subjects were supplemented with Ca and vitamin D. At baseline and after 12 mo , bone mineral density ( BMD ) was measured at the lumbar spine , proximal femur , and distal forearm by dual-energy X-ray absorptiometry . We also measured anthropometric data and maximum static strength . Frequency and grade of pain were assessed by question naire . After 12 mo , significant between-group differences were observed for BMD at the lumbar spine ( P < 0.05 ) and the total hip ( P < 0.05 ) . Whereas the PT group maintained BMD at the spine ( + 0.7 + /- 2.1 % , not significant ) and the total hip ( 0.0 + /- 1.7 % , not significant ) , the ST group lost significantly at both sites ( spine : -0.9 + /- 1.9 % ; P < 0.05 ; total hip : -1.2 + /- 1.5 % ; P < 0.01 ) . No significant between-group differences were observed for anthropometric data , maximum strength , BMD of the forearm , or frequency and grade of pain . These findings suggest that power training is more effective than strength training in reducing bone loss in postmenopausal women Summary The EFOPS trial clearly established the positive effect of long-term exercise on clinical low-trauma fractures in postmenopausal women at risk . Bearing in mind that the complex anti-fracture exercise protocol s also affect a large variety of diseases of increased age , we strongly encourage older adults to perform multi purpose exercise programs . Introduction Physical exercise may be an efficient option for autonomous fracture prevention during increasing age . The aim of the study was to evaluate the effect of exercise on clinical overall fracture incidence and bone mineral density ( BMD ) in elderly subjects at risk . Methods In 1998 initially , 137 early-postmenopausal , osteopenic women living in Erlangen-Nuremberg , Germany , were included in the EFOPS trial . Subjects of the exercise group ( EG ; n = 86 ) conducted two supervised group and two home exercise sessions/week while the control group ( CG ; n = 51 ) was requested to maintain their physical activity . Primary study endpoints were clinical overall low-trauma fractures determined by question naires , structured interviews , and BMD at the lumbar spine and femoral neck assessed by dual-energy X-ray absorptiometry . Results In 2014 , 105 subjects ( EG : n = 59 vs. CG : n = 46 ) representing 1680 participant-years were included in the 16-year follow-up analysis . Risk ratio in the EG for overall low-trauma fractures was 0.51 ( 95 % confidence interval ( 95 % CI ) 0.23 to 0.97 , p = .046 ) , rate ratio was 0.42 ( 95 % CI 0.20 to 0.86 , p = .018 ) . Based on comparable baseline values , lumbar spine ( MV −1.5 % , 95 % CI −0.1 to −2.8 vs. −5.8 % , −3.3 to −7.2 % ) and femoral neck ( −6.5 % , −5.2 to −7.7 vs. −9.6 % , −8.2 to 11.1 % ) BMD decreased in both groups ; however , the reduction was more pronounced in the CG ( p ≤ .001 ) . Conclusion This study clearly evidence d the high anti-fracture efficiency of multi purpose exercise programs . Considering furthermore the favorable effect of exercise on most other risk factors of increasing age , we strongly encourage older adults to perform multi purpose exercise programs Background : Regular exercise has been recommended as a potential strategy to counteract the age-related bone loss experienced by men ; however , the optimal exercise prescription is not known . Objective : To perform a pilot study to examine the osteogenic effect , safety and feasibility of a combined program of upper body resistance exercise and two doses of impact-loading exercise on bone mineral density ( BMD ) of middle-aged and older men . Methods : Forty-two community-dwelling men aged 50 - 74 years were r and omly assigned to either an exercise program of combined upper body resistance exercise and either high-dose impact-loading ( HI ; 80 jumps per session ) or moderate-dose impact-loading ( MOD ; 40 jumps per session ) or a control ( CON ) group . The 9-month intervention involved 4 sessions each week : 2 supervised clinic-based and 2 home-based . BMD of the lumbar spine , femoral neck , total hip , trochanter and whole body as well as lean and fat mass were assessed at baseline and 9 months by dual-energy X-ray absorptiometry . Bone turnover markers , hormone levels , physical function and muscle strength were also assessed . Results : Following 9 months of training , significant differences in BMD among groups were found at the total hip ( p = 0.010 ) and trochanter ( p = 0.047 ) with BMD in the MOD group decreasing relative to the HI group . Although not significant , the HI group consistently preserved BMD , whereas BMD of the MOD and CON groups declined at the hip sites . Mean change for all groups at all skeletal sites was approximately within ±1 % . There was no change in bone turnover markers . There were no adverse events as a result of the intervention ; however , overall attendance for the HI and MOD groups was 53 % ( clinic : 68 % , home : 38 % ) and 65 % ( clinic : 74 % , home : 55 % ) , respectively . Conclusions : This study indicates that while impact-loading exercise can be safely undertaken in middle-aged and older men , the current combined program did not elicit significant improvements in BMD Limited data have suggested that the consumption of fluid milk after resistance training ( RT ) may promote skeletal muscle hypertrophy . The aim of this study was to assess whether a milk-based nutritional supplement could enhance the effects of RT on muscle mass , size , strength , and function in middle-aged and older men . This was an 18-mo factorial design ( r and omized control trial ) in which 180 healthy men aged 50 - 79 yr were allocated to the following groups : 1 ) exercise + fortified milk , 2 ) exercise , 3 ) fortified milk , or 4 ) control . Exercise consisted of progressive RT with weight-bearing impact exercise . Men assigned to the fortified milk consumed 400 ml/day of low-fat milk , providing an additional 836 kJ , 1000 mg calcium , 800 IU vitamin D(3 ) , and 13.2 g protein per day . Total body lean mass ( LM ) and fat mass ( FM ) ( dual-energy X-ray absorptiometry ) , midfemur muscle cross-sectional area ( CSA ) ( quantitative computed tomography ) , muscle strength , and physical function were assessed . After 18 mo , there was no significant exercise by fortified milk interaction for total body LM , muscle CSA , or any functional measure . However , main effect analyses revealed that exercise significantly improved muscle strength ( approximately 20 - 52 % , P < 0.001 ) , LM ( 0.6 kg , P < 0.05 ) , FM ( -1.1 kg , P < 0.001 ) , muscle CSA ( 1.8 % , P < 0.001 ) , and gait speed ( 11 % , P < 0.05 ) relative to no exercise . There were no effects of the fortified milk on muscle size , strength , or function . In conclusion , the daily consumption of low-fat fortified milk does not enhance the effects of RT on skeletal muscle size , strength , or function in healthy middle-aged and older men with adequate energy and nutrient intakes BACKGROUND The beneficial role of exercise in improving bone mineral density , muscle strength and balance , has been documented predominantly in younger population s. These findings may not apply to elderly population s with limited ability to perform exercises of high intensity . OBJECTIVE To examine the effects of Tai Chi ( TC ) and resistance exercise ( RTE ) on bone mineral density ( BMD ) , muscle strength , balance and flexibility in community living elderly people . DESIGN R and omised controlled trial , using blocked r and omization with stratification by sex . SETTING A community in the New Territories Region of Hong Kong , China . SUBJECTS One hundred eighty subjects ( 90 men , 90 women ) aged 65 - 74 , were recruited through advertisements in community centres . METHODS Subjects were assigned to participate in TC , RTE three times a week , or no intervention ( C ) for 12 months . Measurements were carried out at baseline , 6 and 12 months . Analyses of covariance ( ANCOVA ) adjusted for age , and baseline values of variables that were significantly different between groups : i.e. smoking and flexibility for men ; quadriceps strength for women . RESULTS Compliance was high ( TC 81 % , RTE 76 % ) . In women , both TC and RTE groups had less BMD loss at total hip compared with controls . No effect was observed in men . No difference in either balance , flexibility or the number of falls was observed between either intervention or controls after 12 months . CONCLUSION The beneficial effects of TC or RTE on musculoskeletal health are modest and may not translate into better clinical outcomes Summary A 1-year r and omized controlled trial of resistance training compared with a control group was undertaken in 143 men aged 55–80 years . Although hip bone mineral density , lean body mass , and function increased in both groups , lean body mass and function but not bone density increased more in the resistance group . Introduction Previous studies have demonstrated a positive effect of resistance training on bone mineral density ( BMD ) in postmenopausal women , but the effect in men is unclear . The aim was to examine the effect of a 1-year resistance training program on bone and lean body mass in 143 men aged 55–80 years , r and omized to either resistance training or active control . Methods Resistance exercises were selected to provide loading at the hips . Measurements were taken at 0 , 6 , and 12 months for BMD ( whole body , hip , and spine ) , lean body mass , strength , and functional fitness . Results The intervention showed a significant increase in total hip BMD for both groups at 12 months ( active control , 1,014–1,050 mg/cm2 ; resistance , 1,045–1,054 mg/cm2 , p < 0.05 ) with no increased effect of resistance training compared to active control . However , compared to the active control group , the resistance group increased their lean body mass ( active control , 0.1 ± 2.1 % ; resistance , 1.5 ± 2.7 % , p < 0.05 ) , fitness ( active control , 4.6 ± 11.1 % ; resistance , 13.0 ± 13.4 % , p < 0.05 ) , and lower limb muscle strength ( active control , 14.3 ± 16.8 % ; resistance , 39.4 ± 30.87 % , p < 0.05 ) . Conclusions In contrast to previous findings in older women , in older men , a resistance training program does not increase hip bone mass more than walking 30 min three times a week UNLABELLED In a prospect i ve study of 5384 older men , hip BMD was a very strong predictor of hip fracture , much stronger than spine BMD . The relationship between hip BMD and hip fracture risk seemed to be stronger than observed in a large prospect i ve study of women . Hip BMD is an excellent test for predicting fracture risk in men . INTRODUCTION There have been few studies of the relationship between BMD and risk of fractures in men and none for the association between lumbar spine BMD and risk of hip and nonvertebral fractures . There is also controversy about whether the associations between BMD and risk of fracture are the same in men and women . MATERIAL S AND METHODS We measured proximal femur and lumbar spine BMD in 5384 men , 5384 men , > or= 65 years of age . We compared the results to the very similar cohort of 7871 women > or=65 of age . During 4.4 years of 99 % complete follow-up , we vali date d 317 nonvertebral ( 59 hip ) fractures in men and 1169 nonvertebral ( 208 hip ) fractures in women . RESULTS Total hip BMD was very strongly associated with risk hip fracture in men ( 3.2-fold increased risk per sex-specific SD decrease in BMD ; 95 % CI , 2.4 - 4.1 ) . The association was stronger than observed in SOF ( 2.1 ; 95 % CI , 1.8 , 2.4 ; p < 0.001 for interaction ) . Among the men , lumbar spine BMD was weakly associated with risk of hip fracture ( relative risk [ RR ] per sex-specific SD decrease in BMD : 1.5 ; 95 % CI , 1.2 , 2.0 ) . The association between total hip BMD and risk of nonvertebral fractures was somewhat stronger for men ( RR = 1.6 ; 95 % CI , 1.5 , 1.8 ) than found for women
Output:
| This systematic review detected only limited positive effects of exercise on bone mineral density in older men .
Further , based on the present literature , we were unable to suggest dedicated exercise prescriptions for this male cohort that might differ from recommendations based on studies with postmenopausal women .
Based on the present studies , there is only limited evidence for a favorable effect of exercise on BMD in men . |
MS210671 | ***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 To investigate the acceptability and feasibility of using short message services ( SMS ) via cell phones to ensure adherence to management prescriptions by diabetic patients . METHODS Type 2 diabetic patients with 5 or more years of diabetes and having HbA1c between 7.0 % to 10 % were r and omized to the control arm ( n = 105 ) to receive st and ard care and to the intervention arm ( SMS , n = 110 ) . Messages in English on principles of diabetes management were sent once in 3 days , the contents and frequencies varied as per the patients ' preferences . The study duration was 1 year . All participants were advised to report for quarterly clinic visits . A comparative assessment of the clinical , biochemical and anthropometric outcomes was made among the groups at the annual visit . RESULTS Annual review was possible in 71 % of intervention group and 63 % of control group . SMS was acceptable to the patients and the median number requested was 2 per week . HbA1c and plasma lipids improved significantly in the SMS group . CONCLUSIONS The pilot study showed that frequent communication via SMS was acceptable to diabetic patients and it helped to improve the health outcomes A common question in clinical consultations is : “ For this person , what are the likely effects of one treatment compared with another ? ” The central tenet of evidence based medicine is that this task is achieved by using the best evidence combined with consideration of that person 's individual needs.1 A further question then arises : “ What is the best evidence ? ” Two recent studies in the New Engl and Journal of Medicine have caused uproar in the research community by finding no difference in estimates of treatment effects between r and omised controlled trials and non-r and omised trials . The r and omised controlled trial and , especially , systematic review s of several of these trials are traditionally the gold st and ards for judging the benefits of treatments , mainly because it is conceptually easier to attribute any observed effect to the treatments being compared . The role of non-r and omised ( observational ) studies in evaluating treatments is contentious : deliberate choice of the treatment for each person implies that observed outcomes may be caused by differences among people being given the two treatments , rather than the treatments alone . Unrecognised confounding factors can always interfere with attempts to correct for identified differences between groups . These considerations have supported a hierarchy of evidence , with r and omised controlled trials and derivatives at the top , controlled BACKGROUND Non-attendance results in administrative problems and disruption in patient care . Several interventions have been used to reduce non-attendance , with varying degree of success . A relatively new intervention , text messaging , has been shown to be as effective as telephone reminders in reducing non-attendance . However , no study has looked specifically at using text messaging reminders to reduce non-attendance in chronic disease care . AIM To determine if text messaging would be effective in reducing non-attendance in patients on long-term followup , compared with telephone reminders and no reminder . DESIGN OF STUDY A r and omised controlled trial with three arms : text messaging reminder , telephone reminder , and control . SETTING Two primary care clinics in Malaysia . METHOD A total of 931 subjects who had been on at least 6 months of follow-up were r and omised into the three groups . Demographic variables were recorded at the first visit . In the intervention arms , a reminder was sent 24–48 hours prior to the appointment . Non-attendance rate was documented at the second visit . Non-attenders were defined as those who did not attend , attended early , or attended late without rescheduling their appointment . Attenders were defined as participants who had turned up for their scheduled appointment and those who had changed or cancelled their appointment with notification . RESULTS The non-attendance rates in the text messaging group ( odds ratio [ OR ] = 0.62 , 95 % confidence interval [ CI ] = 0.41 to 0.93 , P = 0.020 ) and the telephone reminder group ( OR = 0.53 , 95 % CI = 0.35 to 0.81 ) , P = 0.003 ) were significantly lower than the control group . The absolute non-attendance rate for telephone reminders was lower by 2 % compared to the text messaging group . This difference was not found to be statistically significant ( P = 0.505 ) . CONCLUSION Text messaging was found to be as effective as telephone reminder in reducing non-attendance in patients who required long-term follow-up for their chronic illnesses in this study . It could be used as an alternative to conventional reminder systems Background Adequate antenatal care is important to both the health of a pregnant woman and her unborn baby . Given South Africa ’s high rate of cellphone penetration , mobile health interventions have been touted as a potentially powerful means to disseminate health information . This study aim ed to increase antenatal health knowledge and awareness by disseminating text messages about clinic procedures at antenatal visits , and how to be healthy during pregnancy . Methods Participants recruited were pregnant women attending a primary health care facility in Cape Town . A controlled clinical trial was carried out where the intervention group ( n = 102 ) received text messages staggered according to the week of pregnancy at the time of recruitment . The control group ( n = 104 ) received no text messages . These text messages contained antenatal health information , and were delivered in English , Xhosa or Afrikaans , according to the preference of each participant . A baseline knowledge question naire with nine questions was administered prior to the intervention . The same question naire was used with added health-related behaviour questions for the intervention group at exit . A modified intention-to-treat analysis was done . To compare the control and intervention group ’s knowledge , Fisher ’s exact tests and two- sample t-tests tests were carried out for binary and continuous outcomes , respectively . A focus group of seven participants from the intervention group was then conducted to gain more insight into how the text messages were perceived . Results There was substantial loss to follow-up during the study with only 57 % of the participants retained at exit . No statistically significant difference was detected between the control and intervention group in any of the nine knowledge questions at exit ( all p > 0.05 ) . Responses from the focus group indicated that the text messages acted as a welcome reminder and a source of positive motivation , and were perceived as extended care from the health care provider . Conclusions While the intervention failed to improve antenatal health knowledge , evidence from self-reported behaviour and the focus group suggests that text messages have the potential to motivate change in health-seeking behaviour . One should be mindful of loss to follow-up when rolling out mobile health interventions in developing country setting s . Trial registration Pan African Clinical Trials Registry PACTR201406000841188 . Registered 3 June 2014 OBJECTIVE Hypertension and other noncommunicable diseases represent a growing threat to low/middle-income countries ( LMICs ) . Mobile health technologies may improve noncommunicable disease outcomes , but LMICs lack re sources to provide these services . We evaluated the efficacy of a cloud computing model using automated self-management calls plus home blood pressure ( BP ) monitoring as a strategy for improving systolic BPs ( SBPs ) and other outcomes of hypertensive patients in two LMICs . SUBJECTS AND METHODS This was a r and omized trial with a 6-week follow-up . Participants with high SBPs ( ≥140 mm Hg if nondiabetic and ≥130 mm Hg if diabetic ) were enrolled from clinics in Honduras and Mexico . Intervention patients received weekly automated monitoring and behavior change telephone calls sent from a server in the United States , plus a home BP monitor . At baseline , control patients received BP results , hypertension information , and usual healthcare . The primary outcome , SBP , was examined for all patients in addition to a preplanned subgroup with low literacy or high hypertension information needs . Secondary outcomes included perceived health status and medication-related problems . RESULTS Of the 200 patients recruited , 181 ( 90 % ) completed follow-up , and 117 of 181 had low literacy or high hypertension information needs . The median annual income was $ 2,900 USD , and average educational attainment was 6.5 years . At follow-up intervention patients ' SBPs decreased 4.2 mm Hg relative to controls ( 95 % confidence interval -9.1 , 0.7 ; p=0.09 ) . In the subgroup with high information needs , intervention patients ' average SBPs decreased 8.8 mm Hg ( -14.2 , -3.4 , p=0.002 ) . Compared with controls , intervention patients at follow-up reported fewer depressive symptoms ( p=0.004 ) , fewer medication problems ( p<0.0001 ) , better general health ( p<0.0001 ) , and greater satisfaction with care ( p≤0.004 ) . CONCLUSIONS Automated telephone care management plus home BP monitors can improve outcomes for hypertensive patients in LMICs . A cloud computing model within regional telecommunication centers could make these services available in areas with limited infrastructure for patient-focused informatics support The self-management of asthma can improve clinical outcomes . Recently , mobile telephones have been widely used as an efficient , instant personal communication tool . This study investigated whether a self-care system will achieve better asthma control through a mobile telephone-based interactive programme . This was a prospect i ve , controlled study in outpatient clinics . From 120 consecutive patients with moderate-to-severe persistent asthma , 89 were eventually recruited for the study , with 43 in the mobile telephone group ( with a mobile telephone-based interactive asthma self-care system ) . In the mobile telephone group , mean±sem peak expiratory flow rate significantly increased at 4 ( 378.2±9.3 L·min−1 ; n = 43 ; p = 0.020 ) , 5 ( 378.2±9.2 L·min−1 ; n = 43 ; p = 0.008 ) and 6 months ( 382.7±8.6 L·min−1 ; n = 43 ; p = 0.001 ) compared to the control group . Mean±sem forced expiratory volume in 1 s significantly increased at 6 months ( 65.2±3.2 % predicted ; n = 43 ; p<0.05 ) . Patients in the mobile telephone group had better quality of life after 3 months , as determined using the Short Form-12 ® physical component score , and fewer episodes of exacerbation and unscheduled visits than the control group . Patients in the mobile telephone group significantly increased their mean daily dose of either systemic or inhaled corticosteroids compared with the control group . The mobile telephone-based interactive self-care system provides a convenient and practical self-monitoring and -management of asthma , and improves asthma control OBJECTIVE To determine the effect of mobile phone intervention on HbA1c in type-2 Diabetes Mellitus ( DM ) patients living in rural areas of Pakistan . STUDY DESIGN R and omized controlled trial . PLACE AND DURATION OF STUDY Department of Endocrinology , Liaquat National Hospital , Karachi , from December 2013 to June 2014 . METHODOLOGY A total of 440 patients in intervention and control groups were enrolled . All patients between 18 - 70 years of age , residing in rural areas of Pakistan , HbA1c ³ 8.0 % and having personal functional mobile phone were included . The intervention group patients were called directly on mobile phone after every 15 days for a period of 4 months . They were asked about the self-monitoring blood glucose , intake of medications , physical activity , healthy eating and were physically examined after 4 months . However , the control group was examined initially and after 4 months physically in the clinic and there were no mobile phone contacts with these patients . RESULTS Patients in intervention group showed improvement ( p < 0.001 ) in following diet plan from 17.3 % at baseline to 43.6 % at endline , however , the control group showed insignificant increase ( p=0.522 ) from 13.6 % at baseline to 15.9 % at endline . Intervention group ( RR = 2.71 , 95 % CI = 1.18 - 6.40 ) showed significant positive association with normalization of HbA1c levels . The relationship was adjusted for age , gender , socio-economic status , ethnicity , education , hypertension , medication , BMI , diet , LDL levels and physical activity . Dietary restriction and low LDL levels also showed significant associations with reduced HbA1c levels on multivariate analysis . CONCLUSION Mobile phone technology in rural areas of Pakistan was helpful in lowering HbA1c levels in intervention group through direct communication with the diabetic patients . Lowering LDL and following diabetic diet plan can reduce HbA1c in these patients and help in preventing future complications Please cite this paper as : Lund S , Hemed M , Nielsen B , Said A , Said K , Makungu M , Rasch V. Mobile phones as a health communication tool to improve skilled attendance at delivery in Zanzibar : a cluster‐r and omised controlled trial . BJOG 2012;119:1256–1264 Home peak expiratory flow ( PEF ) measurement is recommended by asthma guidelines . In a 16-week r and omized controlled study on 16 subjects with asthma ( 24.6 6.5 years old , asthma duration small ze , Cyrillic 6 months ) , we examined Global System for Mobile Communications ( GSM ) mobile telephone short-message service ( SMS ) as a novel means of telemedicine in PEF monitoring . All subjects received asthma education , self-management plan , and st and ard treatment . All measured PEF three times daily and kept a symptom diary . In the study group , therapy was adjusted weekly by an asthma specialist according to PEF values received daily from
Output:
| Except for one study all showed rather positive effects of mHealth interventions on reported outcome measures .Furthermore , our results suggest that particular types of mHealth interventions that were found to have positive effects on patients with communicable diseases and for improving maternal care are likely to be effective also for NCDs . |
MS210672 | ***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: OBJECTIVE : To describe the rates of cure , treatment failure , and treatment ab and onment obtained with the basic regimen recommended by the Brazilian National Ministry of Health-rifampin , isoniazid , pyrazinamide , and ethambutol for two months , followed by isoniazid and rifampin for four months-involving the use of fixed-dose combination tablets ( self-administered treatment ) , as well as to describe adverse events and their potential impact on treatment outcomes . METHODS : This was a descriptive study based on prospect i ve data obtained from the medical records of tuberculosis patients ( ≥ 18 years of age ) treated with the basic regimen at either of two primary health care facilities in the greater metropolitan area of Goiânia , Brazil . RESULTS : The study sample comprised 40 tuberculosis patients . The rate of cure was 67.5 % , the rate of treatment ab and onment was 17.5 % , and there were no cases of treatment failure . Of the 40 patients in the sample , 19 ( 47 % ) reported adverse reactions , which were mild and moderate , respectively , in 87 % and 13 % of the cases . It was not necessary to alter the regimen or discontinue the treatment in any of the cases evaluated . CONCLUSIONS : The rate of cure obtained with the self-administered , fixed-dose combination tablet form of the new basic regimen was similar to the historical rates of cure obtained with the previous basic regimen . The rate of treatment ab and onment in our sample was much higher than that considered appropriate ( up to 5 % ) BACKGROUND Novel treatment options are urgently needed for multidrug-resistant ( MDR ) and extensively drug-resistant ( XDR ) tuberculosis , which are associated with immune dysfunction and poor treatment outcomes . Mesenchymal stromal cells ( MSCs ) are immunomodulatory and adjunct autologous treatment with bone marrow-derived MSCs might improve clinical outcome by transforming chronic inflammation into productive immune responses . Our aim was to assess the safety of infusion of autologous MSCs as an adjunct treatment in patients with tuberculosis . METHODS 30 patients with microbiologically confirmed MDR or XDR tuberculosis were treated with single-dose autologous bone marrow-derived MSCs ( aim ed for 1 × 10(6 ) cells per kg ) , within 4 weeks of the start of antituberculosis-drug treatment in a specialist centre in Minsk , Belarus . Inclusion patients were those with pulmonary tuberculosis confirmed by sputum smear microscopy , culture , or both ; MDR or XDR tuberculosis confirmed by drug-susceptibility testing to first-line and second-line drugs ; age older than 21 years to 65 years or younger ; and absence of lesion compatible with a malignant process or ongoing tuberculosis in organs other than the lungs and pleura . In addition to the inclusion criteria , patients were excluded if they were pregnant , coinfected with HIV , or infected with hepatitis B , C , or both . The primary endpoint was safety measured by MSC-infusion related events ; any tuberculosis-related event within the 6 month observation period that related to a worsening of the underlying infectious disease , measured by conversion of Mycobacterium tuberculosis culture or microscopic examination ; or any adverse event defined clinical ly or by changes in blood haematology and biochemistry variables , measured monthly for 6 months after MSC infusion per protocol . This study is registered with the German Clinical Trials Registry , number DRKS00000763 . FINDINGS The most common ( grade 1 or 2 ) adverse events were high cholesterol levels ( 14 of 30 patients ) , nausea ( 11 of 30 patients ) , and lymphopenia or diarrhoea ( ten of 30 patients ) . There were no serious adverse events reported . We recorded two grade 3 events that were transitory-ie , increased plasma potassium ion concentrations in one patient and a transitory grade 3 γ-glutamyltransferase elevation in another patient . INTERPRETATION MSCs as an adjunct therapy are safe and can now be explored further for the treatment of patients with MDR or XDR tuberculosis in combination with st and ard drug regimens . Adjunct treatment with MSCs needs to be evaluated in controlled phase 2 trials to assess effects on immune responses and clinical and microbiological outcomes There is a growing appreciation that our current approach to clinical research leaves important gaps in evidence from the perspective of patients , clinicians , and payers wishing to make evidence -based clinical and health policy decisions . This has been a major driver in the rapid increase in interest in comparative effectiveness research ( CER ) , which aims to compare the benefits , risks , and sometimes costs of alternative health-care interventions in ‘ the real world ’ . While a broad range of experimental and nonexperimental methods will be used in conducting CER studies , many important questions are likely to require experimental approaches – that is , r and omized controlled trials ( RCTs ) . Concerns about the generalizability , feasibility , and cost of RCTs have been frequently articulated in CER method discussion s. Pragmatic RCTs ( or ‘ p RCTs ’ ) are intended to maintain the internal validity of RCTs while being design ed and implemented in ways that would better address the dem and for evidence about real-world risks and benefits for informing clinical and health policy decisions . While the level of interest and activity in conducting p RCTs is increasing , many challenges remain for their routine use . This article discusses those challenges and offers some potential ways forward SETTING Health centres in the South Sulawesi Province , Republic of Indonesia . OBJECTIVES To compare complaints , side-effects and treatment outcome in new smear-positive patients treated with a single-drug short-course ( National TB Programme ( NTP ) ) regimen with those treated with a four-drug fixed-dose combination ( 4FDC ) regimen . DESIGN A prospect i ve study in which patients are r and omly allocated to the NTP or the 4FDC regimen . RESULTS Preliminary results of the first 360 patients ( 162 treated with the NTP regimen and 198 with the 4FDC regimen ) show that two patients , treated with the NTP regimen , developed jaundice . During the intensive phase of treatment , gastro-intestinal and muscle-joint complaints of any duration and gastro-intestinal complaints lasting for 2 consecutive weeks or more were more frequent in patients treated with the NTP regimen . Sputum conversion was 89 % in patients treated with the NTP regimen and 94 % in those treated with the 4FDC regimen . Nine-five per cent of patients , both regimens , were cured . CONCLUSION The results so far show that complaints during the intensive phase of treatment are less frequent among patients treated with the 4FDC regimen . The lower dose of pyrazinamide might be the reason . Treatment results are excellent for both regimens SETTING Veterans General Hospital-Taipei , Taiwan . OBJECTIVE To assess the efficacy and safety of a fixed-dose combination ( FDC ) of Rifater (RFT)/Rifinah ( RFN ) in the treatment of newly diagnosed smear-positive pulmonary tuberculosis . DESIGN Patients were r and omly assigned to two 6-month short-course chemotherapy regimens . One group of patients was treated with FDCs and another was given the four component drugs ( INH , RMP , EMB and PZA ) as separate formulations . RESULTS The 105 patients enrolled in the study were divided into two treatment groups . Fifty-one patients who had completed treatment without interruption , 26 in the FDC group and 25 in the separate regimen , were eligible for analysis at the end of 2 years . Among the patients with a drug susceptibility test result available , four in the FDC group had bacilli resistant to pyrazinamide . In the separate regimen group , two patients had bacilli resistant to ethambutol and six had bacilli resistant to pyrazinamide . The two regimens were of similar effectiveness with regard to sputum conversion , compliance and radiological improvement . No patient with FDC treatment developed gastointestinal symptoms , visual disturbance or peripheral neuropathy ( P < 0.05 ) . However , FDC treatment result ed in drug-induced fever in one patient . One patient ( 3.8 % ) in the FDC group relapsed 5 months after completing treatment . CONCLUSION This study suggests that the two regimens had similar effectiveness in the treatment of smear-positive pulmonary tuberculosis . However , the fewer adverse drug events among those patients treated with the FDC regimen suggests that it has a better safety profile OBJECTIVE To compare the efficacy , safety and acceptability of two short-course regimens of isoniazid , rifampicin , pyrazinamide and ethambutol ( HRZE ) given either as fixed-dose combination ( 4-FDC ) tablets or as single tablets ( ST ) in patients with newly diagnosed pulmonary tuberculosis ( PTB ) . DESIGN This r and omised , open , multicentre , multinational study was conducted in 26 centres and included 1159 patients with smear-positive PTB . 4-FDC daily for 2 months then H+R for 4 months , or single preparations of H , R , Z and E for 2 months followed by H and R for 4 months were administered daily . Sputum smear conversion rates at 2 , 4 and 6 months ( end of treatment [ EOT ] , primary endpoint ) and at 9 and 12 months ( follow-up ) were measured , together with adverse events and the acceptability of the formulations . RESULTS Smear conversion rates for 4-FDC and ST at EOT were 80.4 % ( 468/582 patients ) vs. 82.7 % ( 477/577 ) in the intent-to-treat ( ITT ) population , and 98.1 % ( 404/412 ) vs. 98.6 % ( 416/422 ) in the per- protocol ( PP ) subgroup . Non-inferiority of 4-FDC was demonstrated at month 2 , EOT and follow-up in both the ITT and the PP population s. Overall numbers of adverse events were not significantly different between the groups . CONCLUSION The efficacy of the 4-FDC regimen was non-inferior to that of the ST regimens , but patient acceptability significantly improved with 4-FDC To evaluate the clinical and therapeutic value of 4 and 3 drug fixed dose combinations verses single drug formulations to treat pulmonary tuberculosis patients . The occurrence of adverse effects was also monitored . A total of 293 patients having sputum positive pulmonary tuberculosis were enrolled ( Male : 187 and Female : 106 ) . Patients with renal , hepatic , diabetic , cardiac problem and pregnancy were excluded from study . Patients were r and omly selected into three groups ( A , B , C ) . Group A and B were given FDCs and group C was given single drug formulations . All patients received 4 drugs in the intensive phase and 3 drugs in the continuation phase . Group A showed the highest percentage of patients who achieved sputum conversion ( 98.9 % ) . The numbers of days taken to achieve sputum conversion on average were the least for Group B ( 32 days ) . When comparing the adverse effects , the patients of Group C suffered the most , with 22 patients who vomited repeatedly , 3 complaining of itching , 2 with Jaundice and 1 dead . There was no significant difference in the efficacy among the three treatment regimens . However the side effects observed in all three groups strongly indicate that FDCs are safer for treating TB patients . There were no side effects in the continuation phase CONTEXT Fixed-dose combinations ( FDCs ) of drugs for treatment of tuberculosis have been advocated to prevent the emergence of drug resistance . OBJECTIVE To assess the efficacy and safety of a 4-drug FDC for the treatment of tuberculosis . DESIGN , SETTING , AND PATIENTS The Study C trial , a parallel-group , open-label , noninferiority , r and omized controlled trial conducted in 11 sites in Africa , Asia , and Latin America between 2003 and 2008 . Patients were 1585 adults with newly diagnosed smear-positive pulmonary tuberculosis . INTERVENTIONS Patients were r and omized to receive daily treatment with 4 drugs ( rifampicin , isoniazid , pyrazinamide , ethambutol ) given as an FDC ( n = 798 patients ) or separately ( n = 787 ) in the 8-week intensive phase of treatment . MAIN OUTCOME MEASURE Favorable treatment outcome , defined as negative culture result at 18 months post r and omization and not having already been classified as unfavorable . Noninferiority was dependent on consistent results from a per- protocol and modified intention-to-treat analysis , using 2 different models for the latter , classifying all changes of treatment or refusal to continue treatment ( eg , bacteriological failure/relapse , adverse event , default , drug resistance ) as unfavorable ( model 1 ) and classifying changes of treatment for reasons other than therapeutic outcomes according to their 18-month bacteriological outcome if available ( post hoc model 2 ) . The prespecified noninferiority margin was 4 % . RESULTS In the per- protocol analysis , 555 of 591 patients ( 93.9 % ) had a favorable outcome in the FDC group vs 548 of 579 ( 94.6 % ) in the separate-drugs group ( risk difference , -0.7 % [ 90 % confidence interval { CI } , -3.0 % to 1.5 % ] ) . In the model 1 analysis , 570 of 684 patients ( 83.3 % ) had a favorable outcome in the FDC group vs 56
Output:
| There were no significant differences between the groups in overall incidence of adverse effects .
Conclusions The review ed studies showed that four-drug fixed-dose combination therapy provides greater patient comfort by reducing the number of pills and the incidence of gastrointestinal adverse effects , as well as simplifying pharmaceutical management at all levels |
MS210673 | ***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 Minnesota Coronary Survey was a 4.5-year , open enrollment , single end-time , double-blind , r and omized clinical trial that was conducted In six Minnesota state mental hospitals and one nursing home . It Involved 4393 Institutionalized men and 4664 Institutionalized women . The trial compared the effects of a 39 % fat control diet ( 18 % saturated fat , 5 % polyunsaturated fat , 16 % monounsaturated fat , 446 mg dietary cholesterol per day ) with a 38 % fat treatment diet ( 9 % saturated fat , 15 % polyunsaturated fat , 14 % monounsaturated fat , 166 mg dietary cholesterol per day ) on serum cholesterol levels and the Incidence of myocardlal Infa rct ions , sudden deaths , and all-cause mortality . The mean duration of time on the diets was 384 days , with 1568 subjects consuming the diet for over 2 years . The mean serum cholesterol level In the pre-admission period was 207 mg/dl , falling to 175 mg/dl in the treatment group and 203 mg/dl In the control group . For the entire study population , no differences between the treatment and control groups were observed for cardiovascular events , cardiovascular deaths , or total mortality . A favorable trend for all these end-points occurred In some younger age groups Background — The bulk of cardiovascular disease risk is not explained by traditional risk factors . Recent advances in mass spectrometry allow the identification and quantification of hundreds of lipid species . Molecular lipid profiling by mass spectrometry may improve cardiovascular risk prediction . Methods and Results — Lipids were extracted from 685 plasma sample s of the prospect i ve population -based Bruneck Study ( baseline evaluation in 2000 ) . One hundred thirty-five lipid species from 8 different lipid classes were profiled by shotgun lipidomics with the use of a triple-quadrupole mass spectrometer . Levels of individual species of cholesterol esters ( CEs ) , lysophosphatidylcholines , phosphatidylcholines , phosphatidylethanolamines ( PEs ) , sphingomyelins , and triacylglycerols ( TAGs ) were associated with cardiovascular disease over a 10-year observation period ( 2000–2010 , 90 incident events ) . Among the lipid species with the strongest predictive value were TAGs and CEs with a low carbon number and double-bond content , including TAG(54:2 ) and CE(16:1 ) , as well as PE(36:5 ) ( P=5.1 × 10−7 , 2.2 × 10−4 , and 2.5 × 10−3 , respectively ) . Consideration of these 3 lipid species on top of traditional risk factors result ed in improved risk discrimination and classification for cardiovascular disease ( cross-vali date d & Dgr;C index , 0.0210 [ 95 % confidence interval , 0.0010 - 0.0422 ] ; integrated discrimination improvement , 0.0212 [ 95 % confidence interval , 0.0031 - 0.0406 ] ; and continuous net reclassification index , 0.398 [ 95 % confidence interval , 0.175 - 0.619 ] ) . A similar shift in the plasma fatty acid composition was associated with cardiovascular disease in the UK Twin Registry ( n=1453 , 45 cases ) . Conclusions — This study applied mass spectrometry-based lipidomics profiling to population -based cohorts and identified molecular lipid signatures for cardiovascular disease . Molecular lipid species constitute promising new biomarkers that outperform the conventional biochemical measurements of lipid classes currently used in clinics 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 To assess the effect of dietary reduction of plasma cholesterol concentrations on coronary atherosclerosis , we set up a r and omised , controlled , end-point-blinded trial based on quantitative image analysis of coronary angiograms in patients with angina or past myocardial infa rct ion . Another intervention group received diet and cholestyramine , to determine the effect of a greater reduction in circulating cholesterol concentrations . 90 men with coronary heart disease ( CHD ) , who had a mean ( SD ) plasma cholesterol of 7.23 ( 0.77 ) mmol/l were r and omised to receive usual care ( U , controls ) , dietary intervention ( D ) , or diet plus cholestyramine ( DC ) , with angiography at baseline and at 39 ( SD 3.5 ) months . Mean plasma cholesterol during the trial period was 6.93 ( U ) , 6.17 ( D ) , and 5.56 ( DC ) mmol/l . The proportion of patients who showed overall progression of coronary narrowing was significantly reduced by both interventions ( U 46 % , D 15 % , DC 12 % ) , whereas the proportion who showed an increase in luminal diameter rose significantly ( U 4 % , D 38 % , DC 33 % ) . The mean absolute width of the coronary segments ( MAWS ) studied decreased by 0.201 mm in controls , increased by 0.003 mm in group D , and increased by 0.103 mm in group DC ( p less than 0.05 ) , with improvement also seen in the minimum width of segments , percentage diameter stenosis , and edge-irregularity index in intervention groups . The change in MAWS was independently and significantly correlated with LDL cholesterol concentration and LDL/HDL cholesterol ratio during the trial period . Both interventions significantly reduced the frequency of total cardiovascular events . Dietary change alone retarded overall progression and increased overall regression of coronary artery disease , and diet plus cholestyramine was additionally associated with a net increase in coronary lumen diameter . These findings support the use of a lipid-lowering diet , and if necessary of appropriate drug treatment , in men with CHD who have even mildly raised serum cholesterol concentrations The study deals with 412 men , aged 30 to 64 years , r and omized 1 to 2 years after a first myocardial infa rct ion . For the experimental group a diet low in saturated fats and cholesterol , and high in polyunsaturated fats was recommended . After 5 years , as reported previously , the incidence of fatal and nonfatal myocardial reinfa rct ion was found to be significantly reduced . “ Sudden death ” was uninfluenced . Major coronary heart disease ( CHD ) relapses , including fatal and nonfatal events ( MI ) , were significantly reduced ( P = 0.05).After 11 years , death from all causes had occurred in 101 of the original dieters and 108 controls . A significantly reduced myocardial infa rct ion mortality in the original diet group was found ( 32 versus 57 , P = 0.004 ) . The total number of coronary deaths ( fatal myocardial infa rct ion and sudden death ) was 79 in the diet group and 94 in the control group ( P = 0.097).The CHD mortality was correlated with age , serum cholesterol level , blood pressure , body weight , smoking habits , and a combination of these risk factors STUDY OBJECTIVE To investigate the prevalence and nature of low energy reporting in a dietary survey of British adults over 65 years of age . DESIGN R and omly selected cross sectional sample of 2060 British adults over 65 years . Four day weighed food diaries and question naires on health , lifestyle and socioeconomic characteristics . SETTING Great Britain . PARTICIPANTS 539 women and 558 men over 65 years who were free living and completed four day food diaries . MAIN RESULTS A high proportion of men and women were classified as low energy reporters ( LERs ) . Reported consumption of full fat dairy products , sugar and sweet foods , and alcoholic drinks differed most between LERs and non-LERs . Among LERs , reported protein and starch intakes were higher , fat , sugar and alcohol intakes were lower . LERs of either sex were more likely to be obese , male LERs were also more likely to belong to the manual social classes . CONCLUSIONS The high level of low energy reporting probably result ed from a coalescence of factors such as the weighed diary methodology and a reluctance to report consumption of unhealthy foods . The use of validatory biomarkers such as doubly labelled water needs to be more widespread A controlled intervention trial , with the purpose of testing the hypothesis that the incidence of coronary heart disease ( CHD ) could be decreased by the use of a serum-cholesterol-lowering ( SCL ) diet , was carried out in two mental hospitals near Helsinki in 1959 - 71 . The subjects were hospitalized middle-aged women . One of the hospitals received the SCL diet , ie a diet low in saturated fats and cholesterol and relatively high in poly-unsaturated fats , while the other served as the control with a normal hospital diet . Six years later the diets were reversed , and the trial was continued another six years . The use of the SCL diet was associated with markedly lowered serum cholesterol values . The incidence of CHD , as measured by the appearance of certain electrocardiographic patterns and by the occurrence of coronary deaths , was in both hospitals during the SCL-diet periods lower than during the normal-diet periods . The differences , however , failed to reach statistical significance . An examination of a number of potential confounding variables indicated that the changes in them were small and failed to account for the reduction in the incidence of CHD . Although the results of this trial do not permit firm conclusions , they support the idea that also among female population s the SCL diet exerts a preventive effect on CHD A controlled intervention trial , with the purpose of testing the hypothesis that the incidence of coronary heart disease ( CHD ) could be decreased by the use of serum-cholesterol-lowering ( SCL ) diet , was carried out in 2 mental hospitals near Helsinki in 1959 - -71 . The subjects were hospitalized middle-aged men . One of the hospitals received the SCL diet , i.e. a diet low in saturated fats and cholesterol and relatively high in polyunsaturated fats , while the other served as the control with a normal hospital diet . Six years later the diets were reversed , and the trial was continued another 6 years . The use of the SCL diet was associated with markedly lowered serum-cholesterol values . The incidence of CHD , as measured by the appearance of certain electrocardiographic patterns and by the occurrence of coronary deaths , was in both hospitals during the SCL-diet periods about half that during the normal-diet periods . An examination of a number of potential confounding variables indicated that the changes in them were small and failed to account for the considerable reduction in the incidence of CHD . It is concluded that the use of the serum-cholesterol-lowering diet exerted a substantial preventive effect on CHD A r and omised controlled trial with a factorial design was done to examine the effects of dietary intervention in the secondary prevention of myocardial infa rct ion ( MI ) . 2033 men who had recovered from MI were allocated to receive or not to receive advice on each of three dietary factors : a reduction in fat intake and an increase in the ratio of polyunsaturated to saturated fat , an increase in fatty fish intake , and an increase in cereal fibre intake . The advice on fat was not associated with any difference in mortality , perhaps because it produced only a small reduction ( 3 - 4 % ) in serum cholesterol . The subjects advised to eat fatty fish had a 29 % reduction in 2 year all-cause mortality compared with those not so advised . This effect , which was significant , was not altered by adjusting for ten potential confounding factors . Subjects given fibre advice had a slightly higher mortality than other subjects ( not significant ) . The 2 year incidence of reinfa rct ion plus death from ischaemic heart disease was not significantly affected by any of the dietary regimens . A modest intake of fatty fish ( two or three portions per week ) may reduce mortality in men who have recovered from MI
Output:
| Mean serum cholesterol levels decreased in all intervention groups and all but one control group .
The reductions in mean serum cholesterol levels were significantly greater in the intervention groups ; this did not result in significant differences in CHD or all-cause mortality .
CONCLUSIONS The current available evidence found no significant difference in all-cause mortality or CHD mortality , result ing from the dietary fat interventions .
RCT evidence currently available does not support the current dietary fat guidelines . |
MS210674 | ***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 SenseWear ™ Armb and ( SWA ) ( BodyMedia , Inc. Pittsburgh , PA ) is a physical activity and lifestyle monitor that objective ly and accurately measures free-living energy balance and sleep and includes software for self-monitoring of daily energy expenditure and energy intake . The real-time feedback of the SWA can improve individual self-monitoring and , therefore , enhance weight loss outcomes . Methods We recruited 197 sedentary overweight or obese adults ( age , 46.8 ± 10.8 y ; body mass index ( BMI ) , 33.3 ± 5.2 kg/m2 ; 81 % women , 32 % African-American ) from the greater Columbia , South Carolina area . Participants were r and omized into 1 of 4 groups , a self-directed weight loss program via an evidence -based weight loss manual ( St and ard Care , n = 50 ) , a group-based behavioral weight loss program ( GWL , n = 49 ) , the armb and alone ( SWA-alone , n = 49 ) , or the GWL plus the armb and ( GWL+SWA , n = 49 ) , during the 9-month intervention . The primary outcome was change in body weight and waist circumference . A mixed-model repeated- measures analysis compared change in the intervention groups to the st and ard care group on weight and waist circumference status after adjusting for age , sex , race , education , energy expenditure , and recruitment wave . Results Body weight was available for 62 % of participants at 9 months ( 52 % st and ard care , 70 % intervention ) . There was significant weight loss in all 3 intervention groups ( GWL , 1.86 kg , P = 0.05 ; SWA-alone , 3.55 kg , P = 0.0002 ; GWL+SWA , 6.59 kg , P < 0.0001 ) but not in the St and ard Care group ( 0.89 kg , P = 0.39 ) at month 9 . Only the GWL+SWA group achieved significant weight loss at month 9 compared to the St and ard Care group ( P = 0.04 ) . Significant waist circumference reductions were achieved in all 4 groups at month 9 ( St and ard Care , 3.49 cm , P = 0.0004 ; GWL , 2.42 cm , P = 0.008 ; SWA-alone , 3.59 cm , P < 0.0001 ; GWL+SWA , 6.77 cm , P < 0.0001 ) , but no intervention group had significantly reduced waist circumference compared to the St and ard Care group . Conclusions Continuous self-monitoring from wearable technology with real-time feedback may be particularly useful to enhance lifestyle changes that promote weight loss in sedentary overweight or obese adults . This strategy , combined with a group-based behavioral intervention , may yield optimal weight loss . Trial Registration Clinical Trials.gov : Background : Greater than 65 percent of the United States ( US ) population is overweight , with 32 percent obese . It is a problem in both developed and developing nations . While guidelines exist , counseling by physicians about obesity and weight loss is inconsistent , and physician approaches to obesity management have limited success . This study attempted to increase involvement in translating proven research into practice to improve physician awareness and improve outcomes of overweight/obesity . Twenty-one physicians in a suburban , middle class population in the Midwestern United States participated . Methods : Physician obesity awareness , weight , height , BMI , blood pressure , lipids , and glycohemoglobin were measured from 641 patients at baseline and were compared to 631 at 12-month follow-up . All 21 physicians received academic detailing and were presented with their clinical outcomes . Ten physicians received an Enhanced Intervention . They were additionally asked to place a sticker in the chart of their overweight or obese patients . Results : Fifty-three percent of physicians were not comfortable discussing obesity with their patients at baseline , decreasing to 0 % at followup ( p=0.041 ) . Reference to obesity management by Intervention physicians increased from 2.4 % to 9.2 % ( p=0.001 ) while for Enhanced Intervention physicians documentation increased from 3.9 % to 15.6 % ( p=0.002 ) . Those patients in the Enhanced Intervention group lost an average of 6.19 lbs ( 3.3 % ) ( p=0.083 ) during the one year period versus 4.6 lbs ( 2.5 % ) ( p=0.20 ) in the Intervention group . The BMI dropped 1.2 in the Intervention group and 0.72 in the Enhanced Intervention group . The data from both groups was pooled at both baseline and follow-up . The average weight of patients decreased from 185.7 lbs to 180.3 lbs ( excluding outliers weighing > 311 lbs ) . This 5.4 pound loss was significant ( p=0.027 ) . The BMI decreased from 30.1 to 29.1 ( p=0.095 ) . Cardiovascular co-morbidities improved . Conclusion : Obesity and overweight have a very high prevalence in a primary care community based setting s. Clinicians are not comfortable diagnosing and managing obese and overweight patients . A combination of academic detailing and presentation of outcomes to physicians will improve their awareness and result in improved clinical outcomes including weight loss BACKGROUND Our objective was to test the effect of physicians providing brief health lifestyle counseling to patients with type 2 diabetes mellitus during usual care visits . METHODS We conducted a r and omized controlled trial of a 12-month intervention at 2 large community health centers , enrolling 310 patients with a body mass index ( calculated as weight in kilograms divided by height in meters squared ) of 25 or greater . In the intervention group , self-management goals for nutrition and physical activity were set using a tailored computer program . Goals were then review ed at each clinic visit by physicians . The control group received only printed health education material s. The main outcome measures included change in physical activity and body weight . RESULTS In the intervention group , recommended levels of physical activity increased from 26 % at baseline to 53 % at 12 months ( P < .001 ) compared with controls ( 30 % to 37 % ; P= .27 ) , and 32 % of patients in the intervention group lost 6 or more pounds at 12 months compared with 18.9 % of controls ( odds ratio , 2.2 ; P= .006 ) . CONCLUSION A brief intervention to increase the dialogue between patients and health care providers about behavioral goals can lead to increased physical activity and weight loss IMPORTANCE Few weight loss treatments produce clinical ly meaningful weight loss outcomes among black women , particularly in the primary care setting . New weight management strategies are necessary for this population . Weight gain prevention might be an effective treatment option , with particular benefits for overweight and class 1 obese black women . OBJECTIVE To compare changes in weight and cardiometabolic risk during a 12-month period among black women r and omized to a primary care-based behavioral weight gain prevention intervention , relative to usual care . DESIGN , SETTING , AND PARTICIPANTS Two-arm r and omized clinical trial ( the Shape Program ) . We recruited patients from a 6-site community health center system . We r and omized 194 overweight and class 1 obese ( body mass index [ calculated as weight in kilograms divided by height in meters squared ] , 25 - 34.9 ) premenopausal black women aged 25 to 44 years . Enrollment began on December 7 , 2009 ; 12- and 18-month assessment s were completed in February and October 2 , 2012 . INTERVENTIONS The medium-intensity intervention included tailored behavior change goals , weekly self-monitoring via interactive voice response , monthly counseling calls , tailored skills training material s , and a gym membership . MAIN OUTCOMES AND MEASURES Twelve-month change in weight and body mass index and maintenance of change at 18 months . RESULTS Participants had a mean age of 35.4 years , a mean weight of 81.1 kg , and a mean body mass index of 30.2 at baseline . Most were socioeconomically disadvantaged ( 79.7 % with educational level less than a college degree ; 74.3 % reporting annual income < $ 30,000 ) . The 12-month weight change was larger among intervention participants ( mean [ SD ] , -1.0 [ 0.5 ] kg ) , relative to usual care ( 0.5 [ 0.5 ] kg ; mean difference , -1.4 kg [ 95 % CI , -2.8 to -0.1 kg ] ; P = .04 ) . At month 12 , 62 % of intervention participants were at or below their baseline weights compared with 45 % of usual-care participants ( P = .03 ) . By 18 months , intervention participants maintained significantly larger changes in weight ( mean difference , -1.7 kg ; 95 % CI , -3.3 to -0.2 kg ) . CONCLUSIONS AND RELEVANCE A medium-intensity primary care-based behavioral intervention demonstrated efficacy for weight gain prevention among socioeconomically disadvantaged black women . A " maintain , do n't gain " approach might be a useful alternative treatment for reducing obesity-associated disease risk among some premenopausal black women . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00938535 Summary Background The increasing prevalence of overweight and obesity needs effective approaches for weight loss in primary care and community setting s. We compared weight loss with st and ard treatment in primary care with that achieved after referral by the primary care team to a commercial provider in the community . Methods In this parallel group , non-blinded , r and omised controlled trial , 772 overweight and obese adults were recruited by primary care practice s in Australia , Germany , and the UK . Participants were r and omly assigned with a computer-generated simple r and omisation sequence to receive either 12 months of st and ard care as defined by national treatment guidelines , or 12 months of free membership to a commercial programme ( Weight Watchers ) , and followed up for 12 months . The primary outcome was weight change over 12 months . Analysis was by intention to treat ( last observation carried forward [ LOCF ] and baseline observation carried forward [ BOCF ] ) and in the population who completed the 12-month assessment . This trial is registered , number IS RCT N85485463 . Findings 377 participants were assigned to the commercial programme , of whom 230 ( 61 % ) completed the 12-month assessment ; and 395 were assigned to st and ard care , of whom 214 ( 54 % ) completed the 12-month assessment . In all analyses , participants in the commercial programme group lost twice as much weight as did those in the st and ard care group . Mean weight change at 12 months was −5·06 kg ( SE 0·31 ) for those in the commercial programme versus −2·25 kg ( 0·21 ) for those receiving st and ard care ( adjusted difference −2·77 kg , 95 % CI −3·50 to −2·03 ) with LOCF ; −4·06 kg ( 0·31 ) versus −1·77 kg ( 0·19 ; adjusted difference −2·29 kg , −2·99 to −1·58 ) with BOCF ; and −6·65 kg ( 0·43 ) versus −3·26 kg ( 0·33 ; adjusted difference −3·16 kg , −4·23 to −2·11 ) for those who completed the 12-month assessment . Participants reported no adverse events related to trial participation . Interpretation Referral by a primary health-care professional to a commercial weight loss programme that provides regular weighing , advice about diet and physical activity , motivation , and group support can offer a clinical ly useful early intervention for weight management in overweight and obese people that can be delivered at large scale . Funding Weight Watchers International , through a grant to the UK Medical Research Council Background Obesity and hypertension and their associated health complications disproportionately affect communities of color and people of lower socioeconomic status . Recruitment and retention of these population s in research trials , and retention in weight loss trials has been an ongoing challenge . Methods Be Fit , Be Well was a pragmatic r and omized weight loss and hypertension management trial of patients attending one of three community health centers in Boston , Massachusetts . Participants were asked to complete follow-up assessment s every 6-months for two years . We describe challenges encountered and strategies implemented to recruit and retain trial participants over the 24-month intervention . We also identify baseline participant characteristics associated with retention status . Retention strategies included financial incentives , contact between assessment visits , building relationships with health center primary care providers ( PCPs ) and staff , and putting participant convenience first . Results Active refusal rates were low with 130 of 2,631 patients refusing participation ( 4.9 % ) . Of 474 eligible persons completing telephone screening , 365 ( 77.0 % ) completed their baseline visit and were r and omized into the study . The study population was predominantly non-Hispanic Black ( 71.2 % ) , female ( 68.5 % ) and reported annual household income of less than $ 35,000 ( 70.1 % ) . Recruitment strategies included use of passive approval of potential participants by PCPs , use of part-time staff , and outsourcing calls to a call center . A total of 314 ( 86.0 % )
Output:
| Overall , the evidence suggests that obesity treatment delivered in primary care has limited effectiveness . |
MS210675 | ***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 : The objective is to report the feasibility and technique of treating popliteal artery aneurysms ( PAA ) with a stent made of nitinol rings externally supported by thin polyester ( Anaconda limbs ) . Background : PAA are the most common peripheral aneurysms . The main limitations of stents used in these setting s are : short lengths , longitudinal and horizontal compliance mismatch ; graft failure from angulation and movement at the joint level ; and dislodgment . Methods : This is a prospect i ve multicenter cohort study of consecutive symptomatic and asymptomatic PAA treated in tertiary vascular centers . Outcomes included patency of the stent and postoperative time‐to‐independent‐ambulation and to‐climb‐a‐flight‐of‐stairs . Results : Fourteen PAA were treated in 12 men , age 72 ± 3 years . The median ASA classification was 2.5 . The length of artery covered was 147 ± 41 mm . The PAA diameter was 31 ± 5 mm , 6 were symptomatic . One stent was used in 6 aneurysms , two in 7 , and three in 1 . The average stent diameter was 10 ± 1 mm . The length of the proximal neck was 24 ± 6 mm with a diameter of 9.8 ± 1.9 , and length of the distal neck 23 ± 3 mm with a diameter of 8.7 ± 1.2 mm . In 6 aneurysms , the stent crossed the knee joint . There was no mortality , and one stent occluded ( primary patency 93 % at 6 ± 3 months ) . The median hospital stay was 1.7 days , time to independent ambulation was 3 hr and the time to climbing a flight of stairs was 1 day . Conclusions : The use of Anaconda limbs for endovascular repair of PAA is feasible and safe . © 2008 Wiley‐Liss , AIM The aim of this prospect i ve comparative study was to compare the results of 8-years experience of endovascular treatment ( ET ) of popliteal aneurysms ( PAs ) using the Hemobahn/Viabahn endograft with those achieved with open repair ( OR ) . Endpoints were primary and secondary patency rate . METHODS The study was a prospect i ve r and omized clinical trial from January 1999 to December 2003 and a prospect i ve comparative study from January 2004 to December 2006 . Patients with an asymptomatic aneurismal lesion in the popliteal artery 2 cm at angio-computed tomography were included in the study . Indication for ET was PA ( proximal and distal neck length > 1 cm ) ; contraindications were : 1 ) age < 50 years ; 2 ) poor distal run-off ; 3 ) contraindication to antiplatelet , anticoagulant or thrombolytic therapy . RESULTS Between January 1999 and December 2006 , of a total of 42 patients with 48 PA , 27 were treated with OR ( group A ) and 21 with ET ( group B ) . The primary patency rate was 100 % in group A and 80.9 % in group B at 12 months and 71.4 % and 88.1 % , respectively , at 72 months ; the secondary patency rate at 72 months was 88.15 % and 85.9 % in groups A and B , respectively . No statistical differences were observed at the log-rank test . During the entire study period , 3 ( 14.3 % ) patients in group B required conversion to open surgery because of endograft occlusion . CONCLUSION Within the power limitations of this study , ET for asymptomatic PA in patients with suitable anatomy can be considered safe , with long-term results comparable with those of OR OBJECTIVE The purpose of this study was to compare outcomes after endovascular repair ( ER ) and contemporary open repair ( OR ) of popliteal artery aneurysms ( PAAs ) . METHODS Clinical data of PAA patients treated between 2005 and 2012 were review ed . Primary end points were major adverse events ( MAEs ) including mortality , major amputation , patency , complications , and re interventions . RESULTS A total of 149 PAAs were treated in 120 patients ( mean age , 74 ± 10 years ) . ER was performed in 42 limbs of 35 men ( mean age , 81 ± 6.5 years ) , in 32 electively and in 10 emergently . Technical success was 98 % . The 30-day MAEs were more frequent after emergent repair ( 50 % vs 9 % ; odds ratio [ OR ] , 9.67 ; 95 % confidence interval [ CI ] , 1.74 - 54 ; P = .01 ) ; mortality and amputation rate was 0 % after elective repair , 20 % after emergent repair . Mean follow-up was 2.6 years ( 1 month-6.5 years ) ; 3-year freedom from MAEs was lower after emergent repair than after elective repair ( 40 % vs 66 % ; hazard ratio [ HR ] , 3.13 ; 95 % CI , 1.10 - 8.85 ; P = .03 ) . OR was performed in 107 limbs of 91 patients ( 90 men ; mean age , 71 ± 9.6 years ) , in 93 electively and in 14 emergently . The 30-day MAEs were more frequent after emergent repair ( 43 % vs 5 % ; OR , 13 ; 95 % CI , 3.29 - 53 ; P < .001 ) ; mortality was 1 % after elective repair , 0 % after emergent cases . Amputation rate was 0 % for both elective and emergent repairs . Mean follow-up was 3.8 years ( 1 month-8.4 years ) ; 3-year freedom from MAEs was lower after emergent repair ( 50 % vs 80 % ; HR , 3.78 ; 95 % CI , 1.55 - 9.20 ; P = .003 ) . The 30-day MAE rates were equivalent between ER and OR independent of urgency of repair ( elective : OR , 1.82 ; 95 % CI , 0.41 - 8.09 ; P = .43 ; emergent : OR , 1.33 ; 95 % CI , 0.26 - 6.81 ; P = .73 ) . In elective interventions , ER had a trend to decreased freedom from MAEs ( 66 % vs 80 % at 3 years ; HR , 1.93 ; 95 % CI , 0.92 - 4.07 ; P = .08 ) ; freedom from reintervention was lower after ER ( 72 % vs 88 % ; HR , 2.41 ; 95 % CI , 1.02 - 5.70 ; P = .046 ) . In emergent interventions , 1-year freedom from MAEs was similar ( 40 % vs 50 % ; HR , 1.36 ; 95 % CI , 0.49 - 3.74 ; P = .55 ) . Emergent ER and poor runoff predicted MAEs . CONCLUSIONS Our study failed to prove the superiority of ER over OR . If anatomy is suitable , ER of PAA in the elderly and high-risk patients is justified . For emergent PAA repairs , MAEs are frequent after both ER and OR ; ER has not changed the severe prognosis of acute limb ischemia from PAA . A multicenter r and omized controlled trial of PAA patients with acute presentation is warranted BACKGROUND Aim of this study was to retrospectively compare perioperative ( < 30 days ) and 2-year results of open and endovascular management of popliteal artery aneurysms ( PAAs ) in a single-center experience . METHODS From January 2005 to December 2010 , 64 PAAs in 59 consecutive patients were operated on at our institution ; in 43 cases , open repair was performed ( group 1 ) , whereas the remaining 21 cases had an endovascular procedure ( group 2 ) . Data from all the interventions were prospect ively collected in a dedicated data base , which included main preoperative , intraoperative , and postoperative parameters . Early results in terms of mortality , graft thrombosis , and amputation rates were analyzed and compared by χ(2 ) text or Fisher exact text . The surveillance program consisted of clinical and ultrasonographic examinations at 1 , 6 , and 12 months and yearly thereafter . Follow-up results ( survival , primary and secondary patency , limb salvage ) were analyzed by Kaplan-Meier curves , and differences in the two groups were assessed by log-rank test . RESULTS There were no differences between the two groups in terms of sex , age , risk factors for atherosclerosis , and comorbidities ; PAAs were symptomatic in 48 % of cases in group 1 and in 29 % in group 2 ( P = 0.1 ) . Fifteen patients with mild-to-moderate acute ischemia due to PAA thrombosis underwent preoperative intra-arterial thrombolysis , 13 in group 1 and 2 in group 2 . In open surgery group , nine cases were treated with aneurysmectomy and prosthetic graft interposition , and in seven cases , the aneurysm was opened and a prosthetic graft was placed inside the aneurysm . In 27 cases , ligation of the aneurysm with bypass grafting ( 21 prosthetic grafts and 6 autologous veins ) was carried out . In group 2 , 20 patients had endoprosthesis placement , whereas in the remaining patient , a multilayer nitinol stent was used . There was one perioperative death in a patient of group 2 who underwent concomitant endovascular aneurysm repair and PAA endografting . Cumulative 30-day death and amputation rate was 4.5 % in group 1 and 4.7 % in group 2 ( P = 0.9 ) . Follow-up was available in 61 interventions ( 96 % ) with a mean follow-up period of 22.5 months ( range : 1 - 60 ) . Estimated primary patency rates at 24 months were 78.1 % in group 1 and 59.4 % in group 2 ( P = 0.1 ) . Freedom from reintervention rates at 24 months were 79 % in group 1 and 61.5 % in group 2 ( P = 0.2 ) ; estimated 24-month secondary patency rates were 81.6 % in group 1 and 78.4 % in group 2 ( P = 0.9 ) , and freedom from amputation rates were 92.7 % and 95 % , respectively ( P = 0.7 ) . CONCLUSIONS Endovascular treatment of PAAs provided , in our initial experience , satisfactory perioperative and 1-year results , not significantly different from those obtained with prosthetic open repair in patients with similar clinical and anatomical status . There is , however , a trend toward poorer primary patency rates among patients endovascularly treated , who also seem to require more frequently a reintervention BACKGROUND We describe the organization of a prospect i ve , r and omized , multicenter trial comparing the effectiveness of open popliteal artery aneurysm repair ( OPAR ) and endovascular popliteal artery aneurysm repair ( EPAR ) of asymptomatic popliteal artery aneurysms ( PAAs ) as an example for how to use the Vascular Quality Initiative ( VQI ) framework . Given that many centers participate in the VQI , this model can be used to perform multicenters ' prospect i ve trials on very modest budget . METHODS VQI prospect ively collects data on many vascular procedures . These data include many important perioperative , intraoperative , and postoperative details regarding both patients and their procedures . We describe a study where minimal changes to the collected data by participating centers can provide level-1 evidence regarding a significant clinical question . Data will be collected using modified VQI forms within the existing VQI data reporting structure . We plan to enroll 148 patients with asymptomatic PAAs into the open and endovascular surgery cohorts . Patients from participating VQI centers will be r and omized 1:1 to either OPAR or EPAR and will be followed for an average of 2.5 years . Our primary hypothesis is that major adverse limb event-free survival is lower in the EPAR cohort and that EPAR is associated with more secondary interventions , improved quality of life , and decreased length of stay . The budget for this trial is fixed at $ 10,000/year for the course of the study , and the trial is judged to be feasible because of the functionality of the VQI platform . CONCLUSIONS Using the existing VQI infrastructure , Open versus Endovascular Repair of Popliteal Artery Aneurysm will provide level 1 data for PAA treatment on a modest budget . The proposed trial has an adequately powered comparative design that will use objective performance goals to describe limb-related morbidity and procedural reintervention rates
Output:
| Endovascular repair is associated with inferior perioperative and postoperative outcomes compared with open repair |
MS210676 | ***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 For several years Transcutaneous Electrical Nerve Stimulation ( TENS ) has been used in the management of chronic and acute pain . The aim of this trial was to determine its effectiveness in providing pain relief during labour as well as its influence on the incidence of requests for epidural analgesia . The experimental group ( receiving TENS by a burst – conventional obstetric TENS-apparatus ) and the control population ( not receiving TENS ) consisted of 24 and 35 women respectively . In the experimental group the TENS application was switched off for a period of 15 min . The 24 women were asked to point out the intensity of their pain on a visual analogue scale before , during and after this temporary interruption . Two days postpartum the parturient ’s satisfaction was evaluated by two questions , a procedure which revealed that 96 % degree of satisfaction . The incidence of epidural analgesia in the experimental group was compared to the control-group . During TENS application the pain scores were significantly lower ( p<0.0001 ) , but no statistically significant difference in incidence of epidural analgesia was found between the experimental group and the control group Abstract Transcutaneous electrical nerve stimulation ( TENS ) is one of the non‐pharmacological means of pain relief for labor and delivery . We aim ed to investigate the efficacy and safety of TENS on specific acupuncture points for reducing pain in the first stage of labor . In this double‐blind , placebo‐controlled trial , we r and omly assigned healthy full‐term parturients in active phase of first‐stage labor to either TENS on four acupuncture points ( Hegu [ Li 4 ] and Sanyinjiao [ Sp 6 ] ) ( n = 52 ) or the TENS placebo ( n = 53 ) . Visual analogue scale ( VAS ) was used to assess pain before and 30 and 60 min after treatment . The primary outcome was the rate of VAS score decrease ⩾3 in each group . A question naire was given at 24 h post‐partum to evaluate the satisfaction of pain relieving method and the willingness to have the same treatment again . Mode of delivery and neonatal effect were measured as secondary outcome . One hundred women were eligible for analysis . TENS group experienced VAS score reduction ⩾3 significantly more common than the TENS placebo group ( 31/50 [ 62 % ] vs 7/50 [ 14 % ] , P < 0.001 ) . Willingness of using the same analgesic method for a future childbirth was also significantly different ( TENS : 48/50 [ 96 % ] vs TENS placebo : 33/50 [ 66 % ] , P < 0.001 ) . Operative delivery was increased in the TENS group ( 12/50 [ 24 % ] vs 4/50 [ 8 % ] , P = 0.05 ) , but the neonatal outcomes were not different . The application of TENS on specific acupuncture points could be a non‐invasive adjunct for pain relief in the first stage of labor The analgesic effects of transcutaneous electrical nerve stimulation ( TENS ) in labour and effects on outcome were investigated in a double-blind TENS/TENS placebo controlled trial in 100 primigravidae and 50 women in their third labour . There were no differences between the TENS and the TENS placebo users in terms of pain concept or relief , and only 12 and 13 % of primigravidae and 48 and 39 % of the para 2 women completed labour without requiring other analgesia in their respective groups . The primigravidae who used either TENS or TENS placebo alone had shorter labours than those who required further analgesia . Although the outcome of labour for mother and infant were similar in the two groups , there was a higher operative delivery rate in women who also had epidural analgesia . There were highly significant differences between the TENS and the TENS placebo users in terms of favourable and unfavourable comments by the mothers and the midwives at 1 and 24 h after delivery . The evident consumer satisfaction for TENS suggests TENS has a part to play in analgesia in labour but the equivocal findings in terms of factors associated with pain relief points to the need for apparatus more specifically design ed to cope with the special characteristics of the pain of labour Transcutaneous nerve stimulation ( TNS ) was applied to 100 parturients with a view of decreasing pain during labour . A control group of 100 parturients was r and omly selected . Two hours after delivery the mothers and their midwives independently completed question naires regarding the pain which was subjectively quantified , during the different stages of labour . The distribution of age and parity of the mothers , the duration of labour , and Apgar score of the neonates at one minute were comparable in the two groups . The desire for and administration of analgesic agents was equal in each group . Significantly more mothers in the TNS group reported that labour had been moderately or intensively painful compared to the control group during cervical dilatation from 1 - -7 cm . After this degree of dilation the subjective judgement regarding pain were the same in both groups . The expectation of pain during labour , as well as the experience of pain compared to expectation , was similar in both groups . Thirty-one of the mothers in the TNS group considered the pain relieving affect of the TNS good and 55 considered it moderate . Thirty-two of the mothers in the TNS group wanted a more efficient analgesic method for the next labour The effectiveness of transcutaneous nerve stimulation ( TENS ) for pain relief in labour was evaluated by r and omizing 280 patients in early labour into 2 groups . Inoperative sham machines were applied to patients in the control group and active units to those in the test group . Neither patients nor attending labour ward staff were aware of which group the patient was in . The intensity of low back pain and abdominal pain was assessed by the patient each hour on a visual analogue pain scale . Each patient served as her own control by switching off the machine for 2 contractions every hour and then recording the intensity of pain . The amount of conventional analgesia each patient received was recorded by labour ward staff . There was no difference in the intensity of pain recorded by each group . Nor was there any difference between the 2 groups in the change of pain experienced when the machine was switched off . Moreover there was no difference in the amount of other analgesia required . Some differences were found when those with little low back pain were excluded from the study . We conclude that TENS is ineffective as a routine method of pain relief in labour . It is likely to benefit only those with severe back pain and then only to a modest degree Seventy parturient women were r and omized into two groups , one receiving transcutaneous nerve stimulation , the other mock stimulation with an identical looking apparatus . The patients ' assessment of pain relief and the use of analgesics during labor were recorded . There was no difference between the two groups in the degree of pain relief . There was no reduction in the need for analgesics which could be ascribed to the use of nerve stimulation . The use of analgesics in each patient was correlated to the duration of labor The effectiveness of transcutaneous electric nerve stimulation ( TENS ) for pain relief in labour was compared to inhalation analgesia consisting of 50 % nitrous oxide and 50 % oxygen ( ENTONOX ) . In the first part of the study 101 patients in early labour were allocated to using TENS ( Group A ) or ENTONOX ( Group B ) for pain relief . Our results did not show any beneficial effect on pain relief in labour with the use of TENS over ENTONOX ; 18.8 % of patients in Group A went through labour without any further form of analgesia as opposed to 17.0 % in Group B. In the second part of the study 20 nulliparous patients having induced labour were r and omly allocated to use TENS ( Group C ) or ENTONOX ( Group D ) as the first modality of pain relief . A switchover was made when labour pains were no longer tolerable . The results showed that both TENS and ENTONOX could be used in early labour up to 5 - 6 cm cervical dilatation till the frequency of contractions was nearly 5 in 10 min or the first 3 - 4 hr from the time patients first requested pain relief in labour when frequency of contractions was nearly 4 in 10 min . TENS could be used in early labour for patients who wish to be ambulant and is as effective as ENTONOX . Either modality of pain relief was not adequate for pain relief throughout labour OBJECTIVE We examined the efficacy of transcutaneous electrical nerve stimulation ( TENS ) in general and the new Freemom TENS device ( LifeCare , Israel ) in particular , for pain relief during labor and delivery . METHODS The study group consisted of 104 women . Forty-six nulliparas ( 44.2 % ) and 58 multiparas ( 55.8 % ) , all of whom used the TENS device for pain relief during labor . All participants completed a question naire on the degree of pain relief afforded them by TENS during the delivery and related questions . The objective evaluation was based on the documented labor and delivery parameters including medical interventions during delivery . RESULTS The majority of subjects ( 72 % of the nulliparas and 69 % of the multiparas ) considered TENS effective for the relief of pain during labor . Most of them ( 67 % of the nulliparas and 60 % of the multiparas ) responded positively to the use of TENS in future deliveries . Sixty-five percent of the multiparas considered TENS at least as effective as the other pain relief methods they had used before . TENS significantly reduced the duration of the first stage of labor P < 0.001 for nulliparas , P < 0.005 for multiparas and it significantly decreased the amount of analgesics administered to individual patients . No significant difference was found in fetal heart rate tracings , Apgar scores and cord blood pH between the study group and an equal number of matched controls who used other forms of pain management . CONCLUSIONS TENS is an effective non-pharmacological , non-invasive adjuvant pain relief modality for use in labor and delivery . TENS application reduced the duration of the first stage of labor and the amount of analgesic drug administered . There were no adverse effects on mothers or newborns
Output:
| There was no evidence that TENS interfered in any of the outcomes except the mothers ' desire to use TENS in future deliveries .
The use of TENS had no impact on mother or child and no influence on labor .
According to the results of this review , there is no evidence that TENS reduces the use of additional analgesia |
MS210677 | ***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 this phase 2 , multicenter study was to determine the activity and safety of nonpegylated liposomal doxorubicin as part of " R-COMP " combination in patients with diffuse large B-cell lymphoma and coexisting cardiac disorders . The study was conducted using a Bayesian continuing assessment method using complete remission rate and rate of cardiac events as study endpoints . Between November 2009 and October 2011 , 50 evaluable patients were enrolled ( median age , 76 years ) . Median baseline left ventricular ejection fraction ( LVEF ) was 60 % . Ischemic cardiopathy was the most frequent preexisting cardiac disorder ( 35 % ) , followed by atrial fibrillation ( 15 % ) , left ventricular hypertrophy ( 13 % ) , and baseline LVEF < 50 % ( 12 % ) . Based on the intent to treat analysis , overall response rate was 72 % , including 28 patients in complete remission ( complete remission rate , 56 % ) , and 8 in partial remission ( 16 % ) . At the end of treatment , grade s 3 to 4 cardiac events were observed in 6 patients . No significant modifications from baseline values of LVEF were observed during treatment and follow-up . Nonpegylated liposomal doxorubicin instead of doxorubicin in the R-CHOP ( rituximab , cyclophosphamide , doxorubicin , vincristine , and prednisone ) regimen is a feasible option for patients with diffuse large B-cell lymphoma presenting with concomitant cardiac disorders Chemotherapy is associated with toxicity in elderly patients with potentially curable malignancies , posing the dilemma of whether to intensify therapy , thereby improving the cure rate , or de-escalate therapy , thereby reducing toxicity , with consequent risks for under- or overtreatment . Adequate tools to define doses and combinations have not been identified for lymphoma patients . We conducted a prospect i ve trial aim ed to evaluate the feasibility and efficacy of chemotherapy modulated according to a modified comprehensive geriatric assessment ( CGA ) in elderly ( aged ≥70 years ) patients with diffuse large B-cell lymphoma ( DLBCL ) . In June 2000 to March 2006 , 100 patients were stratified using a CGA into three groups ( fit , unfit , and frail ) , and they received a rituximab plus cyclophosphamide , doxorubicin , vincristine , and prednisone modulated in dose and drugs according to comorbidities and activities of daily living ( ADL ) and instrumental ADL scores . Treatment was associated with a complete response rate of 81 % and mild toxicity : grade 4 neutropenia in 14 % , anemia in 1 % , and neurological and cardiac toxicity in 2 % of patients . At a median follow-up of 64 months , 51 patients were alive , with 5-year disease-free , overall , and cause-specific survival rates of 80 % , 60 % , and 74 % , respectively . Chemoimmunotherapy adjustments based on a CGA are associated with manageable toxicity and excellent outcomes in elderly patients with DLBCL . Wide use of this CGA-driven treatment may result in better cure rates , especially in fit and unfit patients BACKGROUND The combination of rituximab , gemcitabine , and oxaliplatin ( R-GemOx ) has shown high efficacy with a low toxicity profile in elderly patients with relapsed and refractory diffuse large B-cell lymphoma . We aim ed to evaluate the efficacy , safety , and feasibility of the R-GemOx regimen as a first-line treatment in elderly patients with diffuse large B-cell lymphoma . METHODS In this single-arm , open-label , phase 2 clinical trial , we enrolled patients with previously untreated , histologically confirmed , CD20-positive diffuse large B-cell lymphoma , aged 70 years or older , or aged 60 - 69 years with an Eastern Cooperative Oncology Group ( ECOG ) performance status score of 2 or greater . Patients were recruited from Jiangsu Province Hospital ( Jiangsu Sheng , China ) . The R-GemOx regimen was administered intravenously : rituximab 375 mg/m2 on day 0 ; gemcitabine 1 g/m2 on day 1 ; and oxaliplatin 100 mg/m2 on day 1 . The cycle was repeated every 14 days . Six cycles were planned if the patient achieved at least partial remission after the interim assessment . The primary endpoint was the proportion of patients who achieved an overall response at the end of treatment ( defined as complete response plus partial response ) . Analyses were done by intention to treat . The trial is ongoing but no longer recruiting patients . This study is registered with Clinical Trials.gov , number NCT01670370 . FINDINGS Between Aug 22 , 2012 , and Dec 31 , 2015 , 60 patients were enrolled and included in the study . The median age of the patients was 75 years ( IQR 70 - 80 ) and 27 ( 45 % ) patients had a poor performance status with an ECOG score of 2 or greater . 45 ( 75 % ) patients achieved an overall response at the end of the treatment , with 28 ( 47 % ) achieving a complete response . Common grade 3 - 4 adverse events were haematological toxicities ( thrombocytopenia in five [ 8 % ] patients , anaemia in four [ 7 % ] , and neutropenia in nine [ 15 % ] ) and gastrointestinal complications ( nausea in five [ 8 % ] patients , vomiting in three [ 5 % ] , and diarrhoea in one [ 2 % ] ) . No treatment-related deaths were reported . INTERPRETATIONS The R-GemOx regimen shows high efficacy and safety as a front-line treatment in an elderly patient sub population and might be a therapeutic option for management of diffuse large B-cell lymphoma in elderly patients . FUNDING National Natural Science Foundation of China , Jiangsu Province 's Medical Elite Programme , Project of National Key Clinical Specialty , National Science & Technology Pillar Program , Jiangsu Provincial Special Program of Medical , and National Science and Technology Major Project PURPOSE The treatment of patients with diffuse large B-cell lymphoma ( DLBCL ) with cardiac comorbidity is problematic , because this group may not be able to receive anthracycline-containing chemoimmunotherapy . We design ed a single-arm phase II multicenter trial of rituximab , gemcitabine , cyclophosphamide , vincristine , and prednisolone ( R-GCVP ) in patients considered unfit for anthracycline-containing chemoimmunotherapy because of cardiac comorbidity . PATIENTS AND METHODS Sixty-one of 62 patients received R-GCVP , administered on day 1 with gemcitabine repeated on day 8 of a 21-day cycle . Median age was 76.5 years . All patients had advanced disease ; 27 ( 43.5 % ) had left ventricular ejection fraction of ≤ 50 % , and 35 ( 56.5 % ) had an ejection fraction of > 50 % and comorbid cardiac risk factors such as ischemic heart disease , diabetes mellitus , or hypertension [ Corrected ] . Primary end point was overall response rate at the end of treatment . RESULTS Thirty-eight patients ( 61.3 % ; 95 % CI , 49.2 to 73.4 ) achieved disease response ( complete response [ CR ] , n = 18 ; undocumented/unconfirmed CR , n = 6 ; partial response , n = 14 ) . Two-year progression-free survival for all patients was 49.8 % ( 95 % CI , 37.3 to 62.3 ) , and 2-year overall survival was 55.8 % ( 95 % CI , 43.3 to 68.4 ) . Thirty-four patients experienced grade ≥ 3 hematologic toxicity . There were 15 cardiac events , of which seven were grade 1 to 2 , five were grade 3 to 4 , and three were fatal , reflecting the poor cardiac status of the study population . CONCLUSION Our phase II multicenter trial showed that the R-GCVP regimen is an active , reasonably well-tolerated treatment for patients with DLBCL for whom anthracycline-containing immunochemotherapy was considered unsuitable because of coexisting cardiac disease BACKGROUND Diffuse large B-cell lymphoma is a common cancer in elderly patients . Although treatment has been st and ardised in younger patients , no prospect i ve study has been done in patients over 80 years old . We aim ed to investigate the efficacy and safety of a decreased dose of CHOP ( doxorubicin , cyclophosphamide , vincristine , and prednisone ) chemotherapy with a conventional dose of rituximab in elderly patients with diffuse large B-cell lymphoma . METHODS We did a prospect i ve , multicentre , single-arm , phase 2 study of patients aged over 80 years who had diffuse large B-cell lymphoma . Patients were included from 38 centres in France and Belgium . All patients received six cycles of rituximab combined with low-dose CHOP ( R-miniCHOP ) at 3-week intervals . Patients received 375 mg/m(2 ) rituximab , 400 mg/m(2 ) cyclophosphamide , 25 mg/m(2 ) doxorubicin , and 1 mg vincristine on day 1 of each cycle , and 40 mg/m(2 ) prednisone on days 1 - 5 . The primary endpoint was overall survival , both unadjusted and adjusted for treatment and baseline prognostic factors . Analysis was by intention to treat . This study is registered with Clinical Trials.gov , NCT01087424 . FINDINGS 150 patients were enrolled between Jan 9 , 2006 , and Jan 23 , 2009 and 149 were included in the intention-to-treat analyses . Median age was 83 years ( range 80 - 95 ) . After a median follow-up of 20 months ( range 0 - 45 ) , the median overall survival was 29 months ( 95 % CI 21 to upper limit not reached ) ; 2-year overall survival was 59 % ( 49 - 67 % ) . In multivariate analyses , overall survival was only affected by a serum albumin concentration of 35 g/L or less ( hazard ratio 3·2 , 95 % CI 1·4 - 7·1 ; p=0·0053 ) . Median progression-free survival was 21 months ( 95 % CI 13 to upper limit not reached ) , with a 2-year progression free survival of 47 % ( 38 - 56 ) . 58 deaths were reported , 33 of which were secondary to lymphoma progression . 12 deaths were attributed to toxicity of the treatment . The most frequent side-effect was haematological toxicity ( grade ≥3 neutropenia in 59 patients ; febrile neutropenia in 11 patients ) . INTERPRETATION R-miniCHOP offers a good compromise between efficacy and safety in patients aged over 80 years old . R-miniCHOP should be considered as the new st and ard treatment in this subgroup of patients . FUNDING Groupe d'Etude des Lymphomes de l'Adulte ( GELA ) Abstract We conducted a prospect i ve study to compare epirubicin , cyclophosphamide , vinblastine , prednisone and rituximab ( R-miniCEOP ) with cyclophosphamide , doxorubicin , vincristine , prednisone and rituximab ( R-CHOP ) for the treatment of “ fit ” elderly patients with diffuse large B-cell lymphoma ( DLBCL ) . Patients over the age of 65 with stage II – IV DLBCL were screened with a comprehensive geriatric assessment . Patients were r and omized to receive six courses of R-miniCEOP ( n = 114 ) or R-CHOP ( n = 110 ) . Overall , the rate of complete remission was 70 % ( p = 0.466 ) . After a median follow-up of 42 months , 5-year event-free survival ( EFS ) rates were 46 % and 48 % for R-miniCEOP and R-CHOP , respectively ( p = 0.538 ) . Patients older than 72 years and with low-risk disease had a better outcome when treated with R-miniCEOP ( p = 0.011 ) . Overall R-CHOP and R-miniCEOP are similarly effective for elderly “ fit ” patients with DLBCL . The less intense R-miniCEOP may be an acceptable option for the treatment of relatively older patients with low-risk disease
Output:
| CGA was first used in lymphoma trials almost 20 years ago , and growing evidence supports its use to select and stratify elderly patients with diffuse large B-cell lymphoma for curative treatment , but it is still underused in everyday practice .
A systematic review of 15 published studies , including around 11 000 elderly patients with diffuse large B-cell lymphoma , showed that CGA accurately predicts survival and tolerability , and distinguishes good c and i date s for therapy based on anthracycline and rituximab with curative intent from those patients who should receive palliative treatment .
Treating every elderly patient with an anthracyclinefree combination without pre-treatment selection might result in under-treatment of those patients who would be good c and i date s for anthracycline– rituximab therapy with curative intent .
This point is also suggested by meta-analyses of thous and s of elderly patients with diffuse large B-cell lymphoma showing that R-CHOP , compared with anthracyclinefree regimens , is associated with improved survival , even among patients older than 80 years . |
MS210678 | ***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 Control of serum phosphate remains a difficult clinical issue in most hemodialysis ( HD ) patients . This study examines 2 nonpharmacological approaches to improving phosphate control in HD patients . METHODS First , 9 stable HD patients underwent dialysis in r and om fashion for either 4 hours 3 times weekly or 5 hours 3 times weekly . Adjustments were made to blood flow rates such that Kt/V was the same for all sessions , thus allowing independent assessment of the influence of time . The primary end point was weekly dialysate phosphate removal . In the second study , 12 different patients underwent an exercise program in which they pedaled a bicycle ergometer either immediately before or during dialysis . Again , weekly dialysate phosphate removal was measured . RESULTS In the time study , urea reduction ratio ( 69 % + /- 0.02 % versus 68 % + /- 0.07 , 4 versus 5 hours ) and weekly urea removal were no different between the 2 groups . However , weekly phosphate removal ( 3,007 + /- 641 versus 3,400 + /- 647 mg ; P < 0.02 ) significantly improved with longer dialysis duration . Serum phosphate levels improved , but did not reach statistical significance in this short-term study . In the exercise study , weekly phosphate removal improved with exercise , but did not reach significance ( 2,741 + /- 715 [ no exercise ] versus 2,917 + /- 833 [ exercise predialysis ] versus 2,992 + /- 852 mg [ exercise during dialysis ] ; P = 0.055 ) , although comparing only exercise during dialysis with no exercise reached significance ( P = 0.02 ) . There was no significant difference in serum phosphate levels . CONCLUSION Both increased dialysis time and exercise result in increased dialytic removal of phosphate and could be expected in the long term to improve phosphate control Previous studies have suggested that exercise during hemodialysis ( HD ) could increase the efficacy of solute removal , although this hypothesis has not been conclusively evaluated . The goal of this study was to compare the removal of low‐molecular weight solutes between HD sessions , with and without aerobic exercise . It was a controlled clinical trial , including HD patients in a r and omly cross‐over design , such that each patient received a HD session with exercise ( intervention ) and the next one without exercise ( control ) , three times each . In the exercise sessions , patients pedaled on a cycle ergometer for 60 minutes . The total mass of removed urea , potassium , creatinine , and phosphate were calculated from the solutes concentration in dialysate ( continuous spent sampling of dialysate ) . This was evaluated in a total of 132 HD sessions of patients with a mean age of 54 ± 15 years , 75 % male and HD vintage of 3 ( 2–13 ) years . Phosphate removal in dialysate during intervention sessions was significantly higher ( 5.6 [ 2.5–18.9 ] vs. 5.1 [ 1.5–11.2 ] mg/min ) than during control sessions , P = 0.04 . The median mass of phosphate removed during control HD session was 1226 ( 367.8–2697.2 ) vs. 1348.6 ( 613.0–4536.2 ) mg/session during intervention sessions . The exercise did not modify the removal of urea ( control 122.6 [ 61.3–286.0 ] vs. exercise 112.4 [ 51.1–250.3 ] mg/min , P = 0.44 ) , creatinine ( control 5.6 [ 2.5–13.8 ] vs. exercise 5.6 [ 2.5–12.8 ] mg/min , P = 0.49 ) , or potassium ( control 13.3 [ 11.2–15.8 ] vs. exercise 13.8 [ 6.6–15.8 ] mEq/min , P = 0.49 ) . Aerobic exercise during HD increases the efficacy of phosphate removal , without changing urea , creatinine and potassium removal . The implication s of this finding in mineral and bone disease and cardiovascular disease need to be evaluated on future clinical trials Background Functional limitations , altered cardiac autonomic activity , and psychological distress are known disorders in chronic hemodialysis ( HD ) patients , relating to increased morbidity and mortality . The aim of this study was to examine the influence of an exercise training program on emotional parameters and heart rate variability ( HRV ) indices , as well as to determine whether emotional stress contributes to autonomic dysfunction in these patients . Methods Forty-four HD patients were r and omly assigned into group A ( 24 patients , aged 46.3 ± 11.2 years ) , who participated in a 1-year intradialytic exercise training program and group B ( 20 patients , aged 45.8 ± 10.8 years ) , who were used as controls . At baseline and a year after , measures of HRV were obtained for the estimation of st and ard deviation of RR intervals , the mean square successive differences , percentage of RR intervals differing by more than 50 ms from the preceding RR interval ( pNN50 ) , and low to high frequency components . Emotional parameters ( Beck Depression Inventory – BDI and Hospital Anxiety and Depression Scale – HADS ) were also assessed by vali date d question naires . Moreover , all patients performed a spiroergometric study for the estimation of VO2peak . Results At baseline , all measurements were similar in the two groups and remained almost unchanged after a year in group B. After a year of training , VO2peak increased from 16.79 ± 5.24 to 22.33 ± 4.90 ml/kg per min ( P > 0.001 ) in group A. Trained patients also showed an increase in st and ard deviation of RR intervals by 58.8 % ( P > 0.001 ) , the mean square successive differences by 68.1 % ( P > 0.001 ) , pNN50 by 23.5 % ( P > 0.001 ) , and a low to high frequency ratio by 17.3 % ( P > 0.001 ) . Finally , at the end of the study , group A showed a decrease in BDI score by 34.5 % ( P > 0.001 ) and HADS by 23.9 % ( P > 0.001 ) . Canonical correlation revealed significant inverse correlation among depression ( in BDI and HADS ) and HRV indices before and after exercise training . Conclusion Cardiac autonomic modulation seemed to be sensitive to the experience of persistent depression in HD patients . Significantly , exercise training reduced emotional distress and concomitantly improved HRV Summary Background The associations of blood pressure with the different manifestations of incident cardiovascular disease in a contemporary population have not been compared . In this study , we aim ed to analyse the associations of blood pressure with 12 different presentations of cardiovascular disease . Methods We used linked electronic health records from 1997 to 2010 in the CALIBER ( CArdiovascular research using LInked Bespoke studies and Electronic health Records ) programme to assemble a cohort of 1·25 million patients , 30 years of age or older and initially free from cardiovascular disease , a fifth of whom received blood pressure-lowering treatments . We studied the heterogeneity in the age-specific associations of clinical ly measured blood pressure with 12 acute and chronic cardiovascular diseases , and estimated the lifetime risks ( up to 95 years of age ) and cardiovascular disease-free life-years lost adjusted for other risk factors at index ages 30 , 60 , and 80 years . This study is registered at Clinical Trials.gov , number NCT01164371 . Findings During 5·2 years median follow-up , we recorded 83 098 initial cardiovascular disease presentations . In each age group , the lowest risk for cardiovascular disease was in people with systolic blood pressure of 90–114 mm Hg and diastolic blood pressure of 60–74 mm Hg , with no evidence of a J-shaped increased risk at lower blood pressures . The effect of high blood pressure varied by cardiovascular disease endpoint , from strongly positive to no effect . Associations with high systolic blood pressure were strongest for intracerebral haemorrhage ( hazard ratio 1·44 [ 95 % CI 1·32–1·58 ] ) , subarachnoid haemorrhage ( 1·43 [ 1·25–1·63 ] ) , and stable angina ( 1·41 [ 1·36–1·46 ] ) , and weakest for abdominal aortic aneurysm ( 1·08 [ 1·00–1·17 ] ) . Compared with diastolic blood pressure , raised systolic blood pressure had a greater effect on angina , myocardial infa rct ion , and peripheral arterial disease , whereas raised diastolic blood pressure had a greater effect on abdominal aortic aneurysm than did raised systolic pressure . Pulse pressure associations were inverse for abdominal aortic aneurysm ( HR per 10 mm Hg 0·91 [ 95 % CI 0·86–0·98 ] ) and strongest for peripheral arterial disease ( 1·23 [ 1·20–1·27 ] ) . People with hypertension ( blood pressure ≥140/90 mm Hg or those receiving blood pressure-lowering drugs ) had a lifetime risk of overall cardiovascular disease at 30 years of age of 63·3 % ( 95 % CI 62·9–63·8 ) compared with 46·1 % ( 45·5–46·8 ) for those with normal blood pressure , and developed cardiovascular disease 5·0 years earlier ( 95 % CI 4·8–5·2 ) . Stable and unstable angina accounted for most ( 43 % ) of the cardiovascular disease-free years of life lost associated with hypertension from index age 30 years , whereas heart failure and stable angina accounted for the largest proportion ( 19 % each ) of years of life lost from index age 80 years . Interpretation The widely held assumptions that blood pressure has strong associations with the occurrence of all cardiovascular diseases across a wide age range , and that diastolic and systolic associations are concordant , are not supported by the findings of this high-resolution study . Despite modern treatments , the lifetime burden of hypertension is substantial . These findings emphasise the need for new blood pressure-lowering strategies , and will help to inform the design of r and omised trials to assess them . Funding Medical Research Council , National Institute for Health Research , and Wellcome Trust BACKGROUND Cardiovascular disease ( CVD ) mortality rates are greatly elevated in chronic kidney disease patients receiving maintenance haemodialysis therapy . The purpose of this study was to evaluate the efficacy of intradialytic endurance exercise training on novel risk factors that may contribute to this excessive CVD risk . METHODS Seventeen haemodialysis patients were r and omized to either an intradialytic exercise training ( cycling ) group ( EX ; n = 8) or a non-exercising control group ( CON ; n = 9 ) for 4 months . At baseline and following the intervention , we measured serum parameters related to CVD risk and renal function , used echocardiography to measure variables related to cardiac structure and function and assessed physical performance by a vali date d shuttle walk test . RESULTS Performance on the shuttle walk test increased by 17 % in EX ( P < 0.05 ) , but did not change in CON . There was no change in serum lipids or inflammatory markers ( C-reactive protein , interleukin-6 ) in either group . Serum thiobarbituric acid reactive substances , a marker of oxidative stress , were reduced by 38 % in EX ( P < 0.05 ) , but did not change in CON . In addition , serum alkaline phosphatase ( ALP ) , a putative risk factor for vascular calcification , was reduced by 27 % in EX ( P < 0.05 ) , but did not change in CON . There was no change in left atrial volume , left ventricular mass or myocardial performance index in either group . However , the thickness of the epicardial fat layer was reduced by 11 % in EX ( P < 0.05 ) , but did not change in CON . Furthermore , the change in physical performance was inversely correlated to the change in epicardial fat ( r = -0.63 ; P = 0.03 ) . CONCLUSIONS These results suggest that endurance exercise training may improve CVD risk in haemodialysis patients by decreasing novel risk factors including serum oxidative stress , ALP and epicardial fat BACKGROUND Sedentary behavior is associated with an increased risk for death in the general population . However , the association between inactivity and mortality has not been studied in a large cohort of dialysis patients despite the high prevalence of sedentary behavior in this group . METHODS We used the Dialysis Morbidity and Mortality Study Wave 2 , a prospect i ve study of a national sample of 4,024 incident peritoneal dialysis and hemodialysis patients from 1996 to 1997 , to determine whether sedentary behavior is associated with increased mortality during a 1-year period in this group after adjusting for confounding variables . RESULTS The study population consisted of the 2,837 patients with accurate survival data who were able to ambulate and transfer . Eleven percent of the sedentary patients died during the study period compared with 5 % of nonsedentary patients
Output:
| Both aerobic training and combined training again elicited greater improvements in aerobic capacity than control .
For systolic blood pressure , combined training was superior to control .
For diastolic blood pressure , combined training was superior to aerobic training and control .
No modality was superior to control for haemodialysis efficiency .
Combined training was ranked as the most effective treatment for aerobic capacity and arterial blood pressure .
CONCLUSION Combined training was the most effective modality to increase aerobic capacity and blood pressure control in people who require haemodialysis . |
MS210679 | ***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: Despite formal recommendations for dietary change to reduce the incidence of ischaemic heart disease , the acceptability and effectiveness of the proposed diets have not been well investigated in population based studies . In this preliminary investigation of nutritional advice in a well population , subjects in one group practice were r and omized to receive either dietary instruction or simple follow up without instruction . The dietary recommendations were well received , and a substantial proportion of subjects reported altering their diets in accordance with them . There were modest beneficial changes in plasma lipid levels among men . Thus , using general practice as an avenue for promoting dietary change is feasible , and may be effective among men AIMS To assess the effect of regular diabetic health education on cardiovascular risk factors in Chinese Type 2 diabetic patients . METHODS This was a 1-year prospect i ve r and omized study . One hundred and eighty Type 2 diabetic subjects were recruited from three regional diabetic centres in Hong Kong . Ninety received additional structured reinforcement of diabetic health education by a trained nurse after the doctors ' consultations every 3 months ( intervention group ) . The others received the same medical care except no nursing reinforcement ( control group ) . Outcome measures included fasting plasma glucose , HbA(1c ) , body mass index , waist circumference , blood pressure and lipid profiles , which were assessed before the study and after 1 year . RESULTS Two of the controls defaulted follow-up . The intervention group and controls had similar age and sex distribution . At the end of study , the intervention group had reducted their waist circumference , diastolic blood pressure , HbA(1c ) , total cholesterol and low-density lipoprotein cholesterol levels . The controls had reduced their total cholesterol and low-density lipoprotein cholesterol levels . Other cardiovascular risk factors were not significantly changed in the controls . Addition of drugs and /or dosage increment of anti-diabetic drugs , lipid-lowering agents and anti-hypertensive agents were similar between the two groups . CONCLUSIONS Regular structured reinforcement with diabetic health education is useful . It helps to control more successfully some of the cardiovascular risk factors in Chinese Type 2 diabetic patients Cluster r and omization trials are increasingly being used in primary care research . The main feature of these trials is that patients are nested within large clusters such as physician practice s or communities and the intervention is applied to the cluster . This study design necessitates calculation of intraclass correlation coefficients in order to determine the required sample size . The purpose of this study is to determine intraclass correlation coefficients for a number of outcome measures at the primary care practice level . The CEART study is a r and omized trial testing the effectiveness of translating ATP III guidelines into clinical practice , with primary care physician practice s as the unit of r and omization and patients as the unit of data collection . The intraclass correlation coefficient ( ICC ) was<0.02 and the design effect ranged from 1.0 to 2.3 , respectively , for weight , total cholesterol , LDL , non-HDL , glucose , creatinine , and % at non-HDL goal . For smoking status , body mass index , systolic blood pressure , HDL cholesterol triglycerides , total cholesterol/HDL ratio and % at LDL goal , the ICC was 0.02 - 0.047 and the design effect was 2.6 - 4.1 . The largest ICCs ( 0.05 - 0.12 ) and design effects ( 4.4 - 9.4 ) were found for height and diastolic blood pressure . These findings suggest that cluster r and omization may substantially increase the sample size necessary to maintain adequate statistical power for selected outcomes such as diastolic blood pressure studies compared with simple r and omization for most outcomes evaluated in this study where the design effect is small to moderate . Overall , the ICCs presented will be useful in calculating sample sizes at the primary care level A preventive nursing intervention to reduce coronary heart disease ( CHD ) risk was tested . The sample was 19 families composed of 58 first-degreed relatives of young ( age 30 - 55 years ) victims of sudden cardiac death . Families were r and omly assigned to control and experimental groups . The intervention at 3 - 5 months postdeath focused on assessment of health history , health behaviors , health beliefs , informing and educating about CHD risk factors , and methods for detecting and reducing these factors . The control group received mailed question naires and no intervention . The subject 's reduction of CHD risk was measured at 7 months by changes in high risk CHD behaviors , changes in health beliefs , and adherence to screening for serum cholesterol and blood pressure determination . Analysis of covariance ( covarying age and pretest scores ) demonstrated no differences between groups for health beliefs ; however , significant differences for health beliefs existed between the sibling subgroups . The intervention was correlated with a significant reduction in alcohol intake . Reductions in high fat meat consumption were in the desired direction . Greater percentages of subjects in the intervention group obtained blood pressure and cholesterol screening Subjects and design : The study was based on the total patient sample ( n=110 ) of a r and omized controlled trial comparing two intervention methods advising cardiovascular high-risk men of lifestyle changes in general practice . Behaviour and risk factor changes during the one-year intervention study were analysed using multiple regression and logistic regression analyses with the above-mentioned independent variables . Setting : Twenty-two general practice centres in the county of Hordal and , western Norway . Results : Self-efficacy of increased physical exercise was the only variable significantly related to exercise change . Age and self-efficacy were statistical significant predictors of smoking cessation success . None of the independent variables was statistically significantly related to blood pressure or cholesterol change . Educational level related negatively , although statistically insignificantly , with total risk change . Conclusion : The study confirms the importance of self-efficacy in both human behaviour and motivation for behaviour change . Objectives : The objectives of the study were to explore the impact of possible predictors for cardiovascular risk behaviour change ; predictors such as education , age , self-efficacy , doctors ' interpersonal skills , and number of appointments Of 22 r and omized trials of rehabilitation with exercise after myocardial infa rct ion ( MI ) , one trial had results that achieved conventional statistical significance . To determine whether or not these studies , in the aggregate , show a significant benefit of rehabilitation after myocardial infa rct ion , we performed an overview of all r and omized trials , involving 4,554 patients ; we evaluated total and cardiovascular mortality , sudden death , and fatal and nonfatal reinfa rct ion . For each endpoint , we calculated an odds ratio ( OR ) and 95 % confidence interval ( 95 % CI ) for the trials combined . After an average of 3 years of follow-up , the ORs were significantly lower in the rehabilitation than in the comparison group : specifically , total mortality ( OR = 0.80 [ 0.66 , 0.96 ] ) , cardiovascular mortality ( OR = 0.78 [ 0.63 , 0.96 ] ) , and fatal reinfa rct ion ( OR = 0.75 [ 0.59 , 0.95 ] ) . The OR for sudden death was significantly lower in the rehabilitation than in the comparison group at 1 year ( OR = 0.63 [ 0.41 , 0.97 ] ) . The data were compatible with a benefit at 2 ( OR = 0.76 [ 0.54 , 1.06 ] ) and 3 years ( OR = 0.92 [ 0.69 , 1.23 ] ) , but these findings were not statistically significant . For nonfatal reinfa rct ion , there were no significant differences between the two groups after 1 ( OR = 1.09 [ 0.76 , 1.57 ] ) , 2 ( OR = 1.10 [ 0.82 , 1.47 ] ) , or 3 years ( OR = 1.09 [ 0.88 , 1.34 ] ) of follow-up . The observed 20 % reduction in overall mortality reflects a decreased risk of cardiovascular mortality and fatal reinfa rct ion throughout at least 3 years and a reduction in sudden death during the 1st year after infa rct ion and possibly for 2 - 3 years . With respect to the independent effects of the physical exercise component of cardiac rehabilitation , the relatively small number of " exercise only " trials , combined with the possibility that they may have had a formal or informal nonexercise component precludes the possibility of reaching any definitive conclusion . To do so would require a r and omized trial of sufficient size to distinguish between no effect and the most plausible effect based on the results of this overview The effects of cardiovascular risk reduction are typically assessed by self-reported behavior change and physiological outcomes . There is a need to enhance evaluation protocol s by including direct observation measures of targeted health behaviors . To improve the evaluation of a family-based diet and physical activity change program , families were observed during a planned visit to the San Diego Zoo . This st and ardized environment afforded many options for dietary intake and physical activity . Thirty families who had participated in a 1-year intervention program and 30 control families were observed . Caucasian and Mexican-American families were equally represented . Observations in this st and ard environment discriminated between intervention and control families , and the findings indicated that intervention effects generalized to this novel setting . Intervention families consumed fewer calories , ate less sodium , and walked further than did control families . Ethnic differences were noted Abstract Objectives : To estimate the extent to which changes in the main coronary risk factors ( serum cholesterol concentration , blood pressure , and smoking ) explain the decline in mortality from ischaemic heart disease and to evaluate the relative importance of change in each of these risk factors . Design : Predicted changes in ischaemic heart disease mortality were calculated by a ligistic regression model using the risk factor levels assessed by cross sectional population surveys , in 1972 , 1977 , 1982 , 1987 , and 1992 . These predicted changes were compared with observed changes in mortality statistics . Setting : North Karelia and Kuopio provinces , Finl and . Subjects : 14 257 men and 14 786 women aged 30–59 r and omly selected from the national population register . Main outcome measures : Levels of the risk factors and predicted and observed changes in mortality from ischaemic heart disease . Results — The observed changes in the risk factors in the population from 1972 to 1992 predicted a decline in mortality from ischaemic heart disease of 44 % ( 95 % confidence interval 37 % to 50 % ) in men and 49 % ( 37 % to 59 % ) in women . The observed decline was 55 % ( 51 % to 58 % ) and 68 % ( 61 to 74 ) respectively . Conclusion : An assessment of the data on the risk factors for ischaemic heart disease and mortality suggests that most of the decline in mortality from ischaemic heart disease can be explained by changes in the three main coronary risk factors OBJECTIVE To investigate the effect of meal-related self-monitoring of blood glucose on glycemic control and well-being in non-insulin-treated type 2 diabetic patients . RESEARCH DESIGN AND METHODS This 6-month study , which included 6 months of follow-up , adopted a prospect i ve , multicenter , r and omized controlled design . Subjects were r and omized to two groups : one group used a blood glucose-monitoring device , kept a blood glucose/eating diary , and received st and ardized counseling ; the control group received nonst and ardized counseling on diet and lifestyle . The primary efficacy parameter was the change in HbA(1c ) . Secondary efficacy variables included changes in body weight , lipids , and microalbumin and changes in treatment satisfaction and well-being . RESULTS In the per- protocol analysis , the use of a self-monitoring blood glucose device significantly reduced HbA(1c ) levels by 1.0 + /- 1.08 % compared with 0.54 + /- 1.41 % for the control group ( P = 0.0086 ) ; subgroup analysis showed three types of responders . Body weight , total cholesterol , and microalbumin improved when using a glucometer , but there was no statistically significant difference between the two groups . Treatment satisfaction increased in both groups to a similar extent ( P = 0.9 ) . Self-monitoring result ed in a marked improvement of general well-being with significant improvements in the subitems depression ( P = 0.032 ) and lack of well-being ( P = 0.02 ) . CONCLUSIONS Meal-related self-monitoring of blood glucose within a structured counseling program improved glycemic control in the majority of non-insulin-treated type 2 diabetic patients in this study . The finding of three types of responders will be important for future planning of counseling and educational interventions Lifestyle factors like weight , alcohol consumption , salt intake and physical activity have shown to be important in treating hypertension . There have been made some r and omised trials about the effects of lifestyle interventions , but the numbers of patients have been relatively small and the duration s of follow-ups have been short . No controlled trials assessing the effects of lifestyle intervention in a rehabilitation setting have been reported . In this study , the effects of multidisciplinary lifestyle intervention in rehabilitation centres among middle-aged hypertensive employees were described . A total of 731 hypertensives from 45 worksites were r and omised to lifestyle intervention in a rehabilitation centre or to usual care in an occupational or primary health-care centre for 12 months . St and ard measurements were conducted before the intervention and 1-year later . Blood pressure ( BP ) levels were clearly reduced in the intervention group , while only minor changes were observed in the control
Output:
| Evidence suggests that health promotion interventions have limited use in general population |
MS210680 | ***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 To compare the effectiveness of bacterial interference versus placebo in preventing urinary tract infection ( UTI ) . METHODS The main outcome measure was the numbers of episodes of UTI/patient-year . R and omization was computer generated , with allocation concealment by visibly indistinguishable products distributed from a core facility . The healthcare providers and those assessing the outcomes were unaware of the group allocation . Adult patients ( n = 65 ) with neurogenic bladder after spinal cord injury and a history of recurrent UTI were r and omized in a 3:1 ratio to receive either Escherichia coli HU2117 or sterile saline . Urine cultures were obtained weekly during the first month and then monthly for 1 year . The patients were evaluable if they remained colonized with E. coli HU2117 for > 4 weeks ( experimental group ) . The trial is closed to follow-up . RESULTS Of the 59 patients who received bladder inoculations , 27 were evaluable ( 17 in the experimental group and 10 in the placebo group ) . The 2 study groups had comparable clinical characteristics . Of 17 patients colonized with E. coli HU2117 and the 10 control patients , 5 ( 29 % , 95 % confidence interval 0.11 - 0.56 ) and 7 ( 70 % , 95 % confidence interval 0.35 - 0.92 ) developed > 1 episode of UTI ( P = .049 ; 1-sided Fisher 's exact test ) , respectively . The average number of episodes of UTI/patient-year was also lower ( P = .02 , Wilcoxon rank sum test ) in the experimental ( 0.50 ) than in the control group ( 1.68 ) . E. coli HU2117 did not cause symptomatic UTI . CONCLUSIONS Bladder colonization with E. coli HU2117 safely reduces the risk of symptomatic UTI in patients with spinal cord injury . Effective , but less complex , methods for achieving bladder colonization with E. coli HU2117 are under investigation A r and omized prospect i ve trial compared the effect on the bacterial flora of the urine of the instillation of chlorhexidine or of normal saline into the bladder of two groups of elderly patients with indwelling urinary catheters . There was no reduction in urinary bacterial count in either group of patients OBJECTIVES It is st and ard practice to use lignocaine gel during male urethral catheterization . However , it is commonly believed that topical anaesthetic confers no benefit during female catheterization hence lubricating gel alone is more commonly used . The present study aim ed to determine whether lignocaine gel decreased pain compared with water-based lubricating gel for female urethral catheterization in the ED . METHODS This r and omized double-blinded study was carried out at two Sydney hospitals -- an urban district inner western hospital and a south-western major trauma centre . A convenience sample of 62 alert , cooperative adult female ED patients provided written informed consent . The indications for , and technique of catheterization , were at the discretion of the clinical staff . Pre- and immediate post-procedure pain was scored by the patient on a 100 mm Visual Analogue Scale ( VAS ) . The primary outcome was the difference in VAS scores ( post- minus pre-procedure ) in millimetres . Values for each group were expressed as medians and interquartile ranges , statistical significance determined using the Mann-Whitney U-test . RESULTS The groups were well matched for age , indication for catheterization , pre-procedural pain score , catheter size and the number of catheterization attempts . Patients receiving lignocaine gel had a significantly lower median procedural pain score than patients receiving lubricating gel ( 6 mm vs 33 mm , P = 0.007 ) . CONCLUSIONS Lignocaine gel substantially reduces the procedural pain of female urethral catheterization by comparison with use of a water-based lubricating gel Thirty-eight patients with problems with their urinary catheters were r and omly treated with Varidase ® or normal saline solution once a day for 10 days . Photographs were taken by using a cystoscope before treatment , at day 10 and day 24 after the commencement of treatment . The photographs were evaluated according to the occurrence of pus , debris , coagula and rubor . In the Varidase ® group the improvements from baseline to day 10 and day 24 were statistically significant ( p < 0·05 ) in all parameters while there were no statistically significant improvements in the saline group . Comparing the two treatment groups , regarding the changes from baseline to day 10 and day 24 , it was statistically demonstrated that Varidase ® was significantly more effective than saline in all parameters ( p < 0·05 ) . In conclusion , this study shows that Varidase ® effectively cleans the urinary bladder from pus , fibrin , necrotic tissue and blood clots We have evaluated the effect of povidone-iodine ( PVP-I ) bladder irrigation prior to catheter removal on subsequent bacteriuria . Of 264 patients , 138 received PVP-I irrigation and 126 were controls . Both groups were similar with respect to duration of catheterization and bacteriuria before removal of the catheter . Of 497 cultures taken after catheter removal 99 ( 20 % ) were positive . This included 52 of 233 in the control group ( 22 % ) and 47 of 264 in the study group ( 18 % ) . Patients with positive cultures had a significantly longer period of catheterization . Our trial did not demonstrate that PVP-I bladder irrigation before catheter removal reduces subsequent bacteriuria Study design : Non-r and omized pilot trial . Objectives : To determine whether Escherichia coli 83972-coated urinary catheters in persons with spinal cord injury ( SCI ) practicing an intermittent catheterization program ( ICP ) could ( 1 ) achieve bladder colonization with this benign organism and ( 2 ) decrease the rate of symptomatic urinary tract infection ( UTI ) . Setting : Outpatient SCI clinic in a Veterans Affairs hospital ( USA ) . Methods : Participants had neurogenic bladders secondary to SCI , were practicing ICP , had experienced at least one UTI and had documented bacteruria within the past year . All participants received a urinary catheter that had been pre-inoculated with E. coli 83972 . The catheter was left in place for 3 days and then removed . Participants were followed with urine cultures and telephone calls weekly for 28 days and then monthly until E. coli 83972 was lost from the urine . Outcome measures were ( 1 ) the rate of successful bladder colonization , defined as the detection ( ⩾102 cfu ml−1 ) of E. coli 83972 in urine cultures for > 3 days after catheter removal and ( 2 ) the rate of symptomatic UTI during colonization with E. coli 83972 . Results : Thirteen participants underwent 19 insertions of study catheters . Eight participants ( 62 % ) became successfully colonized for > 3 days after catheter removal . In these 8 participants , the rate of UTI during colonization was 0.77 per patient-year , in comparison with the rate of 2.27 UTI per patient-year before enrollment . Conclusions : E. coli 83972-coated urinary catheters are a viable means of achieving bladder colonization with this potentially protective strain in persons practicing ICP The purpose of this study was to evaluate the effects of a nurse-family partnership model on the self-efficacy of family caregivers ( FCs ) and the incidence of catheter-associated urinary tract infection ( CAUTI ) among patients . A r and omized controlled study was conducted . We recruited 61 patients and their FCs , who were r and omly divided into an experimental group ( n = 30 ) and a control group ( n = 31 ) . In the experimental group , the main caregivers comprised a nurse-family partnership , whereas the control participants received routine care . The findings were as follows : ( i ) the incidence of CAUTI was lower in the experimental group than in the control group ( 20 % vs. 38.8 % ) , but the difference was not statistically significant ; and ( ii ) no significant difference emerged for reported Caregiver Self-Efficacy Score between the two groups . The nursing team and FCs must become partners in cooperative caregiving to enhance the quality of patient care Since the long-term catheterized patient is at significant risk of urinary tract infection , and the catheter drainage bags of these patients are at significant risk of becoming reservoirs for nosocomial pathogens , we carried out a r and omized , controlled study to determine the efficacy of intermittent drainage bag instillation of hydrogen peroxide ( H2O2 ) in patients requiring indwelling Foley catheters for 5 days or more . Herein we report the effects of this technique on the rates of catheter and bag bacteriuria , the duration to positive culture , the temporal relationships observed , and the spectrum of organisms recovered . Bag source bacteriuria was found with the same frequency in both control and H2O2 groups . H2O2 did reduce contamination of the drainage bag but did not reduce catheter-associated bacteriuria or frequency of symptomatic urinary tract infection . Furthermore , H2O2 did not reduce the frequency of bag contamination with most of the common nosocomial urinary pathogens The purpose of our investigation was to compare external sphincterotomy , the traditional method of treatment of detrusor-external sphincter dyssynergia ( DESD ) , with two newer methods , balloon dilatation or internal stenting of the external sphincter . Sixty-one spinal cord injured ( SCI ) men were prospect ively evaluated . The indications for treatment were DESD and voiding pressure greater than 60 cmH2O demonstrated during video-urodynamic study . Twenty patients were treated with balloon dilatation of the external sphincter , 26 with an internal stent prosthesis , and 15 with traditional external sphincterotomy . Age and duration of SCI were similar among the three treatment groups . A significant decrease in both voiding pressure and residual urine from presurgery levels persisted during the follow-up period of 3 to 26 months ( mean , 15 months ) in all three groups . Bladder capacity remained constant , renal function improved or stabilized , and autonomic dysreflexia ( AD ) improved in all three groups . Balloon dilatation and prosthesis placement are associated with a significantly shorter length of surgery ( p = 0.045 ) , length of hospitalization ( p = 0.005 ) , decrease in hospitalization cost ( p = 0.01 ) , and decrease in hemoglobin postoperatively ( p = 0.046 ) when compared to external sphincterotomy . Complications of stent insertion included device migration ( three patients ) and secondary bladder neck obstruction ( two patients ) . In the balloon dilatation group , three recurrent sphincter obstructions , one case of bleeding requiring transfusion , and one case of bulbous urethral stricture occurred . After external sphincterotomy , two patients developed recurrent obstruction , two required blood transfusion , and 1 patient noted erectile dysfunction . Balloon dilatation and prosthesis placement both proved to be as effective as external sphincterotomy in the treatment of DESD . ( ABSTRACT TRUNCATED AT 250 WORDS Abstract Purpose Plants extracts are used in urology to manage urinary tract infections . We aim ed to evaluate the efficacy of a preparation with solidago , orthosiphon , birch and cranberry extracts ( CISTIMEV PLUS ® ) in reducing microbial colonization and biofilm development in patients with indwelling urinary catheters . Methods All consecutive out patients attending our department between January and June 2010 for the substitution of indwelling catheters were considered for this single-blinded , r and omized and controlled pilot study to test superiority of the preventative management ( CISTIMEV PLUS ® , 1 tablet daily for 30 days ) in respect to no treatment . A sample size of 10–40 participants per group was considered adequate . All patients underwent urine culture the same day of the catheter substitution and were then r and omized into test group ( n = 48 ) and control group ( n = 35 ) . Ultrastructural analysis was also performed . After 30 days , the catheter was replaced and the analysis repeated . The primary outcome was the rate of positive urinary culture at the end of the entire study period . Results Ten patients ab and oned the study . At 30 days , according to per- protocol analysis , the groups statistically differed regarding the rate of positive urine cultures : test group 10/43 and control group 16/30 ( p = 0.013 ) ( −30.1 % [ 95 % CI −51.94 to −8.21 ] ) . The most common isolated bacteria were Escherichia coli and Enterococcus faecalis . Conclusions The use of solidago , orthosiphon , birch and cranberry extracts result ed in a significant reduction of microbial colonization in patients with indwelling urinary catheters . Larger clinical trials are needed to demonstrate that the effects here reported are sufficient to reduce symptomatic catheter-associated urinary tract infections The purpose of this study was to compare the incidence of urinary infection following sterile catheterisation after either ( 1 ) a h and wash of 30 s and double gloving , ( the shorter sterile technique ) or ( 2 ) after a 3 minute wash from fingertips to elbows and the wearing of a sterile g
Output:
| There is currently insufficient evidence to assess the value of different policies for replacing long-term urinary catheters on patient outcomes . |
MS210681 | ***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 We demonstrate a simple yet comprehensive method to evaluate the sensitivity of endoscopic procedures when no gold st and ard is available . MATERIAL S AND METHODS In 208 consecutive patients with superficial bladder cancer 328 endoscopies were performed to compare the sensitivity of white light and 5-aminolevulinic acid induced fluorescence endoscopy . Both procedures were performed during the same session . RESULTS The maximum interval of observable sensitivity for 5-aminolevulinic acid induced fluorescence endoscopy ranged between 78 and 97.5 % , and the best estimate for sensitivity based on realistic assumptions was 93.4 % ( 95 % confidence intervals 90 to 97.3 ) . The best sensitivity estimate for white light endoscopy was 46.7 % ( 95 % confidence intervals 39.4 to 54.3 , maximum range 47.2 to 53 % ) . CONCLUSIONS This method to determine the maximum possible range of sensitivity estimates for endoscopic procedures without a gold st and ard is easily applied . Depending on the assumptions a range of reasonable scenarios can be constructed and the corresponding sensitivities can be reported . This approach gives fast and valid results , and could further indicate the diagnostic superiority of 5-aminolevulinic acid induced fluorescence compared to white light endoscopy PURPOSE We determined whether the sensitivity of detecting dysplasia or early bladder cancer can be improved by 5-aminolevulinic acid induced porphyrin fluorescence . MATERIAL S AND METHODS A 3 % 5-aminolevulinic acid solution was instilled intravesically before cystoscopy in 104 patients . The 5-aminolevulinic acid induced porphyrin fluorescence was excited by violet light from a krypton ion laser ( wavelength 406.7 nm . ) . RESULTS The sensitivity of the fluorescence cystoscopy ( 96.9 % ) was significantly ( p < 0.0001 ) greater than that of white light cystoscopy ( 72.7 % ) . There was no impact on specificity . CONCLUSIONS Due to the high sensitivity of the procedure fluorescence guided biopsies are recommended instead of r and om biopsies BACKGROUND Preliminary data suggest that photodiagnosis by fluorescence detection of protoporphyrin IX , a biosynthetic product of the photosensitizer 5-amino-levulinic acid ( ALA ) , is superior to conventional cystoscopy in bladder tumor detection . PATIENTS AND METHODS We instilled 1.5 g of ALA into the bladders of 52 patients with suspect bladder lesions 1 to 4 hours prior to transurethral resection or biopsy . Red fluorescence was induced by violet-blue light ( wavelength 380 - 450 nm ) . RESULTS In 13 patients ( 25 % ) , significant tumors were detected by fluorescence that were missed on conventional cystoscopy . In the present series , ALA photodetection had a sensitivity of 94.6 % ( compared with 76 % for cystoscopy ) and a specificity of 43 % . CONCLUSION Fluorescence diagnosis with ALA may become a st and ard procedure for bladder tumor detection and resection , especially in endoscopically difficult situations ( carcinoma in situ , multifocal tumors , multiple prior resections , or previous drug instillation therapy ) PURPOSE In this European multicenter study we compared hexaminolevulinate ( HAL ) fluorescence cystoscopy and st and ard white light cystoscopy for the detection of carcinoma in situ ( CIS ) in patients suspected of having high risk bladder cancer . MATERIAL S AND METHODS This study was a prospect i ve controlled , within-patient comparison of st and ard and HAL fluorescence cystoscopy . Eligible patients received an intravesical instillation of 50 ml HAL 8 mM solution . Cystoscopy was performed using a D light system , which provided white and blue light at 375 to 440 nm . The bladder wall was inspected and mapped , first under white light , followed by blue light . All tumors and suspicious areas identified under white light and by red fluorescence were resected or biopsied . Histological findings were assessed by an independent central pathologist blinded to the identity of the biopsies . RESULTS Of 211 evaluable patients 83 ( 39 % ) had CIS , of whom 18 ( 22 % ) were detected by HAL cystoscopy only , 62 ( 75 % ) were detected by st and ard and HAL cystoscopy , 2 ( 2 % ) were detected by st and ard cystoscopy only and 1 ( 1 % ) was detected by nonguided biopsy . Therefore , HAL cystoscopy identified 28 % more patients with CIS than st and ard cystoscopy . The side effects of HAL instillation were negligible and no unexpected events were reported . CONCLUSIONS HAL fluorescence cystoscopy improves the detection of bladder CIS significantly , which has consequences for clinical management and may improve the patient prognosis . The procedure is easily implemented as an adjunct to st and ard cystoscopy and it adds no significant risk of complications OBJECTIVE The aim of this study was the assessment of flexible cystoscopy assisted by hexaminolevulinate ( HAL ) fluorescence . METHODS This study was a prospect i ve controlled , within-patient comparison of flexible HAL cystoscopy with st and ard flexible cystoscopy , HAL rigid and st and ard white light rigid cystoscopy . Eligible patients received an intravesical instillation of 50 ml hexylaminolevulinate 8 mM solution . First flexible than rigid cystoscopy was performed in each patient using a Combilight PDD system ( Richard Wolf , Germany ) , which provided st and ard white light and blue light at 375 to 440 nm , with mapping of all lesions detected . All tumors and suspicious areas identified under white light and by red fluorescence with flexible or rigid cystoscopy were then resected by TUR or biopsied . The specimen was assessed by an independent blinded pathologist . RESULTS In the 45 patients studied 41 ( 91 % ) patients had exophytic tumors , of which 39 ( 95.1 % ) were detected by HAL flexible cystoscopy and 40 ( 97.5 % ) by HAL rigid cystoscopy . 17 ( 37.8 % ) patients had concomitant or carcinoma in situ only , which was identified by HAL flexible cystoscopy in 14 ( 82.3 % ) , by HAL rigid cystoscopy in 15 ( 88.2 % ) , by flexible st and ard in 11 ( 64.7 % ) and by st and ard white light rigid cystoscopy in 13 ( 76.7 % ) patients . CONCLUSION HAL fluorescence flexible cystoscopy compared to HAL rigid cystoscopy showed almost equivalent results in detecting papillary and flat lesions in bladder cancer patients . Both procedures were superior to st and ard white light flexible cystoscopy OBJECTIVES 1 ) To determine whether fluorescence cystoscopy after intravesical administration of 5-aminolevulinic acid ( 5-ALA ) is more sensitive in detection of dysplasia and bladder cancer when compared with conventional cystoscopy . 2 ) To determine the safety of using 5-ALA . MATERIAL S AND METHODS A 3 % 5-ALA solution was instilled intravesically before cystoscopy in 41 patients . The 5-ALA-induced porphyrin fluorescence was excited by violet light from a xenon arc lamp ( lambda 375 - 440 mm ) . RESULTS Among the 175 biopsies obtained , the sensitivity of the fluorescence cystoscopy was greater than that of conventional cystoscopy ( 89.1 % versus 65.6 % , P < 0.05 ) . Specificity was at 64.8 % and 83.8 % respectively with P < 0.05 . Duration of ALA instillation did not seem to affect the sensitivity and specificity of photodynamic diagnosis . The procedures were well tolerated by all patients with no additional complication . CONCLUSIONS Fluorescence-guided biopsies are more sensitive than r and om biopsies in detecting dysplasia or bladder cancer without additional risk or complication . The duration of ALA instillation did not seem to affect the accuracy of photodynamic diagnosis BACKGROUND AND PURPOSE A major problem diagnosing bladder cancer using conventional white-light cystoscopy is that flat and tiny papillary neoplasms can be overlooked . Fluorescence cystoscopy is based on the detection of protoporphyrin IX (PpIX)-induced fluorescence in urothelial neoplasms through the topical administration of 5-aminolevulinic acid ( ALA ) . The diagnostic efficacy of fluorescence cystoscopy in urothelial neoplasms was evaluated in this study . The focus of this investigation was to ascertain whether fluorescence cystoscopy could make a major contribution to staging and improving the choice of adjuvant therapy after transurethral resection . PATIENTS AND METHODS A series of 62 patients with suspected bladder cancer were investigated by fluorescence cystoscopy . An intravesical instillation of ALA was conducted 2 hours prior to fluorescence . A total of 274 tissue sample s were obtained from the fluorescing and nonfluorescing areas of the bladder . RESULTS The sensitivity and negative predictive value of fluorescence cystoscopy were 98.0 % and 94.7 % , respectively , but the specificity was low ( 42.9 % ) . Among a total of 148 lesions of urothelial neoplasm , 58 foci ( dysplasia in 5 , carcinoma in situ in 19 , stage Ta in 15 , T1 in 15 , above T2 in 4 ) that were invisible under white-light cystoscopy were detected by fluorescence cystoscopy . The final histopathologic status was changed in 45 % of patients ( 28/62 ) according to this technique . Among these patients , eight ( 13 % ) needed additional therapy , including a radical cystectomy in one patient and intravesical therapy in 10 . CONCLUSIONS The ALA-based fluorescence cystoscopy technique is a safe and simple procedure that enhances the detection of flat and papillary urothelial neoplasms . Moreover , it will be able to provide useful information that will enable proper staging and appropriate further treatment PURPOSE We compared hexaminolevulinate ( Hexvix ) fluorescence cystoscopy with white light cystoscopy for detecting carcinoma in situ . MATERIAL S AND METHODS In this multicenter study 298 patients with known or suspected bladder cancer underwent bladder instillation with 50 ml 8 mM hexaminolevulinate for 1 hour . Cystoscopy was then performed , first using st and ard white light and then hexaminolevulinate fluorescence cystoscopy . Lesions or suspicious areas identified under the 2 illumination conditions were mapped and biopsied for histological examination . In addition , 1 directed biopsy was obtained from an area appearing to be normal . RESULTS Of 196 evaluable patients 29.6 % ( 58 of 196 ) had carcinoma in situ , including 18 with carcinoma in situ alone , and 35 with carcinoma in situ and concomitant papillary disease , which was only detected on r and om biopsy in 5 . Of the 18 patients with no concomitant papillary disease carcinoma in situ was detected only by hexaminolevulinate fluorescence in 4 and only by white light in 4 . In the group with concomitant papillary disease carcinoma in situ was found only by hexaminolevulinate fluorescence in 5 patients and only by white light in 3 . The proportion of patients in whom 1 or more carcinoma in situ lesions were found only by hexaminolevulinate cystoscopy was greater than the hypothesized 5 % ( p=0.0022 ) . Overall more carcinoma in situ lesions were found by hexaminolevulinate than by white light cystoscopy in 22 of 58 patients ( 41.5 % ) , while the converse occurred in 8 of 58 ( 15.1 % ) . Biopsy results confirmed cystoscopy findings . Of a total of 113 carcinoma in situ lesions in 58 patients 104 ( 92 % ) were detected by hexaminolevulinate cystoscopy and 77 ( 68 % ) were detected by white light cystoscopy , while 5 were detected only on directed visually normal mucosal biopsy . Hexaminolevulinate instillation was well tolerated with no local or systemic side effects . CONCLUSIONS In patients with bladder cancer hexaminolevulinate fluorescence cystoscopy with blue light can diagnose carcinoma in situ that may be missed with white light cystoscopy . Hexaminolevulinate fluorescence cystoscopy can be used in conjunction with white light cystoscopy to aid in the diagnosis of this form of bladder cancer PURPOSE We determined if improved tumor detection using hexaminolevulinate ( HAL ) fluorescence cystoscopy could lead to improved treatment in patients with bladder cancer . MATERIAL S AND METHODS A total of 146 patients with
Output:
| The occurrence of CIS of the bladder can only be established by the pathological examination of whole bladders .
The true sensitivities of various modes of cystoscopy for detecting CIS can be revealed if patients scheduled for cystectomy are first examined with WLC , FLC , and optionally r and om biopsies . |
MS210682 | ***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 examine binge eating , depression , weight self-efficacy , and weight control success among obese individuals seeking treatment in a managed care organization . DESIGN : Gender-stratified analyses of associations between binge eating , depression , weight self-efficacy , and weight change , using data from a r and omized clinical trial that compared low-cost telephone-based , mail-based , and usual care interventions for weight loss . SUBJECTS : A total of 1632 overweight individuals ( 460 men , 1172 women ; mean age : 50.7 y ; mean body mass index : 34.2 kg/m2 ) were recruited from a large Midwestern US managed care organization . MEASUREMENTS : Height and weight were measured by study personnel at baseline , and self-reported weight was assessed at 6 and 12 months ; self-reported depression status , binge eating , and self-efficacy for weight control were assessed at baseline . RESULTS : Lifetime prevalence rates for depression and probable binge eating disorder were high . Weight self-efficacy was inversely related to weight in both men and women . For women , depression was associated with lower weight self-efficacy and higher body weight . Women reporting depression or lower weight self-efficacy at baseline had less weight loss success at 6 and 12 months . Depression , binge eating disorder , and weight self-efficacy were not significantly associated with weight loss success in men . CONCLUSION : Negative emotional states are highly prevalent and predict poor treatment outcomes , particularly for obese women . As obese women with clinical depression typically are excluded from intervention studies , further research on how to address the intersection of obesity intervention and mood management may be warranted CONTEXT Rapid increases in access to the Internet have made it a viable mode for public health intervention . No controlled studies have evaluated this re source for weight loss . OBJECTIVE To determine whether a structured Internet behavioral weight loss program produces greater initial weight loss and changes in waist circumference than a weight loss education Web site . DESIGN R and omized , controlled trial conducted from April to December 1999 . SETTING AND PARTICIPANTS Ninety-one healthy , overweight adult hospital employees aged 18 to 60 years with a body mass index of 25 to 36 kg/m(2 ) . Analyses were performed for the 65 who had complete follow-up data . INTERVENTIONS Participants were r and omly assigned to a 6-month weight loss program of either Internet education ( education ; n = 32 with complete data ) or Internet behavior therapy ( behavior therapy ; n = 33 with complete data ) . All participants were given 1 face-to-face group weight loss session and access to a Web site with organized links to Internet weight loss re sources . Participants in the behavior therapy group received additional behavioral procedures , including a sequence of 24 weekly behavioral lessons via e-mail , weekly online su bmi ssion of self-monitoring diaries with individualized therapist feedback via e-mail , and an online bulletin board . MAIN OUTCOME MEASURES Body weight and waist circumference , measured at 0 , 3 , and 6 months , compared the 2 intervention groups . RESULTS Repeated- measures analyses showed that the behavior therapy group lost more weight than the education group ( P = .005 ) . The behavior therapy group lost a mean ( SD ) of 4.0 ( 2.8 ) kg by 3 months and 4.1 ( 4.5 ) kg by 6 months . Weight loss in the education group was 1.7 ( 2.7 ) kg at 3 months and 1.6 ( 3.3 ) kg by 6 months . More participants in the behavior therapy than education group achieved the 5 % weight loss goal ( 45 % vs 22 % ; P = .05 ) by 6 months . Changes in waist circumference were also greater in the behavior therapy group than in the education group at both 3 months ( P = .001 ) and 6 months ( P = .005 ) . CONCLUSIONS Participants who were given a structured behavioral treatment program with weekly contact and individualized feedback had better weight loss compared with those given links to educational Web sites . Thus , the Internet and e-mail appear to be viable methods for delivery of structured behavioral weight loss programs Background Self-guided , Web-based interventions for depression show promising results but suffer from high attrition and low user engagement . Online peer support networks can be highly engaging , but they show mixed results and lack evidence -based content . Objective Our aim was to introduce and evaluate a novel Web-based , peer-to-peer cognitive re appraisal platform design ed to promote evidence -based techniques , with the hypotheses that ( 1 ) repeated use of the platform increases re appraisal and reduces depression and ( 2 ) that the social , crowd source d interactions enhance engagement . Methods Participants aged 18 - 35 were recruited online and were r and omly assigned to the treatment group , “ Panoply ” ( n=84 ) , or an active control group , online expressive writing ( n=82 ) . Both are fully automated Web-based platforms . Participants were asked to use their assigned platform for a minimum of 25 minutes per week for 3 weeks . Both platforms involved posting descriptions of stressful thoughts and situations . Participants on the Panoply platform additionally received crowd source d re appraisal support immediately after su bmi tting a post ( median response time=9 minutes ) . Panoply participants could also practice reappraising stressful situations su bmi tted by other users . Online question naires administered at baseline and 3 weeks assessed depression symptoms , re appraisal , and perseverative thinking . Engagement was assessed through self-report measures , session data , and activity levels . Results The Panoply platform produced significant improvements from pre to post for depression ( P=.001 ) , re appraisal ( P<.001 ) , and perseverative thinking ( P<.001 ) . The expressive writing platform yielded significant pre to post improvements for depression ( P=.02 ) and perseverative thinking ( P<.001 ) , but not re appraisal ( P=.45 ) . The two groups did not diverge significantly at post-test on measures of depression or perseverative thinking , though Panoply users had significantly higher re appraisal scores ( P=.02 ) than expressive writing . We also found significant group by treatment interactions . Individuals with elevated depression symptoms showed greater comparative benefit from Panoply for depression ( P=.02 ) and perseverative thinking ( P=.008 ) . Individuals with baseline re appraisal deficits showed greater comparative benefit from Panoply for depression ( P=.002 ) and perseverative thinking ( P=.002 ) . Changes in re appraisal mediated the effects of Panoply , but not the expressive writing platform , for both outcomes of depression ( ab=-1.04 , SE 0.58 , 95 % CI -2.67 to -.12 ) and perseverative thinking ( ab=-1.02 , SE 0.61 , 95 % CI -2.88 to -.20 ) . Dropout rates were similar for the two platforms ; however , Panoply yielded significantly more usage activity ( P<.001 ) and significantly greater user experience scores ( P<.001 ) . Conclusions Panoply engaged its users and was especially helpful for depressed individuals and for those who might ordinarily underutilize re appraisal techniques . Further investigation is needed to examine the long-term effects of such a platform and whether the benefits generalize to a more diverse population of users . Trial Registration Clinical Trials.gov NCT02302248 ; https:// clinical trials.gov/ct2/show/NCT02302248 ( Archived by WebCite at http://www.webcitation.org/6Wtkj6CXU ) BACKGROUND The Internet provides us with tools ( user metrics or para data ) to evaluate how users interact with online interventions . Analysis of these para data can lead to design improvements . OBJECTIVE The objective was to explore the qualities of online participant engagement in an online intervention . We analyzed the para data in a r and omized controlled trial of alternative versions of an online intervention design ed to promote consumption of fruit and vegetables . METHODS Volunteers were r and omized to 1 of 3 study arms involving several online sessions . We created 2 indirect measures of breadth and depth to measure different dimensions and dynamics of program engagement based on factor analysis of para data measures of Web pages visited and time spent online with the intervention material s. Multiple regression was used to assess influence of engagement on retention and change in dietary intake . RESULTS Baseline surveys were completed by 2513 enrolled participants . Of these , 86.3 % ( n = 2168 ) completed the follow-up surveys at 3 months , 79.6 % ( n = 2027 ) at 6 months , and 79.4 % ( n = 1995 ) at 12 months . The 2 tailored intervention arms exhibited significantly more engagement than the untailored arm ( P < .01 ) . Breadth and depth measures of engagement were significantly associated with completion of follow-up surveys ( odds ratios [ OR ] = 4.11 and 2.12 , respectively , both P values < .001 ) . The breadth measure of engagement was also significantly positively associated with a key study outcome , the mean increase in fruit and vegetable consumption ( P < .001 ) . CONCLUSIONS By exploring participants ' exposures to online interventions , para data are valuable in explaining the effects of tailoring in increasing participant engagement in the intervention . Controlling for intervention arm , greater engagement is also associated with retention of participants and positive change in a key outcome of the intervention , dietary change . This paper demonstrates the utility of para data capture and analysis for evaluating online health interventions . TRIAL REGISTRATION NCT00169312 ; http:// clinical trials.gov/ct2/show/NCT00169312 ( Archived by WebCite at http://www.webcitation.org/5u8sSr0Ty ) Background Increased access to the Internet and the availability of efficacious eHealth interventions offer great promise for assisting adults with diabetes to change and maintain health behaviors . A key concern is whether levels of engagement in Internet programs are sufficient to promote and sustain behavior change . Objective This paper used automated data from an ongoing Internet-based diabetes self-management intervention study to calculate various indices of website engagement . The multimedia website involved goal setting , action planning , and self-monitoring as well as offering features such as “ Ask an Expert ” to enhance healthy eating , physical activity , and medication adherence . We also investigated participant characteristics associated with website engagement and the relationship between website use and 4-month behavioral and health outcomes . Methods We report on participants in a r and omized controlled trial ( RCT ) who were r and omized to receive ( 1 ) the website alone ( n = 137 ) or ( 2 ) the website plus human support ( n = 133 ) that included additional phone calls and group meetings . The website was available in English and Spanish and included features to enhance engagement and user experience . A number of engagement variables were calculated for each participant including number of log-ins , number of website components visited at least twice , number of days entering self-monitoring data , number of visits to the “ Action Plan ” section , and time on the website . Key outcomes included exercise , healthy eating , and medication adherence as well as body mass index ( BMI ) and biological variables related to cardiovascular disease risk . Results Of the 270 intervention participants , the average age was 60 , the average BMI was 34.9 kg/m2 , 130 ( 48 % ) were female , and 62 ( 23 % ) self-reported Latino ethnicity . The number of participant visits to the website over 4 months ranged from 1 to 119 ( mean 28 visits , median 18 ) . Usage decreased from 70 % of participants visiting at least weekly during the first 6 weeks to 47 % during weeks 7 to 16 . There were no significant differences between website only and website plus support conditions on most of the engagement variables . In total , 75 % of participants entered self-monitoring data at least once per week . Exercise action plan pages were visited more often than medication taking and healthy eating pages ( mean of 4.3 visits vs 2.8 and 2.0 respectively , P < .001 ) . Spearman nonparametric correlations indicated few significant associations between patient characteristics and summary website engagement variables , and key factors such as ethnicity , baseline computer use , age , health literacy , and education were not related to use . Partial correlations indicated that engagement , especially in self-monitoring , was most consistently related to improvement in healthy eating ( r = .20 , P = .04 ) and reduction of dietary fat ( r = -.31 , P = .001 ) . There was also a significant correlation between self-monitoring and improvement in exercise ( r = .20 , P = .033 ) but not with medication taking . Conclusions Participants visited the website fairly often and used all of the theoretically important sections , but engagement decreased over 4 months . Usage rates and patterns were similar for a wide range of participants , which has encouraging implication s for the potential reach of online interventions . Trial Registration NCT00987285 ; http:// clinical trials.gov/show/NCT00987285 ( Archived by WebCite at http://www.webcitation.org/5vpe4RHTV Background There has been limited study of factors influencing response rates and attrition in online research . Online experiments were nested within the pilot ( study 1 , n = 3780 ) and main trial ( study 2 , n = 2667 ) phases of an evaluation of a Web-based intervention for hazardous drinkers : the Down Your Drink r and omized controlled trial ( DYD- RCT ) . Objectives The objective was to determine whether differences in the length and relevance of question naires can impact upon loss to follow-up in online trials .
Output:
| A conceptual framework is proposed in which engagement with a DBCI is influenced by the DBCI itself ( content and delivery ) , the context ( the setting in which the DBCI is used and the population using it ) and the behaviour that the DBCI is targeting .
The context and “ mechanisms of action ” may moderate the influence of the DBCI on engagement .
Engagement , in turn , moderates the influence of the DBCI on those mechanisms of action . |
MS210683 | ***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 Robot-assisted laparoscopic radical prostatectomy ( RALP ) has become widely used without high- grade evidence of superiority regarding long-term clinical outcomes compared with open retropubic radical prostatectomy ( RRP ) , the gold st and ard . OBJECTIVE To compare patient-reported urinary incontinence and erectile dysfunction 12 mo after RALP or RRP . DESIGN , SETTING , AND PARTICIPANTS This was a prospect i ve , controlled , nonr and omised trial of patients undergoing prostatectomy in 14 centres using RALP or RRP . Clinical -record forms and vali date d patient question naires at baseline and 12 mo after surgery were collected . OUTCOME MEASUREMENTS AND STATISTICAL ANALYSES Odds ratios ( ORs ) were calculated with logistic regression and adjusted for possible confounders . The primary end point was urinary incontinence ( change of pad less than once in 24h vs one time or more per 24h ) at 12 mo . Secondary end points were erectile dysfunction at 12 mo and positive surgical margins . RESULTS AND LIMITATIONS At 12 mo after RALP , 366 men ( 21.3 % ) were incontinent , as were 144 ( 20.2 % ) after RRP . The unadjusted OR was 1.08 ( 95 % confidence interval [ CI ] , 0.87–1.34 ) . Erectile dysfunction was observed in 1200 men ( 70.4 % ) 12 mo after RALP and 531 ( 74.7 % ) after RRP . The unadjusted OR was 0.81 ( 95 % CI , 0.66–0.98 ) . CONCLUSIONS In a Swedish setting , RALP for prostate cancer was modestly beneficial in preserving erectile function compared with RRP , without a statistically significant difference regarding urinary incontinence or surgical margins . PATIENT SUMMARY We compared patient-reported urinary incontinence after prostatectomy with two types of surgical technique . There was no statistically significant improvement in the rate of urinary leakage , but there was a small improvement regarding erectile function after robot-assisted operation Background To evaluate the safety and feasibility of the new robotic TELELAP ALF-X platform in a heterogeneous series of gynecological procedures . Methods Between September 2013 and May 2014 , 146 patients were enrolled in this Phase II study trial . Patients with presumed benign or borderline adnexal disease , and benign and early stage malignant uterine disease were prospect ively included . Results Median age was 52 years ( range 19–79 years ) , and median BMI was 23.7 ( range 17.3–34.0 kg/m2 ) . Sixty-two patients ( 32.5 % ) underwent mono/bilateral salpingo-oophorectomy or cyst removal ( Group A ) , four patients ( 2.7 % ) myomectomy ( Group B ) , 46 patients ( 31.5 % ) total hysterectomy ( Group C ) , and 34 ( 23.3 % ) endometrial cancer staging ( Group D ) . Median docking time was 7 min ( range 3–36 ) . Median OT was 35 min ( range 17–145 ) in the Group A , 40 min ( range 10–50 ) in the Group B , 133 min ( range 58–320 ) in the Group C , and 160 min ( range 69–290 ) in the Group D. Reduction in OT over the study period for hysterectomy ( p < 0.001 ) and adnexal surgery ( p < 0.002 ) was observed . We registered two laparoscopic conversion ( 3.2 % ) in the Group A and two ( 4.3 % ) in the Group C. In the Group D , we showed one ( 2.9 % ) laparoscopic and two ( 5.8 % ) laparotomic conversions . One patient ( 2.17 % ) in the Group C was readmitted in the early postoperative period for severe vaginal bleeding . Conclusions We report the first series of a novel robotic approach for the treatment of various gynecological conditions . When performed by experienced minimally invasive surgeons , TELELAP ALF-X is feasible and safe . Further studies are m and atory to define the benefits , advantages , and costs of this new robotic approach with respect to others minimally invasive approaches
Output:
| Concerning oncological outcomes , there were no significant differences in biochemical recurrence or the positive surgical margin rate .
The effectiveness of the system could not offset the costs , because there was no significant difference in effectiveness among the different procedures , and the robotic cost of RARP was significantly more than that of the other procedures .
The RARP group had less perioperative bleeding and shorter hospital stays .
Reoperation during the hospital stay and seeking health care for cardiovascular reasons were more frequent after ORP .
The authors concluded that RPN is more favorable than laparoscopic partial nephrectomy ( LPN ) in terms of a lower conversion rate to radical nephrectomy , more favorable renal function , a shorter length of hospital stay , and a shorter warm ischemia time . |
MS210684 | ***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 optimal volume of resistance exercise to prescribe for trained individuals is unclear . The purpose of this study was to r and omly assign resistance trained individuals to 6-weeks of squat exercise , prescribed at 80 % of a 1 repetition-maximum ( 1-RM ) , using either one , four , or eight sets of repetitions to failure performed twice per week . Participants then performed the same peaking program for 4-weeks . Squat 1-RM , quadriceps muscle activation , and contractile rate of force development ( RFD ) were measured before , during , and after the training program . 32 resistance-trained male participants completed the 10-week program . Squat 1-RM was significantly increased for all groups after 6 and 10-weeks of training ( P < 0.05 ) . The 8-set group was significantly stronger than the 1-set group after 3-weeks of training ( 7.9 % difference , P < 0.05 ) , and remained stronger after 6 and 10-weeks of training ( P < 0.05 ) . Peak muscle activation did not change during the study . Early ( 30 , 50 ms ) and peak RFD was significantly decreased for all groups after 6 and 10-weeks of training ( P < 0.05 ) . Peak isometric force output did not change for any group . The results of this study support resistance exercise prescription in excess of 4-sets ( i.e. 8-sets ) for faster and greater strength gains as compared to 1-set training . Common neuromuscular changes are attributed to high intensity squats ( 80 % 1-RM ) combined with a repetition to failure prescription . This prescription may not be useful for sports application owing to decreased early and peak RFD . Individual responsiveness to 1-set of training should be evaluated in the first 3-weeks of training We investigated the firing rate of motor units in the vastus lateralis muscle in five healthy young men ( mean = 21.4 yr , SD = 0.9 ) during a sequence of isometric constant-torque contractions repeated to exhaustion . The contractions were sustained at 20 % of the maximal voluntary level , measured at the beginning of the test sequence . Electromyographic ( EMG ) signals were recorded via quadrifilar fine-wire electrodes and subsequently decomposed into their constituent motor unit action potentials to obtain the motor unit firing times . In addition , we measured the whole muscle mechanical properties during the fatigue task using electrical stimulation . The firing rate of motor units first decreased within the first 10 - 20 % of the endurance time of the contractions and then increased . The firing rate increase was accompanied by recruitment of additional motor units as the force output remained constant . The elicited twitch and tetanic torque responses first increased and then decreased . The two processes modulated in a complementary fashion at the same time . Our data suggest that , when the vastus lateralis muscle is activated to maintain a constant torque output , its motoneuron pool receives a net excitatory drive that first decreases to compensate for the short-lived potentiation of the muscle force twitch and then increases to compensate for the diminution of the force twitch . The underlying inverse relationship between the firing rate and the recruitment threshold that has been reported for nonfatigued contractions is maintained . We , therefore , conclude that the central nervous system control of vastus lateralis motor units remains invariant during fatigue in submaximal isometric isotonic contractions We have reported that the acute postexercise increases in muscle protein synthesis rates , with differing nutritional support , are predictive of longer-term training-induced muscle hypertrophy . Here , we aim ed to test whether the same was true with acute exercise-mediated changes in muscle protein synthesis . Eighteen men ( 21 ± 1 yr , 22.6 ± 2.1 kg/m(2 ) ; means ± SE ) had their legs r and omly assigned to two of three training conditions that differed in contraction intensity [ % of maximal strength ( 1 repetition maximum ) ] or contraction volume ( 1 or 3 sets of repetitions ) : 30%-3 , 80%-1 , and 80%-3 . Subjects trained each leg with their assigned regime for a period of 10 wk , 3 times/wk . We made pre- and posttraining measures of strength , muscle volume by magnetic resonance ( MR ) scans , as well as pre- and posttraining biopsies of the vastus lateralis , and a single postexercise ( 1 h ) biopsy following the first bout of exercise , to measure signaling proteins . Training-induced increases in MR-measured muscle volume were significant ( P < 0.01 ) , with no difference between groups : 30%-3 = 6.8 ± 1.8 % , 80%-1 = 3.2 ± 0.8 % , and 80%-3= 7.2 ± 1.9 % , P = 0.18 . Isotonic maximal strength gains were not different between 80%-1 and 80%-3 , but were greater than 30%-3 ( P = 0.04 ) , whereas training-induced isometric strength gains were significant but not different between conditions ( P = 0.92 ) . Biopsies taken 1 h following the initial resistance exercise bout showed increased phosphorylation ( P < 0.05 ) of p70S6 K only in the 80%-1 and 80%-3 conditions . There was no correlation between phosphorylation of any signaling protein and hypertrophy . In accordance with our previous acute measurements of muscle protein synthetic rates a lower load lifted to failure result ed in similar hypertrophy as a heavy load lifted to failure The purpose of this study was to examine the efficacy of 11 wk of resistance training to failure vs. nonfailure , followed by an identical 5-wk peaking period of maximal strength and power training for both groups as well as to examine the underlying physiological changes in basal circulating anabolic and catabolic hormones . Forty-two physically active men were matched and then r and omly assigned to either a training to failure ( RF ; n = 14 ) , nonfailure ( NRF ; n = 15 ) , or control groups ( C ; n = 13 ) . Muscular and power testing and blood draws to determine basal hormonal concentrations were conducted before the initiation of training ( T0 ) , after 6 wk of training ( T1 ) , after 11 wk of training ( T2 ) , and after 16 wk of training ( T3 ) . Both RF and NRF result ed in similar gains in 1-repetition maximum bench press ( 23 and 23 % ) and parallel squat ( 22 and 23 % ) , muscle power output of the arm ( 27 and 28 % ) and leg extensor muscles ( 26 and 29 % ) , and maximal number of repetitions performed during parallel squat ( 66 and 69 % ) . RF group experienced larger gains in the maximal number of repetitions performed during the bench press . The peaking phase ( T2 to T3 ) after NRF result ed in larger gains in muscle power output of the lower extremities , whereas after RF it result ed in larger gains in the maximal number of repetitions performed during the bench press . Strength training leading to RF result ed in reductions in resting concentrations of IGF-1 and elevations in IGFBP-3 , whereas NRF result ed in reduced resting cortisol concentrations and an elevation in resting serum total testosterone concentration . This investigation demonstrated a potential beneficial stimulus of NRF for improving strength and power , especially during the subsequent peaking training period , whereas performing sets to failure result ed in greater gains in local muscular endurance . Elevation in IGFBP-3 after resistance training may have been compensatory to accommo date the reduction in IGF-1 to preserve IGF availability Balancing exercises on instable bases ( sensorimotor training [ SMT ] ) are often used in the rehabilitation process of an injured athlete to restore joint function . Recently it was shown that SMT was able to enhance rate of force development ( RFD ) in a maximal voluntary muscle contraction . The purpose of this study was to compare adaptations on strength capacity following ballistic strength training ( BST ) with those following an SMT during a training period of 1 microcycle ( 4 weeks ) . Maximum voluntary isometric strength ( MVC ) , maximum RFD ( RFDmax ) and the corresponding neural activation of M. soleus ( SOL ) , M. gastrocnemius ( GAS ) , and M. tibialis anterior ( TIB ) were measured during plantar flexion in 33 healthy subjects . The subjects were r and omly assigned to a SMT , BST , or control group . RFDmax increased significantly stronger following BST ( 48 ± 16 % ; p < 0.01 ) compared to SMT ( 14 ± 5 % ; p < 0.05 ) , whereas MVC remained unchanged in both groups . Median frequencies of the electromyographic power spectrum during the first 200 ms of contraction for GAS increased following both BST ( 45 ± 21 % ; p < 0.05 ) and SMT ( 45 ± 22 % ; p < 0.05 ) , but median frequencies for SOL increased only after SMT ( 13 ± 4 % ; p < 0.05 ) . Additionally , mean amplitude voltage increased following BST for SOL ( 38 ± 12 % ; p < 0.01 ) and for GAS ( 73 ± 23 % ; p < 0.01 ) during the first 100 ms , whereas it remained unchanged after SMT . It is concluded that BST and SMT may induce different neural adaptations that specifically affect recruitment and discharge rates of motor units at the beginning of voluntary contraction . Specific neural adaptations indicate that SMT might be used complementarily to BST , especially in sports that require contractile explosive properties in situations with high postural dem and s , e.g. , during jumps in ball sports The purpose of this study was to investigate the importance of training leading to repetition failure in the performance of 2 different tests : 6 repetition maximum ( 6RM ) bench press strength and 40-kg bench throw power in elite junior athletes . Subjects were 26 elite junior male basketball players ( n = 12 ; age = 18.6 ± 0.3 years ; height = 202.0 ± 11.6 cm ; mass = 97.0 ± 12.9 kg ; mean ± SD ) and soccer players ( n = 14 ; age = 17.4 ± 0.5 years ; height = 179.0 ± 7.0 cm ; mass = 75.0 ± 7.1 kg ) with a history of greater than 6 months ' strength training . Subjects were initially tested twice for 6RM bench press mass and 40-kg Smith machine bench throw power output ( in watts ) to establish retest reliability . Subjects then undertook bench press training with 3 sessions per week for 6 weeks , using equal volume programs ( 24 repetitions × 80–105 % 6RM in 13 minutes 20 seconds ) . Subjects were assigned to one of two experimental groups design ed either to elicit repetition failure with 4 sets of 6 repetitions every 260 seconds ( RF4 × 6 ) or allow all repetitions to be completed with 8 sets of 3 repetitions every 113 seconds ( NF8 × 3 ) . The RF4 × 6 treatment elicited substantial increases in strength ( 7.3 ± 2.4 kg , 19.5 % , p < 0.001 ) and power ( 40.8 ± 24.1 W , 110.6 % , p < 0.001 ) , while the NF8 × 3 group elicited 3.6 ± 3.0 kg ( 15.0 % , p < 0.005 ) and 25 ± 19.0 W increases ( 16.8 % , p < 0.001 ) . The improvements in the RF4 × 6 group were greater than those in the repetition rest group for both strength ( p < 0.005 ) and power ( p < 0.05 ) . Bench press training that leads to repetition failure induces greater strength gains than nonfailure training in the bench press exercise for elite junior team sport athletes OBJECTIVE : To test the feasibility of creating a valid and reliable checklist with the following features : appropriate for assessing both r and omised and non-r and omised studies ; provision of both an overall score for study quality and a profile of scores not only for the quality of reporting , internal validity ( bias and confounding ) and power , but also for external validity . DESIGN : A pilot version was first developed , based on epidemiological principles , review s , and existing checklists for r and omised studies . Face and content validity were assessed by three experienced review ers and reliability was determined using two raters assessing 10 r and omised and 10 non-r and omised studies . Using different raters , the checklist was revised and tested for internal consistency ( Kuder-Richardson 20 ) , test-retest and inter-rater reliability ( Spearman correlation coefficient and sign rank test ; kappa statistics ) , criterion validity , and respondent burden . MAIN RESULTS : The performance of the checklist improved considerably after revision of a pilot version . The Quality Index had high internal consistency ( KR-20 : 0.89 ) as did the subscales apart from external validity ( KR-20 : 0.54 ) . Test-retest ( r 0.88 ) and inter-rater ( r 0.75 ) reliability of the Quality Index were good . Reliability of the subscales varied from good ( bias ) to poor ( external validity ) . The Quality Index correlated highly with an existing , established instrument for assessing r and omised studies ( r 0.90 ) . There was little difference between its performance with non-r and omised and with r and omised studies . Raters took about 20 minutes to assess each paper ( range 10 to 45 minutes ) . CONCLUSIONS : This study has shown that it is
Output:
| Conclusion Overall , the results suggest that despite statistically significant effects on muscular strength being found for non-failure compared with failure training , the small percentage of improvement shown for non-failure training is unlikely to be meaningful .
Therefore , it appears that similar increases in muscular strength can be achieved with failure and non-failure training . |
MS210685 | ***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: Forty‐eight patients with symmetrical chronic plaque psoriasis affecting the limbs were recruited for a single‐blind right/left within patient study to assess the effect of combining occlusion with topical calcipotriol . Subjects were r and omized into two groups . Sites of similar severity on opposing limbs were selected as target areas . The first ( group A ) treated one side with calcipotriol alone and the opposite side with calcipotriol plus occlusion . The second ( group 13 ) treated one side with placebo plus occlusion and the opposite side with calcipotriol plus occlusion . In group A the mean improvements were 40 % ( P < 0·001 ) for calcipotriol alone and 61 % ( P < 0·001 ) for calcipotriol plus occlusion . In group B , occlusion plus calcipotriol result ed in a mean 62 % improvement ( P < 0·001 ) while occlusion plus placebo produced no significant change . The combination of calcipotriol plus occlusion was significantly better than calcipotriol alone ( P < 0·005 ) . The results indicate that occlusion improves the response to calcipotriol by enhancing its penetration . Indices of calcium metabolsm remained unchanged throughout the study Ro 10 - 9359 is a retinoic acid derivative , selected for study because of a better tolerance than retinoic acid , shown in animal experiments . Doses of 25 mg b.i.d . , 25 mg t.i.d . and 50 mg b.i.d . were administered orally to 27 patients suffering from severe chronic generalized psoriasis . The clinical efficacy was evaluated by means of a new index , psoriasis area and severity index ( PASI ) based on severity and area of psoriatic lesions . At doses of 25 mg t.i.d . or 50 mg b.i.d . Ro 10 - -9359 proved to be an extremely potent antipsoriatic drug . A more than 90 % reduction of psoriatic lesions could be seen in 10 patients out of 20 after 4 - 8 weeks of treatment . This good effect lasted about 5 weeks after treatment . Side effects were frequent , but mostly mild and completely reversible after termination of treatment BACKGROUND Although potent , topical corticosteroids offer effective and rapid healing of psoriatic lesions . Their long term use is limited because of the risk of side effects . Calcipotriol is safe for long-term treatment , but its initial efficacy is lower than with topical corticosteroids . OBJECTIVES To investigate whether 2 weeks of treatment with clobetasol propionate 0.05 % ointment bd followed by 4 weeks of treatment with calcipotriol 50 microg/g bd would offer therapeutic advantages over 6 weeks of continuous treatment with calcipotriol . METHODS Forty-nine patients with moderate to severe plaque psoriasis were recruited from five centres in Norway . In a r and omised , double-blind , right- versus left-side comparison , ointments were applied to two symmetrically-located areas . RESULTS Two weeks of treatment with clobetasol propionate produced a significantly greater decrease in total symptom score ( combined scores of erythema , in duration and scaling ) than calcipotriol treatment ( P < 0.0001 ) . This improvement on the clobetasol propionate-treated side of the body was maintained throughout a subsequent 4-week treatment period when calcipotriol was applied to both sides of the body ( P < 0.0001 ) . The superiority of the clobetasol propionate followed by calcipotriol treatment was maintained during a 4-week , treatment-free , observation period . Treatments were well tolerated with no rebound effect . CONCLUSIONS Clobetasol propionate ointment bd for 2 weeks followed by treatment with calcipotriol ointment bd for 4 weeks was superior to calcipotriol ointment alone in the treatment of plaque psoriasis In 10 in- patients with chronic plaque psoriasis , the antipsoriatic effect of MC903 , a new synthetic analogue of vitamin D was evaluated . In each patient two symmetrical located psoriatic plaques were selected for the study . Topical treatment with MC903 cream ( containing 1.2 mg MC903 per g cream ) was compared with placebo cream in a double-blind , controlled , left-right , r and omized way during 6 weeks of therapy . Compared with baseline , the clinical ( erythema , scaling and infiltration ) improvement was significant after 1 week of therapy with MC903 cream , while lateral comparison showed MC903 cream significantly better than cream base after 4 weeks of therapy ( p less than 0.05 ) . Measurements of skin blood flow by the laser Doppler technique in evaluating the disease activity was not superior to the clinical assessment s. In 3 patients the psoriatic lesions treated with MC903 cream cleared completely during 6 weeks of therapy . No essential adverse reactions were observed . MC903 has a potent effect on cell proliferation and cell differentiation , but has minimal effect on calcium metabolism . It is concluded that this synthetic vitamin D analogue is potentially useful in the treatment of psoriasis The effect of the non‐calciotropic vitamin D3 analogue MC 903 on psoriasis vulgaris was assessed in a double‐blind , placebo controlled trial in 30 patients . Lesions on one side of the body were treated for 6 weeks with a cream containing 10 μ/g , 33 μg//g or 100 μg/g MC 903 and lesions on the other side were treated with the cream base alone , according to a r and omized design . Nine of the 10 patients in each treatment group completed the study . MC 903 cream gave a statistically significant decrease in erythema , thickness and scaling of the lesions , compared with the control . Overall assessment of psoriasis after 6 weeks showed moderate or excellent improvement in two of nine patients treated with 10 μg/g , in five of nine patients treated with 33 μ/g , and in seven of nine patients treated with 100 μ/g MC 903 . Placebo treatment showed a moderate improvement in only one of the 27 patients . The histopathological picture of the psoriatic lesions corresponded with the clinical changes . The patients reported no adverse reactions , and laboratory tests did not show any significant changes ; in particular there was no change in serum calcium levels . These results suggest that the vitamin D3 analogue MC 903 is an effective and safe topical treattnent for psoriasis Topical treatment of psoriasis with calcipotriol has been proven effective . The efficacy of calcipotriol has been compared to that of topical corticoids in a number of studies using subjective visual scoring systems such as the PASI index . The purpose of this study was to compare , with objective data , the efficacy of calcipotriol and clobetasol propionate 0.05 % in the treatment of plaque type psoriasis . Transepidermal water loss ( TEWL ) and laser Doppler velocimetry ( LDV ) were used to monitor restoration of water barrier and normalization of blood flow , respectively , in psoriatic plaques of the limbs of 24 male patients during 3 weeks of treatment . Data were compared to subjective evaluation using the PASI index of the same areas . Significant differences were recorded during treatment in both groups . The results correlated well with the PASI score . Clobetasol was faster in restoring barrier function than calcipotriol . However , no significant differences were detected between the two groups . The use of vitamin analogues may be effective in the topical treatment of psoriasis by normalizing skin biophysical parameters and minimizing the risks of side-effects induced by potent topical corticoids
Output:
| CONCLUSIONS Calcipotriol is an effective treatment for mild to moderate chronic plaque psoriasis , more so than calcitriol , tacalcitol , coal tar , and short contact dithranol .
Only potent topical corticosteroids seem to have comparable efficacy at eight weeks .
Although calcipotriol caused more skin irritation than topical corticosteroids this has to be balanced against the potential long term effects of corticosteroids .
Skin irritation rarely led to withdrawal of calcipotriol treatment . |
MS210686 | ***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 Inflammatory bowel disease ( IBD ) and colorectal surgery are risk factors for deep venous thrombosis ( DVT ) . The aim of this prospect i ve study was to evaluate the effectiveness of st and ardized prophylactic low molecular weight heparin ( LMWH ) therapy in patients who underwent surgery for ulcerative colitis ( UC ) and Crohn ’s disease ( CD ) . Patients and methods Since 1999 all patients operated on for colorectal diseases in our institute have received 4,000 IU/day LMWH from the day of operation to discharge . The complete series of patients who had major colorectal surgery from 1999 until 2006 were review ed for overt DVT episodes . Furthermore , 60 consecutive patients who were admitted for surgery for IBD were prospect ively enrolled in the 2004–2006 period . Each patient underwent venous color Doppler ultrasound scan at admission and at discharge . Demographic data , disease activity , and clotting parameters were collected . Data were analyzed with Spearman ’s correlation test , multiple regression , and receiver operating characteristics ( ROC ) curves analysis . Results The rate of DVT in UC patients was significantly higher than in colorectal cancer patients ( p = 0.009 ) , and the odds ratio ( OR ) for postoperative DVT in UC patients was 7.4 ( 95 % CI 1.4–44.4 ; p = 0.017 ) . Female gender , UC diagnosis , active rectal bleeding , aPTT value , aCL IgM , aβ2 IgM , and pANCA levels significantly correlated with postoperative DVT . At multivariate analysis only aCL IgM levels were found to be independently associated with postoperative DVT ( p = 0.05 ) . Conclusions In conclusion , our study showed that prophylactic therapy with 4,000 IU/day LMWH was not completely effective for the prevention of postoperative DVT in patients with CD , and even less so in those with UC . In these patients , a more tailored prophylactic therapy should be considered , and further r and omized controlled trials testing the effectiveness of different prophylactic protocol s would be advisable . Furthermore , aCL IgM serum levels might be helpful in identifying IBD patients who are at higher risk of postoperative DVT AIM To evaluate the effect of perioperative parenteral nutrition on serum immunoglobulin , weight change , and post-operative outcome in severely malnourished patients with Crohn 's disease . METHODS Thirty-two severely malnourished patients with Crohn 's disease who had undergone surgery in our hospital were review ed . Sixteen patients who received perioperative parenteral nutrition were enrolled in the study group , and the other 16 patients who did not receive parenteral nutrition were enrolled in the control group . Serum immunoglobulin , body mass index ( BMI ) , liver function , weight change , and postoperative complications were evaluated . RESULTS Serum IgM levels elevated 1 wk before surgery in both groups , and decreased to normal value ( from 139+/-41 to 105+/-29 mg/dL , P = 0.04 ) 4 wk after operation in the study group , while no significant changes was noted in the control group ( from 133+/-16 to 129+/-13 mg/dL , P = 0.34 ) . There were no significant changes in concentrations of IgG and IgA. The BMI of the study group increased from 13.9+/-0.6 to 15.3+/-0.7 kg/m(2 ) ( P = 0.02 ) with no significant change in the control group ( 14.1+/-0.7 and 14.5+/-0.5 , respectively , P = 0.81 ) . The percentage of resuming work was higher in the study group than in the control group . CONCLUSION Perioperative parenteral nutrition possibly ameliorates the humoral immunity , reverses malnutrition , and facilitates rehabilitation Abstract Objective . The effect of preoperative total parenteral nutrition ( TPN ) on the rate of early ( within 30 days ) postoperative complications in patients with moderate to severe Crohn 's disease ( CD ) was examined . Material and methods . A series of 15 consecutive patients with CD ( mean CD activity index score , 270 ) given preoperative TPN for 18–90 days ( mean , 46 days ) and undergoing bowel resection and primary anastomosis was compared with matching controls ( 105 patients ) consecutively selected from all CD patients operated in Stockholm County during a preceding 20-year period without preoperative TPN . Results . During the preoperative TPN , all the patients studied displayed clinical remission of CD as reflected in improvement in their general well-being , relief of abdominal pain , and abatement of fever and diarrhea . There was no significant early postoperative complication in the TPN-treated group , whereas there were 29 patients with early postoperative complications in the control group , which means a significantly higher rate of postoperative complications when preoperative TPN was not provided . During the preoperative TPN , some crucial variables increased such as the body weight , the serum concentrations of albumin and triiodothyronine reflecting improved nutritional state , whereas the serum concentration of haptoglobin and the white cell count decreased reflecting decreased inflammatory activity . Conclusions . This study shows that preoperative TPN for at least 18 days may be recommended to be given to patients with moderate to severe CD until clinical remission is achieved in order to minimize the risk of early postoperative complications BACKGROUND & AIMS Lifestyle factors have been shown to influence prognosis in Crohn 's disease . The purpose of this study was to prospect ively assess the effects of smoking and oral contraceptive use on clinical relapse rates . METHODS Placebo-treated patients formed a prospect i ve cohort , followed up for 48 weeks or until relapse . The influence of smoking and the use of oral contraceptives on relapse risk was examined by life-table analysis ( log rank tests ) and Cox proportional hazards modeling , taking into account demographic and disease characteristics . RESULTS Of 152 patients , 61 ( 40 % ) had a relapse . Univariate analysis showed unfavorable outcomes for women ( P = 0.05 ) , current smokers ( P = 0.005 ) , and use of oral contraceptives ( P = 0.001 ) . Recent surgery was associated with a decreased risk of relapse ( P = 0.02 ) . The Cox model retained current smoking vs. never smoking ( hazard ratio , 2.1 ; 95 % confidence interval , 1.1 - 4.2 ) , oral contraceptive use ( hazard ratio , 3.0 ; 95 % confidence interval , 1.5 - 5.9 ) , and medical compared with surgical induction of remission ( hazard ratio , 2.1 ; 95 % confidence interval , 1.0 - 4.2 ) as predictors of relapse . Ex-smokers did not have an increased risk . Finally , sex , age , time in remission , disease location , and disease duration were not significant predictors . CONCLUSIONS Oral contraceptive use and smoking are associated with an increased risk of relapse in patients with Crohn 's disease Background : Long‐term enteral nutrition may maintain clinical and endoscopic remission in patients with Crohn 's disease ( CD ) . The aim of this prospect i ve study was to investigate the impacts of long‐term enteral nutrition on clinical and endoscopic disease activities and mucosal tissue cytokines in patients with quiescent CD . Methods : Forty patients with CD who achieved clinical remission were included . Of these , 20 received continuous elemental diet ( Elental ) infusion during the nighttime and a low‐fat diet during the daytime ( EN group ) and 20 received neither nutritional therapy nor food restriction ( non‐EN group ) . With these regimens , all 40 patients were monitored for 1 year . Further , ileocolonoscopy was performed at entry , at 6 and 12 months , and mucosal biopsies were taken for cytokine assays . Results : On an intention‐to‐treat basis , 5 patients ( 25 % ) in the EN group and 13 ( 65 % ) in the non‐EN group had a clinical relapse during the 1‐year observation ( P = 0.03 ) . The mean endoscopic inflammation ( EI ) scores were not significantly different between the groups at both entry and 6 months , but at 12 months EI scores were significantly higher in the non‐EN group than in the EN group ( P = 0.04 ) . Additionally , the mucosal tissue interleukin (IL)‐1&bgr ; , IL‐6 , and tumor necrosis factor (TNF)‐&agr ; levels significantly increased with time in the non‐EN group ( entry versus 12 months , IL‐1&bgr ; , P = 0.02 ; IL‐6 , P = 0.002 ; TNF‐&agr ; , P = 0.001 ) . In the EN group these cytokines did not show a significant increase . Conclusions : Long‐term enteral nutrition in patients with quiescent CD has a clear suppressive effect on clinical and endoscopic disease activities and the mucosal inflammatory cytokine levels . ( Inflamm Bowel Dis 2007 Objective : To compare the efficacy and safety of antithrombotic prophylaxis given for 1 week or 4 weeks in patients undergoing laparoscopic surgery for colorectal cancer . Background : Extending antithrombotic prophylaxis beyond 1 week reduces the incidence of venous thromboembolism ( VTE ) after open abdominal surgery for cancer . Methods : In consecutive patients who underwent laparoscopic surgery for colorectal cancer , complete compression ultrasonography of the lower limbs was performed after 8 ± 2 days of antithrombotic prophylaxis . Patients with no evidence of VTE were r and omized to short ( heparin withdrawal ) or to extended ( heparin continued for 3 additional weeks ) prophylaxis . Complete compression ultrasonography was repeated at day 28 ± 2 after surgery by investigators blinded to treatment allocation . The primary outcome of the study was the composite of symptomatic and ultrasonography-detected VTE at day 28 ± 2 after surgery . Results : Overall , 301 patients were evaluated for inclusion in the study and 225 were r and omized . VTE occurred in 11 of 113 patients r and omized to short ( 9.7 % ) and in none of the 112 patients r and omized to extended heparin prophylaxis ( P = 0.001 ) . The incidence of VTE at 3 months was 9.7 % and 0.9 % in patients r and omized to short or to extended heparin prophylaxis , respectively ( relative risk reduction : 91 % , 95 % confidence interval : 30%–99 % ; P = 0.005 ) . The rate of bleeding was similar in the 2 treatment groups . Two patients died during the study period , 1 in each treatment group . Conclusions : After laparoscopic surgery for colorectal cancer , extended antithrombotic prophylaxis is safe and reduces the risk for VTE as compared with 1-week prophylaxis ( NCT01589146 ) Objective : To evaluate the safety of perioperative low-dose steroids ( LDS ) versus high-dose steroids ( HDS ) in steroid-treated patients with inflammatory bowel disease ( IBD ) undergoing major colorectal surgery . Background : Corticosteroid-treated patients undergoing major colorectal surgery are commonly prescribed HDS to prevent perioperative adrenal insufficiency and cardiovascular collapse . There is little evidence to support this practice . Methods : We performed a single-blinded noninferiority trial to compare perioperative hemodynamic instability in 92 steroid-treated IBD patients undergoing major colorectal surgery . Patients were r and omly assigned to receive perioperative high-dose corticosteroids ( HDS ; hydrocortisone , 100 mg , intravenously 3 times daily , followed by taper ) or low-dose corticosteroids ( LDS ; intravenous hydrocortisone equivalent to presurgical oral dosing , followed by taper ) . The primary outcome was the absence of postural hypotension on postoperative day 1 , defined as a decrease in systolic blood pressure by 20 mm Hg after sitting from a supine position . Results : The primary outcome , absence of postural hypotension on postoperative day 1 , occurred in 95 % of those r and omized to receive high doses of corticosteroids compared with 96 % of those who received low doses ( noninferiority 95 % confidence interval = −0.08 to 0.09 ; P = 0.007 ) . Conclusions : In IBD patients undergoing abdominal surgery , the incidence of postural hypotension or adrenal insufficiency is similar among those receiving high doses or low doses of corticosteroids in the perioperative period . To reduce complications associated with unnecessarily high doses of steroids , steroid-treated IBD patients undergoing major colorectal surgery should be treated with low doses of steroids in the perioperative period . ( Clinical trials.gov ID # NCT01559675 BACKGROUND AND AIMS To evaluate the benefit of smoking cessation in individuals with Crohn 's disease , we performed an intervention study in a large cohort of smokers with the disease . METHODS Repeated counseling to stop smoking , with easy access to a smoking cessation program , was given to 4
Output:
| Thiopurines appear to be safe , but it may be prudent to plan the procedure remotely from the last dose of an anti-TNF agent .
Thrombosis prophylaxis prior to surgery is well supported by evidence while extended 4-week prophylaxis needs further research .
Percutaneous ultrasound or CT-guided drainage for intra-abdominal abscesses is recommended , but it is unclear for how long supplementary antibiotics ( ABs ) should be used .
Oral AB 24 h prior to open surgery might improve outcome if given as complementary to IV perioperative AB .
Mechanical bowel preparation is not supported by evidence .
Smoking cessation can be beneficial for wound healing . |
MS210687 | ***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: Women often exhibit larger hormonal and subjective responses to opioid receptor antagonists than men , but the biological mechanisms mediating this effect remain unclear . Among women , fluctuations in estradiol ( E2 ) and progesterone ( P4 ) across the menstrual cycle ( MC ) affect the endogenous opioid system . Therefore , the goal of the current study was to compare acute naltrexone response between women in the early follicular phase of the MC ( low E2 and P4 ) , women in the luteal phase of the MC ( high E2 and P4 ) , and men . Seventy healthy controls ( n=46 women ) participated in two morning sessions in which they received 50 mg naltrexone or placebo in a r and omized , counterbalanced order . Women were r and omized to complete both sessions in either the early follicular ( n=23 ) or luteal phase of the MC . Serum cortisol , salivary cortisol , prolactin , luteinizing hormone ( LH ) , and subjective response were assessed upon arrival to the laboratory and at regular intervals after pill administration . In luteal and early follicular women but not men , naltrexone ( vs. placebo ) increased serum cortisol and prolactin levels from baseline ; however , the naltrexone-induced increases in these hormones were significantly greater in luteal women than early follicular women . Additionally , only luteal women demonstrated an increase from baseline in salivary cortisol levels and the severity of adverse drug effects in response to naltrexone . In sum , the results indicate that luteal phase women are more sensitive to acute hormonal and subjective effects of naltrexone than early follicular women and men . These findings may have important implication s for the use of naltrexone in women Nalbuphine , an agonist-antagonist kappa-opioid , produces brief analgesia followed by enhanced pain/hyperalgesia in male postsurgical patients . However , it produces profound analgesia without pain enhancement when co-administration with low dose naloxone . To examine the effect of nalbuphine or nalbuphine plus naloxone on activity in brain regions that may explain these differences , we employed pharmacological magnetic resonance imaging ( phMRI ) in a double blind cross-over study with 13 healthy male volunteers . In separate imaging sessions subjects were administered nalbuphine ( 5 mg/70 kg ) preceded by either saline ( Sal-Nalb ) or naloxone 0.4 mg ( Nalox-Nalb ) . Blood oxygen level-dependent ( BOLD ) activation maps followed by contrast and connectivity analyses revealed marked differences . Sal-Nalb produced significantly increased activity in 60 brain regions and decreased activity in 9 ; in contrast , Nalox-Nalb activated only 14 regions and deactivated only 3 . Nalbuphine , like morphine in a previous study , attenuated activity in the inferior orbital cortex , and , like noxious stimulation , increased activity in temporal cortex , insula , pulvinar , cau date , and pons . Co-administration/pretreatment of naloxone selectively blocked activity in pulvinar , pons and posterior insula . Nalbuphine induced functional connectivity between cau date and regions in the frontal , occipital , temporal , insular , middle cingulate cortices , and putamen ; naloxone co-admistration reduced all connectivity to non-significant levels , and , like phMRI measures of morphine , increased activation in other areas ( e.g. , putamen ) . Naloxone pretreatment to nalbuphine produced changes in brain activity possess characteristics of both analgesia and algesia ; naloxone selectively blocks activity in areas associated with algesia . Given these findings , we suggest that nalbuphine interacts with a pain salience system , which can modulate perceived pain intensity BACKGROUND Extended-release naltrexone ( XR-NTX ) , an opioid antagonist , and sublingual buprenorphine-naloxone ( BUP-NX ) , a partial opioid agonist , are pharmacologically and conceptually distinct interventions to prevent opioid relapse . We aim ed to estimate the difference in opioid relapse-free survival between XR-NTX and BUP-NX . METHODS We initiated this 24 week , open-label , r and omised controlled , comparative effectiveness trial at eight US community-based inpatient services and followed up participants as out patients . Participants were 18 years or older , had Diagnostic and Statistical Manual of Mental Disorders-5 opioid use disorder , and had used non-prescribed opioids in the past 30 days . We stratified participants by treatment site and opioid use severity and used a web-based permuted block design with r and om equally weighted block sizes of four and six for r and omisation ( 1:1 ) to receive XR-NTX or BUP-NX . XR-NTX was monthly intramuscular injections ( Vivitrol ; Alkermes ) and BUP-NX was daily self-administered buprenorphine-naloxone sublingual film ( Suboxone ; Indivior ) . The primary outcome was opioid relapse-free survival during 24 weeks of outpatient treatment . Relapse was 4 consecutive weeks of any non- study opioid use by urine toxicology or self-report , or 7 consecutive days of self-reported use . This trial is registered with Clinical Trials.gov , NCT02032433 . FINDINGS Between Jan 30 , 2014 , and May 25 , 2016 , we r and omly assigned 570 participants to receive XR-NTX ( n=283 ) or BUP-NX ( n=287 ) . The last follow-up visit was Jan 31 , 2017 . As expected , XR-NTX had a substantial induction hurdle : fewer participants successfully initiated XR-NTX ( 204 [ 72 % ] of 283 ) than BUP-NX ( 270 [ 94 % ] of 287 ; p<0·0001 ) . Among all participants who were r and omly assigned ( intention-to-treat population , n=570 ) 24 week relapse events were greater for XR-NTX ( 185 [ 65 % ] of 283 ) than for BUP-NX ( 163 [ 57 % ] of 287 ; hazard ratio [ HR ] 1·36 , 95 % CI 1·10 - 1·68 ) , most or all of this difference accounted for by early relapse in nearly all ( 70 [ 89 % ] of 79 ) XR-NTX induction failures . Among participants successfully inducted ( per- protocol population , n=474 ) , 24 week relapse events were similar across study groups ( p=0·44 ) . Opioid-negative urine sample s ( p<0·0001 ) and opioid-abstinent days ( p<0·0001 ) favoured BUP-NX compared with XR-NTX among the intention-to-treat population , but were similar across study groups among the per- protocol population . Self-reported opioid craving was initially less with XR-NTX than with BUP-NX ( p=0·0012 ) , then converged by week 24 ( p=0·20 ) . With the exception of mild-to-moderate XR-NTX injection site reactions , treatment-emergent adverse events including overdose did not differ between treatment groups . Five fatal overdoses occurred ( two in the XR-NTX group and three in the BUP-NX group ) . INTERPRETATION In this population it is more difficult to initiate patients to XR-NTX than BUP-NX , and this negatively affected overall relapse . However , once initiated , both medications were equally safe and effective . Future work should focus on facilitating induction to XR-NTX and on improving treatment retention for both medications . FUNDING NIDA Clinical Trials Network Abstract Opioid painkillers are a promising treatment for chronic breathlessness , but are associated with potentially fatal side effects . In the treatment of breathlessness , their mechanisms of action are unclear . A better underst and ing might help to identify safer alternatives . Learned associations between previously neutral stimuli ( e.g. stairs ) and repeated breathlessness induce an anticipatory threat response that may worsen breathlessness , contributing to the downward spiral of decline seen in clinical population s. As opioids are known to influence associative learning , we hypothesized that they may interfere with the brain processes underlying a conditioned anticipatory response to breathlessness in relevant brain areas , including the amygdala and the hippocampus . Healthy volunteers viewed visual cues ( neutral stimuli ) immediately before induction of experimental breathlessness with inspiratory resistive loading . Thus , an association was formed between the cue and breathlessness . Subsequently , this paradigm was repeated in two identical neuroimaging sessions with intravenous infusions of either low‐dose remifentanil ( 0.7 ng/ml target‐controlled infusion ) or saline ( r and omised ) . During saline infusion , breathlessness anticipation activated the right anterior insula and the adjacent operculum . Breathlessness was associated with activity in a network including the insula , operculum , dorsolateral prefrontal cortex , anterior cingulate cortex and the primary sensory and motor cortices . Remifentanil reduced breathlessness unpleasantness but not breathlessness intensity . Remifentanil depressed anticipatory activity in the amygdala and the hippocampus that correlated with reductions in breathlessness unpleasantness . During breathlessness , remifentanil decreased activity in the anterior insula , anterior cingulate cortex and sensory motor cortices . Remifentanil‐induced reduction in breathlessness unpleasantness was associated with increased activity in the rostral anterior cingulate cortex and nucleus accumbens , components of the endogenous opioid system known to decrease the perception of aversive stimuli . These findings suggest that in addition to effects on brainstem respiratory control , opioids palliate breathlessness through an interplay of altered associative learning mechanisms . These mechanisms provide potential targets for novel ways to develop and assess treatments for chronic breathlessness . HighlightsThe mechanisms of how low‐dose opioids relieve breathlessness are unknown . We tested whether low‐dose opioids affect conditioned anticipation and perception of breathlessness . Low‐dose opioids reduced unpleasantness , but not intensity of breathlessness . Reduced breathlessness unpleasantness was associated with activation of the endogenous opioid system . Breathlessness relief was predicted by decreased anticipatory activity in amygdala/hippocampus BACKGROUND Cue-induced craving plays an important role in relapse , and the neural correlates of cue-induced craving have been eluci date d using fMRI . This study examined the utility of real-time fMRI ( rtfMRI ) neurofeedback to strengthen self-regulation of craving-related neural activation and cue-reactivity in cigarette smokers . METHODS Nicotine-dependent smokers were r and omized to rtfMRI neurofeedback or to a no-feedback control group . Participants completed 3 neuroimaging visits . Within each visit , an initial run during which smoking-related cues were used to provoke craving , an individualized craving-related region of interest ( ROI ) in the prefrontal cortex or anterior cingulate cortex was identified . In the rtfMRI group , activity from the ROI was fed back via a visual display during 3 subsequent runs while participants were instructed to reduce craving during cue exposure . The control group had an identical experience with no feedback provided . RESULTS Forty-four nicotine-dependent smokers were recruited to participate in our study ; data from the 33 participants who completed a 1-week follow-up visit were included in the analysis . Subjective craving ratings and cue-induced brain activation were lower in the rtfMRI group than in the control group . LIMITATIONS As participants were not seeking treatment , clinical outcomes are lacking . CONCLUSION Nicotine-dependent smokers receiving rtfMRI feedback from an individualized ROI attenuated smoking cue-elicited neural activation and craving , relative to a control group . Further studies are needed in treatment-seeking smokers to determine if this intervention can translate into a clinical ly meaningful treatment modality The behavioral response to pain is driven by sensory and affective components , each of which is mediated by the CNS . Subjective pain ratings are used as readouts when appraising potential analgesics ; however , pain ratings alone can not enable a characterization of CNS pain circuitry during pain processing or how this circuitry is modulated pharmacologically . Having a more objective readout of potential analgesic effects may allow improved underst and ing and detection of pharmacological efficacy for pain . The pharmacological/functional magnetic resonance imaging ( phMRI/fMRI ) methodology can be used to objective ly evaluate drug action on the CNS . In this context , we aim ed to evaluate two drugs that had been developed as analgesics : one that is efficacious for pain ( buprenorphine ( BUP ) ) and one that failed as an analgesic in clinical trials aprepitant ( APREP ) . Using phMRI , we observed that activation induced solely by BUP was present in regions with μ-opioid receptors , whereas APREP-induced activation was seen in regions expressing NK1 receptors . However , significant pharmacological modulation of functional connectivity in pain-processing pathways was only observed following BUP administration . By implementing an evoked pain fMRI paradigm , these drugs could also be differentiated by comparing the respective fMRI signals in CNS circuits mediating sensory and affective components of pain . We report a correlation of functional connectivity and evoked pain fMRI measures with pain ratings as well as peak drug concentration . This investigation demonstrates how
Output:
| We found convergent evidence that individuals with OUD display widespread heightened neural activation to heroin cues .
This pattern is potentiated by heroin , attenuated by medication-assisted treatments for opioids , predicts treatment response , and is reduced following extended abstinence . |
MS210688 | ***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 Lesbian , gay , and bisexual ( LGB ) men and women represent one of the highest-risk population s for depressive symptomatology and disorders , with young LGB adults being at greatest risk . To date , there have been no r and omized controlled trials ( RCT ) to specifically target depressive symptoms in young LGB adults . This is despite research highlighting unique predictors of depressive symptomatology in this population . Here we outline a protocol for an RCT that will test the preliminary efficacy of a tailored compassion-focused therapy ( CFT ) intervention for young LGB adults compared with a self-directed cognitive behavioral therapy ( CBT ) program with no specific tailoring for LGB individuals . Methods The CFT intervention consists of 8 units with self-directed reading and activities tailored to LGB young adults , and 8 x weekly 1-hour consultations with a therapist . The CBT intervention consists of 8 units with self-guided reading and activities , with 1 x 1-hour session with a therapist at the mid-point of therapy . Fifty LGB individuals with scores of 13 or above on the Beck Depression Inventory-II will be r and omized to either the CFT or CBT condition . The primary outcome measure is depressive symptomatology . Secondary outcome measures are symptoms of anxiety , suicidal ideation , internalized homophobia , self-compassion , and shame and guilt proneness . Assessment s will occur at pre-intervention , post-intervention , and at 3-month post-intervention . Discussion This study is an RCT to test the preliminary efficacy of an LGB-tailored compassion-focused intervention for young LGB adults with depressive symptomatology . If this intervention is efficacious , this could begin to address the substantial mental health disparities amongst sexual minorities . Trial registration ACTRN12616001018404 . Prospect i ve registration , registered 02/08/2016 OBJECTIVE We examined whether a shortened form of dialectical behavior therapy , dialectical behavior therapy for adolescents ( DBT-A ) is more effective than enhanced usual care ( EUC ) to reduce self-harm in adolescents . METHOD This was a r and omized study of 77 adolescents with recent and repetitive self-harm treated at community child and adolescent psychiatric outpatient clinics who were r and omly allocated to either DBT-A or EUC . Assessment s of self-harm , suicidal ideation , depression , hopelessness , and symptoms of borderline personality disorder were made at baseline and after 9 , 15 , and 19 weeks ( end of trial period ) , and frequency of hospitalizations and emergency department visits over the trial period were recorded . RESULTS Treatment retention was generally good in both treatment conditions , and the use of emergency services was low . DBT-A was superior to EUC in reducing self-harm , suicidal ideation , and depressive symptoms . Effect sizes were large for treatment outcomes in patients who received DBT-A , whereas effect sizes were small for outcomes in patients receiving EUC . Total number of treatment contacts was found to be a partial mediator of the association between treatment and changes in the severity of suicidal ideation , whereas no mediation effects were found on the other outcomes or for total treatment time . CONCLUSION DBT-A may be an effective intervention to reduce self-harm , suicidal ideation , and depression in adolescents with repetitive self-harming behavior . Clinical trial registration information-Treatment for Adolescents With Deliberate Self Harm ; http:// Clinical Trials.gov/ ; NCT00675129 OBJECTIVE To identify the independent and differential diagnostic and symptom correlates of suicidal ideation and suicide attempts and determine whether there are gender- and age-specific diagnostic profiles . METHOD The relationships between suicidal ideation , suicide attempts , and psychiatric disorders were examined among 1,285 r and omly selected children and adolescents , aged 9 to 17 years , of whom 42 had attempted suicide and 67 had expressed suicidal ideation only . Youths and their parents were interviewed as part of the Methods for the Epidemiology of Child and Adolescent Mental Disorders ( MECA ) Study , using the Diagnostic Interview Schedule for Children Version 2.3 ( DISC-2.3 ) . RESULTS Logistic regression analyses indicated that mood , anxiety , and substance abuse/dependence disorders independently increased the risk of suicide attempts , after controlling for sociodemographic characteristics . There was no significant independent contribution of disruptive disorders to suicide attempts , although its association with suicidal ideation was significant . Substance abuse/dependence independently differentiated suicide attempters from ideators . Noncriterion symptoms that remained significant predictors of suicide risk , after adjusting for psychiatric disorder , included panic attacks and aggressiveness . Perfectionism did not significantly increase suicide risk after adjusting for psychiatric disorder . The association of specific disorders and noncriterion symptoms with suicidality varied as a function of gender and age . CONCLUSION A monolithic diagnostic risk profile for suicidality , ignoring gender- and age-specific risks , is inadequate . The contribution of substance abuse/dependence in the escalation from suicidal thoughts to suicide attempts is underscored This pilot aims to better underst and the market for childcare in Saudi Arabia – both the supply and dem and sides – and to design a r and omized controlled experiment to test whether access to affordable day care ( in the form of subsidies , for example ) would incentivize Saudi mothers to search actively for employment and to remain employed once they are hired . In addition , the study seeks to underst and the degree to which employment early on in one ’s life impacts employment in later stages . The pilot will provide information on the groups of women the experiment should target , appropriate levels for the childcare subsidy , and the quality and current geographic locations of daycare sites . Expected Impact Determine the effects of facilitating childcare access on Saudi women ’s employment . PRINCIPAL INVESTIGATORS Boston University Patricia Cortes Harvard University Claudia Goldin Swarthmore College Jennifer Summary Background Self-harm in adolescents is common and repetition occurs in a high proportion of these cases . Scarce evidence exists for effectiveness of interventions to reduce self-harm . Methods This pragmatic , multicentre , r and omised , controlled trial of family therapy versus treatment as usual was done at 40 UK Child and Adolescent Mental Health Services ( CAMHS ) centres . We recruited young people aged 11–17 years who had self-harmed at least twice and presented to CAMHS after self-harm . Participants were r and omly assigned ( 1:1 ) to receive manualised family therapy delivered by trained and supervised family therapists or treatment as usual by local CAMHS . Participants and therapists were aware of treatment allocation ; research ers were masked . The primary outcome was hospital attendance for repetition of self-harm in the 18 months after group assignment . Primary and safety analyses were done in the intention-to-treat population . The trial is registered at the IS RCT N registry , number IS RCT N59793150 . Findings Between Nov 23 , 2009 , and Dec 31 , 2013 , 3554 young people were screened and 832 eligible young people consented to participation and were r and omly assigned to receive family therapy ( n=415 ) or treatment as usual ( n=417 ) . Primary outcome data were available for 795 ( 96 % ) participants . Numbers of hospital attendances for repeat self-harm events were not significantly different between the groups ( 118 [ 28 % ] in the family therapy group vs 103 [ 25 % ] in the treatment as usual group ; hazard ratio 1·14 [ 95 % CI 0·87–1·49 ] p=0·33 ) . Similar numbers of adverse events occurred in both groups ( 787 in the family therapy group vs 847 in the treatment as usual group ) . Interpretation For adolescents referred to CAMHS after self-harm , having self-harmed at least once before , our family therapy intervention conferred no benefits over treatment as usual in reducing subsequent hospital attendance for self-harm . Clinicians are therefore still unable to recommend a clear , evidence -based intervention to reduce repeated self-harm in adolescents . Funding National Institute for Health Research Health Technology Assessment programme The purpose of this study was to examine the efficacy of the Youth-Nominated Support Team-Version II ( YST-II ) for suicidal adolescents , an intervention based on social support and health behavior models , which was design ed to supplement st and ard treatments . Psychiatrically hospitalized and suicidal adolescents , 13 - 17 years of age , were r and omly assigned to treatment-as-usual ( TAU ) + YST-II ( n = 223 ) or TAU only ( n = 225 ) . YST-II provided tailored psychoeducation to youth-nominated adults in addition to weekly check-ins for 3 months following hospitalization . In turn , these adults had regular supportive contact with adolescents . Adolescents assigned to TAU + YST-II had an average of 3.43 ( SD = 0.83 ) nominated adults . Measures included the Suicidal Ideation Question naire-Junior ( SIQ-JR ; W. M. Reynolds , 1988 ) , Children 's Depression Rating Scale-Revised ( E. O. Poznanski & H. B. Mokros , 1996 ) , Beck Hopelessness Scale ( A. T. Beck & R. A. Steer , 1993 ) , and Child and Adolescent Functional Assessment Scale ( CAFAS ; K. Hodges , 1996 ) . YST-II had very limited positive effects , which were moderated by history of multiple suicide attempts , and no negative effects . It result ed in more rapid decreases in suicidal ideation ( SIQ-JR ) for multiple suicide attempters during the initial 6 weeks after hospitalization ( small-to-moderate effect size ) . For nonmultiple attempters , it was associated with greater declines in functional impairment ( CAFAS ) at 3 and 12 months ( small effect sizes ) . YST-II had no effects on suicide attempts and no enduring effects on SIQ-JR scores OBJECTIVE To compare group therapy with routine care in adolescents who had deliberately harmed themselves on at least two occasions within a year . METHOD Single-blind pilot study with two r and omized parallel groups that took place in Manchester , Engl and . Sixty-three adolescents aged 12 through 16 years were r and omly assigned to group therapy and routine care or routine care alone . Outcome data on suicide attempts were obtained without knowledge of treatment allocation on all r and omized cases ( 62/63 by direct interview ) on average 29 weeks later . The primary outcomes were depression and suicidal behavior . RESULTS In intention-to-treat analyses , adolescents who had group therapy were less likely to be " repeaters " at the end of the study ( i.e. , to have repeated deliberate self-harm on two or more further occasions ) than adolescents who had routine care ( 2/32 versus 10/31 ; odds ratio 6.3 ) , but the confidence intervals for this ratio were wide ( 95 % confidence interval 1.4 to 28.7 ) . They were also less likely to use routine care , had better school attendance , and had a lower rate of behavioral disorder than adolescents given routine care alone . The interventions did not differ , however , in their effects on depression or global outcome . CONCLUSIONS Group therapy shows promise as a treatment for adolescents who repeatedly harm themselves , but larger studies are required to assess more accurately the efficacy of this intervention OBJECTIVE To examine the course of depression during the treatment of adolescents with depression who had recently attempted suicide . METHOD Adolescents ( N = 124 ) , ages 12 to 18 years , with a 90-day history of suicide attempt , a current diagnosis of depressive disorder ( 96.0 % had major depressive disorder ) , and a Children 's Depression Rating Scale-Revised ( CDRS-R ) score of 36 or higher , entered a 6-month treatment with antidepressant medication , cognitive-behavioral therapy focused on suicide prevention , or their combination ( Comb ) , at five academic sites . Treatment assignment could be either r and om or chosen by study participants . Intent-to-treat , mixed effects regression models of depression and other relevant ratings were estimated . Improvement and remission rates were computed with the last observation carried forward . RESULTS Most patients ( n = 104 or 84 % ) chose treatment assignment , and overall , three fourths ( n = 93 ) received Comb . In Comb , CDRS-R declined from a baseline adjusted mean of 49.6 ( SD 12.3 ) to 38.3 ( 8.0 ) at week 12 and to 27.0 ( 10.1 ) at week 24 ( p < .0001 ) , with a Clinical Global Impression -defined improvement rate of 58.0 % at week 12 and 72.2 % at week 24 and a remission ( CDRS-R ≤ 28 ) rate of 32.5 % at week 12 and 50.0 % at week 24 . The CDRS-R and the Scale for Suicidal Ideation scores were correlated at baseline ( r = 0.43 , p < .0001 ) and declined in parallel . CONCLUSIONS When vigorously treated with a combination of medication and psychotherapy , adolescents with depression who have recently attempted suicide show rates of improvement and remission of depression that seem comparable to those observed in nonsuicidal adolescents with depression BACKG
Output:
| Collapsing across different variations of Cognitive Behavior Therapy ( CBT ) , and classifying Dialectical Behavior Therapy for Adolescents ( DBT-A ) as a type of CBT , CBT is the only intervention with replicated positive impact on reducing self-harm in adolescents .
Conclusion : While the majority of studies were not able to determine efficacy of therapeutic interventions for both primary and secondary outcomes , our systematic review suggests that individual self-driven and socially-driven processes appeared to show the greatest promise for reducing suicide attempts , with benefits of combined self-driven and systems-driven approaches for reducing overall self-harm . |
MS210689 | ***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 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 ; Chronic pain is associated with a range of other problems , including disturbed sleep , depression , anxiety , fatigue , reduced quality of life , and an inability to work or socialise . We investigated whether good symptom control of pain ( using definitions of moderate and substantial benefit ) is associated with improvement in other symptoms . Individual patient data from four r and omised trials in fibromyalgia ( 2575 patients ) lasting 8–14 weeks were used to calculate percentage pain reduction for each completing patient ( 1858 ) , divided into one of five groups according to pain reduction , irrespective of treatment : substantial benefit – ≥50 % pain reduction ; moderate – 30 % to < 50 % ; minimal – 15 % to < 30 % ; marginal – 0 % to < 15 % ; worse – < 0 % ( increased pain intensity ) . We then calculated change from baseline to end of trial for measures of fatigue , function , sleep , depression , anxiety , ability to work , general health status , and quality ‐adjusted life year ( QALY ) gain over a 12‐month period . Substantial and moderate pain intensity reductions were associated with statistically significant reduction from baseline by end of trial in all measures , with values by trial end at or approaching normative values . Substantial pain intensity reduction result ed in 0.11 QALYs gained , and moderate pain intensity reduction in 0.07 QALYs gained over a 12‐month period . Substantial and moderate pain intensity reduction predicts broad beneficial outcomes and improved quality of life that do not occur without pain relief . Pain intensity reduction is a simple and effective predictor of which patients should continue treatment , and which should discontinue and try an alternative therapy BACKGROUND The long-term use of opioid analgesic drugs to treat chronic non-cancer pain ( CNCP ) is a major component of pain pharmacotherapy . The interpretation of the evidence concerning its efficacy and risks is currently debated . METHODS An interdisciplinary evidence - and consensus-based S3 guideline was up date d on the basis of a systematic literature search ( CENTRAL , Medline , and Scopus data bases , from October 2008 to October 2013 ) ; meta-analyses of r and omized controlled trials ( ≥ 4 weeks ) ; and a consensus procedure , as specified by the AWMF regulations , including 22 medical and psychological societies and 2 patient self-help organizations . RESULTS 119 publications were used to up date the guideline , and 6 systematic review s with meta-analyses were performed . A nominal group process was used to formulate recommendations concerning the indications and contraindications for the treatment of CNCP with opioid analgesics and the manner in which such treatments should be carried out . Opioid analgesics are an option for the short-term treatment ( 4 - 12 weeks ) of chronic pain due to osteoarthritis ( pain intensity , st and ardized mean difference [ SMD ] : -0.22 and -0.26 ) , diabetic polyneuropathy ( SMD -0.74 ) , post-herpetic neuralgia ( SMD -0.58 ) , and chronic low back pain ( SMD : -0.29 and -0.74 ) . Long-term opioid treatment ( ≥ 26 weeks ) for these diseases benefits only about 25 % of patients . For other conditions , either short- or long-term treatment with opioid analgesics should be considered an individual therapeutic trial . Opioid treatment for pain is contraindicated by primary headaches and by any functional or mental disorder of which pain is a leading manifestation . CONCLUSION To minimize the risks of opioid analgesic treatment , physicians must be aware of its contraindications and must regularly reassess its efficacy and side effects . Pharmacotherapy should be combined with other types of treatment OBJECTIVE This article describes the rationale and design of the Oxycodone Users Registry ( OUR ) study and lessons learned during study development and data collection . DESIGN The OUR study used a prospect i ve registry design . SETTING Sixty-five academic and private medical practice s across the United States , including both specialists and primary care setting s. PARTICIPANTS A total of 814 patients with 1 ) injury or trauma of the head , neck , back , chest , or extremities ; 2 ) fibromyalgia ; 3 ) arthritis ; 4 ) neuropathic pain ; 5 ) other back or neck pain ; or 6 ) postoperative pain following outpatient orthopedic surgery . INTERVENTIONS Patients received immediate-release oxycodone either as monotherapy or as combination therapy , starting within 3 days following the baseline visit and continuing as needed for at least 5 days . MAIN OUTCOME MEASURES Patient demographics and disease information were recorded at baseline . Follow-up assessment s at days 3 , 7 , 14 , 21 , and 28 included pain intensity , pain relief , opioid-related symptoms , a sleep scale , the Brief Pain Inventory-Short Form , and the Work Limitations Question naire-Short Form . Adverse events , medical re source utilization , and changes to the oxycodone prescription were recorded during the study . At the end of study treatment , patients rated global treatment satisfaction , how bothersome side effects were , and the most important factor that would discourage them from future oxycodone therapy . RESULTS This report describes the study design , rationale , and lessons learned . CONCLUSIONS Underst and ing the rationale , design , and lessons learned from the conduct of the OUR study provides insight that can used in future registry studies Abstract Objective : The first oxycodone once daily ( OOD ) has been developed and after successful pharmacokinetic characterization , therapeutic efficacy and safety were compared to an established oxycodone twice daily ( OTD : Oxygesic/OxyContin , Mundipharma ) . Design and methods : A r and omized , double-blind , multicenter , cross-over , non-inferiority study was conducted in patients ( n = 68 ) with chronic malignant or non-malignant pain . The new OOD was compared to OTD at identical total daily doses ( TDD : 40–120 mg/day ) employing intensive , five times daily current pain ( 0–100 mm visual analog scale , VAS ) and twice daily 12 h recalled pain assessment s as well as safety parameters such as nausea and sedation ( VAS ) over 5 days for each treatment ( after a 5 day run-in phase ) . Results : There was no significant difference in analgesic potency detected between the two treatments based on 95 % CI for difference in the daily mean current pain ( −2.09 mm VAS ) over 5 days , determined as −5.09 to 0.91 mm VAS . A difference ≤12 mm VAS indicated non-inferiority of OOD , i.e. lack of clinical ly relevant difference in analgesia . Intake of rescue medication had no effect on study results as evaluated by ANCOVA . The difference in adverse events ( AEs ) between the two treatments did not reach significance , as 19.1 % and 23.5 % of patients experienced treatment-related AEs while on OOD and OTD , respectively . Advantages for OOD regarding consistency of analgesia ( i.e. use of rescue medication , current and recalled pain ) and sedation did not reach statistical significance in this limited study population . Conclusion : Despite the small number of patients and short study duration , the results support the conclusion that new OOD is ( at least ) equivalent to established OTD regarding safety and efficacy
Output:
| There is no r and omised trial evidence to support or refute the suggestion that oxycodone , alone or in combination with naloxone , reduces pain in fibromyalgia |
MS210690 | ***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: Long-term dietary intake influences the structure and activity of the trillions of microorganisms residing in the human gut , but it remains unclear how rapidly and reproducibly the human gut microbiome responds to short-term macronutrient change . Here we show that the short-term consumption of diets composed entirely of animal or plant products alters microbial community structure and overwhelms inter-individual differences in microbial gene expression . The animal-based diet increased the abundance of bile-tolerant microorganisms ( Alistipes , Bilophila and Bacteroides ) and decreased the levels of Firmicutes that metabolize dietary plant polysaccharides ( Roseburia , Eubacterium rectale and Ruminococcus bromii ) . Microbial activity mirrored differences between herbivorous and carnivorous mammals , reflecting trade-offs between carbohydrate and protein fermentation . Foodborne microbes from both diets transiently colonized the gut , including bacteria , fungi and even viruses . Finally , increases in the abundance and activity of Bilophila wadsworthia on the animal-based diet support a link between dietary fat , bile acids and the outgrowth of microorganisms capable of triggering inflammatory bowel disease . In concert , these results demonstrate that the gut microbiome can rapidly respond to altered diet , potentially facilitating the diversity of human dietary lifestyles ABSTRACT We recently demonstrated that cow 's milk fermented with the probiotic Lactobacillus paracasei CBA L74 ( FM-CBAL74 ) reduces the incidence of respiratory and gastrointestinal tract infections in young children attending school . This effect apparently derives from a complex regulation of non-immune and immune protective mechanisms . We investigated whether FM-CBAL74 could regulate gut microbiota composition and butyrate production . We r and omly selected 20 healthy children ( 12 to 48 months ) from the previous r and omized controlled trial , before ( t0 ) and after 3 months ( t3 ) of dietary treatment with FM-CBAL74 ( FM ) or placebo ( PL ) . Fecal microbiota was profiled using 16S rRNA gene amplicon sequencing , and the fecal butyrate concentration was also measured . Microbial alpha and beta diversities were not significantly different between groups prior to treatment . FM-CBAL74 but not PL treatment increased the relative abundance of Lactobacillus . Individual Blautia , Roseburia , and Faecalibacterium oligotypes were associated with FM-CBAL74 treatment and demonstrated correlative associations with immune biomarkers . Accordingly , PICRUSt analysis predicted an increase in the proportion of genes involved in butyrate production pathways , consistent with an increase in fecal butyrate observed only in the FM group . Dietary supplementation with FM-CBAL74 induces specific signatures in gut microbiota composition and stimulates butyrate production . These effects are associated with changes in innate and acquired immunity . IMPORTANCE The use of a fermented milk product containing the heat-killed probiotic strain Lactobacillus paracasei CBAL74 induces changes in the gut microbiota , promoting the development of butyrate producers . These changes in the gut microbiota composition correlate with increased levels of innate and acquired immunity biomarkers The colonization process of the infant gut microbiome has been called chaotic , but this view could reflect insufficient documentation of the factors affecting the microbiome . We performed a 2.5-y case study of the assembly of the human infant gut microbiome , to relate life events to microbiome composition and function . Sixty fecal sample s were collected from a healthy infant along with a diary of diet and health status . Analysis of > 300,000 16S rRNA genes indicated that the phylogenetic diversity of the microbiome increased gradually over time and that changes in community composition conformed to a smooth temporal gradient . In contrast , major taxonomic groups showed abrupt shifts in abundance corresponding to changes in diet or health . Community assembly was nonr and om : we observed discrete steps of bacterial succession punctuated by life events . Furthermore , analysis of ≈500,000 DNA metagenomic reads from 12 fecal sample s revealed that the earliest microbiome was enriched in genes facilitating lactate utilization , and that functional genes involved in plant polysaccharide metabolism were present before the introduction of solid food , priming the infant gut for an adult diet . However , ingestion of table foods caused a sustained increase in the abundance of Bacteroidetes , elevated fecal short chain fatty acid levels , enrichment of genes associated with carbohydrate utilization , vitamin bio synthesis , and xenobiotic degradation , and a more stable community composition , all of which are characteristic of the adult microbiome . This study revealed that seemingly chaotic shifts in the microbiome are associated with life events ; however , additional experiments ought to be conducted to assess how different infants respond to similar life events BACKGROUND & AIMS It might be possible to manipulate the intestinal microbiota with prebiotics or other agents to prevent or treat obesity . However , little is known about the ability of prebiotics to specifically modify gut microbiota in children with overweight/obesity or reduce body weight . We performed a r and omized controlled trial to study the effects of prebiotics on body composition , markers of inflammation , bile acids in fecal sample s , and composition of the intestinal microbiota in children with overweight or obesity . METHODS We performed a single-center , double-blind , placebo-controlled trial of 2 separate cohorts ( March 2014 and August 2014 ) at the University of Calgary in Canada . Participants included children , 7 - 12 years old , with overweight or obesity ( > 85th percentile of body mass index ) but otherwise healthy . Participants were r and omly assigned to groups given either oligofructose-enriched inulin ( OI ; 8 g/day ; n=22 ) or maltodextrin placebo ( isocaloric dose , controls ; n=20 ) once daily for 16 weeks . Fat mass and lean mass were measured using dual-energy-x-ray absorptiometry . Height , weight , and waist circumference were measured at baseline and every 4 weeks thereafter . Blood sample s were collected at baseline and 16 weeks , and analyzed for lipids , cytokines , lipopolysaccharide , and insulin . Fecal sample s were collected at baseline and 16 weeks ; bile acids were profiled using high-performance liquid chromatography and the composition of the microbiota was analyzed by 16S rRNA sequencing and quantitative polymerase chain reaction . The primary outcome was change in percent body fat from baseline to 16 weeks . RESULTS After 16 weeks , children who consumed OI had significant decreases in body weight z-score ( decrease of 3.1 % ) , percent body fat ( decrease of 2.4 % ) , and percent trunk fat ( decrease of 3.8 % ) compared with children given placebo ( increase of 0.5 % , increase of 0.05 % , and decrease of 0.3 % , respectively ) . Children who consumed OI also had a significant reduction in level of interleukin 6 from baseline ( decrease of 15 % ) compared with the placebo group ( increase of 25 % ) . There was a significant decrease in serum triglycerides ( decrease of 19 % ) in the OI group . Quantitative polymerase chain reaction showed a significant increase in Bifidobacterium spp . in the OI group compared with controls . 16S rRNA sequencing revealed significant increases in species of the genus Bifidobacterium and decreases in Bacteroides vulgatus within the group who consumed OI . In fecal sample s , levels of primary bile acids increased in the placebo group but not in the OI group over the 16-week study period . CONCLUSIONS In a placebo-controlled , r and omized trial , we found a prebiotic ( OI ) to selectively alter the intestinal microbiota and significantly reduce body weight z-score , percent body fat , percent trunk fat , and serum level of interleukin 6 in children with overweight or obesity ( Clinical trials.gov no : NCT02125955 ) Importance Establishment of the infant microbiome has lifelong implication s on health and immunity . Gut microbiota of breastfed compared with nonbreastfed individuals differ during infancy as well as into adulthood . Breast milk contains a diverse population of bacteria , but little is known about the vertical transfer of bacteria from mother to infant by breastfeeding . Objective To determine the association between the maternal breast milk and areolar skin and infant gut bacterial communities . Design , Setting , and Participants In a prospect i ve , longitudinal study , bacterial composition was identified with sequencing of the 16S ribosomal RNA gene in breast milk , areolar skin , and infant stool sample s of 107 healthy mother-infant pairs . The study was conducted in Los Angeles , California , and St Petersburg , Florida , between January 1 , 2010 , and February 28 , 2015 . Exposures Amount and duration of daily breastfeeding and timing of solid food introduction . Main Outcomes and Measures Bacterial composition in maternal breast milk , areolar skin , and infant stool by sequencing of the 16S ribosomal RNA gene . Results In the 107 healthy mother and infant pairs ( median age at the time of specimen collection , 40 days ; range , 1 - 331 days ) , 52 ( 43.0 % ) of the infants were male . Bacterial communities were distinct in milk , areolar skin , and stool , differing in both composition and diversity . The infant gut microbial communities were more closely related to an infant ’s mother ’s milk and skin compared with a r and om mother ( mean difference in Bray-Curtis distances , 0.012 and 0.014 , respectively ; P < .001 for both ) . Source tracking analysis was used to estimate the contribution of the breast milk and areolar skin microbiomes to the infant gut microbiome . During the first 30 days of life , infants who breastfed to obtain 75 % or more of their daily milk intake received a mean ( SD ) of 27.7 % ( 15.2 % ) of the bacteria from breast milk and 10.3 % ( 6.0 % ) from areolar skin . Bacterial diversity ( Faith phylogenetic diversity , P = .003 ) and composition changes were associated with the proportion of daily breast milk intake in a dose-dependent manner , even after the introduction of solid foods . Conclusions and Relevance The results of this study indicate that bacteria in mother ’s breast milk seed the infant gut , underscoring the importance of breastfeeding in the development of the infant gut microbiome The potential influence of maternal obesity on infant gut microbiota may occur either through vertically transmitted microbes or through the dietary habits of the family . Recent studies have suggested that the heritability of obesity may partly be caused by the transmission of “ obesogenic ” gut microbes . However , the findings presented here suggest that maternal obesity per se does not affect the overall composition of the gut microbiota and its development after introduction of complementary foods . Rather , progression in complementary feeding is found to be the major determinant for gut microbiota establishment . Exp and ing our underst and ing of the influence of complementary diet on the development and establishment of the gut microbiota will provide us with the knowledge to tailor a beneficial progression of our intestinal microbial community . ABSTRACT The first years of life are paramount in establishing our endogenous gut microbiota , which is strongly affected by diet and has repeatedly been linked with obesity . However , very few studies have addressed the influence of maternal obesity on infant gut microbiota , which may occur either through vertically transmitted microbes or through the dietary habits of the family . Additionally , very little is known about the effect of diet during the complementary feeding period , which is potentially important for gut microbiota development . Here , the gut microbiotas of two different cohorts of infants , born either of a r and om sample of healthy mothers ( n = 114 ) , or of obese mothers ( n = 113 ) , were profiled by 16S rRNA amplicon sequencing . Gut microbiota data were compared to breastfeeding patterns and detailed individual dietary recordings to assess effects of the complementary diet . We found that maternal obesity did not influence microbial diversity or specific taxon abundances during the complementary feeding period . Across cohorts , breastfeeding duration and composition of the complementary diet were found to be the major determinants of gut microbiota development . In both cohorts , gut microbial composition and alpha diversity were thus strongly affected by introduction of family foods with high protein and fiber contents . Specifically , intake of meats , cheeses , and Danish rye bread , rich in protein and fiber , were associated with increased alpha diversity . Our results reveal that the transition from early infant feeding to family foods is a major determinant for gut microbiota development . IMPORTANCE The potential influence of maternal obesity on infant gut microbiota may occur either through vertically transmitted microbes or through the dietary habits of the family . Recent studies have suggested that the heritability of obesity may partly be caused by the transmission of “ obesogenic ” gut microbes . However , the findings presented here suggest that maternal obesity per se does not affect the overall composition of the gut microbiota and its development after introduction of complementary foods . Rather , progression in complementary feeding is found to be the major determinant for gut microbiota establishment . Exp and ing our underst and ing of the influence of complementary diet on the development and establishment of the gut microbiota will provide us with the knowledge to tailor a beneficial progression of our intestinal microbial community The gut of the human neonate is colonized rapidly after birth from an early sparse and highly distinct microbiota to a more adult-like and convergent state , within
Output:
| Geographic location and 16S rRNA sequencing region were independently associated with microbial proportions . |
MS210691 | ***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 & AIMS Adjuvant 5-fluorouracil (5-FU)-based chemotherapy is st and ard treatment for stage C colorectal cancer ( CRC ) . Approximately 12 % of CRCs are characterized by microsatellite instability ( MSI ) , a hallmark of a DNA mismatch repair defect . We investigated the safety of adjuvant 5-FU-based chemotherapy for MSI(+ ) CRC and compared the prognosis of MSI(+ ) and MSI(- ) CRC patients receiving adjuvant therapy . METHODS Previously , a prospect i ve series consisting of 1044 consecutive CRCs has been collected and the MSI status of each sample determined . Patients with stage C cancer who had received adjuvant chemotherapy ( n = 95 ) were followed up for 7 - 63 months ( median , 31 months ) after surgery . RESULTS No unexpected or serious adverse effects were observed when 5-FU-based chemotherapy was used as adjuvant treatment for MSI(+ ) CRC . Three- year recurrence-free survival was 90 % and 43 % in the MSI(+ ) ( n = 11 ) and MSI(- ) ( n = 84 ) groups , respectively ( P = 0.020 ) . CONCLUSIONS Adjuvant 5-FU-based chemotherapy is feasible for both MSI(+ ) and MSI(- ) CRCs , and patients with MSI(+ ) CRC who receive adjuvant therapy have an excellent prognosis PURPOSE It is uncertain whether modest benefits from adjuvant chemotherapy in stage II colorectal cancer justify the toxicity , cost , and inconvenience . We investigated the usefulness of defective mismatch repair ( dMMR ) , BRAF , and KRAS mutations in predicting tumor recurrence and sensitivity to chemotherapy . PATIENTS AND METHODS Immunohistochemistry for dMMR and pyrosequencing for KRAS/BRAF were performed for 1,913 patients r and omly assigned between fluorouracil and folinic acid chemotherapy and no chemotherapy in the Quick and Simple and Reliable ( QUASAR ) trial . RESULTS Twenty-six percent of 695 right-sided colon , 3 % of 685 left-sided colon , and 1 % of 407 rectal tumors were dMMR . Similarly , 17 % of right colon , 2 % of left colon , and 2 % of rectal tumors were BRAF mutant . KRAS mutant tumors were more evenly distributed : 40 % right colon , 28 % left colon , and 36 % rectal tumors . Recurrence rate for dMMR tumors was half that for MMR-proficient tumors ( 11 % [ 25 of 218 ] v 26 % [ 438 of 1,695 ] recurred ; risk ratio [ RR ] , 0.53 ; 95 % CI , 0.40 to 0.70 ; P < .001 ) . Risk of recurrence was also significantly higher for KRAS mutant than KRAS wild-type tumors ( 28 % [ 150 of 542 ] v 21 % [ 219 of 1,041 ] ; RR , 1.40 ; 95 % CI , 1.12 to 1.74 ; P = .002 ) but did not differ significantly between BRAF mutant and wild-type tumors ( P = .36 ) . No marker predicted benefit from chemotherapy with efficacy not differing significantly by MMR , KRAS , or BRAF status . The prognostic value of MMR and KRAS was similar in the presence and absence of chemotherapy . CONCLUSION MMR assays identify patients with a low risk of recurrence . KRAS mutational analysis provides useful additional risk stratification to guide use of chemotherapy PURPOSE Colorectal cancer ( CRC ) develops as a result of a series of accumulated genomic changes that produce oncogene activation and tumor suppressor gene loss . These characteristics may classify CRC into subsets of distinct clinical behaviors . PATIENTS AND METHODS We studied two of these genomic defects-mismatch repair deficiency ( MMR-D ) and loss of heterozygosity at chromosomal location 18q (18qLOH)-in patients enrolled onto two phase III cooperative group trials for treatment of potentially curable colon cancer . These trials included prospect i ve secondary analyses to determine the relationship between these markers and treatment outcome . A total of 1,852 patients were tested for MMR status and 955 ( excluding patients with MMR-D tumors ) for 18qLOH . RESULTS Compared with stage III , more stage II tumors were MMR-D ( 21.3 % v 14.4 % ; P < .001 ) and were intact at 18q ( 24.2 % v 15.1 % ; P = .001 ) . For the combined cohort , patients with MMR-D tumors had better 5-year disease-free survival ( DFS ; 0.76 v 0.67 ; P < .001 ) and overall survival ( OS ; 0.81 v 0.78 ; P = .029 ) than those with MMR intact ( MMR-I ) tumors . Among patients with MMR-I tumors , the status of 18q did not affect outcome , with 5-year values for patients with 18q intact versus 18qLOH tumors of 0.74 versus 0.65 ( P = .18 ) for DFS and 0.81 versus 0.77 ( P = .18 ) for OS . CONCLUSION We conclude that MMR-D tumor status , but not the presence of 18qLOH , has prognostic value for stages II and III colon cancer PURPOSE The role of high-degree microsatellite instability ( MSI-H ) as a marker to predict benefit from adjuvant chemotherapy remains unclear . PATIENTS AND METHODS To help define its impact , we conducted an analysis of National Surgical Adjuvant Breast and Bowel Project ( NSABP ) patients who were r and omly assigned to a surgery-alone group ( untreated cohort ) and patients assigned to an adjuvant fluorouracil ( FU ) -treated group ( treated cohort ) . MSI-H and other potential markers were assessed ( TGF-BRII , p53 , thymidylate synthase , and Ki67 ) . RESULTS In all , 98 ( 18.1 % ) of 542 patients exhibited MSI-H , and there was a strong inverse relationship between MSI-H and mutant p53 status ( P < .001 ) . The prognostic analyses showed increased recurrence-free survival ( RFS ) for MSI-H patients versus MSS/MSI-L patients ( P = .10 ) , but showed no difference in overall survival ( OS ; P = .67 ) . There was a potential interaction between MSI-H and mutant p53 in terms of improved RFS ( P = .03 ) . In the predictive marker analysis , we observed no interaction between MSI status and treatment for either RFS ( P = .68 ) or OS ( P = .62 ) . Hazard ratios ( HR ) for RFS for MSI-H versus MSS/MSI-L patients were 0.77 ( 95 % CI , 0.40 to 1.48 ) in the untreated- patients group and 0.60 ( 95 % CI , 0.30 to 1.19 ) in the treated- patients group . HRs for OS were 0.82 ( 95 % CI , 0.44 to 1.51 ) and 1.02 ( 95 % CI , 0.56 to 1.85 ) for the respective groups . There was a trend toward improved RFS in patients with MSI-H and mutant p53 . CONCLUSION These results do not support the use of MSI-H as a predictive marker of chemotherapy benefit PURPOSE Prior reports have indicated that patients with colon cancer who demonstrate high-level microsatellite instability ( MSI-H ) or defective DNA mismatch repair ( dMMR ) have improved survival and receive no benefit from fluorouracil ( FU ) -based adjuvant therapy compared with patients who have microsatellite-stable or proficient mismatch repair ( pMMR ) tumors . We examined MMR status as a predictor of adjuvant therapy benefit in patients with stages II and III colon cancer . METHODS MSI assay or immunohistochemistry for MMR proteins were performed on 457 patients who were previously r and omly assigned to FU-based therapy ( either FU + levamisole or FU + leucovorin ; n = 229 ) versus no postsurgical treatment ( n = 228 ) . Data were subsequently pooled with data from a previous analysis . The primary end point was disease-free survival ( DFS ) . RESULTS Overall , 70 ( 15 % ) of 457 patients exhibited dMMR . Adjuvant therapy significantly improved DFS ( hazard ratio [ HR ] , 0.67 ; 95 % CI , 0.48 to 0.93 ; P = .02 ) in patients with pMMR tumors . Patients with dMMR tumors receiving FU had no improvement in DFS ( HR , 1.10 ; 95 % CI , 0.42 to 2.91 ; P = .85 ) compared with those r and omly assigned to surgery alone . In the pooled data set of 1,027 patients ( n = 165 with dMMR ) , these findings were maintained ; in patients with stage II disease and with dMMR tumors , treatment was associated with reduced overall survival ( HR , 2.95 ; 95 % CI , 1.02 to 8.54 ; P = .04 ) . CONCLUSION Patient stratification by MMR status may provide a more tailored approach to colon cancer adjuvant therapy . These data support MMR status assessment for patients being considered for FU therapy alone and consideration of MMR status in treatment decision making BACKGROUND Colon cancers with high-frequency microsatellite instability have clinical and pathological features that distinguish them from microsatellite-stable tumors . We investigated the usefulness of microsatellite-instability status as a predictor of the benefit of adjuvant chemotherapy with fluorouracil in stage II and stage III colon cancer . METHODS Tumor specimens were collected from patients with colon cancer who were enrolled in r and omized trials of fluorouracil-based adjuvant chemotherapy . Microsatellite instability was assessed with the use of mononucleotide and dinucleotide markers . RESULTS Of 570 tissue specimens , 95 ( 16.7 percent ) exhibited high-frequency microsatellite instability . Among 287 patients who did not receive adjuvant therapy , those with tumors displaying high-frequency microsatellite instability had a better five-year rate of overall survival than patients with tumors exhibiting microsatellite stability or low-frequency instability ( hazard ratio for death , 0.31 [ 95 percent confidence interval , 0.14 to 0.72 ] ; P=0.004 ) . Among patients who received adjuvant chemotherapy , high-frequency microsatellite instability was not correlated with increased overall survival ( hazard ratio for death , 1.07 [ 95 percent confidence interval , 0.62 to 1.86 ] ; P=0.80 ) . The benefit of treatment differed significantly according to the microsatellite-instability status ( P=0.01 ) . Adjuvant chemotherapy improved overall survival among patients with microsatellite-stable tumors or tumors exhibiting low-frequency microsatellite instability , according to a multivariate analysis adjusted for stage and grade ( hazard ratio for death , 0.72 [ 95 percent confidence interval , 0.53 to 0.99 ] ; P=0.04 ) . By contrast , there was no benefit of adjuvant chemotherapy in the group with high-frequency microsatellite instability . CONCLUSIONS Fluorouracil-based adjuvant chemotherapy benefited patients with stage II or stage III colon cancer with microsatellite-stable tumors or tumors exhibiting low-frequency microsatellite instability but not those with tumors exhibiting high-frequency microsatellite instability
Output:
| In both treated and untreated patients , high‐level MSI improved disease‐free survival compared with low‐level MSI , suggesting a prognostic role but not supporting the hypothesis of a predictive effect of MSI . |
MS210692 | ***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: Postal health surveys in the general population can provide important information to assist with planning and service provision . 1 High response rates are needed to ensure validity and to minimize costs from following-up non-responders . 2 Only a small number of studies have examined methods to increase response rates in postal surveys . Using a post-office stamp rather than a prepaid business reply envelope may seem more personal and encourage participants to return the question naire . However , results from trials evaluating this are inconsistent and limited to health professionals in North America . 3–5 Consequently there is little evidence to inform the choice of reply envelopes in postal surveys of the general UK population . This was determined in the current study . Methods The sample consisted of 633 adults r and omly selected from a health authority register in the north west of Engl and . A computer-generated r and omization list , stratifying on sex and age ( 18–45 , 46–64 , у65 years ) was used to allocate participants to receive one of two types of reply envelopes , both printed with the return address . One group ( POS ) received a reply envelope with a first-class post-office stamp , while the second group ( PPB ) received a prepaid business-franked envelope to return their health question naire . The initial mail-out included the 16-page health question naire , a personalized letter from the Director of Public Health and one of the two return envelopes . Question naires were sent out in March 2001 and non-responders were sent a reminder postcard 10 days later . The primary outcome was the difference in response rates between the two types of reply envelopes , after follow-up reminders had been sent measured at 4 weeks after posting the survey . The χ 2 test was used to examine statistical significance . Approval was obtained for the study from the Local Research Ethics Committee.2 % ) question naires were returned within 10 days , from the two allocation groups , respectively . After sending reminders to the 182 non-responders in the POS group and 195 in the PPB group ( excluding 6 and 4 participants respectively later found to be not living at that address ) , the return rate increased to 182 ( 58.7 % ) and 179 ( 57.2 % ) in the two groups . This difference of 1.5 % between the two groups is unlikely to be important and was not statistically significant ( χ 2 = 0.08 , P = 0.77 ) . No important difference was observed in return rates between the POS and the PPB group for men or women and across three age groups . However , return rates BACKGROUND Patient surveys are becoming increasingly common and already are an obligatory activity to qualify for a Better Practice Program Grant . Strategies to increase return rates remain unevaluated in Australian general practice . AIM To evaluate the effectiveness of an instant lottery ticket as a response-aiding technique in patient surveys . METHOD A r and om sample of adult patients was selected from an age-sex-disease register , stratified by sex and r and omised to receive an instant lottery ticket with the self-administered question naire mailed out in December 1994 . RESULTS There was no significant difference by group either for women ( P = 0.68 ) , men ( P = 0.88 ) or both sexes combined ( P = 0.68 ) . However , irrespective of inclusion of the lottery ticket , men were significantly less likely to return question naires than women ( P = 0.02 ) . CONCLUSIONS Instant lottery tickets do not increase return rates to question naires and are not recommended . Other strategies need to be tested , particularly to involve male patients in general practice research Study objective : To assess the effectiveness of a telephone reminder in increasing responses to postal surveys and to calculate the differential costs per completed question naire . Design : R and omised controlled trial . Setting : Australian university and rehabilitation medicine practice . Participants : The trial was conducted in 1999 among the 143 non-respondents to a question naire about work related neck and upper body disorders . The question naire was sent to two Australian female sample s : 200 office workers ( Sample A ) and 92 former rehabilitation medicine patients ( Sample B ) . A reminder letter , another copy of the question naire and a final letter were sent at two week intervals . Half of the non-respondents within each sample were r and omly selected to receive a telephone reminder just after the second mailout of the question naire . All direct costs were calculated . Main results : Responses were significantly higher among those who received the telephone reminder intervention ( relative risk 2.54 , 95 % confidence intervals 1.43 to 4.52 ) . Analysed by intention to phone , 47 % of non-respondents in Sample A and 38 % in Sample B returned a complete question naire after the intervention , compared with 21 % and 10 % , respectively , in the control groups . For the 112 women ( combined sample s ) who returned completed question naires before r and omisation , the average cost per respondent was AUD14 . There was a higher total cost for the intervention groups ( AUD851 versus AUD386 for controls ) , but the significantly higher number of additional completed responses ( 31 versus 12 ) result ed in a 15 % lower marginal cost per completed question naire in those groups . Conclusion : Telephone reminders are cost effective in improving responses to postal surveys Proper r and omisation means little if investigators can not include all r and omised participants in the primary analysis . Participants might ignore follow-up , leave town , or take aspartame when instructed to take aspirin . Exclusions before r and omisation do not bias the treatment comparison , but they can hurt generalisability . Eligibility criteria for a trial should be clear , specific , and applied before r and omisation . Readers should assess whether any of the criteria make the trial sample atypical or unrepresentative of the people in which they are interested . In principle , assessment of exclusions after r and omisation is simple : none are allowed . For the primary analysis , all participants enrolled should be included and analysed as part of the original group assigned ( an intent-to-treat analysis ) . In reality , however , losses frequently occur . Investigators should , therefore , commit adequate re sources to develop and implement procedures to maximise retention of participants . Moreover , research ers should provide clear , explicit information on the progress of all r and omised participants through the trial by use of , for instance , a trial profile . Investigators can also do secondary analyses on , for instance , per- protocol or as-treated participants . Such analyses should be described as secondary and non-r and omised comparisons . Mish and ling of exclusions causes serious method ological difficulties . Unfortunately , some explanations for mish and ling exclusions intuitively appeal to readers , disguising the seriousness of the issues . Creative mismanagement of exclusions can undermine trial validity BACKGROUND A range of factors have been shown to affect the response rate to mailed question naires , but particular strategies to improve patients ' response in trials conducted in general practice require further study . METHODS Non-responders in a larger trial were r and omized to receive a telephone or recorded delivery reminder on the third contact . The cost of administration of each method was estimated . RESULTS Significantly more patients returned completed question naires when sent question naires by recorded delivery , although the cost per patient contacted was nearly three times more than for contact by telephone . CONCLUSION Our study indicates that sending reminders by recorded delivery , although more expensive , is more effective than telephone reminders for recruiting patients to a study in general practice using research question naires Objective : To assess whether length of question naire affects response rates . Methods : A quasi-r and omised trial of women aged 70 years and over in a general practice in Engl and . Three question naires of different lengths : a clinical question naire ( four pages ) ; the same question naire plus the EuroQol ( five pages ) ; the same question naire plus the SF-12 ( seven pages ) . The impact of length on the proportion of returned question naires and item completion rates was assessed . Results : In total , 847 question naires were mailed ; response rates were 49 % , 49 % and 40 % to the short , medium and long question naires , respectively . This difference was statistically significant when the short question naire was compared against the longest instrument ( 9 % difference ; 95 % confidence interval ( CI ) of difference=0.3 % to 16.6 % ) . Item completion rates for the clinical question naire did not differ . Respondents did not differ in age or self-reported health status between the three groups . Conclusions : Increasing the length of a question naire from five to seven pages reduces response rates from women aged 70 years and over . However , lengthening a question naire does not seem to affect the quality of responses to questions near the front of the question naire PURPOSE To investigate the impact on subject response of an information brochure and cash incentives included with mailed question naires in case-control studies . METHODS A r and omized trial was carried out within a case-control study investigating cancer in the Province of Ontario . Brochures were included with half of the mailed question naires sent to 7487 cases and 2561 controls . Controls were also sent cash incentives of $ 2 , $ 5 , or no money . RESULTS With the brochure , response changed from 75.0 % to 75.8 % in cases , and from 70.3 % to 71.1 % in controls . Adjusting for differences in age , residence , sex , and cancer site/status , the change was 0.2 % [ 95 % confidence interval ( CI ) = -1.7 - 2.1 ] in cases , and 0.6 % ( 95 % CI = -3.1 - 4.3 ) in controls . The $ 2 and $ 5 incentives increased overall response in controls from 61.9 % to 72.8 % and 77.2 % , respectively , i.e. , by 10.9 % ( 95 % CI = 6.1 - 15.6 ) and 15.1 % ( 95 % CI = 10.4 - 19.7 ) , after adjustment . This effect was largely confined to urban areas ( for $ 2 and $ 5 , respectively : 5.5 % and 14.2 % in Toronto , 15.3 % and 20.4 % in other urban areas vs. 2.7 % and 1.0 % in rural areas ; p = 0.02 ) . Response time showed little or no improvement when the brochure was included , but was markedly reduced for both the $ 2 and $ 5 incentives . CONCLUSIONS Cash incentives can improve subject response in epidemiologic studies , whereas information brochures do not appear to have an effect Mail surveys have been used to follow-up early participants in a Canadian breast cancer prevention trial . To minimize non-response bias , we undertook a r and omized study of two postal strategies , of which one was our usual procedure and the other was a systematic application , known as the total design method ( TDM ) and described by Dillman . The response rates to the two methods were 62 and 88 % respectively . The TDM is a practical , cost-efficient approach to reducing non-response bias in postal surveys and as such has an important role in epidemiological research which involves healthy participants 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 Mailed surveys are widely used to collect epidemiological and health service data on cancer population s. Nonresponse can threaten the validity of surveys and various strategies , including the enclosure of modest incentives , are often used to increase response rates . A study was undertaken to determine whether response rate to a mailed survey differed with provision of immediate versus delayed incentives . A six-page mailed survey to ascertain dietary supplement use was sent to 1402 men who had been diagnosed with prostate cancer . Subjects were block r and omized into two groups based on age ( ≤65 years versus > 65 years ) , race ( white versus nonwhite ) , and disease status ( locoregional versus distant ) . One group received a 30-min prepaid phone card concurrently with their blank survey ( unconditional incentive ) , whereas the other group received the incentive only on receipt of their completed survey ( conditional incentive ) . A 60 % overall response rate was achieved , and no differences in response rates were noted between conditional and unconditional incentive groups ( overall , as well as within defined age , race , and disease-defined strata ) . Nonwhites , however , were significantly less likely to respond than whites ( P < 0.0001 ) . In conclusion , acceptable response rates to a mailed survey can be achieved in a general population of cancer survivors using modest incentives . Given no differences in response rates using conditional versus unconditional incentives , the decision to provide immediate versus delayed incentives is one that should be considered on a study -specific basis , and a decision based primarily on cost . Other means , however , appear necessary to achieve acceptable response rates among minority group cancer survivors Maximizing the response rate of self-administered question naires is key in survey research . We aim ed to evaluate the effects of lottery incentive and length of question naire on health survey response rates when used in isolation or combined . A r and om sample of 440 residents in Western Sydney , Australia was r and omly allocated to four equal groups to receive or not receive an instant lottery ticket and a long ( seven page ) or short ( one
Output:
| No evidence was found that incentives , re-ordering of questions or including an information brochure with the question naire confer any additional advantage .
Conclusion Implementing repeat mailing strategies and /or telephone reminders may improve response to postal question naires in health care research .
Making the question naire shorter may also improve response rates .
There is a lack of evidence to suggest that incentives are useful . |
MS210693 | ***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 Individuals with osteoarthritis can experience difficulty walking and poor strength , possibly leading to falls and fractures . Exercise has been found to increase strength and bone mineral density . The purpose of this study was to determine the effects of 6 months of t'ai chi on knee muscle strength , bone mineral density , and fear of falling in older women with osteoarthritis . METHODS Eighty-two ( 82 ) women with osteoarthritis , recruited from outpatient clinics and community health centers , were r and omly assigned to either a t'ai chi group and took part in a t'ai chi program , or a control group . Of these , 30 subjects ( mean age = 63 years ) in the t'ai chi group and 35 ( mean age = 61 years ) in the control group completed post-test measures at 6 months . RESULTS After the 6-month study period , subjects in the t'ai chi program had significantly greater knee extensor endurance ( pre- to post-test mean increase = 36.4 W/kg , versus 1.1 W/kg for the controls ) , and significantly greater bone mineral density in the neck of the proximal femur ( mean change = 0.09 , versus -0.10 for the controls ) , Ward 's triangle ( mean change = 0.04 , versus -0.04 for the controls ) , and trochanter ( mean change = 0.07 , versus -0.05 for the controls ) than the controls . However , knee extensor and flexor strength did not differ significantly between the groups . The fear of falling during daily activities reduced significantly more in the t'ai chi group ( mean change = -2.40 , versus 0.66 for the controls ) . CONCLUSIONS T'ai chi increased knee extensor muscle endurance and bone mineral density in older women with osteoarthritis , and decreased their fear of falling during daily activities . Further study with long-term follow-up is needed to substantiate the role of t'ai chi exercise in the prevention of fall and its related fracture OBJECTIVE To determine the effectiveness of a manual therapy program compared with an exercise therapy program in patients with osteoarthritis ( OA ) of the hip . METHODS A single-blind , r and omized clinical trial of 109 hip OA patients was carried out in the outpatient clinic for physical therapy of a large hospital . The manual therapy program focused on specific manipulations and mobilization of the hip joint . The exercise therapy program focused on active exercises to improve muscle function and joint motion . The treatment period was 5 weeks ( 9 sessions ) . The primary outcome was general perceived improvement after treatment . Secondary outcomes included pain , hip function , walking speed , range of motion , and quality of life . RESULTS Of 109 patients included in the study , 56 were allocated to manual therapy and 53 to exercise therapy . No major differences were found on baseline characteristics between groups . Success rates ( primary outcome ) after 5 weeks were 81 % in the manual therapy group and 50 % in the exercise group ( odds ratio 1.92 , 95 % confidence interval 1.30 , 2.60 ) . Furthermore , patients in the manual therapy group had significantly better outcomes on pain , stiffness , hip function , and range of motion . Effects of manual therapy on the improvement of pain , hip function , and range of motion endured after 29 weeks . CONCLUSION The effect of the manual therapy program on hip function is superior to the exercise therapy program in patients with OA of the hip OBJECTIVE To compare the responsiveness of the condition-specific Western Ontario and McMaster Universities osteoarthritis ( OA ) index ( WOMAC ) and the generic Short Form-36 ( SF-36 ) in patients with OA of the legs undergoing a comprehensive inpatient rehabilitation intervention . METHODS A prospect i ve follow up study of consecutively referred in patients of a rehabilitation clinic was made . The patients included fulfilled the American College of Rheumatology criteria for knee or hip OA and underwent both passive and , particularly , active physical therapy for three to four weeks . Responsiveness assessment was performed using the st and ardised response mean ( SRM ) , effect size , and Guyatt 's responsiveness statistic between admission and discharge ( end of rehabilitation ) and then again between admission and three months later . For pain and function the SRMs were stratified by sex and OA joint . Effects were tested by the t test and SRMs of different scales were compared by the jack knife test . RESULTS At the three month follow up , complete data were obtained for 223 patients . In general , the three responsiveness statistics showed a similar order of responsiveness . For both instruments , the pain scales were more responsive than the function scales . The responsiveness of the pain scale of both instruments was comparable ( SRM=0.723 for WOMAC and SRM=0.528 for SF-36 at the end of rehabilitation ; SRM=0.377 for WOMAC and SRM=0.468 for SF-36 at the three month follow up ) . In the measurement of function , the WOMAC was significantly more responsive than the SF-36 ( SRMs , end of rehabilitation : 0.628 v 0.249 ; three month follow up : 0.235 v -0.001 ) . Responsiveness tended to be higher in women and in knee OA than in men and hip OA . CONCLUSIONS Both instruments , the WOMAC and the SF-36 , capture improvement in pain in patients undergoing comprehensive inpatient rehabilitation intervention . Functional improvement can be detected better by the WOMAC than by the SF-36 . All the other scales of both instruments were more weakly responsive The feasibility and efficacy of an additional progressive home-based strengthening exercise program ( PHSEP ) on subjects that already attended supervised institutional exercise therapy was investigated . Thirty-six hip patients with hip osteoarthritis ( OA ) and /or total hip replacement in at least one hip joint were r and omly assigned to an intervention group ( IG ) or a control group ( CG ) . IG ( 18 patients , mean age 64.9 , st and ard deviation ( SD ) 7.5 ) followed an 8-week PHSEP in addition to their weekly institutional exercise therapy , while CG ( 18 patients , mean age 64.7 , SD 9 ) solely continued the weekly institutional exercise sessions . Before and after the intervention period , strength of hip muscles was quantified applying isokinetic concentric and isometric measurements , and health-related quality of life was monitored using the SF36 question naire . Adherence to the exercise program was evaluated using exercise logs . The PHSEP was feasible for all subjects in IG with an adherence of 99 % . Exercise logs reported that pain result ing from the PHSEP was low . Increased strength in isokinetic concentric hip adduction ( 13 % ) and isometric hip abduction ( 9 % ) , adduction ( 12 % ) , and flexion ( 7 % ) was found in IG in comparison to CG . The results of the SF36 did not change during the intervention period . Consequently , supervised institutional exercise therapy supplemented by a PHSEP could increase hip muscle strength in patients with hip OA and /or total hip replacement . However , further research should evaluate the optimal frequency and duration of such supplementary sessions and their potential to increase physical function and reduce pain QUESTION Does behavioural grade d activity result in better exercise adherence and more physical activity than usual care in people with osteoarthritis of the hip or knee ? DESIGN Analysis of secondary outcomes of a cluster-r and omised trial with concealed allocation , assessor blinding , and intention-to-treat analysis . PARTICIPANTS Two hundred patients with hip and /or knee osteoarthritis . INTERVENTION Experimental group received 18 sessions of behavioural grade d activity over 12 weeks and up to 7 booster sessions over the next year . The control group received 18 sessions of usual care over 12 weeks according to the Dutch physiotherapy guideline . OUTCOME MEASURES Exercise adherence was measured using a question naire and physical activity was measured using the SQUASH question naire at baseline , 13 , and 65 weeks . RESULTS Adherence to recommended exercises was significantly higher in the experimental group than in the control group at 13 weeks ( OR 4.3 , 95 % CI 2.1 to 9.0 ) and at 65 weeks ( OR 3.0 , 95 % CI 1.5 to 6.0 ) . Significantly more of the experimental than the control group met the recommendations for physical activity at 13 weeks ( OR 5.3 , 95 % CI 1.9 to 14.8 ) and at 65 weeks ( OR 2.9 , 95 % CI 1.2 to 6.7 ) . CONCLUSION Behavioural grade d activity results in better exercise adherence and more physical activity than usual care in people with osteoarthritis of the hip or knee , both in the short- and long-term . TRIAL REGISTRATION NCT00522106 OBJECTIVES To obtain prevalence rates of hip and knee pain in elderly people and compare combinations of symptoms with overall health status . METHODS We performed a cross-sectional postal survey of a r and om sample of 5500 Oxfordshire residents aged 65 yr and older . Prevalence estimates were based on the screening question : ' During the past 12 months , have you had pain in or around either of your hip/knee joints on most days for one month or longer ? ' Overall health status was assessed with the SF-36 question naire . RESULTS The response rate was 66.3 % ( 3341/5039 eligible people ) , and was highest ( approximately reverse similar 72 % ) for the 65 - 74 yr age-group . The percentage reporting hip pain was 19.2 % [ 95 % confidence interval ( CI ) 17.9 - 20.6 ] , and 32.6 % ( 95 % CI 31.0 - 34.3 ) reported knee pain . The percentage reporting hip and knee pain was 11.3 % , and 40.7 % reported hip or knee pain . Less than half ( 48 % ) of the symptomatic respondents had unilateral problems affecting one hip or knee joint only . SF-36 scores worsened as the number of symptomatic hip and knee joints increased ( P<0.001 for physical function , physical role limitation and bodily pain ) . CONCLUSIONS Patterns of hip and knee symptoms are complex in older people . Amongst the symptomatic , most have more than one hip/knee affected . This has implication s for treatment and health status measurement . In the absence of hip and knee symptoms , general health status scores of elderly people are similar to those of people aged under 65 yr OBJECTIVE To study the hip muscle strength and cross sectional area ( CSA ) in men with hip osteoarthritis ( OA ) compared to age and sex matched healthy controls . METHODS Based on the American College of Rheumatology criteria regarding classification of hip OA , 27 men ( aged 47 - 64 yrs ) with unilateral or bilateral hip OA and 30 age matched r and omly selected healthy male controls were studied . The maximal isometric hip abductor , adductor , flexor , and extensor strength ( Nm ) at 0 degree of hip flexion in the supine position was determined with a dynamometer . The isokinetic hip flexion and extension strength ( peak torque , Nm ) was determined using angular velocities of 60 degrees /s and 120 degrees /s . The subjective severity of hip pain was rated by visual analog scale prior to the muscle strength test . CSA of the pelvic and thigh muscles was measured from magnetic resonance images . RESULTS The reliability of intraclass correlation coefficients for repeated measures of muscle strength varied from 0.70 to 0.94 in controls and from 0.84 to 0.98 in subjects with OA . Hip isometric adductor and abductor strength was 25 % and 31 % lower ( p < 0.001 ) in OA subjects than in controls , respectively . The hip isometric and isokinetic flexion strength was 18 - 22 % lower ( p < 0.01 ) in OA subjects than in controls , but extension strength did not differ between groups . In OA subjects , the hip flexion and extension isometric and isokinetic strength values were 13 - 22 % lower ( p < 0.05 ) on the more deteriorated side compared to the better side . CSA of the pelvic and thigh muscles did not differ between the groups . However , in OA subjects , the CSA of the pelvic and thigh muscles was 6 - 13 % less ( p < 0.05 to < 0.001 ) on the more severely affected hip compared to the better hip . CONCLUSION Men with hip OA have significantly lower abduction , adduction , and flexion muscle strength than controls . The decrease of muscle size and hip pain may contribute to the decrease of muscle strength in hip OA . Other possible underlying causes of the muscle weakness need to be studied BACKGROUND Diary recording of pain and disabling activities in osteoarthritis ( OA ) is widely recommended , but , to our knowledge , its impact on symptoms has not been investigated . Exercise programmes have been shown to be effective when patients are closely supervised by nurses or physiotherapists ; however , data are lacking on the efficacy of an unsupervised home based exercise regimen in patients with OA . OBJECTIVES To evaluate the clinical efficacy of patient administered assessment tools and an unsupervised home based exercise programme alone or in combination in patients with OA . METHODS The study was a 24 week , open cluster r and omised controlled trial with a factorial design . Rheumatologists ( n = 867 ) were assigned to four groups according to the treatment given : st and ardised tools ( ST ; n =
Output:
| Pooling the results of these 10 RCTs demonstrated that l and -based therapeutic exercise programmes can reduce pain and improve physical function among people with symptomatic hip OA |
MS210694 | ***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: Computer models of different strategies for the management of dyspepsia in primary care indicate that a ' test- and -treat ' approach is likely to be associated with the lowest costs and acceptable clinical outcomes . We present information on computer modelling studies and report the findings of a r and omised trial comparing a Helicobacter pylori test- and -treat strategy with referral to direct access endoscopy in the management of dyspepsia in general practice . We compared costs and clinical outcomes in patients managed for one year in study ( test- and -treat ) and control ( endoscopy ) practice s in south London . Patients aged less than 45 years presenting with persistent dyspepsia without alarm symptoms ( 141 study patients , 91 control patients ) were studied . In the one-year follow-up period there were 17 endoscopies in the study group : all the control patients underwent initial endoscopy and five further endoscopies were performed . None revealed peptic ulcer or cancer . Forty-three ( 30 % ) of the study patients compared with 16 ( 17 % ) of the controls were referred to hospital clinics ( p < 0.025 ) . The cost of management per patient for one year in the study group was 205.67 Pounds , compared with 404.31 Pounds in the control group ( p < 0.0001 ) . Clinical outcomes in both groups at one year were comparable . An H. pylori test- and -treat strategy for dyspeptic patients aged less than 45 , employing office-based serology testing , appears to be associated with substantially lower costs than initial endoscopy and with similar clinical outcomes Objective : To compare a Helicobacter pylori “ test and treat ” strategy with prompt endoscopy in young Asians with dyspepsia . Methods : A r and omised , prospect i ve study was carried out on uninvestigated dyspeptics aged < 45 years in a single ( academic ) primary care centre . Patients were r and omised to either a [13C]urea breath test ( UBT ) or prompt endoscopy ( oesophagogastroduodenoscopy ( OGD ) and followed-up for 12 months . Results : 432 patients ( mean ( SD ) age 30 ( 8) years , male 46 % , ethnicity : Malays 33.3 % , Chinese 30.6 % , Indians 34.7 % ) were r and omised to UBT ( n = 222 ) or OGD ( n = 210 ) . 387 ( 89.6 % ) patients completed the study . At 12 months , there was no difference in symptom change ( measured by the Leeds Dyspepsia Question naire ) between the two groups , but more patients were very satisfied ( 40.0 % vs 21.6 % , p<0.0001 ) in the OGD group . More additional endoscopy was performed in the UBT group ( 25 vs 10 , p = 0.03 ) , but medication consumption was higher in the OGD group ( proton pump inhibitor 3.6 ( 8.8 ) vs 2.0 ( 7.5 ) weeks , p<0.001 ; H2 receptor antagonist 5.3 ( 9.7 ) vs 3.9 ( 9.2 ) weeks , p = 0.017 ; prokinetics 1.4 ( 4.7 ) vs 0.4 ( 2.5 ) weeks , p<0.001 ) and no differences in medical consultation were noted . The median cost of the initial prompt endoscopy approach at 12 months was significantly higher than a “ test and treat ” strategy ( US$ 179.05 vs US$ 87.10 , p<0.0001 ) . Conclusion : A H pylori “ test and treat ” strategy is more cost-effective but less satisfying than prompt endoscopy in the management of young Asian patients with uncomplicated dyspepsia AIMS To prospect ively evaluate the effectiveness of the test- and -treat strategy in a large group of dyspeptic patients in clinical practice . METHODS Patients with ulcer-like dyspepsia , < 45 years , without alarm symptoms , were prospect ively studied . Helicobacter pylori infection was diagnosed with the 13C-urea-breath-test , and eradication or symptomatic treatment was prescribed accordingly . ' Symptomatic improvement ' was defined as the percentage of patients with a decrease of > or = 2 levels in the dyspepsia-severity-score or with no symptoms after treatment . Health status and use of health re sources were also assessed . Endoscopy was performed in therapeutic failures . RESULTS Out of 736 patients initially included , 422 received eradication , and 314 symptomatic therapy ; 87 % returned at 6 weeks and 67 % at 6 months . At 6 months , ' symptomatic improvement ' was achieved in 73 % and 54 % of the patients , in eradication and symptomatic groups , respectively ( p < .001 ) , and overall in 66 % . A reduction of 78 % in mean self- assessment visual analogical score was observed at 6 months . More than 50 % of patients were ' much better ' at control visits . Endoscopy ( 18 % ) and physician 's visits ( 13 % ) were the main health re sources used . No gastric or oesophageal cancer was diagnosed . CONCLUSION This large prospect i ve study shows that the test- and -treat strategy is effective and safe for management of dyspeptic patients in clinical practice OBJECTIVE --To investigate the association between gastric cancer and prior infection with Helicobacter pylori . DESIGN --Case-control comparison of prevalence of IgG antibodies to H pylori in blood sample s collected prospect ively , before diagnosis of gastric cancer in the cases . Presence of H pylori antibody ( greater than 10 micrograms IgG/ml ) determined by enzyme linked immunosorbent assay ( ELISA ) . SUBJECTS--29 men with a subsequent diagnosis of gastric cancer and 116 aged matched controls selected from over 22,000 middle aged men participating in two ongoing cohort studies ( the British United Provident Association study and the Caerphilly collaborative heart disease study ) , who had provided blood sample s during 1975 - 1982 . RESULTS --20 of the 29 cases ( 69 % ) and 54 of the 116 controls ( 47 % ) were positive for H pylori specific antibody . The median specific IgG concentration was significantly higher in the cases than controls ( 90 micrograms/ml v 3.6 micrograms/ml , p less than 0.01 ) . The estimated odds ratio for the risk of gastric cancer in those with a history of infection with H pylori was 2.77 ( 95 % confidence interval 1.04 to 7.97 , 2p = 0.039 ) . CONCLUSIONS --H pylori infection may be an important cause of gastric cancer ; between 35 % and 55 % of all cases may be associated with such an infection BACKGROUND The value of the " test- and -treat " strategy in the approach to dyspepsia has been evaluated only in a few secondary care studies . Most patients with dyspepsia , however , are treated by their primary care physician . This study evaluated the test- and -treat strategy in primary care . METHODS Patients consulting their general practitioners for dyspepsia were r and omized to either direct open-access endoscopy with Helicobacter pylori testing or a test- and -treat strategy by H pylori serology . In the 12-month follow-up period , any additional treatment or referral for investigations was left at the discretion of the general practitioner . At the end of the study , data were collected concerning the number of endoscopies , changes in symptom severity and quality of life , patient satisfaction , and the use of medical re sources . RESULTS Two hundred seventy patients were enrolled ( 129 who received endoscopy and 141 in the test- and -treat group ) . The prevalence of H pylori infection was 38.3 % and 37.2 % in the test- and -treat and endoscopy groups , respectively . In the test- and -treat group , 46 patients ( 33 % ) were referred for endoscopy during follow-up . Improvement in symptom severity , quality of life , and patient satisfaction was comparable in both groups . Patients in the test- and -treat group paid more dyspepsia-related visits to their general practitioner ( P = .005 ) . Patients in the endoscopy group were more often prescribed proton pump inhibitors ( P = .007 ) , whereas patients in the test- and -treat group were more often prescribed prokinetic drugs ( P = .005 ) . CONCLUSIONS The test- and -treat strategy proved to be as effective and safe as prompt endoscopy . Only a minority of patients were referred for endoscopy after the test- and -treat approach Abstract Objective To compare the efficacy of a “ Helicobacter pylori test and treat ” strategy with that of an empirical trial of omeprazole in the non-endoscopic management by empirical prescribing of young patients with dyspepsia . Design R and omised controlled trial . Setting Hospital gastroenterology unit . Participants 219 patients under 45 years old presenting with dyspepsia without alarm symptoms . Intervention Patients received treatment with omeprazole 20 mg ( group A ) or with a urea breath test followed by an eradication treatment in case of H pylori infection or omeprazole alone in non-infected patients ( group B ) . Lack of improvement or recurrence of symptoms prompted endoscopy . Main outcome measures Improvement in symptoms assessed by a dyspepsia severity score every two months ; use of medical re sources ( endoscopic workload and medical consultation ) ; clinical outcome . Results 96/109 ( 88 % ) patients in group A and 61/110 ( 55 % ) in group B ( P < 0.0001 ) had endoscopy : in 19 patients in group A and 32 in group B ( 20/67 infected and 12/43 non-infected ) because of no improvement ; in 77 further patients in group A and 29 in group B ( 7 infected and 22 non-infected ) because of recurrence of symptoms during follow up . Endoscopy showed peptic ulcers only in group A ; oesophagitis occurred significantly more often in group B than in group A. About 80 % of examinations were normal in both groups , but nine duodenal scars occurred in group A. Conclusions Eradication treatment allows resolution of symptoms in a large number of patients with dyspepsia and reduces the endoscopic workload . After a trial of omeprazole , symptoms recur in nearly every patient . Such treatment is also likely to mask an appreciable number of peptic ulcers and cases of oesophagitis Introduction The respective roles of general practitioners and specialists in the management of most diseases is not clearly defined and dyspepsia is no exception . Ideally , the division of tasks should be based on the characteristics of diVerent diseases and on specific objectives . The prevalence of dyspepsia ranges between 20 and 40 % in industrialised countries and roughly 25 % of patients seek medical help , whereas the remainder often self-medicate . Although frequently idiopathic ( or functional ) , dyspepsia can be secondary to a variety of serious ( and sometimes fatal ) organic , systemic and metabolic diseases that need to be identified . Functional dyspepsia also precipitates a substantial reduction in the quality of life of aVected patients with relevant costs for society . The current economic restrictions prevent referral of every patient and correct management of dyspepsia is a formidable task . Prospect i ve studies have been undertaken to establish the respective eVectiveness of diVerent doctors in the management of some gastroenterological diseases . Zarling et al compared the eYcacy of management of acute diverticulitis provided by general practitioners , internists and gastroenterologists , and observed shorter hospital stay and lower readmission rates in patients treated by gastroenterlogists . Unlike acute diverticulitis , dyspepsia is a very heterogeneous condition and no similar studies are available as yet . Tackling the following questions may help to eluci date the remit of diVerent doctors . + What drives a dyspeptic individual to consult a physician ? + Do diVerent doctors see diVerent types of dyspeptic patients ? + What is the diagnostic yield of an extensive work-up by a specialist ? + Should diVerent doctors adopt diVerent strategies for the management of dyspepsia ? + What is the most cost-eVective way to manage dyspepsia Objective : The diagnostic value of the addition of alarm symptoms in distinguishing functional from organic gastrointestinal disease remains uncertain . We aim ed to establish the value of alarm features in differentiating between organic disease and irritable bowel syndrome ( IBS ) and functional dyspepsia ( FD ) . Methods : A total of 568 consecutive patients ( 63 % female ; mean age 44.7 years ) completed a detailed symptom question naire and then received a complete diagnostic workup , as required . Question naire data were collected prospect ively and audited retrospectively ; the treating physician was blinded to the results of the question naires . Patients were coded and allocated to the following diagnostic groups : IBS , FD , organic diseases of the upper gastrointestinal tract , or organic diseases of the lower gastrointestinal tract . Logistic regression was used to identify the best subset of symptoms that discriminated organic disease from functional illness . Separate models compared IBS ( n = 214 ) with diseases of the lower gastrointestinal tract ( n = 66 ) , and FD ( n = 70 ) with diseases of the upper gastrointestinal tract ( n =
Output:
| The test- and -treat strategy will cure most cases of underlying peptic ulcer disease , prevent most potential cases of gastroduodenal disease , and yield symptomatic benefit in a minority of patients with functional dyspepsia .
: The test- and -treat strategy will cure most cases of underlying peptic ulcer disease and prevent most potential cases of gastroduodenal disease .
In addition , a minority of infected patients with functional dyspepsia will gain symptomatic benefit . |
MS210695 | ***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 AND PURPOSE Percutaneous transluminal angioplasty ( PTA ) is currently being assessed for the treatment of carotid stenosis . In comparison with carotid endarterectomy ( CEA ) , there is evidence of an increased risk of cerebral microembolism during the procedure . We have sought evidence of any neuropsychological sequelae of carotid PTA and compared it with CEA to demonstrate the relative safety of the 2 treatment options . METHODS The neuropsychological outcomes after CEA and PTA were compared in 2 matched groups of patients with severe symptomatic carotid stenosis , 96 % of whom had been r and omized in the Carotid and Vertebral Artery Transluminal Angioplasty Study ( CAVATAS ) , at a single center . Transcranial Doppler insonation of the middle cerebral artery was used to measure cerebral reactivity in response to carbon dioxide inhalation before treatment and then to detect microembolization of the ipsilateral cerebral hemisphere and measure changes in blood flow velocity during the procedures . The performance on a neuropsychological test battery administered before , 6 weeks after , and 6 months after the procedure was compared in 20 patients undergoing PTA and 26 having CEA . RESULTS At 6 weeks , 5 patients in each group showed a similar decline in neuropsychological performance ; global measures showed no significant difference between the 2 procedures , despite a significantly higher incidence of microemboli during PTA . Both groups showed a marked reduction in anxiety after treatment . CONCLUSIONS The findings provide some reassurance that PTA is not associated with greater cerebral complications than CEA , despite the higher embolic load recorded by transcranial Doppler ultrasonography during angioplasty BACKGROUND AND PURPOSE This study reports the surgical results in those patients who underwent carotid endarterectomy in the North American Symptomatic Carotid Endarterectomy Trial ( NASCET ) . METHODS The rates of perioperative stroke and death at 30 days and the final assessment of stroke severity at 90 days were calculated . Regression modeling was used to identify variables that increased or decreased perioperative risk . Non outcome surgical complications were summarized . The durability of carotid endarterectomy was examined . RESULTS In 1415 patients there were 92 perioperative outcome events , for an overall rate of 6.5 % . At 30 days the results were as follows : death , 1.1 % ; disabling stroke , 1.8 % ; and nondisabling stroke , 3.7 % . At 90 days , because of improvement in the neurological status of patients judged to have been disabled at 30 days , the results were as follows : death , 1.1 % ; disabling stroke , 0.9 % ; and nondisabling stroke , 4.5 % . Thirty events occurred intraoperatively ; 62 were delayed . Most strokes result ed from thromboembolism . Five baseline variables were predictive of increased surgical risk : hemispheric versus retinal transient ischemic attack as the qualifying event , left-sided procedure , contralateral carotid occlusion , ipsilateral ischemic lesion on CT scan , and irregular or ulcerated ipsilateral plaque . History of coronary artery disease with prior cardiac procedure was associated with reduced risk . The risk of perioperative wound complications was 9.3 % , and that of cranial nerve injuries was 8.6 % ; most were of mild severity . At 8 years , the risk of disabling ipsilateral stroke was 5.7 % , and that of any ipsilateral stroke was 17.1 % . CONCLUSIONS The overall rate of perioperative stroke and death was 6.5 % , but the rate of permanently disabling stroke and death was only 2.0 % . Other surgical complications were rarely clinical ly important . Carotid endarterectomy is a durable procedure BACKGROUND Percutaneous transluminal angioplasty and stenting ( endovascular treatment ) can be used to treat carotid stenosis , but risks and benefits are uncertain . We therefore compared endovascular treatment with conventional carotid surgery . METHODS In a multicentre clinical trial , we r and omly assigned 504 patients with carotid stenosis to endovascular treatment ( n=251 ) or carotid endarterectomy ( n=253 ) . For endovascular patients treated successfully , we used stents in 55 ( 26 % ) and balloon angioplasty alone in 158 ( 74 % ) . An independent neurologist followed up patients . Analysis was by intention to treat . FINDINGS The rates of major outcome events within 30 days of first treatment did not differ significantly between endovascular treatment and surgery ( 6.4 % vs 5.9 % , respectively , for disabling stroke or death ; 10.0 % vs 9.9 % for any stroke lasting more than 7 days , or death ) . Cranial neuropathy was reported in 22 ( 8.7 % ) surgery patients , but not after endovascular treatment ( p<0.0001 ) . Major groin or neck haematoma occurred less often after endovascular treatment than after surgery ( three [ 1.2 % ] vs 17 [ 6.7 % ] , p<0.0015 ) . At 1 year after treatment , severe ( 70 - 99 % ) ipsilateral carotid stenosis was more usual after endovascular treatment ( 25 [ 14 % ] vs seven [ 4 % ] , p<0.001 ) . However , no substantial difference in the rate of ipsilateral stroke was noted with survival analysis up to 3 years after r and omisation ( adjusted hazard ratio=1.04 , 95 % CI 0.63 - 1.70 , p=0.9 ) . INTERPRETATION Endovascular treatment had similar major risks and effectiveness at prevention of stroke during 3 years compared with carotid surgery , but with wide CIs . Endovascular treatment had the advantage of avoiding minor complications PURPOSE To develop an ex vivo human carotid artery stenting model that can be used for the quantitative analysis of risk for embolization associated with balloon angioplasty and stenting and to correlate this risk with lesion characteristics to define lesions suitable for balloon angioplasty and stenting . METHODS Specimens of carotid plaque ( n = 24 ) were obtained circumferentially intact from patients undergoing st and ard carotid endarterectomy . Carotid lesions were prospect ively characterized on the basis of angiographic and duplex findings before endarterectomy and clinical findings . Specimens were encased in a polytetrafluoroethylene wrap and mounted in a flow chamber that allowed access for endovascular procedures and observations . Balloon angioplasty and stenting were performed under fluoroscopic guidance with either a Palmaz stent or a Wallstent endoprosthesis . Ex vivo angiograms were obtained before and after intervention . Effluent from each specimen was filtered for released embolic particles , which were microscopically examined , counted , and correlated with various plaque characteristics by means of multivariate analysis . RESULTS Balloon angioplasty and stenting produced embolic particles that consisted of atherosclerotic debris , organized thrombus , and calcified material . The number of embolic particles detected after balloon angioplasty and stenting was not related to preoperative symptoms , sex , plaque ulceration or calcification , or artery size . However , echolucent plaques generated a higher number of particles compared with echogenic plaques ( p < 0.01 ) . In addition , increased lesion stenosis also significantly correlated with the total number of particles produced by balloon angioplasty and stenting ( r = 0.55 ) . Multivariate analysis revealed that these two characteristics were independent risk factors . CONCLUSIONS Echolucent plaques and plaques with stenosis > or = 90 % produced a higher number of embolic particles and therefore may be less suitable for balloon angioplasty and stenting . This ex vivo model can be used to identify high-risk lesions for balloon angioplasty and stenting and can aid in the evaluation of new devices being considered for carotid balloon angioplasty and stenting The Stent-Supported Percutaneous Angioplasty of the Carotid Artery versus Endarterectomy ( SPACE ) Trial is investigating if both treatment modalities are equivalent in the treatment of severe symptomatic carotid stenoses . Patients with symptomatic ( transient ischaemic attack or minor stroke ) stenosis ( above 50 % following the North American Symptomatic Endarterectomy Trial criteria ) eligible for both methods can be recruited into this trial . The primary endpoint is the incidence of an ipsilateral stroke or death between r and omisation and day 30 after treatment . Surgeons as well as the interventionalists have to demonstrate their expertise prior to participation in the trial . Funding is mostly by public institutions ( Federal Ministry of Education and Research and German Research Foundation ) . An external monitoring is applied . Thirty-two centres are currently taking part in the SPACE Trial that has been running in Germany , Austria and Switzerl and for 3 years , and they have been able to recruit a total of around 670 patients . The definitive results of this study can not be expected before 3–5 years BACKGROUND AND PURPOSE There has been concern about carotid percutaneous transluminal angioplasty ( PTA ) carrying a greater risk of cerebral ischemia than carotid endarterectomy . We set out to compare cerebral hemodynamics and microembolization during carotid PTA and CEA . METHODS We used transcranial Doppler to monitor the middle cerebral artery of 28 patients undergoing carotid PTA ( n = 14 ) or carotid endarterectomy ( CEA ) with a shunt ( n = 14 ) . Each period during which the internal carotid artery was occluded by PTA balloon or by clamp when the shunt was not in place was timed . Individual periods were summated to give a total occlusion time . Ischemic time was defined as the period for which mean middle cerebral artery velocity fell to a third or less of baseline . Microembolic signals were counted during each procedure . RESULTS CEA result ed in significantly longer individual and total occlusion time than PTA ( mean individual occlusion time , seconds ) , CEA , 168 + /- 51 ; PTA , 20 + /- 7 ; P < .001 ; mean total occlusion time ; CEA , 337 + /- 70 ; PTA , 26 + /- 10 ; P < .001 . Ischemic time was also significantly longer during CEA than during PTA ( CEA , 165 + /- 40 ; PTA , 17 + /- 5 ; P = .001 ) . There were significantly more microembolic signals during PTA than during CEA ( mean number of microembolic signals during CEA , 52 + /- 64 ; during PTA , 202 + /- 119 ; P = .001 ) . There was no correlation between any of the parameters measured and periprocedural stroke , which occurred in one patient in each group . CONCLUSION PTA results in less hemodynamic ischemia but more cerebral microembolism than CEA . In this small series , however , it is not possible to comment on the relations between ischemic time , microembolism , and stroke BACKGROUND Carotid angioplasty ( CA ) has been suggested to be a safer and more cost-effective alternative to carotid endarterectomy ( CEA ) in the management of symptomatic severe internal carotid artery ( ICA ) disease . METHODS The study was conducted as a prospect i ve consecutive r and omized trial of CEA versus CA for symptomatic severe ICA disease in a university teaching hospital . All patients were assessed before and after surgery by a neurologist . The study consisted of 23 patients with focal carotid territory symptoms and severe ICA stenosis ( > 70 % ) who were r and omized to either CEA or CA . However , only 17 had received their allocated treatment before trial suspension . CEA with patching or CA with stenting were used as interventions . The main outcome measures were death or disabling or nondisabling stroke within 30 days . RESULTS All 10 CEA operations proceeded without complication , but 5 of the 7 patients who underwent CA had a stroke ( P=.0034 ) , 3 of which were disabling at 30 days . CONCLUSIONS After referral , the Data Monitoring Committee invoked the stopping rule and the trial was suspended . The investigators and the Ethics Committee subsequently concluded that the trial could not be restarted -- even in an amended format-primarily because of problems with informed consent . We review many of the ethical dilemmas encountered in the performance of this study . If future trials do suggest a selected role for CA , it is essential that both the inclusion and the exclusion criteria are fully documented BACKGROUND Coronary-stent placement is a new technique in which a balloon-exp and able , stainless-steel , slotted tube is implanted at the site of a coronary stenosis . The purpose of this study was to compare the effects of stent placement and st and ard balloon angioplasty on angiographically detected restenosis and clinical outcomes . METHODS We r and omly assigned 410 patients with symptomatic coronary disease to elective placement of a Palmaz-Schatz stent or to st and ard balloon angioplasty . Coronary angiography was performed at base line , immediately after the procedure , and six months later . RESULTS The patients who underwent stenting had a higher rate of procedural success than those who underwent st and ard balloon angioplasty ( 9
Output:
| There was no difference either in the rate of stroke during follow-up , but the confidence intervals were very wide and severe ipsilateral carotid stenosis was more frequent 1 year after endovascular treatment than after carotid surgery .
However , there is little convincing evidence that these new devices reduce the rate of stroke .
Moreover , a systematic review of the existing r and omised trial data concluded that there the current evidence does not support a shift away from recommending carotid endarterectomy as the st and ard treatment for carotid stenosis . |
MS210696 | ***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 Short-term high-carbohydrate ( HC ) diets induce metabolic alterations , including hypertriacylglycerolemia , in both the fasting and postpr and ial states . The underlying tissue-specific alterations in fatty acid metabolism are not well understood . OBJECTIVE We investigated alterations in exogenous and endogenous fatty acid metabolism by using stable isotope tracers to label meal triacylglycerol and plasma fatty acids . DESIGN Eight healthy subjects consumed isocaloric diets containing a high percentage of energy from carbohydrates or a higher percentage of energy from fat for 3 d in a r and omized crossover dietary intervention study . A test meal containing [ U-13C ] palmitate was combined with intravenous infusion of [ 2H2 ] palmitate to label plasma fatty acids and VLDL triacylglycerol . Blood and breath sample s were taken before the meal and for 6 h postpr and ially . Blood sample s were drawn from the femoral artery and from veins draining subcutaneous adipose tissue and forearm muscle for monitoring of tissue-specific metabolic substrate partitioning . RESULTS Systemic triacylglycerol concentrations were increased in both fasting ( P = 0.02 ) and postpr and ial ( P = 0.02 ) periods , and a greater amount of infused labeled fatty acid appeared in VLDL triacylglycerol after the HC diet than after the higher-fat diet ( P = 0.05 ) . Significantly less 13CO2 was exhaled after the HC diet ( P = 0.04 ) and significantly less production of 13CO2 was seen across forearm muscle ( P = 0.04 ) . Systemic 3-hydroxybutyrate was significantly lower , postpr and ially , after the HC diet ( P = 0.02 ) . CONCLUSION Metabolic alterations suggestive of repartitioning of fatty acids away from oxidation toward esterification in both liver and muscle occur in response to short-term adaptation to a HC diet Dietary guidelines for the general population and for the management of obesity , diabetes and heart disease suggest a reduction in dietary fat , and in particular dietary saturated fatty acids ( SFA ) . In order to achieve the recommended levels , changes in food choice patterns are required . Foods are consumed in combination with other foods , and these combinations are often recognizable as cuisine patterns . In this study we examined the food choice patterns of a group of 63 adults with existing type 2 diabetes mellitus who completed a 12 month dietary intervention trial aim ed at changing dietary fat under ' free living ' conditions . In both lower fat ( LF , 27 % ) and modified fat ( MF , 37%E ) groups , a reduction in dietary SFA and an increase in polyunsaturated fat were required , with an additional requirement to increase dietary monounsaturated fat in the MF group . The usual diets of the study sample were on average low in total fat ( 27%E ) , but high in saturated fat ( 12%E ) . Those already consuming total fat at the level concordant with their allocation ( LF or MF ) achieved targets faster than those with a discordant allocation , but there was no significant effect of usual diet on time of target achievement at 12 months . At 6 months , those achieving dietary fat targets had changed to low fat dairy products and leaner meats , were having more spreads , oils , and nuts and were consuming takeaway meals less than twice a week . Contributions to dietary fat shifted from takeaway foods , meat , dairy products and cakes to spreads , oils and nuts . The modified fat and low fat groups chose more Mediterranean and South East Asian cuisines respectively . In this study sample , usual dietary patterns had an initial impact on change in the diet , but identifiable changes in food choice patterns and the adoption of certain cuisines that combined foods indicative of the dietary guidelines result ed in successful achievement of dietary fat targets BACKGROUND The efficacy of ad libitum low-fat diets in reducing body weight and fat in overweight and obese adults remains controversial . METHODS We examined the effect of a 12-week low-fat , high-complex carbohydrate diet alone ( HI-CHO ) and in combination with aerobic exercise training ( HI-CHO + EX ) on body weight and composition in 34 individuals with impaired glucose tolerance ( 20 women and 14 men ; mean + /- SEM age , 66 + /- 1 years ) . Participants were r and omly assigned to a control diet ( 41 % fat , 14 % protein , 45 % carbohydrates , and 7 g of fiber per 1000 kcal ) , a HI-CHO diet ( 18 % fat , 19 % protein , 63 % carbohydrates , and 26 g of fiber per 1000 kcal ) , or a HI-CHO diet plus endurance exercise 4 d/wk , 45 min/d , at 80 % peak oxygen consumption ( HI-CHO + EX ) . Participants were provided 150 % of estimated energy needs and were instructed to consume food ad libitum . Total food intake , body composition , resting metabolic rate , and substrate oxidation were measured . RESULTS There was no significant difference in total food intake among the 3 groups and no change in energy intake over time . The HI-CHO + EX and HI-CHO groups lost more body weight ( -4.8 + /- 0.9 kg [ P=.003 ] and -3.2 + /- 1.2 kg [ P=.02 ] ) and a higher percentage of body fat ( -3.5 % + /- 0.7 % [ P=.01 ] and -2.2 % + /- 1.2 % [ P=.049 ] ) than controls ( -0.1 + /- 0.6 kg and 0.2 % + /- 0.6 % ) . In addition , thigh fat area decreased in the HI-CHO ( P=.003 ) and HI-CHO + EX ( P<.001 ) groups compared with controls . High carbohydrate intake and weight loss did not result in a decreased resting metabolic rate or reduced fat oxidation . CONCLUSION A high-carbohydrate diet consumed ad libitum , with no attempt at energy restriction or change in energy intake , results in losses of body weight and body fat in older men and women
Output:
| Results : There was no evidence that variations of a typical , non-experimental diet influenced rate or ratio of substrate utilization , however there may be an upper and lower threshold for when macronutrient composition may directly alter preferences for fuel oxidation rates during a fasted state .
Conclusion : This review indicates that macronutrient composition of a wide range of typical , non-experimental dietary fat and carbohydrate intakes has no effect on fasting substrate oxidation .
This suggests that strict control of dietary intake prior to fasting indirect calorimetry measurements may be an unnecessary burden for study participants . |
MS210697 | ***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 We compared the angiotensin receptor-neprilysin inhibitor LCZ696 with enalapril in patients who had heart failure with a reduced ejection fraction . In previous studies , enalapril improved survival in such patients . METHODS In this double-blind trial , we r and omly assigned 8442 patients with class II , III , or IV heart failure and an ejection fraction of 40 % or less to receive either LCZ696 ( at a dose of 200 mg twice daily ) or enalapril ( at a dose of 10 mg twice daily ) , in addition to recommended therapy . The primary outcome was a composite of death from cardiovascular causes or hospitalization for heart failure , but the trial was design ed to detect a difference in the rates of death from cardiovascular causes . RESULTS The trial was stopped early , according to prespecified rules , after a median follow-up of 27 months , because the boundary for an overwhelming benefit with LCZ696 had been crossed . At the time of study closure , the primary outcome had occurred in 914 patients ( 21.8 % ) in the LCZ696 group and 1117 patients ( 26.5 % ) in the enalapril group ( hazard ratio in the LCZ696 group , 0.80 ; 95 % confidence interval [ CI ] , 0.73 to 0.87 ; P<0.001 ) . A total of 711 patients ( 17.0 % ) receiving LCZ696 and 835 patients ( 19.8 % ) receiving enalapril died ( hazard ratio for death from any cause , 0.84 ; 95 % CI , 0.76 to 0.93 ; P<0.001 ) ; of these patients , 558 ( 13.3 % ) and 693 ( 16.5 % ) , respectively , died from cardiovascular causes ( hazard ratio , 0.80 ; 95 % CI , 0.71 to 0.89 ; P<0.001 ) . As compared with enalapril , LCZ696 also reduced the risk of hospitalization for heart failure by 21 % ( P<0.001 ) and decreased the symptoms and physical limitations of heart failure ( P=0.001 ) . The LCZ696 group had higher proportions of patients with hypotension and nonserious angioedema but lower proportions with renal impairment , hyperkalemia , and cough than the enalapril group . CONCLUSIONS LCZ696 was superior to enalapril in reducing the risks of death and of hospitalization for heart failure . ( Funded by Novartis ; PARADIGM-HF Clinical Trials.gov number , NCT01035255 . ) The benefits of fixed-dose combination isosorbide dinitrate plus hydralazine ( ID/H ) in African-Americans with heart failure ( HF ) were established by the African-American Heart Failure Trial ( A-HeFT ) , which was terminated early because of a significant survival benefit of ID/H. The Extension to A-HeFT trial ( X-A-HeFT ) , design ed to make ID/H available for ethical reasons after A-HeFT termination , afforded an opportunity to further observe responsiveness and compliance with ID/H. In total 198 patients completing the A-HeFT took ID/H for an additional 209 + /- 116 days . Their age ( 57 + /- 13 years ) , cause and duration of HF , and HF medications were not different from all A-HeFT patients . New York Heart Association class at X-A-HeFT baseline was > or = III in 51 % of patients versus 100 % of all patients at A-HeFT baseline , remained unchanged in most patients , improved in 24 % , and worsened in only 9 % during X-A-HeFT . The average number of ID/H tablets taken during X-A-HeFT was 3.7 + /- 1.8 per day with compliance averaging 87 + /- 25 % . The most common adverse events , headache ( 34 % ) and dizziness ( 16 % ) , were less than in patients taking ID/H in A-HeFT , with only 6 % discontinuations for adverse events . The 6 % annualized mortality rate in X-A-HeFT was the same as for ID/H in A-HeFT . There were no statistically significant differences in baseline characteristics or outcomes in X-A-HeFT patients analyzed according to their A-HeFT r and omization . In conclusion , these results confirm the good compliance , tolerability , and responsiveness , with low mortality and improved symptoms , during treatment with ID/H observed in A-HeFT Resting hemodynamics improve during vasodilator administration in patients with congestive heart failure ( CHF ) , but the effects of these agents on exercise is unknown . Twenty-two patients with class II or III CHF performed bicycle exercise to symptomatic maximum before and 90 minutes after r and om doubleblind administration of oral hydralazine ( 100 mg ) and isosorbide dinitrate ( 40 mg ) ( 11 patients , group 1 ) or placebo ( 11 patients , group 2 ) . Exercise duration was unchanged after treatment in either group . Maximal oxygen consumption changed insignificantly in both groups , from 12.6 ± 1.2 ( SEM ) to 13.6 ± 1.6 ml/kg/min in group 1 , and from 11.7 ± 1.4 to 13.4 ± 1.7 ml/kg/min in group 2 . Maximal cardiac index was unchanged in both group 1 ( 4.00 ± 0.33 to 4.41 ± 0.29 1/min/m2 ) and group 2 ( 4.11 ± 0.43 to 4.14 ± 0.42 1/min/m2 ) . Systemic vascular resistance at peak exercise was also unchanged in both group 1 ( 14.1 1.6 to 11.8 1.0 units ) and group 2 ( 14.7 1.6 to 13.5 ± 1.6 units ) . At submaximal exercise ( 300 kilopond-meters/min ) , however , cardiac index after treatment increased in group 1 ( 0.51 + 0.18 1/min/m2,p < 0.05 ) and systemic vascular resistance decreased ( -3.3 ± 1.3 units , p < 0.05 ) , but were unchanged in group 2 . Thus , although vasodilators do not improve maximal exercise capacity acutely , they can improve hemodynamics at lower work loads which may , therefore , be better tolerated in patients with CHF The efficacy of orally administered isosorbide dinitrate ( IS ) has been question ed . Recently vasodilators have been shown to lower left ventricular filling pressure ( LVFP ) and raise cardiac output in heart failure . In the present study oral IS was evaluated in 12 patients with high LVFP due to heart failure . After right heart catheterization , patients with LVFP > 14 mm Hg were r and omized double-blind to receive either 20 mg IS or placebo ( P ) . Supine heart rate ( HR ) , arterial pressure ( BP ) , and LVFP were monitored for five hours . After this the alternate drug ( P or IS ) was given , followed by five more hours of monitoring . In the 12 patients after receiving IS , LVFP reached a peak reduction of 6.7 mm Hg ( -26 % , P < 0.005 ) at 30 min . Significant reduction persisted for 4.5 hours . Blood pressure fell concomitantly with the LVFP . At 60 min HR was unchanged , systolic BP was reduced by 8.9 mm Hg ( P < 0.025 ) and diastolic BP by 6.3 mm Hg ( P < 0.005 ) . In the ten patients receiving P , control values were not significantly different from those given IS , and after receiving P , HR , BP , and LVFP failed to change significantly over the next five hours . Thus , oral IS produces a sustained reduction in LVFP and therefore merits further evaluation as chronic therapy for left ventricular failure Vasodilators are known to be effective in improving the hemodynamics of congestive heart failure by increasing cardiac output and reducing left ventricular filling pressure ( LVFP ) . Long acting agents are needed to augment the practicality and availability of chronic vasodilator therapy . In the present study the vascular effects of chewable isosorbide dinitrate ( CHIS ) , sublingual nitroglycerin ( NTG ) and placebo ( P ) were compared in eight patients with high LVFP due to heart failure . Patients with LVFP ( pulmonary wedge pressure ) over 14 mm Hg were given CHIS , 10 mg , NTG , 0.6 mg , and P , two chewable tablets , in r and om fashion . Heart rate ( HR ) , blood pressure ( BP ) , and LVFP were monitored for three hours after each drug . HR was not significantly affected by any drug , although it rose slightly after NTG and fell after CHIS . Significant reduction of BP occurred only after NTG , with peak effect at five minutes , but lasting only 15 minutes . NTG reduced LVFP 5.1 mm Hg ( 19.5 % , P < 0.05 ) , at peak effect , but LVFP was no longer significantly lower by 20 minutes after NTG . After CHIS , LVFP fell significantly within five minutes , reached a peak reduction of 8.6 mm Hg ( 32.7 % , P < 0.01 ) at 15 minutes , and remained significantly lower through three hours . Thus CHIS provides a nitrate action of rapid onset and sustained effect that may be useful for chronic vasodilator therapy of heart failure We compared the effects of Hydralazine and Isosorbide dinitrate ( ISDN ) with those of an angiotensin-converting-enzyme inhibitor , captopril on mortality in patients with chronic congestive heart failure ( NYHA class III and IV ) . Patients receiving conventional treatment with digoxin and diuretics were r and omly assigned to receive either placebo ( n = 51 ) , hydralazine-ISDN . ( n = 50 ) or captopril ( n = 52 ) in a double blind trial . At the end of 6 months there were 14 deaths in the placebo group ( 27.4 % ) as compared with 11 deaths in the hydralazine-ISDN group (22%)--a mortality reduction of 20 % ( P > 0.05 ) and 10 deaths in the captopril group (19.2%)--a mortality reduction of 30 % ( p > 0.05 ) . At the end of one year , mortality was 50 % , 42 % and 30 % in the placebo , hydralazine-ISDN and captopril groups respectively with a mortality reduction of 16 % in the hydralazine-ISDN group ( p > 0.05 ) and 40 % in the captopril group ( p < 0.05 ) compared to the placebo group . The mortality reduction was mainly due to reduction in deaths attributed to progressive heart failure . The data suggests that the addition of captopril to conventional treatment significantly reduces mortality in patients with severe congestive heart failure . Hydralazine-isorobide dinitrate also reduced mortality but statistically this was not significant A r and omized double-blind crossover trial included 16 patients with severe congestive heart failure who received isosorbide dinitrate or placebo for eight weeks , and then the opposite treatment for eight more weeks . All patients received their usual maintenance therapy with digitalis and diuretics . Seven morbid events occurred during 85 patient-weeks of isosorbide dinitrate therapy compared with 17 during 76 patient-weeks of placebo . Severity of congestive heart failure improved in all eight patients who received isosorbide dinitrate compared with two patients who showed improvement and five whose symptoms became worse with placebo . No significant differences in physical findings , cardiac dimensions , or resting hemodynamics were observed . Maximal exercise duration increased significantly by 2.54 minutes with isosorbide dinitrate therapy , and rose insignificantly by 1.24 minutes with placebo . This preliminary trial suggests that long-term vasodilator therapy may be clinical ly beneficial in congestive heart failure We evaluated the effects of intravenous hydralazine ( 5 to 30 mg ) and oral nifedipine ( 20 to 80 mg ) on plasma catecholamines , renin , and aldosterone in 18 patients with severe chronic heart failure . Both drugs result ed in a significant decrease in systemic vascular resistance and mean systemic blood pressure , and led to an increase in cardiac output . Baseline plasma norepinephrine concentration was elevated in most patients ; however , augmentation of cardiac output with both drugs did not decrease the values of this hormone ( from 870 + /- 128 to 946 + /- 161 pg/ml with hydralazine and from 1088 + /- 260 to 1106 + /- 187 pg/ml with nifedipine ) . Plasma epinephrine level was also elevated at baseline and did not change significantly following nifedipine therapy ( 164 + /- 44 vs 199 + /- 54 pg/ml ) , but increased in most patients following the administration of hydralazine ( from 105 + /- 45 to 153 + /- 27 pg/ml , p less than 0.01 ) . The renin-aldosterone system was activated in our patients and also demonstrated a different response to both drugs . Hydralazine therapy did not change
Output:
| Compared to placebo , H&N reduces mortality in patients with CHF .
Whether race or background therapy influences benefit is uncertain , but on direct comparison H&N appears inferior to ACEI .
There is little evidence to support the use of either drug alone in CHF |
MS210698 | ***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 a single-blind r and omized study , the efficacy of a single intravenous dose of sulbactam ( 0.5 g ) plus ampicillin ( 1 g ) was compared with that of placebo in the prophylaxis of early postoperative endometritis after abortion with vacuum aspiration in the first trimester . Administration of either sulbactam/ampicillin or placebo occurred immediately before the operation . The two treatment groups were equally matched with respect to patient 's age , gestational age , presence of an intrauterine device , and baseline bacteriologic findings . During the first seven postoperative days , four of 145 patients who had received sulbactam/ampicillin and 11 of 140 patients who had received placebo were diagnosed as having endometritis . No adverse effects and no laboratory test abnormalities attributable to treatment were reported in either group . A single dose of sulbactam/ampicillin reduced the incidence of early postoperative endometritis after abortion with vacuum aspiration in the first trimester A clinical , controlled trial was performed to study the effect of prophylaxis with lymecycline and the role of Chlamydia trachomatis and Mycoplasma hominis in postabortal genital infection . Of 532 women who were to undergo first-trimester abortion , 269 were r and omized to treatment with oral lymecycline ( 300 mg bid ) starting 2 days before the abortion and continuing for a total of 7 days , and 263 were r and omized to placebo treatment . The rate of postabortal infection was 9.3 % in the antibiotic group and 9.5 % in the placebo group , an insignificant difference ( P greater than .8 ) . The presence of C. trachomatis in the cervix/urethra at the time of abortion showed a significant association with the occurrence of postabortal infection ( P less than .005 ) , but there was no correlation between the effect of treatment and the presence of infection ( P greater than .4 ) . The presence of M. hominis , a history of pelvic inflammatory disease , maternal age , gestational age , the number of births , spontaneous and induced abortion , and the Hegar number showed no significant association with postabortal infection ( all P values greater than .05 ) . It is recommended that women who are to undergo induced abortion be examined for the presence of C. trachomatis and treated , as they constitute a risk group PURPOSE Clinical innovations have made it more feasible to incorporate early abortion into family medicine , yet the outcomes of early abortion procedures in this setting have not been well studied . We wished to assess the outcomes of first-trimester medication and aspiration abortion procedures by family physicians . METHODS Prospect i ve observational cohort study conducted from August 2001 to February 2005 of 2,550 women who sought pregnancy termination in 4 clinical practice s of family medicine departments and 1 private office/training site . RESULTS The rate of successful uncomplicated procedures for medication was 96.5 % ( 95 % confidence interval [ CI ] , 95.5%–97.0 % ) and for aspiration was 99.9 % ( CI , 99.3%–1 ) . Adverse events and complications of medication abortions were failed procedure ( ongoing pregnancy ; n = 19 , 1.45 % ) ; incomplete abortion ( n = 16 , 1.22 % ) ; hemorrhage ( n = 9 , 0.69 % ) ; and patient request for aspiration ( n = 1 , 0.08 % ) . One ( 0.08 % ) missed ectopic pregnancy was seen among patients receiving medication . Four types of adverse outcomes were encountered with aspiration : incomplete abortion requiring re-aspiration ( n = 21 , 1.83 % ) ; hemorrhage during the procedure ( n = 4 , 0.35 % ) ; missed ectopic pregnancy ( n = 3 , 0.26 % ) ; and minor endometritis ( n = 1 , 0.09 % ) . Missed ectopic pregnancies were successfully treated in the inpatient setting without mortality ( overall hospitalization rate of 0.16 of 100 ) . All other complications were managed within outpatient family medicine sites . Rates of complication did not vary by experience of physician or by site of care ( residency vs private practice ) . CONCLUSIONS Complications of medication and aspiration procedures occurred at a low rate , and most were minor and managed without incident the risks of morbidity and mortality affect a teenager 's choice between termination of a pregnancy through induced abortion and continuation of the pregnancy . To identify these risks , we analyzed information from two separate sets of data collected by the Centers for Disease Control : that of the Joint Program for the Study of Abortion , a multicenter prospect i ve study of nearly 165,000 legally induced abortions ; and that of a national surveillance of abortion-related mortality . The rates of major complications associated with abortions in teenagers were 1 to 3 per 1000 suction-curettage procedures and approximately 13 per 1000 saline-administration procedures . The death-to-case rate for teenage women was 1.3 per 100,000 procedures . When the data on procedures were adjusted according to gestational age , teenagers generally had lower rates of morbidity and mortality from induced abortion than older women The objective of this study was to determine whether propofol and methohexital differ in their efficacy , acceptability , cost and side effects when used as the single anesthetic agent for inducing general anesthesia in first-trimester vacuum abortion . We r and omized 400 unpremedicated American Society of Anesthesiologists grade I-II women to receive 1 % propofol or 1 % methohexital by intravenous bolus infusion during abortion . No ancillary anesthetic or adjunctive drugs were used . Visual analogue scale scores were used to grade preoperative patient anxiety and the quality of the anesthetic experience . All personnel outside the operating suites , except the data analyst , were blinded . Chi2 , median , analysis of variance and Student 's t-tests were used , as appropriate . There were no statistically significant differences in age , gravidity , parity , spontaneous and induced abortion , body mass index or gestational age . Mean total operating time and total drug dose were similar . Propofol use result ed in a significant reduction in the incidence of postoperative nausea ( 11.5 % vs. 17.5 % ) or vomiting ( 3.5 % vs. 7.0 % ) with a combined p ( mean difference ) = 0.002 ( 95 % confidence interval of the mean difference 1.8 % , 17.2 % ) . Both the nursing and patient appraisal s of the quality of the anesthetic experience favored propofol , but only the nursing scores reached statistical significance ( p < 0.001 ) . The cost differential was more than twofold greater for propofol patients , 9.51 dollars vs. 4.42 dollars . In our population of midwestern patients in a major urban area , propofol use had modest advantages over methohexital when used as single agents as judged by first recovery charge nurses , but patients found them equally acceptable OBJECTIVES We compared complication rates after surgical abortions performed by physician assistants with rates after abortions performed by physicians . METHODS A 2-year prospect i ve cohort study of women undergoing surgically induced abortion was conducted . Ninety-one percent of eligible women ( 1363 ) were enrolled . RESULTS Total complication rates were 22.0 per 1000 procedures ( 95 % confidence interval [ CI ] = 11.9 , 39.2 ) performed by physician assistants and 23.3 per 1000 procedures ( 95 % CI = 14.5 , 36.8 ) performed by physicians ( P = .88 ) . The most common complication that occurred during physician assistant-performed procedures was incomplete abortion ; during physician-performed procedures the most common complication was infection not requiring hospitalization . A history of pelvic inflammatory disease was associated with an increased risk of total complications ( odds ratio = 2.1 ; 95 % CI = 1.1 , 4.1 ) . CONCLUSIONS Surgical abortion services provided by experienced physician assistants were comparable in safety and efficacy to those provided by physicians In a prospect i ve study , 519 women were r and omly selected for cervical dilatation by laminaria tents or Hegar dilators before scheduled vacuum aspiration . In other 68 women r and omly divided into a laminaria group and a control ( Hegar ) group , placenta , decidua and blood were separately aspirated from the uterine cavity before the vacuum aspiration and cultured for micro‐organisms . The rate of postabortal pelvic inflammatory disease ( PID ) was significantly lower after pretreatment with laminaria tent irrespective of patient 's age and parity . However , a higher risk of postabortal PID was found in gestational age of 10–12 weeks than of 5–9 weeks . Previous PID and abortion did not increase the risk of postabortal PID . Vaginalkervical micro‐organisms were , irrespective of method for cervical dilatation , identified in two thirds of the patients A prospect i ve , nonconcurrent cohort analysis of 178 mifepristone/misoprostol and 199 suction curettage abortion subjects , ages > or = 18 years , with intrauterine pregnancies < or = 63 days estimated gestational age , was conducted to compare the outcomes of suction curettage abortion to those of medical abortion . The medical abortion subjects received 600 mg of mifeprisone orally , followed by 400 micrograms of oral misoprostol 2 days later . Surgical abortion subjects underwent electronic vacuum aspiration . All subjects were followed for 2 weeks or until the absence of clinical bleeding . Outcome measures included a successful abortion ( complete abortion without a surgical intervention ) , duration of bleeding , and morbidity . Overall , 18.3 % medical and 4.7 % surgical patients failed their primary procedure and received an unanticipated suction curettage ( RR 3.93 , 95 % CI 1.87 , 8.29 ) . Four mifepristone subjects required curettage for acute bleeding , nine to manage ongoing pregnancy , and five for incomplete abortion . Fourteen mifepristone and eight surgical subjects required curettage for persistent bleeding . The median time delay for therapeutic curettage was significantly longer in the medical abortion group ( 35 versus 8 days ; Mann-Whitney U = 17.0 , p = 0.008 ) . Medical subjects experienced significantly longer bleeding ( mean difference = 9.6 days , 95 % CI 6.8 , 12.4 ) . No significant change in hemoglobin occurred in either group . Mifepristone patients reported significantly greater pain ( 77.1 % vs 10.5 % ; RR 7.4 , 95 % CI 4.7 , 11.5 ) , and nausea or vomiting ( 68.6 % vs 0.6 % ; RR 117.9 , 95 % CI 16.7 , 834.7 ) . Women receiving mifepristone/misoprostol are more likely to require an unplanned surgical intervention than women who undergo suction curettage . They experience more discomfort with their procedure and in the follow-up interval , bleed for a longer period , and remain at risk for surgical completion curettage for several weeks OBJECTIVE To assess the incidence of complications of abortion performed under local anesthesia . DESIGN Prospect i ve study . SETTING A family planning center in the Paris area . POPULATION Eight hundred and fifty-eight women admitted for abortion under local anesthesia . MAIN OUTCOME MEASURES Incidence of immediate ( the day of vacuum aspiration ) and delayed complications ( at the follow-up visit 2 weeks after the procedure ) . RESULTS Among the 858 women who underwent vacuum aspiration , 683 ( 80 % ) attended the follow-up visit 2 weeks after the procedure . Fifty-nine percent of the 858 women had not had a previous abortion , 25 % had had one , and 16 % had had two or more . The average duration of amenorrhea was 8.6 weeks ( 19 % at 6 or 7 weeks , 67 % between 8 and 10 weeks , and 14 % after 10 weeks ) . The overall complication rate was 3.4 % ( 23/683 ) ( 95 % CI=2.0 - 4.8 % ) . The incidence of immediate complications was 1.7 % ( 15/858 ) ( 0.8 - 2.6 % ) and that of delayed complications 1.2 % ( 8/683 ) ( 0.4 - 2.0 % ) . CONCLUSION This study confirms the safety and efficacy of abortion by vacuum aspiration under local anesthesia BACKGROUND Since 1991 , mifepristone in combination with a prostagl and in analogue has been licensed for termination of pregnancy in the UK at up to 9 weeks amenorrhoea , and since 1995 , beyond 13 weeks . Surgical methods are used almost exclusively at 10 - 13 weeks amenorrhoea . METHODS A patient-centred , partially r and omized , controlled trial was carried out . Those who expressed a strong preference for either medical ( n = 15 ) or surgical ( n = 62 ) abortion were allocated
Output:
| The percentage of first-trimester aspiration abortions that required interventions for minor and major complications was very low .
Overall , the prevalence of major complications was similar across clinic context s , indicating that this procedure can be safely performed in an office setting .
IMPLICATION S Laws requiring abortion providers to have hospital admitting privileges or facilities to meet ambulatory surgical center st and ards would be unlikely to improve the safety of first-trimester aspiration abortion in office setting |
MS210699 | ***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 Heart failure patients with primary prevention implantable cardioverter-defibrillators ( ICD ) may experience an improvement in left ventricular ejection fraction ( LVEF ) over time . However , it is unclear how LVEF improvement affects subsequent risk for mortality and sudden cardiac death . OBJECTIVES This study sought to assess changes in LVEF after ICD implantation and the implication of these changes on subsequent mortality and ICD shocks . METHODS We conducted a prospect i ve cohort study of 538 patients with repeated LVEF assessment s after ICD implantation for primary prevention of sudden cardiac death . The primary endpoint was appropriate ICD shock defined as a shock for ventricular tachyarrhythmias . The secondary endpoint was all-cause mortality . RESULTS Over a mean follow-up of 4.9 years , LVEF decreased in 13.0 % , improved in 40.0 % , and was unchanged in 47.0 % of the patients . In the multivariate Cox models comparing patients with an improved LVEF with those with an unchanged LVEF , the hazard ratios were 0.33 ( 95 % confidence interval : 0.18 to 0.59 ) for mortality and 0.29 ( 95 % confidence interval : 0.11 to 0.78 ) for appropriate shock . During follow-up , 25 % of patients showed an improvement in LVEF to > 35 % and their risk of appropriate shock decreased but was not eliminated . CONCLUSIONS Among primary prevention ICD patients , 40.0 % had an improved LVEF during follow-up and 25 % had LVEF improved to > 35 % . Changes in LVEF were inversely associated with all-cause mortality and appropriate shocks for ventricular tachyarrhythmias . In patients whose follow-up LVEF improved to > 35 % , the risk of an appropriate shock remained but was markedly decreased Background —Heart failure with recovered or improved ejection fraction ( HFiEF ) has been proposed as a new category of HF . Whether HFiEF is clinical ly distinct from HF with persistently reduced ejection fraction remains to be vali date d. Methods and Results —Of the 5010 subjects enrolled in the Valsartan Heart Failure Trial ( Val-HeFT ) , 3519 had a baseline left ventricular EF of < 35 % and a follow-up echocardiographic assessment of EF at 12 months . Of these , 321 ( 9.1 % ) patients who had a 12-month EF of > 40 % constituted the subgroup with HFiEF . EF improved from 28.7±5.6 % to 46.5±5.6 % in the subgroup with HFiEF and remained reduced ( 25.2±6.2 % and 27.5±7.1 % ) in the subgroup with HF with reduced ejection fraction . The group with HFiEF had a less severe hemodynamic , biomarker , and neurohormonal profile , and it was treated with a more intense HF medication regimen . Subjects who had higher blood pressure and those treated with a & bgr;-blocker or r and omized to valsartan had greater odds of being in the HFiEF group , whereas those with an ischemic pathogenesis , a more dilated left ventricle , and a detectable hs-troponin had lower odds of an improvement in EF . Recovery of the EF to > 40 % was associated with a better survival compared with persistently reduced EF . Conclusions —Our data support HFiEF as a stratum of HF with reduced ejection fraction with a more favorable outcome , which occurs in a minority of patients with HF with reduced ejection fraction who have a lower prevalence of ischemic heart disease , a less severe hemodynamic , biomarker , and neurohormonal profile , and who are treated with a more intense HF medication regimen . Clinical Trial Registration —URL : http://www . clinical trials.gov . Unique identifier : NCT00336336 Objectives The beneficial effects of cardiac resynchronization therapy ( CRT ) are thought to result from favorable left ventricular ( LV ) reverse remodeling , however CRT is only successful in about 70 % of patients . Whether response to CRT is associated with a decrease in ventricular arrhythmias ( VA ) is still discussed controversially . Therefore , we investigated the incidence of VA in CRT responders in comparison with non-responders . Methods In this nonr and omized , two-center , observational study patients with moderate-to-severe heart failure , LV ejection fraction ( LVEF ) ≤35 % , and QRS duration > 120 ms undergoing CRT were included . After 6 months patients were classified as CRT responders or non-responders . Incidence of VA was compared between both groups by Kaplan-Meier analysis and Cox regression analysis . ROC analysis was performed to determine the aptitude of LVEF cut-off values to predict VA . Results In total 126 consecutive patients ( 64±11years ; 67%male ) were included , 74 were classified as responders and 52 as non-responders . While the mean LVEF at baseline was comparable in both groups ( 25±7 % vs. 24±8 % ; P = 0.4583 ) only the responder group showed an improvement of LVEF ( 36±6 % vs. 24±7 ; p<0.0001 ) under CRT . In total in 56 patients VA were observed during a mean follow-up of 28±14 months , with CRT responders experiencing fewer VA than non-responders ( 35 % vs. 58 % , p<0.0061 ) . Secondary preventive CRT implantation was associated with a higher likelihood of VA . As determined by ROC analysis an increase of LVEF by > 7 % was found to be a predictor of a significantly lower incidence of VA ( AUC = 0.606 ) . Conclusions Improvement of left ventricular function under cardiac resynchronization therapy goes along with a reduced incidence of ventricular arrhythmia Background — We hypothesized that patients with heart failure ( HF ) who recover left ventricular function ( HF-Recovered ) have a distinct clinical phenotype , biology , and prognosis compared with patients with HF with reduced ejection fraction ( HF-REF ) and those with HF with preserved ejection fraction ( HF-PEF ) . Methods and Results — The Penn Heart Failure Study ( PHFS ) is a prospect i ve cohort of 1821 chronic HF patients recruited from tertiary HF clinics . Participants were divided into 3 categories based on echocardiograms : HF-REF if EF was < 50 % , HF-PEF if EF was consistently ≥50 % , and HF-Recovered if EF on enrollment in PHFS was ≥50 % but prior EF was < 50 % . A significant portion of HF-Recovered patients had an abnormal biomarker profile at baseline , including 44 % with detectable troponin I , although in comparison , median levels of brain natriuretic factor , soluble fms-like tyrosine kinase receptor-1 , troponin I , and creatinine were greater in HF-REF and HF-PEF patients . In unadjusted Cox models over a maximum follow-up of 8.9 years , the hazard ratio for death , transplantation , or ventricular assist device placement in HF-REF patients was 4.1 ( 95 % confidence interval , 2.4–6.8 ; P<0.001 ) and in HF-PEF patients was 2.3 ( 95 % confidence interval , 1.2–4.5 ; P=0.013 ) compared with HF-Recovered patients . The unadjusted hazard ratio for cardiac hospitalization in HF-REF patients was 2.0 ( 95 % confidence interval , 1.5–2.7 ; P<0.001 ) and in HF-PEF patients was 1.3 ( 95 % confidence interval , 0.90–2.0 ; P=0.15 ) compared with HF-Recovered patients . Results were similar in adjusted models . Conclusions — HF-Recovered is associated with a better biomarker profile and event-free survival than HF-REF and HF-PEF . However , these patients still have abnormalities in biomarkers and experience a significant number of HF hospitalizations , suggesting persistent HF risk AIMS Some patients show such an important clinical improvement and reverse remodelling after cardiac resynchronization therapy ( CRT ) that anatomy and function approach normal . These patients have been called ' super-responders ' . The aim of our study was to identify predictors of becoming a super-responder after CRT . METHODS AND RESULTS Eighty-seven consecutive patients who underwent CRT were prospect ively studied . Before CRT and 6 months after , clinical and echocardiographic evaluation was performed . Patients with a decrease in New York Heart Association functional class > or=1 , a two-fold or more increase of left ventricular ejection fraction ( LVEF ) or a final LVEF > 45 % , and a decrease in LV end-systolic volume > 15 % were classified as super-responders . There were 12 % super-responders . At baseline , there were no significant differences between super-responders and the other patients , except for the fact that super-responders had significantly smaller mitral regurgitation and LV end-diastolic diameter ( LVEDD ) and a shorter duration of heart failure symptoms . Mitral regurgitation jet area , LVEDD , and duration of heart failure symptoms were correlated with this super-response . Moreover , an evolution of symptoms for < 12 months was an independent predictor of super-response to CRT . CONCLUSION Patients in earlier phases of the cardiomyopathy , with a less altered ventricular geometry , seem to have a greater probability of becoming super-responders AIMS The aim of this study was to determine the relationship between improved ejection fraction ( EF ) and occurrence of arrhythmias in patients with cardiac resynchronization therapy devices with defibrillator function ( CRT-D ) . The hypothesis was that patients who experienced a marked improvement in EF also had fewer appropriate defibrillator interventions . METHODS AND RESULTS We analysed data of 270 patients from 2 prospect i ve registries with follow-up of ≥12 months and echocardiography performed ≥8 months after CRT-D implantation . The discriminator was whether left ventricular ejection fraction ( LVEF ) improved to > 35 % [ cut-off for primary prevention implantable cardioverter-defibrillator ( ICD ) implantation ] . Mean age was 61±11 years , LVEF 22±5 % , and follow-up 40±22 months . Ischaemic cardiomyopathy was present in 48 % , and secondary prevention indication was present in 25 % . Implantable cardioverter-defibrillator interventions were delivered to 35 % of patients . Echocardiography ( 20±15 months after implantation ) showed an improvement in LVEF from 22 % ( SD 5.4 % ) to 30 % ( SD 9.8 % ) . Improvement to > 35 % was seen in 21 % of patients . Those who improved to > 35 % had fewer ICD interventions than those who did not ( 23 vs.38 % ; P-value 0.03 ) . Analysing only patients with a primary prevention indication and stratifying again in patients with and without improvement of LVEF to > 35 % , the latter had highly significant more ICD-therapies ( 6 vs. 31 % ; P-value 0.0008 ) . CONCLUSION Patients with CRT-D for primary prevention , whose LVEF improved to > 35 % during mid-term follow-up , are at low risk of first ICD therapies beyond year 1 . If similar findings are reported in other patient cohorts , this might impact on decision-making at the time of battery depletion BACKGROUND As left ventricular ejection fraction ( LVEF ) may improve , worsen , or remain the same over time , patients ' prognosis may also be expected to change because of the change in LVEF , among other factors . OBJECTIVE To evaluate the effect of LVEF change on outcome in the Defibrillators in Non-Ischemic Cardiomyopathy Treatment Evaluation ( DEFINITE ) trial . METHODS Patients with nonischemic cardiomyopathy with LVEF<36 % , history of symptomatic heart failure , and the presence of significant ventricular ectopic activity were enrolled in the DEFINITE trial . Follow-up LVEF measurements were obtained annually in only a minority ( 17 % ) of trial participants . This study therefore evaluated survival and arrhythmic end points in patients whose LVEF was reassessed between 90 and 730 days after enrollment . RESULTS During the 90 - 730-day postr and omization period , 187 of 449 ( 42 % ) enrolled patients who survived at least 90 days had at least 1 follow-up LVEF measurement ; these patients were younger and white ; had diabetes , better 6-minute walk test results , and higher BMI ; were more likely to have appropriate shocks ; and had fewer deaths compared to those without follow-up LVEF measurements . Patients whose LVEF improved had reduced mortality compared to patients whose LVEF decreased ( hazard ratio 0.09 ; 95 % confidence interval 0.02 - 0.39 ; P = .001 ) . Survival free of appropriate shocks was not significantly related to LVEF improvement during follow-up . CONCLUSIONS LVEF improvement was associated with improved survival , but not with a significant decrease in appropriate shocks . These data highlight that appropriate caution should be exercised not to extrapolate the positive effect of improved L
Output:
| Conclusion In heart failure patients , we identified several baseline characteristics in favour of an improved LVEF , in response to evidence based therapy .
Patients with improved LVEF had significantly lower risks of mortality and appropriate shocks compared with patients with persistently reduced LVEF |
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