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MS212700 | ***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 evaluate the current range of hydrophilic‐coated catheters for intermittent self‐catheterization , focusing on the adherence of the catheter to the urethral mucosa at the end of catheterization OBJECTIVE The frequency of bacteriuria is high in children with neurogenic bladder on intermittent catheterization for bladder emptying . In an effort to decrease bacteriuria , we examined whether the method of catheter care was responsible for the high rate of bacteriuria . For this , the frequency of bacteriuria was examined in the same patient on single-use sterile catheters and on reused clean catheters . METHODS A prospect i ve , r and omized , crossover trial was conducted with 10 patients who were r and omized to 4 months of a new , sterile catheter for intermittent catheterization and 4 months of reuse of a clean catheter for intermittent catheterization . Each week , a urine sample was collected and symptoms of infection and medication use were recorded . RESULTS A total of 158 urine sample s were collected during 164 patient-weeks on the new catheter method for each void ; 115 ( 73 % ) were positive for a pathogen . Of the 161 sample s collected during 169 patient-weeks on the st and ard , reuse method for voiding , 123 ( 76 % ) were positive ( 115 [ 73 % ] of 158 vs 123 [ 76 % ] of 161 ) . Escherichia coli was the most common pathogen detected during both method periods . CONCLUSION A new , sterile catheter for each void did not decrease the high frequency of bacteriuria in patients with neurogenic bladder on intermittent catheterization PURPOSE We compared a recently developed hydrophilic catheter to the st and ard polyethylene catheter in regard to hematuria , infection and patient satisfaction . MATERIAL S AND METHODS A hydrophilic LoFric or st and ard Mentor catheter was assigned at r and om to 17 and 16 boys , respectively , who were skilled in intermittent self-catheterization . They were evaluated by weekly urinalysis and a question naire . RESULTS Significantly fewer episodes of microscopic hematuria occurred in the LoFric than Mentor catheter group ( 9 episodes in 6 subjects versus 19 episodes in 11 , p < 0.05 ) . There were also fewer episodes of bacteriuria in the LoFric group but the difference was not statistically significant . Mean scores plus or minus st and ard deviation on a visual analogue scale with 0 equal to most and 10 equal to least favorable were LoFric 3.3 + /- 2.8 versus Mentor 4.9 + /- 2.7 for catheter convenience and 2.7 + /- 2.4 versus 4.2 + /- 2.6 for insertion comfort , significantly favoring the LoFric group ( p < 0.05 for both ) . Of the 16 LoFric subjects 13 preferred to continue its use , particularly those with a history of urethral trauma or sphincteric spasm . CONCLUSIONS In boys the LoFric catheter appears to cause less trauma . Although it is not reusable and is more expensive than the st and ard catheter , satisfaction is higher with the LoFric device and for select patients it has significant advantages OBJECTIVES To compare the safety and cost of clean versus sterile intermittent bladder catheterization in male nursing home residents . To provide evidence to support the hypothesis that intermittent catheterization is a valid , alternative method of bladder management in male residents of long-term care in whom urinary retention is a documented problem . DESIGN R and omized clinical trial . SETTING Three long-term care sites having predominantly male population s. PARTICIPANTS Eighty male veterans , residents of three long-term care facilities , ranging in age from 36 to 96 years with a mean age of 72 . INTERVENTIONS St and ardized procedures for clean and sterile intermittent catheterization ( IC ) were implemented by staff nurses at each site . Patients were r and omized into clean and sterile IC groups . Nursing time and catheterization equipment usage were recorded using bar code readers . Clinical data were collected from the medical chart . Treatment of urinary tract infection was prescribed by the medical personnel responsible for each individual resident . MEASUREMENTS We compared the number of treatment episodes for symptomatic bacteriuria between groups r and omized to receive either clean or sterile intermittent catheterization . Laboratory analysis of blood and urine was done on predetermined days . Control variables were research site and patient history of urinary tract infection within the last 6 months . A cost comparison of nursing time and equipment usage for the two catheterization techniques was also performed . RESULTS No significant differences were found between clean and sterile groups with regard to number of treatment episodes , time to first infection , type of organism cultured , or cost of antibiotic treatment . The cost of sterile technique was considerably higher both in terms of nursing time and supplies . CONCLUSIONS Findings from this study demonstrate that clean technique intermittent catheterization is a safe and cost-effective bladder management technique with male , nursing home residents , despite the frailty of this high risk population . An annual savings of approximately $ 1460 per patient in nursing time and catheterization supplies could be anticipated if a patient were catheterized an average of four times per day substituting clean IC technique for sterile IC technique Monthly urine cultures were analyzed at the University of Alberta Department of Medical Microbiology and Infectious Diseases to determine whether single-use sterile catheters and clean technique reduced the incidence of bacterial colonization in those using long-term intermittent self-catheterization . Thirty subjects with spina bifida , ages 3 years to 16 years , entered a crossover study with r and om assignment to 6 months of sterile single-use catheters or clean reused catheters . Seventeen subjects were catheterized by a parent or caregiver ; 13 were responsible for self-catheterization and cleaning of the catheters . Six months of descriptive data were also collected at Alberta Children 's Hospital from a similar group of subjects with spina bifida who used sterile catheters only . In the crossover group , 38 % of all urine cultures were positive regardless of whether sterile single-use or clean reused catheters were employed . The other group using only sterile catheters had a 36 % positive culture rate . No difference in positive cultures was found between males and females or between children who catheterized themselves and children whose parents catheterized them . The authors concluded that plastic urethral catheters may be reused OBJECTIVES To compare the performance of SpeediCath hydrophilic-coated catheters versus uncoated polyvinyl chloride ( PVC ) catheters , in traumatic spinal cord injured patients presenting with functional neurogenic bladder-sphincter disorders . METHODS A 1-year , prospect i ve , open , parallel , comparative , r and omised , multi centre study included 123 male patients , > or = 16 y and injured within the last 6 months . Primary endpoints were occurrence of symptomatic urinary tract infection ( UTI ) and hematuria . Secondary endpoints were development of urethral strictures and convenience of use . The main hypothesis was that coated catheters cause fewer complications in terms of symptomatic UTIs and hematuria . RESULTS 57 out of 123 patients completed the 12-month study . Fewer patients using the SpeediCath hydrophilic-coated catheter ( 64 % ) experienced 1 or more UTIs compared to the uncoated PVC catheter group ( 82 % ) ( p = 0.02 ) . Thus , twice as many patients in the SpeediCath group were free of UTI . There was no significant difference in the number of patients experiencing bleeding episodes ( 38/55 SpeediCath ; 32/59 PVC ) and no overall difference in the occurrence of hematuria , leukocyturia and bacteriuria . CONCLUSIONS The results indicate that there is a beneficial effect regarding UTI when using hydrophilic-coated catheters Local reactions of the urethral wall are known to occur by repeated introduction of a catheter in the urethra . Urethritis was found in 2 - 19 % of patients practising intermittent catheterisation . Although the use of catheters of smaller size and the liberal use of lubricants may prevent urethral irritation and trauma , it was postulated that hydrophilic catheters ( LoFric , Astra Tech Ltd , Stroud , Engl and ) induce significantly less trauma than PVC catheters because of the binding of the water molecules to the catheter surface which consists of polyvinylpyrrolidone and sodium chloride . Although urethritis and urethral stricture may represent one end of the spectrum of repeated urethral trauma , minor degrees of inflammation need to be quantitatively determined while assessing two different catheters for intermittent catheterisation . The degree of urethral inflammation in patients practising intermittent catheterisation was studied by urethral cytology and staining the smear by Papanicolaou 's method . The number of neutrophil polymorphs and epithelial cells in three r and om high power fields in the urethral smear was counted and the percentage ratio of polymorphs to epithelial cells was calculated . Group 1 comprised 14 patients practising intermittent catheterisation with a PVC catheter and group 2 comprised 17 patients performing intermittent catheterisation with a LoFric catheter . There was no significant difference between the two groups as regards the age , diagnosis , size of the catheter used for intermittent catheterisation and the number of times that they performed catheterisation during a 24 hour period . Urethral cytology revealed a percentage ( mean ratio ) ratio of polymorphs to epithelial cells of 66 in group 1 and 0.04 in group 2 . ( < 0.0005 ) . Urethral cytology also revealed a significantly greater number of bacteria in group 1 as compared to group 2 ( p < 0.01 ) . In conclusion , use of a LoFric catheter for intermittent catheterisation was associated with significantly lesser degree of urethral inflammatory response when compared to the use of a PVC catheter This study was design ed to determine the effect of sterile and nonsterile intermittent catheterization on the incidence of urinary tract infection ( UTI ) in patients after spinal cord injury . The study included 29 patients with neurogenic bladder dysfunction treated with intermittent catheterization . One group of 14 patients was on sterile catheterization ; another group of 15 patients was on nonsterile catheterization . On a weekly basis , urine sample s were obtained and analyzed . A total of 122 urine sample s were analyzed . The patients on sterile catheterization had a 28.6 % UTI incidence ; the group using a nonsterile catheterization technique had a UTI incidence of 42.4 % . The most common urinary pathogen in both groups was E. coli ( 65 % ) . The cost of antibiotics for patients on the sterile catheterization program was only 43 % of the cost of antibiotics for those on the nonsterile program . However , the sterile kits cost 371 % of the cost of the catheterization kits for the patients in the nonsterile program , so the total cost of managing neurogenic bladder on the sterile program was 277 % of the cost of the nonsterile program To evaluate whether patients performing clean intermittent self‐catheterization ( CISC ) for a short period preferred a prelubricated , hydrophilic , disposable polyvinyl chloride ( PVC ) catheter or a non‐hydrophilic PVC catheter which could be used several times and that had to be lubricated by the patient PURPOSE We compared the safety and patient acceptance of a conventional Nélaton and a prelubricated nonhydrophilic catheter in 18 spinal cord injured patients on intermittent catheterization . MATERIAL S AND METHODS In a prospect i ve crossover study each catheter was used for 7 weeks and the initial course was r and omized . Urinalysis and urine culture were performed at 2 , 4 and 7 weeks . Urethral trauma was evaluated by urethral cell count on the surface of each catheter used on the last day of each study period . Patient satisfaction was assessed at the end of the study by a question naire using multiple visual analog scales . RESULTS Urinary tract infection was identified in 12 and 4 patients on a Nélaton and a prelubricated nonhydrophilic catheter ( p = 0.03 ) , while asymptomatic bacteruria was identified in 18 and 8 ( p = 0.0244 ) , respectively . The mean urethral cell count plus or minus st and ard deviation on the catheter surface was 6.7 + /- 2.8 x 10(4 ) and 15.1 + /- 8.9 x 10(4 ) for the prelubricated nonhydrophilic and the Néelaton catheter , respectively ( p = 0.01 ) . The prelubricated nonhydrophilic catheter result ed in a better mean satisfaction score than the Nélaton catheter ( 2.33 + /- 1.06 versus 4.72 + /- 2.13 , p = 0.022 ) . Urethral bleeding was reported in 2 patients during the study period while using the Nélaton catheter . CONCLUSIONS The prelubricated nonhydrophilic cath
Output:
| There are no definitive studies illustrating that incidence of UTIs is affected by sterile single-use or coated catheters compared to clean reused catheters . |
MS212701 | ***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: Several studies evaluating the clinical effectiveness of endocrine therapy alone in breast cancer patients aged 70 years or older reported comparable survival rates to conventional surgical therapy , although the incidence of local recurrences was higher . Primary endocrine therapy is therefore only recommended as an alternative approach in elderly woman with estrogen receptor positive tumors who are deemed inoperable or who refuse surgery . We report our experience with aromatase inhibitors as primary endocrine therapy for estrogen receptor positive breast cancer in postmenopausal woman who are impaired by other diseases , refuse surgery or are of old age . Fifty-six patients with fifty-seven ER+ operable breast cancers who refused surgery , were judged ineligible for surgery because of comorbidity , or were of old age were treated with endocrine therapy using aromatase inhibitors only . Digital mammography and high-end breast ultrasound were used to assess tumor sizes . The mean age of the patients was 74 years ( range 52 - 102 years ) . All patients suffered from breast cancer . The mean follow-up interval was 40 months ( range 5 - 92 months ) . Seven patients ( 12 % ) achieved complete clinical remission , 31 ( 57 % ) partial response giving an overall objective response rate of 69 % . In addition , seven ( 12 % ) patients showed stable disease , giving a clinical benefit rate ( complete remission + partial response + stable disease rate ) of 81 % . Eleven patients ( 19 % ) progressed after an initial partial response or stable disease . Only one patient ( 2 % ) progressed on endocrine therapy within the first months . Eventually , 22 ( 39 % ) patients underwent surgery after informed consent to achieve better local tumor control . Primary endocrine therapy with aromatase inhibitors may offer an effective and safe alternative to surgery giving a high local control rate in postmenopausal women who refuse surgery , who are judged ineligible for surgery , or are of old age Invasive lobular cancer ( ILC ) responds poorly to neoadjuvant chemotherapy but appears to respond well to endocrine therapy . We examined the effectiveness of neoadjuvant letrozole in postmenopausal women ( PMW ) with estrogen receptor (ER)-rich ILC . PMW were considered for treatment with neoadjuvant letrozole if they had ER-rich , large operable , or locally advanced cancers , or were unfit for surgical therapy . Tumor volume was estimated at diagnosis and at 3 months using calipers ( clinical ) , ultrasound , and mammography . At 3 months , if physically fit , women were assessed for surgery . Responsive women with cancers too large for breast-conserving surgery continued with letrozole . Patients had surgery or were switched to alternative therapy if tumor volume was increasing . Sixty-one patients ( mean age , 76.2 years ) with 63 ILCs were treated with letrozole for ≥3 months . The mean reduction in tumor volume at 3 months was 66 % ( median , 76 % ) measured clinical ly , 61 % ( median , 73 % ) measured by ultrasound , and 54 % ( median , 60 % ) measured by mammography . Surgery was possible at 3 months in 24 cancers in 24 patients , and all but two of the remaining patients continued with letrozole therapy for a median duration of 9 months . At the time of this publication , 40 patients with a total of 41 cancers have undergone surgery . The rate of successful breast conservation was 81 % ( 25/31 ) . Twenty-one patients have continued with letrozole monotherapy , and 19 remain controlled on letrozole at a median of 2.8 years . There is a high rate of response to letrozole in PMW with ER-rich ILC Eighty-eight patients presenting with operable breast cancer of 4 cm or greater in diameter ( T2 , T3 , N0 , N1 , M0 ) have received primary systemic therapy . Response was assessed following 12 weeks of systemic therapy by linear regression analysis of changes in tumour volume . Definitive locoregional surgery ( mastectomy n = 82 , wide local excision n = 6 ) was performed on completion of systemic therapy ( 3 - 6 months ) . Response was observed in 24 ( 39 % ) of the 61 patients who received endocrine therapy ; all 24 had tumours with an oestrogen receptor ( ER ) concentration of greater than or equal to 20 fmol mb-1 cytosol protein . Cytotoxic therapy was reserved for patients with tumours of ER concentration less than 20 fmol mg-1 cytosol protein ( n = 27 ) or when endocrine therapy had failed ( n = 20 ) . Response was observed in 34 patients ( 72 % ) . The overall survival rate at 3 years was 86 % , with 81 % remaining free from local relapse . We propose that the treatment policy outlined in this paper should now be tested against orthodox management by controlled r and omised trial Background In recent years , preoperative volume reduction of locally advanced breast cancers , result ing in higher rates of breast-conserving surgery ( BCS ) , has become increasingly important also in postmenopausal women . Clinical interest has come to center on the third-generation nonsteroidal aromatase inhibitors ( AIs ) , including letrozole , for such neoadjuvant endocrine treatment . This usually lasts 3–4 months and has been extended to up to 12 months , but optimal treatment duration has not been fully established . Methods This study was design ed as a multicenter , open-label , single-arm , exploratory phase IIb/III clinical trial of letrozole 2.5 mg , one tablet daily , for 4–8 months . The primary objective was to investigate the effect of neoadjuvant treatment duration on tumor regression and BCS eligibility to identify optimal treatment duration . Tumor regression ( by clinical examination , mammography , and ultrasound ) , shift towards BCS eligibility , and safety assessment s were the main outcome measures . St and ard parametric and nonparametric descriptive statistics were performed . Results Letrozole treatment was received by 32 of the enrolled 33 postmenopausal women ( median ( range ) : 67.0 ( 56–85 ) years ) with unilateral , initially BCS-ineligible primary breast cancer ( clinical stage ≥ T2 , N0 , M0 ) . Letrozole treatment duration in the modified intent-to-treat ( ITT ; required 4 months ' letrozole treatment ) analysis population ( 29 patients ) was 4 months in 14 patients and > 4 months in 15 patients . The respective per- protocol ( PP ) subgroup sizes were 14 and 11 . The majority of partial or complete responses were observed at 4 months , though some beneficial responses occurred during prolonged letrozole treatment . Compared with baseline , median tumor size in the ITT population was reduced by 62.5 % at Month 4 and by 70.0 % at final study visit ( Individual End ) . Similarly , in the PP population , respective reductions were 64.0 % and 67.0 % . Whereas initially all patients were mastectomy c and i date s , letrozole treatment enabled BCS ( lumpectomy ) in 22 ITT ( 75.9 % ) and 18 PP ( 72.0 % ) patients . Conclusion Over half of patients become BCS-eligible within 4 months of preoperative letrozole treatment . While prolonged treatment for up to 8 months can result in further tumor volume reduction in some patients , there is no clear optimum for treatment duration . Letrozole has a favorable overall safety and tolerability profile . Trial registration Clinical Trials.gov identifier NCT00535418 BACKGROUND Neoadjuvant aromatase inhibitor therapy has been reported to improve surgical outcomes for postmenopausal women with clinical stage II or III hormone receptor-positive breast cancer . A multicenter phase II clinical trial was conducted to investigate the value of this approach for US surgical practice . STUDY DESIGN One hundred fifteen postmenopausal women with > 2 cm , estrogen receptor ( ER ) or progesterone receptor (PgR)-positive breast cancer were enrolled in a trial of 16 to 24 weeks of letrozole 2.5 mg daily before operation . RESULTS One hundred six patients were eligible for primary analysis , 96 underwent operations , 7 received chemotherapy after progressive disease , and 3 did not undergo an operation . Baseline surgical status was marginal for breast-conserving surgery ( BCS ) in 48 ( 45 % ) , 47 were definitely ineligible for BCS ( 44 % ) , and 11 were inoperable by st and ard mastectomy ( 10 % ) . Overall Response Evaluation Criteria In Solid Tumors clinical response rate in the breast was 62 % , with 12 % experiencing progressive disease . Fifty percent underwent BCS , including 30 of 46 ( 65 % ) patients who were initially marginal for BCS and 15 of 39 ( 38 % ) patients who were initially ineligible for BCS . All 11 inoperable patients successfully underwent operations , including 3 ( 27 % ) who had BCS . Nineteen percent of patients undergoing mastectomy had a pathologic T1 tumor , suggesting that some highly responsive tumors were overtreated surgically . CONCLUSIONS Neoadjuvant aromatase inhibitor improves operability and facilitates BCS , but there was considerable variability in responsiveness . Better techniques to predict response , determine residual tumor burden before operation , and greater willingness to attempt BCS in responsive patients could additionally improve the rate of successful BCS It has been proposed that knowledge of estrogen receptor beta ( ER-beta ) expression may refine estrogen receptor alpha ( ER-alpha ) predictivity of response to endocrine therapy . We challenged this hypothesis in ER-alpha-positive breast cancers subjected to preoperative antiestrogen treatment . Forty-seven elderly ( > or = 65 years old ) women with nonmetastatic , ER-alpha-positive ( by immunohistochemistry ) primary breast cancers ( > 2 cm in diameter ) entered a neoadjuvant hormone therapy protocol ( 60 mg/day toremifene for 3 months ) . ER-alpha and ER-beta ( ERs ) mRNA was determined by semiquantitative RT-PCR , before ( on core needle biopsy ) and after ( on surgical specimens ) neoadjuvant treatment . Study end points included : ( 1 ) relation between treatment response and ER mRNA expression ; and ( 2 ) changes in ER expression after treatment . The response was clinical ly assessed as tumor size change at the end of the preoperative treatment . ER mRNA expression was assessable before and after treatment in 38 and 20 cases respectively . ER-beta was co-expressed with ER-alpha at variable levels and significantly correlated only with progesterone receptor ( P = 0.0285 ) . Objective clinical response , including patients with minor change ( > or = 25-<50 % tumor shrinkage after treatment ) , was documented in 68.4 % of cases and was independent of ER-beta levels or changes . ER-alpha levels were higher in tumors from patients in complete remission than in those from women achieving partial response or minor change compared with non-responsive patients ( median expression values : 801 versus 516 versus 320 arbitrary units ) and were consistently down-regulated by preoperative treatment . We conclude that in this elderly patient population with ER-alpha-positive tumors , ER-beta mRNA was neither predictive of response to preoperative toremifene nor provided additional information to the knowledge of ER-alpha mRNA levels , which , conversely , were directly correlated with likelihood of response OBJECTIVES To evaluate the efficacy and safety of combing aromatase inhibitor ( AI ) and cyclooxygenase-2 ( COX-2 ) inhibitor neoadjuvantly in postmenopausal patients with invasive hormone-sensitive breast cancer . METHODS Eighty-two patients were r and omly assigned to receive exemestane 25 mg daily and celecoxib 400 mg twice daily ( group A , n=30 ) , exemestane 25 mg daily ( group B , n=24 ) and letrozole 2.5 mg daily ( group C , n=28 ) . RESULTS All groups showed clinical responses ( 58.6 % for group A , 54.5 % for group B and 62.0 % for group C ) and decrease in tumor area ( 61.8 % for group A , 58.1 % for group B and 55.7 % for group C ) . 3 out of 5 patients with complete clinical response were observed from group A and 2 out of 69 patients operated with pathologic complete response were observed in group C. The mean microscopic tumor size was 2.53 cm for group A , 3.05 cm for group B and 2.10 cm for group C. The differences were only statistically significant when group C was compared with group B ( P=0.025 ) . The toxicity profiles among groups were satisfactory . CONCLUSION AI is effective in treating breast cancer and may be safely used preoperatively . The addition of COX-2 inhibitor may provide additional benefit In 1973 , the European Institute of Oncology performed the first prospect i ve neoadjuvant chemotherapy study in locally advanced , inoperable breast cancer . The original purpose was to downstage the primary tumor in order to achieve surgical resection . This approach has subsequently increased in popularity , and in the last 10 years , r and omized controlled trials of neoadjuvant chemotherapy have been performed with a view to further downstage the primary tumor and lymph nodes in order to achieve greater rates of breast-conserving surgery and to test whether systemic therapy given earlier would confer a survival benefit . Although the net result of these trials did demonstrate
Output:
| In studies comparing tamoxifen with aromatase inhibitors , the latter were superior in terms of tumor response and rates of breast-conserving surgery ( BCS ) . |
MS212702 | ***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 strength training has been shown to be effective for attenuating the age-related physiological decline . However , the adequate volume of strength training volume adequate to promote improvements , mainly during the initial period of training , still remains controversial . Thus , the purpose of this study was to compare the effects of a short-term strength training program with single or multiple sets in elderly women . Maximal dynamic ( 1-RM ) and isometric strength , muscle activation , muscle thickness ( MT ) , and muscle quality ( MQ = 1-RM and MT quadriceps quotient ) of the knee extensors were assessed . Subjects were r and omly assigned into one of two groups : single set ( SS ; n = 14 ) that performed one set per exercise or multiple sets ( MS ; n = 13 ) that performed three-sets per exercise , twice weekly for 6 weeks . Following training , there were significant increases ( p ≤ 0.05 ) in knee extension 1-RM ( 16.1 ± 12 % for SS group and 21.7 ± 7.7 % for MS group ) , in all MT ( p ≤ 0.05 ; vastus lateralis , rectus femoris , vastus medialis , and vastus intermedius ) , and in MQ ( p ≤ 0.05 ) ; 15.0 ± 12.2 % for SS group and 12.6 ± 7.2 % for MS group ) , with no differences between groups . These results suggest that during the initial stages of strength training , single- and multiple-set training demonstrate similar capacity for increasing dynamic strength , MT , and MQ of the knee extensors in elderly women The purpose of this study was to compare single and multiple sets of weight training for strength gains in recreation-ally trained individuals . Sixteen men ( age = 21 ± 2.0 ) were r and omly assigned to 1 set ( S-1 ; n = 8) or 3 set ( S-3 ; n = 8) groups and trained 3 days per week for 12 weeks . One repetition maximum ( 1RM ) was recorded for bench press and leg press at pre- , mid- , and posttest . Subjects trained according to daily undulating periodization ( DUP ) , involving the bench press and leg press exercises between 4RM and 8RM . Training intensity was equated for both groups . Analysis of variance with repeated measures revealed statistically significant differences favoring S-3 in the leg press ( p < 0.05 , effect size [ ES ] = 6.5 ) and differences approaching significance in the bench press ( p = 0.07 , ES = 2.3 ) . The results demonstrate that for recreationally trained individuals using DUP training , 3 sets of training are superior to 1 set for eliciting maximal strength gains A polymorphic variant of the human angiotensin converting enzyme ( ACE ) gene was identified . The ’ D ’ ( rather than ‘ I ’ ) variant was associated with improvements in strength related to physical training . We set out to determine whether the response to different patterns of strength training might also differ . Ninty-nine Caucasian male non-elite athletes were r and omly allocated into one of three groups : 31 non-training/control ( CG : 31 ) , single-set ( SSG : 35 ) and multiple-set ( MSG : 33 ) . SSG and MSG trained three times a week for 6 weeks . Both training groups were underwent a strength-training program with two mesocycles ( 12–15 repetition maximum ( RM ) and 8–12 RM mesocycles ) . One RM loads in half squat and bench press were assessed before training and after the first and second mesocycles . ACE polymorphisms analysed by polymerase chain reaction ( PCR ) methods . Subjects with ACE II genotype in the MST group had improved strength development in 12–15 RM , while SST and MST groups had similar gains in 8–12 RM . Subjects with ACE DD genotype in both the SSG and the MSG had similar benefits from both 12–15 RM and 8–12 RM . Strength gains for subjects with ACE ID genotype in the SSG were similar to MSG gains in response to 8–12 RM loads but not with 12–15 RM loads . Additionally , subjects with DD genotype had superior strength gains in both strength training groups . Tailoring strength training programmes ( single-set vs. multiple set ) according to the athlete ’s ACE genotype may be advantageous 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 aim of this study was to compare the effects of low- and high-volume strength training on strength , muscle activation and muscle thickness ( MT ) of the lower- and upper-body , and on muscle quality ( MQ ) of the lower-body in older women . Twenty apparently healthy elderly women were r and omly assigned into two groups : low-volume ( LV , n=11 ) and high-volume ( HV , n=9 ) . The LV group performed one-set of each exercise , while the HV group performed three-sets of each exercise , twice weekly for 13 weeks . MQ was measured by echo intensity obtained by ultrasonography ( MQEI ) , strength per unit of muscle mass ( MQST ) , and strength per unit of muscle mass adjusted with an allometric scale ( MQAS ) . Following training , there was a significant increase ( p≤0.001 ) in knee extension 1-RM ( 31.8±20.5 % for LV and 38.3±7.3 % for HV ) and in elbow flexion 1-RM ( 25.1±9.5 % for LV and 26.6±8.9 % for HV ) and in isometric maximal strength of the lower-body ( p≤0.05 ) and upper-body ( p≤0.001 ) , with no difference between groups . The maximal electromyographic activation for both groups increased significantly ( p≤0.05 ) in the vastus medialis and biceps brachii , with no difference between groups . All MT measurements of the lower- and upper-body increased similarly in both groups ( p≤0.001 ) . Similar improvements were also observed in MQEI ( p≤0.01 ) , MQST , and MQAS ( p≤0.001 ) for both groups . These results demonstrate that low- and high-volume strength training promote similar increases in neuromuscular adaptations of the lower- and upper-body , and in MQ of the lower-body in elderly women Dual-energy X-ray absorptiometry ( DEXA ) is reported to be inferior to computed tomography ( CT ) to measure changes in appendicular soft tissue composition . We compared CT- and DEXA-measured thigh muscle and fat mass to evaluate the r and om and systematic discrepancies between these two methods . Thigh skeletal muscle area ( single-slice CT ) was suboptimally ( r(2 ) = 0.74 , P < 0.0001 ) related to DEXA-measured thigh fat-free mass ( FFM ) . In contrast , thigh muscle and adipose tissue volumes ( multislice CT ) were highly related to DEXA-measured thigh FFM and fat ( both r(2 ) = 0.96 , P < 0.0001 ) . DEXA-measured leg fat was significantly less than multislice-CT-measured leg adipose tissue volume , whereas multislice-CT-measured leg muscle mass was less ( P < 0.0001 ) than DEXA-measured leg FFM . The systematic discrepancies between the two approaches were consistent with the 10 - 15 % nonfat components of adipose tissue . In conclusion , CT and DEXA measures of appendicular soft tissue are highly related . Systematic differences between DEXA and CT likely relate to the underlying principles of the techniques The purpose of this study was to compare serum growth hormone ( GH ) , testosterone ( T ) , cortisol ( C ) , and whole blood lactate ( L ) responses to single set ( 1S ) versus multiple set ( 3S ) heavy-resistance exercise protocol s. Eight recreationally weight-trained men completed two identical resistance exercise workouts ( 1S vs. 3S ) . Blood was obtained preexercise ( PRE ) , immediately postexercise ( OP ) , and 5 min ( 5P ) , 15 min ( 15P ) , 30 min ( 30P ) and 60 min ( 60P ) postexercise and was analyzed for GH , T , C , and L levels . For 1S and 3S , GH , L , and T significantly increased from PRE to OP and remained significantly elevated to 60P , except for 1S . For GH , T , and L , 3S showed significantly greater increases compared to 1S . For C , 3S and 1S were increased significantly from resting at OP , 5P , and 15P ; 3S increased compared to 1S at 5P , 15P and 30P . Higher volumes of total work produce significantly greater increases in circulating anabolic hormones during the recovery phase following exercise Regular performance of resistance exercise induces an increase in skeletal muscle mass , however , the molecular mechanisms underlying this effect are not yet fully understood . The purpose of the present investigation was to examine acute changes in molecular signalling in response to resistance exercise involving different training volumes . Eight untrained male subjects carried out one , three and five sets of 6 repetition maximum ( RM ) in leg press exercise in a r and om order . Muscle biopsies were taken from the vastus lateralis both prior to and 30 min after each training session and the effect on protein signalling was studied . Phosphorylation of Akt was not altered significantly after any of the training protocol s , whereas that of the mammalian target of rapamycin was enhanced to a similar extent by training at all three volumes . The phosphorylation of p70S6 kinase ( p70S6k ) was elevated threefold after 3 × 6 RM and sixfold after 5 × 6 RM , while the phosphorylation of S6 was increased 30- and 55-fold following the 3 × 6 RM and 5 × 6 RM exercises , respectively . Moreover , the level of the phosphorylated form of the gamma isoform of p38 MAPK was enhanced three to fourfold following each of the three protocol s , whereas phosphorylation of ERK1/2 was unchanged 30 min following exercise . These findings indicate that when exercise is performed in a fasted state , the increase in phosphorylation of signalling molecules such as p70S6k and the S6 ribosomal protein in human muscle depends on the exercise volume Abstract Radaelli , R , Fleck , SJ , Leite , T , Leite , RD , Pinto , RS , Fern and es , L , and Simão , R. Dose-response of 1 , 3 , and 5 sets of resistance exercise on strength , local muscular endurance , and hypertrophy . J Strength Cond Res 29(5 ) : 1349–1358 , 2015—The study 's purpose was to compare the response of performing 1 , 3 , and 5 sets on measures of performance and muscle hypertrophy . Forty-eight men , with no weight training experience , were r and omly assigned to one of the 3 training groups , 1 SET , 3 SETS , 5 SETS , or control group . All training groups performed 3 resistance training sessions per week for 6 months . The 5 repetition maximum ( RM ) for all training groups increased in the bench press ( BP ) , front lat pull down ( LPD ) , shoulder press ( SP ) , and leg press ( LP ) ( p ⩽ 0.05 ) , with the 5RM increases in the BP and LPD being significantly greater for 5 SETS compared with the other training groups ( p ⩽ 0.05 ) . Bench press 20RM in the 3-SET
Output:
| The findings indicate a grade d dose-response relationship whereby increases in RT volume produce greater gains in muscle hypertrophy |
MS212703 | ***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: Diabetes is a risk factor for the development of atherothrombosis and venous thromboembolism ( VTE ) . We investigated whether plasma from patients with type 2 diabetes has an imbalance of pro- versus anti-coagulation result ing in hypercoagulability despite normal conventional coagulation tests . We analyzed blood sample s from 60 patients with type 2 diabetes and 60 gender- and age-matched healthy subjects ( controls ) for the levels of pro- and anti-coagulant factors , for thrombin generation and for the numbers of cell-derived circulating microparticles bearing such pro-coagulant triggers as tissue factor and negatively charged phospholipids . The levels of pro- or anti-coagulants as measured with conventional coagulation tests or single factor measurements were similar to those of the control population . In contrast , the median ( range ) of the height of the thrombin peak ( taken as an index of thrombin generation ) was higher in patients [ 205 nM ( 126–352 ) ] than controls [ 151 nM ( 41−289 ) ] , P < 0.001 . The median numbers of circulating microparticles were higher for patients [ 5,041/μl ( 1,821–13,132 ) ] than for controls [ 1,753/μl ( 554–13,308 ) ] , P < 0.001 and their values were correlated with the height of the thrombin peak ( ρ = 0.66 , P < 0.001 ) . In conclusion , plasma from patients with type 2 diabetes possesses an imbalance of pro- versus anti-coagulation result ing in hypercoagulability that can be detected by thrombin generation tests , but not by the measurement of the single pro- or anti-coagulant factors . This hypercoagulability is associated with increased numbers of circulating microparticles bearing endogenous pro-coagulant triggers . These findings might explain the relatively high risk of atherothrombosis and VTE described in these patients Abstract Background : Diabetic patients also show hypercoagulability and platelet hyperaggregability , with increased levels of platelet activation-markers such as P-selectin ( CD62P ) and platelet-derived microparticles . We investigated the effects of losartan and simvastatin on circulating levels of platelet activation markers , microparticles , soluble selectins , and soluble cell adhesion molecules in hypertensive and hyperlipidemic patients with or without Type 2 diabetes . Methods : The subjects included 25 normotensive healthy controls and 41 hypertensive patients . The 41 hypertensive patients were divided into three groups : group A had hypertension and hyperlipidemia ( n = 11 ) , group B had hypertension and Type 2 diabetes ( n = 14 ) , and group C had hypertension , hyperlipidemia , and diabetes ( n = 16 ) . Losartan was administered to all of the patients at a dose of 50 mg/day for 24 weeks . In addition , simvastatin was administered to the hyperlipidemic patients at a dose of 10 mg/day for 24 weeks . Results : There were significant differences in the levels of CD62P , CD63 , PAC-1 , platelet microparticles , endothelial microparticles , sE-selectin , and sVCAM-1 between the hypertensive patients and healthy controls . These markers were all significantly increased in hypertensive and hyperlipidemic patients with Type 2 diabetes . In hypertensive patients with diabetes , CD62P , CD63 , PAC-1 , platelet and endothelial microparticles , and soluble adhesion markers were all decreased by losartan monotherapy . The decrease of each marker in hypertensive and hyperlipidemic patients given combined therapy with losartan plus simvastatin was greater among those with than without Type 2 diabetes . Low-density lipoprotein was decreased significantly by simvastatin and was correlated with CD62P or platelet microparticles in all of the patients . Conclusion : Administration of losartan plus simvastatin to hypertensive and hyperlipidemic patients with Type 2 diabetes may prevent the development of cardiovascular complications caused by activated platelets and microparticles via another mechanism in addition to reduction of the blood pressure or lipid levels This study investigated the impact of either type 2 diabetes or obesity , separately or in combination , on the absolute amounts of microparticles ( MP ) and the pathways by which these are associated with either condition . The concentrations of circulating MP derived from platelets ( PMP ) , leukocytes ( LMP ) and monocytes ( MMP ) , together with their specific activation markers , were compared in 30 subjects who were characterised across 4 cohorts as obese or type 2 diabetes . The subjects with type 2 diabetes had elevated concentrations of total PMP ( P = 0.003 ) , and PMP that were fibrinogen-positive ( P = 0.04 ) , tissue factor-positive ( P < 0.001 ) , P-selectin-positive ( P = 0.03 ) . Type 2 diabetes did not alter either total or activated LMP or MMP . Obesity per se did not impact on any MP measurement . Elevated concentrations of plasma PMP occurred in subjects with type 2 diabetes , whether they were obese or non-obese . In contrast , obesity in the absence of type 2 diabetes had no effect . The increased concentrations of specific marker-positive PMP in the subjects with diabetes might reflect potential pathways by which PMP may contribute to the pathogenesis of atherosclerosis and type 2 diabetes We investigated the effects of probucol and ticlopidine on circulating levels of platelet activation markers , microparticles , soluble selectins , and malondialdehyde-low density lipoprotein ( MDA-LDL ) in hyperlipidemic patients with or without type 2 diabetes . There were significant differences in the levels of CD62P , PAC-1 , annexin V , PDMP , MDMP , sP-selectin , sE-selectin and MDA-LDL between the hyperlipidemic patients and the controls . In particular , these markers were significantly increased in hyperlipidemic patients who had type 2 diabetes . In the hyperlipidemic patients with diabetes , MDA-LDL was decreased by both monotherapy with probucol and combination therapy ( probucol and ticlopidine ) . In these patients , CD62P , PAC-1 , annexin V , MDMP , PDMP , sP-selectin , and sE-selectin were also significantly decreased after treatment . The decreases of CD62P , PAC-1 , annexin V , PDMP and sP-selectin were greater combination therapy than with monotherapy . These findings suggest that administration of probucol and ticlopidine to hyperlipidemic patients with type 2 diabetes may help to prevent the development of cardiovascular complications caused by modified LDL , selectins , or activated platelets and monocytes We compared the levels of microparticles , platelet activation markers , soluble cell adhesion molecules , and soluble selectins between hypertensive patients with and without type 2 diabetes and control subjects . Binding of anti-glycoprotein IIb/IIIa and anti-glycoprotein Ib monoclonal antibodies to platelets did not differ significantly between the hypertensive patients and controls , but platelet expression of activation markers ( CD62P , CD63 , PAC-1 , and annexin V ) was higher in the hypertensive patients . Platelet-derived microparticle ( PDMP ) and monocyte-derived microparticle ( MDMP ) levels were significantly higher in the hypertensive patients than in the controls . Soluble ICAM-1 , VCAM-1 , P-selectin , and E-selectin levels were also higher in the hypertensive patients , and they were significantly higher in the hypertensive patients with diabetes . After treatment with efonidipine , the levels of PDMPs , CD62P- , CD63- , PAC-1- , and annexin V-positive platelets , sICAM-1 , sVCAM-1 , sP-selectin , and sE-selectin all decreased significantly . The MDMP levels decreased , and the decrease was significant in the hypertensive patients with diabetes . These findings suggest that administration of efonidipine to hypertension patients with diabetes may prevent the development of cardiovascular complications caused by cell adhesion molecules or activated platelets and monocytes AIM The aim of this study was to evaluate the significance of endothelial cell-derived microparticles ( EDMP ) , angiopoietin-2 ( Ang-2 ) and adiponectin in hyperlipidemic patients with and without type 2 diabetes mellitus , and to compare the two for the effects of eicosapentaenoic acid ( EPA ) on these markers . METHODS One hundred and twenty-six hyperlipidemic patients with and without type 2 diabetes mellitus received EPA 1,800 mg daily , and 50 of the patients were non-diabetic . RESULTS EDMP and Ang-2 levels prior to treatment were higher in diabetic patients than in non-diabetic patients , whereas adiponectin levels were lower in diabetics . When diabetic patients were classified into two groups on the basis of Ang-2 levels , the levels of all markers remained unchanged in those without a high Ang-2 level after EPA treatment . In contrast , all markers except for adiponectin were decreased significantly in diabetic patients with high Ang-2 levels after 6 months of EPA treatment . These diabetic patients with high Ang-2 levels displayed a more significant increase in adiponectin levels after EPA treatment than those who did not . CONCLUSION These results suggest that EPA possesses an adiponectin-dependent anti-atherosclerotic effect and may be beneficial for the prevention of vascular complications in diabetic patients with high Ang-2 levels Monocyte-derived microparticles play an important role in the pathogenesis of diabetic vasculopathy , and angiotensin II receptor blocker and statin have been shown to have a beneficial effect on the angiopathies of hypertension and hyperglycemia in patients with type 2 diabetes mellitus . However , the interaction between angiotensin II receptor blocker and statin , and monocyte-derived microparticles in atherosclerosis is poorly understood . The effects of losartan and simvastatin on circulating concentrations of monocyte-derived microparticles , chemokines , and soluble adhesion markers were studied in hypertensive patients with or without type 2 diabetes mellitus . Monocyte-derived microparticles were measured by flow cytometry , and levels of serum chemokines ( MCP-1 and RANTES ) and soluble adhesion markers ( sP-selectin and sVCAM-1 ) were measured by enzyme-linked immunosorbent assay . Losartan decreased both the systolic and diastolic blood pressure in hypertensive patients with and without type 2 diabetes mellitus . The concentrations of monocyte-derived microparticles , chemokines , and soluble adhesion molecules were higher in hypertensive patients who also had type 2 diabetes mellitus vs. those who did not . The administration of angiotensin II receptor blocker decreased the circulating concentration of all these markers . In addition , all markers were decreased by combination therapy , and monocyte-derived microparticles were decreased more with combination therapy with losartan and simvastatin than monotherapy with losartan . The administration of angiotensin II receptor blocker inhibited monocyte-derived microparticle generation and suggests that angiotensin II is intimately related to vascular changes that occur in type 2 diabetes mellitus . Combination therapy with a statin and angiotensin II receptor blocker might be valuable as anti-atherosclerotic therapy in patients with type 2 diabetes mellitus and nephropathy Platelet-derived microparticles , activated platelets , and monocyte-derived microparticles were measured in 73 patients with diabetes mellitus . A comparative study of these parameters was performed before and after administration of ticlopidine . The number of platelet-derived microparticles and activated platelets was increased significantly in diabetic patients . Monocyte-derived microparticles were also increased significantly . After administration of ticlopidine , platelet-derived microparticles and activated platelets corrected positively , not only CD62P- and CD63-positive platelets , but also platelet-derived microparticles and monocyte-derived microparticles showed a significant decrease . These data suggest that in patients with diabetes , platelet-derived microparticles and activated platelets stimulate the activation of monocytes and promote the production of monocyte-derived microparticles , and that ticlopidine is useful for hypercoagulabillity in diabetic patients * Laboratory for Experimental Internal Medicine , Academic Medical Center , University of Amsterdam , Amsterdam ; Department of InternalMedicine , Slotervaart Hospital , Amsterdam ; Laboratory of Haematology and Clinical Chemistry , Onze Lieve Vrouwe Gasthuis , Amsterdam ; and § Department of Internal Medicine and Cardiovascular Research Institute Maastricht , Academic Hospital and University of Maastricht , Maastricht , The Netherl and sTo cite this article : Sommeijer DW , Joop K , Leyte A , Reitsma PH , ten Cate H. Pravastatin reduces fibrinogen receptor gpIIIa on platelet-derivedmicroparticles in patients with type 2 diabetes . J Thromb Haemost 2005 ; 3 : 1168–71.See also Davi ` G , Ferroni P. Microparticles in type 2 diabetes mellitus . This issue , pp 1166–7 The effects of treatment with pitavastatin on inflammatory and platelet activation markers and adip
Output:
| Conclusions : The counts of TMPs , PMPs , MMPs and EMPs elevated in patients with T2DM .
And cell-derived MPs may play a role in the pathogenesis of T2DM |
MS212704 | ***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: Our objective was to assess the efficiency of a home-visit invitation aim ed to increase uptake of cervical cancer screening in women between 35 and 60 years of age . From May , 2006 , we conducted a quasi-r and omized trial to determine if an in-home education and invitation intervention would increase uptake of cervical cancer screening . We r and omly recruited 304 women from the Samliem inner-city community , Khon Kaen , Northeast Thail and , and assigned participants to either the intervention or control zone . Baseline screening coverage interviews were then performed : 58 of 158 women in the intervention zone and 46 of 146 in the control zone were excluded from the study because of having had a Pap smear within 5 years , but these were included in the final analysis . First , 100 women in the intervention group were visited in their homes by one of the research ers , who provided culturally-sensitive health education that emphasized the need for screening . Four months later , post-intervention , screening-coverage interviews were again performed in both groups , in combination with the same health education for 100 women in the control group for a comparison . There was no difference in the baseline Pap smear screening-coverage rate in the intervention vs. control zones ( 36.7 vs. 31.5 % , p=0.339 ) . One hundred women in the intervention group completed the intervention interviews and after four months , 100 women in the intervention group and 100 in the control group also completed the post-intervention interviews . The increased screening-coverage rate in the intervention zone was similar to that of the control zone ( 43.6 vs. 34.9 % , p=0.119 ) ; however , there was a borderline significant increase in the intervention zone compared with baseline ( 36.7 to 43.6 % , p=0.070 ) . Therefore , home visit education and invitation intervention produced only a nominal effect on increasing Pap smear coverage within a 4-month study period BACKGROUND Few Iranian women take the Papanicolaou test despite its important role in preventing cervical cancer . This study aim ed to determine the effectiveness of an educational intervention based on the protection motivation theory ( PMT ) variables and implementation intentions in the first and second Pap test practice among Iranian women . MATERIAL S AND METHODS In this quasi-r and omized controlled trial , 200 women who were referred to 30 primary health care clinics in Tehran were r and omly selected . PMT variables and Pap test practice were measured at baseline and again after 3 and 15 months . The 4-week educational intervention program was conducted for the intervention group . RESULTS Following the intervention , the mean scores of self-efficacy , perceived vulnerability , and behavior intention variables were significantly higher in the intervention group when compared to the control group ( p<0.05 ) . No significant differences were found in the perceived severity , response efficacy , response cost , and fear between the two groups following the intervention . Higher percent of women in the intervention group had obtained first and second Pap test compared to the controls . CONCLUSIONS The PMT and implementation intentions provide a suitable theory-based framework for developing educational interventions regarding Pap test practice in Iran BACKGROUND The North Carolina Native American Cervical Cancer Prevention Project was a 5-year , National Cancer Institute-funded trial of health education design ed to increase screening for cervical cancer among Native-American women in North Carolina . PURPOSE This study was conducted to evaluate the effectiveness of this education program in the Eastern-B and Cherokee target population . METHODS Cherokee tribal l and s were mapped and all households ( N = 2223 ) were listed to ensure maximum coverage of the eligible population ( women , aged 18 years and older , who were enrolled tribal members ) . Eligible women were identified by the use of a brief question naire administered to an adult member of the household . Of the 1279 households with eligible women , 1020 ( 79.8 % ) agreed to participate . The intervention was an individualized health education program delivered by female Cherokee lay health educators . The participants were r and omly assigned to receive or not to receive the intervention ( i.e. , to program and control groups , respectively ) by use of the Solomon Four-Group design . Data were collected in face-to-face interviews conducted in the participant 's home . Of the 996 women who were ultimately enrolled , 540 were r and omly assigned to receive a pretest ( preintervention ) interview that involved administration of a 96-item question naire design ed to collect data on knowledge , intentions , and behaviors related to cervical cancer ; of these 540 women , 263 were r and omly assigned to receive the education program . The remaining 456 women did not receive the pretest , but 218 were r and omly assigned to receive the education program . Six months after receiving the education program , the women in all four groups were administered a post-test that was identical to the pretest . Logistic regression was used to assess the effects of the pretest and the educational program . All P values result ed from two-sided statistical tests . RESULTS Eight hundred and fifteen ( 81.8 % ) of the 996 participants completed the post-test interview . The remaining 181 women who were lost to follow-up were evenly distributed among the four study groups . At the post-test , 282 ( 73.2 % ) of the 385 women who received the education program reported having had a Pap smear following the intervention , compared with 275 ( 64 % ) of the 430 control subjects . Women who received the education program were more likely to answer all knowledge items correctly on the post-test ( odds ratio [ OR ] = 2.18 , 95 % confidence interval [ CI ] = 1.08 - 4.39 ) and to report having obtained a Pap smear in the past year ( OR = 2.06 , 95 % CI = 1.14 - 3.72 ) than women in the control groups . CONCLUSION Women who received the education program exhibited a greater knowledge about cervical cancer prevention and were more likely to have reported having had a Pap smear within the past year than women who did not receive the program Objective Human papillomavirus ( HPV ) self-sampling ( Self-HPV ) may be used as a primary cervical cancer screening method in a low re source setting . Our aim was to evaluate whether an educational intervention would improve women 's knowledge and confidence in the Self-HPV method . Method Women aged between 25 and 65 years old , eligible for cervical cancer screening , were r and omly chosen to receive st and ard information ( control group ) or st and ard information followed by educational intervention ( interventional group ) . St and ard information included explanations about what the test detects ( HPV ) , the link between HPV and cervical cancer and how to perform HPV self-sampling . The educational intervention consisted of a culturally tailored video about HPV , cervical cancer , Self-HPV and its relevancy as a screening test . All participants completed a question naire that assessed sociodemographic data , women 's knowledge about cervical cancer and acceptability of Self-HPV . Results A total of 302 women were enrolled in 4 health care centers in Yaoundé and the surrounding countryside . 301 women ( 149 in the “ control group ” and 152 in the “ intervention group ” ) completed the full process and were included into the analysis . Participants who received the educational intervention had a significantly higher knowledge about HPV and cervical cancer than the control group ( p<0.05 ) , but no significant difference on Self-HPV acceptability and confidence in the method was noticed between the two groups . Conclusion Educational intervention promotes an increase in knowledge about HPV and cervical cancer . Further investigation should be conducted to determine if this intervention can be sustained beyond the short term and influences screening behavior . Trials Registration International St and ard R and omised Controlled Trial Number ( IS RCT N ) Register IS RCT Background Cervical cancer is the second most common form of cancer observed among women in Turkey . The participation of women in cervical cancer screening programs is strongly affected by Turkish attitudes , beliefs , and sociocultural structure . Aim This study was conducted to assess the effectiveness of health education that aim ed to raise awareness about Papanicolaou testing and to emphasize the importance of the early diagnosis of cervical cancer . Material s and Methods The study was conducted as a prospect i ve , r and omized , controlled trial and was carried out in 148 women . Seventy-five women in the control group were asked to fill out question naire forms . A 45-minute conference-style training was given to 73 women in the study group , and all of the subjects were asked to fill out the forms after the training . The sociodemographic characteristics of the 2 groups and the mean “ Health Belief Model Scale for Cervical Cancer and Pap Smear Test ” scores of the 2 groups were statistically analyzed by Statistical Package of Social Sciences ( SPSS ) , version 15 . Results There was no statistically significant difference noticed between the sociodemographic characteristics of the 2 groups ( P > 0.05 ) . The difference in test scores , which represented knowledge about cervical cancer and Papanicolaou testing , was statistically significant between the control group and the study group ( t = 10.122 , P < 0.05 ) . In the Health Belief Model Scale for Cervical Cancer and Pap Smear Test , there were statistically significant differences in the following measures : lower levels of susceptibility to cervical cancer score ( t = −2.035 , P < 0.05 ) , lower levels of perceived benefit from a Papanicolaou test score ( t = 3.278 , P < 0.05 ) and lower levels of perceived barriers to Papanicolaou test score ( t = −3.182 , P < 0.05 ) . Conclusion Nurses should be involved in educating women about cervical cancer and Papanicolaou testing . By doing so , they can change the attitudes , knowledge , and beliefs of the women Background Cervical cancer is a disease of public health importance affecting many women and contributing to avoidably high levels of cancer deaths in Nigeria . In spite of the relative ease of prevention , the incidence is on the increase . This study aim ed to determine the effect of health education on the awareness , knowledge and perception of cervical cancer and screening among women in rural Nigerian communities . Methods The study design was quasi-experimental . The study was carried out among adult women in Odogbolu ( intervention ) and Ikenne ( control ) local government areas ( LGA ) of Ogun state . Three hundred and fifty ( 350 ) women were selected per group by multistage r and om sampling technique . Data was collected by semi structured interviews with the aid of question naire . The intervention consisted of structured health education based on a movie . Result The intervention raised the level of awareness of cervical cancer and screening to 100 % ( p < 0.0001 ) . The proportion of women with very good knowledge of cervical cancer and screening rose from 2 % to 70.5 % ( χ2 = 503.7 , p < 0.0001 ) while the proportion of those with good perception rose from 5.1 % to 95.1 % ( p < 0.0001 ) . The mean knowledge and mean perception scores were also increased ( p < 0.0001 ) . There was increase in the proportion of women who had undertaken cervical screening from 4.3 % to 8.3 % ( p = 0.038 ) . The major reason stated by the women for not having had cervical screening done was lack of awareness about cervical cancer and screening . There was statistically significant difference between the intervention and control groups concerning their knowledge attitude and practice towards cervical and screening ( p < 0.05 ) after the intervention . Conclusion Multiple media health education based on a movie is effective in creating awareness for and improving the knowledge and perception of adult women about cervical cancer and screening . It also improves the uptake of cervical cancer screening . The creation of awareness is very crucial to the success of a cervical cancer prevention programme Background Countries must decide whether or not to replace primary cytology-based screening with primary human papillomavirus (HPV)-based screening . We aim ed to assess how primary screening for an HPV infection , a sexually transmitted infection ( STI ) , and the type of information included in the invitation letter , will affect screening intention . Methods We r and omized a representative sample of Norwegian women to one of three invitation letters : 1 ) Pap smear , 2 ) HPV testing or 3 ) HPV testing with additional information about the nature of the infection . Intention to participate , anxiety level and whether women intend to follow-up abnormal results were measured between groups using chi-squared and nonparametric Kruskal-Wallis tests . Determinants of intention were explored using logistic regression . Results Responses from 3540 women were representative of the Norwegian population with respect to age , civil status and geographic location . No significant difference across invitation letters was found in women ’s stated intention to participate ( range : 91.8 - 92.3 % ) , anxiety ( 39 - 42 % were either quite or very worried ) or to follow-up after an abnormal result ( range : 97.1 - 97.6 % ) . Strength of intention to participate was only marginally lower for HPV-based invitation letters , albeit significant ( p-value = 0.008 ) , when measured on a scale . Only 36–40 % of respondents given the HPV invitations correctly understood that they likely had an STI . Conclusions We found that switching to primary HPV screening , independent of additional information about HPV infections , is not likely to reduce screening participation rates or increase anxiety ; however , women lacked the ability to interpret the meaning of an HPV-test result BACKGROUND Our aim was to determine if cervical cancer screening uptake would increase among under-screened women living in rural Ontario , Canada , if at-home self-collected sampling for human papillomavirus ( HPV
Output:
| We also found that invitation letters alone ( or with a follow up phone contact ) , making an appointment , and sending reminders to patients who are due or overdue for screening had a significant effect on improving participation and CCS rates in population s at risk .
Our findings supports the implementation of theory-based cervical cancer educational interventions to increase women 's participation in cervical cancer screening programs , particularly when targeting communities with low literacy levels . |
MS212705 | ***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: Aminophylline and caffeine are commonly used for prophylaxis of apnea in premature infants . Previous studies have indicated different effects of the drugs on cerebral circulation . Therefore , we have compared the acute effects of bolus administration of caffeine citrate or aminophylline on left ventricular output , heart rate , blood pressure and global cerebral blood flow . The study group consisted of 33 newborn , spontaneously breathing , preterm infants r and omly assigned to receive either aminophylline 5mg/kg ( n= 19 ) or caffeine citrate 20mg/kg ( n= 14 ) . Two hours after iv drug administration , global cerebral blood flow measured by the Xe‐clearance technique was significantly lower after aminophylline than after caffeine ( mean(SD ) ) : 13.2 ( + 2.9/ ‐ 2.3 ) versus 17.2 ( + 7.1/ ‐ 5.1 ) ml/100 g/min ) ( p= 0.01 ) . There were no other statistically significant differences in circulatory or ventilatory parameters between the groups . Further studies are needed to clarify the clinical relevance of these results To determine if the use of oxygen in the delivery room influences subsequent global cerebral blood flow ( CBF ) , 70 infants of gestational age of less than 33 completed weeks were r and omly assigned to receive room air ( group I ) or 80 % oxygen ( group II ) during the initial stabilisation at birth . In group I supplemental oxygen was administered on clinical indications , when required . After being admitted to the neonatal intensive care unit all infants were treated according to our normal practice . At a postnatal age of 2 hours CBF was measured by xenon clearance . Seventy four per cent of the infants in group I were successfully stabilised without the need for supplemental oxygen . CBF was significantly higher in group I than in group II ( CBF median ( interquartile range ) : 15.9 ( 13.6 - 21.9 ) v 12.2 ( 10.7 - 13.8 ) ml/100 g/minute ) . Differences in oxygen exposure seemed to be the only explanation for the differences in CBF . No differences in short term outcome were found between the groups OBJECTIVE To investigate the effects on oxygenation of targeting the higher versus the lower end of the currently recommended range for pulse oximetry ( Spo2 ) . DESIGN Nonr and omized crossover trial with the use of within-subject comparisons ( two-tailed paired t test ) . SETTING Level III neonatal intensive care unit of a university hospital . PATIENTS Twenty infants whose lungs were mechanically ventilated ( mean + /- SD : birth weight , 1192 + /- 396 gm ; gestational age , 28.7 + /- 2.7 weeks ; age at time of study , 42 + /- 26 hours ) . INTERVENTIONS The inspired oxygen concentration was adjusted to achieve Spo2 readings of 93 % to 96 % versus 89 % to 92 % ( Ohmeda pulse oximeter ) or 95 % to 98 % versus 91 % to 94 % ( Nellcor oximeter ) . MEASUREMENTS Cardiac output was measured by echocardiography , oxygen content of arterial blood sample s by cooximetry , and oxygen consumption by indirect calorimetry . RESULTS The inspired oxygen concentrations required to achieve the Spo2 target ranges were 39.8 % + /- 8.3 % versus 28.7 % + /- 6.1 % ( p < 0.001 ) . The respective arterial oxygen contents were 18.0 + /- 2.6 ml/dl versus 16.9 + /- 2.5 ml/dl ( p < 0.001 ) . Oxygen consumption was unchanged . In the lower-oxygen condition no compensatory increase in cardiac output was detected ; thus the estimated mixed venous oxygen tension decreased and the oxygen extraction ratio increased . Venous admixture increased from 15 % + /- 6 % to 31 % + /- 9 % in the lower-oxygen condition ( p < 0.001 ) . CONCLUSIONS The " low normal " Spo2 target range allowed for less oxygen exposure . No signs of mismatch between systemic oxygen delivery and dem and could be detected Sleep fragmentation , decreased rapid eye movement ( REM ) sleep time , and REM sleep hypoxemia have been reported in infants with chronic neonatal lung disease ( CNLD ) in early infancy despite an awake hemoglobin oxygen saturation ( SaO2 ) > 93 % . Interestingly , higher inspired O2 concentrations have been demonstrated to reduce REM sleep fragmentation in CNLD patients in middle infancy . However , the effect of increased SaO2 on sleep architecture in infants with CNLD near the time of discharge from neonatal intensive care has not been reported . We performed paired overnight polysomnography in a sleep laboratory on 16 infants with CNLD ( 4 weeks median corrected age ) in air or their usual inspired oxygen ( SaO2 > 93 % ) and again when receiving 0.25 L/min higher than baseline inspired oxygen via nasal catheters ( SaO2 > 97 % ) . A control group of seven healthy preterm infants was similarly studied . For CNLD infants on supplemented O2 , sleep duration decreased by 15 % ( 422+/-66 min vs. 359+/-89 min ; P < 0.005 ) , and sleep efficiency decreased by 7 % ( 73.2+/-10.6 % vs. 66.4+/-14.0 % ; P < 0.005 ) but percentage of time in REM sleep ( REM% ) ( 31.5+/-8.9 % vs. 29.8+/-8.6 % ; P=0.560 ) , REM epoch duration ( 12.4+/-2.8 min vs. 13.4+/-4.3 min ; P=0.420 ) , and REM arousal index ( 18.6+/-6.5 vs. 18.8+/-7.2 ; P=0.990 ) were not significantly affected . Conversely , higher O2 did not alter sleep architecture in the control group . The mean non-REM ( NREM ) respiratory rate decreased ( CNLD : P=0.003 ; controls : P=0.02 ) , NREM SaO2 increased ( P < 0.05 ) , although the mean transcutaneous CO2 was unaltered in both CNLD and control groups . This study confirmed low REM% in CNLD infants in early infancy and demonstrated that a higher SaO2 adversely affected sleep time but did not influence REM sleep duration or arousal frequency . A target SaO2 > 93 % is , therefore , as efficacious as an SaO2 > 97 % in optimizing sleep architecture in CNLD infants A previous report has shown no difference between the clinical outcome of infants exposed to a high oxygen ( O2 ) regimen and those exposed to a low O2 regimen for the treatment of respiratory distress syndrome ( RDS ) . Mechanical ventilation was not used in either group . In the present study , pulmonary function tests were performed on 14 survivors receiving the low O2 regimen ( low O2 group ) and on nine receiving the high O2 regimen ( high O2 group ) ten years after their initial illness . Similar evidence of abnormalities of large airways was found in both groups of prematurely born children that was comparable with that previously reported for normal prematurely born children . There was evidence in the high O2 group similar to that reported for ventilated survivors with RDS exposed to a high concentration of O2 . From these data , it was concluded that neonatal exposure to high O2 concentrations in the absence of mechanical ventilation is capable of causing long-term change in small airways This study was performed to determine whether the use of continuous transcutaneous oxygen tension ( tcPO2 ) monitoring could reduce the incidence of retinopathy of prematurity in preterm infants receiving oxygen therapy . A total of 296 infants with birth weights less than or equal to 1,300 g were r and omly assigned to a continuous monitoring or a st and ard care group . Infants in the continuous monitoring group had tcPO2 monitored continuously as long as they required supplemental oxygen , and infants in the st and ard care group had tcPO2 monitored only during the more acute state of their illness . Management of both groups was otherwise identical . Of 148 infants in the continuous monitoring group , 101 survived ; of the 148 patients in the st and ard care group , 113 survived . Mean birth weights and gestational ages were similar for both groups . Duration of mechanical ventilation and oxygen therapy was also similar . The overall incidence of retinopathy of prematurity was 51 % in the continuous monitoring group and 59 % in the st and ard care group . As birth weight for infants greater than or equal to 1,000 g increased , a higher risk of retinopathy of prematurity developing was noted in the st and ard care group . Cicatricial retinopathy of prematurity developed in four infants in the continuous monitoring group and five in the st and ard care group . These results suggest that continuous tcPO2 monitoring may reduce the incidence of retinopathy of prematurity in infants with birth weights greater than 1,000 g but not in the smaller infants in whom this complication occurs more frequently and is more severe Between 1966 and 1970 , infants with birthweights between 1000 and 1500 g entered a r and omized controlled trial to determine the short‐term and long‐term results of neonatal intensive care . Of 158 long‐term survivors , five were lost to follow‐up , but the multidisciplinary research team prospect ively followed 143 children up to the age of eight years . Useful data were available for the other 10 children . Of the long‐term survivors 74 had received routine , and 84 had received intensive nursery care Oxygen saturation determined by pulse oximetry was monitored in 152 pediatric surgical patients divided into two groups . In one group , the oximeter data and alarms were available ( N = 76 ) to the anesthesia team , and , in the other group , these data were unavailable ( N = 76 ) . A trained observer recorded all intraoperative hypoxic episodes and informed the anesthesia team of all major events ( i.e. , oxygen saturation less than or equal to 85 % for greater than or equal to 30 s ) ( PaO2 approximately 52 mmHg ) . Thirty-five major events occurred : 24 in the unavailable group , and 11 in the available group ( P = 0.021 ) . A greater number of major events occurred in children less than or equal to 2 yr of age ( P = 0.013 ) . Hypoxic events diagnosed by the oximeter , but not by the anesthesiologist , were more frequent in the unavailable group ( 13 ) than in the available group ( 5 ) ( P = 0.0495 ) . ASA Physical Status 3 and 4 patients were more likely to suffer a major event ( P = 0.009 available , 0.006 unavailable ) . The pulse oximeter diagnosed hypoxemia before the signs and symptoms of hypoxemia were apparent ( i.e. , prior to observed cyanosis or bradycardia ) . Major hypoxic events were unrelated to duration of anesthesia . Major events were evenly distributed among induction , maintenance , and awakening from anesthesia ; a greater number of hypoxic events occurred during induction in the unavailable group ( P = 0.031 ) . No morbidity was documented in any patient who suffered an hypoxic event . ( ABSTRACT TRUNCATED AT 250 WORDS The relation between PaO2 and retrolental fibroplasia ( RLF ) was studied prospect ively in 719 premature infants born in or treated in the intensive care units of a group of university hospitals . Blood gas studies were performed on 589 of these infants , 66 of whom had a diagnosis of RLF ; in 27 of these 66 , some grade of mostly nonblinding cicatricial disease developed . The frequency of RLF was highest among infants of lowest birth weight . A multivariate statistical method was used to analyze simultaneously the effect of possible etiologic factors associated with RLF . The occurrence of RLF was found to be unrelated to PaO2 , as determined by the limited information available from intermittent sampling . RLF is associated with concentration of oxygen administered in the lightest birth weight group , but the strongest association , aside from birth weight , was with time in oxygen . None of the other variables involving blood chemical values appeared to be associated with RLF . The severity of cicatricial RLF is clearly greater in infants weighing less than 1,200 g at birth . Conservative administration of oxygen may have been responsible for failure to demonstrate quantitative association between PaO2 levels and disease . Agreement between the observed and predicted numbers of infants with RLF demonstrate the strength of the multivariate technique employed in making the statistical analyses AIMS : To determine if decreasing arterial blood saturation from 95 % to 90 % could cause vasoconstriction of the pulmonary vasculature and dilatation of a patent ductus arteriosus in preterm newborn infants with respiratory distress syndrome ( RDS ) . METHODS : Doppler echocardiographic studies were compared at 95 % and 90 % pulse oxygen saturation ( SpO2 ) in 13 preterm infants aged 61.7 ( 4.3 ) hours with RDS and Doppler echocardiographic evidence of tricuspid regurgitation . RESULTS : The mean (SD)Doppler echocardiographic indices
Output:
| The one trial that specifically addressed the question of lower versus higher PaO2 found no effect on death , but did not report ( in sufficient detail to warrant inclusion ) the effect of this intervention on eye or other outcomes .
REVIEW ER 'S CONCLUSIONS The results of this meta- analysis confirm the commonly held view of today 's clinicians that a policy of unrestricted , unmonitored oxygen therapy has potential harms , without clear benefits . |
MS212706 | ***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: Pre‐operative anxiety is common and often significant . Ambulatory surgery challenges our pre‐operative goal of an anxiety‐free patient by requiring people to be ‘ street ready ’ within a brief period of time after surgery . Recently , it has been demonstrated that music can be used successfully to relieve patient anxiety before operations , and that audio embedded with tones that create binaural beats within the brain of the listener decreases subjective levels of anxiety in patients with chronic anxiety states . We measured anxiety with the State‐Trait Anxiety Inventory question naire and compared binaural beat audio ( Binaural Group ) with an identical soundtrack but without these added tones ( Audio Group ) and with a third group who received no specific intervention ( No Intervention Group ) . Mean [ 95 % confidence intervals ] decreases in anxiety scores were 26.3%[19–33 % ] in the Binaural Group ( p = 0.001 vs. Audio Group , p < 0.0001 vs. No Intervention Group ) , 11.1%[6–16 % ] in the Audio Group ( p = 0.15 vs. No Intervention Group ) and 3.8%[0–7 % ] in the No Intervention Group . Binaural beat audio has the potential to decrease acute pre‐operative anxiety significantly Many patients in the Surgical Holding Area become stressed and anxious . In a hospital setting music reduces patients ' anxiety . This study determined that music can reduce the anxiety and stress of patients in the Surgical Holding Area . In this study , one group of subjects listed to music while a second group did not . Subjects who listened to music while in the Surgical Holding Area had significantly less stress and anxiety than did those who did not listen to music . Both groups spent similar lengths of time in the Surgical Holding Area . The results strongly suggest that if music were available to all patients in the Surgical Holding Area , most would select this option , and they would experience less anxiety OBJECTIVE To compare the effects of two pediatric venipuncture distress-management distraction strategies that differed in the degree to which they required children 's interaction . METHODS Eighty-eight 1- to 7-year-old children receiving venipuncture were r and omly assigned to one of three treatment conditions : interactive toy distraction , passive movie distraction , or st and ard care . Distress was examined via parent , nurse , self-report ( children over 4 years ) , and observational coding . Engagement in distraction was assessed via observational coding . RESULTS Children in the passive condition were more distracted and less distressed than children in the interactive condition . Although children in the interactive condition were more distracted than st and ard care children , there were no differences in distress between these groups . CONCLUSIONS Despite literature that suggests that interactive distraction should lower distress more than passive distraction , results indicate that a passive strategy might be most effective for children 's venipuncture . It is possible that children 's distress interfered with their ability to interact with the distractor The anticipation of surgery has been recognized as a stressful event that produces anxiety for most patients ( Kapnoullas 1988 ) . Even minor surgical procedures can produce anxiety in patients ; this in turn can affect their postoperative recovery and lead to a risk of physiological complications ( Swindale 1989 ) . Thus , preoperative anxiety is identified as one of the common nursing diagnoses or problems for surgical patients OBJECTIVES Dental anxiety is common in children . This study sought to determine the impact of viewing positive images of dentistry prior to a dental appointment on the anticipatory dental anxiety levels of children attending for dental treatment . METHODS Controlled trial . Assessment of anxiety and analysis of data were conducted blind to experimental condition . Assessment of anxiety was carried out in the waiting room postintervention but before the patient entered the dental surgery for treatment . PARTICIPANTS Thirty-eight children and young adults attending a dental clinic in South West Engl and . INTERVENTION Participants were r and omly assigned to one of two conditions . In both conditions the participant was asked to look at photographs for 2 min in the waiting area prior to their appointment . The intervention consisted of viewing positive images of dentistry and dental treatment , the control condition consisted of dentally neutral images . Positive and neutral images were vali date d independently by four paediatric dentists . The assessment of anticipatory dental anxiety was made blind to experimental condition and statistical analysis was conducted blind to group membership . OUTCOME MEASURE Anticipatory anxiety assessed by the Venham Picture Test . FINDINGS A significant difference in anticipatory dental anxiety was found between the two groups ( median-positive images = 0 , median-neutral images = 3 ; P < 0.001 ) . Anticipatory anxiety was not correlated to age ( rho = 0.04 P > 0.05 ) , there was no difference between male and female participants in their level of anticipatory anxiety ( median-males = 0.5 , median-females = 1 P > 0.05 ) . CONCLUSIONS Viewing positive images of dentistry and dentists results in short-term reductions in anticipatory anxiety in children The aim of this study was to test how distraction influences pain , distress and anxiety in children during wound care . Sixty participants aged 5 - 12 years were r and omized to three groups : serious gaming , the use of lollipops and a control group . Self-reported pain , distress , anxiety and observed pain behaviour were recorded in conjunction with wound care . Serious gaming , an active distraction , reduced the observed pain behaviour and self-reported distress compared with the other groups . A sense of control and engagement in the distraction , together , may be the explanation for the different pain behaviours when children use serious gaming AIMS AND OBJECTIVES To identify the effect of music on preprocedure anxiety levels of Hong Kong Chinese patients undergoing day procedures in a local community based hospital . DESIGN Pre and post-test quasi experimental design with non-r and om assignment . METHOD A total of 113 participants were assigned to the control group or intervention group depending on the day of their procedure . Participants ' anxiety levels were measured objective ly by comparing their vital signs and subjectively by the Spielberger State Trait Anxiety Scale . Participants ' physiological parameters ( blood pressure , pulse and respiration ) and State Trait Anxiety Scale were measured at two time periods . The control group undertook the usual relaxing activities provided in the waiting room compared with the intervention group who listened to music of their own choice in reclining chairs while waiting for the procedure . RESULTS The physiological parameters for both the control and intervention groups dropped significantly during the waiting period , however , only the intervention group had a significant reduction in reported anxiety levels . CONCLUSIONS These results suggest that providing self-selected music to day procedure patients in the preprocedure period assists in the reduction of physiological parameters and anxiety , yet , a relaxing environment can assist in the reduction of physiological parameters . RELEVANCE TO CLINICAL PRACTICE The administration of self-selected music to day procedure patients in the preprocedure period can be effective in the reduction of physiological parameters and anxiety Background . The induction of anesthesia is one of the most stressful moments for a child who must undergo surgery : it is estimated that 60 % of children suffer anxiety in the preoperative period . Preoperative anxiety is characterized by subjective feelings of tension , apprehension , nervousness , and worry . These reactions reflect the child ’s fear of separation from parents and home environment , as well as of loss of control , unfamiliar routines , surgical instruments , and hospital procedures . High levels of anxiety have been identified as predictors of postoperative troubles that can persist for 6 months after the procedure . Both behavioral and pharmacologic interventions are available to treat preoperative anxiety in children . Objective . The aim of this study was to investigate the effects of the presence of clowns on a child ’s preoperative anxiety during the induction of anesthesia and on the parent who accompanies him/her until he/she is asleep . Methods . The sample was composed of 40 subjects ( 5–12 years of age ) who had to undergo minor day surgery and were assigned r and omly to the clown group ( N = 20 ) , in which the children were accompanied in the preoperative room by the clowns and a parent , or the control group ( N = 20 ) , in which the children were accompanied by only 1 of his/her parents . The anxiety of the children in the preoperative period was measured through the Modified Yale Preoperative Anxiety Scale instrument ( observational behavioral checklist to measure the state anxiety of young children ) , and the anxiety of the parents was measured with the State-Trait Anxiety Inventory ( Y-1/Y-2 ) instrument ( self-report anxiety behavioral instrument that measures trait/baseline and state/situational anxiety in adults ) . In addition , a question naire for health professionals was developed to obtain their opinion about the presence of clowns during the induction of anesthesia , and a self-evaluation form was developed to be filled out by the clowns themselves about their interactions with the child . Results . The clown group was significantly less anxious during the induction of anesthesia compared with the control group . In the control group there was an increased level of anxiety in the induction room in comparison to in the waiting room ; in the clown group anxiety was not significantly different in the 2 locations . The question naire for health professionals indicated that the clowns were a benefit to the child , but the majority of the staff was opposed to continuing the program because of perceived interference with the procedures of the operating room . The correlation between the scores of the form to self-evaluate the effectiveness of the clowns and of the Modified Yale Preoperative Anxiety Scale is significant for both the waiting room and induction room . Conclusions . This study shows that the presence of clowns during the induction of anesthesia , together with the child ’s parents , was an effective intervention for managing children ’s and parents ’ anxiety during the preoperative period . We would encourage the promotion of this form of distraction therapy in the treatment of children requiring surgery , but the resistance of medical personnel make it very difficult to insert this program in the activity of the operating room It is common clinical experience that anxiety about pain can exacerbate the pain sensation . Using event-related functional magnetic resonance imaging ( FMRI ) , we compared activation responses to noxious thermal stimulation while perceived pain intensity was manipulated by changes in either physical intensity or induced anxiety . One visual signal , which reliably predicted noxious stimulation of moderate intensity , came to evoke low anxiety about the impending pain . Another visual signal was followed by the same , moderate-intensity stimulation on most of the trials , but occasionally by discriminably stronger noxious stimuli , and came to evoke higher anxiety . We found that the entorhinal cortex of the hippocampal formation responded differentially to identical noxious stimuli , dependent on whether the perceived pain intensity was enhanced by pain-relevant anxiety . During this emotional pain modulation , entorhinal responses predicted activity in closely connected , affective ( perigenual cingulate ) , and intensity coding ( mid-insula ) areas . Our finding suggests that accurate preparatory information during medical and dental procedures alleviates pain by disengaging the hippocampus . It supports the proposal that during anxiety , the hippocampal formation amplifies aversive events to prime behavioral responses that are adaptive to the worst possible outcome OBJECTIVES To review the effect of lavender scent on anticipatory anxiety in dental participants . METHODS In a cluster r and omized-controlled trial , patients ' ( N = 340 ) anxiety was assessed while waiting for a scheduled dental appointment , either under the odor of lavender or with no odor . Current anxiety , assessed by the brief State Trait Anxiety Indicator ( STAI-6 ) , and generalized dental anxiety , assessed by the Modified Dental Anxiety Scale ( MDAS ) were examined . RESULTS Analyses of variance ( anovas ) showed that although both groups showed similar , moderate levels of generalized dental anxiety ( MDAS F((1,338 ) ) = 2.17 , P > 0.05 ) the lavender group reported significantly lower current anxiety ( STAI : F((1,338 ) ) = 74.69 , P < 0.001 ) than the control group . CONCLUSIONS Although anxiety about future dental visits seems to be unaffected , lavender scent reduces state anxiety in dental patients CONTEXT Interest in the use of alternative therapies to reduce anxiety in patients undergoing medical interventions is increasing . We sought to assess the effectiveness of aromatherapy involving essential oils in reducing preoperative anxiety in women undergoing abortions . SETTING An urban , free-st and ing abortion clinic in Vancouver , BC . PATIENTS 66 women waiting for surgical abortions . DESIGN A double blind , r and omized trial . INTERVENTION Ten minutes spent sniffing a numbered container with either a mixture of the essential oils vetivert , bergamot , and geranium ( treatment arm ) or a hair conditioner ( placebo ) . OUTCOME MEASURES Anxiety was measured before and after the intervention by using a verbal anxiety scale from 0 to 10 . RESULTS The anxiety score was reduced by 1.0 point ( 5.0 to 4.0 ) in the aromatherapy group and by 1.1 points ( 6.1 to 5.0 ) in the placebo group ( P = 0.71 ) . The 95 % CI on the 0.1 greater decrease in anxiety for the placebo group extends from 0.55 less ( favors aromatherapy ) to 0.75 greater ( favors placebo ) . CONCLUSION Aromatherapy involving essential oils is no more effective than having patients sniff other pleasant odors in reducing preprocedure anxiety BACKGROUND Stress and anxiety during pregnancy have been associated with premature and low birth weight babies , presumably through fetus over exposion to glucocorticoids . Antenatal stress also seems to have long-term effects upon infant development and adult health . However , medication for stress may carry risks to the expectant mother , therefore the efficacy of non-pharmacological interventions should be investigated . METHODS Pregnant women ( n=15
Output:
| For children , insufficient evidence is available to corroborate the effectiveness of play opportunities , media distractions , and music for mitigating anxiety in children awaiting medical procedures .
CONCLUSIONS : Music is a well-established means of decreasing anxiety in adult patients awaiting medical interventions .
The effect of music on children ’s anxiety is not known . |
MS212707 | ***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: Preventive effect of proprioceptive training is proven by decreasing injury incidence , but its proprioceptive mechanism is not . Major hypothesis : the training has a positive long-term effect on ankle joint position sense in athletes of a high-risk sport ( h and ball ) . Ten elite-level female h and ball-players represented the intervention group ( training-group ) , 10 healthy athletes of other sports formed the control-group . Proprioceptive training was incorporated into the regular training regimen of the training-group . Ankle joint position sense function was measured with the " slope-box " test , first described by Robbins et al. Testing was performed one day before the intervention and 20 months later . Mean absolute estimate errors were processed for statistical analysis . Proprioceptive sensory function improved regarding all four directions with a high significance ( p<0.0001 ; avg . mean estimate error improvement : 1.77 degrees ) . This was also highly significant ( p < or = 0.0002 ) in each single directions , with avg . mean estimate error improvement between 1.59 degrees ( posterior ) and 2.03 degrees ( anterior ) . Mean absolute estimate errors at follow-up ( 2.24 degrees + /-0.88 degrees ) were significantly lower than in uninjured controls ( 3.29 degrees + /-1.15 degrees ) ( p<0.0001 ) . Long-term neuromuscular training has improved ankle joint position sense function in the investigated athletes . This joint position sense improvement can be one of the explanations for injury rate reduction effect of neuromuscular training Objective : To compare the effectiveness of a combination of vibration and wobble board training against wobble board training alone in footballers suffering from functional ankle instability ( FAI ) . Design : A 2 × 3 prefactorial – postfactorial design . Setting : University research laboratory . Participants : Thirty-three male semiprofessional footballers with self-reported unilateral FAI were r and omly assigned in 3 groups : vibration and wobble board ( mean age 22.2 years ) , wobble board ( mean age 22.7 years ) , and control ( mean age 23.1 years ) . Interventions : Participants in each intervention group performed a 6-week progressive rehabilitation program using a wobble board , either with or without the addition of vibration stimulus . Main Outcome Measures : Absolute center of mass ( COM ) distribution during single-leg stance , modified star excursion balance test ( SEBT ) reach distances , and single-leg triple hop for distance ( SLTHD ) were measured before and after 6-week intervention . Results : Combined vibration and wobble board training result ed in reduced COM distribution [ P ⩽ 0.001 , effect size ( ES ) = 0.66 ] , increased SEBT reach distances ( P ⩽ 0.01 and P ⩽ 0.002 , ES = 0.19 and 0.29 , respectively ) , and increased SLTHD ( P ⩽ 0.001 , ES = 0.33 ) compared with wobble board training alone during the course of the 6-week training intervention . Conclusions : Combined vibration and wobble board training improves COM distribution , modified SEBT scores , and SLTHD among footballers suffering FAI compared with wobble board training alone Abstract . This prospect i ve r and omized intervention investigated whether training on a balance board could reduce the amount of traumatic injuries of the lower extremities in female soccer players . A total of 221 female soccer players from 13 different teams playing in the second and third Swedish divisions volunteered to participate in the study . Seven teams ( n=121 ) were r and omized to an intervention group and six teams ( n=100 ) to a control group and were followed during one outdoor season ( April – October ) . Before and after the season muscle flexibility and balance/postural sway of the lower extremities were measured in the players . There were no significant differences in age , height , weight , muscle flexibility and balance/postural sway of the lower extremities between the intervention and the control group . During the season the players in the intervention group performed a special training program consisting of 10–15 min of balance board training in addition to their st and ard soccer practice and games . After a 37 % drop-out the intervention group consisted of 62 players and the control group of 78 players . The results showed no significant differences between the groups with respect either to the number , incidence , or type of traumatic injuries of the lower extremities . The incidence rate of " major " injuries was higher in the intervention group than in the control group . Four of five anterior cruciate ligament injuries occurred in the intervention group , which means that we could not prevent severe knee injuries in female soccer players with balance board training . However , among the players who had been injured during the 3-month period prior to this investigation there were significantly more players from the control group than from the intervention group who sustained new injuries during the study period Eisen , TC , Danoff , JV , Leone , JE , and Miller , TA . The effects of multiaxial and uniaxial unstable surface balance training in college athletes . J Strength Cond Res 24(7 ) : 1740 - 1745 , 2010-The purpose of this study was to compare the effects of 2 different types of unstable surface balance training ( uniaxial on a rocker board [ RB ] and multiaxial on a dynadisc [ DD ] ) on balance in division 1 collegiate athletes in sports that are at high risk for ankle sprains . Subjects ( n = 36 ) consisted of male soccer players and female volleyball and soccer players who were equally and r and omly assigned to 1 of 3 groups ( CON , DD , and RB ) . Balance training consisting of balancing on 1 leg on either the RB or DD , while repeatedly catching a 1-kg ball was performed 3 times per week for 4 weeks . Balance was tested with the Star Excursion Balance Test ( SEBT ) before , halfway through , and at the completion of the balance training . Control ( CON ) subjects also were given the balance test but did not participate in the training . A 3-way repeated analysis of variance revealed that no group individually changed SEBT scores from pre ( CON , 0.98 ± 0.086 ; DD , 0.98 ± 0.083 ; RB , 0.97 ± 0.085 ) to post ( CON , 1.00 ± 0.090 ; DD , 1.01 ± 0.088 ; RB , 1.02 ± 0.068 ) after balance training . When the 2 treatment groups were combined ( DD and RB ) , the p value decreased and came closer to significance ( p = 0.136 ) . When all 3 groups were combined , there was a significant difference in SEBT scores from pretraining ( CON + DD + RB ; 0.98 ± 0.085 ) to posttraining ( CON + DD + RB ; 1.01 ± 0.082 ) , which likely indicates low statistical power . The increase in physical activity the subjects experienced during the return to in-season activity , may have contributed to the significant differences in SEBT scores over time but not between DD or RB training . Therefore , a threshold level of physical activity may exist that is necessary to maintain balance during the off-season BACKGROUND Balance training is widely used in the rehabilitation after an ankle sprain and is thought to have a decreasing effect on postural sway . The present study investigated whether a 5.5-week balance training programme leads to a decreased postural sway showing in a reduced range of centre of pressure excursion . METHODS Thirty university students participated in this study . Twenty-two untrained subjects were r and omly assigned to either an intervention group ( n=11 ) or a control group ( n=11 ) . The remaining eight subjects were participants in an organized volleyball competition and were assigned to an additional volleyball group ( n=8 ) . All subjects of the intervention group and the volleyball group received a 5.5-week balance training programme , while subjects of the control group received no training . Centre of pressure of the ground reaction force was measured as a proxy measure of postural sway , using a force platform . Measurements took place before and after the 5.5-week training programme for st and ing on one leg ( both for right and for left leg ) of single leg stance , both for the eyes-open and eyes-closed situation . From these measurements centre of pressure excursion in the anterior-posterior and the medial-lateral direction was calculated . A linear regression analysis was performed to check for differences in centre of pressure excursion between any of the groups over the training period . FINDINGS No differences in changes of centre of pressure excursion were found between any of the groups over the 5.5-week training period . INTERPRETATION Balance training does not lead to a reduction in centre of pressure excursion in a general population consisting of non-injured and previously injured subjects STUDY DESIGN Controlled cohort repeated- measures experimental design . OBJECTIVES To determine if a neuromuscular training program ( NMTP ) focused on core stability and lower extremity strength would affect performance on the star excursion balance test ( SEBT ) . We hypothesized that NMTP would improve SEBT performance in the experimental group and there would be no side-to-side differences in either group . BACKGROUND The SEBT is a functional screening tool that is used to assess dynamic stability , monitor rehabilitation progress , assess deficits following an injury , and identify athletes at high risk for lower extremity injury . The SEBT requires lower extremity coordination , balance , flexibility , and strength . METHODS Twenty uninjured female soccer players ( 13 experimental , 7 control ) participated . Players trained together as a team , so group allocation was not r and omized . The SEBT was administered prior to and following 8 weeks of NMTP in the experimental group and 8 weeks of no NMTP in the control group . A 3-way mixed-model ANOVA was used to determine the effect of group ( experimental versus control ) , training ( pretraining versus posttraining ) , and limb ( right versus left ) . RESULTS After participation in a NMTP , subjects demonstrated a significant improvement in the SEBT composite score ( mean ± SD ) on the right limb ( pretraining , 96.4 % ± 11.7 % ; posttraining , 104.6 % ± 6.1 % ; P = .03 ) and the left limb ( pretraining , 96.9 % ± 10.1 % ; posttraining , 103.4 % ± 8.0 % ; P = .04 ) . The control group had no change on the SEBT composite score for the right ( pretraining , 95.7 % ± 5.2 % ; posttraining , 94.4 % ± 5.2 % ; P = .15 ) or the left ( 97.4 % ± 7.2 % ; 93.6 % ± 5.0 % ; P = .09 ) limb . Further analysis identified significant improvement for the SEBT in the posterolateral direction on both the right ( P = .008 ) and left ( P = .040 ) limb and the posteromedial direction of the left limb ( P = .028 ) in the experimental group . CONCLUSION Female soccer players demonstrated an improved performance on the SEBT after NMTP that focused on core stability and lower extremity strength Background Ankle sprains are the most common injuries in a variety of sports . Hypothesis A proprioceptive balance board program is effective for prevention of ankle sprains in volleyball players . Study Design Prospect i ve controlled study . Methods There were 116 male and female volleyball teams followed prospect ively during the 2001 - 2002 season . Teams were r and omized by 4 geographical regions to an intervention group ( 66 teams , 641 players ) and control group ( 50 teams , 486 players ) . Intervention teams followed a prescribed balance board training program ; control teams followed their normal training routine . The coaches recorded exposure on a weekly basis for each player . Injuries were registered by the players within 1 week after onset . Results Significantly fewer ankle sprains in the intervention group were found compared to the control group ( risk difference = 0.4/1000 playing hours ; 95 % confidence interval , 0.1 - 0.7 ) . A significant reduction in ankle sprain risk was found only for players with a history of ankle sprains . The incidence of overuse knee injuries for players with history of knee injury was increased in the intervention group . History of knee injury may be a contraindication for proprioceptive balance board training . Conclusions Use of proprioceptive balance board program is effective for prevention of ankle sprain recurrences PURPOSE To investigate the effectiveness of a multistation proprioceptive exercise program for the prevention of ankle injuries in basketball players using a prospect i ve r and omized controlled trial in combination with biomechanical tests of neuromuscular performance . METHODS A total of 232 players participated in the study and were r and omly assigned to a training or control group following the CONSORT statement . The training group performed a multistation proprioceptive exercise program , and the control group continued with their normal workout routines . During one competitive basketball season , the number of ankle injuries was counted and related to the number of sports participation sessions using logistic regression . Additional biomechanical pre – post tests ( angle reproduction and postural sway ) were performed in both groups to investigate the effects on neuromuscular performance . RESULTS In the control group , 21 injuries occurred , whereas in the training group , 7 injuries occurred . The risk for sustaining an ankle injury was significantly reduced in the training group by approximately 65 % . [ corrected ] The corresponding number needed to treat was 7 . Additional biomechanical tests revealed significant improvements in joint position sense and single-limb stance in the training group . CONCLUSIONS The multistation proprioceptive exercise program effectively prevented ankle injuries in basketball players . Analysis of number needed to treat clearly showed the relatively low prevention effort that is necessary to avoid an ankle injury . Additional biomechanical tests confirmed the
Output:
| Furthermore , training seems to improve postural sway and joint position sense .
Conclusion : Balance training reduces the incidence of ankle sprains and increases dynamic neuromuscular control , postural sway , and the joint position sense in athletes |
MS212708 | ***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 primary aim of the present study was to determine the dose of alfentanil that must be added to a rapid-sequence induction ( RSI ) regimen using thiopentone and rocuronium to obtain optimal intubation conditions in > 95 % of the individuals . METHODS A total of 60 ASA I patients were r and omly allocated to five different alfentanil dose groups ( 0 , 15 , 30 , 45 , or 60 microg kg-1 ) . A blinded dose of alfentanil followed by thiopentone 4 mg kg-1 and rocuronium 1 mg kg-1 was administered in rapid succession , and tracheal intubation was attempted 40 s thereafter . The relationship between the alfentanil dose and the probability of optimal intubation conditions was determined by non-linear logistic regression analysis . Blood pressure ( BP ) changes were recorded continuously using an intra-arterial catheter . RESULTS The success rate of optimal intubation conditions increased with increasing doses of alfentanil . The alfentanil dose needed to obtain optimal intubation conditions in > 95 % of the patients was 36.4 ( CI 33.4 - 39.4 ) microg kg-1 . In 12 patients , the systolic BP declined to < 90 mm Hg during the 3 min immediately after intubation . CONCLUSION Adding 36 - 40 microg kg-1 alfentanil to a regimen of thiopentone and rocuronium during RSI of anaesthesia may significantly increase the success rate of optimal intubation conditions . Significant hypotension requiring vasopressor treatment may occur 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 In three groups of 20 patients , anaesthetized with propofol and alfentanil , tracheal intubation conditions and the onset of neuromuscular blockade after administration of three different doses of mivacurium chloride ( 0.11 , 0.15 , and 0.19 mg/kg=1.5 × ED95 2. × ED95 , and 2.5 × ED95 ) were assessed . Intubation conditions were found to be clinical ly acceptable ( good or excellent ) in 83 % of patients . Eighty‐two per cent of patients were successfully intubated on the first attempt after 60–90 s. No difference in intubation scores or number of intubation attempts among the three dosage groups were found . We conclude that mivacurium chloride allows smooth intubation in most patients within 60 90 s , even with the lowest dose ( 0.11 mg/kg ) , after a propofol‐alfentanil induction of anaesthesia . However , because there were a few patients in whom intubating conditions were inadequate at 60–90 s , we are reluctant to advocate the preference of mivacurium chloride over suxamethonium for rapid sequence induction in emergency situations OBJECTIVE To compare the clinical conditions for intubation and neuromuscular parameters after a high dose of mivacurium ( 0.25 mg/kg ; 3 x SD95 ) administered in 30 s to those obtained after use of the usual dose of succinylcholine ( 1 mg/kg ) . PATIENTS AND METHODS Eighty-two patients , 37 in the succinylcholine group and 45 in the mivacurium group , were studied . Intubating conditions were assessed on a scale of 3 to 12 points analyzing ease of laryngoscopy , relaxation of vocal cords and presence of cough 60 seconds after administration of the drug . Neuromuscular parameters were acceleration of the thumb induced by supramaximal train-of-four stimulation of the cubital nerve . Heart rate and non-invasive mean blood pressure were recorded throughout surgery . Cutaneous flush was looked for after administration of the relaxant . RESULTS Time to onset of effect ( 159 s versus 82 s ) and times to recovery after mivacurium were significantly longer than with succinylcholine . Mivacurium afforded excellent/good conditions for intubation in 95.6 % of cases , with a neuromuscular blockade at intubation of 52.68 % . No significant hemodynamic changes or side effects were observed . CONCLUSIONS Given the moderate conditions of intubation achieved at 60 s , mivacurium can not be recommended as a relaxant in situations that require a rapid induction sequence . In elective surgery , 0.25 mg/kg of mivacurium can , however , be considered an alternative to succinylcholine Purpose To compare equi-lasting doses of a short-acting ( mivacurium ) to an intermediate-acting ( rocuronium ) neuromuscular relaxant , with regard to intubating conditions , efficacy , number of maintenance doses , hemodynamic alterations , adverse events and costs , in patients undergoing laparoscopic gynecological surgery . Methods Sixty patients were r and omly allocated to receive either 0.2 mg·kg−1 ( 3 × ED95 ) mivacurium or 0.5 mg·kg−1 ( 1.7 × ED95 ) rocuronium , under propofol/fentanyl anesthesia . TI , first twitch of the train-of-four ( TOF ) and TOF ratio ( T4:TI ) were used to evaluate neuromuscular block using the Relaxometer ® mechanomyograph . The trachea was intubated when TI was maximally suppressed . Neuromuscular block was maintained at 25 % TI with equi-lasting doses of 0.075 mg·kg−1 mivacurium or 0 . 15 mg·kg−1 rocuronium . Results Mean ( min ) ± SD mivacurium onset time ( 1.9 ± 0.4 ) was longer than that of rocuronium ( 1.3 ± 0.3 ) . This did not yield a statistical difference in intubating conditions between the two groups . Interval 25–75 % TI recovery and time to 0.8 TOF recovery were prolonged following rocuronium ( 11.9 ± 3.9 , 52.6 ± 15.5 respectively ) compared to mivacurium ( 6.7 ± 2.3 , 39.2 ± 8 . 1 respectively ) . More patients , 22/30 , required mivacurium maintenance doses compared to 14/30 patients in the rocuronium group . Arterial blood pressure declined and 13/30 patients manifested erythema following mivacurium administration . The acquisition costs of rocuronium ( 6.93 Euro/patient ) were 23 % lower compared to mivacurium ( 8.96 Euro/patient ) . Conclusion Equi-lasting doses of rocuronium result ed in favourable intubating conditions more rapidly , improved hemodynamic stability , required less frequent administration of maintenance doses and were not associated with erythema , compared to mivacurium . RésuméObjectifComparer des doses de durée équivalente d’un myorelaxant à action brève , le mivacurium à celles d’un myorelaxant à effet intermédiaire , le rocuronium , quant aux conditions de l’intubation , l’efficacité , le nombre de doses de maintien , les changements hémodynamiques , les incidents et le coût , chez des patientes qui subissent une laparoscopie gynécologique . MéthodeSoixante patientes ont été réparties au hasard et ont reçu , soit 0,2 mg·kg−1 ( 3 × ED95 ) de mivacurium , soit 0,5 mg·kg−1 ( 1,7 × ED95 ) de rocuronium , sous une anesthésie au propofol et au fentanyl . TI , première stimulation d’un train-de-quatre ( TDQ ) et le ratio du TDQ ( T4 : TI ) ont permis d’évaluer la curarisation avec un relaxomécanomyographe . L’intubation a été réalisée après la suppression maximale de TI . La curarisation a été maintenue à 25 % de TI par des doses de durée équivalente de 0,075 mg·kg−1 de mivacurium ou de 0,15 mg·kg−1 de rocuronium . RésultatsLe délai d’installation moyen ( min ) [ ± l’écart type ] du mivacurium ( 1,9 ± 0,4 ) a été plus long que celui du rocuronium ( 1,3 ± 0,3 ) . Ce résultat ne fournit pas de différence statistique intergroupe . La récupération dans l’intervalle 25–75 % TI et le temps nécessaire à la récupération à 0,8 du TDQ se sont prolongés avec le rocuronium ( 11,9 ± 3,9 , 52,6 ± 15,5 respectivement ) comparé au mivacurium ( 6,7 ± 2,3 , 39,2 ± 8,1 respectivement ) . Un plus gr and nombre de patientes , 22/30 , ont eu besoin de doses de maintien de mivacurium , comparativement à 14/30 patientes ayant reçu du rocuronium . La tension artérielle a baissé et 13/30 patientes ontmanifesté de l’érythème à la suite de l’administration de mivacurium . Le coût d’achat du rocuronium ( 6,93 Euros/patiente ) a été de 23 % plus bas que celui du mivacurium ( 8,96 Euros/patiente ) . Conclusion Des doses de durée équivalente de rocuronium , comparé au mivacurium , ont permis une intubation plus précoce , amélioré la stabilité hémodynamique , exigé des doses de maintien moins fréquentes et n’ont pas été associées à un érythème We have studied the effects of mivacurium after induction of anaesthesia with alfentanil-propofol in healthy adult oral surgical patients . Anaesthesia was maintained with nitrous oxide and 0.75 % ( end-tidal ) enflurane in oxygen after nasotracheal intubation . Recordings were made of the rectified compound adductor pollicis electromyogram in response to train-of-four ( TOF ) ulnar nerve stimulation . First and fourth TOF responses were defined as T1 and T4 , with T1 suppression referenced to pre-mivacurium T1 height ( Tc ) . Onset times ( mean ( SEM ] to 90 % T1 suppression were 2.5 ( 0.2 ) , 2.1 ( 0.3 ) and 1.6 ( 0.1 ) min , respectively , after mivacurium 0.15 mg kg-1 ( n = 18 ) and 0.2 mg kg-1 ( n = 18 ) as 5-s boluses and 0.2 mg kg-1 over 30 s ( n = 9 ) . Intubating conditions 2 min after 0.15 mg kg-1 were good to excellent and not improved by a further 30-s delay or by use of a 0.2-mg kg-1 dose . Recovery to T1/Tc of 5 % occurred on average in 12 - 13 min irrespective of dose . Thereafter , mivacurium infusions commenced at 8 - 10 micrograms kg-1 min-1 were adjusted at intervals of at least 3 min to achieve T1/Tc in the range 1 - 10 % . Mean duration of infusion was 58 ( 3.4 ) min and mean infusion rate after a 15-min stabilization period was 6.6 ( range 2.3 - 12.9 ) micrograms kg-1 min-1 . On cessation of infusions , spontaneous recovery from T1/Tc 8 % ( 1.0 % ) to T4:T1 = 0.7 took 17 ( 1.2 ) min . Neostigmine 0.04 mg kg-1 or edrophonium 0.75 mg kg-1 evoked recovery from T1/Tc 9 % ( SEM 1.2 % and 1.0 % , respectively ) to T4:T1 = 0.7 in 11 ( 0.6 ) and 8 ( 0.9 ) min ( both P less than 0.001 vs spontaneous recovery ) We have studied the effects of mivacurium after induction of anesthesia with fentanyl-propofol in healthy adult women . Anesthesia was maintained with nitrous oxide in oxygen and continuous infusion of propofol ( 6 - 10 mg/kg/hr . ) . A myorelaxograph ( Date x NMT 100 ) measuring the responses of the adductor pollicis to Train of Four ( TOF ) stimulations of the ulnar nerve was installed after induction . Three bolus dosages of mivacurium were administered just after induction : 0.15 mg/kg ( group A ) , 0.17 mg/kg ( group B ) and 0.19 mg/kg ( group C ) . Intubation was attempted at 75 % TI-suppression . The conditions of intubation were good to excellent in the three groups except for one patient in group A ( 0.15 mg/kg ) . Successful intubation was performed faster in group C(p = 0.017 )
Output:
| We conclude that good conditions for tracheal intubation are more likely by delaying laryngoscopy after injecting a higher dose of mivacurium with an opioid , particularly in older people |
MS212709 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Summary Objective Several reports have shown that despite the informed consent process , enrolled patients misunderst and the modalities and goals of r and omized clinical trials ( RCTs ) . We believe that this may be linked to a priori misconceptions in the main population . The purpose of this study is to compare the knowledge about cancer RCTs in enrolled participants ( cases ) versus patients treated under cancer st and ard care who have never taken part in RCTs ( controls ) . Methods We su bmi tted a vali date d question naire ( ICEC-R ) to both population s to explore their knowledge about RCTs . A total of 75 cases and 107 controls were included . Results Globally , the cases ’ knowledge was significantly better , especially about ( i ) the r and omization process , ( ii ) the uncertain potential benefits , and ( iii ) the right to withdraw consent . Both population s presented the lowest scores for items exploring the r and omization process and uncertain treatment benefits . Conclusion Enrolled patients ’ comprehension of the goals and means of RCTs is actually better than controls ’ . Nevertheless , additional efforts should be made to enhance information about clinical research to patients as well as to the main population . Practice Implication s Having better knowledge about patients ’ difficulties in underst and ing RCTs would allow physicians to adjust the information they give and then to enhance patients ’ well-being We attempted to characterize the motivation , comprehension and expectations of patients who had given informed consent to participate in phase I trials of anti-cancer agents at the National Cancer Center of Japan . Thirty-three patients were given a simple multiple-choice question naire and asked to return it at a later date . The completed survey was returned by 32 patients . The patients were surveyed before they had received any investigational phase I agents . Nineteen per cent of patients were motivated to participate in the phase I trials by the possibility of therapeutic benefit , 9 % because participation seemed a better choice than no treatment and only 6 % for altruistic reasons . Most patients comprehended the major features of a phase I trial , namely its investigational nature , the unknown effects of the agent investigated and the unclear benefit to the patients themselves . Fifty-nine per cent of the patients anticipated that they might suffer severe or life-threatening side-effects if they participated in the phase I trial , and 43 % were able to indicate accurately the purpose of the phase I trial as a dose determination study . Although only a minority of the patients indicated that their motivation to participate was possible treatment benefit to themselves , when answering questions regarding expectations , more than half indicated that there might be personal benefits of varying degrees by participation Background and aim : As non-r and omised studies have suggested that surgical decompression may reduce mortality in patients with space occupying hemispheric infa rct ion , r and omisation may be considered unethical in controlled trials testing this treatment strategy . We studied differences in recall of information and in appreciation of the informed consent procedure between representatives included in the Hemicraniectomy After Middle cerebral artery infa rct ion with Life-threatening Edema Trial ( HAMLET ) and representatives of patients participating in the r and omised trial of Paracetamol ( Acetaminophen ) In Stroke ( PAIS ) . Methods : 1 year after study inclusion , we contacted 30 consecutive representatives who had given informed consent for participation of their relative in HAMLET , and 30 for PAIS . Recall of trial details and appreciation of the informed consent procedure were investigated using st and ardised question naires and compared between the two groups . Results : All 30 PAIS representatives and 28 HAMLET representatives were interviewed . Participation of their relative in a clinical trial was remembered by 86 % of HAMLET and 40 % of PAIS representatives ( p<0.001 ) . HAMLET representatives remembered more trial details ( effect of the treatment under study ( 61 % vs 3 % , p<0.001 ) ; r and omised treatment allocation ( 71 % vs 0 % , p<0.001 ) ) . With respect to appreciation of the informed consent procedure , we found no differences between the groups : in each trial , four representatives ( 14 % vs 13 % ) had considered the question of r and omisation unacceptable . Conclusions : Participation of patients in a r and omised controlled trial of surgical decompression for space occupying infa rct ion is generally considered acceptable by their representatives , and recall of trial details is better than in a trial in which less vital issues are at stake Background : R and omised controlled trials of interventions in critical situations are necessary to establish safety and evaluate outcomes . Pregnant women have been identified as a potentially vulnerable population . Objective : To explore women ’s experiences of being recruited to ORACLE , a r and omised controlled trial of antibiotics in pre-term labour . Methods : Twenty qualitative interviews were conducted with women who had participated in ORACLE . Analysis was based on the constant comparative method . Results : Women gave prominence to the socioemotional aspects of their interactions with healthcare professionals in making decisions on trial participation . Comments on the quality of written and spoken information were generally favourable , but women ’s accounts suggest that the stressful nature of the situation affected their ability to absorb the information . Women generally had poor underst and ing of trial design and practice s. The main motivation for trial participation was the possibility of an improved outcome for the baby . The second and less prominent motivation was the opportunity to help others , but this was conditional on there being no risks associated with trial participation . In judging the risks of participation , women seemed to draw on “ common sense ” underst and ings including a perception that antibiotics were risk free . Discussion : Recruitment to trials in critical situations raises important questions . Future studies should explore how rigorous governance arrangements for trials , particularly in critical situations , can protect participants rather than relying on ideals of informed consent that may be impossible to achieve . Future research should include a focus on interactions between research c and i date s and professionals involved in recruitment BACKGROUND : Consent for participation in clinical research is considered valid if it is informed , understood , and voluntary . In the case of minors , parents give permission for their child to participate in research studies after being presented with all information needed to make an informed decision . Although informed consent is a vital component of clinical research , there is little information evaluating its validity in neonatal intensive-care population s. The objective of this project was to determine the validity of informed consent obtained from parents of infants enrolled in the multicenter r and omized research study , neurologic outcomes and pre-emptive analgesia in the neonate ( NEOPAIN ) . DESIGN / METHODS : Parents of infants who survived to discharge and had signed consent for their newborn to participate in the NEOPAIN study at the University of Kentucky were asked 20 open-ended questions to determine their level of underst and ing about the NEOPAIN study . The NEOPAIN consent form , which had been approved by the University of Kentucky Medical Institutional Review Board ( IRB ) , was used to formulate these questions . Questions addressed the timing of consent , parental underst and ing of the purpose , benefits , and risks of the study , the voluntary nature of the project , and their willingness to enroll in future studies if the opportunity presented . Answers were scored on a Likert scale , with 1 for no underst and ing and 5 for complete underst and ing . RESULTS : Five of 64 parents ( 7.8 % ) had no re collection of the NEOPAIN study or of signing consent . Of those who remembered the study , only 67.8 % understood the purpose of the study , with a higher proportion of the mothers than fathers knowing the purpose of the study ( 73.3 % vs 57.1 % ) , ( p=0.029 ) . Of those who understood the purpose of the study 95 % were able to verbalize the benefits , but only 5 % understood any potential risks . No parents reported feeling pressured or coerced to sign consent for the project and all parents reported they would enroll their child in additional studies if asked . CONCLUSIONS : Valid consent in the antenatal/perinatal population is difficult , if not impossible , to obtain . To maximize validity of consent in the antenatal/perinatal population every effort should be made to include mothers in the consent process . Additional attention during the consent process should be given to possible risks of the study Background Informed consent ( IC ) has been an international st and ard for decades for the ethical conduct of clinical trials . Yet frequently study participants have incomplete underst and ing of key issues , a problem exacerbated by language barriers or lack of familiarity with research concepts . Few investigators measure participant comprehension of IC , while even fewer conduct interim assessment s once a trial is underway . Methods and Findings We assessed comprehension of IC using a 20- question true/false quiz administered in 6-month intervals in the context of a placebo-controlled , r and omized trial for the prevention of tuberculosis among HIV-infected adults in Botswana ( 2004–2009 ) . Quizzes were offered in both Setswana and English . To enroll in the TB trial , participants were required to have ≥16/20 correct responses . We examined concepts understood and the degree to which underst and ing changed over three-years . We analyzed 5,555 quizzes from 1,835 participants . The participants ' highest education levels were : 28 % primary , 59 % secondary , 9 % tertiary and 7 % no formal education . Eighty percent of participants passed the enrollment quiz ( Quiz1 ) on their first attempt and the remainder passed on their second attempt . Those having higher than primary education and those who took the quiz in English were more likely to receive a passing score on their first attempt ( adjusted odds ratios and 95 % confidence intervals , 3.1 ( 2.4–4.0 ) and 1.5 ( 1.2 , 1.9 ) , respectively ) . The trial 's purpose or procedures were understood by 90–100 % of participants , while 44–77 % understood r and omization , placebos , or risks . Participants who failed Quiz1 on their initial attempt were more likely to fail quizzes later in the trial . Pass rates improved with quiz re-administration in subsequent years . Conclusions Administration of a comprehension quiz at enrollment and during follow-up was feasible in a large , international collaboration and efficiently determined IC comprehension by trial participants . Strategies to improve underst and ing of concepts like placebos and r and omization are needed . Comprehension assessment s throughout a study may reinforce key concepts In the Beta-blocker Heart Attack Trial ( BHAT ) a number of strategies were implemented to increase the probability of informed voluntary consent among survivors of an acute myocardial infa rct ion . To evaluate the subjects ' comprehension of the study , a bioethicist conducted in-depth home interviews with a r and om sample of 64 participants from 11 geographic areas . The great majority of respondents proved to be well informed about the study design , its scientific logic , and possible risks of the experimental drug . However , five subjects ( 8 % of the sample ) appeared to believe they were involved in a therapeutic program rather than a research project . The analysis of predictor variables indicates that education , race , and age were associated with the degree of respondent awareness of fundamental aspects of the trial Background : In patients with acute life threatening diseases , and in their relatives , the ability to make a balanced decision on participation in a clinical trial may be impaired . Objectives : To assess what relevant information could be recalled by patients who were living independently after a subarachnoid haemorrhage , and by their relatives ; and to determine how these patients and relatives had reacted to the informed consent encounter . Methods : Twenty months ( range 7 to 31 ) after treatment for subarachnoid haemorrhage , 49 patients and 47 relatives who had participated in one of two r and omised trials on medical management were interviewed . The interview consisted of items on : spontaneous recall and knowledge of trial design ; underst and ing of the trial design and the informed consent procedure ; the amount and clarity of the information given ; and reasons for participating . Finally patients and relatives were asked whether they would participate again in similar circumstances . Results : One third of the patients recalled having participated in a clinical trial . Thirteen per cent of the patients and 20 % of the relatives felt that the information supplied had not been sufficient . Nine per cent of the patients and half the relatives had read the written information . None of the patients and one relative thought that participation had been obligatory . Twenty eight per cent of the patients and 94 % of the relatives felt in retrospect that they had been capable of making an adequate decision . Virtually all patients and relatives would participate again in similar circumstances . Conclusions : Many patients and their relatives have little recall of the informed consent procedure and the essentials of acute subarachnoid haemorrhage trials . However , most were satisfied with the overall procedure and would participate again Background and objectives : There are few insights from sub-Saharan Africa on research participants ’ experiences of the informed consent process , particularly in the context of r and omised controlled trials , where issues of r and omisation and the use of placebos may be confusing concepts for participants . This study investigated the knowledge and perceptions of the informed consent process among individuals participating in influenza vaccine trials in two disadvantaged communities in South Africa . Method : Four to 12 months after completion of the trials , participants were contacted to return to participate in the informed consent study . The semistructured question naire administered to assess recall of trial procedures and the informed consent process covered key issues including : purpose of the study ; awareness that the study was not part of routine treatment ; voluntary nature of participation and freedom to withdraw ; r and omisation ; placebos ; and remuneration . Results : A total of 334 participants ( 93 % of the original vaccine trial sample ; mean age 68 years , median level of education grade 8 , 69 % women ) completed the question naire . Only 21 % were able to recall that they were allocated r and omly to the different treatment arms . Only 19 % of those involved in the placebo controlled study had interpreted the concept of placebo as an inactive medication . Conclusion : Although a good general recall of trial concepts was demonstrated , only a small proportion of the participants correctly interpreted and recalled the concepts of r and omisation and placebos . Informed consent in this and similarly disadvantaged communities may often be inadequate and new ways to improve underst and ing of the
Output:
| Investigators could do more to help participants achieve a complete underst and ing |
MS212710 | ***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 Cardiovascular disease is the major cause of death in hemodialysis patients . Regular aerobic or intradialytic exercise may play a role in reducing cardiovascular mortality in these patients . The aim of this study was to evaluate the relationship between intradialytic exercise and echocardiographic findings . METHODS AND MATERIAL S Forty patients were enrolled in the study from Shahrekord Hemodialysis Center . They were r and omly assigned into the exercise and control groups . In the exercise group , the patients had a 30-minute exercise program per dialysis session , 3 times a week , for 3 months . Electrocardiography and echocardiography were done at the beginning of the study and 3 months later . RESULTS The mean age and body mass index of the patients were 43.2 + /- 10.5 years and 21.7 + /- 5.4 kg/m2 , respectively . Left ventricular ejection fraction increased and systolic pulmonary artery pressure and right ventricular size decreased significantly after the study in the exercise group patients . CONCLUSIONS Our results showed the improvement of cardiac systolic and diastolic function in patients who had physical exercise during dialysis sessions . Regular intradialysis exercise can be suggested for hemodialysis patients without cardiac disease Objective To examine how poor reporting and inadequate methods for key method ological features in r and omised controlled trials ( RCTs ) have changed over the past three decades . Design Mapping of trials included in Cochrane review s. Data sources Data from RCTs included in all Cochrane review s published between March 2011 and September 2014 reporting an evaluation of the Cochrane risk of bias items : sequence generation , allocation concealment , blinding , and incomplete outcome data . Data extraction For each RCT , we extracted consensus on risk of bias made by the review authors and identified the primary reference to extract publication year and journal . We matched journal names with Journal Citation Reports to get 2014 impact factors . Main outcomes measures We considered the proportions of trials rated by review authors at unclear and high risk of bias as surrogates for poor reporting and inadequate methods , respectively . Results We analysed 20 920 RCTs ( from 2001 review s ) published in 3136 journals . The proportion of trials with unclear risk of bias was 48.7 % for sequence generation and 57.5 % for allocation concealment ; the proportion of those with high risk of bias was 4.0 % and 7.2 % , respectively . For blinding and incomplete outcome data , 30.6 % and 24.7 % of trials were at unclear risk and 33.1 % and 17.1 % were at high risk , respectively . Higher journal impact factor was associated with a lower proportion of trials at unclear or high risk of bias . The proportion of trials at unclear risk of bias decreased over time , especially for sequence generation , which fell from 69.1 % in 1986 - 1990 to 31.2 % in 2011 - 14 and for allocation concealment ( 70.1 % to 44.6 % ) . After excluding trials at unclear risk of bias , use of inadequate methods also decreased over time : from 14.8 % to 4.6 % for sequence generation and from 32.7 % to 11.6 % for allocation concealment . Conclusions Poor reporting and inadequate methods have decreased over time , especially for sequence generation and allocation concealment . But more could be done , especially in lower impact factor journals Background There is emerging evidence that exercise training could positively impact several of the cardiovascular risk factors associated with sudden cardiac death amongst patients on haemodialysis . The primary aim of this study is to evaluate the effect of an intradialytic exercise programme on left ventricular mass . Method and design Prospect i ve , r and omised cluster open-label blinded endpoint clinical trial in 130 patients with end stage renal disease on haemodialysis . Patients will be r and omised 1:1 to either 1 ) minimum of 30 min continuous cycling thrice weekly during dialysis or 2 ) st and ard care . The primary outcome is change in left ventricular mass at 6 months , assessed by cardiac MRI ( CMR ) . In order to detect a difference in LV mass of 15 g between groups at 80 % power , a sample size of 65 patients per group is required . Secondary outcome measures include abnormalities of cardiac rhythm , left ventricular volumes and ejection fraction , physical function measures , anthropometric measures , quality of life and markers of inflammation , with interim assessment for some measures at 3 months . Discussion This study will test the hypothesis that an intradialytic programme of exercise leads to a regression in left ventricular mass , an important non-traditional cardiovascular risk factor in end stage renal disease . For the first time this will be assessed using CMR . We will also evaluate the efficacy , feasibility and safety of an intradialytic exercise programme using a number of secondary end-points . We anticipate that a positive outcome will lead to both an increased patient uptake into established intradialytic programmes and the development of new programmes nationally and internationally . Trial registration numberIS RCT N11299707 ( registration date 5th March 2015 ) 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 . In a survival analysis , sedentary behavior ( hazard ratio , 1.62 ; 95 % confidence interval , 1.16 to 2.27 ) was associated with an increased risk for death at 1 year after adjusting for all variables that we postulated might be associated with survival and for differences between sedentary and nonsedentary patients . CONCLUSION Sedentary behavior is associated with an increased risk for mortality among dialysis patients similar in magnitude to that of other well-established risk factors , such as a one-point reduction in serum albumin concentration . More attention should be given to exercise behavior in dialysis patients , and controlled clinical trials are needed to further define the association of sedentary behavior with mortality Blinding embodies a rich history spanning over two centuries . Most research ers worldwide underst and blinding terminology , but confusion lurks beyond a general comprehension . Terms such as single blind , double blind , and triple blind mean different things to different people . Moreover , many medical research ers confuse blinding with allocation concealment . Such confusion indicates misunderst and ings of both . The term blinding refers to keeping trial participants , investigators ( usually health-care providers ) , or assessors ( those collecting outcome data ) unaware of the assigned intervention , so that they will not be influenced by that knowledge . Blinding usually reduces differential assessment of outcomes ( information bias ) , but can also improve compliance and retention of trial participants while reducing biased supplemental care or treatment ( sometimes called co-intervention ) . Many investigators and readers naïvely consider a r and omised trial as high quality simply because it is double blind , as if double-blinding is the sine qua non of a r and omised controlled trial . Although double blinding ( blinding investigators , participants , and outcome assessors ) indicates a strong design , trials that are not double blinded should not automatically be deemed inferior . Rather than solely relying on terminology like double blinding , research ers should explicitly state who was blinded , and how . We recommend placing greater credence in results when investigators at least blind outcome assessment s , except with objective outcomes , such as death , which leave little room for bias . If investigators properly report their blinding efforts , readers can judge them . Unfortunately , many articles do not contain proper reporting . If an article cl aims blinding without any accompanying clarification , readers should remain sceptical about its effect on bias reduction Background / Aims : Patients requiring haemodialysis have cardiovascular and immune dysfunction . Little is known about the acute effects of exercise during haemodialysis . Exercise has numerous health benefits but in other population s has a profound impact upon blood pressure , inflammation and immune function ; therefore having the potential to exacerbate cardiovascular and immune dysfunction in this vulnerable population . Methods : Fifteen patients took part in a r and omised-crossover study investigating the effect of a 30-min bout of exercise during haemodialysis compared to resting haemodialysis . We assessed blood pressure , plasma markers of cardiac injury and systemic inflammation and neutrophil degranulation . Results : Exercise increased blood pressure immediately post-exercise ; however , 1 hour after exercise blood pressure was lower than resting levels ( 106±22 vs. 117±25 mm Hg ) . No differences in h-FABP , cTnI , myoglobin or CKMB were observed between trial arms . Exercise did not alter circulating concentrations of IL-6 , TNF-α or IL-1ra nor clearly suppress neutrophil function . Conclusions : This study demonstrates fluctuations in blood pressure during haemodialysis in response to exercise . However , since the fall in blood pressure occurred without evidence of cardiac injury , we regard it as a normal response to exercise superimposed onto the haemodynamic response to haemodialysis . Importantly , exercise did not exacerbate systemic inflammation or immune dysfunction ; intradialytic exercise was well tolerated Abstract Inflammation , endothelial dysfunction , and mineral bone disease are critical factors contributing to morbidity and mortality in hemodialysis ( HD ) patients . Physical exercise alleviates inflammation and increases bone density . Here , we investigated the effects of intradialytic aerobic cycling exercise on HD patients . Forty end-stage renal disease patients undergoing HD were r and omly assigned to either an exercise or control group . The patients in the exercise group performed a cycling program consisting of a 5-minute warm-up , 20 minutes of cycling at the desired workload , and a 5-minute cool down during 3 HD sessions per week for 3 months . Biochemical markers , inflammatory cytokines , nutritional status , the serum endothelial progenitor cell ( EPC ) count , bone mineral density , and functional capacity were analyzed . After 3 months of exercise , the patients in the exercise group showed significant improvements in serum albumin levels , the body mass index , inflammatory cytokine levels , and the number of cells positive for CD133 , CD34 , and kinase insert domain-conjugating receptor . Compared with the exercise group , the patients in the control group showed a loss of bone density at the femoral neck and no increases in EPCs . The patients in the exercise group also had a significantly greater 6-minute walk distance after completing the exercise program . Furthermore , the number of EPCs significantly correlated with the 6-minute walk distance both before and after the 3-month program . Intradialytic aerobic cycling exercise programs can effectively alleviate inflammation and improve nutrition , bone mineral density , and exercise tolerance in HD patients Cardiovascular ( CV ) disease is the most common cause of mortality in end‐stage kidney disease ( ESKD ) , and arterial stiffness , measured by pulse wave velocity ( PWV ) , is an independent predictor of all‐cause and CV mortality . B‐type natriuretic peptide ( BNP ) levels are high in patients with CV disease and ESKD , and increases in BNP may also be a marker of CV risk
Output:
| Conclusions There is insufficient evidence demonstrating whether cycling exercise during HD improves patient outcomes . |
MS212711 | ***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 comparative effectiveness of treatments for prostate cancer that is detected by prostate-specific antigen ( PSA ) testing remains uncertain . METHODS We compared active monitoring , radical prostatectomy , and external-beam radiotherapy for the treatment of clinical ly localized prostate cancer . Between 1999 and 2009 , a total of 82,429 men 50 to 69 years of age received a PSA test ; 2664 received a diagnosis of localized prostate cancer , and 1643 agreed to undergo r and omization to active monitoring ( 545 men ) , surgery ( 553 ) , or radiotherapy ( 545 ) . The primary outcome was prostate-cancer mortality at a median of 10 years of follow-up . Secondary outcomes included the rates of disease progression , metastases , and all-cause deaths . RESULTS There were 17 prostate-cancer-specific deaths overall : 8 in the active-monitoring group ( 1.5 deaths per 1000 person-years ; 95 % confidence interval [ CI ] , 0.7 to 3.0 ) , 5 in the surgery group ( 0.9 per 1000 person-years ; 95 % CI , 0.4 to 2.2 ) , and 4 in the radiotherapy group ( 0.7 per 1000 person-years ; 95 % CI , 0.3 to 2.0 ) ; the difference among the groups was not significant ( P=0.48 for the overall comparison ) . In addition , no significant difference was seen among the groups in the number of deaths from any cause ( 169 deaths overall ; P=0.87 for the comparison among the three groups ) . Metastases developed in more men in the active-monitoring group ( 33 men ; 6.3 events per 1000 person-years ; 95 % CI , 4.5 to 8.8 ) than in the surgery group ( 13 men ; 2.4 per 1000 person-years ; 95 % CI , 1.4 to 4.2 ) or the radiotherapy group ( 16 men ; 3.0 per 1000 person-years ; 95 % CI , 1.9 to 4.9 ) ( P=0.004 for the overall comparison ) . Higher rates of disease progression were seen in the active-monitoring group ( 112 men ; 22.9 events per 1000 person-years ; 95 % CI , 19.0 to 27.5 ) than in the surgery group ( 46 men ; 8.9 events per 1000 person-years ; 95 % CI , 6.7 to 11.9 ) or the radiotherapy group ( 46 men ; 9.0 events per 1000 person-years ; 95 % CI , 6.7 to 12.0 ) ( P<0.001 for the overall comparison ) . CONCLUSIONS At a median of 10 years , prostate-cancer-specific mortality was low irrespective of the treatment assigned , with no significant difference among treatments . Surgery and radiotherapy were associated with lower incidences of disease progression and metastases than was active monitoring . ( Funded by the National Institute for Health Research ; ProtecT Current Controlled Trials number , IS RCT N20141297 ; Clinical Trials.gov number , NCT02044172 . ) BACKGROUND The absence of trial data comparing robot-assisted laparoscopic prostatectomy and open radical retropubic prostatectomy is a crucial knowledge gap in uro-oncology . We aim ed to compare these two approaches in terms of functional and oncological outcomes and report the early postoperative outcomes at 12 weeks . METHOD In this r and omised controlled phase 3 study , men who had newly diagnosed clinical ly localised prostate cancer and who had chosen surgery as their treatment approach , were able to read and speak English , had no previous history of head injury , dementia , or psychiatric illness or no other concurrent cancer , had an estimated life expectancy of 10 years or more , and were aged between 35 years and 70 years were eligible and recruited from the Royal Brisbane and Women 's Hospital ( Brisbane , QLD ) . Participants were r and omly assigned ( 1:1 ) to receive either robot-assisted laparoscopic prostatectomy or radical retropubic prostatectomy . R and omisation was computer generated and occurred in blocks of ten . This was an open trial ; however , study investigators involved in data analysis were masked to each patient 's condition . Further , a masked central pathologist review ed the biopsy and radical prostatectomy specimens . Primary outcomes were urinary function ( urinary domain of EPIC ) and sexual function ( sexual domain of EPIC and IIEF ) at 6 weeks , 12 weeks , and 24 months and oncological outcome ( positive surgical margin status and biochemical and imaging evidence of progression at 24 months ) . The trial was powered to assess health-related and domain-specific quality of life outcomes over 24 months . We report here the early outcomes at 6 weeks and 12 weeks . The per- protocol population s were included in the primary and safety analyses . This trial was registered with the Australian New Zeal and Clinical Trials Registry ( ANZCTR ) , number ACTRN12611000661976 . FINDINGS Between Aug 23 , 2010 , and Nov 25 , 2014 , 326 men were enrolled , of whom 163 were r and omly assigned to radical retropubic prostatectomy and 163 to robot-assisted laparoscopic prostatectomy . 18 withdrew ( 12 assigned to radical retropubic prostatectomy and six assigned to robot-assisted laparoscopic prostatectomy ) ; thus , 151 in the radical retropubic prostatectomy group proceeded to surgery and 157 in the robot-assisted laparoscopic prostatectomy group . 121 assigned to radical retropubic prostatectomy completed the 12 week question naire versus 131 assigned to robot-assisted laparoscopic prostatectomy . Urinary function scores did not differ significantly between the radical retropubic prostatectomy group and robot-assisted laparoscopic prostatectomy group at 6 weeks post-surgery ( 74·50 vs 71·10 ; p=0·09 ) or 12 weeks post-surgery ( 83·80 vs 82·50 ; p=0·48 ) . Sexual function scores did not differ significantly between the radical retropubic prostatectomy group and robot-assisted laparoscopic prostatectomy group at 6 weeks post-surgery ( 30·70 vs 32·70 ; p=0·45 ) or 12 weeks post-surgery ( 35·00 vs 38·90 ; p=0·18 ) . Equivalence testing on the difference between the proportion of positive surgical margins between the two groups ( 15 [ 10 % ] in the radical retropubic prostatectomy group vs 23 [ 15 % ] in the robot-assisted laparoscopic prostatectomy group ) showed that e quality between the two techniques could not be established based on a 90 % CI with a Δ of 10 % . However , a superiority test showed that the two proportions were not significantly different ( p=0·21 ) . 14 patients ( 9 % ) in the radical retropubic prostatectomy group versus six ( 4 % ) in the robot-assisted laparoscopic prostatectomy group had postoperative complications ( p=0·052 ) . 12 ( 8 % ) men receiving radical retropubic prostatectomy and three ( 2 % ) men receiving robot-assisted laparoscopic prostatectomy experienced intraoperative adverse events . INTERPRETATION These two techniques yield similar functional outcomes at 12 weeks . Longer term follow-up is needed . In the interim , we encourage patients to choose an experienced surgeon they trust and with whom they have rapport , rather than a specific surgical approach . FUNDING Cancer Council Queensl and Background Few studies to date have directly compared outcomes of retropubic ( RRP ) and laparoscopic ( LRP ) radical prostatectomy . We investigated a single institution experience with RRP and LRP with respect to functional and pathological outcomes . Methods 168 patients who underwent RRP were compared to 171 patients who underwent LRP at our institution . Pathological and functional outcomes including postoperative urinary incontinence and erectile dysfunction ( ED ) of the two cohorts were examined . Results Patients had bilateral , unilateral and no nerve sparing technique performed in 83.3 % , 1.8 % and 14.9 % of cases for RRP and 23.4 % , 22.8 % and 53.8 % of cases for LRP , respectively ( p < 0.001 ) . Overall positive surgical margin rates were 22.2 % among patients who underwent RRP compared to 26.5 % of patients who underwent LRP ( p = 0.435 ) . Based upon pads/day , urinary continence postoperatively was achieved in 83.2 % and 82.8 % for RRP and LRP , respectively ( p = 0.872 ) . Analysis on postoperative ED was limited due to lack of information on the preoperative erectile status . However , postoperatively there were no differences with respect to ED between the two cohorts ( p = 0.151 ) . Based on ICIQ-scores , surgeons with more experience had lower rates of postoperative incontinence irrespective of surgical technique ( p = 0.001 and p < 0.001 for continuous and stratified data , respectively ) . Conclusions RRP and LRP represent effective surgical approaches for the treatment of clinical ly localized prostate cancer . Pathological outcomes are excellent for both surgical techniques . Functional outcomes including postoperative urinary incontinence and ED are comparable between the cohorts . Surgeon experience is more relevant than surgical technique applied PURPOSE We prospect ively evaluated the morbidity , and minor and major complications of laparoscopic radical prostatectomy performed by a single surgical team . MATERIAL S AND METHODS Between January 28 , 1998 and February 28 , 2001 , 567 patients 42 to 77 years old ( mean age plus or minus st and ard deviation 63.5 + /- 6 ) with clinical ly localized prostate cancer underwent laparoscopic radical prostatectomy , including 458 ( 80.6 % ) , without lymphadenectomy . Mean body mass index was 25.3 + /- 2.9 ( range 17.3 to 37.5 ) . American Society of Anesthesiologists score was 1 to 3 in 65 % , 27 % and 8 % of cases , respectively . A total of 12 patients ( 2.1 % ) had undergone intra-abdominal surgery below the mesocolon and 40 had undergone urological surgery . Intraoperative and postoperative data were recorded as well as all complications and their severity score within the initial 30 days postoperatively . RESULTS A total of 105 complications were observed in 97 patients ( 17.1 % ) , including 21 major ( 3.7 % ) and 83 minor ( 14.6 % ) complications . Of the patients 21 ( 3.7 % ) underwent reoperation for a postoperative complication , including 10 ( 1.76 % ) who required an intensive care unit stay . Seven cases ( 1.2 % ) were converted to conventional retropubic radical prostatectomy . Mean blood loss was 380 + /- 195 ml . and the overall transfusion rate was 4.9 % . In 2 patients ( 0.3 % ) deep vein thrombosis was associated with another surgical complication but not with pulmonary embolism . Urological , bowel and hemorrhagic complications represented 66.6 % , 16.2 % and 7.6 % ( total 89.4 % ) of all complications , and 20 % , 33.3 % and 33.3 % of all repeat interventions , respectively . CONCLUSIONS Laparoscopic radical prostatectomy was performed according to the defined protocol with no complications in 82.9 % of patients . The morbidity of this approach compares favorably with that of retropubic surgery . Growing experience and knowledge sharing concerning the prevention and early management of these complications would make possible a further decrease in the morbidity of laparoscopic radical prostatectomy PURPOSE Given the lack of r and omized trials comparing robot-assisted radical prostatectomy ( RARP ) and open radical prostatectomy ( ORP ) , we sought to re-examine the outcomes of these techniques using a cohort of patients treated in the postdissemination era . PATIENTS AND METHODS Overall , data from 5,915 patients with prostate cancer treated with RARP or ORP within the SEER-Medicare linked data base diagnosed between October 2008 and December 2009 were abstract ed . Postoperative complications , blood transfusions , prolonged length of stay ( pLOS ) , readmission , additional cancer therapies , and costs of care within the first year after surgery were compared between the two surgical approaches . To decrease the effect of unmeasured confounders , instrumental variable analysis was performed . Multivariable logistic regression analyses were then performed . RESULTS Overall , 2,439
Output:
| There is no evidence to inform the comparative effectiveness of LRP or RARP compared with ORP for oncological outcomes .
Urinary and sexual quality of life appear similar .
Overall and serious postoperative complication rates appear similar .
The difference in postoperative pain may be minimal .
Men undergoing LRP or RARP may have a shorter hospital stay and receive fewer blood transfusions |
MS212712 | ***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 To evaluate whether the current European Association for Palliative Care recommendation regarding the starting dose of 5 mg of normal-release morphine ( NRM ) sulfate oral solution every 4 hours in opioid naive patients or 10 mg in patients already being treated with “ weak ” opioids is effective and could be proposed as starting routine dose in clinical practice . Secondary aims were to estimate the percentage of patients who were high responders to NRM and to study the association of baseline patient characteristics with both high analgesic responsivity and the need of opioid dose escalation . Methods Consecutive strong opioid-naive patients with cancer pain were enrolled in a multicenter uncontrolled phase 4 clinical trial . Oral NRM was administered at 2 different dosages : 5 and 10 mg every 4 hours , respectively , for opioids-naive ( group A ) and nonopioids-naive ( group B ) patients as starting therapy . Average daily dosages of NRM and opioid escalation index ( OEI ) were calculated and the reduction in pain score was tested through Student t test both in group A and in group B patients . Results One hundred fifty-nine consecutive patients were enrolled and data analysis was conducted on 151 ( 95 % ) patients . On an average the OEIs were : 3.2 in group A and 6.5 in group B and a significant reduction in pain score both after 3 and 5 days from baseline ( P<0.001 ) was shown in both groups . In multivariate analysis both Karnofsky Performance Status and episodic pain showed to be independent prognostic factors of a high analgesic response . The presence of neuropathic pain showed to be associated with a higher OEI . Discussion These data show that empiric st and ard doses of NRM during titration , recommended by European Association for Palliative Care , are effective in clinical practice To treat cancer pain , physicians often decide to jump directly from step 1 of the World Health Organization ( WHO ) analgesic ladder to step 3 . The use of transdermal fentanyl in patients with cancer pain who had either used no opioid before , or only codeine , is evaluated in the present trial . Both opioid-naive ( N = 14 ) and codeine-using ( N = 14 ) patients started with transdermal fentanyl in the lowest available delivery rate ( 25 microg/hr ) . Immediate-release oral morphine was present as " rescue " medication . Transdermal fentanyl provided good to excellent pain relief in the majority ( 68 % ) of these patients . During the study , 5 patients continued with 25 microg/hr , and the others used a higher dose . Clinical ly relevant respiratory depression was not observed . The common side effects of opioids were found ; constipation was mentioned by 3 patients ( 11 % ) . Transdermal fentanyl appeared a safe analgesic in these opioid-naive cancer pain patients . In this study , WHO step 2 could be skipped without untoward complications BACKGROUND In a multicenter study , 28 patients with cancer pain and insufficient pain relief with analgesic treatment according to step II of the guidelines of the World Health Organization ( WHO ) were switched to oral slow-release morphine . METHODS Patients received intravenous morphine through a patient-controlled pump ( PCA ) for the first 24 hours ( bolus = 1 mg , lockout interval = 5 minutes , maximum dose = 12 mg/hour ) . From day 2 patients were treated with oral slow-release morphine . Daily doses were calculated from the requirements of the day before . Breakthrough pain was treated with PCA until stable doses were reached ( < 2 boluses/day ) and then with oral immediate-release morphine solution . Pain intensity was reported in a diary four times a day , in addition to mood , activity , and quality of sleep once daily . RESULTS Mean duration until adequate pain relief reported ( < 30 on a 101-step numerical scale ; NRS ) was 5 hours ( range = 80 - 620 minutes ) . Mean pain intensity was reduced from 67 NRS to 22 NRS . Mean doses of oral morphine were 133 mg/day initially and then 154 mg/day on day 14 . Serious adverse events such as respiratory depression were not observed . Two patients terminated the study due to progressive symptoms of gastrointestinal obstruction . Seventy-five percent of the patients evaluated the effectiveness of the analgesic regime as good . CONCLUSIONS Dose finding with intravenous PCA may be appropriate for a small minority of patients with severe pain . Higher treatment costs and the risk of complications are drawbacks of this method compared with conventional oral titration & NA ; A titration procedure using immediate‐release morphine given 4‐hourly is recommended during start of oral morphine for cancer pain . This recommendation is not based on evidence from controlled studies , and many physicians start morphine treatment with controlled‐release morphine . We included 40 patients with malignant disease and pain despite treatment with opioids for mild to moderate pain in a r and omized , double‐blind , double‐dummy , parallel‐group study comparing titration with immediate‐release morphine given 4‐hourly with titration with sustained‐release morphine given once daily . The primary end point was the time needed to achieve adequate pain relief Secondary end points were other symptoms ( nausea , tiredness , lack of sleep , vertigo , appetite and constipation ) , health related quality of life and patient satisfaction . The mean times needed for titration were 2.1 ( 95 % CI ; 1.4–2.7 ) days using immediate‐release morphine and 1.7 ( 95 % CI ; 1.1–2.3 ) days using sustained‐release morphine . Patients titrated with immediate‐release reported statistically significant more tiredness at the end of titration . We observed no other differences in adverse effects or health related quality of life functions between the two treatments . Similar global satisfactions with the morphine treatments were reported . In conclusion , a simplified titration using sustained‐release morphine once daily is equally effective as immediate‐release morphine given 4‐hourly SUMMARY Objective : To determine the safety and efficacy of transdermal fentanyl for pain relief in cancer patients and to compare the effects on patients according to whether they had previously received strong opioids , weak opioids or non-opioid analgesia . Methods : Cancer patients requiring strong analgesia were recruited into an open-label , multicentre study , conducted in eight countries . Patients received transdermal fentanyl treatment for 28days . Pain severity , overall satisfaction with pain control , convenience of use of patches and treatment preferences were recorded daily . Results : Of the 292 participants , 135 had previously received a strong opioid , 84 had previously received a weak opioid and 73 had received no regular opioids . Thirty-eight patients did not complete the study , mainly due to adverse events . For all groups the proportion of patients with ‘ good to excellent ’ pain control increased after transdermal fentanyl treatment . Transdermal fentanyl was well tolerated , with the most common treatment-related adverse events being nausea , vomiting and constipation . The percentage of strong-opioid-tolerant patients with constipation decreased following transdermal fentanyl treatment and increased slightly in the strong-opioid-naïve groups . Most patients rated the convenience of the patches as ‘ good to excellent ’ , and most preferred transdermal fentanyl to their previous therapy . Conclusions : Transdermal fentanyl is an effective and well-tolerated treatment for cancer-related pain for patients regardless of whether they have previously received opioids . Previous guidelines have often advocated initial dose finding with short-acting opioids but this study demonstrates that such a complex titration and conversion schedule may not be necessary , and that treatment may be initiated directly with long-acting formulations such as transdermal fentanyl when previous analgesic therapy fails to provide adequate relief BACKGROUND Considerable dose variations and frequent initial side effects have been postulated during start of morphine treatment to patients with pain caused by malignant disease . However , to our knowledge , only one previous study has reported effective doses in morphine naive cancer patients and no prospect i ve evaluation has compared symptoms before with symptoms during morphine titration . METHODS We recruited 40 cancer patients with uncontrolled pain despite receiving codeine or dextropropoxyphen . Baseline data were obtained for two days before start of morphine titration using a fixed scheduled escalation of immediate-release ( IR ) morphine . When a stable morphine dose was achieved , IR morphine was replaced with slow-release ( SR ) morphine in equivalent doses . Intensity of pain and side effects were assessed daily . The daily consumption of morphine , rescue analgesics and rescue antiemetics were registered . RESULTS The mean titration time to achieve adequate analgesia was 2.3 days ( range : 1 - 6 ) using a mean daily morphine dose of 97 mg ( range : 60 - 180 ) . Nausea was unaltered after start with morphine but an increased incidence of vomiting occurred ( premorphine period 5 % , IR morphine period 29 % ) . Transient sedation delayed dose increment in 9 of the 40 patients but mean sedation scores were unaltered . Constipation scores increased while other side effect scores were unaltered . Eighty-two percent of the patients were satisfied or very satisfied with the pain treatment during introduction of morphine . CONCLUSION In cancer patients with uncontrolled pain on weak opioids , successful titration of morphine is achieved fast , with a three-fold morphine dose variation and with little increase in side effects This report is a prospect i ve study of 223 patients with intractable cancer pain who were offered continuing care during the year 1988 at the Pain Relief Unit , Kidwai Memorial Institute of Oncology , Bangalore , India , with a minimum follow‐up of 4 months and a maximum follow‐up of 16 months . A high percentage of pain relief was attained within a mean duration of 4 days , which on follow‐up was maintained at a steady level in most patients ( 91.1 % ) . Oral morphine could not be continued in three patients because of vomiting . The main side effects noticed were nausea and vomiting , itching , and constipation . At any time during the first 140 days , only 30 % of patients had side effects and appropriate medication successfully managed these side effects . During the rest of the study period , the side effects were minimal . Oral morphine used with proper adjuncts offers the best pain palliation in most patients , with minimal side effects Initial dose finding in patients with cancer pain who are started on TTS fentanyl ( Duragesic , TTS-F ) is often unsatisfactory with currently recommended doses and intervals . Acknowledging that studies reveal a " psuedo steady state " 15 to 20 hr after application of TTS-F , we prospect ively investigated an increased initial dose and day-to-day titration of TTS-F in 39 ( evaluable ) patients with uncontrolled cancer pain . Significant pain reduction ( P = 0.001 ) was seen after 24 hr , and satisfactory analgesia was achieved within 48 h and maintained for the rest of the study . Significant increases in TTS-F were necessary during weeks 1 through 4 to maintain pain control . Forty-nine percent of the patients needed one or more early dose increases . Only one patient had side effects partially due to the specific properties of the TTS . Other side effects seemed to be less common compared with usual morphine treatment . TTS-F can be titrated effectively and safely on a day-to-day basis with an increased initial dose and adequate patient monitoring , thus avoiding more complicated approaches . TTS-F seemed to induce less constipation than might be expected This r and omized controlled trial compared intravenous route with oral route for initial dose titration of morphine in 62 patients with end-stage cancer and severe pain . Patients in the intravenous group received 1.5 mg intravenous bolus doses of morphine every ten minutes till pain relief was total or until they became drowsy . After that they got oral morphine at a dose equal to the total initial intravenous requirement four-hourly . Patients in the oral group got oral morphine 5 mg doses ( if opioid-naÖve ) or 10 mg ( if already on weak opioid ) four hourly . Patients in both groups had the option to receive rescue doses of their regular oral dose as and when needed , if necessary hourly . Twenty-seven of 31 in the intravenous group had either total or satisfactory pain relief by the end of one hour , whereas only eight of 31 in the oral group had a similar result . After 24 hours and later both groups had similar results . There was no immediate serious side effect in any of the patients . The late side effects were similar in the two groups . In the intravenous group , the ratio of initial intravenous dose requirement to the subsequent regular single oral dose after two days centred around 1:1 ( range 1:0.5 - 1:3.3 ) . This study found the intravenous method to be safe , effective and superior to the traditional method in providing immediate relief to severe cancer pain Abstract Objective : Moderate to severe pain is commonly experienced by cancer and non-cancer patients . Although opioids are generally the most important drugs in chronic pain management , their use in Italy remains low . We design ed a prospect i ve open trial to assess the efficacy and safety of a st and ard therapy clinical ly available for a large range of patients . Methods : A total of 172 consecutive patients ( 89 women and 83 men ) with chronic pain ( daily mean visual analogue scale ( VAS ) score > 4 ) that was not adequately managed by their existing pain regimen were enrolled to receive an immediate release ( IR ) dose of morphine : 30 mg/day ( opioid-naive patients ) or 60 mg/day ( non-naive patients ) for 5 days . After this period ( start therapy ) , all patients were switched to slow release ( SR ) opioid therapy for 30 days ( steady therapy ) . Each breakthrough pain ( BTP ) episode
Output:
| All treatment strategies result ed in acceptable pain control and were well tolerated . |
MS212713 | ***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: Recent reports and previous r and omized trials conducted at the authors ' institution suggested that children with lower risk febrile neutropenic ( LRFN ) may benefit from substitution of oral antibiotic therapy for parenteral therapy . The objective of this study was to determine the efficacy of parenteral‐oral outpatient therapy in the management of children with LRFN who were receiving treatment for malignant disease A prospect i ve , r and omized clinical trial was conducted to compare the efficacy of piperacillin/tazobactam and amikacin combination with carbapenem monotherapy for the empirical treatment of febrile neutropenic episodes of children with acute lymphoblastic leukemia or acute myeloblastic leukemia . Patients aged 2–16 years with hematological malignancies who had febrile neutropenia were r and omly assigned to receive piperacillin/tazobactam ( 80 mg/kg piperacillin/10 mg/kg tazobactam , q6h ) combined with amikacin ( PTA ) ( 7.5 mg/kg , q12h ) or meropenem or imipenem ( 20 mg/kg , q8h ) ( C ) . Response to antimicrobial therapy , evaluated for etiological agents , was measured . Duration of fever , neutropenia , and hospitalization , mortality , and the need for additional antibiotics or antifungal drugs were compared for the treatment success between the two groups . Out of 87 febrile neutropenic episodes that were evaluable for comparison , 46 patients received PTA and 41 patients were treated with carbapenems ( imipenem or meropenem ) . Overall , the microbiologically documented infection rate was 21.9 % , with Staphylococcus epidermidis as the most common cause of bacteremia . The rate of treatment modification was 56.5 % in the PTA group and 53.6 % in the carbapenem group with no statistical difference ( p > . 05 ) . There was no infection-related mortality during the study period . There was no difference between the two regimens for duration s of fever , neutropenia , and hospitalization ( p > . 05 for all categories ) . PTA was as effective as carbapenem monotherapy as an initial empirical regimen in febrile neutropenic episodes of pediatric hematological malignancies BACKGROUND The aim of this study was to evaluate the efficacy and safety of piperacillin/tazobactam ( PIP/TAZO ) and cefozopran ( CZOP ) monotherapy in pediatric cancer patients with febrile neutropenia ( FN ) . PROCEDURE A total of 119 febrile episodes in 49 neutropenic pediatric cancer patients ( 20 females and 29 males ) with a median age of 6.8 years ( range , 0.3 - 18.4 years ) received r and omized treatment either with PIP/TAZO 125 mg/kg every 8 hr or CZOP 25 mg/kg every 6 hr . Clinical response was determined at completion of therapy . Duration s of fever and neutropenia , the need for modification of the therapy , and mortality rates were compared between the two groups . RESULTS The frequency of success without modification of treatment was not significantly different between PIP/TAZO ( 59.6 % ) and CZOP ( 53.2 % ) . Duration s of fever and antibiotic therapy did not differ between the treatment groups , and no major side effects were observed in either group . CONCLUSIONS PIP/TAZO and CZOP monotherapy were both effective and safe for the initial empirical treatment of pediatric cancer patients with FN PURPOSE To compare outcome and cost of ambulatory versus hospitalized management among febrile neutropenic children at low risk for invasive bacterial infection ( IBI ) . PATIENTS AND METHODS Children presenting with febrile neutropenia at six hospitals in Santiago , Chile , were categorized as high or low risk for IBI . Low-risk children were r and omly assigned after 24 to 36 hours of hospitalization to receive ambulatory or hospitalized treatment and monitored until episode resolution . Outcome and cost were determined for each episode and compared between both groups using predefined definitions and question naires . RESULTS A total of 161 ( 41 % ) of 390 febrile neutropenic episodes evaluated from June 2000 to February 2003 were classified as low risk , of which 149 were r and omly assigned to ambulatory ( n = 78 ) or hospital-based ( n = 71 ) treatment . In both groups , mean age ( ambulatory management , 55 months ; hospital-based management , 66 months ) , sex , and type of cancer were similar . Outcome was favorable in 74 ( 95 % ) of 78 ambulatory-treated children and 67 ( 94 % ) of 71 hospital-treated children ( P = NS ) . Mean cost of an episode was US 638 dollars ( 95 % CI , 572 dollars to 703 dollars ) and US 903 dollars ( 95 % CI , 781 dollars to 1,025 dollars ) for the ambulatory and hospital-based groups , respectively ( P = .003 ) . CONCLUSION For children with febrile neutropenia at low risk for IBI , ambulatory management is safe and significantly cost saving compared with st and ard hospitalized therapy A prospect i ve , open-label , r and omized , comparative study in pediatric cancer patients was conducted to evaluate the efficacy and safety of cefepime and meropenem in the empiric therapy of febrile neutropenic patients . Febrile episodes were classified as microbiologically documented infection , clinical documented infection , or fever of unknown origin . Clinical response to therapy was classified as success or failure . In this period 37 children with solid tumors including lymphoma , 25 males , 12 females , had neutropenia on 65 occasions . Microbiologically documented infections occurred in 21 episodes ( 32.31 % ) . Frequency of positive bacteria isolated was higher than gram-negative bacteria . There was no infection-related death . There were no statistical differences between the cefepime and meropenem groups for duration of fever or neutropenia , response rate , and necessity for modification . Cefepime appears to be as effective and safe as meropenem for empiric treatment of febrile episodes in neutropenic pediatric cancer patients BACKGROUND AND PURPOSE The empirical use of antibiotic therapy is widely accepted for patients with fever and neutropenia during cancer chemotherapy . The use of intravenous monotherapy with broad-spectrum antibiotics in patients at high risk for complications is an appropriate alternative . However , few data are available for pediatric patients . The aim of this study was to compare the efficacy and safety of cefepime ( CFP ) monotherapy with ceftriaxone plus amikacin ( CFT+AK ) in children and adolescents with febrile neutropenia ( FN ) . METHODS A prospect i ve r and omized open study of patients with lymphoma or leukemia who had fever and neutropenia during chemotherapy was conducted . Patients were r and omized to receive CFP or CFT+AK . The r and omization was based on number lists . RESULTS Fifty seven patients with 125 episodes of fever and neutropenia were evaluated ( CFP , 62 episodes ; CFT+AK , 63 episodes ) . The mean neutrophil count at admission to hospital was 118.6 cells/mm(3 ) for patients in the CFP group and 107 cells/mm(3 ) for patients in the CFT+AK group . The mean duration of neutropenia was 9 days for the CFP group and 8 days for the CFT+AK group . Analysis of only the first episodes for each patient showed that CFP treatment was successful for 65.5 % of episodes and CFT+AK was successful for 64.3 % of episodes . The overall rates of success with modification were 90 % for the CFP group and 89 % for the CFT+AK group . No major treatment-emergent toxicity was reported . CONCLUSION Monotherapy with CFP seems to be as effective and safe as CFT+AK for initial empirical therapy in children and adolescents with FN BACKGROUND Febrile neutropenia ( FN ) is a frequent , serious complication of intensive pediatric chemotherapy regimens . The aim of this trial was to compare quality of life ( QOL ) between inpatient and outpatient intravenous antibiotic management of children and adolescents with low risk febrile neutropenia ( LRFN ) . PROCEDURE In this r and omised non-blinded trial , patients between 1 and 21 years old , receiving low/moderate intensity chemotherapy were pre-consented and , on presentation to emergency ( ED ) with FN satisfying low risk criteria , r and omised to either outpatient or inpatient care with intravenous cefepime 50 mg/kg ( 12 hourly ) . All patients continued antibiotics for at least 48 hours , until afebrile for 24 hours and demonstrating a rising absolute neutrophil count ≥200/mm(3 ) . Several domains of QOL were examined by daily question naire . RESULTS Eighty-one patients presented to ED with 159 episodes of fever . Thirty-seven FN presentations involving 27 patients were r and omised to inpatient ( 18 ) and outpatient ( 19 ) management . Combined QOL mean scores for parents were higher for the outpatient group and scores for three specific parent variables ( keeping up with household tasks/time spent with partner/time spent with other children ) were higher among out patients . There was no difference in parent confidence/satisfaction in care between groups . Patients scored better in the outpatient group overall and for sleep and appetite . The mean length of fever was equivalent between groups and there were no serious adverse events attributable to cefepime or outpatient care . CONCLUSION Outpatient cefepime management of LRFN provided significant benefit to parents and patients across several QOL domains and appeared both feasible and safe PURPOSE To determine if granulocyte colony-stimulating factor ( G-CSF ) with empirical antibiotics accelerates febrile neutropenia resolution compared with antibiotics without it . PATIENTS AND METHODS Eligible children were treated without prophylactic G-CSF and presented with fever ( temperature > 38.3 degrees C ) and neutropenia afterward . Patients with acute myelogenous leukemia and myelodysplastic syndrome were excluded . Assignments were r and omized between G-CSF ( 5 microg/kg/day ) or none beginning within 24 hr of antibiotics . Subcutaneous administration was recommended , but intravenous G-CSF was allowed . Patients remained on study until absolute neutrophil count ( ANC ) > 500/microl and > or = 48 hr without fever . RESULTS One of 67 patients enrolled was ineligible , 59 had acute lymphoblastic leukemia ( ALL ) . Thirty-four were assigned to antibiotics , 32 to G-CSF plus antibiotics . Adding G-CSF significantly reduced neutropenia and febrile neutropenia recovery times . Median days to febrile neutropenia resolution was nine earlier with G-CSF ( 4 vs. 13 days ) ( P < 0.0001 ) . However , there was no difference in the resolution of fever between arms . Hospitalization median was shorter by 1 day with G-CSF ( 4 vs. 5 days ) ( P = 0.04 ) . There was no difference in the duration of IV and oral antibiotic treatment , addition of antifungal therapy , and shock incidence . A trend for decreased incidence of late fever with G-CSF was noted ( 6.3 vs. 23.5 % ) ( P = 0.08 ) . CONCLUSIONS Adding G-CSF to empiric antibiotic coverage accelerates chemotherapy-induced febrile neutropenia resolution by 9 days in pediatric patients , mainly with ALL , which results in a small but significant difference in the median length of hospitalization The purpose of this study is to compare the efficacy and safety of piperacillin/tazobactam ( PIP/TAZO ) versus PIP/TAZO plus amikacin in febrile neutropenic children with acute leukemia ( AL ) . Children with AL who had febrile neutropenic episodes were r and omized to treatment with PIP/TAZO versus PIP/TAZO plus amikacin . Modification was defined as addition of other antimicrobials and /or antifungal agents to the empirical therapy . Protocol failure was defined as withdrawal of the empirical regimen and introduction of other antimicrobials due to failure in controlling infection . Seventy-two febrile episodes of 42 patients with a median age of 4.5 years ( 3.5 months to 19 years ) were evaluated . There were 37 and 35 episodes in PIP/TAZO and combination arms , respectively . Success without modification , with modification , protocol failure , duration of treatment were 45.9 % , 35.1 % , 18.9 % , and 10 days in PIP/TAZO arm and 42.9 % , 37.1 % , 20 % , and 12 days in combination arm , respectively ( P > .05 ) . There was no significant difference between the empirical therapy arms regarding median duration of neutropenia and defervescence of fever . Empirical therapy was substituted by other drugs in 6 and 5 episodes in PIP/TAZO and combination arms , respectively . There was no infection-related death . There was reversible increase in serum creatinine in 1 episode on the combination arm . Monotherapy with PIP/TAZO was effective and safe for initial empirical treatment of febrile neutropenic episodes in children with AL . However , local bacterial resistance patterns should be considered in daily practice
Output:
| Antipseudomonal penicillin and fourth-generation cephalosporin monotherapy were associated with similar failure and mortality rates .
Outpatient management and oral antibiotics were safe in low-risk FN with no infection-related mortality observed in any patient and no significant differences in outcomes compared with inpatient management and intravenous therapy .
Monotherapy for high-risk FN and outpatient and oral management for low-risk FN are effective strategies . |
MS212714 | ***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: Antifibrinolytic treatment for 4 weeks after a subarachnoid hemorrhage has been shown to have no effect on outcome since a reduction in the rate of rebleeding was offset by an increase in ischemic events . To determine if a shorter course ( 4 days ) of antifibrinolytic treatment before the expected onset of ischemic complications might reduce the rate of rebleeding yet avoid ischemic complications , we prospect ively studied a series of 119 patients with subarachnoid hemorrhage ; 479 patients with subarachnoid hemorrhage from our previous r and omized double-blind study ( 238 treated with placebo , 241 with long-term tranexamic acid ) served as historical control groups . At 3 months ' follow-up , the outcome of patients treated with short-term tranexamic acid was not different from that of patients treated with long-term tranexamic acid . The rate of rebleeding ( 24 of 119 , 20 % ) was near that with placebo ( 56 of 238 , 24 % ) . In contrast , the rate of cerebral infa rct ion ( 33 of 119 , 28 % ) was almost identical to that after long-term tranexamic acid ( 59 of 241 , 24 % ) , although mortality from cerebral infa rct ion was reduced . Compared with historical control groups , treatment with tranexamic acid for 4 days fails to reduce the incidence of rebleeding but still increases the rate of cerebral infa rct ion OBJECTIVE The aim of this study was to investigate prospect ively in an unselected series of patients with an aneurysmal subarachnoid haemorrhage what at present the complications are , what the outcome is , how many of these patients have “ modern treatment”—that is , early obliteration of the aneurysm and treatment with calcium antagonists — what factors cause a delay in surgical or endovascular treatment , and what the estimated effect on outcome will be of improved treatment . METHODS A prospect i ve , observational cohort study of all patients with aneurysmal subarachnoid haemorrhage in the hospitals of a specified region in The Netherl and s. The condition on admission , diagnostic procedures , and treatments were recorded . If a patient had a clinical deterioration , the change in Glasgow coma score ( GCS ) , the presence of focal neurological signs , the results of additional investigations , and the final diagnosed cause of the deterioration were recorded . Clinical outcome was assessed with the Glasgow outcome scale ( GOS ) at 3 month follow up . In patients with poor outcome at follow up , the cause was diagnosed . RESULTS Of the 110 patients , 47 ( 43 % ) had a poor outcome . Cerebral ischaemia , 31 patients ( 28 % ) , was the most often occurring complication . Major causes of poor outcome were the effects of the initial haemorrhage and rebleeding in 34 % and 30 % of the patients with poor outcome respectively . Of all patients 102 ( 93 % ) were treated with calcium antagonists and 45 ( 41 % ) patients had early treatment to obliterate the aneurysm . The major causes of delay of treatment were a poor condition on admission or deterioration shortly after admission , in 31 % and 23 % respectively . CONCLUSIONS In two thirds of the patients with poor outcome the causes of poor outcome are the effects of the initial bleeding and rebleeding . Improved treatment of delayed or postoperative ischaemia will have only minor effects on the outcome of patients with subarachnoid haemorrhage Summary Tranexamic acid as an antifibrinolytic agent has been investigated in a controlled study in patients with recent subarachnoid haemorrhage . It is concluded that tranexamic acid improves neither rebleeding rates , nor mortality . Predominantly thrombotic complications have been noted as a more serious side effect of tranexamic acid Summary Seventy-four patients with recent subarachnoid haemorrhage were r and omly allocated to placebo or tranexamic acid treatment . Fibrinolytic activity in the blood and cerebrospinal fluid was assessed before treatment , one week later and two weeks later . The natural history of fibrinolysis following subarachnoid haemorrhage was obtained from analysis of the placebo group . Following subarachnoid haemorrhage , fibrin degradation products and plasminogen activity in the cerebrospinal fluid were elevated . Subsequently , fibrin degradation products in the cerebrospinal fluid fell progressively over the following 2 weeks . Changes in cerebrospinal fluid plasminogen activity correlated with those of blood plasminogen activity . Complications such as rebleeding , hydrocephalus or cerebral thrombosis could not be predicted from analysis of fibrinolytic activity . Tranexamic acid treatment result ed in a reduction in cerebrospinal fluid and blood plasminogen activity . The relevance of fibrinolysis in cerebrospinal fluid and blood to the management of subarachnoid haemorrhage is discussed The outcome of treatment with an antifibrinolytic agent ( tranexamic acid ) for six weeks after rupture of an intracranial aneurysm was assessed in a r and omised controlled trial . Twenty-two out of 25 ( 88 % ) treated patients survived at follow-up of three to 33 months compared with 14 out of 25 ( 56 % ) control patients . Among the patients who did not undergo operation the survival rate was 81 % ( 13 out of 16 ) in treated patients and 42 % ( 8 out of 19 ) in controls . Antifibrinolytic treatment has so far been assumed merely to postpone rebleeding and has been used to enable surgery to be deferred . These findings suggest that tranexamic acid may actually prevent rebleeding without operation . Prolonged antifibrinolysis may therefore prove useful in those patients in good condition whose aneurysms do not lend themselves to surgical obliteration Objective : To investigate whether antifibrinolytics in combination with treatment to prevent cerebral ischemia improve outcome in patients with subarachnoid hemorrhage ( SAH ) in whom occlusion of the aneurysm is delayed . Background : Antifibrinolytic treatment reduces rebleeding , but outcome does not improve because of a concurrent increase in the occurrence of cerebral ischemia . Because treatment of ischemia has improved , antifibrinolytics might now have a beneficial effect . Methods : A prospect i ve , double-blind , placebo-controlled multicenter clinical trial was performed . R and omized were 462 patients ( 229 received tranexamic acid , 233 placebo ) admitted within 96 hours after onset of SAH , in whom treatment of the aneurysm was delayed beyond 48 hours after SAH . All patients were treated with calcium antagonists and hypervolemia . At 3 months , outcome was assessed with the Glasgow Outcome Scale . The occurrence of cerebral ischemia and other complications were recorded , and the effects of treatment were related to the clinical condition on admission . Results : Antifibrinolytic treatment had no beneficial effect on outcome ( relative risk [ RR ] , 1.10 ; 95 % confidence limits [ CL ] , 0.91–1.34 ) . Antifibrinolytics significantly reduced the occurrence of rebleeding ( RR , 0.58 ; 95 % CL , 0.42–0.80 ) ; the occurrence of ischemic and other complications was the same in the two groups . Conclusion : Antifibrinolytic treatment combined with treatment to prevent cerebral ischemia does not improve outcome Summary One hundred patients with a verified subarachnoid haemorrhage were studied in a double blind , placebo-controlled trial at a single centre to determine the value and relative risks of tranexamic acid ( TXA ) in the management of ruptured intracranial aneurysms . The incidence of recurrent haemorrhage between active and placebo groups was identical ( 12 % ) and the mortality from recurrent haemorrhage was 7 % and 5 % , respectively . The overall incidence of cerebral infa rct ion before surgery , at discharge and at 6 months follow-up was greater in the TXA group ( 27 % ) than in the control group ( 11 % ) . Post-operative cerebral ischaemia was significantly more frequent in the active , 18 of 29 as compared to 6 of 32 patients , in the placebo group . In a fifth of the patients in whom cerebral blood flow was estimated there was a significant reduction of cerebral blood flow ( CBF ) on the side of the ruptured aneurysm in the TXA treated group . It is suggested that this may be the cause of the increased incidence of cerebral ischaemia in this group . There was no significant difference in the incidence of cerebral vasospasm , hydrocephalus , visual disturbances and gastrointestinal disturbances . More fatalities were encountered from ischaemia and recurrent haemorrhage in the TXA group but these differences did not reach statistical significance at the 5 % level . Given that disability was due to either vasospasm or recurrent haemorrhage then a patient under TXA treatment was significantly more likely to have disability due to vasospasm ( p<0.04 ) ; the reverse was true for the placebo patient ( p<0.05 ) In a series of 176 prospect ively studied patients who survived for at least 24 hours after aneurysmal subarachnoid hemorrhage , 39 had at least one computerized tomography (CT)-proven rebleed within 4 weeks after the first rupture . There were peaks in the incidence of rebleeding at the end of the 2nd and 3rd weeks . Sudden loss of consciousness occurred in 35 patients , preceded in one-third of them by headache . A sudden increase in headache was a symptom of rebleeding in only one patient . Loss of brain-stem reflexes was recorded in 13 patients , respiratory arrest in six , and both symptoms in eight patients . Apnea was temporary in 11 patients . Rebleeding occurred as gross intraventricular hemorrhage in 20 patients , as a space-occupying hematoma in four , as both types of hemorrhage in three , and as a purely subarachnoid hemorrhage in 12 . The location of the rebleed could not be inferred from the clinical features . Rebleeding was fatal in 51 % of cases ( two of 12 patients with a purely subarachnoid hemorrhage , and 18 of the other 27 patients ( p less than 0.005 ) ) . The risk of rebleeding could not be predicted from the patients ' clinical condition on admission or from the amount of subarachnoid blood identified on the initial CT scan . The risk of further rebleeding was significantly increased in survivors of a first rebleed ( 47 % : p less than 0.01 ) . Only seven ( 18 % ) of the 39 patients with rebleeding had survived at 3 months after the initial hemorrhage A r and omized controlled clinical trial was carried out to study the effect of tranexamic acid ( AMCA , Cyklokapron ; AB Kabi , Stockholm , Sweden ) in the prevention of early rebleeding after the rupture of an intracranial aneurysm . The incidence of vasospasm , hydrocephalus , cerebral ischemic and thromboembolic complications , morbidity , and mortality was also evaluated . The series comprises 59 patients , 30 treated with tranexamic acid and 29 controls . The treatment was stopped if there was rebleeding , operation , or discharge from the hospital . There were 6 recurrent hemorrhages in 6 patients in the tranexamic acid-treated group and 11 recurrences in 7 patients in the control group . Recurrent hemorrhages occurred later in tranexamic acid-treated patients than in controls . Five patients in each group died from rebleeding . Five additional treated patients and 2 controls died from cerebral ischemic dysfunction . The results suggest that tranexamic acid may protect patients with ruptured aneurysms from rebleeding for 1 or 2 weeks , but that it also may produce cerebral ischemic complications A double‐blind clinical trial of tranexamic acid was carried out on 39 patients with fresh subarachnoid hemorrhage from a ruptured aneurysm . Twenty patients received tranexamic acid , 6 gm daily for 14 to 21 days , while 19 patients received conventional therapy of bedrest and dexamethasone when cerebral edema developed , plus isotonic saline . Rebleeding and mortality were reduced by one‐fourth and one‐fifth , respectively ( p < 0.001 ) . No side‐effects were observed . Tranexamic acid is valuable in the treatment of subarachnoid hemorrhage caused by ruptured intracranial aneurysms MODIFICATION of the blood-clotting mechanisms as an adjunct to , or a substitute for , surgery in intracranial aneurysms has interested several workers ( Uihlein et al. , 1966 ; Gibbs & O'Gorman , 1967 ; Mullan & Dawley , 1968 ; Uttley & Buckell , 1968 ; Mullan , 1969 , personal communication ) . Uihlein et al. ( 1966 ) used the anti-fibrinolytic agent epsilonamino caproic acid ( EACA ) with hypothermia in the surgery of aneurysms , and Mullan & Dawley ( 1968 ) reported two recurrent haemorrhages only among thirty cases of angiographically proved aneurysms treated with EACA but no surgery . Since then , Mullan ( personal communication ) has combined this treatment with lowering of the systemic blood pressure by hypotensive drugs . Gibbs & O'Gorman ( 1967 ) studied fibrinolysis in 109 cases of proved intracranial aneurys
Output:
| REVIEW ER 'S CONCLUSIONS Treatment does not improve clinical outcome because the benefit is offset by an increase in poor outcome caused by cerebral ischemia as a result of treatment with antifibrinolytics .
These data do not support the routine use of antifibrinolytic drugs in the treatment of patients with aneurysmal subarachnoid haemorrhage |
MS212715 | ***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 Assessment of the change in tumour burden is an important feature of the clinical evaluation of cancer therapeutics : both tumour shrinkage ( objective response ) and disease progression are useful endpoints in clinical trials . Since RECIST was published in 2000 , many investigators , cooperative groups , industry and government authorities have adopted these criteria in the assessment of treatment outcomes . However , a number of questions and issues have arisen which have led to the development of a revised RECIST guideline ( version 1.1 ) . Evidence for changes , summarised in separate papers in this special issue , has come from assessment of a large data warehouse ( > 6500 patients ) , simulation studies and literature review s. HIGHLIGHTS OF REVISED RECIST 1.1 : Major changes include : Number of lesions to be assessed : based on evidence from numerous trial data bases merged into a data warehouse for analysis purpose s , the number of lesions required to assess tumour burden for response determination has been reduced from a maximum of 10 to a maximum of five total ( and from five to two per organ , maximum ) . Assessment of pathological lymph nodes is now incorporated : nodes with a short axis of 15 mm are considered measurable and assessable as target lesions . The short axis measurement should be included in the sum of lesions in calculation of tumour response . Nodes that shrink to < 10 mm short axis are considered normal . Confirmation of response is required for trials with response primary endpoint but is no longer required in r and omised studies since the control arm serves as appropriate means of interpretation of data . Disease progression is clarified in several aspects : in addition to the previous definition of progression in target disease of 20 % increase in sum , a 5 mm absolute increase is now required as well to guard against over calling PD when the total sum is very small . Furthermore , there is guidance offered on what constitutes ' unequivocal progression ' of non-measurable/non-target disease , a source of confusion in the original RECIST guideline . Finally , a section on detection of new lesions , including the interpretation of FDG-PET scan assessment is included . Imaging guidance : the revised RECIST includes a new imaging appendix with up date d recommendations on the optimal anatomical assessment of lesions . FUTURE WORK A key question considered by the RECIST Working Group in developing RECIST 1.1 was whether it was appropriate to move from anatomic unidimensional assessment of tumour burden to either volumetric anatomical assessment or to functional assessment with PET or MRI . It was concluded that , at present , there is not sufficient st and ardisation or evidence to ab and on anatomical assessment of tumour burden . The only exception to this is in the use of FDG-PET imaging as an adjunct to determination of progression . As is detailed in the final paper in this special issue , the use of these promising newer approaches requires appropriate clinical validation studies Purpose : Medullary thyroid carcinoma ( MTC ) is a manifestation of multiple endocrine neoplasia type 2 ( MEN2 ) syndromes caused by germline , activating mutations in the RET ( REarranged during Transfection ) proto-oncogene . V and etanib , a VEGF and EGF receptor inhibitor , blocks RET tyrosine kinase activity and is active in adults with hereditary MTC . Experimental Design : We conducted a phase I/II trial of v and etanib for children ( 5–12 years ) and adolescents ( 13–18 years ) with MTC to define a recommended dose and assess antitumor activity . The starting dose was 100 mg/m2 administered orally , once daily , continuously for 28-day treatment cycles . The dose could be escalated to 150 mg/m2/d after two cycles . Radiographic response to v and etanib was quantified using RECIST ( v1.0 ) , biomarker response was measured by comparing posttreatment serum calcitonin and carcinoembryonic antigen ( CEA ) levels to baseline , and a patient-reported outcome was used to assess clinical benefit . Results : Sixteen patients with locally advanced or metastatic MTC received v and etanib for a median ( range ) 27 ( 2–52 ) cycles . Eleven patients remain on protocol therapy . Diarrhea was the primary dose-limiting toxicity . In subjects with M918 T RET germline mutations ( n = 15 ) the confirmed objective partial response rate was 47 % ( exact 95 % confidence intervals , 21%–75 % ) . Biomarker partial response was confirmed for calcitonin in 12 subjects and for CEA in 8 subjects . Conclusion : Using an innovative trial design and selecting patients based on target gene expression , we conclude that v and etanib 100 mg/m2/d is a well-tolerated and highly active new treatment for children and adolescents with MEN2B and locally advanced or metastatic MTC . Clin Cancer Res ; 19(15 ) ; 4239–48 . © 2013 AACR BACKGROUND A r and omized phase III trial demonstrated that v and etanib treatment is effective in patients with metastatic medullary thyroid cancer ( MTC ) , leading to regulatory approval , but its use may be associated with toxicities that require specific monitoring and management . The objective of the present study performed in France was to describe the toxicity profile and efficacy of v and etanib treatment when given outside any trial . METHODS Sixty-eight patients were treated with v and etanib in the frame of a temporary use authorization ( ATU ) in France from August 2010 to February 2012 , when the drug was available on request for patients with locally advanced or metastatic MTC . Patients were registered by the French health authorities , and characteristics , treatment parameters , toxicity profile , and efficacy were retrospectively review ed . Eight patients were excluded from the analysis because v and etanib treatment was not administered ( n=3 ) , had been given in a trial before ATU ( n=3 ) , or was given for a non-MTC cancer ( n=2 ) . RESULTS Data from the 60 MTC patients were analyzed . Mean age was 58 years ( range 11 - 83 years ) , 39 patients were male , and six had hereditary MTC . Fifty-six ( 93 % ) had metastatic disease in the mediastinum ( 82 % ) , bones ( 65 % ) , liver ( 53 % ) , or lung ( 53 % ) , and four had only locally advanced disease . At the time of study evaluation , with a median follow-up of 20 months and a median duration of treatment of 9.7 months ( range 0.3 - 36 months ) , 15 patients were continuing v and etanib treatment ( range 18 - 36 months ) . Median progression-free survival was 16.1 months . Twenty-five patients discontinued treatment for disease progression ( range 0.3 - 29 months ) . Best tumor response was a complete response in one patient , a partial response in 12 ( 20 % ) , stable disease in 33 ( 55 % ) , and progression in seven patients ( 12 % ) . All patients had at least one adverse event ( AE ) during treatment . The main AEs were skin toxicity , diarrhea , and asthenia . Sixteen patients ( 27 % ) discontinued treatment for toxicity , and one patient died from v and etanib-induced cardiac toxicity . CONCLUSIONS V and etanib is an effective option for patients with advanced MTC . AEs should be monitored carefully and should be minimized by educating both patients and care providers and by applying symptomatic treatment and dose reduction OBJECTIVE In a phase III trial , Western patients with medullary thyroid cancer ( MTC ) treated with the oral multikinase inhibitor v and etanib showed significantly improved progression-free survival ( PFS ) and objective response rate ( ORR ) compared with placebo . The biology of MTC and pharmacokinetics ( PK ) are similar for Japanese and Western patients ; therefore , similar clinical benefit is anticipated in the Japanese population . This study evaluated the safety and tolerability of v and etanib in Japanese patients with unresectable locally advanced or metastatic MTC . METHODS This was a phase I/II , open-label , nonr and omized study . Patients received v and etanib ( 300 mg daily ) until objective disease progression . The primary endpoints were safety and tolerability . Secondary endpoints included efficacy and PK . Final data analysis was conducted once all patients with measurable baseline disease had been followed to progression , or for 56 weeks . RESULTS Fourteen patients received v and etanib . All patients experienced at least one adverse event ( AE ) , and 7 patients ( 50 % ) experienced grade ≥3 AEs . Common AEs included diarrhea ( 79 % ) , hypertension ( 64 % ) , and rash ( 43 % ) . Four patients reported a total of five serious AEs ( SAEs ) . Eleven patients ( 79 % ) had dose interruptions , and 8 patients ( 57 % ) had dose reductions . One patient discontinued treatment because of an SAE ( interstitial lung disease ) . No patients met the prespecified criterion for QTc prolongation . The ORR was 38 % and PFS at 12 months was 85 % . CONCLUSION Safety and efficacy data were comparable to those previously reported , and AEs were generally manageable by st and ard clinical practice or dose modifications . Overall , v and etanib was considered to be beneficial for Japanese MTC patients . ABBREVIATIONS AE = adverse event CI = confidence interval Css , max = maximum steady-state plasma concentration DCR = disease control rate EGFR = epidermal growth factor receptor ILD = interstitial lung disease MTC = medullary thyroid cancer ORR = objective response rate PFS = progression-free survival PK = pharmacokinetics RECIST = Response Evaluation Criteria in Solid Tumors RET = re-arranged during transfection SAE = serious adverse event VEGFR = vascular endothelial growth factor receptor
Output:
| Conclusion V and etanib should be considered as a promising treatment in advanced MTC .
However , data based on RECIST endpoints do not currently provide high-level evidence on its efficacy |
MS212716 | ***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 its effectiveness , methadone maintenance is rarely provided in American correctional facilities . This study is the first r and omized clinical trial in the US to examine the effectiveness of methadone maintenance treatment provided to prisoners with pre-incarceration heroin addiction . METHODS A three-group r and omized controlled trial was conducted between September 2003 and June 2005 . Two hundred eleven Baltimore pre-release inmates who were heroin dependent during the year prior to incarceration were enrolled in this study . Participants were r and omly assigned to the following : counseling only : counseling in prison , with passive referral to treatment upon release ( n=70 ) ; counseling+transfer : counseling in prison with transfer to methadone maintenance treatment upon release ( n=70 ) ; and counseling+methadone : methadone maintenance and counseling in prison , continued in a community-based methadone maintenance program upon release ( n=71 ) . RESULTS Two hundred participants were located for follow-up interviews and included in the current analysis . The percentages of participants in each condition that entered community-based treatment were , respectively , counseling only 7.8 % , counseling+transfer 50.0 % , and counseling+methadone 68.6 % , p<.05 . All pairwise comparisons were statistically significant ( all ps<.05 ) . The percentage of participants in each condition that tested positive for opioids at 1-month post-release were , respectively , counseling only 62.9 % , counseling+transfer 41.0 % , and counseling+methadone 27.6 % , p<.05 , with the counseling only group significantly more likely to test positive than the counseling+methadone group . CONCLUSIONS Methadone maintenance initiated prior to or immediately after release from prison appears to have beneficial short-term impact on community treatment entry and heroin use . This intervention may be able to fill an urgent treatment need for prisoners with heroin addiction histories Aim To test the efficacy and safety of osmotic release oral system ( OROS ) methylpheni date ( MPH ) in doses up to 180 mg/day to treat attention deficit hyperactivity disorder ( ADHD ) and prevent any drug relapse in individuals with a co-diagnosis of ADHD and amphetamine dependence . Design R and omized placebo-controlled 24-week double-blind trial with parallel groups design . Setting Participants were recruited from medium security prisons in Sweden . The medication started within 2 weeks before release from prison and continued in out-patient care with twice-weekly visits , including once-weekly cognitive behavioural therapy . Participants Fifty-four men with a mean age of 42 years , currently incarcerated , meeting DSM-IV criteria for ADHD and amphetamine dependence . Measurements Change in self-reported ADHD symptoms , relapse to any drug use ( amphetamine and other drugs ) measured by urine toxicology , retention to treatment , craving and time to relapse . Findings The MPH-treated group reduced their ADHD symptoms during the trial ( P = 0.011 ) and had a significantly higher proportion of drug-negative urines compared with the placebo group ( P = 0.047 ) , including more amphetamine-negative urines ( P = 0.019 ) and better retention to treatment ( P = 0.032 ) . Conclusions Methylpheni date treatment reduces attention deficit hyperactivity disorder symptoms and the risk for relapse to substance use in criminal offenders with attention deficit hyperactivity disorder and substance dependence BACKGROUND Screening , brief intervention , and referral to treatment ( SBIRT ) is an evidence -based practice that has been shown to reduce alcohol and drug use in healthcare , educational , and other setting s , but research on the effectiveness of SBIRT with population s involved in the criminal justice system is limited . These population s have high rates of substance use but have limited access to interventions . METHODS The study r and omized 732 jail inmates from a large urban jail to the SBIRT intervention or to the control group . Using the Alcohol , Smoking , and Substance Involvement Screening Test ( ASSIST ) , the intervention assessed the risk level for drug and alcohol misuse by inmates and provided those who were at low or medium risk with a brief intervention in jail and referred those at high risk to community treatment following release , including the opportunity to participate in a brief treatment ( eight sessions ) protocol . Using interview and records data from a 12-month follow-up , analyses compared the two groups with respect to the primary study outcomes of reductions in drug and alcohol use and the secondary outcomes of participation in treatment , rearrest , reduction in HIV risk behaviors , and quality of life . In addition , the costs of delivering the SBIRT intervention were calculated . RESULTS When baseline differences were controlled , the groups did not differ at follow-up on any of the primary or secondary outcomes . CONCLUSIONS Future research should develop and evaluate SBIRT models that are specifically adapted to the characteristics and needs of the jail population . Until more favorable results emerge , attempts to use SBIRT with jail inmates should be implemented with caution , if at all . TRIAL REGISTRATION NUMBER NCT01683643 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 OBJECTIVES To describe and evaluate a pilot methadone maintenance program for heroin-dependent inmates of Las Malvinas men 's prison in San Juan , Puerto Rico . METHODS Data from self-report of inmates ' drug use before and during incarceration , attitudes about drug treatment in general and methadone maintenance in particular , and expectations about behaviors upon release from prison and from testing inmates ' urine were analyzed comparing program patients ( n=20 ) and inmates selected at r and om from the prison population ( n=40 ) . Qualitative data obtained by interviewing program staff , the correctional officers and superintendent , and commonwealth officials responsible for establishing and operating the program were analyzed to identify attitudes about methadone and program effectiveness . RESULTS Heroin use among prisoners not in treatment was common ; 58 % reported any use while incarcerated and 38 % reported use in past 30 days . All patients in the treatment program had used heroin in prison in the 30 days prior to enrolling in treatment . While in treatment , the percentage of patients not using heroin was reduced , according to both self-report and urine testing , to one in 18 ( 94 % reduction ) and one in 20 ( 95 % reduction ) , respectively . Participation in treatment was associated with an increased acceptance of methadone maintenance . Prison personnel and commonwealth officials were supportive of the program . CONCLUSIONS The program appears to be a success , and prison officials have begun an expansion from the current ceiling of 24 inmates to treat 300 or more inmates AIMS To examine the long-term impact of methadone maintenance treatment ( MMT ) on mortality , re-incarceration and hepatitis C seroconversion in imprisoned male heroin users . DESIGN , SETTING AND PARTICIPANTS The study cohort comprised 382 imprisoned male heroin users who had participated in a r and omized controlled trial of prison-based MMT in 1997/98 . Subjects were followed-up between 1998 and 2002 either in the general community or in prison . MEASUREMENTS All-cause mortality , re-incarceration , hepatitis C and HIV serostatus and MMT retention . FINDINGS There were no deaths recorded while subjects were enrolled in MMT . Seventeen subjects died while out of MMT , representing an untreated mortality rate of 2.0 per 100 person-years ( 95 % CI , 1.2 - 3.2 ) . Re-incarceration risk was lowest during MMT episodes of 8 months or longer ( adjusted hazard ratio 0.3 ( 95 % CI , 0.2 - 0.5 ; P < 0.001 ) , although MMT periods 2 months or less were associated with greatest risk of re-incarceration ( P < 0.001 ) . Increased risk of hepatitis C seroconversion was significantly associated with prison sentences of less than 2 months [ adjusted hazard ratio 20 ( 95 % CI , 5 - 76 ; < P = 0.001 ) ] and MMT episodes less than 5 months [ adjusted hazard ratio 4.2 ( 95 % CI , 1.4 - 12.6 ; P = 0.01 ) ] . Subjects were at greatest risk of MMT dropout during short prison sentences of 1 month or less ( adjusted hazard ratio 10.4 ( 95 % CI , 7.0 - 15.7 ; P < 0.001 ) . HIV incidence was 0.3 per 100 person-years ( 95 % CI , 0.03 - 0.99 ) . CONCLUSIONS Retention in MMT was associated with reduced mortality , re-incarceration rates and hepatitis C infection . Prison-based MMT programmes are integral to the continuity of treatment needed to ensure optimal outcomes for individual and public health This study examined benefits of methadone maintenance among prerelease prison inmates . Incarcerated males with preincarceration heroin dependence ( n = 197 ) were r and omly assigned to ( a ) group educational counseling ( counseling only ) ; ( b ) counseling , with opportunity to begin methadone maintenance on release ( counseling + transfer ) ; or ( c ) counseling and methadone maintenance in prison , with opportunity to continue methadone maintenance on release ( counseling + methadone ) . At 90-day follow-up , counseling + methadone participants were significantly more likely than counseling-only and counseling + transfer participants to attend drug treatment ( p = .0001 ) and less likely to be reincarcerated ( p = .019 ) . Counseling + methadone and counseling + transfer participants were significantly less likely ( all ps < .05 ) to report heroin use , cocaine use , and criminal involvement than counseling-only participants . Follow-up is needed to determine whether these findings hold over a longer period AIMS Recent studies have demonstrated the efficacy of both methadone and buprenorphine when used with opioid dependent men transitioning from prison to the community , but no studies have been conducted with women in the criminal justice ( CJ ) system . The aim of this study was to determine the efficacy of buprenorphine for relapse prevention among opioid dependent women in the CJ system transitioning back to the community . METHODS 36 women under CJ supervision were recruited from an inpatient drug treatment facility that treats CJ individuals returning back to the community . Nine were enrolled in an open label buprenorphine arm then 27 were r and omized to buprenorphine ( n=15 ) or placebo ( n=12 ; double-blind ) . All women completed baseline measures and started study medication prior to release . Participants were followed weekly , provided urine drug screens ( UDS ) , received study medication for 12 weeks , and returned for a 3-month follow-up . Intent-to-treat analyses were performed for all time points through 3 month follow-up . RESULTS The majority of participants were Caucasian ( 88.9 % ) , young ( M±SD=31.8±8.4 years ) , divorced/separated ( 59.2 % ) women with at least a high school/GED education ( M±SD=12±1.7 years ) . GEE analyses showed that buprenorphine was efficacious in maintaining abstinence across time compared to placebo . At end of treatment , 92 % of placebo and 33 % of active medication participants were positive for opiates on urine drug screen ( Chi-Square=10.9 , df=1 ; p<0.001 ) . However , by the three month follow-up point , no differences were found between the two groups , with 83 % of participants at follow-up positive for opiates . CONCLUSIONS Women in the CJ system who received buprenorphine prior to release from a treatment facility had fewer opiate positive UDS through the 12 weeks of treatment compared to women receiving placebo . Initiating buprenorphine in a controlled environment prior to release appears to be a viable strategy to reduce opiate
Output:
| Results suggest therapeutic communities are effective in reducing recidivism and , to a lesser extent substance use after release .
There is also evidence to suggest that opioid maintenance treatment is effective in reducing the risk of drug use after release from prison for opioid users .
Furthermore , care after release from prison appears to enhance treatment effects for both types of interventions . |
MS212717 | ***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: An elevated level of C-reactive protein is a strong predictor of cardiovascular events in elderly persons . Whether C-reactive protein has direct adverse vascular effects or is a marker of aspecific systemic inflammation remains to be determined . The aim of this study was to investigate the relation between C-reactive protein and the occurrence of fatal strokes in elderly persons . In the Leiden 85-Plus Study , a population -based prospect i ve follow-up study , we studied the levels of C-reactive protein in 80 participants who died from stroke within the first 5 years of follow-up . Levels of C-reactive protein were determined in serum sample s at baseline . Levels of C-reactive protein were also determined in 82 control subjects who survived for the first 5 years of follow-up and in 83 participants who died from noncardiovascular causes . Mortality risks were estimated with logistic regression and adjusted for differences in age , sex , smoking , medication , total cholesterol , history of diabetes or hypertension , and previous cardiovascular events . Levels of C-reactive protein at baseline were 2-fold higher in subjects who died from stroke than in control subjects ( median 5.7 versus 2.7 mg/L , P<0.005 ) . The levels of C-reactive protein in subjects who died from stroke or from noncardiovascular causes were similar ( median 5.7 versus 4.9 mg/L , P=0.7 ) . The risk of death from stroke as well as from noncardiovascular causes increased linearly up to 10-fold in subjects with the highest levels of C-reactive protein at baseline ( P<0.001 ) . The levels of C-reactive protein were lower when more time had elapsed between blood sampling and time of death during follow-up ( P=0.01 ) . C-reactive protein is a strong but nonspecific risk factor of fatal stroke in old persons . The data do not support the idea that C-reactive protein has direct vascular effects that underlie fatal cerebrovascular disease Little is known about the prospect i ve associations of fibrinogen , factor VII , or factor VIII with cardiovascular disease ( CVD ) and mortality in the elderly . At baseline in the Cardiovascular Health Study ( 5888 white and African American men and women ; aged > /=65 years ) , we measured fibrinogen , factor VIII , and factor VII . We used sex-stratified stepwise Cox survival analysis to determine relative risks ( RRs ) for CVD events and all-cause mortality ( up to 5 years of follow-up ) , both unadjusted and adjusted for CVD risk factors and sub clinical CVD . After adjustment , comparing the fifth quintile to the first , fibrinogen was significantly associated in men with coronary heart disease events ( RR=2.1 ) and stroke or transient ischemic attack ( RR=1.3 ) , and also with mortality within 2.5 years of follow-up ( RR=5.8 ) and later ( RR=1.7 ) . Factor VIII was significantly associated in men with coronary heart disease events ( RR=1.5 ) and mortality ( RR=1.8 ) , and in women with stroke/transient ischemic attack ( RR=1.4 ) . For both factors , values were higher in those who died , whether causes were CVD-related or non-CVD-related , but highest in CVD death . Factor VII exhibited associations with incident angina ( RR=1.44 ) in men and with death in women ( RR , middle quintile compared with first=0.66 ) . However , in general , factor VII was not consistently associated with CVD events in this population . We conclude that , if confirmed in other studies , the measurement of fibrinogen and /or factor VIII may help identify older individuals at higher risk for CVD events and mortality BACKGROUND Among apparently healthy men , elevated levels of C-reactive protein ( CRP ) , a marker for systemic inflammation , predict risk of myocardial infa rct ion and thromboembolic stroke . Whether increased levels of CRP are also associated with the development of symptomatic peripheral arterial disease ( PAD ) is unknown . METHODS AND RESULTS Using a prospect i ve , nested , case-control design , we measured baseline levels of CRP in 144 apparently healthy men participating in the Physicians ' Health Study who subsequently developed symptomatic PAD ( intermittent claudication or need for revascularization ) and in an equal number of control subjects matched on the basis of age and smoking habit who remained free of vascular disease during a follow-up period of 60 months . Median CRP levels at baseline were significantly higher among those who subsequently developed PAD ( 1.34 versus 0.99 mg/L ; P=.04 ) . Furthermore , the risks of developing PAD increased significantly with each increasing quartile of baseline CRP concentration such that relative risks of PAD from lowest ( referent ) to highest quartile of CRP were 1.0 , 1.3 , 2.0 , and 2.1 ( Ptrend=.02 ) . Compared with those with no clinical evidence of disease , the subgroup of case patients who required revascularization had the highest baseline CRP levels ( median= 1.75 mg/L ; P= .04 ) ; relative risks from lowest to highest quartile of CRP for this end point were 1.0 , 1.8 , 3.8 , and 4.1 ( Ptrend=.02 ) . Risk estimates were similar after additional control for body mass index , hypercholesterolemia , hypertension , diabetes , and a family history of premature atherosclerosis . CONCLUSIONS These prospect i ve data indicate that among apparently healthy men , baseline levels of CRP predict future risk of developing symptomatic PAD and thus provide further support for the hypothesis that chronic inflammation is important in the pathogenesis of atherothrombosis BACKGROUND AND PURPOSE Several cross-sectional and prospect i ve studies have indicated that high titers of antibodies to Chlamydia pneumoniae and cytomegalovirus ( CMV ) are associated with coronary heart disease . The aim of the present study was to examine whether elevated titers of antibodies to these pathogens are predictive of not only coronary but also cerebrovascular disease . METHODS Serum titers of antibodies to C pneumoniae ( IgM , IgG , IgA , IgG immune complex ) and CMV ( IgG ) were determined at baseline ( n=130 ) and after 3.5 years ( n=111 ) in a total sample of 152 men . All individuals had treated hypertension and at least 1 additional risk factor for cardiovascular disease ( hypercholesterolemia , smoking , or diabetes mellitus ) and constituted 93 % of a r and omly selected subgroup ( n=164 ) of patients participating in a multiple risk factor intervention study . RESULTS Elevations of any or both of the IgA or IgG titers to C pneumoniae at entry or after 3.5 years were found in 84 cases ( 55 % ) . Of those with high titers at entry , 97 % remained high at the 3.5 year reexamination . After 6.5 years of follow-up , high titers to C pneumoniae at entry were associated with an increased risk for future stroke ( relative risk [ RR ] , 8.58 ; P=0.043 ; 95 % CI , 1.07 to 68.82 ) and for any cardiovascular event ( RR , 2.69 ; P=0.042 ; 95 % CI , 1.04 to 6.97 ) . A high serum titer of antibodies to CMV was found in 125 cases ( 85 % ) , and this was not associated with an increased risk of future cardiovascular events . CONCLUSIONS Seropositivity for C pneumoniae , but not for CMV , was associated with an increased risk for future cardiovascular disease and , in particular , stroke OBJECTIVE : To determine whether Helicobacter pylori , a chronic bacterial infection often acquired in childhood , is associated with increased risk of coronary heart disease and stroke later in life . DESIGN : Nested case-control study . SETTING : Prospect i ve study of cardiovascular disease in men aged 40 - 59 years at entry ( 1978 - 1980 ) in 24 British towns . SUBJECTS : 135 cases of myocardial infa rct ion and 137 cases of stroke occurring before December 1991 ; 136 controls were identified , frequency matched to cases by town and age group . METHODS : Serum sample s stored at entry were analysed by an enzyme linked immunosorbent assay for the presence of H pylori specific IgG antibodies . RESULTS : 95 of the myocardial infa rct ion cases ( 70 % ) and 93 ( 68 % ) of the stroke cases were seropositive for H pylori compared with 78 ( 57 % ) of the controls ( odds ratio for myocardial infa rct ion 1.77 , 95 % confidence interval ( CI ) 1.06 to 2.95 , P = 0.03 ; odds ratio for stroke 1.57 , 95 % CI 0.95 to 2.60 , P = 0.07 ) . Helicobacter pylori infection was associated with manual social class , residence in Northern Engl and or Scotl and , cigarette smoking , higher systolic pressure and blood glucose , and a lower height-st and ardised forced expiratory volume in one second . Adjustment for these factors attenuated the relation between H pylori and myocardial infa rct ion ( odds ratio = 1.31 , 95 % CI 0.70 to 2.43 , P = 0.40 ) and effectively abolished the relation with stroke ( odds ratio = 0.96 , 0.46 to 2.02 , P = 0.92 ) . The relation between helicobacter infection and fatal myocardial infa rct ion was slightly stronger ( odds ratio 2.41 , 95 % CI 1.13 to 5.12 ) but was also markedly attenuated after adjustment ( 1.56 , 95 % CI 0.68 to 3.61 ) . CONCLUSION : In this prospect i ve study the association between Helicobacter pylori infection and increased risk of myocardial infa rct ion and stroke was substantially confounded by the relation between this infection , adult social class , and major cardiovascular risk factors BACKGROUND Sinking prebeta lipoprotein is a putative marker for elevated levels of lipoprotein ( a ) . Although prospect i ve data suggest that increased plasma lipoprotein ( a ) is an independent risk factor for coronary heart disease in men , no prospect i ve studies are available in women . METHODS AND RESULTS From 1968 through 1975 , sinking prebeta lipoprotein was determined by paper electrophoresis in 3103 women Framingham Heart Study participants who were free of prevalent cardiovascular disease . A sinking prebeta lipoprotein b and was detectable in 434 of the women ( 14 % ) studied . The median follow-up interval was approximately 12 years . Incident cardiovascular disease was associated with b and presence using a proportional hazards model that included age , smoking , body mass index , systolic blood pressure , glucose intolerance , low- and high-density lipoprotein cholesterol , and ECG left ventricular hypertrophy . Multivariable adjusted relative risk estimates ( with 95 % confidence intervals ) for outcomes in the b and present versus absent groups were as follows : myocardial infa rct ion ( 82 events ) , 2.37 ( 1.48 to 3.81 ) ; intermittent claudication ( 62 events ) , 1.94 ( 1.07 to 3.50 ) ; cerebrovascular disease ( 83 events ) , 1.88 ( 1.12 to 3.15 ) ; total coronary heart disease ( 174 events ) , 1.61 ( 1.13 to 2.29 ) ; and total cardiovascular disease ( 305 events ) , 1.44 ( 1.09 to 1.91 ) . A subset analysis indicated that b and presence was 50.9 % sensitive and 95.4 % specific for detecting plasma lipoprotein ( a ) levels of > 30 mg/dL , the threshold value linked to increased cardiovascular disease risk in men . CONCLUSIONS Sinking prebeta lipoprotein was a valid surrogate for elevated lipoprotein ( a ) levels in Framingham Heart Study women . B and presence and , equivalently , elevated plasma lipoprotein ( a ) , was a strong , independent predictor of myocardial infa rct ion , intermittent claudication , and cerebrovascular disease . Confirmation of these findings in other longitudinal studies of women is needed Background : To decide whether a person with certain characteristics should be given any kind of intervention to prevent a cardiovascular event , it would be helpful to classify subjects in low , medium and high risk categories . The study evaluated which well known cerebrovascular and cardiovascular correlates , in particular fibrinogen level and ECG characteristics , are able to predict the occurrence of stroke in men of the general population using data from three European cohorts participating in EUROSTROKE . Methods : EUROSTROKE is a collaborative project among ongoing European population based cohort studies and design ed as a prospect i ve nested case-control study . For each stroke case two controls were sample d. Strokes were classified according to MONICA criteria or review ed by a panel of four neurologists . Complete data were available of 698 men ( 219 stroke events ) from cohorts in Cardiff ( 84 cases
Output:
| Conclusion : Data on novel risk factors for stroke are lacking compared with the equivalent data for acute coronary events , and there are very few data on specific subtypes of ischaemic stroke |
MS212718 | ***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 . Multiple laser systems are available for the purpose of hair removal . Objective . The purpose of this study was to determine the safety and long‐term efficacy of the 800 nm , pulsed diode laser at reducing hair count . Methods . Fifty volunteers , primarily Fitzpatrick skin types II and III , with dark brown or black hair , were treated with a diode laser ( 800 nm , 10–40 J/cm2 , 5–30 msec , 9 mm 9 mm , 5 ° C chilled h and piece ) . Each subject had eight treatment sites at varying fluences and pulse duration s , as well as a varying number of treatments and pulses . Hair counts were obtained at each site at baseline , 1 , 3 , 6 , 9 , and an average of 20 months after treatment . Results . After one treatment , hair regrowths ranged from 22 to 31 % at the 1‐month follow‐up visit , then remained stable between 65 and 75 % from the 3‐month to the averaged 20‐month follow‐up . After two treatments there were relatively longer growth delays , with hair regrowths plateauing beginning at 6 months after treatment and ranging from 47 to 66 % for the remainder of the follow‐up evaluations . Side effects were limited to pigmentary changes , transient in subjects with skin types II and III . Conclusions . This 800 nm diode laser with a chilled sapphire tip and variable pulse duration is safe and effective for long‐term hair reduction in individuals with skin types II and III Background . The C and ela alex and rite and the Coherent diode laser systems come equipped with built‐in skin cooling systems that are design ed to both protect the epidermis , allowing higher fluences , and to alleviate discomfort . Nevertheless , pain can be a significant problem especially with treatment of larger areas . Scatter of the laser beam is reportedly affected by the spot size . It is cl aim ed that larger spot sizes are more effective at identical fluences . Objective . This study evaluated the effectiveness of a topical 5 % lidocaine cream ( ELA‐Max ) to control pain and compared pain levels at identical fluences between the 8 mm and 12 mm spot size of the alex and rite laser and between the alex and rite and diode laser with its 9 mm spot size . Methods . The study was conducted in the axillae of 12 patients . Each axilla was divided in half for side‐by‐side comparison . Half of the right axilla was treated with the alex and rite 8 mm and the other half with the 12 mm spot size at identical fluences . The left axilla was treated at the maximum tolerated fluences with the alex and rite 12 mm spot size and the diode 9 mm spot size . Results . At identical fluences and other parameters , there was significantly more pain with the alex and rite 12 mm spot size than with the alex and rite 8 mm spot size , both with or without topical anesthesia . The alex and rite laser was significantly less painful than the diode laser both with and without topical anesthetic . The difference was most noticeable between the alex and rite 8 mm spot size and the diode 9 mm spot size . Topical 5 % lidocaine anesthesia was effective in reducing pain , though not completely , for both the alex and rite and the diode lasers . Conclusion . Topical 5 % lidocaine cream is a simple and effective method for reducing patient discomfort during laser hair removal procedures , even when a skin cooling device is being used . A larger spot size causes more pain than a smaller spot size at identical fluences . The 800 nm diode laser causes greater discomfort than the 755 nm alex and rite laser Promising clinical results have been obtained with the normal mode ruby laser for removal of unwanted hair . Melanin within the hair follicles is thought to act as target for the ruby laser pulses , whereas epidermal melanin is thought to be a competitive chromophore , responsible for potential side effects . This study aim ed ( i ) to objectify postoperative changes in skin pigmentation and texture and ( ii ) to evaluate the importance of variations in preoperative skin pigmentation for the development of side effects 12 weeks after 1 treatment with the normal-mode ruby laser . A total of 17 volunteers ( skin types I-IV ) were laser-treated in the hairy pubic region ( n = 51 test areas ) . A shaved test area served as control . Skin reflectance spectroscopical measurements , 3-dimensional surface contour analysis and ultrasonography objectified postoperative changes in skin pigmentation and texture . Blinded clinical assessment s revealed postoperative hyperpigmentation ( 2 % of test areas ) and hypopigmentation ( 10 % ) , whereas no textural changes were seen . Reflectance spectroscopically-determined pigmentary changes depended on the degree of preoperative skin pigmentation , fairly pigmented skin types experiencing sub clinical hyperpigmentation and darkly pigmented skin types experiencing sub clinical hypopigmentation . Three-dimensional surface profilometry documented similar pre- and postoperative surface contour parameters , indicating that the skin surface texture is preserved after laser exposure . Ultrasonography revealed similar skin thicknesses in laser-exposed and untreated control areas . It is concluded that normal-mode ruby laser treatment is safe for hair removal in skin types I-IV BACKGROUND AND OBJECTIVES The aim was to study hair removal efficacy , and possible side effects of two commercially available long pulsed diode lasers . The radiant exposure was selected to a value of 35 J/cm2 , which is frequently used in the clinic in accordance with manufacturer 's recommendations . STUDY DESIGN / MATERIAL S AND METHODS A prospect i ve clinical study was performed on twenty-nine patients with hair color ranging from light brown to black on the upper lip . One half of the upper lip was r and omly selected for treatment with the MedioStar laser ; the contralateral half of the lip was treated with the LightSheer laser . Three treatments were performed at 6 - 8 week intervals . Percent hair reduction and acute- and long-term side effects were evaluated after treatment . RESULTS The average hair reductions 6 months after the first treatment were 49 % with the MedioStar laser and 48 % with the LightSheer laser . No scarring or pigmentary change of the skin was observed after any of the treatments with either laser . However , differences in acute side effects such as degree of erythema and burned hairs were observed . CONCLUSIONS No statistically significant differences in hair removal efficacy were observed . These results agree with mathematical modeling , which also offers a method to estimate hair removal efficacy and adverse effects for a range of hair characteristics and laser parameters BACKGROUND AND OBJECTIVE The aim was to investigate the efficacy , side effects , and the long-term results of a long pulsed Nd : YAG-Laser for hair removal in different hair colors and skin types . STUDY DESIGN / MATERIAL S AND METHODS We performed a prospect i ve clinical study with 29 volunteers . Treatment was performed on the lower leg with a long pulsed Nd : YAG-Laser . Five test areas were treated 1 - 5 times in monthly intervals ; one served as control . Follow-up investigations were performed at each session , and 3 , 6 , and 12 months after the last therapy . No depilatory treatment except shaving was allowed during the time of follow-up . Percentual hair loss , short- and long-term side effects , and pain during the treatment were evaluated . RESULTS After one month , a hair loss of greater than 50 % was found in 44.9 % of the areas treated once . With up to five treatments , this percentage increased up to 71.5 % . One year after therapy , a greater than 50 % hair reduction was still present in 40 % of the five-treatment- areas and in 0 % of the areas treated only once . There were no permanent side effects despite one small scar after a folliculitis . CONCLUSIONS The long pulsed Nd : YAG is suitable to remove hair for more than 12 months effectively , although 4 - 5 sessions are necessary for these results . Blond hair can also be removed , although much less effective . No lasting side effects could be seen . Darker skin types or tanned skin can also be treated without side effects . A cooling may be advisable due to the pain reported by the volunteers OBJECTIVE To determine the safety and effectiveness of a long-pulsed Nd : YAG laser at 1064 nm in effecting long-term hair reduction in patients with darkly pigmented skin . DESIGN Nonr and omized before-after clinical and histological trial . SETTING Private practice , ambulatory care facility . PATIENTS Twenty women with skin phototypes IV through VI and dark brown to black terminal hair on the face , axillae , or legs . INTERVENTION A series of 3 long-pulsed ( 50-millisecond ) 1064-nm Nd : YAG laser treatments at fluences ranging from 40 to 50 J/cm(2 ) were delivered to the identified treatment areas on a monthly basis by a single operator . MAIN OUTCOME MEASURES Global clinical grading scores of comparable before-after treatment photographs were determined by 2 independent medical assessors during each laser session and 1 , 3 , 6 , and 12 months postoperatively . A dermatopathologist review ed unmarked histological specimens obtained at baseline , immediately after the initial laser treatment , and at 1 and 6 months after the final laser session . RESULTS Substantial hair reduction was seen after each of the 3 treatment sessions . Prolonged hair loss was observed 12 months after the final laser treatment ( 70%-90 % hair reduction ) . Axillary hair was substantially more responsive to laser irradiation than was hair located on the legs and face . Adverse effects included mild to moderate treatment pain and rare occurrences of vesiculation and transient pigmentary alteration without fibrosis or scarring . Histological tissue changes mirrored clinical response rates , with evidence of selective follicular injury without epidermal disruption . CONCLUSION The long-pulsed 1064-nm Nd : YAG laser is a safe and effective method of long-term hair reduction in patients with darkly pigmented skin Laser-assisted hair removal has been reported previously with the Nd : YAG laser , the long-pulse ruby laser , the long-pulse Alex and rite laser , and the short-pulse Alex and rite laser . Results with all these lasers have been successful ; however , it has been postulated that the long-pulse Alex and rite laser would have a lower complication rate and greater efficacy at identical fluences than the short-pulse Alex and rite laser . The authors chose to compare directly the pulsed Alex and rite lasers for speed of application , complications , and results . Eighteen patients who desired hair removal were entered into the study . There were 10 female and 8 male patients , with a mean age of 36 years . All skin types from Fitzpatrick classes I through VI were treated . The body areas treated consisted of the face , ears , neck , back , arms , upper thighs , bikini lines , legs , and breasts . One side of the body was treated with the short-pulse ( 2-msec ) Alex and rite laser ( Sharplan Epitouch 5100 ) . The other half was treated with a long-pulse ( 20-msec ) Alex and rite laser . Both lasers were set at the same fluence for each patient . Patients reported a 60 % to 80 % reduction in hair growth at 6 months . Both sides were identical with regard to return of hair growth and complications such as hypopigmentation . Both the long- and short-pulse Alex and rite laser systems yielded an effective method of hair reduction with minimal complications . Equal results and complications were obtained with the two systems . The only exception was that the length of the procedure was shorter with the short-pulse Alex and rite laser OBJECTIVE To determine the most effective treatment parameters for laser-assisted hair removal using a Q-switched neodymium : yttrium-aluminum-garnet ( Nd : YAG ) laser . DESIGN Prospect i ve study to determine the effectiveness of Q-switched ND : YAG laser-assisted hair removal under varying pretreatment protocol s. Hair growth was assessed after laser treatment , and the results were compared with those of wax epilation at 4 , 12 , and 24 weeks . SETTING A private ambulatory laser facility and academic referral center . INTERVENTION Laser-assisted hair removal was performed under 4 different pretreatment conditions . Eighteen areas of unwanted body and facial hair from 12 study subjects were divided into 4 quadrants . Wax epilation followed by application of a carbon-based solution and exposure to Q-switched Nd : YAG laser radiation was performed on 1 quadrant . A second quadrant was wax epilated and exposed to Q-switched Nd : YAG laser radiation without prior carbon solution application . A third quadrant was exposed to laser radiation alone , and a final quadrant was wax epilated to serve as the control . Follow-up evaluations at 1 , 3 , and 6 months consisted of photographic documentation , manual hair counts , and patient hair-density estimates . MAIN OUTCOME MEASURE Percentage of hair regrowth as assessed by objective hair counts and patient subjective evaluations . RESULTS Mean percentage of hair regrowth at 1 month was 39.9 % for the wax-carbon-laser quadrant , 46.7 % for the wax-laser quadrant , 66.1 % for the laser-alone quadrant , and 77.9 % for the wax control quadrant . The percentage of hair regrowth approximately doubled by 3 months but was significantly delayed in all laser-treated quadrants regardless of pretreatment protocol . Full hair regrowth in all anatomic locations was observed by month 6 . Patient subjective evaluations of hair density closely approximated hair count data . No adverse effects or long-term complications were observed . CONCLUSIONS A single hair-removal treatment with the Q-switched Nd : YAG las
Output:
| There appeared to be a short-term effect of approximately 50 % hair reduction with alex and rite and diode lasers up to six months after treatment , whereas little evidence was obtained for an effect of intense pulsed light , neodymium : YAG or ruby lasers .
Long-term hair removal was not documented with any treatment .
Pain , skin redness , swelling , burned hairs and pigmentary changes were infrequently reported adverse effects .
Some treatments lead to temporary short-term hair removal . |
MS212719 | ***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 : Different anesthetic agents have different effects on cerebrovascular physiology . However , the importance of these differences In neuroanesthetic practice are unclear . In an effort to determine whether important clinical differences are present , the authors compared three anesthetic techniques in 121 adults undergoing elective surgical removal of a supratentorial , intracranial mass lesion . Methods : Patients were assigned r and omly to one of three groups . In group 1 ( n=40 ) , anesthesia was induced with propofol and maintained with fentanyl ( ≊10 µg/kg load , 2 - 3 µg · kg-1 · h-1 infusion ) and propofol ( 50 - 300 µg · kg-1 · mln-1 ) . In group 2 ( n=40 ) , anesthesia was induced with thiopental and maintained with isoflurane and nitrous oxide . Up to 2 µg/kg fentanyl was given after replacement of the bone flap . In group 3 ( n=41 ) , anesthesia was induced with thiopental and maintained with fentanyl ( ≊10 µg/kg load , 2 - 3 µg · kg-1 · h1 infusion ) , nitrous oxide , and low-dose Isoflurane , if required . Blood pressure , heart rate , expired gas concentrations , and ventilatory parameters were recorded automatically in all patients . Epidural intracranial pressure ( ICP ) was measured via the first burr hole , brain swelling was rated at the time of dural opening , and emergence was monitored closely . Preoperative computed tomography or magnetic resonance imaging scans were evaluated , and pre- and postoperative neurologic exams were performed by a neurosurgeon unaware of group assignments . Total hospital stay ( days ) and total hospital cost ( exclusive of physician charges ) also were review ed . Results : During induction , higher heart rates were seen in isoflurane/nitrous oxide patients , whereas mean arterial pressure was ≊10 mmHg less during the maintenance phase ( compared with both other groups ) . Otherwise , there were few intergroup hemodynamic differences . While there were no clinical ly important intergroup differences in mean ICP (±SD)—group 1 , ICP=12 ± 7 mmHg ; group 2,15 ± 12 mmHg ; group 3 , ICP=11 ± 8 mmHg — more isoflurane/nitrous oxide patients ( nine , group 2 ) had an ICP £ 24 mmHg than in the other groups ( two each ) . Emergence was , overall , more rapid with fentanyl/nitrous oxide . For example , the median time until the patient could be awakened by quiet verbal comm and , e.g. , “ Open your eyes , ” was 5 min , versus 10 min in the other groups . There were no relationships between ICP and any measurement of emergence ( e.g. , time to response to comm and s ) . Seven of 41 ( 17 % ) fentanyl/nitrous oxide patients vomited In the early postoperative period , compared with only 1 of 40 ( 2.5 % ) of those given propofol/fentanyl and 2 of 40 ( 5 % ) receiving isoflurane/nitrous oxide ( P=0.03 ) . There were no differences in the incidence of new postoperative deficits , total hospital stay , or cost . Conclusions : Although there are modest differences among the three tested anesthetics , short-term outcome was not affected . These results indicate that , despite their respective cerebrovascular effects , all of the anesthetic regimens used were acceptable in these patients undergoing elective surgery During the last years huge amounts of literature have been review ed systematic ally . Recently , guidelines have been proposed . For the first time a large prospect i ve study has been performed on the effect of combining antiemetics . In this review we try to propose a rational approach to postoperative nausea and vomiting . The scoring of patients at risk , rational anaesthetic agents , prophylactic administration of antiemetics to patients at risk and effective postoperative antiemetic treatment are suggested Background : Nitrous oxide rapidly inflates gas‐filled spaces such as the intestines ; but whether the result ing bowel distension is clinical ly important remains unclear . We therefore tested the hypothesis that nitrous oxide produces clinical ly important bowel distension The incidence of postoperative nausea and vomiting and requirements for anti-emetic medication were assessed in 80 female patients undergoing day-case anaesthesia during assisted conception therapy . Anaesthesia was induced with alfentanil 50 μg · kg−1 and propofol 1 mg · kg−1 ; atracurium 0.5 mg · kg−1 was given to facilitate tracheal intubation . The patients were allocated to receive either total intravenous maintenance of anaesthesia with an infusion of propofol and increments of alfentanil ( Group P ) or inhalational maintenance of anaesthesia with nitrous oxide and enflurane ( Group E ) . Postoperative nausea , retching , vomiting , requirements for anti-emetic therapy , and unplanned admission for overnight stay in hospital were recorded . Overall incidence of nausea was 64 % in group E and 39 % in Croup P ( P < 0.05 ) . Incidence of vomiting was 67 % in Group E and 34 % in Group P ( P < 0.05 ) . Metoclopramide was requested by 62 % of patients in Group E , and 32 % of those in Group P ( P < 0.05 ) ; 21 % of the patients in Group E were admitted to hospital overnight , while only 5 % of the patients in Group P required unscheduled admission to hospital ( P < 0.05 ) . We conclude that total intravenous anaesthesia with propofol and alfentanil is superior to inhalational maintenance with nitrous oxide and enflurane in that it is associated with less nausea and vomiting , less requirement for anti-emetic medication , and a lower probability of unplanned admission to hospital after day-care gynaecological surgery . RésuméL’incidence de nausées et vomissements en période postopératoire et le besoin de médication antiémétique a été évalué chez 80 patientes devant subir une anesthésie ( cas d’un jour ) pendant une séance de conception assistée . L’induction de l’anesthésie s’est faite à l’aide d’alfentanil 50 μg · kg−1 et de propofol 1 mg · kg−1 ; l’intubation endotrachéale a été facilitée à l’aide d’atracurium 0,5 mg · kg−1 . L’anesthésie était maintenue soit à l’aide d’une technique intraveineuse totale , en utilisant une infusion de propofol et des bolus d’alfentanil ( groupe P ) , soit à l’aide d’une technique d’inhalation en utilisant le protoxyde d’azote et l’enflurane ( groupe E ) . Pendant la période postopératoire , les nausées , les efforts de vomissement , les vomissements , le besoin de thérapie antiémétique , et les admissions hospitalières imprévues pour une nuit étaient notés . L’incidence globale de nausées était de 64 % dans le groupe E et 39 % dans le groupe P ( P < 0,05 ) . L’incidence de vomissements était de 67 % dans le groupe E et de 34 % dans le groupe P ( P < 0,05 ) . Soixante-deux pourcent des patientes du groupe E ont dem and é du métoclopramide , comparativement à 32 % du groupe P ( P < 0,05 ) ; 21 % des patientes du grope E ont été admises à l’hôpital pour une nuit , t and is que seulement 5 % des patientes du groupe P l’ont été ( P < 0,05 ) . Nous concluons que l’anesthésie à l’aide d’une technique intraveineuse totale , avec propofol et alfentanil , est supérieure à une anesthésie par inhalation à l’aide de protoxyde d’azote et d’enflurane car elle est associée à une incidence moins élevée de nausées et vomissements , un besoin moindre de médication antiémétique , et une probabilité plus faible d’admissions hospitalières imprévues après une chirurgie gynécologique d’un jour An intravenous anesthetic drug , propofol was considered to pose antiemetic action . A r and omized controlled trial was conducted to evaluate whether propofol could effectively reduce post-operative nausea and vomiting ( PONV ) compared to thiopental-nitrous oxide ( N2O ) . One-hundred and eight patients undergoing outpatient gynecologic laparoscopy were assigned to receive 3 techniques of anesthesia ; thiopental-N2O ( T/N ) , propofol-N2O ( P/N ) and total intravenous anesthesia ( TIVA ) using propofol ( P/P ) . The results showed that in the early period ( 0 - 5 hours ) , post-operative nausea in T/N , P/N and P/P groups was 72 per cent , 44 per cent and 31 per cent , respectively ( P = 0.002 ) , and post-operative vomiting was 58 per cent , 36 per cent and 11 per cent respectively ( P = 0.00014 ) . Patients in the P/N and P/P groups experienced nausea less frequently than the T/N group [ relative risk ( RR ) = 0.62 , ( 95 % CI 0.41 - 0.93 ) and RR = 0.42 ( 0.25 - 0.72 ) respectively ] . Patients in the P/N and P/P groups experienced vomiting less frequently than the T/N group [ RR = 0.62 ( 0.37 - 1.04 ) and RR = 0.19 ( 0.07 - 0.5 ) respectively ] . Two patients in the T/N group were admitted because of severe nausea and vomiting . In conclusion , TIVA using propofol and propofol-N2O anesthesia can significantly reduce the incidence of PONV in the early period . Concerning the economic crisis of the country as well as the quality of care , propofol-N2O would be the most appropriate anesthetic of choice Background It is commonly stated that risk factors for postoperative nausea are the same as for vomiting . The authors design ed a prospect i ve study to identify and differentiate the risk factors for postoperative nausea and vomiting in various surgical population s in a clinical audit setting . Methods The study included 671 consecutive surgical in patients , aged 15 yr or more , undergoing various procedures . The study focused on postoperative nausea visual analog scale scores every 4 h and vomiting episodes within 72 h. Both vomiting and retching were considered as emetic events . Patient- , anesthesia- , and surgery-related variables that were considered to have a possible effect on the proportion of patients experiencing postoperative nausea and /or vomiting were examined . The bivariate Dale model for binary correlated outcomes was used to identify selectively the potential risk factors of postoperative nausea and vomiting . Results Among the 671 patients in the study , 126 ( 19 % ) reported one or more episodes of nausea , and 66 patients ( 10 % ) suffered one or more emetic episodes during the studied period . There was a highly significant association between the two outcomes . Some risk factors were predictive of both nausea and vomiting ( female gender , nonsmoking status , and general anesthesia ) . History of migraine and type of surgery were mainly responsible for nausea but not for vomiting . The predictive effect of risk factors was controlled for postoperative pain and analgesic drugs . Conclusion This study shows that differences exist in risk factors of postoperative nausea and vomiting . These could be explained by differences in the physiopathology of the two symptoms BACKGROUND Refractory postoperative nausea and vomiting ( PONV ) requiring repeated treatment with antiemetic drugs is a miserable experience for the patient that may substantially increase the cost of care . As risk stratification may aid in prophylaxis and treatment , we explored risk factors for severe PONV in patients enrolled in a large international , r and omized controlled trial ( the ENIGMA trial ) . METHODS Two thous and and fifty patients , aged > or = 18 yr and undergoing surgery anticipated to exceed 2 h in duration , were recruited . Patients were r and omized to nitrous oxide ( N(2)O)-based or N(2)O-free anaesthesia . Choice of other anaesthetic , analgesic , and antiemetic drugs was left to the discretion of the anaesthetist . Anaesthetic depth was adjusted according to clinical judgement and , if available , bispectral index ( BIS ) monitoring . Severe PONV was defined as : ( i ) two or more episodes of expulsion of gastric contents at least 6 h apart ; ( ii ) received at least three doses of antiemetic medication for treatment of PONV , within 24 h of surgery ; or both . We used logistic regression , and classification and regression tree analysis , to define risk factors for severe PONV . RESULTS Three hundred and thirty-three ( 16.6 % ) patients experienced severe PONV . Age < 55 yr , female sex , abdominal surgery , N(2)O administration , absence of BIS monitoring , and longer duration of anaesthesia were predictors of severe PONV [ area under receiver operating characteristic curve=0.70 ( 95 % confidence interval : 0.67 - 0.73 ) ] . CONCLUSIONS Severe
Output:
| We conclude that avoiding nitrous oxide does reduce the risk of postoperative nausea and vomiting , especially in women , but the overall impact is modest |
MS212720 | ***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 Exercise training is an effective and safe way to counteract cancer-related fatigue ( CRF ) and to improve health-related quality of life ( HRQoL ) . High-intensity interval training has proven beneficial for the health of clinical population s. The aim of this r and omized controlled trial was to compare the effects of resistance and high-intensity interval training ( RT – HIIT ) , and moderate-intensity aerobic and high-intensity interval training ( AT – HIIT ) to usual care ( UC ) in women with breast cancer undergoing chemotherapy . The primary endpoint was CRF and the secondary endpoints were HRQoL and cancer treatment-related symptoms . Methods Two hundred and forty women planned to undergo chemotherapy were r and omized to supervised RT – HIIT , AT – HIIT , or UC . Measurements were performed at baseline and at 16 weeks . Question naires included Piper Fatigue Scale , EORTC-QLQ-C30 , and Memorial Symptom Assessment Scale . Results The RT – HIIT group was superior to UC for CRF : total CRF ( p = 0.02 ) , behavior/daily life ( p = 0.01 ) , and sensory/physical ( p = 0.03 ) CRF . Role functioning significantly improved while cognitive functioning was unchanged for RT – HIIT compared to declines shown in the UC group ( p = 0.04 ) . AT – HIIT significantly improved emotional functioning versus UC ( p = 0.01 ) and was superior to UC for pain symptoms ( p = 0.03 ) . RT – HIIT reported a reduced symptom burden , while AT – HIIT remained stable compared to deteriorations shown by UC ( p < 0.01 ) . Only RT – HIIT was superior to UC for total symptoms ( p < 0.01 ) . Conclusions 16 weeks of resistance and HIIT was effective in preventing increases in CRF and in reducing symptom burden for patients during chemotherapy for breast cancer . These findings add to a growing body of evidence supporting the inclusion of structured exercise prescriptions , including HIIT , as a vital component of cancer rehabilitation . Trial registration Clinical trials.gov Registration Number : NCT02522260 Background Promoting quality of life ( QoL ) is a key priority in cancer care . We investigated the hypothesis that , in comparison to usual care , exercise post-neoadjuvant chemoradiation therapy/prior to surgical resection will reduce pain , fatigue , and insomnia , and will improve physical and mental health perceptions in patients with locally advanced stage rectal cancer . Methods In this non-r and omized controlled pilot trial , patients in the supervised exercise group ( EG ; Mage = 64 years ; 64 % male ) and in the control group ( CG ; Mage = 72 years ; 69 % male ) completed the European Organization for Research and Treatment of Cancer core Quality of Life question naire and the R AND 36-Item Health Survey three times : pre-neoadjuvant chemoradiation therapy ( Time 1 ; nEC = 24 ; nCG = 11 ) , post-neoadjuvant chemoradiation therapy/pre-exercise intervention ( Time 2 ; nEC = 23 ; nCG = 10 ) , and post-exercise intervention ( Time 3 ; nEC = 22 ; nCG = 10 ) . The 6-week exercise intervention was delivered in hospital and comprised of interval aerobic training . Patients trained in pairs three times per week for 30 to 40 min . Data were analyzed by Mann – Whitney tests and by Wilcoxon matched-pairs signed-rank tests . Results No significant between-group differences in changes were found for any of the outcomes . In both groups , fatigue levels decreased and physical health perceptions increased from pre- to post-exercise intervention . Pain levels also decreased from pre- to post-exercise intervention , albeit not significantly . Conclusions The findings from this study can be used to guide a more definitive trial as they provide preliminary evidence regarding the potential effects of pre-operative exercise on self-reported pain , fatigue , insomnia , and health perceptions in patients with locally advanced rectal cancer . Trial registration : This study has been registered with clinical trials.gov ( NCT01325909 ; March 29 , 2011 ) BACKGROUND Patients requiring surgery for locally advanced rectal cancer often additionally undergo neoadjuvant chemoradiotherapy ( NACRT ) , of which the effects on physical fitness are unknown . The aim of this feasibility and pilot study was to investigate the effects of NACRT and a 6 week structured responsive exercise training programme ( SRETP ) on oxygen uptake [ Formula : see text ] at lactate threshold ( [ Formula : see text ] ) in such patients . METHODS We prospect ively studied 39 consecutive subjects ( 27 males ) with T3 - 4/N+ resection margin threatened rectal cancer who completed st and ardized NACRT . Subjects underwent cardiopulmonary exercise testing at baseline ( pre-NACRT ) , at week 0 ( post-NACRT ) , and week 6 ( post-SRETP ) . Twenty-two subjects undertook a 6 week SRETP on a training bike ( three sessions per week ) between week 0 and week 6 ( exercise group ) . These were compared with 17 contemporaneous non-r and omized subjects ( control group ) . Changes in [ Formula : see text ] at [ Formula : see text ] over time and between the groups were compared using a compound symmetry covariance linear mixed model . RESULTS Of 39 recruited subjects , 22 out of 22 ( exercise ) and 13 out of 17 ( control ) completed the study . There were differences between the exercise and control groups at baseline [ age , ASA score physical status , World Health Organisation performance status , and Colorectal Physiologic and Operative Severity Score for the Enumeration of Mortality and Morbidity ( CR-POSSUM ) predicted mortality ] . In all subjects , [ Formula : see text ] at [ Formula : see text ] significantly reduced between baseline and week 0 [ -1.9 ml kg(-1 ) min(-1 ) ; 95 % confidence interval ( CI ) -1.3 , -2.6 ; P<0.0001 ] . In the exercise group , [ Formula : see text ] at [ Formula : see text ] significantly improved between week 0 and week 6 ( + 2.1 ml kg(-1 ) min(-1 ) ; 95 % CI + 1.3 , + 2.9 ; P<0.0001 ) , whereas the control group values were unchanged ( -0.7 ml kg(-1 ) min(-1 ) ; 95 % CI -1.66 , + 0.37 ; P=0.204 ) . CONCLUSIONS NACRT before rectal cancer surgery reduces physical fitness . A structured exercise intervention is feasible post-NACRT and returns fitness to baseline levels within 6 weeks . CLINICAL TRIAL REGISTRATION NCT 01325909 OBJECTIVES Poor aerobic fitness is a potential modifiable risk factor for long-term survival and quality of life in patients with lung cancer . This r and omized trial evaluates the impact of adding rehabilitation ( Rehab ) with high-intensity interval training ( HIIT ) before lung cancer surgery to enhance cardiorespiratory fitness and improve long-term postoperative outcome . METHODS Patients with operable lung cancer were r and omly assigned to usual care ( UC , n = 77 ) or to intervention group ( Rehab , n = 74 ) that entailed HIIT that was implemented only preoperatively . Cardiopulmonary exercise testing ( CPET ) and pulmonary functional tests ( PFTs ) including forced vital capacity ( FVC ) , forced expiratory volume ( FEV 1 ) and carbon monoxide transfer factor ( KCO ) were performed before and 1 year after surgery . RESULTS During the preoperative waiting time ( median 25 days ) , Rehab patients participated to a median of 8 HIIT sessions ( interquartile [ IQ ] 25 - 75 % , 7 - 10 ) . At 1 year follow-up , 91 % UC patients and 93 % Rehab patients were still alive ( P = 0.506 ) . Pulmonary functional changes were non-significant and comparable in both groups ( FEV 1 mean -7.5 % , 95 % CI , -3.6 to -12.9 and in KCO mean 5.8 % 95 % CI 0.8 - 11.8 ) Compared with preoperative CPET results , both groups demonstrated similar reduction in peak oxygen uptake ( mean -12.2 % 95 % CI -4.8 to -18.2 ) and in peak work rate ( mean -11.1 % 95 % CI -4.2 to -17.4 ) . CONCLUSIONS Short-term preoperative rehabilitation with HIIT does not improve pulmonary function and aerobic capacity measured at 1 year after lung cancer resection . TRIAL REGISTRY Clinical Trials.gov ; No. NCT01258478 ; www . clinical trials.gov Flaws in the design , conduct , analysis , and reporting of r and omised trials can cause the effect of an intervention to be underestimated or overestimated . The Cochrane Collaboration ’s tool for assessing risk of bias aims to make the process clearer and more OBJECTIVES The aim of this study was to determine whether ectopic fat depots are prospect ively associated with cardiovascular disease , cancer , and all-cause mortality . BACKGROUND The morbidity associated with excess body weight varies among individuals of similar body mass index . Ectopic fat depots may underlie this risk differential . However , prospect i ve studies of directly measured fat are limited . METHODS Participants from the Framingham Heart Study ( n = 3,086 ; 49 % women ; mean age of 50.2 years ) underwent assessment of fat depots ( visceral adipose tissue , pericardial adipose tissue , and periaortic adipose tissue ) using multidetector computed tomography and were followed up longitudinally for a median of 5.0 years . Cox proportional hazards regression models were used to examine the association of each fat depot ( per 1 SD increment ) with the risk of incident cardiovascular disease , cancer , and all-cause mortality after adjustment for st and ard risk factors , including body mass index . RESULTS Overall , there were 90 cardiovascular events , 141 cancer events , and 71 deaths . After multivariable adjustment , visceral adipose tissue was associated with cardiovascular disease ( hazard ratio : 1.44 ; 95 % confidence interval : 1.08 to 1.92 ; p = 0.01 ) and cancer ( hazard ratio : 1.43 ; 95 % confidence interval : 1.12 to 1.84 ; p = 0.005 ) . Addition of visceral adipose tissue to a multivariable model that included body mass index modestly improved cardiovascular risk prediction ( net reclassification improvement of 16.3 % ) . None of the fat depots were associated with all-cause mortality . CONCLUSIONS Visceral adiposity is associated with incident cardiovascular disease and cancer after adjustment for clinical risk factors and generalized adiposity . These findings support the growing appreciation of a pathogenic role of ectopic fat BACKGROUND Development of this guideline was undertaken by the Exercise for People with Cancer Guideline Development Group , a group organized by Cancer Care Ontario 's Program in Evidence -Based Care ( pebc ) . The purpose of the guideline was to provide guidance for clinicians with respect to exercise for patients living with cancer , focusing on the benefits of specific types of exercise , recommendations about screening requirements for new referrals , and safety concerns . METHODS Consistent with the pebc 's st and ardized approach , a systematic search was conducted for existing guidelines , and systematic literature search es were performed in medline and embase for both systematic review s and primary literature . Content and methodology experts performed an internal review , which was followed by an external review by targeted experts and intended users . RESULTS The search identified three guidelines , eighteen systematic review s , and twenty-nine r and omized controlled trials with relevance to the topic . The present guideline provides recommendations for the duration , frequency , and intensity of exercise appropriate for people living with cancer . It also provides recommendations for pre-exercise assessment , safety concerns , and delivery models . CONCLUSIONS There is sufficient evidence to show that exercise provides benefits in quality of life and muscular and aerobic fitness for people with cancer both during and after treatment , and that it does not cause harm . The present guideline is intended to support the Canadian Society for Exercise Physiology 's Canadian physical activity guidelines . The recommendations are intended for clinicians and institutions treating cancer patients in Ontario , and for policymakers and program planners involved in the delivery of exercise programs for cancer patients Purpose Peak oxygen consumption ( VO2peak ) is an important predictive factor for long-term prognosis in patients with non-small cell lung cancer ( NSCLC ) . The purpose of this study was to investigate whether 8 weeks of exercise training improves exercise capacity , as assessed by VO2peak , and other related factors in patients with NSCLC receiving targeted therapy . Methods A total of 24 participants with adenocarcinoma were r and omly assigned to either the control group ( n = 11 ) or the exercise group ( n = 13 ) . Subjects in the exercise group participated in individualized , high-intensity aerobic interval training of exercise . The outcome measures assessed at baseline and after 8 weeks were as follows : VO2peak and the percentage of predicted VO2peak ( % predVO2peak ) , muscle strength and endurance of the right quadriceps , muscle oxygenation during exercise , insulin resistance as calculated by the homeost
Output:
| Similarly , no superior effects of HIIT compared to MIE were found for quality of life or changes in lean mass , while evidence was provided for a larger reduction in fat mass .
Conclusion This systematic review showed that short-term HIIT induces similar positive effects on physical fitness and health-related outcomes as MIE but seems to be superior compared to UC .
Thus , HIIT might be a time-efficient intervention for cancer patients across all stages of therapy and aftercare .
Implication s for Cancer SurvivorsHigh-intensity interval training ( HIIT ) is superior compared to usucal care in improving physical fitness and health-related outcomes in cancer patients across all stages of therapy and aftercare .
Currently , there is no evidence for the benefits of HIIT compared to aerobic training of moderate intensity ( MIE ) for changes in cardiorespiratory fitness , lean mass and patient-reported outcomes .
Reductions in fat mass may be more pronounced in HIIT compared to MIE when training is performed in aftercare |
MS212721 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: CONTEXT The Women 's Health Initiative trial of combined estrogen plus progestin was stopped early when overall health risks , including invasive breast cancer , exceeded benefits . Outst and ing issues not previously addressed include characteristics of breast cancers observed among women using hormones and whether diagnosis may be influenced by hormone effects on mammography . OBJECTIVE To determine the relationship among estrogen plus progestin use , breast cancer characteristics , and mammography recommendations . DESIGN , SETTING , AND PARTICIPANTS Following a comprehensive breast cancer risk assessment , 16 608 postmenopausal women aged 50 to 79 years with an intact uterus were r and omly assigned to receive combined conjugated equine estrogens ( 0.625 mg/d ) plus medroxyprogesterone acetate ( 2.5 mg/d ) or placebo from 1993 to 1998 at 40 clinical centers . Screening mammography and clinical breast examinations were performed at baseline and yearly thereafter . MAIN OUTCOME MEASURES Breast cancer number and characteristics , and frequency of abnormal mammograms by estrogen plus progestin exposure . RESULTS In intent-to-treat analyses , estrogen plus progestin increased total ( 245 vs 185 cases ; hazard ratio [ HR ] , 1.24 ; weighted P<.001 ) and invasive ( 199 vs 150 cases ; HR , 1.24 ; weighted P = .003 ) breast cancers compared with placebo . The invasive breast cancers diagnosed in the estrogen plus progestin group were similar in histology and grade but were larger ( mean [ SD ] , 1.7 cm [ 1.1 ] vs 1.5 cm [ 0.9 ] , respectively ; P = .04 ) and were at more advanced stage ( regional/metastatic 25.4 % vs 16.0 % , respectively ; P = .04 ) compared with those diagnosed in the placebo group . After 1 year , the percentage of women with abnormal mammograms was substantially greater in the estrogen plus progestin group ( 716 [ 9.4 % ] of 7656 ) compared with placebo group ( 398 [ 5.4 % ] of 7310 ; P<.001 ) , a pattern which continued for the study duration . CONCLUSIONS Relatively short-term combined estrogen plus progestin use increases incident breast cancers , which are diagnosed at a more advanced stage compared with placebo use , and also substantially increases the percentage of women with abnormal mammograms . These results suggest estrogen plus progestin may stimulate breast cancer growth and hinder breast cancer diagnosis OBJECTIVES To analyze prospect ively the association between hormone replacement therapy ( HRT ) and mortality in women before old age . DESIGN AND METHODS A group of 11,667 women ( 91 % of the age cohort of the area ) aged 52 - 62 years from the population -based Kuopio Osteoporosis Risk Factor and Prevention Study were followed for 7 years in 1994 - 2001 . Information about HRT use and health events was obtained from two repeated question naires in 1989 and 1994 . Information about deaths and causes of death from the follow-up period was obtained from the Statistics Finl and . Cox 's proportional-hazards models were used to calculate risk of death related to the use of HRT . RESULTS At the start of follow-up , 2203 women had used HRT > 5 years , 3945 women < or = 5 years and 5519 women had never used it . During the follow-up , 361 deaths occurred . Compared with non-users of HRT , the adjusted hazard ratio ( HR ) of death from any cause was 1.05 ( 95 % confidence interval ( CI ) 0.80 - 1.36 ) in women who used HRT < or = 5 years and 1.06 ( 95 % CI 0.78 - 1.46 ) in women who used HRT > 5 years . The adjusted HR for coronary heart disease ( CHD ) mortality in women who used HRT < or = 5 years was 0.79 ( 95 % CI 0.36 - 1.73 ) , and in women who used HRT > 5 years , 2.16 ( 95 % CI 0.93 - 4.98 ) . For breast cancer mortality the adjusted HR for < or = 5 years of HRT use was 0.96 ( 95 % CI 0.32 - 2.82 ) and 2.62 ( 95 % CI 0.98 - 7.00 ) for > 5 years of HRT use . CONCLUSIONS History of HRT use does not affect overall or CHD mortality in women . More than 5 years of HRT use may increase the risk of breast cancer mortality Of 256 patients with breast cancer diagnosed between 1972 and 1981 , 102 have died ( mortality , 39.8 % ) . More hormone users had negative axillary nodes ( 57.1 % ) than did nonusers ( 41.8 % ) . The mortality of the hormone users ( 22.2 % ) was significantly lower ( p less than or equal to 0.01 ) than that of the nonusers ( 45.5 % ) . In 162 patients whose diagnosis of breast cancer was made prior to 1979 , the 5-year survival rate in hormone users was 76.2 % compared to 48.1 % in nonusers . During the prospect i ve phase of the study from 1975 to 1981 , the lowest incidence of breast carcinoma ( 67.3:100,000 ) was observed in the estrogen-progestogen users and was significantly lower than that of the untreated group ( 342.3:100,000 ) and lower than that expected from both the Third National Cancer Survey and the National Cancer Institute System for Electronic Evaluation and Retrieval ( SEER ) data ( p less than or equal to 0.01 ) . Estrogen therapy does not increase the risk of mammary malignancy , but added progestogen significantly decreases the risk BACKGROUND Hormone replacement therapy ( HRT ) is typically avoided for women with a history of breast cancer because of concerns that estrogen will stimulate recurrence . In this study , we sought to evaluate the impact of HRT on recurrence and mortality after a diagnosis of breast cancer . METHODS Data were assembled from 2755 women aged 35 - 74 years who were diagnosed with incident invasive breast cancer while they were enrolled in a large health maintenance organization from 1977 through 1994 . Pharmacy data identified 174 users of HRT after diagnosis . Each HRT user was matched to four r and omly selected nonusers of HRT with similar age , disease stage , and year of diagnosis . Women in the analysis were recurrence free at HRT initiation or the equivalent time since diagnosis . Rates of recurrence and death through 1996 were calculated . Adjusted relative risks were estimated by use of the Cox regression model . All statistical tests were two-sided . RESULTS The rate of breast cancer recurrence was 17 per 1000 person-years in women who used HRT after diagnosis and 30 per 1000 person-years in nonusers ( adjusted relative risk for users compared with nonusers = 0.50 ; 95 % confidence interval [ CI ] = 0.30 to 0.85 ) . Breast cancer mortality rates were five per 1000 person-years in HRT users and 15 per 1000 person-years in nonusers ( adjusted relative risk = 0.34 ; 95 % CI = 0.13 to 0.91 ) . Total mortality rates were 16 per 1000 person-years in HRT users and 30 per 1000 person-years in nonusers ( adjusted relative risk = 0.48 ; 95 % CI = 0.29 to 0.78 ) . The relatively low rates of recurrence and death were observed in women who used any type of HRT ( oral only = 41 % of HRT users ; vaginal only = 43 % ; both oral and vaginal = 16 % ) . No trend toward lower relative risks was observed with increased dose . CONCLUSION We observed lower risks of recurrence and mortality in women who used HRT after breast cancer diagnosis than in women who did not . Although residual confounding may exist , the results suggest that HRT after breast cancer has no adverse impact on recurrence and mortality Summary Nine hundred and eighty-four breast cancer patients were interviewed regarding exogenous hormonal use . This represents a r and om sample of breast cancer patients in Southern Sweden referred to the Department of Oncology at Lund for treatment between 1978 and 1997 ( excluding 1980 and 1981 ) with a 100 % follow-up . Ever-use of hormone replacement therapy ( HRT ) prior to diagnosis was significantly associated with a longer overall survival in women with their breast cancer diagnosed at ages 45 and above , relative risk ( RR ) of dying 0.73 ( 95 % confidence interval ( CI ) 0.62–0.87 ; P = 0.0005 ) . Ever use of HRT prior to breast cancer diagnosis was significantly positively associated with overall longer survival after adjustment for T-stage , N-stage , M-stage , year of diagnosis and age at diagnosis , RR of dying 0.78 ( 95 % CI 0.65–0.93 ; P = 0.006 ) . Hormone replacement therapy use and oestrogen receptor positivity were independently significantly associated with overall longer survival , P = 0.005 and P < 0.0001 , respectively , in one model . HRT use and progesterone receptor positivity were also independently significantly associated with longer overall survival , P = 0.003 and P = 0.0003 , respectively , in another model . The mode of diagnosis was known in 705 women . Mammography screening was not more common among HRT users compared with never-users , where this information was available . Both mammography screening and HRT use were independently associated with longer survival , P = 0.002 and P = 0.038 respectively It is well known that a family history of breast cancer is an important risk factor for the disease . A critical issue is how to advise patients with a family history of breast cancer about perimenopausal and postmenopausal use of hormone replacement therapy ( HRT ) . Hoskins and colleagues [ 1 ] have provided guidelines on assessment and counseling of women with such a history , including a recommendation that they avoid exogenous estrogens . A considerable body of literature has discussed the association of HRT and risk for breast cancer . Interpretation of available data is not consistent : Two meta-analyses [ 2 , 3 ] found a positive association , and two others [ 4 , 5 ] found no association . More recent studies have not clarified the issue [ 6 - 8 ] . Findings on increased risk in women with a family history of breast cancer have been more consistent . A meta- analysis [ 3 ] of five studies that had examined the issue suggested that the risk for breast cancer associated with HRT was elevated among women without a family history of breast cancer ( relative risk [ RR ] , 1.5 [ 95 % CI , 1.2 to 1.7 ] ) but was even greater among women with a family history ( RR , 3.4 [ CI , 2.0 to 6.0 ] ) . Of the studies not included in the meta- analysis , some [ 9 - 12 ] but not all [ 6 , 7 , 13 ] reported similar observations . Beyond the issue of the effects of HRT on the incidence of breast cancer , further consideration of the concomitant effect of HRT on risk for death is warranted . A recent report from the Nurses ' Health Study [ 8 ] suggests that hormonal therapy lasting at least 5 years is associated with a 45 % increase in the rate of death from breast cancer . Analytic epidemiologic studies suggest that women who receive HRT have a significantly lower risk for death , primarily because of protection against cardiovascular disease [ 14 - 17 ] . Thus , it is important to examine all-cause mortality when considering the risks and benefits of HRT use [ 18 ] , especially among women with a family history of breast cancer . As part of the Iowa Women 's Health Study , a prospect i ve cohort study of 41 837 women who were 55 to 69 years of age at baseline in 1986 , data were collected on self-reported family history of breast cancer in first-degree relatives and on history of HRT use . These data were used to examine the risks for postmenopausal breast cancer , case fatality , and total mortality . Methods The Iowa Women 's Health Study Cohort Participants in the Iowa Women 's Health Study were selected from a r and om sample of all women between 55 and 69 years of age who had a valid Iowa driver 's license in 1985 [ 19 ] . This sampling frame comprised approximately 94 % of female Iowa residents in that age range . The primary purpose of the study was to examine the association of obesity and body fat distribution with the incidence of cancer and mortality rate . A total of 41 837 women returned a mailed question naire ( response rate , 42.7 % ) . Three follow-up question naires mailed in October 1987 , August 1989 , and June 1992 were used to collect information on incident self-reported disease and each participant 's current residence . Only minor demographic differences were seen at baseline between respondents and nonrespondents [ 20 ] . Nonrespondents have subsequently been found to have a higher 5-year incidence of cancer and rate of death ( primarily death from diseases related to smoking ) [ 21 ] . The incidence of breast cancer , however , was similar among respond
Output:
| Postdiagnosis HRT use also showed a beneficial effect on breast cancer survival .
In the subgroup analyses , we found that patients who were current users at diagnosis or who received combined hormone therapy before diagnosis seemed to show more benefit from HRT use .
In conclusion , the average effect of HRT use seems not harmful to breast cancer survival . |
MS212722 | ***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: There is increasing evidence that sleep promotes off-line enhancement of a variety of explicitly learned motor tasks in young adults . However , whether sleep promotes off-line consolidation of implicitly learned motor tasks is still under question . Furthermore , the role of sleep in promoting transfer of learning remains unknown . This study examined the role of sleep in learning and transfer of learning of an implicit continuous motor task . Twenty-three neurologically intact individuals ( mean age 26.4 years ) were r and omly assigned to either a sleep group or a no-sleep group . The sleep group practice d a continuous tracking task in the evening and underwent retention and transfer testing the following morning , while the no-sleep group practice d the tracking task in the morning and underwent retention and transfer testing in the evening . The results show that in both the sleep and no-sleep groups , performance improved off-line without further practice for both the general skill and the sequence-specific skill . The results also indicate that sleep and time promote transfer of learning of both sequence-specific and general skill learning to a spatial and temporal variation of the motor task . These findings demonstrate that sleep does not play a critical role in promoting off-line learning and transfer of learning of an implicit continuous motor task Decline in cognitive functions , including impaired acquisition of novel skills , is a feature of older age that impacts activities of daily living , independence , and integration in modern societies Background and Purpose : The purpose of this study was to identify which characteristics of a multidimensional sequence containing motor , spatial , and temporal elements would be most salient for motor sequence learning and whether age might differentially affect this learning . Subjects : Younger ( n=11 , mean age=26.0 years ) , middle-aged ( n=13 , mean age=50.7 years ) , and older ( n=11 , mean age=77.5 years ) adults who were neurologically intact participated in the study . Methods : Participants practice d a sequencing task with repeated motor , spatial , and temporal dimensions for 2 days ; on a separate third day , participants completed retention and interference tests design ed to assess sequence learning and which elements of the sequence were learned . The mean median response time for each block of responses was used to assess motor sequence learning . Results : Younger and middle-aged adults demonstrated sequence-specific motor learning at retention testing via faster response times for repeated sequences than r and om sequences ; both of these groups showed interference for the motor dimension . In contrast , older adults demonstrated nonspecific learning ( ie , similar improvements in response time for both r and om and repeated sequences ) . These findings were shown by a lack of difference between r and om and repeated sequence performance in the older adult group both at retention testing and during interference tests . Conclusion and Discussion : Our data suggest that , when younger and middle-aged adults practice sequences containing multiple dimensions of movement , the motor element is most important for motor learning . The absence of sequence-specific change demonstrated by an older adult group that was healthy suggests an age-related impairment in motor learning that may have profound implication s for rehabilitation The frequencies of five common sleep complaints -- trouble falling asleep , waking up , awaking too early , needing to nap and not feeling rested -- were assessed in over 9,000 participants aged 65 years and older in the National Institute on Aging 's multicentered study entitled " Established Population s for Epidemiologic Studies of the Elderly " ( EPESE ) . Less than 20 % of the participants in each community rarely or never had any complaints , whereas over half reported at least one of these complaints as occurring most of the time . Between 23 % and 34 % had symptoms of insomnia , and between 7 % and 15 % percent rarely or never felt rested after waking up in the morning . In multivariate analyses , sleep complaints were associated with an increasing number of respiratory symptoms , physical disabilities , nonprescription medications , depressive symptoms and poorer self-perceived health . Sleep disturbances , particularly among older persons , oftentimes may be secondary to coexisting diseases . Determining the prevalence of specific sleep disorders , independent of health status , will require the development of more sophisticated and objective measures of sleep disturbances OBJECTIVE The present study examined whether the combination of a short daytime nap with caffeine , bright light and face washing was effective against mid-afternoon sleepiness . METHODS Ten young healthy adults participated in 5 experimental conditions ; those experiments were-Nap only : taking a 20 min nap ; Caffeine+Nap : taking 200 mg of caffeine followed by a nap ; Nap+Bright-light : being exposed to 2000 lx of bright light for 1 min immediately after napping ; Nap+Face-washing : washing their faces immediately after napping ; and No-Nap : taking a rest without sleep . These naps were taken at 12:40 hours . The subjects engaged in computer tasks for 15 min before napping and for 1 h after napping . RESULTS Caffeine+Nap was the most effective for subjective sleepiness and performance level ; its effects lasted throughout 1 h after napping . Nap+Bright-light was comparable with Caffeine+Nap , except for performance level . Nap+Face-washing showed mild and transient effects , however , it suppressed subjective sleepiness immediately after napping . CONCLUSIONS The effects of a short nap against mid-afternoon sleepiness could be enhanced by combining caffeine intake , exposure to bright light , or face washing . SIGNIFICANCE The present study would provide effective counter measures against mid-afternoon sleepiness and sleepiness related accidents Memory consolidation is facilitated by sleep . Specifying the functional domain of sleep-dependent consolidation ( SDC ) is important for identifying the neural mechanisms underlying this phenomenon . Previous work indicates that SDC may be limited to conditions in which learning is explicit . In the present study , we tested the hypothesis that SDC may also occur with implicit learning when learning benefits from the formation of context ual associations , a function associated with the hippocampus . Three versions of the serial-reaction-time task ( SRTT ) were examined , and SDC was assessed by comparing performance after 12 hr breaks that included or did not include sleep . SDC was observed in the Explicit condition . Two implicit conditions were compared . In the Implicit Non context ual condition , participants performed a concurrent tone-counting task with the pitch of each tone selected at r and om , precluding cross-dimensional associations . In the Implicit Context ual condition , participants responded to the color of the cues while the spatial location of the cues followed a correlated sequence . Whereas learning was observed in both implicit conditions , SDC was restricted to the context ual condition . Given that the formation of context ual associations is dependent on the hippocampus , we suggest that SDC is a hippocampus-mediated process OBJECTIVES To determine whether sleep benefits motor memory in healthy elderly adults and , if so , whether the observed sleep-related benefits are comparable with those observed in healthy young adults . DESIGN Repeated- measures cross-over design . SETTING Boston , Massachusetts ( general community ) and Harvard University . PARTICIPANTS Sixteen healthy older and 15 healthy young participants . MEASUREMENTS Motor sequence task ( MST ) performance was assessed at training and at the beginning and end of the retest session ; polysomnographic sleep studies were recorded for the elderly participants . RESULTS After 12 hours of daytime wakefulness , elderly participants showed a dramatic decline in MST performance on the first three retest trials , and only a nonsignificant improvement by the end of retest ( the last 3 retest trials ) . In contrast , when the same participants trained in the morning but were retested 24 hours after training , after a day of wake plus a night of sleep , they maintained their performance at the beginning of retest and demonstrated a highly significant 17.4 % improvement by the end of the retest session , essentially identical to the 17.3 % improvement seen in young participants . These strikingly similar improvements occurred despite the presence of other age-related differences , including overall slower motor speed , a lag in the appearance of sleep-dependent improvement , and an absence of correlations between overnight improvement and sleep architecture or sleep spindle density in the elderly participants . CONCLUSION These findings provide compelling evidence that sleep optimizes motor skill performance across the adult life span BACKGROUND Studies in young healthy volunteers provided evidence of a beneficial impact of an anodal time-varied transcranial direct current stimulation ( tDCS ) during early slow wave rich sleep on declarative memory but not on procedural memory . OBJECTIVE /HYPOTHESIS The present study investigated whether sleep-dependent memory consolidation can also be affected by slow oscillating tDCS in a population of elderly subjects . METHODS 26 subjects ( 69.1 years ± 7.7 years ) received bi-frontal anodal stimulation ( max . current density : 0.331 mA/cm(2 ) ) during early NREM sleep in a double-blind placebo-controlled r and omized crossover study . Stimulation effects on offline consolidation were tested by using a declarative and a procedural memory task . Furthermore , sleep stages were scored , EEG power was analyzed and spindle densities were assessed . RESULTS Independently from stimulation condition , performance in both memory tasks significantly decreased overnight . Stimulation revealed no significant effect on sleep-dependent memory consolidation . Verum tDCS was accompanied by significantly more time awake and significantly less NREM stage 3 sleep during five 1-min stimulation free intervals . CONCLUSIONS The results of the present study are in line with other studies showing that offline consolidation during sleep varies with age and is less pronounced in the elderly than in young or middle-aged subjects . Contrary to an almost identical positive study in young adults , slow oscillatory tDCS applied to the elderly failed to show a beneficial effect on memory consolidation in the present study Background Sleep has been demonstrated to enhance simple motor skill learning “ offline ” in young adults . “ Offline learning ” refers to either the stabilization or the enhancement of a memory through the passage of time without additional practice . It remains unclear whether a functional motor task will benefit from sleep to produce offline motor skill enhancement . Physical therapists often teach clients functional motor skills ; therefore , it is important to underst and how sleep affects learning of these skills . Objective The purpose of this study was to determine whether sleep enhances the learning of a functional motor task . Design A prospect i ve , cross-sectional , repeated- measures design was used . Methods Young participants who were healthy ( N=24 ) were r and omly assigned to either a sleep group or a no-sleep group . The sleep group practice d a novel walking task in the evening and underwent retention testing the following morning , and the no-sleep group practice d the task in the morning and underwent retention testing in the evening . Outcome measures included time around the walking path and spatiotemporal gait parameters . Results Only participants who slept after practicing the novel walking task demonstrated a significant offline improvement in performance . Compared with the no-sleep group , participants in the sleep group demonstrated a significant decrease in the time around the walking path , an increase in t and em velocity , an increase in t and em step length , and a decline in t and em step time . Limitations Time-of-day effect and inability to ensure a certain amount of sleep quantity and quality of participants were limitations of the study . Conclusions This study is the first to provide evidence that sleep facilitates learning clinical ly relevant functional motor tasks . Sleep is an important factor that physical therapists should consider when teaching clients motor skills A worksite study was conducted to examine whether a 15-min nap during a post-lunch rest period would affect subsequent alertness , performance , and nocturnal sleep in eight factory workers under a 3-week protocol . Subjects were asked to take the nap at 12:30 h on a reclining chair during the nap week , and to remain awake during the no-nap week . The order of these 2 weeks was counterbalanced between the subjects . During the third , follow-up week , each subject determined whether or not she/he would nap . Alertness on the job and nocturnal sleep were assessed using a sleep diary . Wrist activity was also recorded during sleep at night . Choice reaction time task ( RT ) was performed at 10:00 and 15:00 h every day of the nap week and every other day of the no-nap and follow-up weeks . Perceived alertness was significantly higher in the afternoon after nap than after no nap at the end of the week . Similar effects were observed during the follow-up week where almost half of the subjects napped . No significant differences between the three weeks were found for RT performance or nocturnal sleep . Workers ' attitudes toward the nap were favourable . Although further intervention research is required , our results suggest that post-lunch napping may have the potential to promote daytime alertness at work Background and Purpose : Although sleep has been shown to enhance motor skill learning , it remains unclear whether sleep enhances learning of a functional motor task in middle-aged and older individuals . The purpose of this study was to examine whether sleep enhances motor learning of a functional motor task in middle-aged and older adults . Methods : Twenty middle-aged and 20 older individuals were r and omly assigned to either the sleep condition or the no-sleep condition . Participants in the sleep condition practice d a novel walking task in the evening , and returned the following morning for retesting . Participants in the no-sleep condition practice d the walking task in the morning and returned the same day in the evening for a retest . Outcome measures included time around the walking path and spatiotemporal gait parameters . Results : Only the middle-aged and older adults in the sleep condition demonstrated significant off-line improvement in performance , measured as a decline in time to walk around the novel path and improvement in spatiotemporal gait parameters . The middle-aged and older adults in the no-sleep condition failed to demonstrate off-line improvements in performance of this functional task . Conclusions : This is the first study to provide evidence that sleep facilitates learning a clinical ly relevant functional motor task in middle-aged and older adults . Because many neurologic conditions occur in the middle-aged and older adults and sleep issues are very prevalent in many neurologic conditions , it is imperative that physical therapists consider sleep as a factor that may impact motor learning and recovery in these individuals . Video Abstract available . ( See Video , Supplemental Digital Content 1 , http://links.lww.com/JNPT/A73 ) for more insights from the authors
Output:
| Overall , sleep was found to enhance motor performance in people after stroke in comparison to an equivalent time of wakefulness .
In addition , although evidence is limited , sleep only enhanced motor performance in people after stroke and not in age-matched healthy older adults .
In older adults the effect of a sleep intervention did - in general - not differ from equivalent periods of wakefulness .
The results suggest a delayed retention effect after longer breaks including sleep , hinting towards a changed learning strategy as a result of aging .
Current evidence for sleep dependent learning in people after stroke is promising , however sparse |
MS212723 | ***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 After breast-conserving surgery , 90 % of local recurrences occur within the index quadrant despite the presence of multicentric cancers elsewhere in the breast . Thus , restriction of radiation therapy to the tumour bed during surgery might be adequate for selected patients . We compared targeted intraoperative radiotherapy with the conventional policy of whole breast external beam radiotherapy . METHODS Having safely piloted the new technique of single-dose targeted intraoperative radiotherapy with Intrabeam , we launched the TARGIT-A trial on March 24 , 2000 . In this prospect i ve , r and omised , non-inferiority trial , women aged 45 years or older with invasive ductal breast carcinoma undergoing breast-conserving surgery were enrolled from 28 centres in nine countries . Patients were r and omly assigned in a 1:1 ratio to receive targeted intraoperative radiotherapy or whole breast external beam radiotherapy , with blocks stratified by centre and by timing of delivery of targeted intraoperative radiotherapy . Neither patients nor investigators or their teams were masked to treatment assignment . Postoperative discovery of predefined factors ( eg , lobular carcinoma ) could trigger addition of external beam radiotherapy to targeted intraoperative radiotherapy ( in an expected 15 % of patients ) . The primary outcome was local recurrence in the conserved breast . The predefined non-inferiority margin was an absolute difference of 2.5 % in the primary endpoint . All r and omised patients were included in the intention-to-treat analysis . This trial is registered with Clinical Trials.gov , number NCT00983684 . FINDINGS 1113 patients were r and omly allocated to targeted intraoperative radiotherapy and 1119 were allocated to external beam radiotherapy . Of 996 patients who received the allocated treatment in the targeted intraoperative radiotherapy group , 854 ( 86 % ) received targeted intraoperative radiotherapy only and 142 ( 14 % ) received targeted intraoperative radiotherapy plus external beam radiotherapy . 1025 ( 92 % ) patients in the external beam radiotherapy group received the allocated treatment . At 4 years , there were six local recurrences in the intraoperative radiotherapy group and five in the external beam radiotherapy group . The Kaplan-Meier estimate of local recurrence in the conserved breast at 4 years was 1.20 % ( 95 % CI 0.53 - 2.71 ) in the targeted intraoperative radiotherapy and 0.95 % ( 0.39 - 2.31 ) in the external beam radiotherapy group ( difference between groups 0.25 % , -1.04 to 1.54 ; p=0.41 ) . The frequency of any complications and major toxicity was similar in the two groups ( for major toxicity , targeted intraoperative radiotherapy , 37 [ 3.3 % ] of 1113 vs external beam radiotherapy , 44 [ 3.9 % ] of 1119 ; p=0.44 ) . Radiotherapy toxicity ( Radiation Therapy Oncology Group grade 3 ) was lower in the targeted intraoperative radiotherapy group ( six patients [ 0.5 % ] ) than in the external beam radiotherapy group ( 23 patients [ 2.1 % ] ; p=0.002 ) . INTERPRETATION For selected patients with early breast cancer , a single dose of radiotherapy delivered at the time of surgery by use of targeted intraoperative radiotherapy should be considered as an alternative to external beam radiotherapy delivered over several weeks . FUNDING University College London Hospitals (UCLH)/UCL Comprehensive Biomedical Research Centre , UCLH Charities , National Institute for Health Research Health Technology Assessment programme , Ninewells Cancer Campaign , National Health and Medical Research Council , and German Federal Ministry of Education and Research ( BMBF ) PURPOSE To report interim cosmetic and toxicity results of a multicenter r and omized trial comparing accelerated partial-breast irradiation ( APBI ) using three-dimensional conformal external beam radiation therapy ( 3D-CRT ) with whole-breast irradiation ( WBI ) . PATIENTS AND METHODS Women age > 40 years with invasive or in situ breast cancer ≤ 3 cm were r and omly assigned after breast-conserving surgery to 3D-CRT APBI ( 38.5 Gy in 10 fractions twice daily ) or WBI ( 42.5 Gy in 16 or 50 Gy in 25 daily fractions ± boost irradiation ) . The primary outcome was ipsilateral breast tumor recurrence ( IBTR ) . Secondary outcomes were cosmesis and toxicity . Adverse cosmesis was defined as a fair or poor global cosmetic score . After a planned interim cosmetic analysis , the data , safety , and monitoring committee recommended release of results . There have been too few IBTR events to trigger an efficacy analysis . RESULTS Between 2006 and 2011 , 2,135 women were r and omly assigned to 3D-CRT APBI or WBI . Median follow-up was 36 months . Adverse cosmesis at 3 years was increased among those treated with APBI compared with WBI as assessed by trained nurses ( 29 % v 17 % ; P < .001 ) , by patients ( 26 % v 18 % ; P = .0022 ) , and by physicians review ing digital photographs ( 35 % v 17 % ; P < .001 ) . Grade 3 toxicities were rare in both treatment arms ( 1.4 % v 0 % ) , but grade 1 and 2 toxicities were increased among those who received APBI compared with WBI ( P < .001 ) . CONCLUSION 3D-CRT APBI increased rates of adverse cosmesis and late radiation toxicity compared with st and ard WBI . Clinicians and patients are caution ed against the use of 3D-CRT APBI outside the context of a controlled trial Between 1979–1987 , the National Cancer Institute conducted a r and omized , prospect i ve study of mastectomy ( MT ) versus breast conservation therapy ( BCT ) in the treatment of patients with early‐stage breast carcinoma . After a median potential follow‐up of 18.4 years , the authors present the up date d results Breast cancer multifocality was studied in mastectomy specimens by correlated specimen radiography and histologic techniques . The patients chosen for study were comparable to those eligible for breast‐conserving surgical therapy . Two study groups , one with 282 invasive cancers ( T1‐2 ) and the other with 32 intraductal cancers , were selected from a group of 399 consecutive cases by omitting patients who were clearly , or very probably , not c and i date s for breast‐conserving surgical therapy according to current trial criteria . Omitted patients included those with clinical ly and /or radiologically multifocal cancers and patients with tumor extension into the chest wall or skin ( 7 % ) . Also excluded were the socalled diffuse invasive cancers ( 8 % ) , the clinical ly and radiologically occult tumors ( 3 % ) , and the invasive cancers larger than 5 cm ( 3 % ) . Of the 282 invasive cancers , 105 ( 37 % ) showed no tumor foci in the mastectomy specimen around the reference mass . In 56 ( 20 % ) tumor foci were present within 2 cm , and in 121 ( 43 % ) tumor was found more than 2 cm from the reference tumor . In 75 ( 27 % ) the tumor foci beyond 2 cm were histologically noninvasive cancers , and in 46 cases ( 16 % ) they contained invasive cancers as well . A comparison between the group with reference tumors less than 2 cm and the group with reference tumors more than 2 cm in size showed no significant difference between the groups in terms of presence or absence of tumor foci or distance of tumor foci from the reference tumor . If the 264 invasive cancers in this series that were 4 cm or less in diameter had been removed with a margin of 3 to 4 cm , 7 % to 9 % of the patients would have had invasive cancer left in the remaining breast tissue , and 4 % to 9 % would have had foci of noninvasive cancer left in the remaining breast tissue . On the basis of the data on the distribution of tumor at different distances from the reference tumor , the current study estimates the expected rates of local recurrences after breast‐conserving surgical procedures relative to the extensiveness of the excision . The possible impact of postoperative local radiation therapy on the rates of expected local recurrence is discussed BACKGROUND AND PURPOSE To report the long-term results of a single-institution r and omized study comparing the results of breast-conserving treatment with partial breast irradiation ( PBI ) or conventional whole breast irradiation ( WBI ) . PATIENTS AND METHODS Between 1998 and 2004 , 258 selected women with pT1 pN0 - 1mi M0 , grade 1 - 2 , non-lobular breast cancer without the presence of extensive intraductal component and resected with negative margins were r and omized after BCS to receive 50 Gy WBI ( n=130 ) or PBI ( n=128 ) . The latter consisted of either 7 × 5.2 Gy high-dose-rate ( HDR ) multi-catheter brachytherapy ( BT ; n=88 ) or 50 Gy electron beam ( EB ) irradiation ( n=40 ) . Primary endpoint was local recurrence ( LR ) as a first event . Secondary endpoints were overall survival ( OS ) , cancer-specific survival ( CSS ) , disease-free survival ( DFS ) , and cosmetic results . RESULTS After a median follow up of 10.2 years , the ten-year actuarial rate of LR was 5.9 % and 5.1 % in PBI and WBI arms , respectively ( p=0.77 ) . There was no significant difference in the ten-year probability of OS ( 80 % vs 82 % ) , CSS ( 94 % vs 92 % ) , and DFS ( 85 % vs 84 % ) , either . The rate of excellent-good cosmetic result was 81 % in the PBI , and 63 % in the control group ( p<0.01 ) . CONCLUSIONS Partial breast irradiation delivered by interstitial HDR BT or EB for a selected group of early-stage breast cancer patients produces similar ten-year results to those achieved with conventional WBI . Significantly better cosmetic outcome can be achieved with HDR BT implants compared with the outcome after WBI BACKGROUND The TARGIT-A trial compared risk-adapted radiotherapy using single-dose targeted intraoperative radiotherapy ( TARGIT ) versus fractionated external beam radiotherapy ( EBRT ) for breast cancer . We report 5-year results for local recurrence and the first analysis of overall survival . METHODS TARGIT-A was a r and omised , non-inferiority trial . Women aged 45 years and older with invasive ductal carcinoma were enrolled and r and omly assigned in a 1:1 ratio to receive TARGIT or whole-breast EBRT , with blocks stratified by centre and by timing of delivery of targeted intraoperative radiotherapy : r and omisation occurred either before lumpectomy ( prepathology stratum , TARGIT concurrent with lumpectomy ) or after lumpectomy ( postpathology stratum , TARGIT given subsequently by reopening the wound ) . Patients in the TARGIT group received supplemental EBRT ( excluding a boost ) if unforeseen adverse features were detected on final pathology , thus radiotherapy was risk-adapted . The primary outcome was absolute difference in local recurrence in the conserved breast , with a prespecified non-inferiority margin of 2·5 % at 5 years ; prespecified analyses included outcomes as per timing of r and omisation in relation to lumpectomy . Secondary outcomes included complications and mortality . This study is registered with Clinical Trials.gov , number NCT00983684 . FINDINGS Patients were enrolled at 33 centres in 11 countries , between March 24 , 2000 , and June 25 , 2012 . 1721 patients were r and omised to TARGIT and 1730 to EBRT . Supplemental EBRT after TARGIT was necessary in 15·2 % [ 239 of 1571 ] of patients who received TARGIT ( 21·6 % prepathology , 3·6 % postpathology ) . 3451 patients had a median follow-up of 2 years and 5 months ( IQR 12 - 52 months ) , 2020 of 4 years , and 1222 of 5 years . The 5-year risk for local recurrence in the conserved breast was 3·3 % ( 95 % CI 2·1 - 5·1 ) for TARGIT versus 1·3 % ( 0·7 - 2·5 ) for EBRT ( p=0·042 ) . TARGIT concurrently with lumpectomy ( prepathology , n=2298 ) had much the same results as EBRT : 2·1 % ( 1·1 - 4·2 ) versus 1·1 % ( 0·5 - 2·5 ; p=0·31 ) . With delayed TARGIT ( postpathology , n=1153 ) the between-group difference was larger than 2·5 % ( TARGIT 5·4 % [ 3·0 - 9·7 ] vs EBRT 1·7 % [ 0·6 - 4·9 ] ; p=0·069 ) . Overall , breast cancer mortality was much the same between groups
Output:
| We found no data for the outcomes of acute toxicity , new ipsilateral breast primaries , costs , quality of life or consumer preference .
The limitations of the data currently available mean that we can not make definitive conclusions about the efficacy and safety or ways to deliver of PBI/APBI . |
MS212724 | ***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 evaluate the relative efficacy of ( 1 ) individual cognitive-behavioral family-based therapy ( CBFT ) ; ( 2 ) group CBFT ; and ( 3 ) a waitlist control group in the treatment of childhood obsessive-compulsive disorder ( OCD ) . METHOD This study , conducted at a university clinic in Brisbane , Australia , involved 77 children and adolescents with OCD who were r and omized to individual CBFT , group CBFT , or a 4- to 6-week waitlist control condition . Children were assessed before and after treatment and at 3 months and 6 months following the completion of treatment using diagnostic interviews , symptom severity interviews , and self-report measures . Parental distress , family functioning , sibling distress , and levels of accommodation to OCD dem and s were also assessed . Active treatment involved a manualized 14-week cognitive-behavioral protocol , with parental and sibling components . RESULTS By an evaluable patient analysis , statistically and clinical ly significant pretreatment-to-posttreatment change occurred in OCD diagnostic status and severity across both individual and group CBFT , with no significant differences in improvement ratings between these conditions . There were no significant changes across measures for the waitlist condition . Treatment gains were maintained up to 6 months of follow-up . CONCLUSIONS Contrary to previous findings and expectations , group CBFT is as effective in reducing OCD symptoms for children and adolescents as individual treatment . Findings support the efficacy and durability of CBFT in treating childhood OCD The relative effectiveness of group care ( GC ) and multidimensional treatment foster care ( MTFC ) was compared in terms of their impact on criminal offending , incarceration rates , and program completion outcomes for 79 male adolescents who had histories of chronic and serious juvenile delinquency . Results show that boys who participated in MTFC had significantly fewer criminal referrals and returned to live with relatives more often . Multiple regression analyses showed that assignment to a treatment condition ( i.e. , GC or MTFC ) predicted official and self-reported criminality in follow-up beyond other well-known predictors of chronic juvenile offending ( i.e. , age at 1st offense , number of previous offenses , age at referral ) BACKGROUND Previous studies in non clinical sample s have shown psychosocial treatments to be efficacious in the treatment of adolescent depression , but few psychotherapy treatment studies have been conducted in clinical ly referred , depressed adolescents . METHODS One hundred seven adolescent patients with DSM-III-R major depressive disorder ( MDD ) were r and omly assigned to 1 of 3 treatments : individual cognitive behavior therapy , systemic behavior family therapy ( SBFT ) , or individual nondirective supportive therapy ( NST ) . Treatments were 12 to 16 sessions provided in as many weeks . Intent-to-treat analyses were conducted using all follow-up data . RESULTS Of the 107 patients enrolled in the study , 78 ( 72.9 % ) completed the study , 4 ( 3.7 % ) never initiated treatment , 10 ( 9.3 % ) had exclusionary criteria that were undetected at entry , 8 ( 7.5 % ) dropped out , and 7 ( 6.5 % ) were removed for clinical reasons . Cognitive behavior therapy showed a lower rate of MDD at the end of treatment compared with NST ( 17.1 % vs 42.4 % ; P = .02 ) , and result ed in a higher rate of remission ( 64.7 % , defined as absence of MDD and at least 3 consecutive Beck Depression Inventory scores < 9 ) than SBFT ( 37.9 % ; P = .03 ) or NST ( 39.4 % ; p = .04 ) . Cognitive behavior therapy result ed in more rapid relief in interviewer-rated ( vs both treatments , P = .03 ) and self-reported depression ( vs SBFT , P = .02 ) . All 3 treatments showed significant and similar reductions in suicidality and functional impairment . Parents ' views of the credibility of cognitive behavior therapy improved compared with parents ' views of both SBFT ( P = .01 ) and NST ( P = .05 ) . CONCLUSIONS Cognitive behavior therapy is more efficacious than SBFT or NST for adolescent MDD in clinical setting s , result ing in more rapid and complete treatment response OBJECTIVE To test the hypotheses that in children with attention-deficit/hyperactivity disorder ( ADHD ) ( 1 ) symptoms of ADHD , oppositional defiant disorder , and overall functioning are significantly improved by methylpheni date combined with intensive multimodal psychosocial treatment compared with methylpheni date alone and with methylpheni date plus attention control and ( 2 ) more children receiving combined treatment can be taken off methylpheni date . METHOD One hundred three children with ADHD ( ages 7 - 9 ) , free of conduct and learning disorders , who responded to short-term methylpheni date were r and omized for 2 years to ( 1 ) methylpheni date alone ; ( 2 ) methylpheni date plus psychosocial treatment that included parent training and counseling , social skills training , psychotherapy , and academic assistance , or ( 3 ) methylpheni date plus attention psychosocial control treatment . Assessment s included parent , teacher , and psychiatrist ratings , and observations in academic and gym classes . RESULTS Combination treatment did not lead to superior functioning and did not facilitate methylpheni date discontinuation . Significant improvement occurred across all treatments and continued over 2 years . CONCLUSIONS In stimulant-responsive children with ADHD , there is no support for adding ambitious long-term psychosocial intervention to improve ADHD and oppositional defiant disorder symptoms . Significant benefits from methylpheni date were stable over 2 years Sixty children , ages 7 - 17 years , who fulfilled Diagnostic and Statistical Manual of Mental Disorders ( 4th ed . ; American Psychiatric Association , 1994 ) diagnosis for various specific phobias were r and omized to ( a ) 1-session exposure treatment alone , ( b ) 1-session treatment with a parent present , or ( c ) wait-list control group for 4 weeks . After the waiting period , the wait-list patients were rer and omized to the active treatments . The patients ' phobias were assessed with behavioral approach tests ( approach behavior , experienced anxiety , and physiological reactions ) , whereas general anxiety , depression , phobic tendencies , and anxiety sensitivity were assessed with self-report inventories . Assessment s were done pre- , post- , and 1-year following treatment . Results showed that both treatment conditions did significantly better than the control condition , whereas the treatment groups did equally well on most measures , and the effects were maintained at follow-up . The implication s of these results are discussed This study evaluated the relative efficacy of an exposure-based contingency management ( CM ) treatment condition and an exposure-based cognitive self-control ( SC ) treatment condition relative to an education support ( ES ) control condition for treating children with phobic disorders . Eighty-one children and their parents completed a 10-week treatment program in which children and parents were seen in separate treatment sessions with the therapist , followed by a brief conjoint meeting . Children in both the CM and SC conditions showed substantial improvement on all of the outcome measures . These gains were maintained at 3- , 6- , and 12-month follow-ups . Interestingly , children in the ES condition also showed comparable improvements at posttreatment and at 3- , 6- , and 12-month follow-ups . Implication s of the findings are discussed with respect to knowledge development and clinical practice OBJECTIVE To evaluate two different parent-based therapies for preschool attention-deficit/hyperactivity disorder ( ADHD ) in a community sample . METHOD Three-year-old children displaying a preschool equivalent of ADHD ( n = 78 ) were r and omly assigned to either a parent training ( PT ; n = 30 ) , a parent counseling and support ( PCO&S ; n = 28 ) , or a waiting-list control group ( n = 20 ) . The PT group received coaching in child management techniques . The PC&S group received nondirective support and counseling . Measures of child symptoms and mothers ' well-being were taken before and after intervention and at 15 weeks follow-up . RESULTS ADHD symptoms were reduced ( F2,74 = 11.64 ; p < .0001 ) and mothers ' sense of well-being was increased by PT relative to both other groups ( F2,74 = 10.32 ; p < .005 ) . Fifty-three percent of children in the PT group displayed clinical ly significant improvement ( chi 2 = 4.08 ; p = .048 ) . CONCLUSIONS PT is a valuable treatment for preschool ADHD . PC&S had little effect on children 's behavior . Constructive training in parenting strategies is an important element in the success of parent-based interventions . Psychostimulants are not a necessary component of effective treatment for many children with preschool ADHD The state of the art for treatment efficacy studies now requires manual guided treatments and tests of therapist adherence . This report provides findings regarding adherence assessment of therapists participating in an investigation of treatment matching in adolescent substance abusers . The Group Sessions Rating Scale ( GSRS ) , a group-therapy process measure , was studied to determine its appropriateness for assessing group treatment of adolescents with a ) substance use disorders ( SUD ) , b ) interrater reliability , c ) internal consistency , and d ) ability to discriminate the active ingredients of cognitive-behavioral therapy ( CBT ) from interactional therapy ( IT ) . Interrater reliabilities were moderate to high , with those for CBT generally higher than those for IT . Internal consistency of CBT items was moderate , whereas those of IT were moderately high . Discriminability between the two treatment modalities was high . The frequency of active ingredients was generally therapy-specific : high for the relevant and low for the nonrelevant therapeutic modality items . The GSRS was found to be effective in the measurement of treatment process in adolescents with SUD OBJECTIVE A r and omized , controlled effectiveness trial of group cognitive-behavioral therapy ( CBT ) for depressed adolescent offspring of depressed parents in a health maintenance organization ( HMO ) was conducted . METHOD Potential adult cases were found by review ing antidepressant medication prescriptions , mental health appointments , and medical charts . Introductory study letters signed by each parent 's treating physician were mailed to the appropriate adults . Eligible offspring aged 13 to 18 who met current DSM-III-R criteria for major depression and /or dysthymia were r and omly assigned to either usual HMO care ( n = 47 ) or usual care plus a 16-session group CBT program ( n = 41 ) . Assessment s were conducted at baseline , after treatment , and at 12- and 24-month follow-up . RESULTS Using intent-to-treat analyses , the authors were unable to detect any significant advantage of the CBT program over usual care , either for depression diagnoses , continuous depression measures , nonaffective measures , or functioning outcomes . CONCLUSIONS Group CBT does not appear to be incrementally beneficial for depressed offspring of depressed parents who are receiving other mental health care . However , given that many other studies have found positive effects of CBT for youth depression , this single study should not be viewed as evidence that CBT is ineffective overall In this article , we examine the impact of two universal , grade 1 preventive interventions on the onset of tobacco smoking as assessed in early adolescence . The classroom-centered ( CC ) intervention was design ed to reduce the risk for tobacco smoking by enhancing teachers ' behavior management skills in first grade and , thereby , reducing child attention problems and aggressive and shy behavior-known risk behaviors for later substance use . The family-school partnership ( FSP ) intervention targeted these early risk behaviors via improvements in parent-teacher communication and parents ' child behavior management strategies . A cohort of 678 urban , predominately African-American , public school students were r and omly assigned to one of three Grade 1 classrooms at entrance to primary school ( age 6 ) . One classroom featured the CC intervention , a second the FSP intervention , and the third served as a control classroom . Six years later , 81 % of the students completed audio computer-assisted self-interviews . Relative to controls , a modest attenuation in the risk of smoking initiation was found for students who had been assigned to either the CC or FSP intervention classrooms ( 26 % versus 33 % ) ( adjusted relative risk for CC/control contrast=0.57 , 95 % confidence interval ( CI ) , 0.34 - 0.96 ; adjusted relative risk for FSP/control contrast=0.69 , 95 % CI , 0.50 - 0.97 ) . Results lend support to targeting the early antecedent risk behaviors for tobacco smoking Fifty-three child and adolescent psychiatric patients with depressive disorders were r and omly allocated to brief cognitive-behaviour therapy ( CBT ) or to a control treatment , relaxation training . Forty-eight patients completed the treatment phase of the trial , which comprised 5 - 8 treatment sessions . Post-treatment assessment s showed a clear advantage of CBT over relaxation on measures of both depression and overall outcome . However , there were no significant differences between the treatments on comorbid anxiety and conduct symptoms . At follow-up , the differences between the groups were reduced , partly because of a high relapse rate in the DTP group and partly because subjects in the relaxation group continued to recover OBJECTIVES This study examined ( 1 ) the effect of a cognitive-behavioral group intervention on anxiety , depression , and coping strategies in school-age
Output:
| Findings suggest that many child psychotherapy treatment studies have not inadequately controlled for nonspecific factors such as attention and treatment intensity and have failed to assess specific mediators of change . |
MS212725 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: STUDY OBJECTIVE To compare the intrapulmonary percussive ventilator ( IPV ) to chest physiotherapy ( P&PD ) with respect to acute changes in ( 1 ) pulmonary function and ( 2 ) sputum physical properties in patients with cystic fibrosis ( CF ) . DESIGN R and omized crossover . SETTING Community-based CF referral center . PARTICIPANTS Nine nonhospitalized person ( range , 7 to 40 years ; median , 12.4 years ) with moderate to excellent Shwachman scores . INTERVENTIONS Three treatment regimens : ( 1 ) 2.5 mg albuterol delivered via IPV ( internal percussive component activated ) ; ( 2 ) 2.5 mg . albuterol delivered via IPV ( internal percussive component inactivated ) , followed by P&PD ; and ( 3 ) 2.5 mg albuterol delivered via updraft nebulizer , followed by P&PD . MEASUREMENTS AND RESULTS Outcome measures included pulmonary function testing ( PFTs ) and quantitative and qualitative sputum analysis . Among the three treatment groups , there were no significant differences in the change in predicted PFTs 1 h or 4 h after treatment , nor in the volume of sputum expectorated in the first 4 or in the subsequent 20 h. Among patients receiving IPV , more serious disease was associated with greater improvement in FEF25 - 75 1 h after treatment , but these differences disappeared by 4 h. There were no meaningful differences in viscoelastic characteristics of sputum expectorated after each treatments . Participants reported general satisfaction with no adverse effects while using IPV . CONCLUSIONS This initial pilot study suggests ( 1 ) stable patients with CF tolerated one treatment of IPV without adverse sequelae , and ( 2 ) IPV was as effective as st and ard aerosol and P&PD in improving short-term PFT results and enhancing sputum expectoration We studied the acute effects of 4 different chest physical therapy regimens using a r and omised cross-over design in 14 patients with cystic fibrosis . Treatment A consisted of postural drainage , percussion and vibration ; treatment B of postural drainage and periodic application of a face mask with positive expiratory pressure ( PEP ) ; treatment C of PEP in the sitting position ; treatment D of the forced expiration technique in the sitting position . In terms of sputum expectorated , treatments B and C were superior to treatment D and especially to treatment A ( p less than 0.05 ) . Skin oxygen tension , PSO2 was monitored continuously during and for 35 min after treatment . A substantial and prolonged decay in PSO2 was observed during treatment A , quite different from other patterns seen . During and even following treatment C , an increase in PSO2 was noted . PEP was well accepted by the patients , who preferred treatment C , and we suggest it is incorporated in chest physical therapy regimens if the therapeutic objective is to increase expectoration To compare the short-term effects of postural drainage with clapping ( PD ) and autogenic drainage ( AD ) on oxygen saturation , pulmonary function , and sputum recovery , we studied ten patients with cystic fibrosis ( CF ) r and omly treated with PD or AD on separate days . Pulse oximetry was monitored and sputum was collected during and for 1 h following each treatment . Pulmonary function was measured before and then 1 , 15 , and 60 min after each treatment . There was no significant difference in the amount of sputum recovered with AD ( 14.0 + /- 3.5 g ) vs PD ( 10.4 + /- 3.0 g ) and no significant differences in pulmonary function occurred . Oxygen saturation during PD fell from 93.3 + /- 0.7 % to 91.2 + /- 0.8 % ( p < 0.01 ) and required 15 min following treatment to return to baseline . Oxygen saturation did not fall during AD and increased to 94.5 + /- 0.7 % by 1 h following treatment ( baseline , 93.3 + /- 0.8 % ; p < 0.01 ) . We conclude that AD is less likely to produce oxygen desaturation and may be better tolerated by patients with CF , while producing similar benefits in sputum clearance The use of a positive expiratory pressure ( PEP ) mask was compared with postural drainage in the treatment of 10 patients with cystic fibrosis . The patients were allocated r and omly in a crossover fashion to the two regimens and evaluated initially by a physiotherapist and over a 4 week treatment period by use of a diary card . There was no significant difference in sputum production or change in lung function between each technique as assessed by the physiotherapist . Diary card evaluation also failed to demonstrate a difference in sputum production , symptom score or peak expiratory flow rate between the 4 week treatment periods . It was concluded that PEP mask therapy is an acceptable and effective alternative to postural drainage in interval therapy of patients with cystic fibrosis , although the patients have tended to revert to postural drainage during acute exacerbations We studied the effectiveness of some of the components of a physiotherapy regimen on the removal of mucus from the lungs of 6 subjects with cystic fibrosis . On 5 r and omized study days , after inhalation of a 99mTc-human serum albumin aerosol to label primarily the large airways , the removal of lung radioactivity was measured during 40 min of ( a ) spontaneous cough while at rest ( control ) , ( b ) postural drainage , ( c ) postural drainage plus mechanical percussion , ( d ) combined maneuvers ( postural drainage , deep breathing with vibrations , and percussion ) administered by a physiotherapist , ( e ) directed vigorous cough . Measurements continued for an additional 2 h of quiet rest . Compared with the control day , all forms of intervention significantly improved the removal of mucus : cough ( p less than 0.005 ) , physiotherapy maneuvers ( 0.005 less than or equal to p less than 0.01 ) , postural drainage ( p less than 0.05 ) , and postural drainage plus percussion ( p less than 0.01 ) . However , there was no significant difference between regimented cough alone and therapist-administered combined maneuvers , nor between postural drainage alone and with mechanical percussion . We conclude that in cystic fibrosis , vigorous , regimented cough sessions may be as effective as therapist-administered physiotherapy in removing pulmonary secretions . Postural drainage , although better than the control maneuver , was not as effective as cough and was not enhanced by mechanical percussion . Frequent , vigorous self-directed cough sessions are potentially as useful as more complex measures for effective bronchial toilet Bronchial hygiene therapy is a st and ard part of the treatment of patients with cystic fibrosis ( CF ) . Coughing alone promotes sputum expectoration and is probably the primary effective component of st and ard bronchial hygiene therapy . The purpose of this study was to determine whether substituting regular exercise , which also promotes coughing , for two of three daily bronchial hygiene treatments would affect the expected improvements in pulmonary function and exercise response in hospitalized patients with CF . Seventeen patients with CF hospitalized ( means length of stay = 13.0 + /- 2.6 days ) for an acute exacerbation of their pulmonary disease participated in the study . The patients were r and omly assigned to either a group that participated in two cycle ergometer exercise sessions and one bronchial hygiene treatment session per day ( EX Group [ n = 9 ] ) or a group that participated in three bronchial hygiene treatment sessions per day ( PD Group [ n = 8 ] ) . Pulmonary functions and responses to a progressive , incremental cycle ergometer exercise test were measured on admission and before discharge . Bronchial hygiene therapy consisted of postural drainage , in six positions , with chest percussion and vibration . Therapeutic exercise was of moderate intensity and was individually adjusted based on the patient 's heart rate and arterial oxygen saturation response to the admission exercise test . Coughing was encouraged during and after all treatments . Pulmonary function and exercise response were significantly improved over the period of hospitalization in both groups ; the improvements were the same in the two groups . These results indicate that , in some hospitalized patients with CF , exercise therapy may be substituted for at least part of the st and ard protocol of bronchial hygiene therapy Impaired mucociliary clearance due to defective ion and water transport and the effects of chronic airway infections lead to stasis of secretions and progressive pulmonary damage in patients with cystic fibrosis ( CF ) . Methods to improve removal of tenacious lung secretions in CF patients contribute to slowing the decline in respiratory function . We have evaluated an intrapulmonary percussive ventilator ( IPV ) , which is a device design ed to enhance airway clearance and preserve lung function . A previous pilot study by us had determined that the device was acceptable to patients and is safe . We undertook a 6 month parallel comparative trial of the IPV versus st and ard , manual chest physiotherapy in 16 CF children and adults . No significant differences in spirometric measures , numbers of hospitalizations , use of oral or IV antibiotics , or anthropometric measurements were detected between the st and ard aerosol/chest physiotherapy group and the IPV group over the duration of the trial . Patient acceptance , as determined by participant survey , was good . The device appeared to be safe and durable . It was concluded that the IPV is as effective as st and ard aerosol and chest physiotherapy in preserving lung function and anthropometric measures , and there was no difference in the use of antibiotics and hospitalizations Promotion of sputum expectoration by chest physiotherapy is an essential part of cystic fibrosis management . The role of exercise in improving sputum expectoration and lung function in these patients is more contentious . We therefore investigated the effect of adding an exercise programme to conventional chest physiotherapy in eight adult subjects ( four male ) with cystic fibrosis . Subjects were treated on two non-consecutive days of the second week of a course of in-patient antibiotic therapy in a cross-over fashion . On the exercise and physiotherapy day , subjects exercised 60 min before physiotherapy . On the physiotherapy alone day , subjects rested for 60 min instead of exercising . Physiotherapy was administered on both study days ( postural drainage , percussion , deep breathing , vibrations , forced expiratory technique and coughing ) . Lung function tests were performed at baseline , after exercise or rest and again immediately and 30 min after physiotherapy . Sputum weights were measured in the 60 min of exercise or rest ( period A ) and for the 60 min physiotherapy period and 30 min after physiotherapy ( period B ) . Mean total sputum expectoration ( period A and B ) was 14 g on physiotherapy alone and 21.5 g ( 4.8 ) on exercise and physiotherapy ( mean difference 7.5 g , 95 % CI 1.4 - 13.6 g , P = 0.02 ) . Mean sputum weights during period A ( i.e. rest vs. exercise ) on physiotherapy alone and exercise and physiotherapy were 2.6 and 7 g respectively ( mean difference 4.4 g , 95 % CI-0.07 - 8.8 g , P = 0.053 ) . ( ABSTRACT TRUNCATED AT 250 WORDS OBJECTIVE We report the results of a long-term comparative trial of physiotherapy by the positive expiratory pressure ( PEP ) technique with a PEP mask ( Astra Meditec ) versus conventional postural drainage and percussion ( PD&P ) . Forty patients , ages 6 to 17 years , with Shwachman scores between 52 and 93 , attending the cystic fibrosis clinic were enrolled in the study and r and omly assigned to one of two groups . Group A ( control ) continued to perform physiotherapy by using PD&P for a 1-year period , whereas patients assigned to group B performed physiotherapy with the PEP technique for the same period . Compliance with physiotherapy was closely monitored for both groups throughout the study . Clinical status and pulmonary function ( forced vital capacity [ FVC ] , FEV1 , and FEF25 - 75 ) were measured at 3-month intervals . Group B ( PEP ) demonstrated improved pulmonary function in all parameters as measured by change in percent predicted value for age , gender , and height . The changes in pulmonary function over the study period were : FVC , + 6.57 ; FEV1 , + 5.98 ; and FEF25 - 75 , + 3.32 . This improvement was significantly different from that of group A ( PD&P ) whose pulmonary function declined in all parameters ( FVC , -2.17 ; FEV1 , -2.28 ; FEF25 - 75 , -0.24 ) . The differences between treatment groups were statistically significant for the changes in FVC ( p = 0.02 ) and FEV(1 ) ( p = 0.04 ) . Our results indicate that for our patients with cystic fibrosis , pulmonary physiotherapy with the PEP technique was superior to conventional physiotherapy with the PD&P technique In Pol and the st and ard treatment of pulmonary manifestation of cystic fibrosis consists of physiotherapy techniques of postural drainage with clapping . However many studies demonstrated that various alternative airway clearance techniques performed in Europe the last few years have been more effective than postural drainage . The aim of the study was a comparative analysis of the efficiency of selected chest physiotherapy methods used in the treatment of children with cystic fibrosis . We studied 21 patients , aged 5 - 18 ( x 10.57 ) , who were
Output:
| There was no difference between CCPT and other airway clearance techniques in terms of respiratory function measured by st and ard lung function tests .
Studies undertaken during acute exacerbations demonstrated relatively large gains in respiratory function irrespective of airway clearance technique .
Longer-term studies demonstrated smaller improvements or deterioration over time .
This review demonstrated no advantage of CCPT over other airway clearance techniques in terms of respiratory function .
There was a trend for participants to prefer self-administered airway clearance techniques . |
MS212726 | ***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 The treatment of chronic leg ulcers remains a stubborn problem in many patients . Topical 2 % ketanserin ointment , a 5HT2-serotoninergic blocking agent , has been reported to improve healing of decubitus , venous , diabetic and ischaemic ulcers . METHOD The present double-blind intra-individual comparative study was performed in 12 women with diabetes presenting with at least two similar leg ulcers . In each subject , the two lesions were r and omly assigned to be treated for 8 weeks by 2 % ketanserin ointment or its unmedicated vehicle . OBJECTIVE assessment s of the dynamics of wound healing were performed using computerized morphometry . Evaluations were performed at 2-week intervals for 8 weeks . RESULTS A significant decrease in relative wound area was observed on the ketanserin-treated ulcers compared with the placebo group . CONCLUSION Topical ketanserin is a valuable therapy for difficult-to-treat leg ulcers OBJECTIVE : A r and omized controlled trial to evaluate the effectiveness of a polyhexamethylene biguanide ( PHMB ) foam dressing compared with a similar non-antimicrobial foam for the treatment of superficial bacterial burden , wound-associated pain , and reduction in wound size . SETTING AND PARTICIPANTS : This study was conducted in 2 wound healing clinics-a university hospital-based clinic and a community-based clinic . Forty-five chronic wound subjects , stratified to either foot or leg ulcers , were followed for 5 weeks . METHODS : A multicenter , prospect i ve , double-blind , pilot , r and omized controlled clinical trial with 3 study visits ( Weeks 0 , 2 , 4 ) documented pain and local wound characteristics using NERDS and STONEES clinical criteria to determine superficial bacterial damage or deep/surrounding infection . RESULTS : The use of PHMB foam dressing was a significant predictor of reduced wound superficial bacterial burden ( P = .016 ) at week 4 as compared with the foam alone . Pain reduction was also statistically significant at week 2 ( P = .0006 ) and at week 4 ( P = .02 ) in favor of the PHMB foam dressings . Polymicrobial organisms were recovered at week 4 in 5.3 % in the PHMB foam dressing group versus 33 % in the control group ( P = .04 ) . Subjects r and omized to the PHMB foam dressing had a 35 % median reduction in wound size by week 4 , compared with 28 % in the control group . CONCLUSIONS : PHMB foam dressing successfully reduced chronic wound pain and bacterial burden Chronic skin ulcers such as diabetic ulcers and venous leg ulcers are increasing and are a costly problem in healthcare . We have developed a novel artificial dermis , collagen/gelatin sponge ( CGS ) , which is capable of sustained release of basic fibroblast growth factor ( bFGF ) for more than 10 days . The objective of this study was to investigate the safety and efficacy of CGS impregnated with bFGF in the treatment of chronic skin ulcers . Patients with chronic skin ulcers that had not healed in at least 4 weeks were treated with CGS impregnated with bFGF at 7 or 14 μg/cm(2 ) after debridement , and the wound bed improvement was assessed 14 days after application . Wound bed improvement was defined as a granulated and epithelialized area on day 14 with a proportion to the baseline wound area after debridement of 50 % or higher . The wound area , the wound area on day 14 , and the granulation area on day 14 were independently measured by blinded review ers in a central review using digital images of wounds taken with a calibrator . Patients were followed up until 28 days after application to observe the adverse reactions related to the application of CGS . From May 2010 to June 2011 , 17 patients were enrolled and , in 16 patients , the wound bed improved . Among the r and omized patients in step 2 , no significant difference was seen between the low-dose group and the high-dose group . No serious adverse reactions were observed . Adverse reactions with a clear causal relationship to the study treatment were mild and patients quickly recovered from them . This study is the first-in-man clinical trial of CGS and showed the safety and efficacy of CGS impregnated with bFGF in the treatment of chronic skin ulcers . This combination therapy could be a promising therapy for chronic skin ulcers OBJECTIVE To assess whether topical morphine is pharmacologically effective in relieving pain from ulcers caused by arterial insufficiency and identify whether this effect is central ly or peripherally mediated . METHOD The analgesic effect of a topically applied hydrogel containing 0.5 % of morphine was evaluated in a double-blind , placebo-controlled , three-way crossover pilot study involving nine patients with painful arterial leg ulcers . All patients had a baseline pain intensity of at least 5 on a 10-point numeric rating scale . They received the following three treatments in r and om order : morphine hydrogel plus a subcutaneous ( SC ) placebo infusion ; placebo gel plus a SC infusion of 5 mg morphine over six hours and a placebo gel plus a SC placebo infusion . Each treatment lasted one day . Pain was assessed during the first 24 hours after application of the hydrogel and the start of the subcutaneous infusion . RESULTS There was a statistically significant difference between average baseline pain scores and those reported during treatment , but this difference was not clinical ly relevant . The three treatments did not differ in terms of the pain relief provided . CONCLUSION Topical morphine does not have a clinical ly relevant analgesic effect in patients with painful arterial leg ulcers . Further research should focus on ulcers of other aetiology OBJECTIVE To determine the healing effect of topical becaplermin gel vs hydrogel dressing on hypertensive leg ulcers . DESIGN R and omized , double-blind , parallel-assignment , controlled study . SETTING Ambulatory or hospitalized patients from 17 dermatology departments . PATIENTS Among 64 consecutive r and omized patients with 1 or more hypertensive leg ulcers who fulfilled all inclusion criteria , 59 received the allocated intervention , and findings were analyzed . INTERVENTION Becaplermin gel ( human recombinant platelet-derived growth factor-BB , 0.1 % , in hydrogel ) or hydrogel dressing was applied , both in doses of 1 cm/cm(2 ) , once daily for 8 weeks . Follow-up continued for 4 weeks beyond the final gel application . MAIN OUTCOME MEASURES The primary end point was complete wound closure rate after 8 weeks of treatment . Secondary end points were percentages of patients with complete wound closure at week 12 ; changed ulcer area after treatment vs baseline ; and changed ulcer-related pain and health-related quality of life during the study . RESULTS Complete wound closure rates were comparable after 8 weeks for becaplermin ( 5 of 28 patients ) and hydrogel ( 3 of 31 patients ) ( 8 percentage-point difference ; 95 % confidence interval , -10 % to 26 % ) . No statistically significant differences were observed between the 2 groups for percentages of complete closure at week 12 , changed ulcer area at week 8 , or changed ulcer-related pain and quality of life during the study ( P > .05 for all comparisons ) . CONCLUSIONS Topical becaplermin gel is not superior to hydrogel dressing for hypertensive leg ulcer wound closure . Surgical management by grafting remains the most promising treatment strategy but requires further evaluation . Trial Registration clinical trials.gov Identifier : NCT00970697 BACKGROUND Elase is a widely used ointment consisting of a combination of 2 proteolytic enzymes , fibrinolysin and desoxyribonuclease ( DNAse ) . It is said to promote debridement of necrotic and purulent debris from skin ulcers . OBJECTIVE Our purpose was to assess the efficacy and safety of this ointment and its components in the treatment of chronic ulcers of the lower extremity . METHODS This was a double-blind , r and omized , prospect i ve study of 84 patients with leg ulcers exhibiting necrotic and purulent debris , who were treated for 21 days with twice-daily applications of the ointment , fibrinolysin , DNAse , or who received the ointment vehicle ( placebo ) . We assessed 6 efficacy features : ulcer size , purulent exu date , necrotic tissue , erythema , pain , and overall condition of the lesion at days 8 , 15 , and 21 after initiation of treatment . We also assessed the frequency of adverse effects . RESULTS All treatments produced some improvement in the efficacy parameters and overall condition of the ulcers by week 3 , but no statistically significant difference was found when compared with placebo . No serious adverse effects were noted . A later retrospective re analysis of the data found a statistically significant reduction of purulent exu date only at days 3 and 7 of treatment in the group treated with the complete ointment , but not in the other features . CONCLUSION The proteolytic ointment provides no long-term clinical benefit in reducing purulent exu date , pain , erythema , necrotic tissue , or overall condition of chronic leg ulcers when compared with either of its two components or placebo OBJECTIVE To evaluate the performance ( efficacy , safety and acceptability ) of a new micro-adherent absorbent dressing ( UrgoClean ® ) compared with a hydrofiber dressing ( Aquacel ® ) in the local management of venous leg ulcers , in the debridement stage . METHOD A non-inferiority European r and omised controlled clinical trial ( RCT ) was conducted in 37 centres , on patients presenting with venous or predominantly venous , mixed aetiology leg ulcers at their sloughy stage ( with more than 70 % of the wound bed covered with slough at baseline ) . Patients were followed over a 6-week period and assessed weekly . The primary judgement criteria was the relative regression of the wound surface area after the 6-week treatment period . Secondary endpoints were the relative reduction of sloughy tissue and the percentage of patients presenting with a debrided wound . RESULTS Altogether , 159 patients were r and omised to either UrgoClean ( test group ; n=83 ) or Aquacel ( control group ; n=76 ) dressings . Regarding the wound healing process predictive factors ( wound area , duration , ABPI value , recurrence ) , at baseline , the two groups were well balanced , for both wound and patient characteristics . Compression therapy was administered to both groups and after a median 42-day treatment period , the percentage of relative reduction of the wound surface area was very similar ( -36.9 % vs -35.4 % in the UrgoClean and control groups , respectively ) . When considering the secondary criteria at week 6 , the relative reduction of sloughy tissue was significantly higher in the UrgoClean group than in the control group ( -65.3 % vs -42,6 % ; p=0.013 ) . The percentage of debrided wounds was also significantly higher in the test group ( 52.5 % vs 35.1 % ; p=0.033 ) . CONCLUSION This ' EARTH ' RCT confirmed that the UrgoClean dressing has similar efficacy and safety compared to Aquacel . However , UrgoClean also showed better autolytic properties than the control group in the management of venous leg ulcers at the sloughy stage . The new UrgoClean dressing therefore represents a promising therapeutic option within the current range of autolytic dressings available . DECLARATION OF INTEREST This study was sponsored by a grant from the pharmaceutical company Laboratoires Urgo . S. Bohbot and O. Tacca are employees of Laboratoires Urgo . S. Meaume , J. Dissemond and G. Perceau have received monetary compensation as presenters for Laboratoires Urgo . Data management and statistical analyses were conducted independently by Vertical ( Paris , France ) Abstract Aims / Introduction Dysregulated inflammatory response is believed to be an important factor in the pathogenesis of several late complications of diabetes mellitus . β‐Glucans are potent inducers of immune function . The present r and omized , double blind , two‐center , placebo‐controlled study was undertaken to explore safety , tolerability and efficacy of soluble β‐1,3/1,6‐glucan ( SBG ) as a local treatment of diabetic foot ulcers . Material s and Methods A total of 60 patients with type 1 or 2 diabetes and lower extremity ulcers ( Wagner grade 1–2 , Ankle/Brachial Index ≥0.7 ) received SBG or a comparator product ( methylcellulose ) locally three times weekly up to 12 weeks in addition to conventional management scheme . A total of 54 patients completed the study . Results A tendency for shorter median time to complete healing in the SBG group was observed ( 36 vs 63 days , P = 0.130 ) . Weekly percentage reduction in ulcer size was significantly higher in the SBG group than in the methylcellulose group between weeks 1–2 , 3–4 and 5–6 ( P < 0.05 ) . The proportion of ulcers healed by week 12 was also in favor of SBG ( 59 % vs 37 % , P = 0.09 ) , with a significantly higher healing incidence in the SBG group at week 8 ( 44 % vs 17 % , P = 0.03 ) . SBG was safe and well tolerated . There was a clinical ly significant difference regarding the incidence of serious adverse events in favor of the
Output:
| There is insufficient evidence to determine whether the choice of topical agent or dressing affects the healing of arterial leg ulcers |
MS212727 | ***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 A r and omized trial was conducted to test the effectiveness of a videotape for increasing mammography screening among a multiethnic sample of older women . METHODS A multiethnic sample of Caucasian , African-American , and Hispanic women between the ages of 50 and 70 was recruited from Resident Lists compiled by the State of Massachusetts . After completing a baseline question naire , women were r and omized to receive either a videotape or pamphlet about mammography and recontacted at 2 and 12 months after baseline to assess attitudes , beliefs , and mammography screening . A total of 581 women completed question naires at all three time points . RESULTS At baseline , approximately 75 % of women reported having a mammogram in the past year and 90 % reported having one in the past 2 years . Rates did not differ between groups . At the 12-month follow-up , mammography rates , adjusted for baseline screening , were 80.4 % in the video and 74.8 % in the pamphlet group . Logistic regression analysis of mammography at 12 months ( within past year vs. > 1 year ago ) controlling for baseline mammogram produced an odds ratio of 1.48 for the video group that was not significantly different from unity ( 95 % CI = 0.95 - 2.28 ) . CONCLUSIONS The videotape had a small effect on increasing mammography screening . Although the effect was smaller than more intensive interventions , the video is a convenient , low cost , and easily implemented method to increase mammography screening Background Whether early detection and treatment of prostate cancer ( PCa ) will reduce disease-related mortality remains uncertain . As a result , tools are needed to facilitate informed decision making . While there have been several decision aids ( DAs ) developed and tested , very few have included an exercise to help men clarify their values and preferences about PCa screening . Further , only one DA has utilized an interactive web-based format , which allows for an expansion and customization of the material . We describe the development of two DAs , a booklet and an interactive website , each with a values clarification component and design ed for use in diverse setting s. Methods We conducted two feasibility studies to assess men 's ( 45 - 70 years ) Internet access and their willingness to use a web- vs. a print-based tool . The booklet was adapted from two previous versions evaluated in r and omized controlled trials ( RCTs ) and the website was created to closely match the content of the revised booklet . Usability testing was conducted to obtain feedback regarding draft versions of the material s. The tools were also review ed by a plain language expert and the interdisciplinary research team . Feedback on the content and presentation led to iterative modifications of the tools . Results The feasibility studies confirmed that the Internet was a viable medium , as the majority of men used a computer , had access to the Internet , and Internet use increased over time . Feedback from the usability testing on the length , presentation , and content of the material s was incorporated into the final versions of the booklet and website . Both the feasibility studies and the usability testing highlighted the need to address men 's informed decision making regarding screening . Conclusions Informed decision making for PCa screening is crucial at present and may be important for some time , particularly if a definitive recommendation either for or against screening does not emerge from ongoing prostate cancer screening trials . We have detailed our efforts at developing print- and web-based DAs to assist men in determining how to best meet their PCa screening preferences . Following completion of our ongoing RCT design ed to test these material s , our goal will be to develop a dissemination project for the more effective tool . Trial Registration OBJECTIVE Adherence to self-care behaviors improves heart failure ( HF ) morbidity and life quality . We examined short-term impact of video education ( VE ) in addition to st and ard education ( SE ) on HF healthcare utilization and self-care behavior adherence . METHODS One hundred and twelve hospitalized patients were r and omly assigned to SE ( n=53 ) or SE plus VE ( n=59 ) . Differences between groups were analyzed in patients who underwent 3-month follow-up ( 39 SE and 37 VE patients ) . Mean age was 60+/-14 years ; mean HF length was 57 months . RESULTS Three-month healthcare utilization was similar between groups but VE patients needed less extra diuretic dosing ( P<0.02 ) , received more HF literature ( P<0.03 ) , and had less healthcare team telephone communication ( P<0.04 ) . VE patients had greater sign/symptom reduction ( P<0.04 ) ; especially related to edema ( P<0.01 ) and fatigue ( P<0.01 ) and initiated more actions for edema ( P<0.05 ) and dyspnea ( with exercise or rest , both P<0.01 ) . Overall , VE patients had a higher mean self-care behavior score ( P<0.01 ) , reflecting greater self-care adherence . CONCLUSION Video education prompts self-care behavior adherence to control worsening signs/symptoms of volume overload . During 3-month follow-up , utilization of most healthcare re sources was unchanged . PRACTICE IMPLICATION S VE is a useful adjunct to in-person education In this study we compared 3 methods of conducting the preanesthetic visit . We prospect ively studied 197 consecutive surgical patients who were to undergo general anesthesia . The patients were r and omized to a routine preanesthetic interview , a brochure plus an interview , or a self-made documentary video plus an interview . After the preanesthetic visit , the degree of patient satisfaction and information gain was quantified by a question naire for each method . The questions on patient satisfaction were assessed on a six-point scale , and those on information gain were assessed on a multiple-choice basis . The video plus interview group showed the highest point scores ( 98 % of the possible maximum sum point score in patient satisfaction and 93 % of the maximum sum score in information gain ) . In contrast , the patients of the brochure plus interview group revealed 93 % for patient satisfaction and 80 % for information gain , and in the st and ard interview group , the corresponding figures were 91 % and 72 % , respectively . The maximum sum scores in patient satisfaction and information gain were significantly different between the interview and the video groups , but not between the interview and the brochure groups . Therefore , these data suggest that the use of a documentary video to supplement a preoperative interview may enhance patient satisfaction and maximize information gain Background Although many men who have sex with men ( MSM ) in Peru are unaware of their HIV status , they are frequent users of the Internet , and can be approached by that medium for promotion of HIV testing . Methods We conducted an online r and omized controlled trial to compare the effect of HIV-testing motivational videos versus st and ard public health text , both offered through a gay website . The videos were customized for two audiences based on self- identification : either gay or non-gay men . The outcomes evaluated were ‘ intention to get tested ’ and ‘ HIV testing at the clinic . ’ Findings In the non-gay identified group , 97 men were r and omly assigned to the video-based intervention and 90 to the text-based intervention . Non-gay identified participants r and omized to the video-based intervention were more likely to report their intention of getting tested for HIV within the next 30 days ( 62.5 % vs. 15.4 % , Relative Risk ( RR ) : 2.77 , 95 % Confidence Interval ( CI ) : 1.42–5.39 ) . After a mean of 125.5 days of observation ( range 42–209 days ) , 11 participants r and omized to the video and none of the participants r and omized to text attended our clinic requesting HIV testing ( p = 0.001 ) . In the gay-identified group , 142 men were r and omized to the video-based intervention and 130 to the text-based intervention . Gay-identified participants r and omized to the video were more likely to report intentions of getting an HIV test within 30 days , although not significantly ( 50 % vs. 21.6 % , RR : 1.54 , 95 % CI : 0.74–3.20 ) . At the end of follow up , 8 participants who watched the video and 10 who read the text visited our clinic for HIV testing ( Hazard Ratio : 1.07 , 95 % CI : 0.40–2.85 ) . Conclusion This study provides some evidence of the efficacy of a video-based online intervention in improving HIV testing among non-gay-identified MSM in Peru . This intervention may be adopted by institutions with websites oriented to motivate HIV testing among similar MSM population s. Trial registration Clinical trials.gov OBJECTIVE The Centers for Disease Control and Prevention recommends that HIV testing be a st and ard part of medical care ; however , testing is voluntary and some patients decline . We evaluated 2 brief interventions to promote rapid HIV testing among STD clinic patients who initially declined testing . METHOD Using a r and omized controlled trial , patients either viewed an educational digital video disc ( DVD ) or participated in stage-based behavioral counseling ( SBC ) provided by a nurse . Sixty clients presenting for care at a STD clinic who initially declined HIV testing at registration and during risk behavior screening participated in the study . RESULTS The primary outcome was whether patients agreed to be tested for HIV . The secondary outcomes included attitudes , knowledge , and stage-of-change regarding HIV testing . Patients receiving both interventions improved their attitudes and knowledge about testing ( ps < .01 ) . Patients receiving SBC agreed to testing more often ( 45 % ) than did patients who viewed the DVD ( 19 % ; p < .05 ) . CONCLUSIONS Brief interventions can increase rapid HIV testing acceptance among patients who are reluctant to be tested ; counseling guided by behavioral science theory is more effective than a well- design ed information-based intervention BACKGROUND Morbidity and mortality from colorectal cancer ( CRC ) are heightened among the socioeconomically disadvantaged . METHOD A r and omized controlled trial was conducted to evaluate the efficacy of a videotaped intervention using peer educators as well as a health professional to increase compliance with fecal occult blood test ( FOBT ) screening . Participants were 160 older individuals attending a medical outpatient clinic . Compliance with FOBT use was the dependent measure . Demographic variables , family history of CRC , viewing the videotape , perceived risk , self-efficacy , physician recommendation , knowledge about CRC screening , and intent to use the FOBT were independent measures . RESULTS Approximately 41 % of participants complied with FOBT screening . Significant relationships were found between intent and family history of CRC , viewing the video , perceived risk , self-efficacy , and CRC knowledge . However , none of these variables was significantly related to compliance with FOBT use . CONCLUSIONS Although modest compliance rates were shown for both experimental and control groups , their compliance did not differ significantly . Further investigation of the impact of a video as part of an enhanced intervention program should be considered OBJECTIVES : The success of colonoscopy depends on high- quality bowel preparation by patients ; yet inadequate preparation is common . We developed and tested an educational booklet to improve bowel preparation quality . METHODS : We conducted patient cognitive interviews to identify knowledge and belief barriers to colonoscopy preparation . We used these interviews to create an educational booklet to enhance preparatory behaviors . We then prospect ively r and omized patients scheduled for outpatient colonoscopy at a VA Medical Center to receive usual instructions vs. the booklet before colonoscopy . Patients in both groups received st and ard pharmacy instructions for single-dose bowel preparation ; the protocol did not specify which purgatives to prescribe . The primary outcome was preparation quality based on blinded ratings using the vali date d Ottawa score . We performed bivariate analyses to compare mean scores between groups using a t-test , and logistic regression to measure the booklet effect on preparation quality , adjusting for potential confounders . RESULTS : A total of 436 patients were r and omized between arms . In an intention-to-treat analysis of the primary outcome , mean Ottawa scores were superior in patients allocated to booklet vs. controls ( P=0.03 ) . An intention-to-treat analysis of the secondary outcome revealed a “ good ” preparation in 68 vs. 46 % of booklet and control patients , respectively ( P=0.054 ) . In a per- protocol analysis limited to patients who actually received the booklet , preparation was good in 76 vs. 46 % patients , respectively ( P<0.00001 ) . Regression analysis revealed that booklet receipt increased the odds of good preparation by 3.7 times ( 95 % confidence interval=2.3–5.8 ) . CONCLUSIONS : Provision of a novel educational booklet considerably improves preparation quality in patients receiving single-dose purgatives . The effect of the booklet on split-dose purgatives remains untested and will be evaluated in future research Abstract BACKGROUND : Little is known about the relative advantages of video versus internet-based decision aids to facilitate shared medical decision making . This study compared internet and video patient education modalities for men considering the prostate specific antigen ( PSA ) test . METHODS : Two hundred and twenty-six men , aged 50 years or older , and scheduled to complete a physical examination at an HMO Health Appraisal Clinic were r and omly assigned to access a website ( N=114 ) or view a 23-minute videotape in the clinic ( N=112 ) prior to deciding whether they wanted to be screened for prostate cancer . RESULTS : There were no between-groups differences in participants ’ ratings of convenience , effort , or satisfaction following exposure to the decision aid . Participants assigned to the video group were more likely to review the material s than individuals assigned to the internet group ( 98.2 % vs 53.5 % ) . Participants in the video group showed significantly greater increases in PSA
Output:
| Video interventions were variably effective for modifying health behaviors depending on the target behaviors to be influenced .
Video interventions appear to be effective in breast self-examination , prostate cancer screening , sunscreen adherence , self-care in patients with heart failure , HIV testing , treatment adherence , and female condom use .
However , videos have not shown to be effective in influencing addiction behaviors when they are not tailored .
Compared to loss-framing , gain-framed messages may be more effective in promoting certain types of health behavior change . |
MS212728 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: PURPOSE To evaluate the impact of preoperative chemoradiation with raltitrexed ( Tomudex(1 ) ) on tumor response , sphincter preservation , and toxicity in patients with locally advanced rectal cancer . METHODS AND MATERIAL S Between 1998 and 2002 , 54 consecutive patients with Stage T3 or T2N+ resectable rectal carcinoma were treated with preoperative chemoradiation , i.v . bolus of raltitrexed on Days 1 , 19 , and 38 and concurrent 50 Gy external beam radiotherapy . Surgery was performed 6 - 8 weeks after the end of chemoradiation . RESULTS No patients had Grade 4 acute toxicity . Grade 3 acute toxicity occurred in 16.6 % of cases and was hematologic in 6 patients and GI in 2 . The overall clinical response rate was 88.8 % , with a complete response in 5.5 % , partial response in 83.3 % , and no change in 9.2 % . No patient showed disease progression . All patients underwent surgery . Sphincter saving was obtained in 83.3 % of patients . No perioperative mortality occurred , and the perioperative morbidity rate was 5.5 % . Of 20 resected patients ( 37 % ) who were c and i date s for abdominoperineal resection at diagnosis ( anorectal ring distance < or = 30 mm ) , 13 ( 65 % ) underwent a sphincter-saving procedure . At pathologic examination , 13 ( 24 % ) of 54 patients had a complete pathologic response ( pT0 ) and 10 ( 18.5 % ) had rare isolated residual cancer cells ( pT , microscopic foci ) . Overall , 42.5 % had major downstaging . The tumor regression grade ( TRG ) , using M and ard 's score system , was also applied and was TRG1 in 13 patients , TRG2 in 11 , TRG3 in 20 , and TRG4 in 10 patients ; no patient had TRG5 . CONCLUSION The use of raltitrexed in a neoadjuvant chemoradiation schedule promoted high pathologic tumor downstaging and use of a sphincter-saving procedure . The low toxicity profile supports the rationale to explore raltitrexed combined with other drugs with different biologic targets Background Magnetic resonance imaging ( MRI ) methods for chemoradiotherapy ( CRT ) response assessment of rectal cancer include posttreatment T staging ( ymrT ) , tumor regression grading ( mrTRG ) , volume reduction posttreatment , and modified RECIST measurement . We compared these methods in identifying good versus poor responders with the histopathological st and ards of T stage ( ypT ) and tumor regression grading ( TRG ) . Methods A total of 86 patients underwent CRT in a prospect i ve phase II trial for MRI-defined locally advanced rectal cancer . Two readers independently assessed MRIs for ymrT , mrTRG , volume change , and RECIST . Parameters for each case were categorized as good or poor response and analyzed against ypT and TRG by univariate logistic regression . Results A total of 83 patients had evaluable imaging , and 78 had final pathology ( five did not undergo surgery ) . Of these , 34 patients had good response ( ypT0 - 3a ) and 44 had poor response ( > ypT3a ) . Also , 27 patients had favorable pathologic TRG ( predominant fibrosis ) and 51 had unfavorable TRG ( predominant tumor ) . Good mrTRG and ymr < T3b stage were both significantly ( P = 0.001 ) associated with favorable pathology odds ratio [ OR ] = 16.11 ( 95 % confidence interval [ 95 % CI ] : 3.36–77.29 ) and 17.50 ( 95 % CI : 5.38–56.89 ) , respectively . RECIST measurements and volume reduction of > 80 % showed an OR of 3.23 ( 95 % CI : 1.14–9.17 ) , 4.25 ( 95 % CI : 0.92–15.45 ) , respectively , for a good ypT score ( P = 0.028 ) , but there was no association for histopathological TRG . Conclusion Favorable and unfavorable histopathology are predicted by both ymrT and mrTRG , and we recommend these parameters for post-treatment assessment of rectal cancers treated with CRT PURPOSE We assessed the impact of tumor regression grading ( TRG ) and its value in correlation to established prognostic factors in a cohort of rectal carcinoma patients treated by preoperative chemoradiotherapy ( CRT ) . PATIENTS AND METHODS TRG was evaluated on surgical specimens of 385 patients treated within the preoperative CRT arm of the CAO/ARO/AIO-94 trial : 50.4 Gy was delivered , fluorouracil was given in the first and fifth week , and surgery was performed 6 weeks thereafter . TRG was determined by the amount of viable tumor versus fibrosis , ranging from TRG 4 when no viable tumor cells were detected , to TRG 0 when fibrosis was completely absent . TRG 3 was defined as regression more than 50 % with fibrosis outgrowing the tumor mass , TRG 2 was defined as regression less than 50 % , and TRG 1 was defined basically as a morphologically unaltered tumor mass . We performed an initially unplanned , hypothesis-generating analysis with respect to the prognostic value of this TRG system . RESULTS TRG 4 , 3 , 2 , 1 , 0 was found in 10.4 % , 52.2 % , 13.8 % , 15.3 % , and 8.3 % of the resected specimens , respectively . Five-year disease-free survival ( DFS ) after CRT and curative resection was 86 % for TRG 4 , 75 % for grouped TRG 2 + 3 , and 63 % for grouped TRG 0 + 1 ( P = .006 ) . On multivariate analysis , the pathologic T category and the nodal status after CRT were the most important independent prognostic factors for DFS . CONCLUSION In this exploratory analysis , complete ( TRG 4 ) and intermediate pathologic response ( TRG 2 + 3 ) suggested improved DFS after preoperative CRT . TRG assessment should be implemented in pathologic evaluation and prospect ively vali date d in further studies PURPOSE The aim this study was to determine the pathologic complete response ( pCR ) rate defined as tumor regression grade 1 ( TRG1 ) and toxicity profile of the combination of high-dose pre-operative radiotherapy and simultaneous UFT/leucovorin ( LV ) in patients with locally advanced rectal cancer . MATERIAL S/ METHODS Eligibility included biopsy proven rectal adenocarcinoma ; T3-T4 N0-N2 ; performance status < 2 ( ECOG ) and adequate blood , hepatic and renal function . Treatment consisted of radiotherapy 54 Gy at 1.8 Gy/day and UFT 300 mg/m(2)/day and LV 60 mg/day , given simultaneously daily for 6 weeks . Surgery was performed within 4 - 6 weeks period after chemoradiotherapy . Patients who did not achieve TGR1 were to receive 4 cycles of adjuvant UFT/LV on days 1 - 28 , every 5 weeks . RESULTS Sixty-eight patients were included . All but one received full dose of radiation and 62 had the total planned pre-operative UFT/LV dose . Grade 3 toxicities were diarrhea 7 % and proctitis 3 % . Complete resection was achieved in 62 patients ( 91 % ) . Tumor regression grade 1 ( TRG1 ) was seen in 11 patients ( 16 % ) . Forty-eight patients received adjuvant UFT/LV . Grade 3 toxicity during adjuvant UFT/LV included diarrhea 12 % , asthenia 4 % , neutropenia 2 % , and h and -foot syndrome 2 % . The 3-year disease-free survival was 71 % . CONCLUSIONS Simultaneous high-dose pre-operative localized radiation therapy concurrent with UFT/LV is feasible and has a low toxicity profile . This schedule is highly effective and merits further investigation BACKGROUND AND PURPOSE To explore the utility of tumour regression grading ( TRG , the amount of residual tumour cells in relation to extension of fibrosis ) after chemoradiation of rectal cancer . MATERIAL S AND METHODS Of 131 patients who received preoperative chemoradiation in the frame of the r and omized trial , pathological complete response ( pCR , TRG0 ) , good regression ( TRG1 ) , moderate regression ( TRG2 ) , and poor regression ( TRG3 ) were recorded in 17 % , 31 % , 31 % , and 22 % of patients , respectively . RESULTS The rates of ypN-positive category for TRG0 , TRG1 , TRG2 , and TRG3 groups were 5 % , 23 % , 45 % , and 46 % , respectively , p=0.001 . When ypT-category and TRG were evaluated by the logistic regression analysis , only ypT-category remained significant for independent prediction of the risk for mesorectal nodal metastases , p=0.006 . The 4-year ( median follow-up ) disease-free survival ( DFS ) for TRG0 , TRG1 , TRG2 , and TRG3 groups were 91 % , 67 % , 54 % , and 47 % . When patients with persistent disease ( TRG1 vs. TRG2 vs. TRG3 ) were analyzed separately , TRG had no prognostic value for DFS , p=0.402 . CONCLUSIONS TRG in patients with residual cancer had no prognostic value for the incidence of nodal disease and for DFS . Our findings and literature data question the need for the inclusion of TRG assessment into a routine pathological report AIM The value of grading tumor regression after neoadjuvant therapy of rectal carcinoma was evaluated . PATIENTS AND METHODS Analysis was carried out using prospect i ve data of 225 patients with rectal carcinoma treated by neoadjuvant radiochemotherapy followed by radical resection with curative intent . For the histological regression grading , the method of Dworak et al. ( 1997 ) was used with a slight modification . RESULTS After neoadjuvant radiochemotherapy , the most important prognostic factors are pathologically assessed circumferential resection margin , quality of surgery ( plane of surgery ) , and the ypT and ypN classification . In addition , the histological regression grade of primary tumor and regional lymph nodes influence outcome , especially the local recurrence rate . CONCLUSION After neoadjuvant therapy , the histological tumor regression grading should be assessed . A regression grading system based on the proposals of Dworak et al. ( 1997 ) is recommended PURPOSE To assess magnetic resonance imaging ( MRI ) and pathologic staging after neoadjuvant therapy for rectal cancer in a prospect ively enrolled , multicenter study . METHODS In a prospect i ve cohort study , 111 patients who had rectal cancer treated by neoadjuvant therapy were assessed for response by MRI and pathology staging by T , N and circumferential resection margin ( CRM ) status . Tumor regression grade ( TRG ) was also assessed by MRI . Overall survival ( OS ) was estimated by using the Kaplan-Meier product-limit method , and Cox proportional hazards models were used to determine associations between staging of good and poor responders on MRI or pathology and survival outcomes after controlling for patient characteristics . RESULTS On multivariate analysis , the MRI-assessed TRG ( mrTRG ) hazard ratios ( HRs ) were independently significant for survival ( HR , 4.40 ; 95 % CI , 1.65 to 11.7 ) and disease-free survival ( DFS ; HR , 3.28 ; 95 % CI , 1.22 to 8.80 ) . Five-year survival for poor mrTRG was 27 % versus 72 % ( P = .001 ) , and DFS for poor mrTRG was 31 % versus 64 % ( P = .007 ) . Preoperative MRI-predicted CRM independently predicted local recurrence ( LR ; HR , 4.25 ; 95 % CI , 1.45 to 12.51 ) . Five-year survival for poor post-treatment pathologic T stage ( ypT ) was 39 % versus 76 % ( P = .001 ) ; DFS for the same was 38 % versus 84 % ( P = .001 ) ; and LR for the same was 27 % versus 6 % ( P = .018 ) . The 5-year survival for involved pCRM was 30 % versus 59 % ( P = .001 ) ; DFS , 28 versus 62 % ( P = .02 ) ; and LR , 56 % versus 10 % ( P = .001 ) . Pathology node status did not predict outcomes . CONCLUSION MRI assessment of TRG and CRM are imaging markers that predict survival outcomes for good and poor responders and provide an opportunity for the multidisciplinary team to offer additional treatment options before planning definitive surgery . Postoperative histopathology
Output:
| MRI indicates good and poor response by mrTRG1 - 3 and mrTRG4 - 5 , respectively |
MS212729 | ***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: R and omized controlled trials have yielded promising results for internet-delivered cognitive behavior therapy ( iCBT ) for patients with social anxiety disorder ( SAD ) . The present study investigated anxiety-related neural changes after iCBT for SAD . The amygdala is a critical hub in the neural fear network , receptive to change using emotion regulation strategies and a putative target for iCBT . Twenty-two subjects were included in pre- and post-treatment functional magnetic resonance imaging at 3 T assessing neural changes during an affective face processing task . Treatment outcome was assessed using social anxiety self-reports and the Clinical Global Impression-Improvement ( CGI-I ) scale . ICBT yielded better outcome than ABM ( 66 % vs. 25 % CGI-I responders ) . A significant differential activation of the left amygdala was found with relatively decreased reactivity after iCBT . Changes in the amygdala were related to a behavioral measure of social anxiety . Functional connectivity analysis in the iCBT group showed that the amygdala attenuation was associated with increased activity in the medial orbitofrontal cortex and decreased activity in the right ventrolateral and dorsolateral ( dlPFC ) cortices . Treatment-induced neural changes with iCBT were consistent with previously reported studies on regular CBT and emotion regulation in general Patients with anxiety disorders exhibit excessive neural reactivity in the amygdala , which can be normalized by effective treatment like cognitive behavior therapy ( CBT ) . Mechanisms underlying the brain ’s adaptation to anxiolytic treatments are likely related both to structural plasticity and functional response alterations , but multimodal neuroimaging studies addressing structure – function interactions are currently missing . Here , we examined treatment-related changes in brain structure ( gray matter ( GM ) volume ) and function ( blood – oxygen level dependent , BOLD response to self-referential criticism ) in 26 participants with social anxiety disorder r and omly assigned either to CBT or an attention bias modification control treatment . Also , 26 matched healthy controls were included . Significant time × treatment interactions were found in the amygdala with decreases both in GM volume ( family-wise error ( FWE ) corrected PFWE=0.02 ) and BOLD responsivity ( PFWE=0.01 ) after successful CBT . Before treatment , amygdala GM volume correlated positively with anticipatory speech anxiety ( PFWE=0.04 ) , and CBT-induced reduction of amygdala GM volume ( pre – post ) correlated positively with reduced anticipatory anxiety after treatment ( PFWE⩽0.05 ) . In addition , we observed greater amygdala neural responsivity to self-referential criticism in socially anxious participants , as compared with controls ( PFWE=0.029 ) , before but not after CBT . Further analysis indicated that diminished amygdala GM volume mediated the relationship between decreased neural responsivity and reduced social anxiety after treatment ( P=0.007 ) . Thus , our results suggest that improvement-related structural plasticity impacts neural responsiveness within the amygdala , which could be essential for achieving anxiety reduction with CBT Background Amygdala is considered as the core pathogenesis of generalized social anxiety disorder ( GSAD ) . However , it is still unclear whether effective group cognitive behavioral therapy ( CBT ) could modulate the function of amygdala-related network . We aim ed to examine the resting-state functional connectivity ( rsFC ) of the amygdala before and after group CBT . Methods Fifteen patients with GSAD were scanned on a 3 T MR system before and after 8 weeks of group CBT . For comparison , nineteen healthy control participants also underwent baseline fMRI scanning . We used bilateral amygdala as seed regions and the rsFC maps of the right and left amygdala were created separately in a voxel-wise way . Clusters survived two-tailed Gaussian R and om Field ( GRF ) correction at p < 0.05 ( voxel z value > 2.3 ) . Results Compared with baseline , patients with CBT showed significantly decreased connectivity of the left amygdala with the right putamen , the left dorsal medial prefrontal cortex ( dmPFC ) and the right dorsal anterior cingulate cortex ( dACC ) . Especially , the changes of the connectivity between the left amygdala and the dACC positively correlated with changes of the anxiety symptom in patients . Furthermore , in relative to controls , patients showed higher connectivity of left amygdala with dmPFC and dACC at baseline , while normal after CBT . Conclusions Short-term group CBT could down-regulate the abnormal higher connectivity of prefrontal-amygdala network , along with clinical improvement . This may provide a potential biomarker to monitor the treatment effect of CBT in GSAD patients Social anxiety disorder ( SAD ) is characterized at a neurobiological level by disrupted activity in emotion regulation neural circuitry . Previous work has demonstrated amygdala hyperreactivity and disrupted prefrontal responses to social cues in individuals with SAD ( Kim et al. , 2011 ) . While exposure-based psychological treatments effectively reduce SAD symptoms , not all individuals respond to treatment . Better underst and ing of the neural mechanisms involved offers the potential to improve treatment efficacy . In this study , we investigated functional connectivity in emotion regulation neural circuitry in a r and omized controlled treatment trial for SAD . Participants with SAD underwent fMRI scanning while performing an implicit emotion regulation task prior to treatment ( n=62 ) . Following 12 weeks of cognitive behavioral therapy , acceptance and commitment therapy , or wait-list , participants completed a second scan ( n=42 ) . Psychophysiological interaction analyses using amygdala seed regions demonstrated differences between SAD and healthy control participants ( HC ; n=16 ) in right amygdala-vmPFC connectivity . SAD participants demonstrated more negative amygdala-to-vmPFC connectivity , compared to HC participants , an effect that was correlated with SAD symptom severity . Post-treatment symptom reduction was correlated with altered amygdala-to-vm/vlPFC connectivity , independent of treatment type . Greater symptom reduction was associated with more negative amygdala-to-vm/vlPFC connectivity . These findings suggest that effective psychological treatment for SAD enhances amygdala-prefrontal functional connectivity Background : Cognitive behavioral therapy ( CBT ) is an effective treatment for panic disorder with agoraphobia ( PD/AG ) . It is unknown , how variants of CBT differentially modulate brain networks involved in PD/AG . This study was aim ed to evaluate the effects of therapist-guided ( T+ ) versus self-guided ( T- ) exposure on the neural correlates of fear conditioning in PD/AG . Method : In a r and omized , controlled multicenter clinical trial in medication-free patients with PD/AG who were treated with 12 sessions of manualized CBT , functional magnetic resonance imaging ( fMRI ) was used during fear conditioning before ( t1 ) and after CBT ( t2 ) . Quality -controlled fMRI data from 42 patients and 42 healthy subjects ( HS ) were obtained . Patients were r and omized to two variants of CBT ( T+ , n = 22 , and T- , n = 20 ) . Results : The interaction of diagnosis ( PD/AG , HS ) , treatment group ( T+ , T- ) , time point ( t1 , t2 ) and stimulus type ( conditioned stimulus : yes , no ) revealed activation in the left hippocampus and the occipitotemporal cortex . The T+ group demonstrated increased activation of the hippocampus at t2 ( t2 > t1 ) , which was positively correlated with treatment outcome , and a decreased connectivity between the left inferior frontal gyrus and the left hippocampus across time ( t1 > t2 ) . Conclusion : After T+ exposure , contingency-encoding processes related to the posterior hippocampus are augmented and more decoupled from processes of the left inferior frontal gyrus , previously shown to be dysfunctionally activated in PD/AG . Linking single procedural variants to neural substrates offers the potential to inform about the optimization of targeted psychotherapeutic interventions BACKGROUND Neurofunctional changes underlying effective antianxiety treatments are incompletely characterized . This study explored the effects of citalopram and cognitive-behavioral therapy on regional cerebral blood flow ( rCBF ) in social phobia . METHODS By means of positron emission tomography with oxygen 15-labeled water , rCBF was assessed in 18 previously untreated patients with social phobia during an anxiogenic public speaking task . Patients were matched for sex , age , and phobia severity , based on social anxiety question naire data , and r and omized to citalopram medication , cognitive-behavioral group therapy , or a waiting-list control group . Scans were repeated after 9 weeks of treatment or waiting time . Outcome was assessed by subjective and psychophysiological state anxiety measures and self-report question naires . Questions were readministered after 1 year . RESULTS Symptoms improved significantly and roughly equally with citalopram and cognitive-behavioral therapy , whereas the waiting-list group remained unchanged . Four patients in each treated group and 1 waiting-list patient were classified as responders . Within both treated groups , and in responders regardless of treatment approach , improvement was accompanied by a decreased rCBF-response to public speaking bilaterally in the amygdala , hippocampus , and the periamygdaloid , rhinal , and parahippocampal cortices . Between-group comparisons confirmed that rCBF in these regions decreased significantly more in treated groups than control subjects , and in responders than nonresponders , particularly in the right hemisphere . The degree of amygdalar-limbic attenuation was associated with clinical improvement a year later . CONCLUSIONS Common sites of action for citalopram and cognitive-behavioral treatment of social anxiety were observed in the amygdala , hippocampus , and neighboring cortical areas , ie , brain regions subserving bodily defense reactions to threat The 16-item Quick Inventory of Depressive Symptomatology ( QIDS ) , a new measure of depressive symptom severity derived from the 30-item Inventory of Depressive Symptomatology ( IDS ) , is available in both self-report ( QIDS-SR(16 ) ) and clinician-rated ( QIDS-C(16 ) ) formats . This report evaluates and compares the psychometric properties of the QIDS-SR(16 ) in relation to the IDS-SR(30 ) and the 24-item Hamilton Rating Scale for Depression ( HAM-D(24 ) ) in 596 adult out patients treated for chronic nonpsychotic , major depressive disorder . Internal consistency was high for the QIDS-SR(16 ) ( Cronbach 's alpha = .86 ) , the IDS-SR(30 ) ( Cronbach 's alpha = .92 ) , and the HAM-D(24 ) ( Cronbach 's alpha = .88 ) . QIDS-SR(16 ) total scores were highly correlated with IDS-SR(30 ) ( .96 ) and HAM-D(24 ) ( .86 ) total scores . Item-total correlations revealed that several similar items were highly correlated with both QIDS-SR(16 ) and IDS-SR(30 ) total scores . Roughly 1.3 times the QIDS-SR(16 ) total score is predictive of the HAM-D(17 ) ( 17-item version of the HAM-D ) total score . The QIDS-SR(16 ) was as sensitive to symptom change as the IDS-SR(30 ) and HAM-D(24 ) , indicating high concurrent validity for all three scales . The QIDS-SR(16 ) has highly acceptable psychometric properties , which supports the usefulness of this brief rating of depressive symptom severity in both clinical and research setting Background : The present study examined the prevalence of social phobia in the Swedish general population and demographic characteristics associated with this anxiety disorder . Methods : Data were obtained by means of a postal survey administrated to 2000 r and omly selected adults . A question naire , vali date d against clinical interviews and established social phobia scales , was used to assess social distress in a broad range of phobic situations , as well as the diagnostic criteria for social phobia corresponding to DSM-IV . Interpretable question naires were obtained from 1202 respondents ( 60.1 % ) . Results : The point prevalence of social phobia was estimated at 15.6 % , but prevalence rates varied between 1.9 and 20.4 % across the different levels of distress and impairment used to define cases . Public speaking was the most common social fear . Social phobia was associated with female gender , low educational attainment , psychiatric medication use , and lack of social support . Conclusions : Although the exact diagnostic boundaries for social phobia are difficult to determine , it can be concluded that social anxiety is a distressing problem for a considerable proportion of the general population BACKGROUND Learning by conditioning is a key ability of animals and humans for acquiring novel behavior necessary for survival in a changing environment . Aberrant conditioning has been considered a crucial factor in the etiology and maintenance of panic disorder with agoraphobia ( PD/A ) . Cognitive-behavioral therapy ( CBT ) is an effective treatment for PD/A. However , the neural mechanisms underlying the effects of CBT on conditioning processes in PD/A are unknown . METHODS In a r and omized , controlled , multicenter clinical trial in medication-free patients with PD/A who were treated with 12 sessions of manualized CBT , functional magnetic resonance imaging ( fMRI ) was used during fear conditioning before and after CBT . Quality -controlled f
Output:
| Conclusion : Neuroimaging studies suggest that abnormalities in hippocampus , amygdala , iFG , uncus and areas linked with emotional regulation ( dlPFC and ACC ) , predict a good outcome to psychotherapy in anxiety disorders .
HighlightsNeuroimaging studies suggest that hippocampus , amygdala , iFG , uncus dlPFC and ACC predict a good outcome to psychotherapy in anxiety disorders |
MS212730 | ***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 Whether there is an association between depression at the time of acute myocardial infa rct ion and subsequent risk of cardiac complications and death remains controversial . Most studies of this risk factor have been limited to patients of single institutions , and this might account for the varying results . We prospect ively evaluated patients admitted to 5 tertiary care and 5 community hospitals and followed them for 1 year to measure the prevalence and prognostic impact of depressive symptoms after acute myocardial infa rct ion . METHODS Patients were recruited for the study by trained nurse interviewers who had documented acute myocardial infa rct ion within 2 - 3 days of admission . The nurses collected information from the medical records and asked study subjects to complete the Beck Depression Inventory question naire during their stay in hospital and using a mailed question naire 30 days , 6 months and 1 year later . We obtained information on vital status for patients lost to follow-up from a central death registry . RESULTS Of the 587 study subjects , 550 ( 94 % ) completed the Beck Depression Inventory at baseline and 191 ( 35 % ) had a score of 10 or more , indicating at least mild depression . Rates of depression did not vary over the follow-up period and were similar among patients admitted to tertiary care or community hospitals . Depressed patients were more likely to undergo catheterization ( 57 % v. 47 % , 95 % confidence interval [ CI ] around the difference 0.1%-19.6 % ) and were more likely to undergo percutaneous coronary intervention ( 32 % v. 24 % , 95 % CI around the difference 0.1%-16.2 % ) within 30 days of first admission to hospital . Patients with depression on admission had higher rates of a composite of cardiac complications , including recurrent ischemia , infa rct ion or congestive heart failure during their first stay in hospital or readmission for angina , recurrent acute myocardial infa rct ion , congestive heart failure or arrhythmia ( adjusted hazard ratio 1.4 , 95 % CI 1.05 - 1.86 ) , compared with patients who were not depressed on admission . After 1 year , death rates were higher among patients who were depressed at admission ( 30 patients , 16 % ) compared with nondepressed patients ( 28 patients , 8 % ) , although the difference was not statistically significant ( hazard ratio 1.3 , 95 % CI 0.59 - 3.05 ) . INTERPRETATION Depressive symptoms are common after acute myocardial infa rct ion and are associated with a slight increase in risk of in-hospital catheterization and angiography and readmission because of cardiac complications . Death was infrequent , with no statistically significant difference between the 2 groups Background —Women have an unexplained worse outcome after myocardial infa rct ion ( MI ) compared with men in many studies . Depressive symptoms predict adverse post-MI outcomes and are more prevalent among women than men . We examined whether depressive symptoms contribute to women ’s worse outcomes after MI . Methods and Results —In a prospect i ve multicenter study ( PREMIER ) , 2411 ( 807 women ) MI patients were enrolled . Depressive symptoms were assessed with the Patient Health Question naire . Outcomes included 1-year rehospitalization , presence of angina using the Seattle Angina Question naire , and 2-year mortality . Multivariable analyses were used to evaluate the association between sex and these outcomes , adjusting for clinical characteristics . The depressive symptoms score was added to the models to evaluate whether it attenuated the association between sex and outcomes . Depressive symptoms were more prevalent in women compared with men ( 29 % versus 18.8 % , P<0.001 ) . After adjusting for demographic factors , comorbidities , and MI severity , women had a mildly higher risk of rehospitalization ( hazard ratio , 1.20 ; 95 % CI , 1.04 to 1.40 ) , angina ( odds ratio , 1.32 ; 95 % CI , 1.00 to 1.75 ) , and mortality ( hazard ratio , 1.27 ; 95 % CI , 0.98 to 1.64 ) . After adding depressive symptoms to the multivariable models , the relationship further declined toward the null , particularly for rehospitalization ( hazard ratio , 1.14 ; 95 % CI , 0.98 to 1.34 ) and angina ( odds ratio , 1.22 ; 95 % CI , 0.91 to 1.63 ) , whereas there was little change in the estimate for mortality ( hazard ratio , 1.24 ; 95 % CI , 0.95 to 1.62 ) . Depressive symptoms were significantly associated with each of the study outcomes with a similar magnitude of effect in both women and men . Conclusions —A higher prevalence of depressive symptoms in women modestly contributes to their higher rates of rehospitalization and angina compared with men but not mortality after MI . Our results support the recent recommendations of improving recognition of depressive symptoms after MI BACKGROUND Depression is associated with an increased risk for mortality after acute myocardial infa rct ion ( MI ) . The purpose of this study was to determine whether low heart rate variability ( HRV ) mediates the effect of depression on mortality . METHODS Twenty-four-hour ambulatory electrocardiograms were obtained from 311 depressed patients with a recent acute MI who were enrolled in the Enhancing Recovery in Coronary Heart Disease ( ENRICHD ) clinical trial and from 367 nondepressed patients who met the ENRICHD medical inclusion criteria . St and ard HRV indexes were extracted from the recordings . RESULTS The log of very low-frequency ( LnVLF ) power , an index of HRV derived from power spectral analysis of the electrocardiogram signal ( 0.0033 - 0.04 Hz [ in milliseconds squared ] ) , was lower in the depressed than in the nondepressed patients ( P<.001 ) . There were 47 deaths ( 6.1 % ) during a 30-month follow-up . After adjusting for potential confounders , the depressed patients remained at higher risk for all-cause mortality compared with the nondepressed patients ( hazard ratio , 2.8 ; 95 % confidence interval [ CI ] , 1.4 - 5.4 ; P<.003 ) . When LnVLF power was entered into the model , the hazard ratio for depression dropped to 2.1 ( 95 % CI , 1.1 - 4.2 ; P = .03 ) . The proportion of the risk for depression attributable to LnVLF power was 0.27 ( 95 % CI , 0.23 - 0.31 ; P<.001 ) . CONCLUSIONS Low HRV partially mediates the effect of depression on survival after acute MI . This finding helps to clarify the physiological mechanisms underlying depression 's role as a risk factor for mortality in patients with coronary heart disease . It also raises the possibility that treatments that improve both depression and HRV might also improve survival in these patients Background — The American Heart Association ( AHA ) statement has recommended routine screening for depression in coronary artery disease with a 2-stage implementation of the Patient Health Question naire ( PHQ ) . Because there is little evidence on feasibility , accuracy , and impact of such a program on depression recognition in coronary patients , the AHA recommendation has met substantial debate and criticism . Methods and Results — Before the AHA statement was released , the Mid America Heart and Vascular Institute ( MAHVI ) had implemented a depression screening protocol for patients with acute myocardial infa rct ion that was virtually identical to the AHA recommendations . To ( 1 ) evaluate this MAHVI quality improvement initiative , ( 2 ) compare MAHVI depression recognition rates with those of other hospitals , and ( 3 ) examine health care providers ' implementation feedback , we compared the results of the MAHVI screening program with data from a parallel prospect i ve acute myocardial infa rct ion registry and interviewed MAHVI providers . Depressive symptoms ( PHQ-2 , PHQ-9 ) were assessed among 503 MAHVI acute myocardial infa rct ion patients and compared with concurrent depression assessment s among 3533 patients at 23 US centers without a screening protocol . A qualitative summary of providers ' suggestions for improvement was also generated . A total of 135 ( 26.8 % ) eligible MAHVI patients did not get screened . Among screened patients , 90.9 % depressed ( PHQ-9 ≥10 ) patients were recognized . The agreement between the screening and registry data using the full PHQ-9 was 61.5 % for positive cases ( PHQ-9 ≥10 ) but only 35.6 % for the PHQ-2 alone . Although MAHVI had a slightly higher overall depression recognition rate ( 38.3 % ) than other centers not using a depression screening protocol ( 31.5 % ) , the difference was not statistically significant ( P=0.31 ) . Staff feedback suggested that a single-stage screening protocol with continuous feedback could improve compliance . Conclusions — In this early effort to implement a depression screening protocol , a large proportion of patients did not get screened , and only a modest impact on depression recognition rates was realized . Simplifying the protocol by using the PHQ-9 alone and providing more support and feedback may improve the rates of depression detection and treatment CONTEXT Depression and low perceived social support ( LPSS ) after myocardial infa rct ion ( MI ) are associated with higher morbidity and mortality , but little is known about whether this excess risk can be reduced through treatment . OBJECTIVE To determine whether mortality and recurrent infa rct ion are reduced by treatment of depression and LPSS with cognitive behavior therapy ( CBT ) , supplemented with a selective serotonin reuptake inhibitor ( SSRI ) antidepressant when indicated , in patients enrolled within 28 days after MI . DESIGN , SETTING , AND PATIENTS R and omized clinical trial conducted from October 1996 to April 2001 in 2481 MI patients ( 1084 women , 1397 men ) enrolled from 8 clinical centers . Major or minor depression was diagnosed by modified Diagnostic and Statistical Manual of Mental Disorders , Fourth Edition criteria and severity by the 17-item Hamilton Rating Scale for Depression ( HRSD ) ; LPSS was determined by the Enhancing Recovery in Coronary Heart Disease Patients ( ENRICHD ) Social Support Instrument ( ESSI ) . R and om allocation was to usual medical care or CBT-based psychosocial intervention . INTERVENTION Cognitive behavior therapy was initiated at a median of 17 days after the index MI for a median of 11 individual sessions throughout 6 months , plus group therapy when feasible , with SSRIs for patients scoring higher than 24 on the HRSD or having a less than 50 % reduction in Beck Depression Inventory scores after 5 weeks . MAIN OUTCOME MEASURES Composite primary end point of death or recurrent MI ; secondary outcomes included change in HRSD ( for depression ) or ESSI scores ( for LPSS ) at 6 months . RESULTS Improvement in psychosocial outcomes at 6 months favored treatment : mean ( SD ) change in HRSD score , -10.1 ( 7.8 ) in the depression and psychosocial intervention group vs -8.4 ( 7.7 ) in the depression and usual care group ( P<.001 ) ; mean ( SD ) change in ESSI score , 5.1 ( 5.9 ) in the LPSS and psychosocial intervention group vs 3.4 ( 6.0 ) in the LPSS and usual care group ( P<.001 ) . After an average follow-up of 29 months , there was no significant difference in event-free survival between usual care ( 75.9 % ) and psychosocial intervention ( 75.8 % ) . There were also no differences in survival between the psychosocial intervention and usual care arms in any of the 3 psychosocial risk groups ( depression , LPSS , and depression and LPSS patients ) . CONCLUSIONS The intervention did not increase event-free survival . The intervention improved depression and social isolation , although the relative improvement in the psychosocial intervention group compared with the usual care group was less than expected due to substantial improvement in usual care patients BACKGROUND Depression predicts worse outcomes after myocardial infa rct ion ( MI ) , but whether its time course in the month following MI has prognostic importance is unknown . Our objective was to evaluate the prognostic importance of transient , new , or persistent depression on outcomes at 6 months after MI . METHODS In a prospect i ve registry of acute MI ( Prospect i ve Registry Evaluating outcomes after Myocardial Infa rct ion : Events and Recovery [ PREMIER ] ) , depressive symptoms were measured in 1873 patients with the Patient Health Question naire ( PHQ ) during hospitalization and 1 month after discharge and were classified as transient ( only at baseline ) , new ( only at 1 month ) , or persistent ( at both times ) . Outcomes at 6 months included ( 1 ) all-cause rehospitalization or mortality and ( 2 ) health status ( angina , physical limitation , and quality of life using the Seattle Angina Question naire ) . RESULTS Compared with nondepressed patients , all categories of depression were associated with higher rehospitalization or mortality rates , more frequent angina , more physical limitations , and worse quality of life . The adjusted hazard ratios for rehospitalization or mortality were 1.34
Output:
| Despite limitations in some individual studies , our review identified generally consistent associations between depression and adverse outcomes . |
MS212731 | ***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 value of mailed educational videotapes as a means of enhancing compliance with drug therapy was studied . Members of a health maintenance organization with a pharmacy cl aim for benazepril , metoprolol , simvastatin , or transdermal estrogen were r and omly assigned to a study group or a control group . Subjects in the study group were mailed one of four videotape programs giving information on the drug prescribed and the inferred disease state . Control subjects received no educational material s. Subjects were enrolled from July 1 , 1993 , through January 2 , 1994 . Refill data were collected from July 1 , 1993 , through April 1 , 1994 . The medication possession ratio ( MPR ) was calculated as the total number of days ' supply of a drug obtained by a member divided by the number of days between the time of enrollment and April 1 , 1994 , or the date the member was terminated from the plan . A subject was deemed compliant if his or her MPR was > or = 0.80 . There were no significant differences in mean MPRs between the study group ( n = 1993 ) and the control group ( n = 2253 ) . None of the mean MPRs was > or = 0.80 , although 44 % of control subjects and 46 % of study -group subjects were compliant . Of 97 respondents to a survey mailed to a r and omly selected subset of the study group , almost 87 % reported that they had viewed the videotapes , and of these subjects , about 88 % said they found them very useful or somewhat useful . A one-time mailing of videotapes to patients , with no individual follow-up , did not increase compliance with the medications monitored OBJECTIVE : Noxious adverse effects frequently limit patient acceptance of niacin and bile acid sequestrants ( BAS ) , first-line agents in the management of hypercholesterolemia . The purpose of this study was to determine whether telephone contacts from a healthcare professional could improve drug adherence and tolerance in patients prescribed these medications . PATIENTS AND METHODS : This was a r and omized , single-blind trial of telephone contacts vs. no intervention in patients with hyperlipidemia who were prescribed either niacin or BAS in a large , Veterans Affairs , lipid clinic . Patients r and omized to telephone contact ( n=81 ) received weekly calls from a trained healthcare professional during the first month of drug therapy . Counseling regarding adverse effects , and prescriptions to overcome minor adverse effects , were provided as needed to patients during the telephone contact . RESULTS : Significant differences were not observed between groups in the drug discontinuance rate , adherence assessed by two independent methods , or in the final dosage of medication ingested . CONCLUSIONS : Telephone contacts do not improve either adherence or tolerance to niacin or BAS . Alternative approaches to enhance acceptance of these medications requires further evaluation BACKGROUND Noncompliance with cardiovascular therapy and prevention initiatives is well documented . OBJECTIVES The purpose of the First Myocardial Infa rct ion ( MI ) Risk Reduction Program , an open-label drug registry involving mainly primary -care patients at increased risk of a first MI , was to examine the effects of postal and telephone reminders , as well as demographic and other baseline characteristics , on patient self-reported compliance with pravastatin treatment . A second objective was to determine whether regimen adherence was associated with the adoption of other lifestyle modifications recommended to decrease the risk of coronary artery disease . METHODS Patients with risk scores of > or = 4 on a scale of -1 to + 16 for men and -1 to + 17 for women on the First Heart Attack Risk Test were considered to be at increased risk of a first MI and eligible for enrollment in the registry program . An elevated total cholesterol level despite dietary interventions was an additional inclusion criterion . Patients were prospect ively r and omized ( 4:1 ) to either an intervention involving postal and telephone reminders ( about coronary risk reduction and medication compliance ) , which were sent during the first 2 months of pravastatin treatment , or usual care . Both groups received reminder postcards at 4 and 5 months , in addition to counseling by physicians about coronary risk reduction . At 3 and 6 months ( or study discontinuation ) , patients completed and mailed to the program-coordinating center question naires concerning compliance with care , including current use of prescribed pravastatin , as well as self-reported adoption of other lifestyle modifications , such as changing eating habits , losing weight , increasing physical activity , and /or quitting smoking . Compliance with pravastatin therapy and with these coronary risk-reducing behaviors was also assessed by physicians at the 3-month follow-up visit . RESULTS A total of 10,335 patients were in the intervention group , and 2765 received usual care . The 2 groups were well balanced at baseline with respect to age , race , and total cholesterol values . Neither early reminders nor baseline patient characteristics were significantly associated with reported pravastatin compliance rates , which were approximately 79 % overall . However , according to self-reports at 6 months , regimen compliance was associated with the adoption of other coronary risk-reducing behaviors . CONCLUSIONS The results of this study suggest that early telephone and postal reminders do not improve compliance with drug treatment or with recommended coronary risk-reducing behaviors During the last quarter of the third year of follow-up in the Helsinki Heart Study , compliance to medication was measured in 1739 patients with digoxin used as a marker substance , capsule counting and a compliance question naire . The estimates for good and poor compliers were found to be highly dependent on the method and the cut-off points chosen for the compliance allocation . The methods studied here were more reliable for the detection of poor rather than good compliance . In the poor compliance group , defined with the use of the digoxin marker , there was 39 % of subjects who returned less than 5 % of their capsule dosage or reported a deviation less than 5 % . In the good compliance group , defined by the digoxin marker , only 11.8 % of patients either returned or reported a deviation of at least 25 % of their dose . The compliance was better when measured by the question naire than by capsule counting . The size of the poor compliance group , defined by the use of the digoxin marker , was as large as a group who had returned at least 27 % of their capsule dose and a group who had reported a deviation of 11 % or more from their dosing schedule . The size of the group allocated to the good compliance category by the use of the digoxin marker was equivalent in size to a group of patients who had returned less than 15 % of their prescribed dose or reported a deviation of less than 6 % from their prescription . When the strictest criteria for the combination of all three methods were used , 57 % of subjects were classified as good and 31 % as poor compliers to medication in the third year of the primary prevention trial design ed to reduce the incidence of coronary heart disease STUDY OBJECTIVE To assess the accuracy of patient-kept diaries relative to electronic monitoring of compliance with isosorbide dinitrate prescribed 3 times/day for ischemic heart disease . DESIGN Unblinded , prospect i ve , three-phase study . METHODS Patients with coronary artery disease prescribed isosorbide dinitrate 3 times/day were asked to record the time of administration of each dose in a pocket diary while being monitored for compliance with a computerized Medication-Event Monitoring System ( MEMS-4 ) vial that electronically recorded the date and time the vial was opened . RESULTS Sixty-eight stable out patients with documented coronary artery disease who were prescribed isosorbide dinitrate 3 times/day were evaluated . Based on a prospect ively chosen definition including a nitrate-free period , the mean ( + /-SD ) overall compliance rates were 71 % ( + /-30 ) versus 55 % ( + /-32 ) for the patient-kept diaries and the MEMS vials respectively ( p = 0.001 ) . The concordance between patient-kept diaries and MEMS data indicate that 67 % of patients overestimate their compliance when using a self-recording tool . An average of 30 % of diary entries were in error compared with the MEMS vial recordings . CONCLUSIONS Patient-kept diaries statistically overestimate actual compliance relative to that determined by MEMS devices . Given the prevalence of the use of diaries as the predominant tool on which research ers depend to document compliance with study drugs , our findings suggest that this practice should be reevaluated specifically when the time of the dose and documentation of administration are critical to qualifying the outcome of drug therapy . Such is the case with isosorbide dinitrate use in patients with ischemic heart disease . Furthermore , the overall poor compliance documented in this study suggests that the utility of isosorbide dinitrate prescribed 3 times/day be reevaluated as a clinical ly effective antianginal drug The efficacy , safety , and tolerability of a moderate dose , 3-drug lipid-lowering regimen were evaluated among 29 male patients with hyperlipidemia and coronary artery disease . In an initial 12-month phase , regular niacin , 500 mg qid , lovastatin , 20 mg bid , and colestipol , 10 g/bid , were given with dose adjustment for lipid targets and side effects . This was followed by 2 r and om sequence crossover phases ( 8 months each ) alternating regular niacin with a polygel controlled-release formulation of niacin for use in this regimen . Lipid , lipoprotein , apoprotein , and clinical chemistry determinations were obtained at baseline , during the initial phase , at the 2 crossover phases , and at 6 weeks after therapy . A final question naire queried specific side effects and overall preferences . Low-/high-density lipoprotein ( LDL/HDL ) changed from means of 215/46 mg/dl at baseline , to 94/59 mg/dl after run-in , to 85/52 mg/dl after 8 months of controlled-release niacin , and to 98/56 mg/dl after 8 months of regular niacin ( regular niacin vs controlled-release niacin , p < 0.005/<0.05 ) . The target of LDL < or = 100 mg/dl was achieved at 8 months by 83 % of these patients with controlled-release niacin and by 52 % with regular niacin ( p < 0.01 ) . Compliance was 95 % with controlled-release niacin versus 85 % with regular niacin ( p < 0.001 ) . The controlled-release niacin and regular niacin regimens did not differ in terms of uric acid , glucose , insulin , or asparate aminotransferase levels . Overall , 21 % of patients called the 3 drugs " very easy " and 72 % " fairly easy " to take . The controlled-release niacin-containing regimen was preferred by 21 patients and the regular niacin by 4 . In conclusion , these regimens achieve striking lipid changes among hyperlipidemic patients . Controlled release is the preferred niacin preparation in terms of LDL reduction , compliance , patient preference , and achieving the National Cholesterol Education Program guideline of LDL < or = 100 mg/dl . The 2 niacin preparations did not differ in evidence of toxicity This r and omized , controlled trial evaluated the impact of personalized follow-up on compliance rates in high-risk patients receiving combination lipid-lowering therapy over 2 years . A r and om sample of 30 patients 7 - 30 days after cardiac surgery had baseline fasting low-density lipoprotein levels higher than 130 mg/dl . All patients received lovastatin 20 mg/day and colestipol 5 g twice/day . Weekly telephone contact was made with each patient for 12 weeks . Short- and long-term compliance was assessed by pill and packet counts and refill records . Compliance and lipid profile results were significantly better in the intervention group ( p<0.05 ) up to 2 years after the start of therapy than in the control group for all parameters except high-density lipoprotein . However , this effect was not apparent during the first 12 weeks of therapy . Short-term telephone follow-up favorably affected compliance and lipid profile results up to 2 years after start of therapy OBJECTIVE To analyse the efficacy of health education ( HE ) through group session with postal back-up in furthering compliance with therapy for Lipaemia . DESIGN Controlled clinical trial , with r and om distribution . SETTING Primary care . PATIENTS 110 patients with Hypercholesterolaemia , with new diagnoses or not in treatment , in which medical treatment with statins was indicated as a start or change in medication . INTERVENTIONS They were distributed in two groups at r and om , with observation four months after being included in the study and appointments after one , two and four months . 1 . Control group ( CG ) : 55 patients who received HE from their family doctor . 2 . Intervention group ( IG ) : 55 patients whose HE was monitored : a ) a group HE session and b ) back-up by letter sent to their homes . MEASUREMENTS AND RESULTS Patients whose consumption was between 80 and 110 % of the amount prescribed were defined as compliant . The pill count was recorded . The percentages of compliant patients and mean compliance ( chi squared , Student 's t ) were analysed . 108 individuals , 41 men and 67 women , completed the trial . There was no difference between the two groups as to age , sex , evolution time , number of diseases and dosage of medicines consumed . 71.3 % were compliant ( CI , 62.8 - 79.8 % ) , CG = 61.8 % and IG 81.1 % ( p < 0.05 ) . The mean percentage of compliance was
Output:
| Intensified patient care appears to be the most promising intervention in terms of improved adherence to lipid-lowering drugs . |
MS212732 | ***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 Inflammation and oxidative stress are associated with atrial fibrillation ( AF ) . Statins have antioxidant and anti-inflammatory properties . We tested if atorvastatin reduced AF recurrence after DC cardioversion ( CV ) by modifying systemic oxidative stress and inflammation ( NCT00252967 ) . METHODS AND RESULTS In a r and omized , double-blinded , placebo-controlled trial , patients with atrial fibrillation/flutter ( AF ) were r and omized to receive either atorvastatin 80 mg ( n = 33 ) or placebo ( n = 31 ) before CV . Treatment was continued for 12 months or until AF recurred . Serum oxidative stress markers ( ratios of oxidized to reduced glutathione and cysteine , derivatives of reactive oxygen species , isoprostanes ) and inflammatory markers ( high-sensitivity C- reactive protein [ hs-CRP ] , interleukin-6 [ IL-6 ] , interleukin-1β[IL-1β ] , tumor necrosis factor alpha [ TNFα ] ) were measured at baseline and on follow-up . AF recurred in 22 ( 66.7 % ) of atorvastatin and 26 ( 83.9 % ) of placebo group ( P = 0.2 ) . The adjusted hazard ratio of having recurrence on atorvastatin versus on placebo was 0.99 ( 95 % CI : 0.98 - 1.01 , P = 0.3 ) . There was no significant difference in the time to recurrence using Kaplan-Meier survival estimates ( median [ IR ] : 29 [ 2 - 145 ] days versus 22 [ 7 - 70 ] days , P = 0.9 ) . Although no significant effect was seen on oxidative stress , 2 of 4 inflammatory markers , IL-6 ( adjusted OR : 0.59 , 95 % CI : 0.35 - 0.97 , P = 0.04 ) and hs-CRP ( adjusted OR : 0.59 , 95 % CI : 0.37 - 0.95 , P = 0.03 ) were significantly lowered with atorvastatin . Cholesterol levels significantly decreased with atorvastatin ( P = 0.03 ) . CONCLUSIONS High-dose atorvastatin did not reduce the recurrence of AF after CV . It reduced selective markers of inflammation without affecting systemic oxidative stress . Failure of atorvastatin to prevent AF recurrence may be due to its failure to affect oxidative stress In a multicenter , open-label trial , 696 Hispanic patients with low-density lipoprotein ( LDL ) cholesterol levels > or = 130 and < or = 300 mg/dl and triglyceride levels < 400 mg/dl at medium or high risk of coronary heart disease were r and omized to receive 10 or 20 mg of rosuvastatin or 10 or 20 mg of atorvastatin for 6 weeks . At week 6 , LDL cholesterol was decreased more by 10 mg of rosuvastatin than by 10 mg of atorvastatin ( 45 % vs 36 % , p < 0.0001 ) and more by 20 mg of rosuvastatin than by 20 mg of atorvastatin ( 50 % vs 42 % , p < 0.0001 ) . Significantly greater decreases were also observed with rosuvastatin for total cholesterol , non-high-density lipoprotein cholesterol , apolipoprotein-B , and lipid ratios compared with milligram-equivalent doses of atorvastatin . Overall , National Cholesterol Education Program Adult Treatment Program III LDL cholesterol goals were achieved by 78 % and 88 % of patients who received 10 and 20 mg of rosuvastatin and by 60 % and 73 % of patients who received 10 and 20 mg of atorvastatin , respectively . Among high-risk patients , the LDL cholesterol goal of < 100 mg/dl was achieved by 74 % and 91 % of patients who received 10 and 20 mg of rosuvastatin and by 52 % and 62 % who received 10 and 20 mg of atorvastatin , respectively . All treatments were well tolerated , and adverse events were similar in frequency across treatment groups . No cases of myopathy or rhabdomyolysis were observed . In conclusion , treatment with rosuvastatin and atorvastatin produced beneficial lipid changes in this group of Hispanic patients that appear comparable in magnitude to those observed in primarily non-Hispanic white study population s. These benefits were accompanied by a favorable safety profile that suggests no concerns particular to this population Statin therapy may target both hypercholesterolemia and cholestasis in primary biliary cirrhosis ( PBC ) . However , little is known about the efficacy and safety of statins in PBC . The aim of this single‐center study was therefore to prospect ively examine the effects of atorvastatin on serum markers of cholestasis , aminotransferases , and lipid and bile acid metabolism as well as inflammatory and immunological markers in patients with PBC . Fifteen patients with early‐stage PBC and an incomplete biochemical response to ursodeoxycholic acid ( UDCA ) therapy ( defined as alkaline phosphatase 1.5‐fold above the upper limit of normal after 1 year ) were treated with atorvastatin 10 mg/day , 20 mg/day , and 40 mg/day for 4 weeks , respectively . Serum levels of alkaline phosphatase increased during atorvastatin 20 mg and 40 mg ( P < 0.05 ) , whereas leucine aminopeptidase and γ‐glutamyltransferase remained unchanged . No statistical differences in overall serum ALT , AST , bilirubin , and IgM levels were observed . However , atorvastatin was discontinued in 1 out of 15 patients because of ALT 2‐fold above baseline , and 2 patients showed ALT elevations 3‐fold above the upper limit of normal at the end of the atorvastatin treatment period . Serum total cholesterol and low‐density lipoprotein cholesterol levels decreased by 35 % and 49 % , respectively ( P < 0.001 ) . Precursors of cholesterol bio synthesis ( lanosterol , desmosterol , lathosterol ) showed a similar pattern . No changes in serum bile acid levels and composition were observed during treatment . Conclusion : Atorvastatin does not improve cholestasis in PBC patients with an incomplete biochemical response to UDCA but effectively reduces serum cholesterol levels . ( HEPATOLOGY 2007 . OBJECTIVE The primary objective of this study was to assess the cost-effectiveness of the most commonly prescribed doses of rosuvastatin , atorvastatin , simvastatin , and pravastatin for managing various lipid parameters in patients with hypercholesterolemia over a 1-year time horizon from a Canadian health care perspective . METHODS Incremental cost-effectiveness ratios ( ICERs ) were estimated for br and ed rosuvastatin compared with br and ed atorvastatin , generic simvastatin , and generic pravastatin in patients with hypercholesterolemia in terms of percent reduction in low-density lipoprotein cholesterol ( LDL-C ) and total cholesterol (TC)/high-density lipoprotein cholesterol ( HDL-C ) ratio , as well as in TC , HDL-C , triglycerides ( TG ) , apolipoprotein ( Apo ) B , the ApoB/ApoA-I ratio , and attainment of the Canadian LDL-C goal . The pharmacoeconomic model was constructed for a 1-year time horizon using efficacy data from a r and omized , open-label trial including 2268 adults and the wholesale acquisition costs of br and ed rosuvastatin and atorvastatin and generic simvastatin and pravastatin in British Columbia . RESULTS The most commonly prescribed doses of each of the 4 statins in British Columbia were as follows : rosuvastatin 10 mg ( 75.8 % of all rosuvastatin doses ) ; atorvastatin 10 and 20 mg ( 46.4 % and 35.3 % , respectively , of all atorvastatin doses ) ; simvastatin 20 and 40 mg ( 42.5 % and 31.8 % , respectively , of all simvastatin doses ) ; and pravastatin 20 and 40 mg ( 55.0 % and 34.1 % , respectively , of all pravastatin doses ) . Rosuvastatin 10 mg was dominant ( ie , was more effective at a lower cost ) relative to atorvastatin 10 and 20 mg , simvastatin 20 and 40 mg , and pravastatin 40 mg in terms of reductions in LDL-C , TC/ HDL-C ratio , TC , ApoB , and ApoB/ApoA-I ratio , increases in HDL-C , and attainment of the LDL-C goal . Compared with pravastatin 20 mg , the ICER per percent reduction in LDL-C , TC/HDL-C ratio , TC , TG , ApoB , or ApoB/ApoA-I or increase in HDL-C ranged from $ 3.89 to $ 26.07 ; the value for 1 additional patient achieving the LDL-C goal was $ 419.75 . When the statin doses were aggregated based on the Canadian statin-utilization pattern , rosuvastatin was dominant relative to atorvastatin on all effectiveness measures evaluated . When rosuvastatin was compared with generic simvastatin and pravastatin , the annual costs for 1 additional patient achieving the LDL-C goal were $ 144.51 and $ 373.91 , respectively . Based on the sensitivity analysis , rosuvastatin was associated with the highest probability of cost-effectiveness compared with the other statins over a broad range of monetary values per unit of clinical effect . CONCLUSION When percent changes in lipid parameters and rates of LDL-C goal attainment were considered in patients with hypercholesterolemia in British Columbia , rosuvastatin 10 mg was more cost-effective than the most frequently used doses of atorvastatin ( 10 and 20 mg ) , generic simvastatin ( 20 and 40 mg ) , and generic pravastatin ( 20 and 40 mg ) The primary objective of this 6-week , parallel-group , open-label , r and omized , multicenter trial was to compare rosuvastatin with atorvastatin , pravastatin , and simvastatin across dose ranges for reduction of low-density lipoprotein ( LDL ) cholesterol . Secondary objectives included comparing rosuvastatin with comparators for other lipid modifications and achievement of National Cholesterol Education Program Adult Treatment Panel III and Joint European Task Force LDL cholesterol goals . After a dietary lead-in period , 2,431 adults with hypercholesterolemia ( LDL cholesterol > or = 160 and < 250 mg/dl ; triglycerides < 400 mg/dl ) were r and omized to treatment with rosuvastatin 10 , 20 , 40 , or 80 mg ; atorvastatin 10 , 20 , 40 , or 80 mg ; simvastatin 10 , 20 , 40 , or 80 mg ; or pravastatin 10 , 20 , or 40 mg . At 6 weeks , across-dose analyses showed that rosuvastatin 10 to 80 mg reduced LDL cholesterol by a mean of 8.2 % more than atorvastatin 10 to 80 mg , 26 % more than pravastatin 10 to 40 mg , and 12 % to 18 % more than simvastatin 10 to 80 mg ( all p < 0.001 ) . Mean percent changes in high-density lipoprotein cholesterol in the rosuvastatin groups were + 7.7 % to + 9.6 % compared with + 2.1 % to + 6.8 % in all other groups . Across dose ranges , rosuvastatin reduced total cholesterol significantly more ( p < 0.001 ) than all comparators and triglycerides significantly more ( p < 0.001 ) than simvastatin and pravastatin . Adult Treatment Panel III LDL cholesterol goals were achieved by 82 % to 89 % of patients treated with rosuvastatin 10 to 40 mg compared with 69 % to 85 % of patients treated with atorvastatin 10 to 80 mg ; the European LDL cholesterol goal of < 3.0 mmol/L was achieved by 79 % to 92 % in rosuvastatin groups compared with 52 % to 81 % in atorvastatin groups . Drug tolerability was similar across treatments Background : Coronary heart disease ( CHD ) is the number one cause of death in Western societies . Elevated levels of plasma low-density lipoprotein ( LDL ) cholesterol and triglycer ides ( TG ) increase the risk for CHD . 3-Hydroxy-3
Output:
| Log dose-response data revealed linear dose-related effects on blood total cholesterol , low-density lipoprotein (LDL)-cholesterol and triglycerides .
There was no significant dose-related effects of atorvastatin on blood high-density lipoprotein (HDL)-cholesterol .
Blood total cholesterol , LDL-cholesterol and triglyceride lowering effect of atorvastatin was dependent on dose . |
MS212733 | ***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 comprehend the results of a r and omised controlled trial ( RCT ) , readers must underst and its design , conduct , analysis , and interpretation . That goal can be achieved only through total transparency from authors . Despite several decades of educational efforts , the reporting of RCTs needs improvement . Investigators and editors developed the original CONSORT ( Consoli date d St and ards of Reporting Trials ) statement to help authors improve reporting by use of a checklist and flow diagram . The revised CONSORT statement presented here incorporates new evidence and addresses some criticisms of the original statement . The checklist items pertain to the content of the Title , Abstract , Introduction , Methods , Results , and Discussion . The revised checklist includes 22 items selected because empirical evidence indicates that not reporting this information is associated with biased estimates of treatment effect , or because the information is essential to judge the reliability or relevance of the findings . We intended the flow diagram to depict the passage of participants through an RCT . The revised flow diagram depicts information from four stages of a trial ( enrolment , intervention allocation , follow- up , and analysis ) . The diagram explicitly shows the number of participants , for each intervention group , included in the primary data analysis . Inclusion of these numbers allows the reader to judge whether the authors have done an intention- to-treat analysis . In sum , the CONSORT statement is intended to improve the reporting of an RCT , enabling readers to underst and a trial 's conduct and to assess the validity of its results Abstract Inflammatory pathways are involved in the development of atherosclerosis . Interaction of vessel wall cells and invading monocytes by cytokines may trigger local inflammatory processes . 3-Hydroxy-3-methylglutaryl coenzyme A reductase inhibitors ( statins ) are st and ard medications used in cardiovascular diseases . They are thought to have anti-inflammatory capacities , in addition to their lipid-lowering effects . We investigated the anti-inflammatory effect of statins in the cytokine-mediated-interaction-model of human vascular smooth muscle cells ( SMC ) and human mononuclear cells ( MNC ) . In this atherosclerosis-related inflammatory model LPS ( lipopolysaccharide , endotoxin ) , as well as high mobility group box 1 stimulation result ed in synergistic ( i.e. over-additive ) IL-6 ( interleukin-6 ) production as measured in ELISA . Recombinant IL-1 , tumour necrosis factor-α and IL-6 mediated the synergistic IL-6 production . The st and ard anti-inflammatory drugs aspirin and indomethacin ( Indo ) reduced the synergistic IL-6 production by 60 % . Simvastatin , atorvastatin , fluvastatin or pravastatin reduced the IL-6 production by 53 % , 50 % , 64 % and 60 % , respectively . The inhibition by the statins was dose dependent . Combination of statins with aspirin and /or Indo result ed in complete inhibition of the synergistic IL-6 production . The same inhibitors blocked STAT3 phosphorylation , providing evidence for an autocrine role of IL-6 in the synergism . MNC from volunteers after 5 day aspirin or simvastatin administration showed no decreased IL-6 production , probably due to drug removal during MNC isolation . Taken together , the data show that anti-inflammatory functions ( here shown for statins ) can be sensitively and reproducibly determined in this novel SMC/MNC coculture model . These data implicate that statins have the capacity to affect atherosclerosis by regulating cytokine-mediated innate inflammatory pathways in the vessel wall OBJECTIVES Our aim was to investigate if the peroxisome proliferator-activated receptor (PPAR)-gamma agonist pioglitazone modulates inflammation through PPARalpha mechanisms . BACKGROUND The thiazolidinediones ( TZDs ) pioglitazone and rosiglitazone are insulin-sensitizing PPARgamma agonists used to treat type 2 diabetes ( T2DM ) . Despite evidence for TZDs limiting inflammation and atherosclerosis , questions exist regarding differential responses to TZDs . In a double-blinded , placebo-controlled 16-week trial among recently diagnosed T2DM subjects ( n = 34 ) , pioglitazone-treated subjects manifested lower triglycerides and lacked the increase in soluble vascular cell adhesion molecules (sVCAM)-1 evident in the placebo group . Previously we reported PPARalpha but not PPARgamma agonists could repress VCAM-1 expression . Since both triglyceride-lowering and VCAM-1 repression characterize PPARalpha activation , we studied pioglitazone 's effects via PPARalpha . METHODS Pioglitazone effects on known PPARalpha responses -- lig and binding domain activation and PPARalpha target gene expression -- were tested in vitro and in vivo , including in wild-type and PPARalpha-deficient cells and mice , and compared with the effects of other PPARgamma ( rosiglitazone ) and PPARalpha ( WY14643 ) agonists . RESULTS Pioglitazone repressed endothelial TNFalpha-induced VCAM-1 messenger ribonucleic acid expression and promoter activity , and induced hepatic IkappaBalpha in a manner dependent on both pioglitazone exposure and PPARalpha expression . Pioglitazone also activated the PPARalpha lig and binding domain and induced PPARalpha target gene expression , with in vitro effects that were most pronounced in endothelial cells . In vivo , pioglitazone administration modulated sVCAM-1 levels and IkappaBalpha expression in wild-type but not PPARalpha-deficient mice . CONCLUSIONS Pioglitazone regulates inflammatory target genes in hepatic ( IkappaBalpha ) and endothelial ( VCAM-1 ) setting s in a PPARalpha-dependent manner . These data offer novel mechanisms that may underlie distinct TZD responses Introduction The benefit of corticosteroids as adjunctive treatment in patients with severe community-acquired pneumonia ( CAP ) requiring hospital admission remains unclear . This study aim ed to evaluate the impact of corticosteroid treatment on outcomes in patients with CAP . Methods This was a prospect i ve , double-blind and r and omized study . All patients received treatment with ceftriaxone plus levofloxacin and methyl-prednisolone ( MPDN ) administered r and omly and blindly as an initial bolus , followed by a tapering regimen , or placebo . Results Of the 56 patients included in the study , 28 ( 50 % ) were treated with concomitant corticosteroids . Patients included in the MPDN group show a more favourable evolution of the pO2/FiO2 ratio and faster decrease of fever , as well as greater radiological improvement at seven days . The time to resolution of morbidity was also significantly shorter in this group . Six patients met the criteria for mechanical ventilation ( MV ) : five in the placebo group ( 22.7 % ) and one in the MPDN group ( 4.3 % ) . The duration of MV was 13 days ( interquartile range 7 to 26 days ) for the placebo group and three days for the only case in the MPDN group . The differences did not reach statistical significance . Interleukin (IL)-6 and C-reactive protein ( CRP ) showed a significantly quicker decrease after 24 h of treatment among patients treated with MPDN . No differences in mortality were found among groups . Conclusions MPDN treatment , in combination with antibiotics , improves respiratory failure and accelerates the timing of clinical resolution of severe CAP needing hospital admission . Trial Registration International St and ard R and omized Controlled Trials Register , IS RCT N22426306 Objective To determine whether statins protect against all cause mortality after a diagnosis of pneumonia . Design Cohort study using propensity score based method to control for differences between people prescribed and not prescribed statins . Setting United Kingdom Health Improvement Network data base , which contains electronic primary care medical records of more than six million patients . Participants Every patient starting a statin between 1995 and 2006 ( 129 288 ) matched with up to five non-statin users ( n=600 241 ) ; 9073 patients had a recorded diagnosis of pneumonia , of whom 1398 were using a statin . Main outcome measure All cause mortality within six months of diagnosis of pneumonia . Results Among users and non-users of statins with comparable propensity scores , 95/942 users and 686/3615 non-users died on the day that pneumonia was diagnosed . In the following six month period , 109/847 statin users died compared with 578/2927 non-users , giving an adjusted hazard ratio of 0.67 ( 0.49 to 0.91 ) . If these observed benefits translated into clinical practice , 15 patients would need to be treated with a statin for six months after pneumonia to prevent one death . Conclusions Compared with people who were not taking statins , the risk of dying in the six month period after pneumonia was substantially lower among people who were already established on long term statin treatment when the pneumonia occurred . Whether some or all of this protective effect would be obtained if statin treatment begins when a patient first develops pneumonia is not known . However , given that statins are cheap , safe , and well tolerated , a clinical trial in which people with pneumonia are r and omised to a short period of statin treatment is warranted Recent studies suggest that statins and angiotensin-converting enzyme ( ACE ) inhibitors may have beneficial effects for some types of infections . The present study aim ed to examine the association of outpatient use of these medications on 30-day mortality for subjects aged > 65 yrs and hospitalised with community-acquired pneumonia . A retrospective national cohort study was conducted using the Department of Veterans Affairs administrative data including subjects aged ≥65 yrs hospitalised with community-acquired pneumonia , and having ≥1 yr of prior Veterans Affairs outpatient care . In total , 8,652 subjects were identified with a mean age of 75 yrs , 98.6 % were male , and 9.9 % of subjects died within 30 days of presentation . In this cohort , 18.1 % of subjects were using statins and 33.9 % were using ACE inhibitors . After adjusting for potential confounders , current statin use ( odds ratio ( OR ) 0.54 , 95 % confidence interval ( CI ) 0.42–0.70 ) and ACE inhibitor use ( OR 0.80 , 95 % CI 0.68–0.89 ) were significantly associated with decreased 30-day mortality . Use of statins and angiotensin-converting enzyme inhibitors prior to admission is associated with decreased mortality in subjects hospitalised with community-acquired pneumonia . R and omised controlled trials are needed to examine whether the use of these medications in patients hospitalised with community-acquired pneumonia may be beneficial Background Recent studies suggested that administration of corticosteroids may improve clinical outcomes in patients with severe pneumonia . Objectives The aim of this study was to assess the effectiveness of corticosteroids as an adjunctive therapy in community-acquired pneumonia ( CAP ) requiring hospitalization . Design and Setting An open label , prospect i ve , r and omized control study was conducted from September 2003 to February 2004 in a community general hospital in Japan . Patients Thirty-one adult CAP patients who required hospitalization were enrolled . Measurements and Results Fifteen patients received 40 mg of prednisolone intravenously for 3 days ( steroid group ) . Sixteen patients did not receive prednisolone ( control group ) . Both groups were also evaluated for their adrenal function . The primary endpoint was length of hospital stay . Secondary endpoints were duration of intravenous ( IV ) antibiotics and time required to stabilize vital signs . Both groups demonstrated similar baseline characteristics and length of hospital stay , and yet a shorter duration of IV antibiotics was observed in the steroid group ( p < 0.05 ) . In addition , vital signs were stabilized earlier in the steroid group ( p < 0.05 ) . These differences were more prominent in the moderate – severe subgroup but not as significant in the mild – moderate subgroup . The prevalence of relative adrenal insufficiency ( RAI ) in both groups was high ( 43 % ) , yet there was no difference in baseline characteristics between patients , with or without RAI . In multiple regression models , RAI seemed to have no influence on clinical courses . Conclusions In moderate – severe CAP , administration of corticosteroids promotes resolution of clinical symptoms and reduces the duration of intravenous antibiotic therapy In the study presented here , data collected prospect ively from 340 adult patients hospitalised in five countries with bacteremic pneumococcal CAP and treated with a ß-lactam + /− a macrolide were analysed retrospectively to evaluate the efficacy of this antimicrobial combination . Univariate and multivariate analyses revealed no significant effect on case fatality rate when a macrolide/ß-lactam regimen was used as initial therapy . Results were not affected by severity of illness , or by excluding patients who died within 2 days of admission . Identified predictors of death in a multivariate regression model were age > 65 years ( OR=2.6 ) , two or more lung lobes affected ( OR=2.2 ) , and severity of disease as estimated using the acute physiology score (APS)>8 Objective To determine if statin therapy reduces the incidence of severe sepsis and the levels of inflammatory cytokines in patients with acute bacterial infection . Design Double-blind placebo controlled r and omized clinical trial . Setting Department of medicine and medical intensive care unit in a tertiary university medical center . Patients and participants A total of 83 patients with suspected or
Output:
| Although r and omized control trials have not been done , clinical evidence favors the addition of a macrolide to a beta-lactam for the treatment of pneumococcal pneumonia and supports a role for macrolides in the treatment of all-cause CAP without regard to their anti-microbial activity .
The weight of several retrospective studies suggests that statins be considered in treating acute CAP .
Further support for the use of statins derives from the high association between pneumonia and acute myocardial infa rct ion .
Aspirin might also be of benefit in treating patients hospitalized for pneumonia because of its anti-inflammatory activity as well as its benefits in acute myocardial infa rct ion .
Ibuprofen is not of benefit in treating sepsis in humans and glitazones may increase the risk of severe pneumonia |
MS212734 | ***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 African Americans suffer disproportionately from diabetes complications , but little research has focused on how to improve diabetic control in this population . There are also few or no data on a combined primary care and community-based intervention approach . METHODS We r and omly assigned 186 urban African Americans with type 2 diabetes ( 76 % female , mean A SD age 59 A 9 years ) to 1 of 4 parallel arms : ( 1 ) usual care only ; ( 2 ) usual care + nurse case manager ( NCM ) ; ( 3 ) usual care + community health worker ( CHW ) ; ( 4 ) usual care + nurse case manager/community health worker team . Using the framework of the Precede-Proceed behavioral model , interventions included patient counseling regarding self-care practice s and physician reminders . RESULTS The 2-year follow-up visit was completed by 149 individuals ( 84 % ) . Compared to the Usual care group , the NCM group and the CHW group had modest declines in HbA(1c ) over 2 years ( 0.3 and 0.3 % , respectively ) , and the combined NCM/CHW group had a greater decline in HbA(1c ) ( 0.8 % . P = 0.137 ) . After adjustment for baseline differences and /or follow-up time , the combined NCM/CHW group showed improvements in triglycerides ( -35.5 mg/dl ; P = 0.041 ) and diastolic blood pressure , compared to the usual care group ( -5.6 mmHg ; P = 0.042 ) . CONCLUSIONS Combined NCM/CHW interventions may improve diabetic control in urban African Americans with type 2 diabetes . Although results were clinical ly important , they did not reach statistical significance . This approach deserves further attention as a means to reduce the excess risk of diabetic complications in African Americans BACKGROUND The goal of our study was to measure the effectiveness of a home-based intervention for prevention of low birth weight with 154 high-risk , low-income black women attending a prenatal clinic in Clevel and . METHODS Based on previous research , risk was defined by clinic registration between the 17th and 28th weeks of gestation , low family functioning score , and experience of at least one stressful life event prior to registration . Optional factors included being a smoker , a low maternal weight-height ratio , being age 27 or older , and a previous premature birth . A 21-item family function screen previously vali date d in a similar population was the primary determinant of psychosocial risk . Low birth weight was defined as weight less than 2,500 g regardless of gestational age . RESULTS There was no decrease in the rate of low birth weight for women who received four home visits focusing on smoking , drug and nutrition education , support , and links with community services , compared to women who received no visits . The number of prenatal visits was significantly higher in the intervention group , but an increased number of prenatal visits did not correlate with a reduced rate of low birth weight . Despite previous research , the family function screen was not an effective predictor of low birth weight in our study . A revised equation involving a history of previous premature birth , smoking , and a low maternal weight-height ratio did predict low birth weight . CONCLUSIONS These findings question the utility of short-term psychosocial interventions for influencing low birth-weight rates in low-income black clinic population s. The family function screen was not cross vali date d. Integration of any psychosocial intervention with the routine prenatal care occurring in the obstetrical clinic is suggested for future research We evaluated the single and combined effects of introducing a motivational video and peer counseling into four matched WIC clinics on breastfeeding initiation and continuation at 7 - 10 days among African-American WIC participants . Of the 242 women with complete data , 48 % initiated breastfeeding , but only 31 % were still breastfeeding at 7 - 10 days . Initiation was associated with cesarean delivery , infant feeding instruction , no artificial milk discharge pack , attending the peer counselor only-intervention site , and intention to breastfeed . Continuation was influenced by infant feeding instruction , no artificial milk discharge pack , and intention to breastfeed . Overall , trends toward a positive impact of the breastfeeding promotion activities were evident but weak , and largely gone by 7 - 10 days postpartum OBJECTIVES To evaluate the costs of implementing a church-based , telephone-counseling program for increasing mammography use , and to identify the components of costs and the likely cost-effectiveness in hypothetical communities with varying characteristics . DATA SOURCES / STUDY SETTING An ethnically and socioeconomically diverse sample of 1,443 women recruited from 45 churches participating in the Los Angeles Mammography Promotion ( LAMP ) program were followed from 1995 to 1997 . STUDY DESIGN Churches were stratified into blocks and r and omized into three intervention arms-telephone counseling , mail counseling , and control . We surveyed participants before and after the intervention to collect data on mammography use and demographic characteristics . DATA COLLECTION / EXTRACTION METHODS We used call records , activity reports , and interviews to collect data on the time and material s needed to organize and carry out the intervention . We constructed a st and ard model of costs and cost-effectiveness based on these data and the Year One results of the LAMP program . PRINCIPAL FINDINGS The cost in material s and overhead to the church site was $ 10.89 per participant and $ 188 per additional screening . However , when the estimated cost for church volunteers ' time was included , the cost of the intervention increased substantially . CONCLUSIONS A church-based program to promote the use of mammography would be feasible for many churches with the use of volunteer labor and re sources Purpose Large-scale effectiveness trials design ed to translate evidence -based diabetes care to community setting s are few . Studies describing these methods among high-risk minority population s are particularly limited . Methods The authors describe Project Sugar , a r and omized controlled trial conducted in 2 phases : Project Sugar 1 ( 1994 - 1999 ) , which piloted a 4-arm clinic and homebased intervention using nurse case management and community health workers in 186 urban African Americans with type 2 diabetes , and Project Sugar 2 ( 2000 - 2005 ) , which examined effectiveness of this intervention among 542 diabetic , urban African Americans . Results and Conclusions Project Sugar had success with regard to recruitment and retention , both in phase 1 ( 80 % rate at 24 months ) and phase 2 ( > 90 % at 24 months ) . Using the RE- AIM framework , planning and research design for Project Sugar 2 is described in detail for elements that contributed to the reach , effectiveness , adoption , implementation , and maintenance of this study within a minority community setting . In addition to successful strategies , challenges to conducting effectiveness trials in an inner-city African American community are identified PURPOSE The purpose of this r and omized controlled trial is to determine the effectiveness of an intervention led by promotoras ( community lay workers ) on the glycemic control , diabetes knowledge , and diabetes health beliefs of Mexican Americans with type 2 diabetes living in a major city on the Texas-Mexico border . METHODS One hundred fifty Mexican American participants were recruited at a Catholic faith-based clinic and r and omized into 2 groups . Personal characteristics , acculturation , baseline A1C level , diabetes knowledge , and diabetes health beliefs were measured . The intervention was culturally specific and consisted of participative group education , telephone contact , and follow-up using inspirational faith-based health behavior change postcards . The A1C levels , diabetes knowledge , and diabetes health beliefs were measured 3 and 6 months postbaseline , and the mean change between the groups was analyzed . RESULTS The 80 % female sample , with a mean age of 58 years , demonstrated low acculturation , income , education , health insurance coverage , and strong Catholicism . No significant changes were noted at the 3-month assessment , but the mean change of the A1C levels , F(1 , 148 ) = 10.28 , P < .001 , and the diabetes knowledge scores , F(1 , 148 ) = 9.0 , P < .002 , of the intervention group improved significantly at 6 months , adjusting for health insurance coverage . The health belief scores decreased in both groups . CONCLUSIONS The intervention result ed in decreased A1C levels and increased diabetes knowledge , suggesting that using promotoras as part of an interdisciplinary team can result in positive outcomes for Mexican Americans who have type 2 diabetes . Clinical implication s and recommendations for future research are suggested OBJECTIVES A community trial was undertaken to evaluate the effectiveness of the North Carolina Breast Cancer Screening Program , a lay health advisor network intervention intended to increase screening among rural African American women 50 years and older . METHODS A stratified r and om sample of 801 African American women completed baseline ( 1993 - 1994 ) and follow-up ( 1996 - 1997 ) surveys . The primary outcome was self-reported mammography use in the previous 2 years . RESULTS The intervention was associated with an overall 6 percentage point increase ( 95 % confidence interval [ CI ] = -1 , 14 ) in community-wide mammography use . Low-income women in intervention counties showed an 11 percentage point increase ( 95 % CI = 2 , 21 ) in use above that exhibited by low-income women in comparison counties . Adjustment for potentially confounding characteristics did not change the results . CONCLUSIONS A lay health advisor intervention appears to be an effective public health approach to increasing use of screening mammography among low-income , rural population Objective : To evaluate the effectiveness of a lay delivered intervention to reduce Latino children ’s exposure to environmental tobacco smoke ( ETS ) . The a priori hypothesis was that children living in households that were in the intervention group would have lower exposure over time than measurement only controls . Design : A two group , r and omised control trial was conducted . Setting : Areas of San Diego county with a large Latino population . Participants : 143 Latino parent – child pairs . Intervention : Trained bicultural and bilingual Latina lay community health advisors , or promotoras , conducted problem solving aim ed at lowering the target child ’s exposure to ETS in the household . Six home and telephone sessions were delivered by the promotoras over a four month period . Main outcome measures : Outcome measures were collected at baseline , immediately post-intervention , three months post-intervention , and 12 months post-intervention . Four outcomes were considered : ( 1 ) parent ’s paper- and -pencil reports of the child ’s past month exposure ; ( 2 ) hair sample s from the child analysed for past month nicotine ; ( 3 ) hair sample s from the child analysed for past month cotinine ; and ( 4 ) per cent confirmed reducers . Results : There were no significant condition-by-time interactions , the term indicative of a differential intervention effect . Significant or near significant time main effects were seen for children ’s hair cotinine , per cent confirmed reducers , and , in particular , parent reports of exposure . Conclusions : Applying a lay promotora model to deliver the behavioural problem solving intervention unfortunately was not effective . A likely explanation relates to the difficulty of delivering a relatively complex intervention by lay women untrained in behaviour change theory and research methods OBJECTIVES This study examined differences between nurses and paraprofessionals in implementation of a home visiting program for low-income , first-time parents during pregnancy and the first 2 years of the child 's life . METHODS Mothers were r and omly assigned to either a nurse-visited ( n = 236 ) or a paraprofessional-visited ( n = 244 ) condition . Nurse- and paraprofessional-visited families were compared on number and length of visits , topics covered , number of program dropouts , and relationship with home visitor . RESULTS On average , nurses completed more visits than paraprofessionals ( 28 vs 23 ; P < .001 ) and spent a greater proportion of time on physical health issues during pregnancy ( 38 % vs 27 % ; P < .001 ) and on parenting issues during infancy ( 46 % vs 32 % ; P < .001 ) . Paraprofessionals conducted visits that lasted longer and spent a greater proportion of time on environmental health and safety issues ( 15 % vs 7 % pregnancy ; 15 % vs 8 % infancy ; P < .001 ) . While home visitors were viewed equally positively by mothers , nurses had fewer dropouts than did paraprofessionals ( 38 % vs 48 % ; P = .04 ) . More paraprofessional-visited families than nurse-visited families experienced staff turnover . CONCLUSIONS Nurses and paraprofessionals , even when using the same model , provide home visiting services in different ways OBJECTIVE To assess the effectiveness of a volunteer-driven outreach program on immunization rates in children younger than 2 years . DESIGN R and omized controlled trial . SETTING Pediatric ambulatory clinics in New York , NY . PATIENTS A total of 163 children were r and omly assigned to receive services from the volunteer-driven outreach program or to serve as control subjects . All children were ( 1 ) younger than 2 years , ( 2 ) no-shows for a scheduled appointment in the pediatric clinic , and ( 3 ) due or overdue for a vaccine . INTERVENTION Immunization outreach , tracking , and follow-up were provided by community volunteers throughout follow-up ( mean , 6.5 months ) . Control children were notified of immunization status at enrollment but received no further contact until the conclusion of follow-up ( mean , 6.4 months ) . MAIN OUTCOME MEASURE Immunization status 6 months
Output:
| Conclusions : CHWs can improve outcomes for underserved population s for some health conditions . |
MS212735 | ***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 : An antimicrobial susceptibility test for Helicobacter pylori before second‐line treatment is often performed , although whether the test is truly necessary remains unknown BACKGROUND & AIMS The major obstacle to 100 % effective eradication of Helicobacter pylori infection is represented by antimicrobial-resistant H. pylori strains . This r and omized study was design ed to evaluate whether regimens based on pretreatment susceptibility testing were more effective and cost saving compared with st and ard nonsusceptibility testing-based therapy in the eradication of H. pylori infection . METHODS We studied 150 consecutive H. pylori-infected dyspeptic subjects . Patients were r and omly assigned to omeprazole 20 mg twice daily , clarithromycin 500 mg twice daily , and metronidazole 500 mg twice daily for 7 days or to omeprazole 20 mg twice daily and 2 antimicrobials chosen based on susceptibility testing . H. pylori status was reevaluated 12 weeks after the end of treatment by the (13)C-urea breath test . RESULTS Susceptibility testing-based regimens led to the following results . ( 1 ) Eradication rates were 97.3 % ( 95 % confidence interval [ CI ] , 91.2%-99.5 % ) ( 71 of 73 ) and 94.6 % ( 95 % CI , 87.6%-98.3 % ) ( 71 of 75 ) in the per- protocol and intention-to-treat analysis , respectively . These were significantly higher ( P < 0.005 ) than eradication rates obtained without susceptibility testing , that is , 79.4 % ( 95 % CI , 69.1%-87.6 % ) ( 58 of 73 ) and 77.3 % ( 95 % CI , 66.9%-85.7 % ) ( 58 of 75 ) in the per- protocol and intention-to-treat analyses , respectively . ( 2 ) There were savings of approximately $ 5 U.S. per patient compared with st and ard triple therapy . CONCLUSIONS Pretreatment antimicrobial susceptibility testing is more effective and cost saving and , in health systems that confirm cost advantage , microbial susceptibility testing should be routinely used for eradication of H. pylori infection Helicobacter pylori eradication rates by triple therapy with a proton pump inhibitor , amoxicillin , and clarithromycin at st and ard doses depend on bacterial susceptibility to clarithromycin and patient CYP2C19 genotypes . We examined the usefulness of a personalized therapy for H. pylori infection based on these factors as determined by genetic testing . First , optimal lansoprazole dosing schedules that would achieve sufficient acid inhibition to allow H. pylori eradication therapy in each of different CYP2C19 genotype groups were determined by a 24‐h intragastric pH monitoring . Next , 300 H. pylori‐positive patients were r and omly assigned to the st and ard regimen group ( lansoprazole 30 mg twice daily ( b.i.d . ) ) , clarithromycin 400 mg b.i.d . , and amoxicillin 750 mg b.i.d . for 1 week ) or the tailored regimen group based on CYP2C19 status and bacterial susceptibility to clarithromycin assessed by genetic testing . Patients with failure of eradication underwent the second‐line regimen . The per‐patient cost required for successful eradication was calculated for each of the groups . In the first‐line therapy , the intention‐to‐treat eradication rate in the tailored regimen group was 96.0 % ( 95 % CI=91.5–98.2 % , 144/150 ) , significantly higher than that in the st and ard regimen group ( 70.0 % : 95 % CI=62.2–77.2 % , 105/150 ) ( P<0.001 ) . Final costs per successful eradication in the tailored and st and ard regimen groups were $ 669 and $ 657 , respectively . In conclusion , the pharmacogenomics‐based tailored treatment for H. pylori infection allowed a higher eradication rate by the initial treatment without an increase of the final per‐patient cost for successful eradication . However , the precise cost‐effectiveness of this strategy remains to be determined BACKGROUND Clarithromycin-resistant Helicobacter pylori is associated with point mutations in the 23S ribosomal RNA ( rRNA ) gene . METHODS A total of 1232 patients participated and were divided into 2 control groups and 1 case group . Patients in the APC control group , which consisted of 308 r and omly assigned participants , were treated with st and ard triple therapy , consisting of amoxicillin , rabeprazole , and clarithromycin ; 308 participants in the APM control group were treated with amoxicillin , rabeprazole , and metronidazole . For the 616 participants in the case group , a test for point mutations in the 23S rRNA gene of H. pylori was conducted . A total of 218 individuals in the case group received a new tailored therapy regimen , in which amoxicillin , rabeprazole , and clarithromycin were given in the absence of a mutation , whereas clarithromycin was replaced by metronidazole if the mutation was detected . RESULTS The rate of eradication of H. pylori in the tailored group was 91.2 % ( 176/193 ) , which was significantly higher than that in the APC ( 75.9 % [ 214/282 ] ; P < .001 ) and APM ( 79.1 % [ 219/277 ] ; P < .001 ) control groups . CONCLUSION The rate of H. pylori eradication among patients who received tailored therapy on the basis of detection of a clarithromycin resistance mutation by polymerase chain reaction was much higher than the rate among patients who received a st and ard triple therapy regimen . CLINICAL TRIALS REGISTRATION NCT0145303 Helicobacter pylori eradication therapies do not achieve 100 % success rates . Antibiotic resistant strains are among the major causes of failure . Current recommendations concerning the management of treatment failures are not fully clear AIM : Eradication therapy with proton pump inhibitor , clarithromycin and amoxicillin fails in a considerable number of cases . A rescue therapy still fails in more than 20 % of the cases . Our aim was to evaluate the efficacy and tolerability of a third-line levofloxacin-based regimen in patients with two consecutive Helicobacter pylori eradication failures . METHODS : Design : Prospect i ve multicenter study . Patients : In whom a first treatment with omeprazole-clarithromycin-amoxicillin and a second with omeprazole-bismuth-tetracycline-metronidazole ( or ranitidine bismuth citrate with these antibiotics ) had failed . Intervention : A third eradication regimen with levofloxacin ( 500 mg b.i.d . ) , amoxicillin ( 1 g b.i.d . ) , and omeprazole ( 20 mg b.i.d . ) was prescribed for 10 days . Outcome : Eradication was confirmed with 13C-urea breath test 4–8 wk after therapy . RESULTS : One-hundred patients were initially included , and nine were lost for follow-up . All patients but five took all the medications correctly . Per- protocol and intention-to-treat eradication rates were 66 % ( 95 % CI = 56–75 % ) and 60 % ( 50–70 % ) . Adverse effects were reported in 25 % of the patients , mainly including metallic taste ( 8 % ) , nausea ( 8 % ) , myalgia/arthralgia ( 5 % ) , and diarrhea ( 4 % ) ; none of them were severe . CONCLUSION : Levofloxacin-based rescue therapy constitutes an encouraging empirical third-line strategy after multiple previous H. pylori eradication failures with key antibiotics such as amoxicillin , clarithromycin , metronidazole , and tetracycline Successful eradication of Helicobacter pylori after failure of st and ard triple therapy is difficult because of the higher resistance to metronidazole and clarithromycin . We evaluated the efficacy of susceptibility-guided vs. empiric retreatment for H. pylori after at least one treatment failure and determined the prevalence of posttreatment antibiotic resistance . Forty-nine patients in whom at least one treatment regimen for H. pylori eradication had failed underwent gastric biopsy and culture and were retreated according to the in vitro susceptibility results . Findings were compared with those for 49 control patients referred to our center for a 13C-urea breath test . H. pylori eradication was assessed by urea breath test at least 6 weeks after retreatment in both groups . Susceptibility-guided retreatment was associated with better eradication rates than empiric treatment . The difference remained significant in stratified and multivariate analysis . Susceptibility-guided retreatment appears to be significantly more effective than empiric retreatment in eradicating H. pylori after at least one previous treatment failure BACKGROUND Levofloxacin has been proposed as an alternative to classic therapy in secondary resistance to Helicobacter pylori . AIM To evaluate primary and secondary resistance of H. pylori to levofloxacin , and to test the role of susceptibility test on the efficacy of levofloxacin-based triple therapy . METHODS Eighty consecutive dyspeptic patients with positive (13)C-urea breath test never treated were r and omly allocated into group A(1 ) ( 40 patients ) and group B(1 ) ( 39 patients ) . Eighty-three patients already treated unsuccessfully with positive (13)C-urea breath test were divided into group A(2 ) ( 51 patients ) and group B(2 ) ( 32 patients ) . Patients in group A(1 ) and group A(2 ) underwent upper gastrointestinal endoscopy for H. pylori susceptibility test to amoxicillin , clarithromycin , tinidazole , rifabutin , and levofloxacin . These patients were treated with levofloxacin ( 500 mg b.i.d . ) , amoxicillin ( 1 g b.i.d . ) and esomeprazole ( 20 mg b.i.d . ) for 10 days if sensitive to these two antibiotics . If H. pylori was found resistant to amoxicillin and /or levofloxacin the treatment was based on the indications of the susceptibility test . Patients in group B(1 ) and group B(2 ) were treated empirically with levofloxacin , amoxicillin , and esomeprazole at the same dose and duration as group A. All patients underwent (13)C-urea breath test 2 months after the end of therapy . RESULTS The antibiotic resistance of H. pylori strains in group A(1 ) and group A(2 ) was ( % ) : amoxicillin : 2.4 , 10 ; clarithromycin : 21.9 , 43.1 ; tinidazole : 31.7 , 70 ; rifabutin : 2.4 , 4 ; and levofloxacin : 9.7 , 12.2 , respectively . In group A(1 ) with susceptibility test-driven therapy , eradication was 97.2 % , and in group B(1 ) with empirical treatment , 94.1 % ( n.s . ) . In group A(2 ) with susceptibility test , eradication was 97.5 % , whereas in group B(2 ) with empirical treatment 81.2 % ( p < .01 ) . CONCLUSION Primary and secondary resistance of H. pylori to levofloxacin is approximately 10 % of the tested strains . The susceptibility test does not influence therapeutic outcome of triple therapy with amoxicillin and levofloxacin in patients never treated , while it is determinant for patients who were previously treated without success BACKGROUND & AIMS Eradication of Helicobacter pylori using empiric therapy has become difficult as a result of increasing resistance to antibiotics . We evaluated the efficacy of specific treatments , selected based on response of bacterial sample s to culture with clarithromycin , levofloxacin , and metronidazole , for patients infected with resistant strains of H pylori . METHODS We performed a prospect i ve study at a single center of 236 consecutive patients with persistent H pylori infection , despite 1 or more treatment attempts , and documented resistance to at least 1 antimicrobial agent ( based on bacterial culture tests ) . Biopsy sample s were collected by endoscopy and cultured in selective media . Patients received either 10 days of levofloxacin ( 250 mg twice daily for 131 patients with susceptible infections ) or 12 days of rifabutin ( 150 mg once daily for 105 patients resistant to levofloxacin ) in combination with amoxicillin ( 1 g twice daily ) and esomeprazole ( 4
Output:
| Conclusions : SGT may be an acceptable option as rescue treatment .
However , cure rates are , at best , moderate and this approach has never been compared with a well-devised empirical therapy .
The evidence in favor of SGT as rescue therapy is currently insufficient to recommend its use |
MS212736 | ***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 — The role of uric acid as a risk factor for myocardial infa rct ion is controversial , and little is known about its role as a risk factor for stroke . Recent evidence suggests that uric acid may be an important causal agent in cardiovascular disease , for example , by inducing renal disease and hence hypertension . We investigated the association between serum uric acid and coronary heart disease and stroke in a large prospect i ve population -based study . Methods — The study was based on 4385 participants of the Rotterdam Study who , at baseline ( 1990 to 1993 ) , were ≥55 years of age , free from stroke and coronary heart disease , and had blood taken . Follow-up for incident stroke and myocardial infa rct ion was complete until January 1 , 2002 . Data were analyzed with Cox proportional hazards models with adjustment for relevant confounders . Results — Average follow-up was 8.4 years . High serum uric acid levels were associated with risk of myocardial infa rct ion and stroke ; age- and sex-adjusted hazard ratios ( 95 % CIs ) for highest versus lowest quintile of uric acid were 1.68 ( 1.24 to 2.27 ) for cardiovascular disease ( 515 cases ) , 1.87 ( 1.12 to 3.13 ) for myocardial infa rct ion ( 194 cases ) , 1.57 ( 1.11 to 2.22 ) for stroke ( 381 cases ) , 1.77 ( 1.10 to 2.83 ) for ischemic stroke ( 205 cases ) , and 1.68 ( 0.68 to 4.15 ) for hemorrhagic stroke ( 46 cases ) . Adjustment for other vascular risk factors only slightly attenuated these associations . Associations were stronger in persons without hypertension than in those with hypertension . Conclusions — Uric acid is a strong risk factor for myocardial infa rct ion and stroke BACKGROUND The role of serum uric acid ( SUA ) as a risk factor for cardiovascular disease ( CVD ) remains controversial . Little is known about its predictive value for mortality from congestive heart failure ( CHF ) and stroke , particularly in elderly , post-menopausal women . METHODS The relation of SUA to risk of death from total CVD , CHF , stroke and coronary heart disease ( CHD ) was examined prospect ively in a large cohort of 28613 elderly Austrian women ( mean age 62.3 years ) , followed-up for a median of 15.2 years . Adjusted Cox proportional hazards models were calculated to evaluate SUA as an independent predictor for fatal CVD events . RESULTS SUA in the highest quartile ( > or=5.41 mg/dL ) was significantly associated with mortality from total CVD ( p<0.0001 ) , showing a clear dose-response relationship ; the adjusted hazard ratio ( 95%CI ) in comparison to the lowest SUA quartile was 1.35 ( 1.20 - 1.52 ) . In subgroup analyses SUA was independently predictive for deaths from acute and subacute ( p<0.0001 ) and chronic forms ( p=0.035 ) of CHD , yielding adjusted hazard ratios for the highest versus lowest SUA quartile of 1.58 ( 1.19 - 2.10 ) and 1.25 ( 1.01 - 1.56 ) , respectively . SUA was further significantly related to fatal CHF ( p<0.0001 ) and stroke ( p=0.018 ) ; the adjusted hazard ratios for the highest versus lowest SUA quartile were 1.50 ( 1.04 - 2.17 ) and 1.37 ( 1.09 - 1.74 ) , respectively . CONCLUSIONS These findings , for the first time , demonstrate that SUA is an independent predictor for all major forms of death from CVD including acute , subacute and chronic forms of CHD , CHF and stroke in elderly , post-menopausal women BACKGROUND The role of serum uric acid ( SUA ) as an independent risk factor for cardiovascular disease ( CVD ) remains controversial , and little is known about its prognostic importance for mortality from congestive heart failure ( CHF ) and stroke . Few large-scale epidemiologic studies with sufficient follow-up have addressed the association of SUA and CVD mortality in apparently healthy men across a wide age range . METHODS A cohort of 83 683 Austrian men ( mean age , 41.6 years ) was prospect ively followed for a median of 13.6 years . We used Cox proportional hazards models adjusted for established risk factors to evaluate SUA as an independent predictor for CVD mortality . RESULTS The highest quintile of SUA concentration ( > 398.81 mumol/L ) was significantly related to mortality from CHF ( P = 0.03 ) and stroke ( P < 0.0001 ) ; adjusted hazard ratios ( 95 % confidence interval ) for the highest vs lowest quintiles of SUA were 1.51 ( 1.03 - 2.22 ) and 1.59 ( 1.23 - 2.04 ) , respectively . SUA was not associated , however , with mortality from acute , subacute , or chronic forms of coronary heart disease ( CHD ) after adjustment for potential confounding factors ( P = 0.12 ) . Age was a significant effect modifier for the relation of SUA to fatal CHF ( P = 0.05 ) , with markedly stronger associations found in younger individuals . CONCLUSIONS Our study demonstrates for the first time in a large prospect i ve male cohort that SUA is independently related to mortality from CHF and stroke . Although increased SUA is not necessarily a causal risk factor , our results suggest the clinical importance of monitoring and intervention based on the presence of an increased SUA concentration , especially because SUA is routinely measured The association of serum uric acid with cardiovascular disease has been appreciated for nearly half a century ( 1 ) . Several prospect i ve studies have shown an association between baseline hyperuricemia and incident coronary heart disease , cardiovascular disease , and death ( 2 - 10 ) . Despite the strength of these associations , uric acid has not been established as a causal risk factor for cardiovascular disease . Instead , uric acid seems inextricably linked to hypertension , dyslipidemia , and disordered glucose metabolism , which play a causal role in the pathogenesis of cardiovascular disease . As such , uric acid may be merely a marker of risk for cardiovascular disease . Several recent reports , however , have attempted to dispel this notion ( 3 , 9 , 11 - 14 ) . Using data from the First National Health and Nutrition Examination Study ( NHANES I ) , Freedman and colleagues ( 3 ) demonstrated that each 60-mol/L increment in uric acid level was associated with a 48 % increase in risk for incident ischemic heart disease among women . Furthermore , a growing body of laboratory and clinical evidence suggests that uric acid plays a role in platelet adhesiveness ( 15 - 17 ) , formation of free radicals ( 18 ) , and oxidative stress ( 19 , 20 ) . As a result of this growing controversy , we revisited this question in the Framingham Heart Study sample . Longer and more contemporary follow-up and more outcome events allowed us to exp and on a previous Framingham report [ 2 ] . In this paper , we describe the relation of baseline serum uric acid level to 1 ) incident coronary heart disease events [ death from coronary heart disease , recognized myocardial infa rct ion , and coronary insufficiency ] , 2 ) death from cardiovascular disease , and 3 ) death from all causes . Because previous studies ( 2 , 3 , 7 , 21 ) have suggested that uric acid is more strongly associated with adverse events in women than in men , we chose a priori to perform sex-specific analyses . Methods Study Sample The selection criteria and study design of the Framingham Heart Study and the Framingham Offspring Study have been described elsewhere ( 22 , 23 ) . Original participants of the Framingham Heart Study who took part in the 13th biennial examination ( 1972 to 1976 ) and adult participants in the first examination of the Framingham Offspring Study ( 1971 to 1975 ) were eligible for this investigation ( n=7940 ) . Blood sample s for uric acid measurement were obtained in 7650 ( 96.3 % ) persons . Participants were excluded ( n=887 ) for the following reasons : use of more than 2 g of salicylates per day ( n=17 ) , missing covariate or follow-up data ( n=117 ) , and prevalent cardiovascular disease ( n=753 ) . The remaining 6763 participants were followed prospect ively until 1994 . Baseline Measurements and Definitions Medical histories and physical examinations were performed for each participant at every clinic visit . Systolic and diastolic blood pressure were measured twice in the left arm of seated participants by using a mercury-column sphygmomanometer positioned near eye level . The average of the two readings was used for each blood pressure variable . The diagnosis of hypertension was based on a systolic blood pressure of 140 mm Hg or higher , a diastolic blood pressure of 90 mm Hg or higher , or the current use of antihypertensive drugs ( 24 ) . Height and weight were measured at each examination , and body mass index was calculated as the weight in kilograms divided by the square of the height in meters . Participants who reported smoking at least one cigarette per day during the year before the examination were classified as current smokers . Alcohol use was ascertained by self-report and was categorized as ounces of ethanol consumed per week . Menopause was defined as the absence of menses for 1 year or more . Diabetes was defined on the basis of a nonfasting blood glucose level of 11.1 mmol/L ( 200 mg/dL ) or greater , a fasting blood glucose level of 7.8 mmol/L ( 140 mg/dL ) or greater , or the use of insulin or an oral hypoglycemic agent . Serum uric acid levels were measured with an autoanalyzer that used a phosphotungstic acid reagent ( 25 ) . Cholesterol levels were determined according to the Abell-Kendall method ( 26 ) . Outcome Events The primary outcome measures were incident coronary heart disease events , death from cardiovascular disease ( coronary heart disease , congestive heart failure , stroke , or other cardiovascular disease ) , and death from all causes . Coronary heart disease events included the following : death from coronary heart disease ( available information suggested coronary heart disease as the probable cause ) , recognized myocardial infa rct ion ( serial electrocardiographic changes leading to development of new pathologic Q waves , characteristic increase and decrease in serum myocardial markers with a suggestive clinical history , or evidence at necropsy of new or recent infa rct ion ) , and coronary insufficiency ( prolonged ischemic chest discomfort associated with transient repolarization abnormality , without criteria for myocardial infa rct ion ) . Events that were more equivocal , such as unrecognized myocardial infa rct ion and angina pectoris , were not included as coronary heart disease events for this analysis . A panel of three physicians determined the outcome events according to previously published criteria ( 27 ) after review ing Framingham Heart Study and outside hospital and physician records . Statistical Analysis Separate analyses were performed for men and women . All participants were divided according to sex-specific uric acid quintiles . Crude event rates were calculated for each quintile . Cox proportional-hazards regression models ( 28 ) were used to examine the relations of uric acid quintiles ( with quintile 1 as the reference category ) and the relation of uric acid level as a continuous variable to incidence of coronary heart disease events , cardiovascular disease mortality rates , and all-cause mortality rates . For comparative purpose s , hazard ratios were calculated without adjustment . For inferential purpose s , hazard ratios were calculated with adjustment for age only and also with adjustment for age and other clinical variables associated with uric acid level or atherosclerotic events : body mass index ( kg/m2 ) , diabetes ( yes/no ) , systolic blood pressure ( mm Hg ) , current diuretic use ( yes/no ) , use of antihypertensive medications other than diuretics ( yes/no ) , left ventricular hypertrophy shown on electrocardiography ( yes/no ) , total cholesterol level ( mmol/L ) , smoking status ( yes/no ) , alcohol use ( ounces consumed per week ) , and menopausal status in women ( yes/no ) . Post hoc subgroup analyses were done to determine any possible relations between quintiles of uric acid and the outcome events in participants stratified according to diuretic use and hypertension status . All analyses were performed on a Sun UltraSPARC computer ( Sun Microsystems , Mountain View , California ) using SAS software ( SAS Institute , Cary , North Carolina ) ( 29 ) . A two-sided P value less than 0.05 was the criterion for statistical significance . Results Participant Characteristics Table 1 shows the baseline clinical characteristics for men and women . The mean uric acid level was 379 mol/L in men ( range , 119 to 738 mol/L ) and 285 mol/L in women ( range , 24 to 696 mol/L ) . The effect of age on mean serum uric acid level is illustrated in the Figure . In men , uric acid levels changed minimally with age . In women , mean
Output:
| Hyperuricemia may modestly increase the risks of both stroke incidence and mortality . |
MS212737 | ***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 Patients with acute proximal deep-vein thrombosis are usually treated first in the hospital with intravenous st and ard ( unfractionated ) heparin . However , the longer plasma half-life , better bioavailability after subcutaneous administration , and more predictable anticoagulant response of low-molecular-weight heparins make them attractive for possible home use . We compared these two approaches . METHODS Patients with acute proximal deep-vein thrombosis were r and omly assigned to receive either intravenous st and ard heparin in the hospital ( 253 patients ) or low-molecular-weight heparin ( 1 mg of enoxaparin per kilogram of body weight subcutaneously twice daily ) administered primarily at home ( 247 patients ) . The study design allowed out patients taking low-molecular-weight heparin to go home immediately and hospitalized patients taking low-molecular-weight heparin to be discharged early . All the patients received warfarin starting on the second day . RESULTS Thirteen of the 247 patients receiving low-molecular-weight heparin ( 5.3 percent ) had recurrent thromboembolism , as compared with 17 of the 253 patients receiving st and ard heparin ( 6.7 percent ; P=0.57 ; absolute difference , 1.4 percentage points ; 95 percent confidence interval , -3.0 to 5.7 ) . Five patients receiving low-molecular-weight heparin had major bleeding , as compared with three patients receiving st and ard heparin . After r and omization , the patients who received low-molecular-weight heparin spent a mean of 1.1 days in the hospital , as compared with 6.5 days for the st and ard-heparin group ; 120 patients in the low-molecular-weight- heparin group did not need to be hospitalized at all . CONCLUSIONS Low-molecular-weight heparin can be used safely and effectively to treat patients with proximal deep-vein thrombosis at home Warfarin induction is accomplished by titrating dosage to coagulation test results . Algorithms can guide this process but not identify the starting dose . We hypothesized that an initial warfarin dose approximating the maintenance value would safely enhance rapidity of induction . In a r and omized trial we compared a fixed-dose to a maintenance-dose strategy for beginning warfarin therapy . To predict the maintenance dose among patients with differing warfarin requirements we performed regression analysis on clinical factors derived from chart review . Four community hospitals supplied records for retrospective analysis . The prospect i ve trial was conducted in one , a 350-bed teaching institution . A sample of in patients anticoagulated during 1998 formed the development set for retrospective study ; a 1999 sample formed the validation set . A one year trial recruited consecutive eligible in patients initiated on warfarin . We r and omly assigned patients to a first warfarin dose calculated using our regression formula or fixed at 5 mg . All patients ' subsequent doses were determined ( as a percentage of initial ) from coagulation testing . We compared days to anticoagulation , hospitalized hours , complications , and activity of factor II and protein C in a patient sample at intervals after induction . Weight , age , serum albumin , and presence of malignancy explained 25 - 30 % of variance in maintenance dose . Ninety patients ( 44 calculated-dose and 46 st and ard-dose ) evaluated in the clinical trial . Mean time to anticoagulation ( among patients achieving anticoagulation ) was 4.2 and 5.0 days , respectively ( p = 0.007 ) . We observed no significant differences in other endpoints . Individualized initial dosing may safely hasten warfarin induction BACKGROUND Warfarin sodium therapy is usually initiated with a loading dose to reduce the time required to elevate the international normalized ratio ( INR ) . Warfarin loading doses are associated with early overanticoagulation and the development of a potential hypercoagulable state ; they also may not hasten achieving an INR value between 2.0 and 3.0 . This study was design ed to prospect ively confirm our observation that a 5-mg warfarin sodium loading dose is as effective as a 10-mg loading dose in achieving a therapeutic INR for 2 consecutive days on days 3 and 4 or 4 and 5 of therapy . METHODS Fifty-three patients initiating warfarin therapy with a target INR of 2.0 to 3.0 were r and omly allocated to receive an initial dose of 5 or 10 mg of warfarin . Subsequent doses were based on dosing algorithms . The INR was measured daily for 5 days . The primary end point of the study was the proportion of patients whose INR values were between 2.0 and 3.0 on 2 consecutive daily determinations on days 3 , 4 , or 5 of the study and whose INR did not exceed 3.0 at any point during the study . RESULTS Five ( 24 % ) of 21 patients in the 10-mg group and 21 ( 66 % ) of 32 patients in the 5-mg group achieved the primary end point ( relative risk 2.22 , 95 % confidence interval 1.30 - 3.70 [ P < .003 ] ) . A trend toward less overanticoagulation was seen in the 5-mg warfarin group . CONCLUSION A 10-mg loading dose of warfarin is unlikely to be more effective than a 5-mg loading dose in achieving an INR of 2.0 to 3.0 by day 4 or 5 of therapy Context The optimal methods for achieving therapeutic levels of anticoagulation with warfarin remain uncertain . Contribution In this r and omized trial of two warfarin dosing nomograms , a 10-mg initiation dose led to a therapeutic international normalized ratio ( INR ) 1.4 days sooner than a 5-mg initiation dose . The two nomograms had the same rate of adverse events and the same proportion of INR values greater than 5.0 . Clinical Implication s Physicians can more quickly get their patients to a therapeutic INR with warfarin by using a dosing nomogram that starts with a 10-mg dose rather than a 5-mg initiation dose . The Editors The management of venous thromboembolism has improved substantially in the past 10 years . Conventional therapy consists of unfractionated or low-molecular-weight heparin for 5 to 7 days , together with oral anticoagulation with warfarin given for a minimum of 3 months ( 1 , 2 ) . Low-molecular-weight heparin facilitates outpatient treatment , and warfarin is usually initiated within 24 hours . Clinical trials have demonstrated that low-molecular-weight heparin may be safely discontinued after 5 days once the international normalized ratio ( INR ) has remained greater than 1.9 for 24 hours ( 2 , 3 ) . Nurses or pharmacists often coordinate outpatient management of venous thromboembolism with appropriate physician support ( 4 ) . For outpatient therapy , minimizing the time to a therapeutic INR is advantageous because it potentially decreases the cost and inconvenience of low-molecular-weight heparin therapy . The initiation of warfarin treatment is problematic , however , because of variations in dose response . A dosing nomogram to facilitate safe , timely warfarin initiation to achieve therapeutic INRs would be useful . We previously developed and tested a nomogram for the initiation of warfarin therapy using a 10-mg loading dose and found that it was superior to st and ard physician practice because it result ed in shorter time to a therapeutic INR ( 5 ) . This nomogram , however , required daily INR testing and was therefore not ideal for outpatient management . We subsequently revised the nomogram so that it requires INR assessment s only on days 3 and 5 during the first 8 days of therapy . We found that the revised nomogram was successful : Almost 90 % of patients had a therapeutic INR by the 5th day of treatment ( 6 ) . The objective of our current study was to perform a r and omized , controlled trial comparing the effectiveness and feasibility of a warfarin nomogram using a 10-mg loading dose with those of a nomogram using a 5-mg loading dose for the management of out patients with acute venous thromboembolism . Methods Patients Consecutive out patients with a diagnosis of objective ly confirmed acute venous thromboembolism ( deep venous thrombosis or pulmonary embolism ) who presented to the thrombosis clinics of four Canadian academic centers were c and i date s for study inclusion . Patients were not admitted to the study if they had a baseline INR greater than 1.4 , had thrombocytopenia ( platelet count < 50 109 cells/mL ) , were younger than 18 years of age , required hospitalization , had received oral anticoagulant therapy within the previous 2 weeks , or were at high risk for major bleeding ( as judged by the attending physician ) . Design This study was a r and omized , double-blind ( physicianpatient ) , controlled trial . R and omization was stratified by study center and presence of active malignant disease . The r and omization sequence was computer generated by the trial statistician . The details of the r and omization sequence , which were not known to the investigators or to the study coordinator , were contained in sets of sequentially numbered , opaque , sealed envelopes . The outside of each envelope was marked only with the name of the hospital , whether the patient had a malignant condition , and a patient number . Patients were assigned to 5-mg or 10-mg warfarin induction by using previously vali date d nomograms ( Table 1 and Figure 1 ) ( 6 , 7 ) . The 5-mg nomogram , as published , specifies a dose range on each day after the first day of treatment with no indication of how to choose the dose ( 7 ) . For the current study , we chose the higher dose whenever a range was indicated . The research ethics boards at each of the participating institutions approved the study , and informed consent was obtained from all participants . Table 1 . 5-mg Warfarin Initiation Nomogram Figure 1 . 10-mg warfarin initiation nomogram . Interventions Study participants were r and omly allocated to warfarin induction with a 10-mg or 5-mg warfarin nomogram ( Table 1 and Figure 1 ) ( 6 , 7 ) . Baseline data collected included demographic characteristics ( age , sex ) , diagnosis , weight , presence of active malignant disease , complete blood count , and INR . International normalized ratios were measured in local licensed clinical laboratories . Treatment was initiated on the first day ( day 1 ) with subcutaneous low-molecular-weight heparin ( dalteparin [ 200 U/kg of body weight ] or tinzaparin [ 175 U/kg ] ) . Low-molecular-weight heparin was continued for a minimum of five daily injections until the INR was therapeutic ( > 1.9 ) . The initial warfarin dose was determined by using treatment allocation . All warfarin doses were administered in the evening , and blood sample s for INR assessment s were drawn before 10:00 a.m. Patients in the 10-mg group received 10 mg of warfarin on each of the first 2 days , whereas patients in the 5-mg group were given 5 mg on each of the first 2 days . Subsequent dose adjustments after day 3 were made by using the respective nomograms . International normalized ratios were measured in all patients on the mornings of days 3 , 4 , and 5 . The 10-mg nomogram , unlike the 5-mg nomogram , did not require an INR measurement on day 4 for dosing ; however , a measurement was performed for study end point purpose s only . If a patient did not have a therapeutic INR by day 5 , the INR was measured daily until it was therapeutic . Local attending physicians directed management of warfarin monitoring from day 8 to day 90 . End Points The primary end point of the study was time in days to a therapeutic INR ( > 1.9 ) . The secondary end points included the proportion of patients whose INRs were within the therapeutic range ( 2.0 to 3.0 ) on the 5th day , incidence of recurrent venous thromboembolism within 90 days of diagnosis ( as defined by previously published criteria [ 2 , 3 ] ) , incidence of major bleeding within 28 days of diagnosis ( as defined by previously published criteria [ 2 , 3 ] ) , number of INR measurements greater than 5 , absolute number of INR assessment s in the first 28 days , and 90-day survival . An adjudication committee consisting of three study investigators evaluated all clinical events in a blinded fashion , and end points were determined by consensus . Hypothesis We tested the hypothesis that patients managed with a 10-mg warfarin induction nomogram would achieve therapeutic INRs more rapidly than patients managed with a 5-mg warfarin nomogram . We believed these improvements would occur without increased risk for bleeding . Sample Size Using data from our pilot nomogram to estimate st and ard deviation ( 1 day ) , we calculated that 92 patients per group would be required to show a 0.5-day difference in time to a therapeutic INR ( 90 % power ; two-sided = 0.05 ) . We considered a 0.5-day difference to be the minimal clinical ly important difference because it would yield a significant proportion of patients who would not require low-molecular-weight heparin therapy beyond 5 days . Statistical Analysis All statistical analyses were performed according to a pre-established analysis plan and by intention to treat . We used SPSS software for
Output:
| In patients with acute thromboembolism ( DVT or PE ) aged 18 years or older , considerable uncertainty surrounds the use of a 10-mg or a 5-mg loading dose for initiation of warfarin to achieve an INR of 2.0 to 3.0 on the fifth day of therapy . |
MS212738 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
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Input: OBJECTIVE To assess the potential benefit of preimplantation aneuploidy testing on the outcome of in vitro fertilization ( IVF ) for women of advanced maternal age ( AMA ) . DESIGN Prospect i ve r and omized clinical trial . SETTING Private IVF clinic . PATIENT(S ) Sixty-two infertile AMA couples undergoing fertility treatment . INTERVENTION(S ) Fluorescent in situ hybridization ( FISH ) for chromosomes X , Y , 13 , 15 , 16 , 17 , 18 , 21 , and 22 . MAIN OUTCOME MEASURE(S ) Preimplantation aneuploidy testing of biopsied blastomeres on day 3 of development . RESULT ( S ) Fertilization and blastocyst developmental rates were similar for the test and control groups : 80 % versus 77.4 % and 49 % versus 48.2 % , respectively . The average number of embryos transferred was comparable at 2.2 for the test group and 2.7 for the control group . Implantation rates were also equivalent across the two groups : 37.3 % in the control group versus 36.5 % in the test group . Nevertheless , the spontaneous abortion rate was observed to be lower for the test group : 25.9 % versus 32.26 % in the control group . This result ed in an observed increase in delivery rates for the test group : 78 % versus 67.74 % in the control group . CONCLUSION ( S ) Preimplantation aneuploidy testing does not appear to statistically significantly improve outcome parameters in infertile AMA patients ; however , a trend toward a decrease in the spontaneous abortion rate with a subsequent higher delivery rate was observed BACKGROUND Single-embryo transfer is a well-accepted strategy to avoid multiple pregnancies in an assisted reproductive technology ( ART ) programme . Besides the morphological quality and embryo kinetics up to the blastocyst stage , preimplantation genetic screening ( PGS ) of aneuploidy has been advocated as an adjuvant approach to select the embryo . METHODS Couples with a female partner younger than 36 were r and omly assigned to undergo transfer of a single blastocyst in a cycle with or without PGS using FISH for the chromosomes X , Y , 13 , 16 , 18 , 21 , 22 . RESULTS After the enrolment of 120 of the projected 447 patients in each group , study recruitment was terminated prematurely on the basis of futility . The observed live birth delivery rates after ART were 30.8 versus 30.8 % per r and omized patient , 34.6 versus 34.6 % per cycle initiated , 37.8 versus 37.0 % per aspirated cycle and 41.6 versus 43.5 % per embryo transfer for the control versus the PGS group , respectively , with absolute between-group differences ( 95 % CI ; P value ) of 0 % ( -11.7 to 11.7 ; P = 1.00 ) , 0 % ( -12.7 to 12.7 ; P = 1.00 ) , -0.8 % ( -14.2 to 12.7 ; P = 0.91 ) and 2.1 % ( -12.7 to 16.7 ; P = 0.79 ) , respectively . Even in this younger age group , only 61 % of the embryos had a normal diploid status . CONCLUSIONS The absence of a beneficial treatment effect in this r and omized clinical trial provides no arguments in favour of PGS to improve live birth delivery rate following single-embryo transfer in women under the age 36 . Clinical Trials.gov : NCT00670059 Meiotic errors during oocyte maturation are considered the major contributors to embryonic aneuploidy and failures in human IVF treatment . Various technologies have been developed to screen polar bodies , blastomeres and trophectoderm cells for chromosomal aberrations . Array-CGH analysis using bacterial artificial chromosome ( BAC ) arrays is widely applied for preimplantation genetic diagnosis ( PGD ) using single cells . Recently , an increase in the pregnancy rate has been demonstrated using array-CGH to evaluate trophectoderm cells . However , in some countries , the analysis of embryonic cells is restricted by law . Therefore , we used BAC array-CGH to assess the impact of polar body analysis on the live birth rate . A disadvantage of polar body aneuploidy screening is the necessity of the analysis of both the first and second polar bodies , result ing in increases in costs for the patient and complex data interpretation . Aneuploidy screening results may sometimes be ambiguous if the first and second polar bodies show reciprocal chromosomal aberrations . To overcome this disadvantage , we tested a strategy involving the pooling of DNA from both polar bodies before DNA amplification . We retrospectively studied 351 patients , of whom 111 underwent polar body array-CGH before embryo transfer . In the group receiving pooled polar body array-CGH ( aCGH ) analysis , 110 embryos were transferred , and 29 babies were born , corresponding to live birth rates of 26.4 % per embryo and 35.7 % per patient . In contrast , in the control group , the IVF treatment was performed without preimplantation genetic screening ( PGS ) . For this group , 403 embryos were transferred , and 60 babies were born , result ing in live birth rates of 14.9 % per embryo and 22.7 % per patient . In conclusion , our data show that in the aCGH group , the use of aneuploidy screening result ed in a significantly higher live birth rate compared with the control group , supporting the benefit of PGS for IVF couples in addition to the suitability and effectiveness of our polar body pooling strategy BACKGROUND It is generally accepted that the age-related increased aneuploidy rate is correlated with reduced implantation and a higher abortion rate . Therefore , advanced maternal age ( AMA ) couples are a good target group to assess the possible benefit of preimplantation genetic diagnosis for aneuploidy screening ( PGD-AS ) on the outcome after assisted reproductive technology ( ART ) . METHODS A prospect i ve r and omized controlled clinical trial ( RCT ) was carried out comparing the outcome after blastocyst transfer combined with PGD-AS using fluorescence in situ hybridization ( FISH ) for the chromosomes X , Y , 13 , 16 , 18 , 21 and 22 in AMA couples ( aged > or = 37 years ) with a control group without PGD-AS . From the 400 ( 200 for PGD-AS and 200 controls ) couples that were allocated to the trial , an oocyte pick-up was performed effectively in 289 cycles ( 148 PGD-AS cycles and 141 control cycles ) . RESULTS Positive serum HCG rates per transfer and per cycle were the same for PGD-AS and controls : 35.8 % ( 19.6 % ) [ % /per embryo transfer ( per cycle ) ] and 32.2 % ( 27.7 % ) , respectively ( NS ) . Significantly fewer embryos were transferred in the PGD-AS group than in the control group ( P<0.001 ) . The implantation rate ( with fetal heart beat ) was 17.1 % in the PGD-AS group versus 11.5 % in the control group ( not significant ; P=0.09 ) . We observed a normal diploid status in 36.8 % of the embryos . CONCLUSIONS This RCT provides no arguments in favour of PGD-AS for improving clinical outcome per initiated cycle in patients with AMA when there are no restrictions in the number of embryos to be transferred STUDY QUESTION Do preimplantation genetic diagnosis ( PGD ) couples experience higher levels of stress during pregnancy and the perinatal period compared with couples who conceive spontaneously ( SC ) or with ICSI ? SUMMARY ANSWER PGD couples did not experience more psychological stress during pregnancy and beyond than ICSI or SC couples . WHAT IS ALREADY KNOWN Previous studies have shown that assisted reproduction technology ( ART ) couples are more prone to pregnancy-related anxieties than SC couples , but display depressed feelings to an equal or lesser extent . However , only one study has focused on a female PGD sample , which may be a more vulnerable group than other ART groups , due to the potentially complex hereditary background , adverse childhood experiences and losses . In that study , PGD women experienced a reduction in state anxiety , and maternal-antenatal attachment did not differ from normative data . Unfortunately , no data exist on pregnancy-related anxiety , depression and parental-antenatal attachment . Valuable information from both parents ( e.g. : couples ) is also lacking . STUDY DESIGN , SIZE , DURATION For this longitudinal prospect i ve study question naire , data from 185 women and 157 men ( 157 couples ) were collected between February 2012 until April 2014 . Data were analysed using multilevel analysis . The couples conceiving after PGD , ICSI or SC were followed from the first trimester of the pregnancy until the third month post-partum . PARTICIPANTS / MATERIAL S , SETTING , METHODS A total of 60 PGD , 58 ICSI and 69 SC couples were initially recruited by various departments of Universitair Ziekenhuis Brussel ( UZ Brussel ) . At each trimester ( T1 : 12 - 14 weeks , T2 : 20 - 22 weeks , T3 : 30 - 32 weeks ) of pregnancy , depression ( EPDS ) , pregnancy-related anxieties ( PRAQ ) and parental-antenatal attachment ( M/PAAS ) were recorded . At T4 ( 3 months post-partum ) , depression ( EPDS ) was assessed again . In the first trimester ( T1 ) broad socio-demographic data and at T4 perinatal health data of both mother and child were recorded . Differences between conception groups over time were analysed using multilevel analyses , taking into account covariation between measurements and within couples . Several perinatal covariates as well as social desirability , coping and adult attachment style were controlled for . MAIN RESULTS AND THE ROLE OF CHANCE All three conception groups had similar scores for depression during pregnancy and beyond . Also , pregnancy-related anxiety scales did not differ among the three groups . All groups also followed a similar trajectory in time regarding their scores for anxiety , depression and parental-antenatal attachment . ART groups did not give more socially desirable answers than SC controls . The subsequent moderators : coping and adult attachment style did not add any relevant information . No interaction effects occurred between gender and conception groups . LIMITATIONS , REASONS FOR CAUTION The participants were Caucasian , Dutch-speaking couples , with medium to high socio-economic status , from a single centre . Our data should be replicated by multicultural and multicentre studies . Furthermore , the inclusion of an additional control group of couples who did not opt for PGD but for prenatal diagnosis may point to the most beneficial strategy for the couple . WIDER IMPLICATION S OF THE FINDINGS PGD parents invest a similar amount of time and emotion in their future children compared with controls . This implies that successful PGD treatment makes an important psychological contribution towards the well-being of couples given their complex hereditary and family background s. STUDY FUNDING /COMPETING INTERESTS This research project was funded by grants from the internal research council of the Vrije Universiteit Brussel ( OZR ) , the Flemish Fonds Wetenschappelijk Onderzoek ( FWO ) and the Wetenschappelijk Fonds Willy Gepts ( WGFG ) . UZ Brussel and the Centre for Medical Genetics have received several educational grants for organizing the data collection , from IBSA , Ferring , Organon , Shering-Plough , Merck and Merck Belgium . M.B. has received consultancy and speaker 's fees from Organon , Serono Symposia and Merck STUDY QUESTION Does embryo biopsy inherent to preimplantation genetic screening ( PGS ) affect neurological , cognitive and behavioural development of 4-year-old children ? SUMMARY ANSWER PGS does not seem to affect neurological , cognitive and behavioural development of 4-year-old singletons ; however , our data suggest that it may be associated with altered neurodevelopment in twins . WHAT IS KNOWN ALREADY Evidence concerning the safety of PGS on neurodevelopmental outcome in offspring is scarce . The present study provides information on neurodevelopmental , cognitive and behavioural outcome of 4-year-old PGS offspring . STUDY DESIGN , SIZE , DURATION A prospect i ve , assessor-blinded follow-up study of children born to women who participated in a multi-centre RCT on the effect of IVF with or without PGS . PARTICIPANTS / MATERIAL S , SETTING , METHODS At 4 years , 49 children ( 31 singletons , 9 sets of twins ) born following IVF with PGS and 64 children ( 42 singletons , 11 sets of twins ) born following IVF without PGS ( controls ) were assessed ( post-natal attrition 18 % ) . Neurological development was evaluated with the st and ardized , age-specific and sensitive neurological examination according to Hempel , result ing in a neurological optimality score ( NOS ) , a fluency score and the rate of adverse neurological outcome . Primary outcome was the fluency score , as fluency of movements is easily reduced by subtle dysfunction of the brain . C
Output:
| Conclusions Comprehensive chromosome screening-based PGD/S can improve clinical pregnancy and live birth rates without adversely affecting functioning in childhood at least up to age 9 . |
MS212739 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
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Input: Background Various adipokines are reported to be associated with the development of heart failure ( HF ) through insulin resistance and chronic inflammation . Omentin-1 is a novel adipokine and is associated with incident coronary artery disease . However , it remains unclear whether serum omentin-1 levels are associated with cardiac prognosis in patients with HF . Methods We measured serum omentin-1 levels at admission in 136 consecutive patients with HF , and 20 control subjects without signs of significant heart disease . We prospect ively followed patients with HF to endpoints of cardiac death or re-hospitalization for worsening HF . Results Serum omentin-1 levels were markedly lower in HF patients with cardiac events compared with to without . The patients who were in New York Heart Association ( NYHA ) functional class IV showed significantly lower serum omentin-1 levels compared to those in class II and III , whereas serum omentin-1 levels did not correlate with serum brain natriuretic peptide levels ( r = 0.217 , P = 0.011 ) . We divided the HF patients into three groups based on the tertiles of serum omentin-1 level ( low T1 , middle T2 , and high T3 ) . Multivariate Cox hazard analysis showed that the lowest serum omentin-1 level ( T1 ) was independently associated with cardiac events after adjustment for confounding factors ( hazard ratio 5.78 , 95 % confidence interval 1.20 - 12.79 ) . We divided the HF patients into two groups according to the median serum omentin-1 levels . Kaplan-Meier analysis revealed that the patients with low serum omentin-1 levels had a higher risk of cardiac events compared with those with high serum omentin-1 levels ( log-rank test p < 0.001 ) . Conclusion Decreased serum omentin-1 levels were associated with a poor cardiac outcome in patients with HF BACKGROUND Epidemiological studies have reported that patients with type 2 diabetes mellitus ( DM ) have increased mortality and morbidity from cardiovascular diseases , independent of other risk factors . However , most of these studies have been performed in selected patient groups . The purpose of the present study was prospect ively to assess the impact of type 2 DM on cardiovascular morbidity and mortality in an unselected population . METHODS A total of 13,105 subjects from the Copenhagen City Heart Study were followed up prospect ively for 20 years . Adjusted relative risks of first , incident , admission for , or death from ischemic heart disease , acute myocardial infa rct ion , or stroke , as well as total mortality in persons with type 2 DM compared with healthy controls , were estimated . RESULTS The relative risk of first , incident , and admission for myocardial infa rct ion was increased 1.5- to 4.5-fold in women and 1.5- to 2-fold in men , with a significant difference between sexes . The relative risk of first , incident , and admission for stroke was increased 2- to 6.5-fold in women and 1.5- to 2-fold in men , with a significant difference between sexes . In both women and men the relative risk of death was increased 1.5 to 2 times . CONCLUSIONS In persons with type 2 DM , the risk of having an incident myocardial infa rct ion or stroke is increased 2- to 3-fold and the risk of death is increased 2-fold , independent of other known risk factors for cardiovascular diseases OBJECTIVE Omentin is a protein expressed and secreted from visceral but not subcutaneous adipose tissue , which increases insulin sensitivity in human adipocytes . However , its pathophysiologic role in humans remains largely unknown . The objective of this study is to assess plasma omentin-1 levels in patients with type 2 diabetes mellitus ( T2DM ) and matched control subjects and to investigate the effects of liraglutide on plasma omentin-1 levels in patients with T2DM . PATIENTS AND METHODS Thirty T2DM patients with poor glycemic control after more than 3 months of treatment with one or two OHA(s ) ( T2DM ) , and 30 matched normal glycaemic controls ( NGT ) participated in the study . The T2DM group was given an injection of liraglutide once-daily for 16 weeks . Plasma omentin-1 levels were measured by enzyme-linked immunosorbent assay and the relationship between plasma omentin-1 levels and metabolic parameters was also analyzed . RESULTS Plasma omentin-1 levels were lower in T2DM than in the control ( 19.3 ± 4.0 μg/L vs. 26.4 ± 6.0 μg/L , P < 0.01 ) . Plasma omentin-1 levels increased significantly in T2DM patients after treatment with liraglutide compared with pre-treatment ( 19.3 ± 4.0 μg/L vs. 21.2 ± 3 . 9 μg/L , P < 0.01 ) . In all diabetic patients , multiple regression analysis showed that FINS and HOMA-IR were independently associated with plasma omentin-1 levels . CONCLUSIONS In T2DM patients , plasma omentin-1 levels decreased , but significantly increased after the treatment with liraglutide and metformin . These data suggest that liraglutide may play a role in increasing omentin-1 levels in T2DM patients
Output:
| Conclusion We found that serum omentin level is significantly lower in T2DM and IGT patients but not in T1DM ones .
These data could be used by clinicians for early diagnosis and management of diabetes . |
MS212740 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
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Input: BACKGROUND Previous studies found that medication errors result from lack of sufficient information during the prescribing step . Therefore , it is proposed that having a pharmacist available when patients are evaluated during the rounding process may reduce the likelihood of preventable adverse drug events ( ADEs ) . The objectives of this study were to evaluate the impact of having a pharmacist participate with a physician rounding team on preventable ADEs in general medicine units and to document pharmacist interventions made during the rounding process . METHODS A single-blind , st and ard care-controlled study design was used to compare patients receiving care from a rounding team including a pharmacist with patients receiving st and ard care ( no pharmacist on rounding team ) . Patients admitted to and discharged from the same general medicine unit were included in the study . The main outcome measure of this study was preventable ADEs . Patient records were r and omly selected and evaluated by a blinded process involving independent senior pharmacist specialists and a senior staff physician . Interventions made by the pharmacists in the treatment group were documented . RESULTS The rate of preventable ADEs was reduced by 78 % , from 26.5 per 1000 hospital days to 5.7 per 1000 hospital days . There were 150 documented interventions recommended during the rounding process , 147 of which were accepted by the team . The most common interventions were ( 1 ) dosing-related changes and ( 2 ) recommendations to add a drug to therapy . CONCLUSION Pharmacist participation with the medical rounding team on a general medicine unit contributes to a significant reduction in preventable ADEs Sc and J Prim Health Care 2003;21:00 - 00 . ISSN 0281 - 3432 Objective r - r To investigate general practitioner ( GP ) assessment of a structured oncology information pack sent to GPs when newly referred patients had visited a department of oncology for the first time , and to compare their assessment of this material with their assessment of traditional information provided by the department . Design r - r R and omised , unblinded clinical trial . Setting r - r Patients and GPs in the catchment area of a regional oncology department . Subjects / patients r - r 248 cancer patients and their 199 GPs . Main outcome measures r - r GP assessment of the quality of the information material received for each patient . Results r - r 88.3 % of the 248 question naires were returned . The structured information pack improved GP knowledge of oncology ; GPs found themselves better equipped to support and counsel patients during the course of their illness , and practitioner satisfaction with the department rose . Conclusion r - r Intervention , though reasonably simple , inexpensive and not particularly time-consuming , improved cooperation between the specialist department and the GP . While this is a small step in the right direction , the need remains for new initiatives and further studies into how to improve cooperation and communication between the primary and secondary healthcare sectors OBJECTIVE To test the effectiveness of a nursing-centered intervention to prevent functional decline among hospitalized elderly medical patients . DESIGN Prospect i ve cohort study with stratified and matched cohort analyses . SETTING General medicine wards of a university teaching hospital . PATIENTS Two hundred sixteen patients aged > or = 70 years ( 85 intervention and 131 control patients ) . INTERVENTION The intervention included identification and surveillance of frail older patients , twice-weekly rounds of the Geriatric Care Team , and a nursing-centered educational program . MAIN OUTCOME MEASURE Functional decline , defined as a net decline in five activities of daily living ( ADLs ) . RESULTS In stratified analyses , the intervention result ed in a beneficial effect with a relative risk of 0.82 ( 95 % confidence interval [ CI ] 0.54 to 1.24 ) in patients ( n = 106 ) with one of four geriatric target conditions at baseline ( eg , delirium , functional impairment , incontinence , and pressure sores ) . The intervention had no effect in patients without target conditions at baseline ( n = 110 ) ; thus , this subgroup was excluded from further analyses . When patients were matched on number of target conditions and risk for functional decline at baseline ( n = 66 ) , the intervention result ed in a significant beneficial effect , with a reduction in functional decline from 64 % in controls to 41 % in the intervention group , for a relative risk of 0.64 ( 95 % CI , 0.43 to 0.96 ) . The intervention group had significantly less decline in ADL score and in individual ADLs than control subjects . Specific interventions aim ed at maximizing function , such as physical therapy , were received more often by intervention patients ; however , the beneficial effects of the intervention were achieved without increasing per-day hospital costs . CONCLUSIONS The intervention appears effective to decrease functional decline in targeted elderly hospitalized medical patients BACKGROUND Patients with cardiac arrests or who die in general wards have often received delayed or inadequate care . We investigated whether the medical emergency team ( MET ) system could reduce the incidence of cardiac arrests , unplanned admissions to intensive care units ( ICU ) , and deaths . METHODS We r and omised 23 hospitals in Australia to continue functioning as usual ( n=11 ) or to introduce a MET system ( n=12 ) . The primary outcome was the composite of cardiac arrest , unexpected death , or unplanned ICU admission during the 6-month study period after MET activation . Analysis was by intention to treat . FINDINGS Introduction of the MET increased the overall calling incidence for an emergency team ( 3.1 vs 8.7 per 1000 admissions , p=0.0001 ) . The MET was called to 30 % of patients who fulfilled the calling criteria and who were subsequently admitted to the ICU . During the study , we recorded similar incidence of the composite primary outcome in the control and MET hospitals ( 5.86 vs 5.31 per 1000 admissions , p=0.640 ) , as well as of the individual secondary outcomes ( cardiac arrests , 1.64 vs 1.31 , p=0.736 ; unplanned ICU admissions , 4.68 vs 4.19 , p=0.599 ; and unexpected deaths , 1.18 vs 1.06 , p=0.752 ) . A reduction in the rate of cardiac arrests ( p=0.003 ) and unexpected deaths ( p=0.01 ) was seen from baseline to the study period for both groups combined . INTERPRETATION The MET system greatly increases emergency team calling , but does not substantially affect the incidence of cardiac arrest , unplanned ICU admissions , or unexpected death OBJECTIVES To determine the effect of collaborative care management for depression on physical functioning in older adults . DESIGN Multisite r and omized clinical trial . SETTING Eighteen primary care clinics from eight healthcare organizations . PARTICIPANTS One thous and eight hundred one patients aged 60 and older with major depressive disorder . INTERVENTION Patients were r and omized to the Improving Mood : Promoting Access to Collaborative Treatment ( IMPACT ) intervention ( n=906 ) or to a control group receiving usual care ( n=895 ) . Control patients had access to all health services available as part of usual care . Intervention patients had access for 12 months to a depression clinical specialist who coordinated depression care with their primary care physician . MEASUREMENTS The 12-item short form Physical Component Summary ( PCS ) score ( range 0 - 100 ) and instrumental activities of daily living ( IADLs ) ( range 0 - 7 ) . RESULTS The mean patient age was 71.2 , 65 % were women , and 77 % were white . At baseline , the mean PCS was 40.2 , and the mean number of IADL dependencies was 0.7 ; 45 % of participants rated their health as fair or poor . Intervention patients experienced significantly better physical functioning at 1 year than usual-care patients as measured using between-group differences on the PCS of 1.71 ( 95 % confidence interval (CI)=0.96 - 2.46 ) and IADLs of -0.15 ( 95 % CI=-0.29 to -0.01 ) . Intervention patients were also less likely to rate their health as fair or poor ( 37.3 % vs 52.4 % , P<.001 ) . Combining both study groups , patients whose depression improved were more likely to experience improvement in physical functioning . CONCLUSION The IMPACT collaborative care model for late-life depression improves physical function more than usual care OBJECTIVE To test a quality improvement intervention , a learning collaborative based on the Institute for Healthcare Improvement 's Breakthrough Series methodology , specifically intended to improve care and outcomes for patients with childhood asthma . DESIGN R and omized trial in primary care practice s. SETTING Practice s in greater Boston , Mass , and greater Detroit , Mich. PARTICIPANTS Forty-three practice s , with 13 878 pediatric patients with asthma , r and omized to intervention and control groups . Intervention Participation in a learning collaborative project based on the Breakthrough Series methodology of continuous quality improvement . MAIN OUTCOME MEASURES Change from baseline in the proportion of children with persistent asthma who received appropriate medication therapy for asthma , and in the proportion of children whose parent received a written management plan for their child 's asthma , as determined by telephone interviews with parents of 631 children . RESULTS After adjusting for state , practice size , child age , sex , and within- practice clustering , no overall effect of the intervention was found . CONCLUSIONS This method ologically rigorous assessment of a widely used quality improvement technique did not demonstrate a significant effect on processes or outcomes of care for children with asthma . Potential deficiencies in program implementation , project duration , sample selection , and data sources preclude making the general inference that this type of improvement program is ineffective . Additional rigorous studies should be undertaken under more optimal setting s to assess the efficacy of this method for improving care AIM To study the effects of a team-based model for continuous quality improvement ( CQI ) on primary care practice management . DESIGN OF STUDY R and omised controlled trial . SETTING Twenty-six intervention and 23 control primary care practice s in the Netherl and s. METHOD Practice s interested in taking part in the CQI project were , after assessment of their practice organisation , r and omly assigned to the intervention or control groups . During a total of five meetings , a facilitator helped the teams in the intervention group select suitable topics for quality improvement and follow a structured approach to achieve improvement objectives . Checklists completed by an outreach visitor , question naires for the GPs , staff and patients were used to assemble data on the number and quality of improvement activities undertaken and on practice management prior to the start of the intervention and 1 year later . RESULTS Pre-test and post-test data were compared for the 26 intervention and 23 control practice s. A significant intervention effect was found for the number of improvement objectives actually defined ( 93 versus 54 , P<0.001 ) and successfully completed ( 80 versus 69 % of the projects , P<0.001 ) . The intervention group also improved on more aspects of practice management , as measured by our practice visit method , than the control group but none of these differences proved statistically significant . CONCLUSION The intervention exerted a significant effect on the number and quality of improvement projects undertaken and self-defined objectives met . Failure of the effects of the intervention on the other dimensions of practice management to achieve significance may be due to the topics selected for some of the improvement projects being only partly covered by the assessment instrument CONTEXT Most older adults with dementia will be cared for by primary care physicians , but the primary care practice environment presents important challenges to providing quality care . OBJECTIVE To test the effectiveness of a collaborative care model to improve the quality of care for patients with Alzheimer disease . DESIGN , SETTING , AND PATIENTS Controlled clinical trial of 153 older adults with Alzheimer disease and their caregivers who were r and omized by physician to receive collaborative care management ( n = 84 ) or augmented usual care ( n = 69 ) at primary care practice s within 2 US university-affiliated health care systems from January 2002 through August 2004 . Eligible patients ( identified via screening or medical record ) met diagnostic criteria for Alzheimer disease and had a self-identified caregiver . INTERVENTION Intervention patients received 1 year of care management by an interdisciplinary team led by an advanced practice nurse working with the patient 's family caregiver and integrated within primary care . The team used st and ard protocol s to initiate treatment and identify , monitor , and treat behavioral and psychological symptoms of dementia , stressing nonpharmacological management . MAIN OUTCOME MEASURES Neuropsychiatric Inventory ( NPI ) administered at baseline and at 6 , 12 , and 18 months . Secondary outcomes included the Cornell Scale for Depression in Dementia ( CSDD ) , cognition , activities of daily living , re source use , and caregiver 's depression severity . RESULTS Initiated by caregivers ' reports , 89 % of intervention patients triggered at least 1 protocol for behavioral and psychological symptoms of dementia with a mean of 4 per patient from a total of 8 possible protocol s. Intervention patients were more likely to receive cholinesterase inhibitors ( 79.8 % vs 55.1 % ; P = .002 ) and antidepressants ( 45.2 % vs 27.5 % ; P = .03 ) . Intervention patients had significantly fewer behavioral and psychological symptoms of dementia as measured by the total NPI score at 12 months ( mean difference , -5.6 ; P = .01 ) and at 18 months ( mean difference , -5.4 ; P = .01 ) . Intervention caregivers also
Output:
| Monthly multidisciplinary team meetings improved prescribing of psychotropic drugs in nursing homes .
Videoconferencing compared to audioconferencing multidisciplinary case conferences showed mixed results ; there was a decreased number of case conferences per patient and shorter length of treatment , but no differences in occasions of service or the length of the conference .
There was also no difference between the groups in the number of communications between health professionals recorded in the notes .
Multidisciplinary meetings with an external facilitator , who used strategies to encourage collaborative working , was associated with increased audit activity and reported improvements to care . |
MS212741 | ***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: Butorphanol tartrate ( 4 mg and 8 mg ) was compared to codeine phosphate ( 60 mg ) and placebo for oral analgesic activity and side-effects employing a double-blind design in ninety-three out- patients suffering from moderate to very severe musculoskeletal pain . The study duration was 72 hours with medication administered every 4 to 6 hours ( four times daily ) for a total of twelve doses per patient . The results demonstrate that both the 4 mg and 8 mg doses of butorphanol were significantly better ( p<0.05 ) than placebo . While codeine 60 mg also proved active , it appears to be less efficacious than the high dose of butorphanol . The peak effect appeared to be evident in 1 to 2 hours . Butorphanol may be at least seven times more potent than codeine on a milligram basis . Although no serious side-effects were observed , butorphanol appeared to present a greater incidence of side-effects than codeine and placebo in this study Short-term and long-term effects of neonatal pain and its analgesic treatment have been topics of translational research over the years . This study aim ed to identify the long-term effects of continuous morphine infusion in the neonatal period on thermal pain sensitivity , the incidence of chronic pain , and neurological functioning . Eighty-nine of the 150 participants of a neonatal r and omized controlled trial on continuous morphine infusion versus placebo during mechanical ventilation underwent quantitative sensory testing and neurological examination at the age of 8 or 9 years . Forty-three children from the morphine group and 46 children from the placebo group participated in this follow-up study . Thermal detection and pain thresholds were compared with data from 28 healthy controls . Multivariate analyses revealed no statistically significant differences in thermal detection thresholds and pain thresholds between the morphine and placebo groups . The incidence of chronic pain was comparable between both groups . The neurological examination was normal in 29 ( 76 % ) of the children in the morphine group and 25 ( 61 % ) of the children in the control group ( P = .14 ) . We found that neonatal continuous morphine infusion ( 10 μg/kg/h ) has no adverse effects on thermal detection and pain thresholds , the incidence of chronic pain , or overall neurological functioning 8 to 9 years later . Perspective : This unique long-term follow-up study shows that neonatal continuous morphine infusion ( 10 μg/kg/h ) has no long-term adverse effects on thermal detection and pain thresholds or overall neurological functioning . These findings will help clinicians to find the most adequate and safe analgesic dosing regimens for neonates and infants & NA ; The current analysis compares changes in pain with changes in function and health status in individuals with painful diabetic peripheral neuropathy ( DPN ) . The post hoc analysis is based on a 12 week , multinational , placebo‐controlled trial of pregabalin in which 401 patients were r and omized to treatment . Study measures included the Brief Pain Inventory short‐form ( BPI‐sf ) , EQ‐5D and other patient‐reported outcomes . Cutpoints were derived on the BPI‐sf 0–10 average pain numeric rating scale [ NRS ] to classify pain grade s of “ mild ” ( 1–3 ) , moderate ( 4–6 ) and severe ( 7–10 ) , adjusting for geographical regions where data were collected . Two different metrics were used to classify the importance of change in pain severity from baseline to 12 weeks : changes in pain severity grade s ( defined by cutpoint categories ) and percent reduction in the NRS ( categories ranging from 0–9 % to ≥50 % ) . An improvement in one pain grade or a ≥30 % reduction in the NRS served as determinants of a clinical ly important difference . Patients with a one‐ grade reduction in pain severity , either from “ severe‐to‐moderate ” or “ moderate‐to‐mild , ” had a 3‐point improvement the BPI‐sf Pain Interference Index ( PII ; a composite measure of function ) ; a reduction from “ severe‐to‐mild ” pain corresponded to a 6‐point improvement in the PII . Similarly , a reduction in the NRS of ≥30 % and ≥50 % corresponded to a 3‐point and a 5‐point improvement in the PII , respectively . Changes in pain were also associated with changes in health status . Results suggest that patients whose pain is not reduced to a mild level of severity can still experience clinical ly important changes in function and health status & 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 : Recent warnings from Health Canada regarding codeine for children have led to increased use of nonsteroidal anti-inflammatory drugs and morphine for common injuries such as fractures . Our objective was to determine whether morphine administered orally has superior efficacy to ibuprofen in fracture-related pain . Methods : We used a parallel group , r and omized , blinded superiority design . Children who presented to the emergency department with an uncomplicated extremity fracture were r and omly assigned to receive either morphine ( 0.5 mg/kg orally ) or ibuprofen ( 10 mg/kg ) for 24 hours after discharge . Our primary outcome was the change in pain score using the Faces Pain Scale — Revised ( FPS-R ) . Participants were asked to record pain scores immediately before and 30 minutes after receiving each dose . Results : We analyzed data from 66 participants in the morphine group and 68 participants in the ibuprofen group . For both morphine and ibuprofen , we found a reduction in pain scores ( mean pre – post difference ± st and ard deviation for dose 1 : morphine 1.5 ± 1.2 , ibuprofen 1.3 ± 1.0 , between-group difference [ δ ] 0.2 [ 95 % confidence interval ( CI ) −0.2 to 0.6 ] ; dose 2 : morphine 1.3 ± 1.3 , ibuprofen 1.3 ± 0.9 , δ 0 [ 95 % CI −0.4 to 0.4 ] ; dose 3 : morphine 1.3 ± 1.4 , ibuprofen 1.4 ± 1.1 , δ −0.1 [ 95 % CI −0.7 to 0.4 ] ; and dose 4 : morphine 1.5 ± 1.4 , ibuprofen 1.1 ± 1.2 , δ 0.4 [ 95 % CI −0.2 to 1.1 ] ) . We found no significant differences in the change in pain scores between morphine and ibuprofen between groups at any of the 4 time points ( p = 0.6 ) . Participants in the morphine group had significantly more adverse effects than those in the ibuprofen group ( 56.1 % v. 30.9 % , p < 0.01 ) . Interpretation : We found no significant difference in analgesic efficacy between orally administered morphine and ibuprofen . However , morphine was associated with a significantly greater number of adverse effects . Our results suggest that ibuprofen remains safe and effective for outpatient pain management in children with uncomplicated fractures . Trial registration : Clinical Trials.gov , no. NCT01690780 SUMMARY Two double-blind between-patient comparisons of the analgesic activity of orally administered pentazocine 50 mg , dihydrocodeine 60 mg and placebo are described , which involved 99 patients in " severe " or " moderate " pain , mainly of skeletal origin , and 103 patients in " severe " or " moderate " pain predominatly of postoperative origin . In both studies pain was assessed by a single observer prior to and 1 hour after the administration of a single dose of one of the test preparations . Both active drugs were significantly superior to placebo , and in both studies a firm trend showed pentazocine to be more effective than dihydrocodeine which was in turn more effective than placebo . Drowsiness more commonly followed pentazocine administration , but nausea and vomiting more commonly followed dihydrocodeine Background : The aim was to compare the efficacy and safety of a combination of intramuscular ketorolac and chlorpromazine for the treatment of acute exacerbations of chronic pain with the more commonly used regimen of intramuscular meperidine and promethazine . Methods : Use-effective case series were drawn from a real-life , rural emergency department practice , in which 200 consecutive patients coming to a rural emergency department with acute exacerbations of chronic pain syndromes were assigned on an every-other basis in a single-blind fashion to one of the two treatment conditions . Patients were given intramuscular doses of either 60 mg of ketorolac plus 50 mg of chlorpromazine ( 75 mg of chlorpromazine for patients weighing more than 100 kg ) , or 50 mg of meperidine plus 25 mg of promethazine ( 50 mg of promethazine for patients weighing more than 75 kg ) ; patients weighing more than 100 kg were given 1.5 doses . Patients older than 65 years or whose blood pressure at the time of injection was less than 110/70 mmHg were given half-doses . Patients could receive one additional half-dose injection if they had no results within 30 to 60 minutes after the first injection . Patients were assessed on self-report and on a verbal and visual analog scale of pain rating . Temperature , blood pressure , heart rate , and respirations were monitored every 15 minutes . Results : Both regimens performed well , with more than 90 percent of patients reporting good or excellent improvement on acute exacerbations of chronic pain . Ketorolac-chlorpromazine offered significant advantages compared with meperidine-promethazine when patients rated their pain on a visual analog pain scale ( P < 0.05 ) but not on a verbal scale . Adverse reactions were minimal and consisted of more respiratory tract depression with meperidine and more vertigo or dizziness with chlorpromazine . There was no difference in incidence of hypotension between the two groups . Conclusions : The combination of ketorolac and chlorpromazine is a safe and efficacious alternative to meperidine plus promethazine for the treatment of exacerbations of chronic pain in the rural emergency department setting BACKGROUND Gastrointestinal ( GI ) adverse effects are common with oral opioid treatments ; their impact on health-related quality of life ( HRQoL ) is poorly understood . OBJECTIVES To estimate the extent to which GI adverse effects impact HRQoL. DESIGN 28-day prospect i ve , multicenter , observational registry . SETTING Outpatient setting s. PARTICIPANTS Six hundred thirty-nine patients with acute pain ( AP ; n = 243 ) and acute episodes of chronic pain ( CP ; pain ≥3 months ; n = 396 ) requiring treatment with a prescription medication containing oxycodone immediate-release on an as-needed basis for ≥5 days . MEASUREMENTS Modified Memorial Symptom Assessment Scale ; 12-item Short Form Health Survey ( SF-12 ) Physical ( PCS ) ; and Mental Component Scales ( MCS ) on days 3 , 7 , 14 , 21 , and 28 . Repeated measures mixed models provided estimates of impact of GI events on HRQoL. RESULTS Forty-seven percent of AP patients and 24 percent of CP patients developed constipation . More AP patients than CP developed nausea ( 31 percent vs 19 percent ) . After adjustment for confounders , constipation was associated with a 3.9-point reduction in PCS and a 2.3-point reduction in MCS among AP patients ( p < 0.0001 ) . Among AP patients , nausea/vomiting was associated with a reduction in PCS ( PCS = 3.2 ; p < 0.0001 ) and MCS ( MCS = 2.2 ; p = 0.0042 ) . Among CP patients , constipation was not associated with reductions in HRQoL , and nausea/vomiting was associated with a reduction in MCS but not PCS ( MCS = 2
Output:
| There was no evidence from r and omised controlled trials to support or refute the use of opioids to treat chronic non-cancer pain in children and adolescents .
We are unable to comment about efficacy or harm from the use of opioids to treat chronic non-cancer pain in children and adolescents .
We know from adult r and omised controlled trials that some opioids , such as morphine and codeine , can be effective in certain chronic pain conditions .
This means that no conclusions could be made about efficacy or harm in the use of opioids to treat chronic non-cancer pain in children and adolescents |
MS212742 | ***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 , in young active adults with an acute anterior cruciate ligament ( ACL ) tear , the mid-term ( five year ) patient reported and radiographic outcomes between those treated with rehabilitation plus early ACL reconstruction and those treated with rehabilitation and optional delayed ACL reconstruction . Design Extended follow-up of prospect i ve r and omised controlled trial . Setting Orthopaedic departments at two hospitals in Sweden . Participants 121 young , active adults ( mean age 26 years ) with acute ACL injury to a previously uninjured knee . One patient was lost to five year follow-up . Intervention All patients received similar structured rehabilitation . In addition to rehabilitation , 62 patients were assigned to early ACL reconstruction and 59 were assigned to the option of having a delayed ACL reconstruction if needed . Main outcome measure The main outcome was the change from baseline to five years in the mean value of four of the five subscales of the knee injury and osteoarthritis outcome score ( KOOS4 ) . Other outcomes included the absolute KOOS4 score , all five KOOS subscale scores , SF-36 , Tegner activity scale , meniscal surgery , and radiographic osteoarthritis at five years . Results Thirty ( 51 % ) patients assigned to optional delayed ACL reconstruction had delayed ACL reconstruction ( seven between two and five years ) . The mean change in KOOS4 score from baseline to five years was 42.9 points for those assigned to rehabilitation plus early ACL reconstruction and 44.9 for those assigned to rehabilitation plus optional delayed reconstruction ( between group difference 2.0 points , 95 % confidence interval −8.5 to 4.5 ; P=0.54 after adjustment for baseline score ) . At five years , no significant between group differences were seen in KOOS4 ( P=0.45 ) , any of the KOOS subscales ( P≥0.12 ) , SF-36 ( P≥0.34 ) , Tegner activity scale ( P=0.74 ) , or incident radiographic osteoarthritis of the index knee ( P=0.17 ) . No between group differences were seen in the number of knees having meniscus surgery ( P=0.48 ) or in a time to event analysis of the proportion of meniscuses operated on ( P=0.77 ) . The results were similar when analysed by treatment actually received . Conclusion In this first high quality r and omised controlled trial with minimal loss to follow-up , a strategy of rehabilitation plus early ACL reconstruction did not provide better results at five years than a strategy of initial rehabilitation with the option of having a later ACL reconstruction . Results did not differ between knees surgically reconstructed early or late and those treated with rehabilitation alone . These results should encourage clinicians and young active adult patients to consider rehabilitation as a primary treatment option after an acute ACL tear . Trial registration Current Controlled Trials IS RCT N84752559 We performed a prospect i ve , double-blind , r and omised , clinical trial to investigate the efficacy of two regimes of rehabilitation for knees with anterior cruciate ligament deficiency ( ACLD ) . Fifty ACLD patients were r and omly allocated to one of two treatment groups : a programme of muscle strengthening ( T ) or a programme design ed to enhance proprioception and improve hamstring contraction reflexes ( P ) . An indirect measure of proprioception , the reflex hamstring contraction latency ( RHCL ) , and a functional scoring system were used to record the status of the knee before and after the 12-week course of physiotherapy . Sagittal knee laxity was also measured . There was improvement in mean RHCL and in the mean functional score in both groups after treatment . The improvement in group P was significantly greater than that in group T. There was no significant change in joint laxity after treatment in either group . In both groups there was a positive correlation between improvement in RHCL and functional gain BACKGROUND The optimal management of a torn anterior cruciate ligament ( ACL ) of the knee is unknown . METHODS We conducted a r and omized , controlled trial involving 121 young , active adults with acute ACL injury in which we compared two strategies : structured rehabilitation plus early ACL reconstruction and structured rehabilitation with the option of later ACL reconstruction if needed . The primary outcome was the change from baseline to 2 years in the average score on four subscales of the Knee Injury and Osteoarthritis Outcome Score (KOOS)--pain , symptoms , function in sports and recreation , and knee-related quality of life ( KOOS(4 ) ; range of scores , 0 [ worst ] to 100 [ best ] ) . Secondary outcomes included results on all five KOOS subscales , the Medical Outcomes Study 36-Item Short-Form Health Survey , and the score on the Tegner Activity Scale . RESULTS Of 62 subjects assigned to rehabilitation plus early ACL reconstruction , 1 did not undergo surgery . Of 59 assigned to rehabilitation plus optional delayed ACL reconstruction , 23 underwent delayed ACL reconstruction ; the other 36 underwent rehabilitation alone . The absolute change in the mean KOOS(4 ) score from baseline to 2 years was 39.2 points for those assigned to rehabilitation plus early ACL reconstruction and 39.4 for those assigned to rehabilitation plus optional delayed reconstruction ( absolute between-group difference , 0.2 points ; 95 % confidence interval , -6.5 to 6.8 ; P=0.96 after adjustment for the baseline score ) . There were no significant differences between the two treatment groups with respect to secondary outcomes . Adverse events were common in both groups . The results were similar when the data were analyzed according to the treatment actually received . CONCLUSIONS In young , active adults with acute ACL tears , a strategy of rehabilitation plus early ACL reconstruction was not superior to a strategy of rehabilitation plus optional delayed ACL reconstruction . The latter strategy substantially reduced the frequency of surgical reconstructions . ( Funded by the Swedish Research Council and the Medical Faculty of Lund University and others ; Current Controlled Trials number , IS RCT N84752559 . BACKGROUND AND PURPOSE Treatment techniques involving perturbations of support surfaces may induce compensatory muscle activity that could improve knee stability and increase the likelihood of returning patients to high-level physical activity . The purpose of this study was to determine the efficacy of augmenting st and ard nonoperative anterior cruciate ligament ( ACL ) rehabilitation programs with a perturbation training program . SUBJECTS Twenty-six patients with acute ACL injury or ruptures of ACL grafts participated in the study . Subjects had to have a unilateral ACL injury , be free of concomitant multiple ligament or meniscal damage requiring surgical repair , and pass a screening examination design ed to identify patients who had the potential to return to high-level physical activity with nonoperative treatments . Subjects also had to be regular participants in level I activities ( eg , soccer , football , basketball ) or level II activities ( eg , racquet sports , skiing , construction work ) . METHODS Subjects were r and omly assigned to either a group that received a st and ard rehabilitation program ( st and ard group ) or a group that received the st and ard program augmented with a perturbation training program ( perturbation group ) . Treatment outcome was determined from scores on the Knee Outcome Survey 's Activities of Daily Living Scale ( ADLS ) and Sports Activity Scale , a global rating of knee function , scores on a series of single-limb hop tests , measurements of maximum isometric quadriceps femoris muscle force output , and the group frequency of unsuccessful rehabilitation . Unsuccessful rehabilitation was defined as the occurrence of an episode of giving way of the knee or failure to maintain the functional status of a rehabilitation c and i date on retesting . RESULTS More subjects had unsuccessful rehabilitation in the st and ard group compared with the perturbation group . There was a within-group x time interaction for the ADLS , global rating of knee function , and crossover hop test scores . These scores decreased from posttraining to the 6-month follow-up for the st and ard group . CONCLUSION AND DISCUSSION Although both the st and ard program and the perturbation training program may allow subjects to return to high-level physical activity , the perturbation training program appears to reduce the risk of continued episodes of giving way of the knee during athletic participation and allows subjects to maintain their functional status for longer periods We investigated whether preoperative perturbation training would help anterior cruciate ligament ( ACL ) deficient individuals who complain of knee instability ( " non-copers " ) regain quadriceps strength and walk normally after ACL reconstruction . Nineteen non-copers with acute ACL injury were r and omly assigned into a perturbation group ( PERT ) or a strengthening group ( STR ) . The PERT group received specialized neuromuscular training and progressive quadriceps strength training , whereas the STR group received progressive quadriceps strength training only . We compared quadriceps strength indexes and knee excursions during the mid-stance phase of gait preoperatively to data collected 6 months after ACL reconstruction . Analyses of Variance with repeated measures ( time/limb ) were conducted to compare quadriceps strength index values over time ( time x group ) and differences in knee excursions in limbs between groups over time ( limb x time x group ) . If significance was found , post hoc analyses were performed using paired and independent t-tests . Quadriceps strength indexes before intervention ( Pert : 87.2 % ; Str : 75.8 % ) improved 6 months after ACL reconstruction in both groups ( Pert : 97.1 % ; Str : 94.4 % ) . Non-copers who received perturbation training preoperatively had no differences in knee excursions between their limbs 6 months after ACL reconstruction ( p = 0.14 ) , whereas those who received just strength training continued to have smaller knee excursions during the mid-stance phase of gait ( p = 0.007 ) . Non-copers strength and knee excursions were more symmetrical 6 months postoperatively in the group that received perturbation training and progressive quadriceps strength training than the group who received strength training alone Abstract . Rehabilitation after anterior cruciate ligament ( ACL ) reconstruction has focused over the past decade on closed kinetic chain ( CKC ) exercises due to presumably less strain on the graft than with isokinetic open kinetic chain exercises ( OKC ) ; however , recent reports suggest that there are only minor differences in ACL strain values between some CKC and OKC exercises . We studied anterior knee laxity , thigh muscle torque , and return to preinjury sports level in 44 patients with unilateral ACL ; group 1 carried out quadriceps strengthening only with CKC while group 2 trained with CKC plus OKC exercises starting from week 6 after surgery . Anterior knee laxity was determined with a KT-1000 arthrometer ; isokinetic concentric and eccentric quadriceps and hamstring muscle torque were studied with a Kin-Com dynamometer before and 6 months after surgery . At an average of 31 months after surgery the patients answered a question naire regarding their current knee function and physical activity/sports to determine the extent and timing of their recovery . No significant differences in anterior knee laxity were noted between the groups 6 months postsurgery . Patients in group 2 increased their quadriceps torque significantly more than those in group 1 , but no differences were found in hamstring torque between the groups . A significantly higher number of patients in group 2 ( n=12 ) than in group 1 ( n=5 ) returned to sports at the same level as before the injury ( P<0.05 ) . Patients from group 2 who returned to sports at the same level did so 2 months earlier than those in group 1 . Thus the addition of OKC quadriceps training after ACL reconstruction results in a significantly better improvement in quadriceps torque without reducing knee joint stability at 6 months and also leads to a significantly higher number of athletes returning to their previous activity earlier and at the same level as before injury BACKGROUND AND PURPOSE Assessment of the quality of r and omized controlled trials ( RCTs ) is common practice in systematic review s. However , the reliability of data obtained with most quality assessment scales has not been established . This report describes 2 studies design ed to investigate the reliability of data obtained with the Physiotherapy Evidence Data base ( PEDro ) scale developed to rate the quality of RCTs evaluating physical therapist interventions . METHOD In the first study , 11 raters independently rated 25 RCTs r and omly selected from the PEDro data base . In the second study , 2 raters rated 120 RCTs r and omly selected from the PEDro data base , and disagreements were resolved by a third rater ; this generated a set of individual rater and consensus ratings . The process was repeated by independent raters to create a second set of individual and consensus ratings . Reliability of ratings of PEDro scale items was calculated using multirater kappas , and reliability of the total ( summed ) score was calculated using intraclass correlation coefficients ( ICC [ 1,1 ] ) . RESULTS The kappa value for each of the 11 items ranged from.36 to.80 for individual assessors and from.50 to.79 for consensus ratings generated by groups of 2 or 3 raters . The ICC for the total score was.56 ( 95 % confidence interval=.47-.65 ) for ratings by individuals , and the ICC for consensus ratings was.68 ( 95 % confidence interval=.57-.76 ) . DISCUSSION AND CONCLUSION The reliability of ratings of PEDro scale items varied from " fair " to " substantial , " and the reliability of the total PEDro score was " fair " to " good . Background There is no consensus regarding the optimal rehabilitation regimen for increasing quadriceps strength after anterior cruciate ligament ( ACL ) injury . Hypothesis A comprehensive rehabilitation program supplemented with quadriceps strengthening in open kinetic chain ( OKC ) exercise will increase quadrice
Output:
| This review found that pre-operative physiotherapy rehabilitation is effective for improving the outcomes of treatment following anterior cruciate ligament injury , including increasing knee-related function and improving muscle strength .
However , whilst there was a significant improvement in quality of life from baseline following intervention , no significant difference in quality of life was found between the control and intervention groups .
Conclusions : There is evidence to suggest that pre-operative physiotherapy rehabilitation is beneficial to patients with anterior cruciate ligament injury |
MS212743 | ***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 To evaluate whether the in vitro incubation of spermatozoa with myoinositol may improve the fertilization rate in ICSI cycles . Methods This is a prospect i ve , bicentric , r and omized study on 500 MII sibling oocytes injected in 78 ICSI cycles performed between March and October 2013 . R and omization of the oocytes into two groups was performed at the time of the denudation . Fertilization rates ( per oocyte injected with spermatozoa treated with myoinositol versus per oocyte injected with spermatozoa treated with placebo ) were measured as primary outcome and embryo morphology as secondary outcome . Clinical outcomes were also documented . Result (s)Fertilization rate ( 78.9 ± 28.6 % vs 63.2 ± 36.7 , P = 0.002 ) and percentage of grade A embryos on day 3 ( 59.8 ± 35.6 % vs 43.5 ± 41.5 , P = 0.019 ) were significantly higher when spermatozoa were treated in vitro with myoinositol versus placebo . No differences were found for the exp and ed blastocyst formation rate . Conclusion (s)In vitro treatment of spermatozoa with myoinositol may optimize ICSI outcomes by improving the fertilization rate and embryo quality on day 3 . The improvement of the number and the quality of embryos available in an ICSI cycle may have clinical utility if these findings can be confirmed OBJECTIVE To evaluate the mitochondrial membrane potential ( MMP ) of spermatozoa and its correlation with semen parameters and production of reactive oxygen species ( ROS ) in infertile men and healthy donors . DESIGN Controlled prospect i ve study . SETTING Male infertility clinic , Glickman Urological Institute , The Clevel and Clinic Foundation , Clevel and , Ohio . PATIENT(S ) Nineteen infertile men and 7 healthy volunteers . INTERVENTION(S ) St and ard semen analysis , assessment of MMP and ROS production in spermatozoa . The MMP was assessed by flow cytometry using the probe carbocyanine DiOC(6)(3 ) and ROS was measured with chemiluminescence assay using luminol . MAIN OUTCOME MEASURE(S ) The results of MMP are reported as the median interquartile range ( IQR ) number of cells counted in different areas of fluorescence . Results of ROS measurement are expressed as x10(6 ) counted photons per minute per 20 million sperm ( cpm ) . RESULT ( S ) The patients with abnormal semen parameters had a significantly lower MMP [ 1337.7 ( 1066.38 , 1879.2 ) ] , and higher ROS [ 1.12 ( 0.26 , 3.86 ) ] than the donors [ MMP : 2482.9 ( 2162.5 , 3520.6 ) ] and [ ROS : 0.10 ( 0.01 , 0.14 ) ] . The MMP was positively correlated with sperm concentration ( r = 0.62 ) and negatively correlated with the ROS produced ( r = -0.45 ) . CONCLUSION ( S ) Measuring MMP in spermatozoa provides useful information about a man 's fertility potential . Increased ROS production by spermatozoa is associated with a decreased MMP We investigated the effects of folic acid and zinc sulphate supplementation on the improvement of sperm function in subfertile oligoasthenoteratozoospermic ( OAT ) men . Eighty‐three OAT men participated in a 16‐week intervention r and omised , double‐blind clinical trial with daily treatment of folic acid ( 5 mg day−1 ) and zinc sulphate ( 220 mg day−1 ) , or placebo . Before and after treatment , semen and blood sample s were obtained for determining sperm concentration , motility , and morphology , sperm viability , sperm mitochondrial function , sperm chromatin status using toluidine blue , aniline blue , acridine orange and chromomycin A3 staining ; and semen and blood folate , zinc , B12 , total antioxidant capacity ( TAC ) and malondialdehyde ( MDA ) concentrations . Sperm concentration ( ×106 ml−1 ) increased in subfertile men receiving the combined treatment of folic acid and zinc sulphate and also in the group receiving only folic acid treatment ; however , it was not statistically significant ( P = 0.056 and P = 0.05 , respectively ) . Sperm chromatin integrity ( % ) increased significantly in subfertile men receiving only zinc sulphate treatment ( P = 0.048 ) . However , this improvement in sperm quality was not significant after adjusting placebo effect . This study showed that zinc sulphate and folic acid supplementation did not ameliorate sperm quality in infertile men with severely compromised sperm parameters , OAT . Male infertility is a multifactorial disorder , and also nutritional factors play an important role in results of administration of supplementation on sperm parameters . However , these results should be confirmed by multiple studies in larger population s of OAT men Introduction Infertility affects 50 to 80 million ( between 8 and 12 % of couples ) . Male factor is a cause of infertility in almost half of the cases , mainly due to oligoasthenoteratozoospermia . DNA fragmentation is now considered an important factor in the aetiology of male infertility . We studied the effects on semen analysis and on DNA fragmentation of in vivo admnistration of Myo-Inositol and Tribulus Terrestris plus Alga Ecklonia plus Biovis ( Tradafertil ; Tradapharma Sagl , Swizerl and ) in men with previously diagnosed male infertility . Material s and Methods Sixty patients were enrolled in the present study and were r and omized into two subgroups : the group A who received Myo-inositol 1000 mg , Tribulus Terrestris 300 mg , Alga Ecklonia Bicyclis 200 mg and Biovis one tablet a day for 90 days , and the group B ( placebo group ) who received one placebo tablet a day for 90 days . The primary efficacy outcome was the improvement of semen characteristics after 3 months ’ therapy and the secondary outcome was the reduction of the DNA fragmentation after treatment . Results The groups were homogenous for age , hormonal levels , sperm concentration and all parameters of sperm analysis . Sperm concentration and progressive motility improved after treatment with Tradafertil ( 3.82 Mil/ml vs. 1.71 Mil/ml ; p<0.05 ; 4.86 % vs. 1.00 % ; p<0.05 ) as well as the DNA fragmentation ( -1.64 % vs -0.39 % , p<0.001 ) . No side effects were revealed . Conclusions In conclusion , we can affirm that Tradafertil is safe and tolerable . It is a new phytotherapic approach to Oligoasthenoteratospermia ( OAT ) syndrome that could lead to good results without interacting with hypothalamic – pituitary – gonadal axis The aim of this study was to evaluate the possible beneficial effects of diet supplementation with a highly concentrated and purified docosahexaenoic acid ( DHA ) formula on human sperm function . We performed a prospect i ve , r and omized , double blind , placebo-controlled intervention study . One-hundred eighty human semen sample s from sixty infertile patients recruited in a private assisted reproduction center were included . All sample s were examined according to World Health Organization guidelines . We analyzed macroscopic and microscopic sperm parameters , oxidative stress , apoptosis , lipid peroxidation , mitochondrial membrane potential and DNA fragmentation before and after supplementation with different DHA daily doses ( 0.5 , 1 and 2 g ) or placebo for 1 and 3 months . No differences were found in traditional sperm parameters except for progressive sperm motility , with a significant increase after DHA ingestion after the first month with 1 or 2 g doses and after 3 months with 0.5 g of DHA . This effect was more evident in asthenozoospermic patients . No differences were found in any molecular semen parameter except oxidative stress , in which a slight benefit was observed after DHA treatment . In conclusion , this study support previous indications that highlight the importance of DHA supplementation as a means of improving sperm quality in asthenozoospermic men Male infertility is a multifactorial disorder that affects a significant percentage of couples . Its etiology and pathogenesis remain elusive in about one‐third of the cases ; this is referred to as idiopathic infertility . Inositols mediate the sperm processes involved into oocyte fertilization , such as penetration of the ovum cumulus oophorus , binding with the zona pellucida and the acrosome reaction . The aim of this double‐blind , r and omized , placebo‐controlled trial was to evaluate the efficacy and safety of myoinositol ( the most abundant form of inositols present in nature ) treatment in men with idiopathic infertility . To accomplish this , we evaluated the effects of myoinositol on sperm parameters and reproductive hormones at baseline and after 3 months of treatment in men with idiopathic infertility . No adverse reaction was observed . Myoinositol significantly increased the percentage of acrosome‐reacted spermatozoa , sperm concentration , and total count and progressive motility compared to placebo . In addition , myoinositol rebalanced serum luteinizing hormone , follicle‐stimulating hormone , and inhibin B concentrations . The clinical improvement of idiopathic infertile patients should encourage myoinositol use for the treatment of this disorder , even though its detailed mechanisms at the testicular level remain still unclear
Output:
| This is the first systematic review that has attempted to evaluate the effects of antioxidants on MMP and sperm motility .
Although results are not conclusive due to the dearth of studies , the close relationship between mitochondria and sperm motility is clear .
The investigation of this correlation could provide valuable information to be exploited in clinical practice for the treatment of male infertility |
MS212744 | ***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: Objective To determine the clinical effectiveness and cost-effectiveness of nurse-led care ( NLC ) for people with rheumatoid arthritis ( RA ) . Methods In a multicentre pragmatic r and omised controlled trial , the assessment of clinical effects followed a non-inferiority design , while patient satisfaction and cost assessment s followed a superiority design . Participants were 181 adults with RA r and omly assigned to either NLC or rheumatologist-led care ( RLC ) , both arms carrying out their normal practice . The primary outcome was the disease activity score ( DAS28 ) assessed at baseline , weeks 13 , 26 , 39 and 52 ; the non-inferiority margin being DAS28 change of 0.6 . Mean differences between the groups were estimated controlling for covariates following per- protocol ( PP ) and intention-to-treat ( ITT ) strategies . The economic evaluation ( NHS and healthcare perspectives ) estimated cost relative to change in DAS28 and quality -adjusted life-years ( QALY ) derived from EQ5D . Results Demographics and baseline characteristics of patients under NLC ( n=91 ) were comparable to those under RLC ( n=90 ) . Overall baseline-adjusted difference in DAS28 mean change ( 95 % CI ) for RLC minus NLC was −0.31 ( −0.63 to 0.02 ) for PP and -0.15 ( −0.45 to 0.14 ) for ITT analyses . Mean difference in healthcare cost ( RLC minus NLC ) was £ 710 ( −£352 , £ 1773 ) and −£128 ( −£1263 , £ 1006 ) for PP and ITT analyses , respectively . NLC was more cost-effective with respect to cost and DAS28 , but not in relation to QALY utility scores . In all secondary outcomes , significance was met for non-inferiority of NLC . NLC had higher ‘ general satisfaction ’ scores than RLC in week 26 . Conclusions The results provide robust evidence to support non-inferiority of NLC in the management of RA . Trial registration IS RCT Background Workers with rheumatoid arthritis ( RA ) often experience restrictions in functioning at work and participation in employment . Strategies to maintain work productivity exist , but these interventions do not involve the actual workplace . Therefore the aim of this study is to investigate the (cost)effectiveness of an intervention program at the workplace on work productivity for workers with RA . Methods / design This study is a r and omized controlled trial ( RCT ) in specialized rheumatology treatment centers in or near Amsterdam , the Netherl and s. R and omisation to either the control or the intervention group is performed at patient level . Both groups will receive care as usual by the rheumatologist , and patients in the intervention group will also take part in the intervention program . The intervention program consists of two components ; integrated care , including a participatory workplace intervention . Integrated care involves a clinical occupational physician , who will act as care manager , to coordinate the care . The care manager has an intermediate role between clinical and occupational care . The participatory workplace intervention will be guided by an occupational therapist , and involves problem solving by the patient and the patients ’ supervisor . The aim of the workplace intervention is to achieve consensus between patient and supervisor concerning feasible solutions for the obstacles for functioning at work . Data collection will take place at baseline and after 6 and 12 months by means of a question naire . The primary outcome measure is work productivity , measured by hours lost from work due to presenteeism . Secondary outcome measures include sick leave , quality of life , pain and fatigue . Cost-effectiveness of the intervention program will be evaluated from the societal perspective . Discussion Usual care of primary and outpatient health services is not aim ed at improving work productivity . Therefore it is desirable to develop interventions aim ed at improving functioning at work . If the intervention program will be (cost)effective , substantial improvements in work productivity might be obtained among workers with RA at lower costs . Results are expected in 2015.Trial registration Background Comprehensive rehabilitation , involving health professionals from various disciplines , is widely used as an adjunct to pharmacological and surgical treatment in people with rheumatic diseases . However , the evidence for the clinical - and cost-effectiveness of such interventions is limited , and the majority of those who receive rehabilitation are back to their initial health status six to 12 months after discharge . Methods / design To evaluate the goal attainment , health effects and cost-effectiveness of a new rehabilitation programme compared to current traditional rehabilitation programmes for people with rheumatic diseases , a stepped-wedge cluster r and omized trial will be performed . Patients admitted for rehabilitation at six centres in the south-eastern part of Norway will be invited to participate . In the trial , six participating centres will switch from a control ( current rehabilitation programme ) to an intervention phase ( the new rehabilitation programme ) in a r and omized order . Supported by recent research , the new programme will be a supplement to the existing programme at each centre , and will comprise four elements design ed to enhance and support lifestyle changes introduced in the rehabilitation period : structured goal -planning , motivational interviewing , a self-help booklet and four follow-up telephone calls during the first five months following discharge . The primary outcome will be health-related quality of life and goal attainment , as measured by the Patient Generated Index directly before and after the rehabilitation stay , as well as after six and 12 months . Secondary outcomes will include self-reported pain , fatigue , a global assessment of disease activity and motivation for change ( measured on 11-point numeric ratings scales ) , health-related quality of life as measured by the Short Form 36 Health Survey ( SF-36 ) and utility assessed by the SF6D utility index . The main analysis will be on an intention to treat basis and will assess the clinical - and cost-effectiveness of the structured goal planning and tailored follow-up rehabilitation programme for patients with rheumatic diseases . Discussion The findings will constitute an important contribution to more cost-effective- and evidence -based rehabilitation services for people with rheumatic diseases . Trial registration IS RCT N91433175 AIM To compare the long-term effectiveness of care delivered by a clinical nurse specialist ( CNS ) with inpatient team care and day patient team care in patients with rheumatoid arthritis and increasing functional limitations . Background . The role of CNSs in the management of patients with rheumatoid arthritis ( RA ) is evolving , and their effectiveness in comparison with care provided by a rheumatologist alone has been established . However , long-term controlled studies showing how the effectiveness of CNSs compares with that of other forms of co-ordinated care , such as multidisciplinary team care , are lacking . METHODS Two hundred and ten patients rheumatoid arthritis patients were r and omized to care delivered by a CNS in a rheumatology outpatient clinic ( 12 weeks ) , inpatient team care ( 2 weeks ) and day patient team care ( 3 weeks ) . Clinical assessment s recorded on study entry , weeks 12 , 26 , 52 , 78 and 104 comprised the health assessment question naire ( HAQ ) and MacMaster Toronto Arthritis ( MACTAR ) patient preference interview as primary outcome measures . Grip strength , walk test , R AND -36 , Rheumatoid Arthritis Quality of Life question naire and disease activity score ( DAS ) were applied as secondary outcome measures . RESULTS No significant differences in medical treatment , use of services of other health professionals , introduction of adaptive equipment or number of hospitalizations were observed between the three treatment groups during 2 year follow-up , except that visits to nurse specialists were more frequent and home help was less frequent in the CNS group . A comparison of clinical outcomes among the three groups and a comparison between the nurse specialist and inpatient and day patient care groups together did not show any significant differences . Within all three groups functional status , quality of life and disease activity improved significantly ( P < 0.05 ) . In general , the results obtained after 12 weeks remained stable until 104 weeks after the start of the study . CONCLUSION Care provided by a CNS in an outpatient rheumatology clinic has a similar long-term clinical outcome to inpatient and day patient team care in patients with rheumatoid arthritis . A CNS intervention appears to be an effective innovation in the care for patients with rheumatoid arthritis Objective Multidisciplinary team ( MDT ) meetings are assumed to produce better decisions and are extensively used to manage chronic disease in the National Health Service ( NHS ) . However , evidence for their effectiveness is mixed . Our objective was to investigate determinants of MDT effectiveness by examining factors influencing the implementation of MDT treatment plans . This is a proxy measure of effectiveness , because it lies on the pathway to improvements in health , and reflects team decision making which has taken account of clinical and non- clinical information . Additionally , this measure can be compared across MDTs for different conditions . Methods We undertook a prospect i ve mixed- methods study of 12 MDTs in London and North Thames . Data were collected by observation of 370 MDT meetings , interviews with 53 MDT members , and from 2654 patient medical records . We examined the influence of patient-related factors ( disease , age , sex , deprivation , whether their preferences and other clinical /health behaviours were mentioned ) and MDT features ( as measured using the ‘ Team Climate Inventory ’ and skill mix ) on the implementation of MDT treatment plans . Results The adjusted odds ( or likelihood ) of implementation was reduced by 25 % for each additional professional group represented at the MDT meeting . Implementation was more likely in MDTs with clear goals and processes and a good ‘ Team Climate ’ ( adjusted OR 1.96 ; 95 % CI 1.15 to 3.31 for a unit increase in Team Climate Inventory ( TCI ) score ) . Implementation varied by disease category , with the lowest adjusted odds of implementation in mental health teams . Implementation was also lower for patients living in more deprived areas ( adjusted odds of implementation for patients in the most compared with least deprived areas was 0.60 , 95 % CI 0.39 to 0.91 ) . Conclusions Greater multidisciplinarity is not necessarily associated with more effective decision making . Explicit goals and procedures are also crucial . Decision implementation should be routinely monitored to ensure the equitable provision of care Purpose . To examine the effect of an interdisciplinary , out-patient rehabilitation programme for patients with chronic inflammatory arthritis on aerobic capacity and health-related quality of life ( HRQOL ) . Method . One hundred and seventy-four patients , 115 with peripheral arthritis ( PA ) ( 91 women , mean age 53 years , disease duration 16 years ) and 59 with spondylarthropathies ( SpA ) , ( 27 women , mean age 46 years , disease duration 14 years ) were consecutively enrolled in 18 days of interdisciplinary rehabilitation . We report data from evaluations at inclusion , at discharge , and at 4 and 12 months using a sub-maximal treadmill test of aerobic capacity and the Nottingham Health Profile ( NHP ) ( t-test ) . Results . At inclusion , less than 20 % of all patients tested had aerobic capacity classified as ‘ average ’ or better . At discharge , 41 % ( PA ) and 54 % ( SpA ) reached the ‘ average ’ level or better with improvements maintained for 12 months . The total NHP scores improved in both groups ( mean change −12 ( 99%CI –15 , –9 ) for PA ; mean change –13 ( 99%CI –19 , –8 ) for SpA ) and were maintained . Conclusion . Aerobic capacity and HRQOL improved significantly in this interdisciplinary out-patient rehabilitation study , and improvements were maintained for 12 months . The preserved level of aerobic capacity after 12 months indicated a change to a more physically active lifestyle among the participants Background Evidence supports the use of educational and physical training programs for people with rheumatoid arthritis ( RA ) . Objective The purpose of this study was to evaluate the effects of a group-based exercise and educational program on the physical performance and disease self-management of people with RA . Design This was a r and omized controlled trial . Setting The study was conducted at a rehabilitation center in the Netherl and s. Participants Thirty-four people diagnosed with RA participated in the study . Participants were r and omly assigned to either an intervention group ( n=19 ) or a waiting list control group ( n=15 ) . Intervention The intervention in this study was an 8-week , multidisciplinary , group therapy program for people with RA , consisting of physical exercise design ed to increase aerobic capacity and muscle strength ( force-generating capacity ) together with an educational program to improve health status and self-efficacy for disease-self-management . Measurements The main outcome measures were maximum oxygen uptake ( V̇o2max ) , muscle strength of the elbow and knee flexors and extensors , health status , and perceived self-efficacy . All data were recorded before intervention in week 1 , after intervention in week 9 , and at follow-up in week 22 . Results The intervention group showed significant improvement ( 12.1 % ) in V̇o2max at week 9 compared with the control group ( −1.7 % ) . Although significant within-group changes were found over time for muscle strength of the upper and lower extremities and health status that favored the intervention group , no between-group changes were found regarding these outcomes . Limitations An important limitation was the small number of participants included in our study , which may have result ed in a lack of power . Conclusions The present group-based exercise and educational program for people with RA had a beneficial effect on aerobic capacity but not on muscle strength , health status , or self-efficacy OBJECTIVE To study health-related quality of life ( HRQoL ) in arthritis rehabilitation performed by mult
Output:
| There is limited evidence evaluating the effect of MDT care on disability , disease activity or QoL in people with RA .
There is likely to be no effect of MDT care on disability at 12 months or other time points |
MS212745 | ***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 : To examine the incidence of infections and to describe them and their outcome in intensive care unit ( ICU ) patients . Design and setting : International prospect i ve cohort study in which all patients admitted to the 28 participating units in eight countries between May 1997 and May 1998 were followed until hospital discharge . Patients : A total of 14,364 patients were admitted to the ICUs , 6011 of whom stayed less than 24 h and 8353 more than 24 h. Results : Overall 3034 infectious episodes were recorded at ICU admission ( crude incidence : 21.1 % ) . In ICU patients hospitalised longer than 24 h there were 1581 infectious episodes ( crude incidence : 18.9 % ) including 713 ( 45 % ) in patients already infected at ICU admission . These rates varied between ICUs . Respiratory , digestive , urinary tracts , and primary bloodstream infections represented about 80 % of all sites . Hospital-acquired and ICU-acquired infections were documented more frequently microbiologically than community-acquired infections ( 71 % and 86 % , respectively vs. 55 % ) . About 28 % of infections were associated with sepsis , 24 % with severe sepsis and 30 % with septic shock , and 18 % were not classified . Crude hospital mortality rates ranged from 16.9 % in non-infected patients to 53.6 % in patients with hospital-acquired infections at the time of ICU admission and acquiring infection during the ICU stay . Conclusions : The crude incidence of ICU infections remains high , although the rate varies between ICUs and patient subsets , illustrating the added burden of nosocomial infections in the use of ICU re sources OBJECTIVE The aim of the study was to evaluate the expression of tumor necrosis factor (TNF)-alpha protein in the subcutaneous and visceral adipose tIssue in correlation with adipocyte cell Volume , serum TNF-alpha , soluble TNF-receptor-2 ( sTNFR-2 ) and indirect parameters of insulin resistance in overweight/obese and lean healthy persons . DESIGN A cross-sectional case-control study was used . PATIENTS Twenty-eight overweight/obese prob and s with normal glucose tolerance ( BMI > 27 kg/m(2 ) ) and 15 lean people ( BMI < 25 kg/m(2 ) ) , all of them undergoing planned surgical operation , participated in the study . METHODS Two to four grams of subcutaneous and visceral adipose tIssue were removed and studied using semi-quantitative immunohistochemical staining of the TNF-alpha protein . Serum TNF-alpha , sTNFR-2 ( ELISA ) and fasting C-peptide ( RIA ) were measured . RESULTS TNF-alpha protein was expressed in adipocytes of both depots . The expression was evaluated visually and found to be greater in the obese patients . Significantly higher serum TNF-alpha ( 5.58+/-0.87 pg/ml vs 4.21+/-0.55 , mean+/-s.d . , P<0.01 , Mann-Whitney ) and sTNFR-2 levels ( 7.84+/-3.56 ng/ml vs 4.59+/-1.35 , P=0.005 ) were found in the obese subgroup in correlation with the fasting C-peptide level ( r=0.49 , P=0.003 ; and r=0.74 , P=0.001 ) and the C-peptide/ blood glucose ratio ( r=0.47 , Spearman , P=0.005 ; and r=0.70 , P=0.001 ) . The cell Volume of both adipocyte depots was found to have a significant positive correlation with serum TNF-alpha and sTNFR-2 levels in the total group of patients ( subcutaneous : r=0.52 , P=0.0003 ; r=0.69 , P<0.0001 ; visceral : r=0.65 , P<0.0001 ; r=0.63 , P<0.0001 ) and in both subgroups . CONCLUSIONS Adipocyte cell Volume of both the subcutaneous and visceral fat depots may be determinants of TNF-alpha , sTNFR-2 production and obesity-linked insulin resistance BACKGROUND In a single-center study published more than a decade ago involving patients presenting to the emergency department with severe sepsis and septic shock , mortality was markedly lower among those who were treated according to a 6-hour protocol of early goal -directed therapy ( EGDT ) , in which intravenous fluids , vasopressors , inotropes , and blood transfusions were adjusted to reach central hemodynamic targets , than among those receiving usual care . We conducted a trial to determine whether these findings were generalizable and whether all aspects of the protocol were necessary . METHODS In 31 emergency departments in the United States , we r and omly assigned patients with septic shock to one of three groups for 6 hours of resuscitation : protocol -based EGDT ; protocol -based st and ard therapy that did not require the placement of a central venous catheter , administration of inotropes , or blood transfusions ; or usual care . The primary end point was 60-day in-hospital mortality . We tested sequentially whether protocol -based care ( EGDT and st and ard-therapy groups combined ) was superior to usual care and whether protocol -based EGDT was superior to protocol -based st and ard therapy . Secondary outcomes included longer-term mortality and the need for organ support . RESULTS We enrolled 1341 patients , of whom 439 were r and omly assigned to protocol -based EGDT , 446 to protocol -based st and ard therapy , and 456 to usual care . Resuscitation strategies differed significantly with respect to the monitoring of central venous pressure and oxygen and the use of intravenous fluids , vasopressors , inotropes , and blood transfusions . By 60 days , there were 92 deaths in the protocol -based EGDT group ( 21.0 % ) , 81 in the protocol -based st and ard-therapy group ( 18.2 % ) , and 86 in the usual-care group ( 18.9 % ) ( relative risk with protocol -based therapy vs. usual care , 1.04 ; 95 % confidence interval [ CI ] , 0.82 to 1.31 ; P=0.83 ; relative risk with protocol -based EGDT vs. protocol -based st and ard therapy , 1.15 ; 95 % CI , 0.88 to 1.51 ; P=0.31 ) . There were no significant differences in 90-day mortality , 1-year mortality , or the need for organ support . CONCLUSIONS In a multicenter trial conducted in the tertiary care setting , protocol -based resuscitation of patients in whom septic shock was diagnosed in the emergency department did not improve outcomes . ( Funded by the National Institute of General Medical Sciences ; ProCESS Clinical Trials.gov number , NCT00510835 . ) We report the findings from a prospect i ve study determining the magnitude of errors in the visual estimation of weight and height of critically ill patients . Forty-two consecutive patients were weighed by a physician with a calibrated stretcher scale and length measured with a steel measuring tape . The predicted body weight was calculated using the ARDSnet formulae . Attending physicians and nurses were asked to estimate patient 's actual weight , predicted weight and height . The average percent errors in estimation of actual and predicted weight were 11.4 and 14.6 % , respectively . Errors greater than 20 % in patient 's actual and predicted weight were observed in 15 and 24 % of cases , respectively . The majority of height estimations ( 86 % ) had an error < 10 % . There were non-significant differences between the estimations made by intensive care unit physicians and nurses . Our study shows that estimations of patient 's weight made by intensive care unit staff are often inaccurate . In contrast , estimations of height made by intensive care unit staff are usually adequate . Estimated body weight of critically ill patients has implication s for drug and respiratory therapy and should be used with caution Purpose . Data suggest that obesity in critical illness is associated with improved outcomes . We postulate that these findings may be influenced by preillness comorbidities . We sought to determine if critically ill obese patients without significant comorbidity had improved mortality compared to obese patients with multiple comorbidities . Material s and Methods . We analyzed data from a prospect i ve observational study conducted in 3 tertiary ICUs . Severely obese ( body mass index ≥30 ) adults in the ICU for ≥24 hours were identified and classified into limited comorbid illnesses ( 0 - 1 ) or multiple comorbidities ( ≥2 ) . The primary outcome was the odds ratio ( OR ) of mortality at day 28 . Important secondary outcomes were ICU length of stay and ICU free days in the first 28 days . Results . 598 patients were enrolled ; 183 had BMI ≥30 . Of these , 38 had limited comorbidities and 145 had multiple comorbidities . In unadjusted analyses , obese patients with multiple comorbidities were 4.70 times ( 95 % CI 1.07–20.6 ) as likely to die by day 28 compared to patients with limited comorbidities ( P = 0.04 ) . After stratifying by admission diagnosis and adjusting for APACHE II score , the influence of comorbidities remained large and trended toward significance ( OR 4.28 , 95 % CI 0.92–20.02 , P = 0.06 ) . In adjusted analyses , obese patients with multiple comorbidities tended to have longer ICU duration ( 3.06 days , SE 2.28 , P = 0.18 ) and had significantly fewer ICU free days in the first 28 days ( −3.92 days , SE 1.83 , P = 0.03 ) . Conclusions . Not all critically ill obese patients are the same . Those with less comorbidity may have better outcomes than those with multiple comorbidities . This may be important when considering prognosis and discussing care with patients and families Background Recent sepsis guidelines have focused on the early identification and risk stratification of patients on presentation . Obesity is associated with alterations in multiple inflammatory regulators similar to changes seen in sepsis , suggesting a potential interaction between the presence of obesity and the severity of illness in sepsis . Methods We performed a retrospective chart review of patients admitted with a primary billing diagnosis of sepsis at a single United States university hospital from 2007 to 2010 . Seven hundred and ninety-two charts were identified meeting inclusion criteria . Obesity was defined as a body mass index ( BMI ) ≥ 30 kg/m2 . The data recorded included age , race , sex , vital signs , laboratory values , length of stay , comorbidities , weight , height , and survival to discharge . A modified APACHE II score was calculated to estimate disease severity . The primary outcome variable was inpatient mortality . Results Survivors had higher average BMI than nonsurvivors ( 27.6 vs. 26.3 kg/m2 , p = 0.03 ) in unadjusted analysis . Severity of illness and comorbid conditions including cancer were similar across BMI categories . Increased incidence of diabetes mellitus type 2 was associated with increasing BMI ( p < 0.01 ) and was associated with decreased mortality , with an odds ratio of 0.53 compared with nondiabetic patients . After adjusting for age , gender , race , severity of illness , length of stay , and comorbid conditions , the trend of decreased mortality for increased BMI was no longer statistically significant , however diabetes continued to be strongly protective ( odds ratio 0.52 , p = 0.03 ) . Conclusions This retrospective analysis suggests obesity may be protective against mortality in septic in patients . The protective effect of obesity may be dependent on diabetes , possibly through an unidentified hormonal intermediary . Further prospect i ve studies are necessary to elaborate the specific mechanism of this protective effect Objective : To better define the incidence of sepsis and the characteristics of critically ill patients in European intensive care units . Design : Cohort , multiple-center , observational study . Setting : One hundred and ninety-eight intensive care units in 24 European countries . Patients : All new adult admissions to a participating intensive care unit between May 1 and 15 , 2002 . Interventions : None . Measurements and Main Results : Demographic data , comorbid diseases , and clinical and laboratory data were collected prospect ively . Patients were followed up until death , until hospital discharge , or for 60 days . Of 3,147 adult patients , with a median age of 64 yrs , 1,177 ( 37.4 % ) had sepsis ; 777 ( 24.7 % ) of these patients had sepsis on admission . In patients with sepsis , the lung was the most common site of infection ( 68 % ) , followed by the abdomen ( 22 % ) . Cultures were positive in 60 % of the patients with sepsis . The most common organisms were Staphylococcus aureus ( 30 % , including 14 % methicillin-resistant ) , Pseudomonas species ( 14 % ) , and Escherichia coli ( 13 % ) . Pseudomonas species was the only microorganism independently associated with increased mortality rates . Patients with sepsis had more severe organ
Output:
| Site of underlying infection and illness severity may have favored overweight and obese BMI s. Conclusions This is the first meta- analysis to show that overweight or obese BMI s reduce adjusted mortality in adults admitted to the ICU with sepsis , severe sepsis , or septic shock . |
MS212746 | ***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: Endovenous laser ablation ( EVLA ) and radiofrequency ablation ( RFA ) are both associated with excellent technical , clinical and patient‐reported outcomes for the treatment of varicose veins . The aim of this study was to compare the techniques in a r and omized clinical trial Quality of life may be considerably reduced in patients who are suffering from chronic lower limb venous insufficiency , although existing generic quality of life instruments ( NHP , SF-36 or SIP ) can not completely identify their specific complaints . The Chronic Venous Insufficiency Question naire ( CIVIQ ) has been developed by iterative process . First , a pilot group of 20 patients was used to identify a number of important features of quality of life affected by venous insufficiency , other than physical symptoms of discomfort . A second study involving 2,001 subjects was used to reduce the number of items . Subjects were asked to score both the severity of their problems and the importance they attributed to each problem on a 5-point Likert scale . The importance items found in patients with venous insufficiency were subjected to factorial analyses ( PCA , PAF ) . The final version is a 20-item self-administered question naire which explores four dimensions : psychological , physical and social functioning and pain . Internal consistency of the question naire was vali date d for each dimension ( Cronbach 's alpha > 0.820 for three out of four factors ) . Reproducibility was confirmed in a 60 patient test-retest study . Pearson 's correlation coefficients for both the four dimension subscales and for the global score at 2-week intervals were greater than 0.940 . Finally , the question naire was tested in a r and omized clinical trial of 934 patients in order to assess responsiveness and the convergent validity of the instrument , together with the patient 's own quality of life . This study demonstrated that convergence was valid : Pearson 's correlation coefficients between clinical score differences and quality of life score differences were small ( from 0.199–0.564 ) but were statistically different from 0 ( p<0.001 ) . St and ardized response mean ( SRM ) and effect size ( ES ) were calculated to assess sensitivity to change . SRM and ES both demonstrated considerble responsiveness to change ( > 0.80 ) . Reliability , face , content , construct validity and responsiveness were also determined for this specific quality of life question naire relating to venous insufficiency . Results suggest that this question naire may be used with confidence to assess quality of life in clinical trials on chronic venous insufficiency OBJECTIVES This study aims to compare the efficacy and side effects of foam sclerotherapy of the saphenous veins with or without post-treatment compression using graduated elastic stockings . DESIGN This is a prospect i ve open r and omised controlled trial conducted in two centres . PATIENTS AND METHODS Sixty patients with incompetent great ( GSV ) or small saphenous veins ( SSV ) underwent ultrasound-guided foam sclerotherapy . R and omisation was conducted immediately after sclerotherapy to two parallel groups , one ( CG ) with compression stockings ( 15 - 20 mmHg worn during the day , for 3 weeks ) and the other ( WCG ) without compression . Efficacy of sclerotherapy and all of the side effects were assessed , including side effects in the treated region . On days 14 and 28 , clinical and duplex ultrasound ( DUS ) assessment s were performed by independent experts . Patients also completed quality of life ( QOL ) , symptom question naires and provided satisfaction scores . RESULTS Five men and 55 women ranging in age from 32 to 78 ( mean 57 years ) years were included : 29 in the WCG and 31 in the CG group . On day 28 , abolition of venous reflux and occlusion of the vein was obtained in 100 % of the cases in both groups . The length of the occluded vein was the same in both groups ( mean 36 cm for the GSV and 30 cm for the SSV ) as was the mean diameter of the occluded vein ( 5 mm ) . Symptoms and QOL question naires showed equivalent improvement in both groups on day 28 compared to pre-treatment assessment s. Side effects were few with no statistical difference between the two groups . Patient satisfaction scores were high in both groups for the outcome of sclerotherapy results , and good or very good for compression in 50 % of the CG cases . CONCLUSION We found no difference between compression and control groups when comparing efficacy , side effects , satisfaction scores , symptoms and QOL . Further studies are required to establish the role of compression in sclerotherapy and to evaluate other compression strategies BACKGROUND / OBJECTIVES We prospect ively measured change in quality of life ( QOL ) during the 2 years after a diagnosis of deep vein thrombosis ( DVT ) and evaluated determinants of QOL , including development of the post-thrombotic syndrome ( PTS ) . PATIENTS / METHODS Consecutive patients with acute DVT were recruited from 2001 to 2004 at eight hospitals in Canada . At study visits at baseline , and 1 , 4 , 8 , 12 and 24 months , clinical data were collected , st and ardized PTS assessment s were performed , and QOL question naires were self-completed . Generic QOL was measured using the Short-Form Health Survey-36 ( SF-36 ) question naire . Venous disease-specific QOL was measured using the Venous Insufficiency Epidemiological and Economic Study (VEINES)-QOL/Sym question naire . The change in QOL scores over a 2-year follow-up was assessed . The influence of PTS and other characteristics on QOL at 2 years was evaluated using multivariable regression analyses . RESULTS Among the 387 patients recruited , the average age was 56 years , two-thirds were out patients , and 60 % had proximal DVT . The cumulative incidence of PTS was 47 % . On average , QOL scores improved during follow-up . However , patients who developed PTS had lower scores at all visits and significantly less improvement in QOL over time ( P-values for PTS*time interaction were 0.001 , 0.012 , 0.014 and 0.006 for PCS , MCS , VEINES-QOL and VEINES-Sym ) . Multivariable regression analyses showed that PTS ( P < 0.0001 ) , age ( P = 0.0009 ) , proximal DVT ( P = 0.01 ) and inpatient status ( P = 0.04 ) independently predicted 2-year SF-36 PCS scores . PTS alone independently predicted 2-year VEINES-QOL ( P < 0.0001 ) and VEINES-Sym ( P < 0.0001 ) scores . CONCLUSIONS Development of PTS is the principal determinant of health-related QOL 2 years after DVT . Our study provides prognostic information on patient-reported outcomes after DVT and emphasizes the need for effective prevention and treatment of the PTS BACKGROUND Great saphenous vein ( GSV ) incompetence is the most common cause of superficial venous insufficiency . Radiofrequency catheter ablation ( RFA ) is superior to conventional ligation and stripping , and endovenous laser treatment ( EVL ) has emerged as an effective alternative to RFA . This r and omized study evaluated RFA and EVL for superficial venous insufficiency due to GSV incompetence and compared early and 1-year results . METHODS Between June 2006 and May 2008 , patients with symptomatic primary venous insufficiency due to GSV incompetence were r and omized to RFA or EVL . Patients with bilateral disease were r and omized for treatment of the first leg and received the alternative method on the other . Pretreatment examination included a leg assessment using the Venous Clinical Severity Score ( VCSS ) and CEAP classification . Patients completed the Chronic Venous Insufficiency Question naire 2 ( CIVIQ2 ) . RFA was performed with the ClosurePlus system ( VNUS Medical Technologies , Sunnyvale , Calif ) . EVL was performed with the EVLT system ( AngioDynamics Inc , Queensbury , NY ) . Early ( 1-week and 1-month ) postoperative results of pain , bruising , erythema , and hematoma were recorded . Duplex ultrasound ( DU ) imaging was used at 1 week and 1 year to evaluate vein status . VCSS scores and CEAP clinical class were recorded at each postoperative visit , and quality of life ( QOL ) using CIVIQ2 was assessed at 1 month and 1 year . RESULTS The study enrolled 118 patients ( 141 limbs ) : 46 ( 39 % ) were r and omized to RFA and 48 ( 40 % ) to EVL , and 24 ( 20 % ) had bilateral GSV incompetence . At 1 week , one patient in the RFA group had an open GSV and was deemed a failure . More bruising occurred in the EVL group ( P = .01 ) at 1 week , but at 1 month , there was no difference in bruising between groups . At 1 year , DU imaging showed evidence of recanalization with reflux in 11 RFA and 2 EVL patients ( P = .002 ) . The mean VCSS score change from baseline to 1 week postprocedure was higher for RFA than EVL ( P = .002 ) , but there was no difference between groups at 1 month ( P = .07 ) and 1 year ( P = .9 ) . Overall QOL mean score improved over time for all patients ( P < .001 ) . CEAP clinical class scores of > or=3 were recorded in 21 RFA ( 44 % ) and 24 EVL patients ( 44 % ) pretreatment , but at 1-year , 9 RFA ( 19 % ) and 12 EVL patients ( 24 % ) had scores of > or=3 ( P < .001 ) . This represented a significant improvement in all patients compared with baseline . CONCLUSION Both methods of endovenous ablation effectively reduce symptoms of superficial venous insufficiency . EVL is associated with greater bruising and discomfort in the perioperative period but may provide a more secure closure over the long-term than RFA Objectives To investigate whether additional catheter-directed thrombolysis ( CDT ) improves long-term quality of life ( QOL ) compared with st and ard treatment with anticoagulation and compression stockings alone in patients with proximal deep vein thrombosis ( DVT ) . Design Open-label r and omised controlled trial . Setting 19 Hospitals in the Norwegian southeastern health region . Participants Patients ( 18–75 years ) with a high proximal DVT , symptoms < 21 days and no increased risk of bleeding were eligible . 189 of 209 recruited patients completed 24 months of follow-up . Interventions Participants were r and omised to additional CDT with alteplase for 1–4 days or to st and ard treatment only with 6 months of anticoagulation and 24 months of compression stockings . Primary and secondary outcome measures Planned secondary outcome measures included QOL as assessed with the generic instrument EQ-5D and the disease-specific instrument VEINES-QOL/Sym . Primary outcome measure was post-thrombotic syndrome ( PTS ) after 24 months . Results After 24 months there were no differences in QOL between the additional CDT and st and ard treatment arms ; mean difference for the EQ-5D index was 0.04 ( 95 % CI −0.10 to 0.17 ) , for the VEINES-QOL score 0.2 ( 95 % CI −2.8 to 3.0 ) and for the VEINES-Sym score 0.5 ( 95 % CI −2.4 to 3.4 ; p values>0.37 ) . Independent of treatment arms , patients with PTS had poorer outcomes than patient without PTS ; mean difference for EQ-5D was 0.09 ( 95 % CI 0.03 to 0.15 ) , for VEINES-QOL score 8.6 ( 95 % CI 5.9 to 11.2 ) and for VEINES-Sym score 9.8 ( 95 % CI 7.3 to 12.3 ; p values<0.001 ) . Conclusions QOL did not differ between patients treated with additional CDT compared with st and ard treatment alone . Patients who developed PTS reported poorer QOL and more symptoms than patients without PTS . QOL should be included as an outcome measure in clinical studies on patients at risk of PTS . Trial registration AIM The early results of a r and omised clinical trial comparing local anaesthesia endovenous laser ablation ( EVLA ) with concurrent phlebectomies versus ultrasound-guided foam sclerotherapy ( UGFS ) into the great saphenous vein ( GSV ) revealed that laser was more expensive but the results on abolition of reflux were similar . The interim results at 15 month follow-up are reported . METHODS Evaluations included ultrasound , the venous clinical severity score ( VCSS ) , the Aberdeen varicose vein question naire ( AVVQ ) and the saphenous treatment score ( STS ) . The global absence of reflux defined technical success . Adjuvant sclerotherapy to areas of reflux was administered on patient choice . RESULTS Occlusion of the GSV was more effective with EVLA at 42/44 ( 95.5 % ) versus 31/46 ( 67.4 % ) for UGFS . However both techniques were equally effective at abolishing global venous reflux . The number of legs ( N.=100 ) with total reflux
Output:
| Among them , the ChronIc Venous Insufficiency Question naire ( CIVIQ ) , Aberdeen Varicose Vein Question naire ( AVVQ ) , and VEnous INsufficiency Epidemiological and Economic Study on Quality of Life ( VEINES-QOL ) scales were the most highly used according to the literature , and CIVIQ and VEINES-QOL were the most extensively vali date d scales and had the longest iterative validation process .
This systematic review confirmed that CVDs have an important effect on QOL .
Two scales , CIVIQ and VEINES-QOL , emerged as being thoroughly vali date d instruments , although factorial stability was not demonstrated for the VEINES-QOL . |
MS212747 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
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Input: This study evaluated the efficacy of two brief personalized feedback interventions ( PFIs ) using identical feedback and motivational interviewing strategies aim ed at reducing alcohol consumption and alcohol-related problems to two control conditions among a sample of high-risk drinking college students . Students ( N = 152 ) were r and omly assigned to a computer-delivered PFI with a video interviewer , a face-to-face PFI with a live interviewer , a comprehensive assessment condition , or a minimal assessment -only condition . At 10 weeks posttreatment , the face-to-face PFI significantly reduced weekly drinking quantity and peak and typical blood alcohol concentration compared with the comprehensive assessment and minimal assessment -only conditions ( d values ranged from 0.32 to 0.61 ) . No significant between-group differences were evidence d for the computer-delivered PFI condition , although effect sizes were comparable to other college drinking studies using computer-delivered interventions ( d values ranged from 0.20 to 0.27 ) . Results provide further support for the use of a face-to-face PFI to help reduce college students ' alcohol consumption and suggest that a video interviewer in the context of a computer-delivered PFI is likely a helpful but not necessarily a complete substitute for a live interviewer In this study , the authors evaluated the efficacy of a brief motivational intervention ( BMI ) and a computerized program for reducing drinking and related problems among college students sanctioned for alcohol violations . Referred students ( N = 198 , 46 % women ) , stratified by gender , were r and omly assigned to a BMI or to the Alcohol 101 Plus computer program . Data obtained at baseline , 1 , 6 , and 12 months were used to evaluate intervention efficacy . Planned analyses revealed 3 primary findings . First , women who received the BMI reduced drinking more than did women who received the computer intervention ; in contrast , men 's drinking reductions did not differ by condition . Second , readiness to change and hazardous drinking status predicted drinking reductions at 1 month postintervention , regardless of intervention . Third , by 1 year , drinking returned to presanction ( baseline ) levels , with no differences in recidivism between groups . Exploratory analyses revealed an overall mean reduction in drinking immediately after the sanction event and before taking part in an intervention . Furthermore , after the self-initiated reductions prompted by the sanction were accounted for , participation in the BMI but not the computer intervention was found to produce additional reduction in drinking and related consequences This study tested 3 forms of alcohol risk reduction programming for young adults . Volunteers were r and omly assigned to receive a 6-week class and discussion group , a 6-unit self-help manual , or a single 1-hr feedback and advice session with professional staff . Results reveal significant reductions in self-reported drinking at the end of the intervention phase and maintenance of drinking changes throughout a 2-year follow-up period . Comparable drinking reductions were rated across treatments ; however , noncompliance with the self-help reading program suggested limited utility . Treatment response was related to subject age , as subjects showed increased drinking during the year they reached legal drinking status . The efficacy of brief motivational interventions and client matching in prevention programs is discussed OBJECTIVE This study tested the effectiveness of brief primary care provider interventions delivered in a college student health center to a sample of college students who screened positive for high-risk drinking . METHOD Between November 2005 and August 2006 , 8,753 students who presented as new patients to the health service at a large public university were screened for high-risk drinking , and 2,484 students ( 28 % ) screened positive on the 5/4 gender-specific high-risk drinking question ( i.e. , five or more drinks per occasion for men and four or more for women ) . Students who screened positive for high-risk drinking and consented to participate ( N= 363 ; 52 % female ) were r and omly assigned either to a control group ( n = 182 ) or to an experimental group ( n = 181 ) . Participants in the experimental group received two brief intervention sessions that were founded in motivational interviewing techniques and delivered by four specially trained providers within the student health center . Data on alcohol use and related harms were obtained from a Web-based Healthy Lifestyle Question naire , 30-day Timeline Followback alcohol-use diaries , the Rutgers Alcohol Problem Index ( RAPI ) , and eight items from the Drinker Inventory of Consequences-2L . RESULTS Repeated measures analysis showed that , compared with the control group ( C ) , the intervention group ( I ) had significant reductions in typical estimated blood alcohol concentration ( BAC ) ( C = .071 vs I = .057 at 3 months ; C = .073 vs I = .057 at 6 months ) , peak BAC ( C = . 142 vs I = .112 at 3 months ; C = .145 vs I = .108 at 6 months ) , peak number of drinks per sitting ( C = 8.03 vs I = 6.87 at 3 months ; C = 7.98 vs I = 6.52 at 6 months ) , average number of drinks per week ( C = 9.47 vs I = 7.33 at 3 months ; C = 8.90 vs I = 6.16 at 6 months ) , number of drunk episodes in a typical week ( C = 1.24 vs I = 0.85 at 3 months ; C = 1.10 vs I = 0.71 at 6 months ) , number of times taken foolish risks ( C = 2.24 vs I = 1.12 at 3 months ) , and RAPI sum scores ( C = 6.55 vs I = 4.96 at 6 months ; C = 6.17 vs I = 4.58 at 9 months ) . CONCLUSIONS Brief interventions delivered by primary care providers in a student health center to high-risk-drinking students may result in significantly decreased alcohol consumption , high-risk drinking , and alcohol-related harms The authors evaluated the efficacy of Brief Alcohol Screening and Intervention for College Students ( BASICS - L. A. Dimeff , J. S. Baer , D. R. Kivlahan , & G. A. Marlatt , 1999 ) , a single session of drinking-related feedback intended to reduce heavy drinking and related harm . College student drinkers ( N = 99 ) were assigned to BASICS , an educational intervention , or an assessment -only control group . At 3 months postintervention . there were no overall significant group differences , but heavier drinking BASICS participants showed greater reductions in weekly alcohol consumption and binge drinking than did heavier drinking control and education participants . At 9 months , heavier drinking BASICS participants again showed the largest effect sizes . BASICS participants evaluated the intervention more favorably than did education participants . This study suggests that BASICS may be more efficacious than educational interventions for heavier drinking college students Background Matriculation from high school to college is typified by an increase in alcohol use and related harm for many students . Therefore , this transition period is an ideal time for preventive interventions to target alcohol use and related problems . Purpose The purpose of this report is to describe the design and methods used in the Transitions Project , a r and omized controlled trial of two interventions design ed to prevent and reduce heavy episodic drinking and alcohol-related negative consequences among incoming college students . Methods This study used a 2 × 2 factorial design to investigate the effects of a two-session brief motivational intervention delivered to students and a h and book-based parent intervention . Interventions were administered to students and parents . Follow-up assessment took place at 10- and 22-months post-baseline . Results The Transitions Project successfully recruited and retained participants across a major transition period ( i.e. , entering college ) , administered and compared two distinct but complementary interventions , and collected and analyzed highly skewed data . The application of a factorial design and two-part latent growth curve modeling allowed us to examine main and interactive intervention effects in terms of both initiation and growth in heavy drinking and alcohol-related problems . Limitations While we conducted successful tests of our primary and secondary study hypotheses over a lengthy follow-up period , our study design did not permit full interpretation of null findings . We suggest that research ers carefully consider assessment timing , tests of assessment reactivity , and ensure objective tests of intervention efficacy when conducting clinical trials of motivational interventions . Conclusions The lessons we learned while conducting this trial have the potential to assist other research ers design ing and conducting future preventive interventions targeting parents and college students . The data analytic procedures presented can also help guide trials that plan to analyze zero-inflated non-normal outcome data This r and omized controlled trial evaluated the efficacy of a brief intervention design ed to reduce the harmful consequences of heavy drinking among high-risk college students . Students screened for risk while in their senior year of high school ( 188 women and 160 men ) were r and omly assigned to receive an individualized motivational brief intervention in their freshman year of college or to a no-treatment control condition . A normative group selected from the entire screening pool provided a natural history comparison . Follow-up assessment s over a 2-year period showed significant reductions in both drinking rates and harmful consequences , favoring students receiving the intervention . Although high-risk students continued to experience more alcohol problems than the natural history comparison group over the 2-year period , most showed a decline in problems over time , suggesting a developmental maturational effect This study consisted of a r and omized controlled trial of a 1-session motivational intervention for college student binge drinkers . Sixty students who reported binge drinking 2 or more times in the past 30 days were r and omly assigned to either a no-treatment control or a brief intervention group . The intervention provided students with feedback regarding personal consumption , perceived drinking norms , alcohol-related problems , situations associated with heavy drinking , and alcohol expectancies . At 6-week follow-up , the brief intervention group exhibited significant reductions on number of drinks consumed per week , number of times drinking alcohol in the past month , and frequency of binge drinking in the past month . Estimates of typical student drinking mediated these reductions . This study replicates earlier research on the efficacy of brief interventions with college students and extends previous work regarding potential mechanisms of change OBJECTIVE This study evaluated the relative efficacy of personalized drinking feedback ( PDF ) delivered with and without a motivational interview ( MI ) for college student drinkers . METHOD Heavy-drinking college students ( N = 54 ; 691 % female ) were identified from a large screening sample and r and omly assigned either to receive PDF during a single MI session or to receive PDF without an MI . Of these participants , 51 ( 94 % ) completed a 6-month follow-up assessment that included measures of alcohol consumption and alcohol-related problems . RESULTS At 6-months postintervention , participants in both groups showed significant , small to moderate reductions in alcohol consumption , but the groups did not differ . Women showed larger reductions than men . Rates of alcohol-related problems remained relatively unchanged . CONCLUSIONS The hypothesis that an MI would enhance the efficacy of PDF was not supported This study is the first reported test of the unique and combined effects of Brief Motivational Intervention ( BMI ) and Alcohol Expectancy Challenge ( AEC ) with heavy drinking college students . Three hundred and thirty-five participants were r and omly assigned in a 2x2 factorial design to either : BMI , AEC , BMI and AEC , and assessment only conditions . Follow-ups occurred at 1 , 3 , and 6 months . Unconditional latent curve analyses suggested that alcohol use ( Q-F ) , heavy episodic drinking , and alcohol problems were best modeled as quadratic effects . BMI produced significant decreases in Q-F , heavy drinking , and problems , while AEC produced significant decreases in Q-F and heavy drinking . There was no evidence of an additive effect of combining the interventions . Intervention effects decayed somewhat for BMI and completely for AEC over 6 months . Multi-group analyses suggested similar intervention effects for men and women . BMI effects on alcohol problems were mediated by perceived norms . These findings extend previous research with BMI and AEC but do not support their utility as a combined preventive intervention to reduce collegiate alcohol abuse The Lifestyle Management Class ( LMC ) was evaluated as a universal and targeted alcohol prevention program among voluntary and m and ated college students . The relative efficacy of peer- and professional-led group interventions was also tested in this r and omized , controlled design . LMC participants showed decreases in driving after drinking relative to control participants . Changes in heavy drinking varied as a function of treatment condition , readiness to change , and gender , with a trend toward larger decreases among voluntary LMC participants high in readiness to change and a comparable though nonsignificant advantage for male LMC participants in the m and ated sample . The LMC was comparably effective for m and ated and voluntary students , with no clear advantage for peer- or professional-led groups OBJECTIVE The current study tested the efficacy of a brief intervention design ed to reduce drinking and drinking-related consequences among first-year fraternity members . METHOD Twelve fraternities were r and omly assigned to receive either a motivational enhancement intervention with individual and housewide feedback components ( n = 6 houses ) or a treatment-as-usual control condition ( n = 6 houses ) . Individual feedback was delivered either by peer interviewers or professional research staff . Participants were assessed during their pledge ( first ) year of house membership and during a follow-up period 1 year later . RESULTS Of the participants who completed follow-up ( N = 120 ) , fraternity members who received the brief intervention reported significant reductions in alcohol use ( total average consumption ) and typical peak blood alcohol concentrations when compared with fraternity members in the control condition . No differences in drinking-related consequences were observed . Fraternity members who received their individualized feedback from peer interviewers and professional members of the research staff reported similar outcomes . CONCLUSIONS Results provide support for the efficacy of a brief
Output:
| Conclusions Overall , BASICS lowered both alcohol consumption and negative consequences in college students .
Gender and peer factors seem to play an important role as moderators of behavior change in college drinking .
Characteristics of BASICS procedure have been evaluated as more favorable and acceptable by students in comparison with others interventions or control conditions . |
MS212748 | ***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 : The aim of this prospect i ve registry-based population study was to investigate the efficacy of extralevator abdominoperineal excision ( ELAPE ) regarding local recurrence rates within 3 years after surgery . Background : Local recurrence of rectal cancer is more common after abdominoperineal excision ( APE ) than after anterior resection . Extralevator abdominoperineal excision was introduced to address this problem . No large-scale studies with long-term oncological outcomes have been published . Methods : All Swedish patients operated on with an APE and registered in the Swedish ColoRectal Cancer Registry 2007 to 2009 were included ( n = 1397 ) and analyzed with emphasis on the perineal part of the operation . Local recurrence at 3 years was collected from the registry . Results : The local recurrence rates at 3 years [ median follow-up , 3.43 years ( APE , 3.37 years ; ELAPE , 3.41 years ; not stated : 3.43 years ) ] were significantly higher for ELAPE compared with APE ( relative risk , 4.91 ) . Perioperative perforation was also associated with an increased risk of local recurrence ( relative risk , 3.62 ) . There was no difference in 3-year overall survival between APE and ELAPE . In the subgroup of patients with very low tumors ( ⩽4 cm from the anal verge ) , no significant difference in the local recurrence rate could be observed . Conclusions : Extralevator abdominoperineal excision results in a significantly increased 3-year local recurrence rate as compared with st and ard APE . Intraoperative perforation seems to be an important risk factor for local recurrence . In addition to significantly increased 3-year local recurrence rates , the significantly increased incidence of wound complications leads to the conclusion that ELAPE should only be considered in selected patients at risk of intraoperative perforation PURPOSE Despite the major improvements that have been made due to total mesorectal excision ( TME ) , low rectal cancer still remains a challenge . METHODS By investigating a prospect i ve r and omized rectal cancer trial in which surgeons had undergone training in TME the factors responsible for the poor outcome were determined and a new method for assessing the quality of surgery was tested . RESULTS Survival differed greatly between abdominoperineal resection ( APR ) and anterior resection ( AR ; 38.5 % v 57.6 % , P = .008 ) . Low rectal carcinomas have a higher frequency of circumferential margin involvement ( 26.5 % v 12.6 % , P < .001 ) . More positive margins were present in the patients operated with APR ( 30.4 % ) compared to AR ( 10.7 % , P = .002 ) . Furthermore , more perforations were present in these specimens ( 13.7 % v 2.5 % , P < .001 ) . The plane of resection lies within the sphincteric muscle , the submucosa or lumen in more than 1/3 of the APR cases , and in the remainder lay on the sphincteric muscles . CONCLUSION We systematic ally described and investigated the pathologic properties of low rectal cancer in general , and APR in particular , in a prospect i ve r and omized trial including surgeons who had been trained in TME . The poor prognosis of the patients with an APR is ascribed to the resection plane of the operation leading to a high frequency of margin involvement by tumor and perforation with this current surgical technique . The clinical results of this operation could be greatly improved by adopting different surgical techniques and possibly greater use of radiochemotherapy Summary Background Local recurrence rates in operable rectal cancer are improved by radiotherapy ( with or without chemotherapy ) and surgical techniques such as total mesorectal excision . However , the contributions of surgery and radiotherapy to outcomes are unclear . We assessed the effect of the involvement of the circumferential resection margin and the plane of surgery achieved . Methods In this prospect i ve study , the plane of surgery achieved and the involvement of the circumferential resection margin were assessed by local pathologists , using a st and ard pathological protocol in 1156 patients with operable rectal cancer from the CR07 and NCIC-CTG CO16 trial , which compared short-course ( 5 days ) preoperative radiotherapy and selective postoperative chemoradiotherapy , between March , 1998 , and August , 2005 . All analyses were by intention to treat . This trial is registered , number IS RCT N 28785842 . Findings 128 patients ( 11 % ) had involvement of the circumferential resection margin , and the plane of surgery achieved was classified as good ( mesorectal ) in 604 ( 52 % ) , intermediate ( intramesorectal ) in 398 ( 34 % ) , and poor ( muscularis propria plane ) in 154 ( 13 % ) . We found that both a negative circumferential resection margin and a superior plane of surgery achieved were associated with low local recurrence rates . Hazard ratio ( HR ) was 0·32 ( 95 % CI 0·16–0·63 , p=0·0011 ) with 3-year local recurrence rates of 6 % ( 5–8 % ) and 17 % ( 10–26 % ) for patients who were negative and positive for circumferential resection margin , respectively . For plane of surgery achieved , HRs for mesorectal and intramesorectal groups compared with the muscularis propria group were 0·32 ( 0·16–0·64 ) and 0·48 ( 0·25–0·93 ) , respectively . At 3 years , the estimated local recurrence rates were 4 % ( 3–6 % ) for mesorectal , 7 % ( 5–11 % ) for intramesorectal , and 13 % ( 8–21 % ) for muscularis propria groups . The benefit of short-course preoperative radiotherapy did not differ in the three plane of surgery groups ( p=0·30 for trend ) . Patients in the short-course preoperative radiotherapy group who had a resection in the mesorectal plane had a 3-year local recurrence rate of only 1 % . Interpretation In rectal cancer , the plane of surgery achieved is an important prognostic factor for local recurrence . Short-course preoperative radiotherapy reduced the rate of local recurrence for all three plane of surgery groups , almost abolishing local recurrence in short-course preoperative radiotherapy patients who had a resection in the mesorectal plane . The plane of surgery achieved should therefore be assessed and reported routinely . Funding Medical Research Council ( UK ) and the National Cancer Institute of Canada Purpose Local recurrences are more common after abdominoperineal excision ( APE ) than after anterior resection of rectal cancer . Extralevator APE was introduced to address this problem . This prospect i ve registry-based population study aims to investigate the efficacy of extralevator APE ( ELAPE ) in improving short-term oncological outcome . Methods All Swedish patients operated with any kind of abdominoperineal excision and registered in the Swedish Rectal Cancer Registry 2007–2009 were included ( n = 1,397 ) and analyzed with emphasis on the perineal part of the operation . Short-term perioperative and oncological results were collected from the registry . Results Extralevator APE did not result in fewer intraoperative perforations or involved circumferential resection margins as compared to st and ard APE for the entire group . Intraoperative perforations were significantly fewer for patients with low tumours ( ≤4 cm ) ( ELAPE : n = 28/386 versus APE : n = 9/58 ) ( p = 0.043 ) and for early ( T0–T2 ) T-stages ( ELAPE : n = 3/172 versus APE : n = 6/75 ) ( p = 0.025 ) . There were significantly more post-operative wound infections for ELAPE than for APE ( n = 106 ( 20.4 % ) versus n = 25 ( 12.0 % ) , p = 0.011 ) . Conclusions The short-term results indicate that selective use of extralevator APE can be warranted , for example , for subgroups with low tumours . In conclusion , selective use of the extralevator APE is advocated as not all patients seem to benefit from the technique , and there are significantly more short-term complications after extralevator APE Background The extralevator abdominoperineal excision ( ELAPE ) has been proposed as oncologically superior to st and ard abdominoperineal excision ( SAPE ) . However , little is known regarding comparative margins achieved in ELAPE and SAPE . The purpose of this study was to compare patterns of tissue removal between these two groups that can aid patient selection . Methods Twenty APE specimens , comprising 10 SAPEs and 10 ELAPEs , were selected r and omly from a single UK centre . Transverse slices of pathological specimens were matched to corresponding axial MRI images obtained from conventional pelvic MRI imaging . Measurements from the muscularis propria to the resection margin [ muscularis to margin ( MTM ) distance ] were recorded by height ( from anal verge ) and quadrant for each surgical group . MTM distances achieved on histopathological assessment were also compared to MRI assessed distances necessary to achieve a clear CRM . Results ELAPE specimens had a greater mean MTM distance than for SAPE ( 7.75 vs. 5.61 mm , p = 0.02 ) . ELAPE had significantly greater MTM distances in lateral and posterior quadrants ( p < 0.05 ) than SAPE at 30–49 mm . There was no significant difference in mean anterior distances ( 1.57 vs. 1.16 mm , p = 0.507 ) with the smallest difference at a height of 60–69 mm . Two ( 2 % ) of pathological MTM distances within ELAPE group failed to achieve the minimum MRI assessed distance compared with 30 ( 23 % ) in the SAPE group , which had higher CRM positivity . Conclusions ELAPE appears to confer oncological benefit over SAPE but with notable exceptions , including tumours located above and below the puborectalis sling and anteriorly at the level of prostate where exenteration may be more appropriate OBJECTIVE To evaluate the oncological results and possible benefits associated with extralevatory abdominoperineal excision ( ELAPE ) when compared with conventional abdominoperineal excision ( APE ) . BACKGROUND ELAPE was introduced in 2007 with the purpose of reducing the rate of positive resection margins after resection of low rectal cancers . Preliminary studies have shown promising results . No large-scale or nationwide data have been presented . METHODS Data base study based on data from the Danish Colorectal Cancer Group 's prospect i ve data base . Data on all ELAPEs and APEs performed in Denmark in the period January 1 , 2009 , through August 2012 were retrieved and evaluated for differences in demography , tumor characteristics , and oncological results . Uni- and multivariate logistic regression analyses were performed to identify risk factors for resection with a positive circumferential resection margin ( CRM+ ) . RESULTS A total of 554 patients were included , 301(54 % ) were operated by ELAPE ; 253(46 % ) by APE . Sixty-three percent were men , median ( interquartile range ) age was 69 ( 61 - 76 years ) years , and tumors removed had predominantly T-stages T2 and T3 ( 32 % and 45 % , respectively ) . Overall , CRM+ was found in 13 % of patients . When divided according to type of procedure , we found no significant differences in demography and tumor T- and N-stages . Resections with a CRM+ were more common after ELAPE ( 16 % vs 7 % ; P = 0.006 ) . After uni- and multivariate logistic regression analyses , surgery by ELAPE remained a risk factor for a CRM+ [ odds ratio , 2.59 ( 95 % confidence interval , 1.31 - 5.12 ) ; P = 0.006 ) . CONCLUSIONS In this nationwide study , resection of low rectal cancers by ELAPE did not improve short-term oncological results , when compared with conventional APE BACKGROUND : There is debate whether performing the perineal part of the abdominoperineal resection in a prone position in comparison with a lithotomy position optimizes circumferential resection margins and , subsequently , cancer outcomes . OBJECTIVE : The aim of this study was to compare outcomes of patients undergoing abdominoperineal in a prone vs a lithotomy position . DESIGN : A single-center , prospect ively maintained colorectal cancer data base was queried for patients with stages I to III rectal cancer undergoing abdominoperineal resection in a prone vs a lithotomy position from 1997 to 2007 . Patients were compared with respect to demographics , tumor and treatment characteristics , perioperative morbidity , and oncologic outcomes . Oncologic outcomes were adjusted for age , ASA class , tumor stage , and use of adjuvant treatments . & khgr;2 , Fisher exact probability test , Wilcoxon rank-sum test , Kaplan-Meier estimates , log-rank sum test , and Cox regression models were used for the analysis . P < .05 was considered significant . RESULTS : The query returned 168 patients ( 81 prone and 87 lithotomy ) , with a median age of 63 ( interquartile range , 52–74 ) years and a median follow-up of 42 ( interquartile range , 23–69 ) months . Prone and lithotomy patients were not statistically different regarding demographics , tumor stage , rates of R0 resection
Output:
| The ELAPE was associated with a significantly lower intraoperative perforation rate .
There were no differences regarding the circumferential margin involvement , R0 resections , and local recurrence rate .
There was less blood loss in ELAPE patients .
The ELAPE significantly lowered the intraoperative perforation rate , with no benefits regarding circumferential resection margin involvement and local recurrence rate |
MS212749 | ***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 Therapeutic decisions in atrial fibrillation ( AF ) are often influenced by assessment of bleeding risk . However , existing bleeding risk scores have limitations . Objectives We sought to develop and vali date a novel bleeding risk score using routinely available clinical information to predict major bleeding in a large , community-based AF population . Methods We analysed data from Outcomes Registry for Better Informed Treatment of Atrial Fibrillation ( ORBIT-AF ) , a prospect i ve registry that enrolled incident and prevalent AF patients at 176 US sites . Using Cox proportional hazards regression , we identified factors independently associated with major bleeding among patients taking oral anticoagulation ( OAC ) over a median follow-up of 2 years ( interquartile range = 1.6–2.5 ) . We also created a numerical bedside risk score that included the five most predictive risk factors weighted according to their strength of association with major bleeding . The predictive performance of the full model , the simple five-item score , and two existing risk scores ( hypertension , abnormal renal/liver function , stroke , bleeding history or predisposition , labile INR , elderly , drugs/alcohol concomitantly , HAS-BLED , and anticoagulation and risk factors in atrial fibrillation , ATRIA ) were then assessed in both the ORBIT-AF cohort and a separate clinical trial population , Rivaroxaban Once-daily oral direct factor Xa inhibition compared with vitamin K antagonism for prevention of stroke and embolism trial in atrial fibrillation ( ROCKET-AF ) . Results Among 7411 ORBIT-AF patients taking OAC , the rate of major bleeding was 4.0/100 person-years . The full continuous model ( 12 variables ) and five-factor ORBIT risk score ( older age [ 75 + years ] , reduced haemoglobin/haematocrit/history of anaemia , bleeding history , insufficient kidney function , and treatment with antiplatelet ) both had good ability to identify those who bled vs. not ( C-index 0.69 and 0.67 , respectively ) . These scores both had similar discrimination , but markedly better calibration when compared with the HAS-BLED and ATRIA scores in an external validation population from the ROCKET-AF trial . Conclusions The five-element ORBIT bleeding risk score had better ability to predict major bleeding in AF patients when compared with HAS-BLED and ATRIA risk scores . The ORBIT risk score can provide a simple , easily remembered tool to support clinical decision making OBJECTIVES The objective of this study was to compare the predictive performance of bleeding risk-estimation tools in a cohort of patients with atrial fibrillation ( AF ) undergoing anticoagulation . BACKGROUND Three bleeding risk-prediction schemes have been derived for and vali date d in patients with AF : HEMORR(2)HAGES ( Hepatic or Renal Disease , Ethanol Abuse , Malignancy , Older Age , Reduced Platelet Count or Function , Re-Bleeding , Hypertension , Anemia , Genetic Factors , Excessive Fall Risk and Stroke ) , ATRIA ( Anticoagulation and Risk Factors in Atrial Fibrillation ) , and HAS-BLED ( Hypertension , Abnormal Renal/Liver Function , Stroke , Bleeding History or Predisposition , Labile International Normalized Ratio , Elderly , Drugs/Alcohol ) . Τhe relative predictive values of these bleeding scores have not previously been compared . METHODS We analyzed the data set from the AMADEUS ( Evaluating the Use of SR34006 Compared to Warfarin or Acenocoumarol in Patients With Atrial Fibrillation ) trial , a multicenter , r and omized , open-label noninferiority study that compared fixed-dose idraparinux with adjustable-dose oral vitamin K antagonist therapy in patients with AF . The principal safety outcome was any clinical ly relevant bleeding event , which was a composite of major bleeding plus clinical ly relevant nonmajor bleeding . RESULTS The HAS-BLED score performed best in predicting any clinical ly relevant bleeding , reflected both in net reclassification improvement ( 10.3 % and 13 % improvement compared with HEMORR(2)HAGES and ATRIA , respectively ) and receiver-operating characteristic ( ROC ) analyses ( c-indexes : 0.60 vs. 0.55 and 0.50 for HAS-BLED vs. HEMORR(2)AGES and ATRIA , respectively ) . Using decision-curve analysis , the HAS-BLED score demonstrated superior performance compared with ATRIA and HEMORR(2)HAGES at any threshold probability for clinical ly relevant bleeding . HAS-BLED was the only score that demonstrated a significant predictive performance for intracranial hemorrhage ( c-index : 0.75 ; p = 0.03 ) . An ATRIA score > 3 was not significantly associated with the risk for any clinical ly relevant bleeding on Cox regression or on ROC analysis ( c-index : 0.50 ; p = 0.87 ) . CONCLUSIONS All 3 tested bleeding risk-prediction scores demonstrated only modest performance in predicting any clinical ly relevant bleeding , although the HAS-BLED score performed better than the HEMORR(2)HAGES and ATRIA scores , as reflected by ROC analysis , reclassification analysis , and decision-curve analysis . Only HAS-BLED demonstrated a significant predictive performance for intracranial hemorrhage . Given its simplicity , the HAS-BLED score may be an attractive method for the estimation of oral anticoagulant-related bleeding risk for use in clinical practice , supporting recommendations in international guidelines Context Guidelines for prescribing anticoagulants in atrial fibrillation do not use contemporary stroke rates or account for intracranial bleeding risk . Contribution The authors studied 6-year rates of ischemic stroke and intracranial hemorrhage in 13559 adults with nonvalvular atrial fibrillation . They calculated ischemic stroke rates in patients receiving and not receiving warfarin ( treatment benefit ) and intracranial hemorrhage rates ( treatment harm ) . Benefit minus harm ( net treatment benefit ) was highest in patients with previous stroke , age older than 84 years , and others with high stroke risk . Caution Patients received warfarin according to clinical judgment , not r and omly . Implication Age and other stroke risk factors should drive the decision to use warfarin in atrial fibrillation . The Editors Warfarin anticoagulation is very efficacious in preventing thromboembolism ( primarily ischemic stroke but also systemic thromboembolism ) in patients with atrial fibrillation and is highly effective in practice ( 1 , 2 ) . Nonetheless , warfarin therapy increases the risk for major hemorrhage and is burdensome for both physicians and patients . Therefore , clinical guidelines ( 3 , 4 ) recommend warfarin only for patients with atrial fibrillation who are considered to be at intermediate or high risk for ischemic stroke . However , these risk-based anticoagulation guidelines have substantial limitations . First , they do not explicitly account for the risk for fatal and disabling hemorrhage due to warfarin . Second , they are primarily based on studies conducted more than 15 years ago . Recent studies ( 2 , 5 , 6 ) of patients with atrial fibrillation suggest a lower absolute risk for stroke while not receiving warfarin therapy , perhaps reflecting better treatment of hypertension or other risk factors . Finally , the net clinical benefit of risk-based recommendations for anticoagulation in patients with atrial fibrillation has not been demonstrated in large population s followed for long periods . In our observational study , we quantify the net clinical benefit of warfarin anticoagulation , defined as the estimated reduction in rate of thromboembolism , mainly ischemic stroke , minus 1.5 times the estimated increase in rate of intracranial hemorrhage attributable to warfarin therapy in st and ard stroke risk subgroups in the community-based cohort of patients in the ATRIA ( AnTicoagulation and Risk Factors In Atrial Fibrillation ) Study . Methods Study Population The ATRIA Study cohort consists of 13559 adults with diagnosed nonvalvular atrial fibrillation who received care within Kaiser Permanente of Northern California , a large integrated health care delivery system . Cohort assembly is described in detail elsewhere ( 2 , 7 ) . In brief , we identified patients with a diagnosis of atrial fibrillation between 1 July 1996 and 31 December 1997 by search ing outpatient data bases for internal medicine or cardiology visits in which an International Classification of Diseases , Ninth Revision , Clinical Modification ( ICD-9-CM ) , diagnosis of atrial fibrillation ( 427.31 ) was assigned and by search ing electrocardiographic data bases for a diagnosis of atrial fibrillation . The date of the first diagnosis of atrial fibrillation during the period of cohort assembly was considered the patient 's index date . Cohort assembly was finalized by November 1998 , and the cohort was followed through 30 September 2003 with a combination of retrospective ( back to July 1996 ) and prospect i ve ( through September 2003 ) review of health plan data bases and medical records . Patients who died or withdrew from the health plan during follow-up were censored at their date of death or on the last day of the month in which they terminated their membership . Date of death was ascertained from health plan clinical or administrative files , the California Automated Mortality Linkage System , or the Social Security Administration Death Master File . The institutional review boards at Massachusetts General Hospital and the Kaiser Foundation Research Institute approved the research . Patient Characteristics We search ed data bases of clinical inpatient and ambulatory visits ( outpatient clinic and emergency department ) during the 5 years before each patient 's index date to identify previously diagnosed ischemic stroke , heart failure , coronary heart disease , and hypertension by using relevant ICD-9-CM codes ( 2 ) . We used a vali date d , comprehensive health plan diabetes registry to identify patients with diabetes mellitus . Ascertainment of these stroke risk factors was vali date d against review of sample s of outpatient medical records ; crude agreement was high ( 78 % to 96 % ) , and corresponding statistics ranged from 0.51 to 0.89 . Of note , stroke risk prediction based on risk factors ascertained in the ATRIA Study was in good agreement with risk schemes generated by pooled r and omized trial and chart-based cohort study data ( 2 , 810 ) . Information from medical care received at both health plan and nonhealth plan facilities was obtained through these data bases . Data on age and sex were obtained from administrative data bases . Warfarin Exposure We determined warfarin exposure on the basis of information from automated clinical , pharmacy , and laboratory data bases by using methods described elsewhere ( 2 ) . We vali date d this computerized approach in 1207 patients by comparing it with warfarin status documented in their medical record at the time of an outcome event ; the result ing statistic was 0.84 . Nearly all discrepancies were due to transient discontinuation of warfarin treatment . If medical chart review of an outcome event showed that the patient stopped receiving warfarin within 5 days before the event , the event was considered to take place while the patient was receiving warfarin . For patients considered to be receiving warfarin , an adapted linear interpolation method was used to determine the person-time spent in the therapeutic international normalized ratio ( INR ) range of 2.0 to 3.0 ( 11 ) . If the interval between consecutive INR measurements was greater than 8 weeks , the INR person-time for this period was considered not available . Outcome Assessment Thromboembolic Events We search ed hospitalization and billing cl aims data bases through 30 September 2003 for primary ICD-9-CM discharge diagnoses that indicated potential thromboembolism , including ischemic stroke and other systemic embolism ( ICD-9-CM codes available on request ) ( 2 ) . For both potential thromboembolic events and hemorrhagic events , medical record analysts obtained the relevant medical records by using a structured protocol . We did not investigate hospitalizations with the selected discharge diagnosis codes in a secondary position , because such hospitalizations rarely were prompted by new thromboembolic events . We estimate that our rates of ischemic stroke would have been increased relatively by 6 % had we review ed all such hospitalizations ( 2 ) . We defined a vali date d ischemic stroke as a sudden neurologic deficit lasting more than 24 hours , corresponding to a vascular territory in the absence of primary hemorrhage , that was not explained by other causes ( for example , trauma or infection ) . We defined a valid peripheral embolism as being identified by radiographic imaging , intraoperative examination , or pathologic findings ( with no atherosclerotic disease in the affected artery ) . Thromboembolic events occurring after hospital admission , generally as a complication of medical care , were not included as outcome events . Two members of the physician outcomes review committee review ed all potential thromboembolic events by using a formal protocol . Disagreements were resolved by a third committee member or by a consulting neurologist , if needed . Intracranial Hemorrhage We search ed hospitalization and billing data bases for primary and secondary discharge diagnoses of intracranial hemorrhage , including intraparenchymal , subdural , subarachnoid , and other hemorrhage ( ICD-9-CM codes available on request ) . We excluded intracranial hemorrhage associated with a concomitant discharge diagnosis of major trauma ( ICD-9-CM codes 852.1 , 852.3 , 852.5 , and 853.1 ) and events not leading to hospitalization or those that occurred as a complication of a hospitalization for another problem . Net Clinical Benefit We defined the core net clinical benefit of warfarin therapy in atrial fibrillation as the annualized rate of thromboembolic events ( TE rate ) prevented minus the annualized rate of intracran
Output:
| Conclusions Compared with HAS-BLED , the ORBIT score does not perform better in predicting major bleeding events in anticoagulated atrial fibrillation patients .
More anticoagulated AF patients and major bleeding events were categorized as low risk when using ORBIT |
MS212750 | ***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 treatment of advanced renal cell carcinoma has been revolutionised by targeted therapy with drugs that block angiogenesis . So far , no phase 3 r and omised trials comparing the effectiveness of one targeted agent against another have been reported . We did a r and omised phase 3 study comparing axitinib , a potent and selective second-generation inhibitor of vascular endothelial growth factor ( VEGF ) receptors , with sorafenib , an approved VEGF receptor inhibitor , as second-line therapy in patients with metastatic renal cell cancer . METHODS We included patients coming from 175 sites ( hospitals and outpatient clinics ) in 22 countries aged 18 years or older with confirmed renal clear-cell carcinoma who progressed despite first-line therapy containing sunitinib , bevacizumab plus interferon-alfa , temsirolimus , or cytokines . Patients were stratified according to Eastern Cooperative Oncology Group performance status and type of previous treatment and then r and omly assigned ( 1:1 ) to either axitinib ( 5 mg twice daily ) or sorafenib ( 400 mg twice daily ) . Axitinib dose increases to 7 mg and then to 10 mg , twice daily , were allowed for those patients without hypertension or adverse reactions above grade 2 . Participants were not masked to study treatment . The primary endpoint was progression-free survival ( PFS ) and was assessed by a masked , independent radiology review and analysed by intention to treat . This trial was registered on Clinical Trials.gov , number NCT00678392 . FINDINGS A total of 723 patients were enrolled and r and omly assigned to receive axitinib ( n=361 ) or sorafenib ( n=362 ) . The median PFS was 6·7 months with axitinib compared to 4·7 months with sorafenib ( hazard ratio 0·665 ; 95 % CI 0·544 - 0·812 ; one-sided p<0·0001 ) . Treatment was discontinued because of toxic effects in 14 ( 4 % ) of 359 patients treated with axitinib and 29 ( 8 % ) of 355 patients treated with sorafenib . The most common adverse events were diarrhoea , hypertension , and fatigue in the axitinib arm , and diarrhoea , palmar-plantar erythrodysaesthesia , and alopecia in the sorafenib arm . INTERPRETATION Axitinib result ed in significantly longer PFS compared with sorafenib . Axitinib is a treatment option for second-line therapy of advanced renal cell carcinoma . FUNDING Pfizer BACKGROUND We conducted a multinational , r and omized study to compare radiotherapy alone with radiotherapy plus cetuximab , a monoclonal antibody against the epidermal growth factor receptor , in the treatment of locoregionally advanced squamous-cell carcinoma of the head and neck . METHODS Patients with locoregionally advanced head and neck cancer were r and omly assigned to treatment with high-dose radiotherapy alone ( 213 patients ) or high-dose radiotherapy plus weekly cetuximab ( 211 patients ) at an initial dose of 400 mg per square meter of body-surface area , followed by 250 mg per square meter weekly for the duration of radiotherapy . The primary end point was the duration of control of locoregional disease ; secondary end points were overall survival , progression-free survival , the response rate , and safety . RESULTS The median duration of locoregional control was 24.4 months among patients treated with cetuximab plus radiotherapy and 14.9 months among those given radiotherapy alone ( hazard ratio for locoregional progression or death , 0.68 ; P=0.005 ) . With a median follow-up of 54.0 months , the median duration of overall survival was 49.0 months among patients treated with combined therapy and 29.3 months among those treated with radiotherapy alone ( hazard ratio for death , 0.74 ; P=0.03 ) . Radiotherapy plus cetuximab significantly prolonged progression-free survival ( hazard ratio for disease progression or death , 0.70 ; P=0.006 ) . With the exception of acneiform rash and infusion reactions , the incidence of grade 3 or greater toxic effects , including mucositis , did not differ significantly between the two groups . CONCLUSIONS Treatment of locoregionally advanced head and neck cancer with concomitant high-dose radiotherapy plus cetuximab improves locoregional control and reduces mortality without increasing the common toxic effects associated with radiotherapy to the head and neck . ( Clinical Trials.gov number , NCT00004227 . BACKGROUND Trastuzumab , a monoclonal antibody against human epidermal growth factor receptor 2 ( HER2 ; also known as ERBB2 ) , was investigated in combination with chemotherapy for first-line treatment of HER2-positive advanced gastric or gastro-oesophageal junction cancer . METHODS ToGA ( Trastuzumab for Gastric Cancer ) was an open-label , international , phase 3 , r and omised controlled trial undertaken in 122 centres in 24 countries . Patients with gastric or gastro-oesophageal junction cancer were eligible for inclusion if their tumours showed overexpression of HER2 protein by immunohistochemistry or gene amplification by fluorescence in-situ hybridisation . Participants were r and omly assigned in a 1:1 ratio to receive a chemotherapy regimen consisting of capecitabine plus cisplatin or fluorouracil plus cisplatin given every 3 weeks for six cycles or chemotherapy in combination with intravenous trastuzumab . Allocation was by block r and omisation stratified by Eastern Cooperative Oncology Group performance status , chemotherapy regimen , extent of disease , primary cancer site , and measurability of disease , implemented with a central interactive voice recognition system . The primary endpoint was overall survival in all r and omised patients who received study medication at least once . This trial is registered with Clinical Trials.gov , number NCT01041404 . FINDINGS 594 patients were r and omly assigned to study treatment ( trastuzumab plus chemotherapy , n=298 ; chemotherapy alone , n=296 ) , of whom 584 were included in the primary analysis ( n=294 ; n=290 ) . Median follow-up was 18.6 months ( IQR 11 - 25 ) in the trastuzumab plus chemotherapy group and 17.1 months ( 9 - 25 ) in the chemotherapy alone group . Median overall survival was 13.8 months ( 95 % CI 12 - 16 ) in those assigned to trastuzumab plus chemotherapy compared with 11.1 months ( 10 - 13 ) in those assigned to chemotherapy alone ( hazard ratio 0.74 ; 95 % CI 0.60 - 0.91 ; p=0.0046 ) . The most common adverse events in both groups were nausea ( trastuzumab plus chemotherapy , 197 [ 67 % ] vs chemotherapy alone , 184 [ 63 % ] ) , vomiting ( 147 [ 50 % ] vs 134 [ 46 % ] ) , and neutropenia ( 157 [ 53 % ] vs 165 [ 57 % ] ) . Rates of overall grade 3 or 4 adverse events ( 201 [ 68 % ] vs 198 [ 68 % ] ) and cardiac adverse events ( 17 [ 6 % ] vs 18 [ 6 % ] ) did not differ between groups . INTERPRETATION Trastuzumab in combination with chemotherapy can be considered as a new st and ard option for patients with HER2-positive advanced gastric or gastro-oesophageal junction cancer . FUNDING F Hoffmann-La Roche BACKGROUND Treatment with cetuximab , a monoclonal antibody directed against the epidermal growth factor receptor , improves overall and progression-free survival and preserves the quality of life in patients with colorectal cancer that has not responded to chemotherapy . The mutation status of the K-ras gene in the tumor may affect the response to cetuximab and have treatment-independent prognostic value . METHODS We analyzed tumor sample s , obtained from 394 of 572 patients ( 68.9 % ) with colorectal cancer who were r and omly assigned to receive cetuximab plus best supportive care or best supportive care alone , to look for activating mutations in exon 2 of the K-ras gene . We assessed whether the mutation status of the K-ras gene was associated with survival in the cetuximab and supportive-care groups . RESULTS Of the tumors evaluated for K-ras mutations , 42.3 % had at least one mutation in exon 2 of the gene . The effectiveness of cetuximab was significantly associated with K-ras mutation status ( P=0.01 and P<0.001 for the interaction of K-ras mutation status with overall survival and progression-free survival , respectively ) . In patients with wild-type K-ras tumors , treatment with cetuximab as compared with supportive care alone significantly improved overall survival ( median , 9.5 vs. 4.8 months ; hazard ratio for death , 0.55 ; 95 % confidence interval [ CI ] , 0.41 to 0.74 ; P<0.001 ) and progression-free survival ( median , 3.7 months vs. 1.9 months ; hazard ratio for progression or death , 0.40 ; 95 % CI , 0.30 to 0.54 ; P<0.001 ) . Among patients with mutated K-ras tumors , there was no significant difference between those who were treated with cetuximab and those who received supportive care alone with respect to overall survival ( hazard ratio , 0.98 ; P=0.89 ) or progression-free survival ( hazard ratio , 0.99 ; P=0.96 ) . In the group of patients receiving best supportive care alone , the mutation status of the K-ras gene was not significantly associated with overall survival ( hazard ratio for death , 1.01 ; P=0.97 ) . CONCLUSIONS Patients with a colorectal tumor bearing mutated K-ras did not benefit from cetuximab , whereas patients with a tumor bearing wild-type K-ras did benefit from cetuximab . The mutation status of the K-ras gene had no influence on survival among patients treated with best supportive care alone . ( Clinical Trials.gov number , NCT00079066 . BACKGROUND Cetuximab , an IgG1 chimeric monoclonal antibody against epidermal growth factor receptor ( EGFR ) , has activity against colorectal cancers that express EGFR . METHODS From December 2003 to August 2005 , 572 patients who had colorectal cancer expressing immunohistochemically detectable EGFR and who had been previously treated with a fluoropyrimidine , irinotecan , and oxaliplatin or had contraindications to treatment with these drugs underwent r and omization to an initial dose of 400 mg of cetuximab per square meter of body-surface area followed by a weekly infusion of 250 mg per square meter plus best supportive care ( 287 patients ) or best supportive care alone ( 285 patients ) . The primary end point was overall survival . RESULTS In comparison with best supportive care alone , cetuximab treatment was associated with a significant improvement in overall survival ( hazard ratio for death , 0.77 ; 95 % confidence interval [ CI ] , 0.64 to 0.92 ; P=0.005 ) and in progression-free survival ( hazard ratio for disease progression or death , 0.68 ; 95 % CI , 0.57 to 0.80 ; P<0.001 ) . These benefits were robust after adjustment in a multivariable Cox proportional-hazards model . The median overall survival was 6.1 months in the cetuximab group and 4.6 months in the group assigned to supportive care alone . Partial responses occurred in 23 patients ( 8.0 % ) in the cetuximab group but in none in the group assigned to supportive care alone ( P<0.001 ) ; the disease was stable in an additional 31.4 % of patients assigned to cetuximab and in 10.9 % of patients assigned to supportive care alone ( P<0.001 ) . Quality of life was better preserved in the cetuximab group , with less deterioration in physical function and global health status scores ( both P<0.05 ) . Cetuximab treatment was associated with a characteristic rash ; a rash of grade 2 or higher was strongly associated with improved survival ( hazard ratio for death , 0.33 ; 95 % CI , 0.22 to 0.50 ; P<0.001 ) . The incidence of any adverse event of grade 3 or higher was 78.5 % in the cetuximab group and 59.1 % in the group assigned to supportive care alone ( P<0.001 ) . CONCLUSIONS Cetuximab improves overall survival and progression-free survival and preserves quality -of-life measures in patients with colorectal cancer in whom other treatments have failed . ( Clinical Trials.gov number , NCT00079066 [ C
Output:
| Targeted drugs with companion diagnostics are associated with improved safety , and tolerability .
Differences were most marked for gastrointestinal , cutaneous and neurological toxicity |
MS212751 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: We assessed the non-academic and academic functioning of young adults with DCD , and investigated the emotional influences and the role of strategy use within this population . A r and om sample of 2379 adolescents and young adults aged 19 - 25 ( 1081 males [ 45.4 % ] ; mean age=20.68 , SD=3.42 ) was used to develop the instruments . From this sample , three study groups were identified ( n=429 ) based on the Adolescents & Adults Coordination Question naire : probable DCD ( n=135 ; 67.2 % males ) , suspected borderline DCD ( n=149 ; 51.4 % males ) and control ( 145 ; 70.5 % males ) . Participants completed the Daily Life Functions Question naire ( assessing non-academic and academic functioning ) , the Recent Emotional State Test ( assessing feelings result ing from task performance ) , the Internal Factors Attributed to Success Question naire and the Problem Solving Question naire to assess strategy and executive strategy use . A MANOVA revealed statistically significant differences between-groups ( F[7,422]=16.19 ; p<.001 ; η=.197 ) ; post hoc analyses revealed differences for all measures ( except the Problem Solving Question naire ) , with the probable DCD and suspected borderline DCD groups performing worse than controls . Severity of motor deficits was correlated with all outcomes except strategy use . Logistic regression revealed that non-academic functioning was the most significant predictor of group placement ( B=-1.32 ; p<.001 ) ; academic functioning/h and writing was the second most significant predictor ( B=0.44 ; p=.047 ) . Deficits in motor coordination continue into adulthood and have an effect on academic and non-academic function , as well as on the emotional state of the individual Timing ability is essential for common everyday performance . The aim of the study was to compare timing abilities and temporal aspects of h and writing performance and relationships between these two components among children with Developmental Coordination Disorders ( DCD ) and a control group . Forty two children , 21 diagnosed as DCD and 21 with typical development , aged 7 - 12 , were matched for age , gender and school performed 14 tasks of the interactive metronome ( IM ) and three functional h and writing tasks on an electronic tablet that was part of a computerized system ( ComPET -- computerized penmanship evaluation tool ) . The IM supplies response time , while on-paper and in-air time per written stroke is received from the ComPET . Results indicated significant differences between the groups for both IM and h and writing tasks ( ComPET ) . Linear regression indicated that the mean IM response time explained 37 % of variance of the in-air time per stroke during a paragraph-copying task . Furthermore , based on one discriminate function including two measures reflected timing ability , 81 % of all participants were correctly classified into groups . Study results strongly recommend consideration of the IM as an evaluation and intervention tool for children with DCD who are faced with timing deficits in their everyday functioning The current research aim ed at examining the executive function ( EF ) of young adults with Developmental Coordination Disorder ( DCD ) in comparison to young adults without DCD . The study used a r and omized cohort ( N=429 ) of young adults with DCD ( n=135 ) , borderline DCD ( n=149 ) and control ( n=145 ) , from a previous study . This initial cohort was asked to participate in the current study three to four years later . Twenty-five individuals with DCD ( mean age=24 years , 1 month [ SD=0.88 ] ; 18 males ) , 30 with borderline DCD ( mean age=24 years , 2 month [ SD=0.98 ] ; 18 males ) and 41 without DCD ( mean age=25 years , 2 months [ SD=1.91 ] ; 20 males ) participated in this study . Participants completed the BRIEF-A question naire , assessing EF abilities and the WURS question naire , assessing attention abilities . The DCD and borderline DCD groups had significantly lower EF profiles in comparison with the control group but no significant differences were found between the DCD and borderline DCD groups . While a high percentage of attention problems were found in both DCD groups , the executive functioning profiles remained consistent even when using the attention component as a covariate . The study results suggest that young adults with DCD have EF problems which remain consistent with or without attention difficulties UNLABELLED Children with developmental coordination disorder ( DCD ) struggle to learn new motor skills . It is unknown whether children with DCD learn motor skills more effectively with an external focus of attention ( focusing on impact of movement on the environment ) or an internal focus of attention ( focusing on one 's body movements ) during implicit ( unconscious ) and explicit ( conscious ) motor learning . PURPOSE This paper aims to determine the trends of implicit motor learning in children with DCD , and how focus of attention influences motor learning in children with DCD in comparison with typically developing children . METHODS 25 children , aged 8 - 12 , with ( n=12 ) and without ( n=13 ) DCD were r and omly assigned to receive instructions that focused attention externally or internally while completing a computer tracking task during acquisition , retention , and transfer phases . The motor task involved tracking both repeated and r and om patterns , with the repeated pattern indicative of implicit learning . RESULTS Children with DCD scored lower on the motor task in all three phases of the study , demonstrating poorer implicit learning . Furthermore , graphical data showed that for the children with DCD , there was no apparent difference between internal and external focus of attention during retention and transfer , while there was an advantage to the external focus of attention group for typically developing children . CONCLUSION Children with DCD demonstrate less accuracy than typically developing children in learning a motor task . Also , the effect of focus of attention on motor performance is different in children with DCD versus their typically developing counterparts during the three phases of motor learning . IMPLICATION S Results may inform clinicians how to facilitate motor learning in children with DCD by incorporating explicit learning with either internal or external focus of attention within interventions OBJECTIVE To assess executive function in children with developmental dyspraxia . PATIENTS AND METHOD INCLUSION CRITERIA children aged 8 years to 12 years 5 months at the time of the study , diagnosed with developmental dyspraxia between January , 2008 and August , 2009 by a multidisciplinary team in one single center . ASSESSMENT TOOLS ( 1 ) Paper- and -pencil neuropsychological and ecological tests to assess flexibility , planning , inhibition and prospect i ve memory ; ( 2 ) two question naires answered by parents ; ( 3 ) the ' Children 's Cooking Task ' ( CCT ) , an ecological task performed in a real environment ( Chevignard et al. , 2009 [ 15 ] ) . In this last test , children were compared to matched controls . Non-parametric statistical tests were used . RESULTS Thirteen patients participated in the study ( 11 boys-2 girls ; mean age 10.3 years [ SD=1.3 ] ) . Neuropsychological tests highlighted planning and inhibition disorders , but no impaired flexibility . For more than half of the children , the question naires indicated impaired executive functions in daily life tasks . Finally , patients showed a significantly increased rate of errors during the CCT , compared with the control group ( P<0.001 ) . CONCLUSION Overall results suggest that some children diagnosed with developmental dyspraxia also exhibit executive function disorders . Ecological tests seem more sensitive for identifying executive function disorders than conventional tests Background Children with Developmental Coordination Disorder ( DCD ) have multiple impairments in movement , in learning , and in the activities of daily living . Studies from other countries have associated these impairments with cognitive function , particularly executive functioning , but these findings have not been confirmed in China . Aim Compare the executive functioning of children with DCD with that of normal children . Methods The Wisconsin Card Sorting Test ( WCST ) was administered to 39 children who met DSM-IV criteria of DCD identified at the Seventh People 's Hospital of Hangzhou from March 2008 through March 2010 . The WCST was also administered to a control group of 39 r and omly selected children from one elementary school in Hangzhou . Results The total responses on the WCST and the number of non-perseverative errors for cases and controls were similar , but cases had significantly more errors , more perseverative responses and more perseverative errors ; moreover , they completed fewer categories than controls and required more trials to complete the first category . Conclusion Our study confirms previous studies which show significantly impaired executive functioning in patients with DCD . Collectively , these studies suggest that the deficits in executive functioning of children with DCD significantly impair their intellectual and social development
Output:
| RESULTS Behavioural data from 91 studies showed a broad cluster of deficits in the anticipatory control of movement , basic processes of motor learning , and cognitive control .
Importantly , however , performance issues in DCD were often shown to be moderated by task type and difficulty .
As well , we saw new evidence of compensatory processes and strategies in several studies .
Data from diffusion-weighted magnetic resonance imaging suggested reduced white matter organization involving sensorimotor structures and altered structural connectivity across the whole brain network .
INTERPRETATION Taken together , results support the hypothesis that children with DCD show differences in brain structure and function compared with typically developing children .
Behaviourally , these differences may affect anticipatory planning and reduce automatization of movement skill , prompting greater reliance on slower feedback-based control and compensatory strategies . |
MS212752 | ***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: A study was conducted to compare transvaginal ultrasound ( TVS ) , saline infusion sonography ( SIS ) and outpatient hysteroscopy for examining the uterine cavity in women with postmenopausal bleeding and unscheduled bleeding on hormone replacement therapy ( HRT ) . Fourty Subjects agreed to undergo TVS , SIS and hysteroscopy in addition to endometrial sampling . The abnormalities detected by each imaging method were recorded together with the discomfort ( visual analogue scale ) . Thirty women completed all three imaging procedures . In 18 cases TVS suggested an abnormal cavity . SIS and hysteroscopy were of similar efficacy in clarifying the nature of this , and confirmed an abnormality in 12 cases ( 40 % ) . TVS was significantly less painful than the other procedures ( p < 0.001 ) . SIS and hysteroscopy were associated with pain scores similar to endometrial sampling . These findings justify the need for a large r and omised trial of TVS , SIS , hysteroscopy and endometrial sampling , in order to develop the most appropriate strategy for investigating postmenopausal bleeding and unscheduled bleeding on HRT Women with postmenopausal bleeding should be evaluated efficiently to exclude endometrial carcinoma Objective . To develop and test a risk-scoring model for the prediction of endometrial cancer among symptomatic postmenopausal women at risk of intrauterine malignancy . Methods . We prospect ively studied 624 postmenopausal women with vaginal bleeding and endometrial thickness > 4 mm undergoing diagnostic hysteroscopy . Patient characteristics and endometrial assessment of women with or without endometrial cancer were compared . Then , a risk-scoring model , including the best predictors of endometrial cancer , was tested . Univariate , multivariate , and ROC curve analysis were performed . Finally , a split-sampling internal validation was also performed . Results . The best predictors of endometrial cancer were recurrent vaginal bleeding ( odds ratio ( OR ) = 2.96 ) , the presence of hypertension ( OR = 2.01 ) endometrial thickness > 8 mm ( OR = 1.31 ) , and age > 65 years ( OR = 1.11 ) . These variables were used to create a risk-scoring model ( RHEA risk-model ) for the prediction of intrauterine malignancy , with an area under the curve of 0.878 ( 95 % CI 0.842 to 0.908 ; P < 0.0001 ) . At the best cut-off value ( score ≥ 4 ) , sensitivity and specificity were 87.5 % and 80.1 % , respectively . Conclusion . Among symptomatic postmenopausal women with endometrial thickness > 4 mm , a risk-scoring model including patient characteristics and endometrial thickness showed a moderate diagnostic accuracy in discriminating women with or without endometrial cancer . Based on this model , a decision algorithm was developed for the management of such a population We conducted this study to test the hypothesis that transvaginal ultrasonography and color Doppler imaging of the uterine arteries are complementary methods in the assessment of patients with postmenopausal bleeding . Sixty-seven patients were studied . Seventeen suffered from endometrial carcinoma , 12 from benign endometrial lesions ( six polyp , six hyperplasia ) and 38 had no organic pathology . Transvaginal ultrasonography was found to be superior to CDI in the detection of pathologic conditions of the endometrium , but neither method can distinguish benign lesions from their malignant counterparts . CDI does not give additional information over that obtained by transvaginal ultrasonography in the assessment of patients with postmenopausal bleeding , and the limitations of both methods in the differentiation of endometrial carcinoma from benign lesions need to be recognized In this prospect i ve study , 139 patients , 83 premenopausal patients with abnormal uterine bleeding and 56 postmenopausal patients either with metrorrhagia ( 33 ) or a suspect sonographic finding ( 23 ) , were examined preoperatively with transvaginal sonography ( TVS ) and saline contrast hysterosonography ( SCHS ) . The histological results , obtained by hysteroscopy , were compared with the preoperative findings . Uterine pathology ( benign polyps , submucous fibroids , endometrial hyperplasia and carcinoma ) was found in 74.7 % and 76.8 % of the pre- and postmenopausal patients , respectively . TVS and SCHS are very sensitive at diagnosing uterine pathology , the latter being more specific and enabling better surgical management and a reduction in unnecessary interventions OBJECTIVE To evaluate the role of one-stop clinic for early diagnosis and management of women with postmenopausal bleeding by means of transvaginal ultrasonography , outpatient hysteroscopy and endometrial biopsy . STUDY DESIGN A prospect i ve analysis was performed on 522 women with postmenopausal bleeding who were referred directly to the gynecology outpatient clinic for evaluation of postmenopausal bleeding . Endometrial thickness of 6 mm , as measured by a transvaginal scan , was considered the cutoff limit for further investigation by hysteroscopy and endometrial biopsy . RESULTS One hundred ninety-one women were using hormone replacement therapy . Thirty-two were taking tamoxifen . Outpatient hysteroscpoy was performed in 157 ( 71.3 % ) cases . Thirty-seven ( 16.8 % ) cases had general anesthesia for hysteroscopy . Twenty-four ( 11 % ) cases had only an endometrial sample obtained . Twenty-one cases of endometrial carcinoma , 20 of endometrial hyperplasia , 4 of cervical carcinoma and 5 of other genital tract malignancies along with several benign pathologies , including submucosal myomas , were detected . Seven ( 2.3 % ) cases of endometrial thickness below the cutoff limit had recurrent bleeding due to benign conditions . CONCLUSION A one-stop clinic is effective for early diagnosis of genital tract malignancy in a majority of patients with postmenopausal bleeding and significantly help in reducing the hospital waiting list PURPOSE To assess the accuracy of hysterosonography ( HSG ) and its role in diagnostic confidence and therapeutic clinical decision making among referring physicians caring for patients with postmenopausal bleeding ( PMB ) . MATERIAL S AND METHODS One hundred twenty-three patients with PMB underwent transvaginal ultrasonography ( US ) and HSG . They were examined for cancer , polyp , leiomyoma , and hyperplasia . Physicians assessed the effect of the studies on diagnostic confidence and care , including biopsy , dilation and curettage , hysteroscopy , hormone manipulation , and /or patient reassurance . Abnormality was proved with histopathologic evaluation , and normality , with 6-month follow-up . RESULTS In 10 patients , HSG was unsuccessful , and in 15 , follow-up was incomplete ; this left 98 patients . Endometrial polyps were seen in 46 ( 47 % ) patients ; leiomyoma , in 11 ( 11 % ) ; cancer , in four ( 4 % ) ; hyperplasia , in eight ( 8 % ) ; and normal findings , in 29 ( 30 % ) . Our calculations yielded a sensitivity of 98 % and a specificity of 88 % . In 86 ( 88 % ) patients , US added certainty to the diagnosis ; in 78 ( 80 % ) , it result ed in a change in patient treatment . CONCLUSION HSG and transvaginal US in patients with PMB improves diagnostic accuracy , clinical decision making , and the clinician 's diagnostic certainty . In patients with benign causes of PMB , the absence of abnormality at HSG and a normal endometrial biopsy result may eliminate the need for further studies OBJECTIVE The purpose of this study was to use transvaginal ultrasonographic measurements to find the thickness of the endometrium below which the risk of endometrial abnormality in women with postmenopausal bleeding is low . STUDY DESIGN This multicenter study was carried out at eight clinics in four Nordic countries . The study included 1168 women with postmenopausal bleeding scheduled for curettage Before the curettage was performed , the thickness of the endometrium was measured with transvaginal ultrasonography . The measurement included both endometrial layers ( double-layer technique ) . The transvaginal ultrasonographic measurement was compared with the histopathologic diagnosis of the curettage specimens . RESULTS In women with atrophic endometrium the mean endometrial thickness ( + /- SD ) was 3.9 + /- 2.5 mm . The corresponding figures for women with endometrial cancer were 21.1 + /- 11.8 mm . No malignant endometrium was thinner than 5 mm . In 30 women ( 2.8 % ) it was not possible to measure the thickness of the endometrium ; one of these women had endometrial cancer . The 95 % confidence limit for the probability of excluding endometrial abnormality was 5.5 % when the endometrial thickness was < or = 4 mm as measured by transvaginal ultrasonography . CONCLUSION The risk of finding pathologic endometrium at curettage when the endometrium is < or = 4 mm as measured by transvaginal ultrasonography is 5.5 % . Thus in women with postmenopausal bleeding and an endometrium < or = 4 mm it would seem justified to refrain from curettage OBJECTIVE This study was undertaken to evaluate whether it was possible to abstain from performing an endometrial biopsy when endometrial thickness according to transvaginal ultrasonography was < /=4 mm in women with postmenopausal bleeding or irregular bleeding during hormone replacement therapy . STUDY DESIGN Transvaginal ultrasonography was performed in 361 women aged > /=50 years who were referred because of postmenopausal bleeding or irregular bleeding during hormone replacement therapy . If endometrial thickness was < /=4 mm , a Papanicolaou cervical smear was performed and the woman was reexamined with transvaginal ultrasonography after 4 and 12 months . Subjects were also instructed to return if they had recurrent bleeding , in which case transvaginal ultrasonography was performed and an endometrial biopsy specimen was obtained . Women with an endometrial thickness > /=5 mm underwent either curettage or endometrial biopsy . RESULTS One hundred sixty-three women had an endometrial thickness < /=4 mm . In this group one endometrial cancer that was missed by ultrasonography was diagnosed by cervical cytologic examination and two adnexal malignancies were diagnosed by ultrasonography . Endometrial malignancy was diagnosed in 0.6 % of the women with an endometrial thickness < /=4 mm . Endometrial biopsy was performed because of recurrent bleeding in 6.1 % of cases and because of endometrial thickening in 8.1 % . No cancer or hyperplasia was subsequently diagnosed among the women with an endometrial thickness < /=4 mm . Endometrial cancer was diagnosed in 18.7 % of the women with an endometrial thickness > /=5 mm . The corresponding figure when atypical hyperplasia and endometrial metastases were included was 20 . 2 % . CONCLUSION If the false-negative rate of endometrial biopsy techniques is taken into account , then the combination of transvaginal ultrasonography and cervical cytologic examination is an adequate form of management for women with postmenopausal bleeding or irregular bleeding during hormone replacement therapy as long as endometrial thickness is < /=4 mm . A r and omized prospect i ve study is necessary to verify this finding Background Abnormal uterine bleeding ( AUB ) is one of the most common debilitating menstrual problems and has remained one of the most frequent indications for hysterectomy in developing countries . Approximately in 40 % of hysterectomy specimens , no definite organic pathology could be established . The problem is common worldwide but causes may vary from one region to another . This study may help gynecologists in our population to improve their therapeutic strategies by promoting minimally invasive uterus sparing modalities such as endometrial ablation and hysteroscopic resection of early proliferative lesions . Methods It was a prospect i ve , cross-sectional study conducted at Liaquat National Hospital from 15th January 2010 till 14th July 2011 over a period of 18 months . Women who underwent dilatation and curettage for endometrial sampling with complaints of AUB were included in the study and histopathologic spectrum was determined . Results Polymenorrhea was the most common presenting pattern ( 30 % , 72/241 ) with reproductive age women being the most susceptible ( 49.3%,119/241 ) . The commonest histopathological spectrum was normal menstrual pattern ( 34 % , 82/241 ) and the commonest pathology was hormonal imbalance ( 27 % , 65/241 ) , followed by endometrial polyp ( 14 % , 34/241 ) , chronic endometritis ( 12 % , 28/241 ) , atrophic endometrium ( 6 % , 15/241 ) , endometrial hyperplasia ( 5 % , 12/241 ) , and endometrial carcinoma ( 2 % , 5/241 ) . Chronic endometritis was commonly seen in reproductive age ( 18 % , 21/119 ) ; h
Output:
| Conclusions and Relevance Early detection strategies focused on women with PMB have the potential to capture as many as 90 % of endometrial cancers ; however , most women with PMB will not be diagnosed with endometrial cancer . |
MS212753 | ***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: Objective : To compare the diagnostic accuracy of CSF biomarkers and amyloid PET for diagnosing early-stage Alzheimer disease ( AD ) . Methods : From the prospect i ve , longitudinal BioFINDER study , we included 122 healthy elderly and 34 patients with mild cognitive impairment who developed AD dementia within 3 years ( MCI-AD ) . β-Amyloid ( Aβ ) deposition in 9 brain regions was examined with [18F]-flutemetamol PET . CSF was analyzed with INNOTEST and EUROIMMUN ELISAs . The results were replicated in 146 controls and 64 patients with MCI-AD from the Alzheimer 's Disease Neuroimaging Initiative study . Results : The best CSF measures for identifying MCI-AD were Aβ42/total tau ( t-tau ) and Aβ42/hyperphosphorylated tau ( p-tau ) ( area under the curve [ AUC ] 0.93–0.94 ) . The best PET measures performed similarly ( AUC 0.92–0.93 ; anterior cingulate , posterior cingulate/precuneus , and global neocortical uptake ) . CSF Aβ42/t-tau and Aβ42/p-tau performed better than CSF Aβ42 and Aβ42/40 ( AUC difference 0.03–0.12 , p < 0.05 ) . Using nonoptimized cutoffs , CSF Aβ42/t-tau had the highest accuracy of all CSF/PET biomarkers ( sensitivity 97 % , specificity 83 % ) . The combination of CSF and PET was not better than using either biomarker separately . Conclusions : Amyloid PET and CSF biomarkers can identify early AD with high accuracy . There were no differences between the best CSF and PET measures and no improvement when combining them . Regional PET measures were not better than assessing the global Aβ deposition . The results were replicated in an independent cohort using another CSF assay and PET tracer . The choice between CSF and amyloid PET biomarkers for identifying early AD can be based on availability , costs , and doctor/patient preferences since both have equally high diagnostic accuracy . Classification of evidence : This study provides Class III evidence that amyloid PET and CSF biomarkers identify early-stage AD equally accurately BACKGROUND Brain amyloid deposition is one of the key pathological hallmarks underlying the cognitive changes associated with Alzheimer 's disease . Growing interest has been given to the earliest clinical manifestations of amyloid plaques . However , the relationship between amyloid status and activities of everyday function remains largely unknown . In the present study , we examined the relationship between instrumental activities of daily living performance ( using the ADL-PI score ) and amyloid status in older adults . METHODS Cross-sectional analyses of data from the Multidomain Alzheimer Preventive Trial ( MAPT ) were performed . Volunteers underwent a brain 18F-AV45 positron emission tomography examination . Bivariate analysis and regression models were conducted to study the relationships between brain amyloid deposition and the total ADL-PI score . RESULTS We included 271 participants ( women = 60 % ; age = 76±4 years ) . Amyloid positron emission tomography was positive ( st and ard uptake value ≥1.17 ) for 103 participants ( 38 % ) . The ADL-PI score was lower in amyloid positive participants than in their amyloid negative counterparts ( 38.8 vs 40.3 , p = .007 ) . This association was also confirmed in regression models adjusted for age , gender , and familial history of Alzheimer 's disease ( odds ratio = 0.94 ; 95 % confidence interval 0.89 - 0.99 ; p = .02 ) . This finding was consistent in cognitively normal individuals and in those with mild cognitive impairment , using the clinical dementia rating scale . CONCLUSIONS This study highlighted an association between early functional limitations and brain amyloid deposition in elderly subjects . These symptoms could be the clinical manifestations of amyloid plaques even in the absence of overt dementia . Further prospect i ve studies are warranted for examining the evolution of ADL-PI score over the course of Alzheimer 's disease BACKGROUND Alzheimer 's disease ( AD ) pathology is common in patients with amnestic mild cognitive impairment ( aMCI ) without dementia , but the prevalence of AD pathology in patients with subjective cognitive impairment ( SCI ) and non-amnestic mild cognitive impairment ( naMCI ) is unknown . AD is characterised by decreased CSF concentrations of Abeta(42 ) and increased concentrations of tau . We investigated the prevalence of a CSF AD profile in patients with SCI , naMCI , or aMCI and the association of this profile with cognitive outcome in each group . METHODS Patients with SCI , naMCI , aMCI , and neurologically healthy controls were recruited from 20 memory clinics across Europe , between January , 2003 , and June , 2005 , into this prospect i ve cohort study . A CSF AD profile was defined as an abnormal ratio of Abeta(42):tau . Patients were assessed annually up to 3 years . Outcome measures were changes in memory , overall cognition , mini-mental state examination ( MMSE ) score , daily function , and progression to AD-type dementia . FINDINGS The CSF AD profile was more common in patients with SCI ( 31 of 60 [ 52 % ] ) , naMCI ( 25 of 37 [ 68 % ] ) , and aMCI ( 56 of 71 [ 79 % ] ) than in healthy controls ( 28 of 89 [ 31 % ] ) . The profile was associated with cognitive decline in patients with naMCI ( memory , MMSE , and daily function ) and in patients with aMCI ( MMSE and daily function ) . In patients with aMCI , a CSF AD profile was predictive of AD-type dementia ( OR 26.8 , 95 % CI 1.6 - 456.4 ) . INTERPRETATION AD is a common cause of SCI , naMCI , and aMCI and is associated with cognitive decline in patients with naMCI or aMCI . Patients with SCI might be in the early stages of AD , and cognitive decline might become apparent only after longer follow-up . FUNDING European Commission ; Ana Aslan International Foundation OBJECTIVE In the course of performing systematic review s on the prevalence of low back and neck pain , we required a tool to assess the risk of study bias . Our objectives were to ( 1 ) modify an existing checklist and ( 2 ) test the final tool for interrater agreement . STUDY DESIGN AND SETTING The final tool consists of 10 items addressing four domains of bias plus a summary risk of bias assessment . Two research ers tested the interrater agreement of the tool by independently assessing 54 r and omly selected studies . Interrater agreement overall and for each individual item was assessed using the proportion of agreement and Kappa statistic . RESULTS Raters found the tool easy to use , and there was high interrater agreement : overall agreement was 91 % and the Kappa statistic was 0.82 ( 95 % confidence interval : 0.76 , 0.86 ) . Agreement was almost perfect for the individual items on the tool and moderate for the summary assessment . CONCLUSION We have addressed a research gap by modifying and testing a tool to assess risk of study bias . Further research may be useful for assessing the applicability of the tool across different conditions Our objectives were ( 1 ) to test the association between the report of subjective cognitive decline ( SCD ) and prospect i ve objective cognitive performance in high age individuals and ( 2 ) to study the course of longitudinal cognitive performance before and after the first report of SCD The objective is to evaluate the prognosis of subjective cognitive complaints ( SCC ) patients during 4-year follow-up . A prospect i ve study on 92 SCC patients investigating their cognitive , affective and behavioural aspects . SCC patients were classified as having no objective cognitive impairment ( NOCI ) , mild cognitive impairment ( MCI ) , or subtypes of MCI . Results : 43 patients were found to have NOCI and 49 MCI . During the follow-up , 45.5 % of NOCI patients remained unchanged , 13.9 % were diagnosed as MCI and only one progressed to dementia . Of the MCI patients , 32.3 % remained stable , 18.4 % became demented and 4 % reverted to NOCI . Visual attention , behavioural memory , long-term verbal memory , apathy and caregiver distress , provided independent predictors of progression to dementia BACKGROUND Imaging with amyloid-β PET can potentially aid the early and accurate diagnosis of Alzheimer 's disease . Florbetaben ( ¹⁸F ) is a promising ¹⁸F-labelled amyloid-β-targeted PET tracer in clinical development . We aim ed to assess the sensitivity and specificity of florbetaben ( ¹⁸F ) PET in discriminating between patients with probable Alzheimer 's disease and elderly healthy controls . METHODS We did a multicentre , open-label , non-r and omised phase 2 study in 18 centres in Australia , Germany , Switzerl and , and the USA . Imaging with florbetaben ( ¹⁸F ) PET was done on patients with probable Alzheimer 's disease ( age 55 years or older , mini-mental state examination [ MMSE ] score=18 - 26 , clinical dementia rating [CDR]=0·5 - 2·0 ) and age-matched healthy controls ( MMSE ≥ 28 , CDR=0 ) . Our primary objective was to establish the diagnostic efficacy of the scans in differentiating between patients with probable disease and age-matched healthy controls on the basis of neocortical tracer uptake pattern 90 - 110 min post-injection . PET images were assessed visually by three readers masked to the clinical diagnosis and all other clinical findings , and quantitatively by use of pre-established brain volumes of interest to obtain st and ard uptake value ratios ( SUVRs ) , taking the cerebellar cortex as the reference region . This study is registered with Clinical Trials.gov , number NCT00750282 . FINDINGS 81 participants with probable Alzheimer 's disease and 69 healthy controls were assessed . Independent visual assessment of the PET scans showed a sensitivity of 80 % ( 95 % CI 71 - 89 ) and a specificity of 91 % ( 84 - 98 ) for discriminating participants with Alzheimer 's disease from healthy controls . The SUVRs in all neocortical grey-matter regions in participants with Alzheimer 's disease were significantly higher ( p < 0·0001 ) compared with the healthy controls , with the posterior cingulate being the best discriminator . Linear discriminant analysis of regional SUVRs yielded a sensitivity of 85 % and a specificity of 91 % . Regional SUVRs also correlated well with scores of cognitive impairment such as the MMSE and the word-list memory and word-list recall scores ( r -0·27 to -0·33 , p ≤ 0·021 ) . APOE ɛ4 was more common in participants with positive PET images compared with those with negative scans ( 65%vs 22 % [ p=0·027 ] in patients with Alzheimer 's disease ; 50%vs 16 % [ p = 0·074 ] in healthy controls ) . No safety concerns were noted . INTERPRETATION We provide verification of the efficacy , safety , and biological relevance of florbetaben ( ¹⁸F ) amyloid-β PET and suggest its potential as a visual adjunct in the diagnostic algorithm of dementia . FUNDING Bayer Schering Pharma AG BACKGROUND There is very limited data on the prevalence of abnormal cerebrospinal fluid ( CSF ) biomarkers of Alzheimer 's disease ( AD ) and their predictive value for clinical progression in memory clinic patients with subjective cognitive decline ( SCD ) . OBJECTIVE To assess the frequency of abnormal CSF biomarkers of AD and their predictive value for clinical progression in memory clinic patients with SCD in comparison to patients with mild cognitive impairment ( MCI ) from the same cohort . METHODS We analyzed prospect i ve data from memory clinic patients of the German Competence Network Dementia cohort with a baseline diagnosis of SCD ( n = 82 ) or MCI ( n = 134 ) , distinguished by actuarial neuropsychological MCI criteria ( " Jak-Bondi criteria ") . Risk of clinical progression during 3-year follow-up was evaluated with Cox-Proportional-Hazard models . RESULTS Prevalence of abnormal values in CSF markers of tau-mediated neurodegeneration ( 67.8 % versus 46.3 % ) but not of amyloid deposition ( 40.3 % versus 35.4 % ) was significantly higher in MCI compared to SCD . The rate of incident AD dementia ( 26.1 % versus 12.2 % ) was also significantly higher in MCI . In SCD , additional 22 % progressed to MCI during follow-up . Combined amyloid/tau abnormality was the strongest predictor of clinical progression in both groups . CONCLUSION High prevalence of biomarker abnormality and clinical progression , together with the predictive value of CSF biomarkers , in memory clinic patients with SCD support the validity and usefulness of this condition as a " pre-MCI " at risk stage of AD
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| Conclusion Available data consistently show that risk of progression increases across the pre clinical AD stages , where Stage 3 shows a risk of progression comparable to MCI due to AD .
The possibility to define , in the clinical routine , a patient as “ pre-MCI due to AD ” could offer these subjects the opportunity to use disease-modifying drugs at best |
MS212754 | ***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 Purpose The goal of the study was to evaluate the efficacy of additional axillary nerve block ( ANB ) with suprascapular nerve block ( SSNB ) and patient-controlled anaesthesia ( PCA ) with no device assistance after arthroscopic rotator cuff repair . The hypothesis is that patients with intravenous ( IV ) PCA and the blockade of the two main nerves ( SSNB + ANB ) experienced lesser pain than patients with IV PCA or IV PCA + SSNB . Methods The 114 patients undergoing arthroscopic rotator cuff repair were allocated r and omly to three groups as follows : group I , intravenous PCA pumps ( only PCA ) ; group II , IV PCA + SSNB using a blind technique ( PCA + SSNB ) ; and group III , IV PCA + SSNB + ANB using a blind technique ( PCA + SSNB + ANB ) . Pain visual analogue scale ( VAS ) scores were evaluated at 1 , 6 , 12 , 24 , 36 , and 48 post-operative hours . Furthermore , the degree of pain was compared according to cuff tear size . Results The pain VAS score of group III was lower than that of the other two groups and was significantly lower at post-operative hours 1 , 6 , and 12 . In addition , the larger cuff tear tended to be indicative of greater pain . However , all groups experienced rebound pain . Conclusion PCA + SSNB + ANB using a blind technique is a better pain control method than PCA + SSNB and only PCA during the initial 12 post-operative hours . PCA + SSNB + ANB is a cost-effective , time-saving , and easily performed method for post-operative pain control as an axis of multimodal pain control strategy .Level of evidence II BACKGROUND Local analgesic injections are commonly used for pain relief after shoulder surgery . The aim of this study was to compare the efficacy of local injections administered in the glenohumeral joint , the subacromial space , or both locations after arthroscopic rotator cuff repair . METHODS Between March 2011 and December 2011 , 121 consecutive patients who had undergone arthroscopic rotator cuff repair surgery were enrolled in the study and all patients were r and omly allocated to 3 groups . In group 1 , 40 patients received a postoperative glenohumeral injection of bupivacaine ( 20 mL ) and lidocaine ( 10 mL ) . In group 2 , 42 patients received the same postoperative injection , but it was administered in the subacromial space . In group 3 , 39 patients received the same amount of local anesthesia but with half injected in the glenohumeral joint and half in the subacromial space . The visual analog scale was used to assess pain intensity before surgery and at postoperative hours 1 , 2 , 6 , 12 , and 24 . Demerol was used as a postinjection rescue analgesic , and the total number of administrations was recorded at each time point . RESULTS There were no significant differences between groups in patient age , sex , or rotator cuff tear size ( P > .05 ) . The visual analog scale scores for pain between each group were not significantly different at any time point , including before surgery ( P > .05 ) . In addition , the amount of supplementary analgesic administered was not significantly different between the groups ( P > .05 ) . CONCLUSION Injection of local analgesics after arthroscopic rotator cuff repair relieves postoperative pain regardless of the injection location Purpose This prospect i ve study was undertaken to compare the effectiveness and safety of a multimodal pain control protocol with those of intravenous patient-controlled analgesia in rotator cuff repair . Methods Seventy patients scheduled for rotator cuff repair were r and omized to either a multimodal pain control group ( group 1 , 40 patients ) or an intravenous patient-controlled analgesia group ( group 2 , 30 patients ) . We compared these two groups with respect to level of pain before surgery to the fifth postoperative day , duration of postoperative rehabilitation , consumption of additional analgesics , and adverse effects . Results Mean visual analogue scale scores immediately after surgery ( day 0 ) and on postoperative days 1–5 were 6.9 , 5.5 , 4.3 , 3.3 , 3.0 , and 2.6 in group 1 and 7.8 , 5.9 , 4.4 , 4.7 , 4.3 , and 3.7 in group 2 . Pain relief was significantly better in group 1 on days 0 , 3 , 4 , and 5 ( P = 0.026 , 0.006 , 0.010 , and 0.009 , respectively ) . Furthermore , functional recovery occurred earlier in group 1 . No significant differences were observed between the two groups with respect to nausea , vomiting , urinary retention , and headache ( n.s . ) , but group 1 was found to be significantly less likely to experience dizziness or urticaria ( P = 0.007 , 0.017 , respectively ) . One other significant difference was observed : 1 patient ( 2.5 % ) in group 1 and 6 patients ( 20 % ) in group 2 discontinued regimen because of medication-related adverse effects ( P = 0.016 ) . Conclusion The multimodal pain control protocol was found to offer more effective postoperative pain control with fewer adverse effects than intravenous patient-controlled analgesia . However , achieving adequate pain control within the first 48 h of surgery remains challenging , and thus , the developments of more effective and safer multimodal pain control protocol s are required BACKGROUND : Early mobilization after shoulder surgery plays a vital role in successful functional rehabilitation . However , postoperative pain often reduces , or even prevents , effective physiotherapy . We investigated the effect of analgesia via patient-controlled interscalene technique on early functional rehabilitation after open shoulder surgery . METHODS : Eighty-seven patients were r and omly assigned to one of two groups : patient-controlled continuous interscalene block ( PCISB ) and patient-controlled IV ( opioid ) analgesia ( PCA ) . Interscalene block was performed preoperatively ; otherwise analgesic protocol s were started in the postanesthesia care unit and were continued for 72 h. Physiotherapy was performed for 60 min a day on day 2 and 3 after surgery according to a st and ardized protocol . Maximum mobility was defined as the range of motion that could be achieved with pain as the limiting factor . Efficiency of functional rehabilitation was evaluated 1 day before and 3 days after surgery with the help of a multimodal scoring system ( Constant-Score ) that evaluates pain , daily life activity , strength and range of motion . Maximum intensity of pain was also monitored via Visual Analog Scales for the first 72 h after surgery and during in-hospital physiotherapy . RESULTS : Constant-Score rates were significantly improved by the interscalene block . However , no significant differences in mobility and strength sub-scores were observed between the groups . Compared with PCA , PCISB proved to be beneficial concerning pain at rest at 6 h ( P < 0.001 ) , 24 h ( P = 0.044 ) , and 72 h ( P = 0.013 ) and for pain during physiotherapy at 48 h after surgery ( P = 0.016 ) . CONCLUSION : Compared with opioid-based PCA , PCISB improved analgesia , but not function , during early rehabilitation of the shoulder joint PURPOSE To compare the effect of early versus delayed motion protocol s on quality of life , clinical outcomes , and repair integrity in patients who have undergone arthroscopic single-tendon rotator cuff repair . METHODS This was a prospect i ve , r and omized , investigator-blinded clinical trial . Seventy-three patients from a single surgeon 's practice who underwent arthroscopic repair of a single-tendon rotator cuff tear were r and omized to either an early motion protocol ( starting 2 to 3 days after surgery ) or a delayed motion protocol ( starting 28 days after surgery ) . The primary outcome measure was the Western Ontario Rotator Cuff index ( WORC ) . Secondary outcome measures included clinical outcome scores , integrity of the repair on 6-month magnetic resonance imaging scans , pain scores , physical examination data , and ultrasonography . Study participants were followed up at 3 , 6 , and 12 weeks ; 6 months ; and 1 year postoperatively . RESULTS There was no statistically significant difference in WORC scores at 6 months ( 529 ± 472 in delayed group vs 325 ± 400 in early group , P = .08 ) . Mixed-effects analysis indicated the early group maintained lower WORC scores throughout the postoperative period ( estimated difference of 191 , P = .04 ) . The proportions of patients with tears on the 6-month postoperative magnetic resonance imaging scan were comparable ( 31 % in delayed group vs 34 % in early group , P = .78 ) . CONCLUSIONS There was no difference between the delayed and early motion groups in WORC scores at 6 months after surgery . Early motion was associated with lower WORC scores throughout the postoperative period ; however , both groups had a similar trajectory of improvement , suggesting both protocol s have the same effect on patient-reported improvement . Although failure rates were similar between the groups , the sample size was not sufficient to support a statement regarding the relation between tear morphology and the rehabilitation protocol . LEVEL OF EVIDENCE Level II , lesser- quality r and omized controlled trial Purpose The aim of this study was to compare the pain relieving effect of ultrasound-guided interscalene brachial plexus block ( ISB ) combined with arthroscopy-guided suprascapular nerve block ( SSNB ) with that of ultrasound-guided ISB alone within the first 48 h after arthroscopic rotator cuff repair . Methods Forty-eight patients with rotator cuff tears who had undergone arthroscopic rotator cuff repair were enrolled . The 24 patients in group 1 received ultrasound-guided ISB and arthroscopy-guided SSNB ; the remaining 24 patients in group 2 underwent ultrasound-guided ISB alone . Visual analogue scale pain score and patient satisfaction score were checked at 1 , 3 , 6 , 12 , 18 , 24 , and 48 h post-operatively . Results Group 1 had a lower visual analogue scale pain score at 3 , 6 , 12 , 18 , 24 , and 48 h post-operatively ( 1.7 < 2.6 , 1.6 < 4.0 , 3.5 < 5.8 , 3.6 < 5.2 , 3.2 < 4.2 , 1.3 < 2.0 ) , and a higher patient satisfaction score at 6 , 12 , 18 , 24 , and 36 h post-operatively than group 2 ( 7.8 > 6.0 , 6.2 > 4.3 , 6.4 > 5.1 , 6.9 > 5.9 , 7.9 > 7.1 ) . Six patients in group 1 developed rebound pain twice , and the others in group 1 developed it once . All of the patients in group 2 had one rebound phenomenon each ( p = 0.010 ) . The mean timing of rebound pain in group 1 was later than that in group 2 ( 15.5 > 9.3 h , p < 0.001 ) , and the mean size of rebound pain was smaller in group 1 than that in group 2 ( 2.5 > 4.0 , p = 0.001 ) . Conclusion Arthroscopy-guided SSNB combined with ultrasound-guided ISB result ed in lower visual analogue scale pain scores at 3–24 and 48 h post-operatively , and higher patient satisfaction scores at 6–36 h post-operatively with the attenuated rebound pain compared to scores in patients who received ultrasound-guided ISB alone after arthroscopic rotator cuff repair . The combined blocks may relieve post-operative pain more effectively than the single block within 48 h after arthroscopic cuff repair . Level of evidence R and omized controlled trial , Level I. Clinical Trials.gov Identifier : NCT02424630 BACKGROUND Arthroscopic rotator cuff repair ( ARCR ) can be associated with significant postoperative pain . Concern for opioid abuse has led surgeons to identify alternative , efficacious methods of postoperative analgesia . To determine whether transcutaneous electrical nerve stimulation ( TENS ) can have a similarly beneficial effect after shoulder procedures , we conducted a prospect i ve double-blinded r and omized trial in patients undergoing outpatient ARCR . METHODS All patients undergoing ARCR of a full-thickness rotator cuff tear by the senior authors were identified . Patients with a history of recent narcotic use or prior narcotic abuse and those under management of a pain control specialist were excluded . Patients were r and omized into 2 groups , active or placebo TENS , and used the device for 4 sessions/day for 45 minutes/session for the first postoperative week . All patients received Percocet 5/325 mg ( oxycodone/acetaminophen ) for use as rescue pain pills . One-week narcotic consumption and visual analog scale pain scores were compared between groups . RESULTS The final analysis included 37 patients ( 21 active,16 placebo ) . Baseline and procedural differences were not different between groups . At 1 week postoperatively , patients in the active group had significantly lower pain scores ( 3.6 ± 2.1 vs. 5.8 ± 1.2 ; P= .008 ) . Postoperative Percocet consumption during the initial 48 hours ( 12.
Output:
| Limited evidence was found for pre-operative gabapentin , perineural adjuncts ( opioids , glucocorticoids , or α-2-adrenoceptor agonists added to the local anaesthetic solution ) or postoperative transcutaneous electrical nerve stimulation .
Inconsistent evidence was found for subacromial/intra-articular injection , and for surgical technique-linked interventions , such as platelet-rich plasma .
No evidence was found for stellate ganglion block , cervical epidural block , specific postoperative rehabilitation protocol s or postoperative compressive cryotherapy . |
MS212755 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: OBJECTIVE . We examined whether mild traumatic brain injuries in children and adolescents , especially when associated with acute clinical features reflecting more severe injury , result in different postinjury trajectories of postconcussive symptoms compared with mild orthopedic injuries . PARTICIPANTS AND METHODS . Participants in this prospect i ve and longitudinal cohort study were 8- to 15-year-old children , 186 with mild traumatic brain injuries and 99 with mild orthopedic injuries , who were recruited from consecutive admissions to emergency departments in 2 large children 's hospitals . Parents rated current postconcussive symptoms within 3 weeks of injury and at 1 , 3 , and 12 months after injury . At the initial assessment , parents also provided retrospective ratings of preinjury symptoms , and children with mild traumatic brain injuries received MRI of the brain . Clinical features examined as predictors of postconcussive symptoms included loss of consciousness , Glasgow Coma Scale score below 15 , other injuries , acute symptoms of concussion , and intracranial abnormalities on the MRI . RESULTS . Finite mixture modeling identified 4 longitudinal trajectories of postconcussive symptoms ( ie , no postconcussive symptoms , moderate persistent postconcussive symptoms , high acute/resolved postconcussive symptoms , high acute/persistent postconcussive symptoms ) . The mild traumatic brain injuries and orthopedic injuries groups demonstrated a different distribution of trajectories . Children with mild traumatic brain injuries were more likely than those with orthopedic injuries to demonstrate high acute/resolved and high acute/persistent trajectories relative to the no postconcussive symptoms group . The 2 trajectories with high acute levels of postconcussive symptoms were especially likely among children with mild traumatic brain injuries whose acute clinical presentation reflected more severe injury . CONCLUSIONS . Mild traumatic brain injuries , particularly those that are more severe , are more likely than orthopedic injuries to result in transient or persistent increases in postconcussive symptoms in the first year after injury . Additional research is needed to eluci date the range of factors , both injury related and non – injury related , that place some children with mild traumatic brain injuries at risk for postconcussive symptoms OBJECTIVES This study of concussed adolescents sought to determine if a computer-based neurocognitive assessment ( Immediate Postconcussion Assessment and Cognitive Test [ ImPACT ] ) performed on patients who present to the emergency department ( ED ) immediately following head injury would correlate with assessment s performed 3 to 10 days postinjury and if ED neurocognitive testing would detect differences in concussion severity that clinical grading scales could not . METHODS A prospect i ve cohort sample of patients 11 to 17 years of age presenting to the ED within 12 hours of a head injury were evaluated using two traditional concussion grading scales and neurocognitive testing . ED neurocognitive scores were compared to follow-up scores obtained at least 3 days postinjury . Postconcussive symptoms , outcomes , and complications were assessed via telephone follow-up for all subjects . RESULTS Sixty patients completed phone follow-up . Thirty-six patients ( 60 % ) completed follow-up testing a median of 6 days postinjury . Traditional concussion grading did not correlate with neurocognitive deficits detected in the ED or at follow-up . For the neurocognitive domains of verbal memory , processing speed , and reaction time , there was a significant correlation between ED and follow-up scores trending toward clinical improvement . By 2 weeks postinjury , 23 patients ( 41 % ) had not returned to normal activity . At 6 weeks , six patients ( 10 % ) still had not returned to normal activity . CONCLUSIONS Immediate assessment in the ED can predict neurocognitive deficits seen in follow-up and may be potentially useful to individualize management or test therapeutic interventions . Neurocognitive assessment in the ED detected deficits that clinical grading could not and correlated with deficits at follow-up Childhood traumatic brain injury ( TBI ) is a common , acquired disability , which has significant implication s for subsequent development , and for later quality of life . To date few studies have documented outcomes in these children into adolescence , when academic , social and personal dem and s increase . The objective of this study was to document functional outcomes at 10 years post-injury , and to identify predictors of outcome including injury , socio-demographic and pre-injury characteristics . The study employed consecutive recruitment to a prospect i ve , longitudinal study . Children with a diagnosis of TBI between 2 and 12 years were initially recruited and divided according to injury severity ( mild , moderate , severe ) . The sample was review ed at 10 years post-injury and intellectual , adaptive , executive and social domains were investigated . Results indicated that , at 10 years post child TBI , survivors ' functional abilities fell overall within the low average to average range regardless of injury severity , suggesting no extreme impairments at a group level for any of the domains under investigation . Significant group differences were identified , though , for adaptive abilities and for speed of processing , with more severe injury associated with poorer performances in each instance . Further , a similar trend was identified for measures of intellectual ability and executive functions . Individual rates of impairment were considerably higher than population expectations across all severity groups for these domains . Although rates of social impairment were also elevated , they were less related to injury factors , suggesting that cognitive/adaptive outcomes and social consequences of TBI may have different bases Primary objective : Comparison of healthcare costs for youth with mild traumatic brain injuries ( TBIs ) to costs in a matched cohort of children without TBI in the 3 years following injury . Research design : This study used a prospect i ve cohort design with 3-year follow-up . Costs were examined using the well-established two-step model and controlling for potential confounding variables . Methods and procedures : Four-hundred and ninety subjects from a large health maintenance organization , 14 years old or younger , who sustained a mild TBI in 1993 , were identified using computerized records . For each youth with mild TBI , three control subjects were selected ( n = 1470 ) , matched on age , sex and enrolment at the time of injury . Experimental interventions : Not applicable . Main outcomes and results : TBI exposure was associated with an increase in the proportion of subjects who had non-zero medical costs in all categories examined and a 75 % increase in mean total costs . Presence of psychological distress was also associated with increased proportion of subjects with costs in all categories examined and was associated with an approximate doubling of mean total costs . Conclusions : Mild TBI and psychological distress were each associated with significant increases in healthcare costs in an HMO setting Objective : To test the feasibility of inpatient neurocognitive testing and measure the degree of disability in children hospitalized with mild traumatic brain injury ( MTBI ) . Summary Background Data : MTBI is common in the pediatric population . A st and ardized approach to identify neurocognitive impairment and determine optimal time to return to exertional activities ( eg , school , sports ) is lacking . Methods : For a 2-year period , children ( age : 11–17 years ) hospitalized at a level 1 urban Pediatric Trauma Center with MTBI were prospect ively enrolled . Neurocognitive performance was assessed utilizing previously vali date d computer-based tests ( Immediate Postconcussion Assessment and Cognitive Testing ) as inpatient and in follow-up clinic after discharge . The feasibility of inpatient testing and the degree neurocognitive impairment and symptomatology were assessed . This study was approved by the IRB and registered with clinical trials.gov ( NCT00715949 ) . Results : For the 2 years of study , 116 subjects were prospect ively enrolled and tested . The population had a mean age of 14 years and 69.8 % were male . On initial in-hospital testing , the overall population demonstrated considerable neurocognitive deficits ( mean values for all 4 subtests below 25th percentile , norm 50 % ) with at least one subtest score below 25 % in 95.7 % and an abnormal symptom score in 83.4 % of patients . In comparing initial testing to follow-up testing ( N = 63 ) , significant improvements were noted for all subtests ( verbal memory : 28.0 % vs. 37.5 % , respectively , norm 50 % , P = 0.02 ; visual memory : 24.9 % vs. 38.1 % , respectively , norm 50 % , P < 0.01 ; visual motor : 21.8 % vs. 31.1 % , respectively , norm 50 % , P = 0.01 ; reaction time : 21.8 % vs. 30.3 % , respectively , norm 50 % , P = 0.05 ) , with a decline in the symptom score ( 26.9 vs. 9.2 , respectively , norm 0 - 8 , P < 0.01 ) as well . Patients not seen in follow-up ( N = 53 ) did not differ demographically from those seen in clinic . Conclusions : Inpatient neurocognitive testing was feasible in pediatric MTBI patients . Neurocognitive abnormalities were nearly universally present on initial evaluation with significant improvements demonstrated at the time of outpatient follow-up . Return to activity recommendations are thus best deferred for most hospitalized MTBI children until formal assessment can be performed after discharge The degree to which postinjury posttraumatic stress disorder ( PTSD ) and /or depressive symptoms in adolescents are associated with cognitive and functional impairments at 12 and 24 months after traumatic brain injury ( TBI ) is not yet known . The current study used a prospect i ve cohort design , with baseline assessment and 3- , 12- , and 24-month followup , and recruited a cohort of 228 adolescents ages 14 - 17 years who sustained either a TBI ( n = 189 ) or an isolated arm injury ( n = 39 ) . Linear mixed-effects regression was used to assess differences in depressive and PTSD symptoms between TBI and arm-injured patients and to assess the association between 3-month PTSD and depressive symptoms and cognitive and functional outcomes . Results indicated that patients who sustained a mild TBI without intracranial hemorrhage reported significantly worse PTSD ( Hedges g = 0.49 , p = .01 ; Model R(2 ) = .38 ) symptoms across time as compared to the arm injured control group . Greater levels of PTSD symptoms were associated with poorer school ( η(2 ) = .07 , p = .03 ; Model R(2 ) = .36 ) and physical ( η(2 ) = .11 , p = .01 ; Model R(2 ) = .23 ) functioning , whereas greater depressive symptoms were associated with poorer school ( η(2 ) = .06 , p = .05 ; Model R(2 ) = .39 ) functioning OBJECT The aim of this study was to determine whether the presence of intracranial pathophysiology on computed tomography ( CT ) scans obtained within 24 hours of mild traumatic brain injury ( MTBI ) in children adversely affects neuropsychological outcome during the 1st year postinjury . METHODS A prospect i ve longitudinal design was used to examine the neuropsychological outcomes in children ( ages 5 - 15 years ) who had been treated for MTBI , which was defined as a loss of consciousness for up to 30 minutes and a lowest Glasgow Coma Scale ( GCS ) score of 13 - 15 . Exclusion criteria included any preinjury neurological disorder . Outcome assessment s were performed within 2 weeks and at 3 , 6 , and 12 months postinjury . Outcomes were compared between patients with MTBI whose postinjury CT scans revealed complications of brain pathophysiology ( 32 patients , CMTBI group ) and those with MTBI but without complications ( 48 patients , MTBI group ) . RESULTS Significant interactions confirmed that the pattern of recovery over 12 months after injury differed depending on the intracranial pathology , presence and severity of injuries to body regions other than the head , preinjury attention-deficit hyperactivity disorder ( ADHD ) , and socioeconomic status . Children in the CMTBI group had significantly poorer episodic memory , slower cognitive processing , diminished recovery in managing cognitive interference , and poorer performance in calculating and reading than patients in the MTBI group . Among the patients with mild or no extracranial injury , visuomotor speed was slower in those in the CMTBI group ; and among patients without preinjury ADHD , working memory was worse in those in the CMTBI group . CONCLUSIONS Neuropsychological recovery during the 1st year following MTBI is related to the presence of radiographically detectable intracranial pathology . Children with intracranial pathology on acute CT performed more poorly in several cognitive domains when compared with patients whose CT findings were normal or limited to a linear skull fracture . Depending on the presence of preinjury ADHD and concomitant extracranial injury , working memory and visuomotor speed were also diminished in patients whose CT findings revealed complications following MTBI . Computed tomography within 24 hours postinjury appears to be useful for identifying children with an elevated risk for residual neuropsychological changes The occurrence of postconcussive symptoms ( PCS ) following mild traumatic brain injury ( TBI ) in children may depend on cognitive reserve capacity . This prospect i ve , longitudinal study examined whether the relationship between mild TBI and PCS is moderated by cognitive ability , which served as a proxy for cognitive reserve . Participants included 182 children with mild TBI and 99 children with orthopedic injuries ( OI ) , r
Output:
| CONCLUSIONS The results suggest that not all children with mild or moderate TBI recover without long-term problems .
Few studies followed children and adolescents with mild TBIs for extended periods of time , although it is clinical ly important to monitor patients over time |
MS212756 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Background : Patients with cirrhosis and tense ascites treated by paracentesis alone have a decrease in effective arterial blood volume after ascites removal . Although intravenous albumin is effective in preventing paracentesis induced decreased arterial blood volume , its clinical use is controversial . As paracentesis induces arteriolar vasodilation which plays a role in the development of decreased effective arterial blood volume , administration of a vasoconstrictor ( terlipressin ) could prevent circulatory alterations due to paracentesis . Aims : To perform a pilot study comparing the effects of terlipressin and albumin on effective arterial blood volume in patients with cirrhosis treated by paracentesis for tense ascites . Methods : Twenty patients with cirrhosis and tense ascites were r and omly assigned to be treated by either paracentesis and terlipressin or paracentesis and albumin . Terlipressin ( 3 mg ) or albumin ( 8 g/l of removed ascites ) were administered on the day of paracentesis . Effective arterial blood volume was assessed by measuring plasma renin concentrations at baseline and on the day of hospital discharge ( 4–6 days after treatment ) . Decreased effective arterial blood volume was defined as an increase in plasma renin concentrations on the day of hospital discharge of more than 50 % of baseline values . Results : Irrespective of the treatment group , mean values for plasma renin concentrations at hospital discharge did not differ from their respective baseline values ( p=0.10 ) . Baseline plasma levels of renin concentrations did not differ between the terlipressin and albumin groups ( p=0.61 ) . Changes from baseline in plasma renin concentrations did not differ between groups ( p=0.39 ) . Three patients in the terlipressin group and three in the albumin group developed decreased arterial blood volume . Conclusions : This r and omised pilot study suggests that terlipressin may be as effective as intravenous albumin in preventing a decrease in effective arterial blood volume in patients with cirrhosis treated by paracentesis for tense ascites OBJECTIVES : Intravenous albumin has been used to prevent paracentesis-induced circulatory dysfunction ( PICD ) in cirrhotics ; however , its use is costly and controversial . Splanchnic arterial vasodilatation is primarily responsible for PICD . There are no reports of use of midodrine in the prevention of PICD . In this pilot study , we evaluated midodrine and albumin in the prevention of PICD . METHODS : Forty patients with cirrhosis underwent therapeutic paracentesis with midodrine or albumin in a r and omized controlled trial at a tertiary center . Effective arterial blood volume was assessed by plasma renin activity . RESULTS : Plasma renin activity at baseline and at 6 days after paracentesis did not differ in the two groups ( 43.18 ± 10.73 to 45.90 ± 8.59 ng/mL/h , P= 0.273 in the albumin group and 44.44 ± 8.44 to 41.39 ± 10.21 ng/mL/h , P= 0.115 in the midodrine group ) . Two patients had an increase in plasma renin activity of more than 50 % from baseline in the albumin group , and none in the midodrine group . A significant increase in 24-h urine volume and urine sodium excretion was noted in the midodrine group . Midodrine therapy was cheaper than albumin therapy . CONCLUSIONS : The study suggests that midodrine may be as effective as albumin in preventing PICD in cirrhotics , but at a fraction of the cost , and can be administered orally . Midodrine also result ed in an increase in 24-h urine volume and sodium excretion AIM To investigate the effects of long-term albumin administration on survival , recurrence of ascites and onset of other complications . METHODS One hundred consecutive patients admitted for first-onset ascites were r and omized to receive diuretics plus human albumin 25 g/wk in the first year and 25 g every two wk thereafter ( group 1 ) or diuretics alone ( group 2 ) . The primary endpoint was survival without liver transplantation . Secondary endpoints were recurrence of ascites and occurrence of other complications . RESULTS Median follow-up was 84 ( 2 - 120 ) mo . Albumin-treated patients had significantly greater cumulative survival rate ( Breslow test=7.05 , P=0.0078 ) and lower probability of ascites recurrence ( 51 % versus 94 % , P<0.0001 ) . Chronic albumin infusion result ed in a mean increase in survival of 16 mo . CONCLUSION Long-term albumin administration after first-onset ascites significantly improves patients ' survival and decreases the risk of ascites recurrence Background Transjugular intrahepatic portosystemic shunt ( TIPS ) has recently been reported to be effective in the treatment of cirrhotic patients with refractory ascites . However , the clinical utility of TIPS in the subset of refractory ascitic patients with good hepatic and renal function is uncertain . The aim of this study was to compare the efficacy of TIPS to that of large-volume paracentesis in cirrhotic patients with refractory ascites who have good hepatic and renal function . Methods Sixty cirrhotic patients with refractory ascites who presented with a Child – Pugh score of < 11 , serum bilirubin of <3 mg/dl and creatinine of < 1.9 mg/dl were assigned r and omly to TIPS ( n = 30 ) or large-volume paracentesis plus albumin ( n = 30 ) . The primary endpoint was survival . The secondary endpoints were response to treatment and development of hepatic encephalopathy . Results The baseline characteristics were similar in the two groups . Seventeen patients treated with TIPS and 21 treated with paracentesis died during the study period . The cumulative probabilities of survival at 1 and 2 years were 80 and 64 % in the TIPS group and 49 and 35 % in the paracentesis group ( p < 0.005 ) . TIPS was significantly superior to paracentesis in the control of ascites ( p < 0.005 ) . Treatment failure was more frequent in the paracentesis group , whereas the frequency of hepatic encephalopathy was greater in the TIPS group . Conclusions In cirrhotic patients with refractory ascites who have good hepatic and renal function , TIPS improves survival and provides better control of ascites than large-volume paracentesis BACKGROUND AND AIMS The clinical utility of transjugular intrahepatic portosystemic shunts ( TIPS ) vis-à-vis total paracentesis in the management of refractory ascites is unclear . METHODS A multicenter , prospect i ve , r and omized clinical trial was performed in which 109 subjects with refractory ascites were r and omized to either medical therapy ( sodium restriction , diuretics , and total paracentesis ) ( n = 57 ) or medical therapy plus TIPS ( n = 52 ) . The principal end points were recurrence of tense symptomatic ascites and mortality . RESULTS A technically adequate shunt was created in 49 of 52 subjects . TIPS plus medical therapy was significantly superior to medical therapy alone in preventing recurrence of ascites ( P < 0.001 ) . The total number of deaths in the 2 groups was identical ( TIPS vs. medical therapy alone : 21 vs. 21 ) . There were no significant differences in the 2 arms with respect to overall and transplant-free survival . There was a higher incidence of moderate to severe encephalopathy in the TIPS group ( 20 of 52 vs. 12 of 57 ; P = 0.058 ) . There were no significant differences in the number of subjects who developed liver failure ( 7 vs. 3 ) , variceal hemorrhage ( 5 vs. 8) , or acute renal failure ( 3 vs. 2 ) . There were also no significant differences between the 2 groups in the frequency of emergency-department visits , medically indicated hospitalizations , or quality of life . CONCLUSIONS Although TIPS plus medical therapy is superior to medical therapy alone for the control of ascites , it does not improve survival , affect hospitalization rates , or improve quality of life BACKGROUND & AIMS Paracentesis associated with plasma exp and ers is widely used for the treatment of ascites in cirrhosis . This study investigated the clinical importance of paracentesis-induced-circulatory dysfunction and compared the efficacy of albumin , dextran 70 , and polygeline in preventing this complication . METHODS A total of 289 cirrhotic patients with ascites were r and omized to treatment by total paracentesis plus intravenous albumin ( 97 patients ) , dextran 70 ( 93 patients ) , or polygeline ( 99 patients ) . Postparacentesis circulatory dysfunction was defined as an increase in plasma renin activity on the sixth day after paracentesis of more than 50 % of the pretreatment value to a level > 4 ng.mL-1.h-1 . RESULTS Postparacentesis circulatory dysfunction occurred more frequently in patients treated with dextran 70 ( 34.4 % ; P = 0.018 ) or polygeline ( 37.8 % ; P = 0.004 ) than in those receiving albumin ( 18.5 % ) . The plasma exp and er used and the volume of ascites removed were independent predictors of this complication . Postparacentesis circulatory dysfunction persisted during follow-up and was associated with a shorter time to first readmission ( 1.3 + /- 0.5 vs. 3.5 + /- 0.8 months , median + /- SEM ; P = 0.03 ) and shorter survival ( 9.3 + /- 4.2 vs. 16.9 + /- 4.3 months ; P = 0.01 ) . Creatinine and sodium levels in serum , and Child-Pugh score at inclusion , and postparacentesis circulatory dysfunction were independent predictors of survival . CONCLUSIONS Postparacentesis circulatory dysfunction is not spontaneously reversible and is associated with a shorter time to first readmission and shorter survival . Albumin is the best plasma exp and er to prevent this complication Background Refractory ascites ( RA ) is a complication of cirrhosis which is treated with large volume paracentesis ( LVP ) as the st and ard of care . Alfapump ® system is a fully implantable pump system which reduces the need for LVP . The aim was to assess health-related quality of life ( HRQL ) in patients treated with alfapump ® versus LVP . Methods The data were collected in a multicenter open-label r and omized controlled trial ( clinical trials.gov # NCT01528410 ) . Subjects with cirrhosis Child – Pugh class B or C accompanied by RA were r and omized to receive alfapump ® or LVP . The SF-36v2 and CLDQ scores were compared between the two treatment arms at screening and monthly during treatment . Results Of 60 subjects r and omized , HRQL data were available for 58 ( N = 27 received alfapump ® and N = 31 received LVP only ) . At baseline , no differences were seen between the treatment arms ( all p > 0.05 ) : age 61.9 ± 8.4 , 79.3 % male , MELD scores 11.7 ± 3.3 , 85.2 % Child – Pugh class B , 70.7 % had alcoholic cirrhosis . The mean number of LVP events/subject was lower in alfapump ® than LVP ( 1.1 vs. 8.6 , p < 0.001 ) . The HRQL scores showed a moderate improvement from the baseline levels in subjects treated with alfapump ® ( p < 0.05 for abdominal and activity scores of CLDQ ) but not with LVP ( all one-sided p > 0.05 ) in the first 3 months . Multivariate analysis showed that treatment with alfapump ® was independently associated with better HRQL at 3 months ( total CLDQ score : beta = 0.67 ± 0.33 , p = 0.05 ) . Conclusion As compared to LVP , the use of alfapump ® system is associated with both a reduction in the number of LVP events and improvement of health-related quality of life The aim of the current study was to compare total paracentesis associated with dextran-40 infusion with diuretics in the treatment of tense ascites in patients with cirrhosis . Eighty patients were r and omly allocated to two groups : 40 patients were treated with paracentesis plus dextran-40 infusion ( 8 g per liter of ascitic fluid removed ) , and 40 patients with diuretics . After treatment patients were discharged with diuretics , and patients developing tense ascites during follow up ( 54 + /- 4 weeks ) were treated according to their initial schedule . Paracentesis was more effective than diuretics in mobilizing the ascitic fluid . The incidence of complications was significantly higher ( p < 0.05 ) in the diuretic group ( 38 % ) than in the paracentesis group ( 15 % ) . This difference was mainly due to a higher incidence of hepatic encephalopathy in the former group ( 30 % vs. 2.5 % ) . A significantly higher incidence of
Output:
| Based on very low-certainty evidence , there is considerable uncertainty about whether interventions for ascites in people with decompensated liver cirrhosis decrease mortality , adverse events , or liver transplantation compared to paracentesis plus fluid replacement in people with decompensated liver cirrhosis and ascites .
Based on very low-certainty evidence , transjugular intrahepatic portosystemic shunt and adding aldosterone antagonists to paracentesis plus fluid replacement may increase the resolution of ascites compared to paracentesis plus fluid replacement .
Based on very low-certainty evidence , aldosterone antagonists plus loop diuretics may increase the decompensation rate compared to paracentesis plus fluid replacement |
MS212757 | ***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: Aim : To evaluate the effect of local injury to the endometrium during spontaneous menstrual cycles before in vitro fertilization ( IVF ) treatment on implantation and pregnancy rates in women with recurrent implantation failure ( RIF ) . Methods : In a prospect i ve r and omized controlled trial ( RCT ) , a total of 36 patients , with RIF undergoing IVF , were r and omized to two groups . In 18 patients , endometrial biopsies were performed using a pipelle curette on days 9–12 and 21–24 of the menstrual cycle preceding IVF treatment . In 18 control patients , a cervical pipelle was performed . Results : The implantation rate ( 2.08 % versus 11.11 % ; p = 0.1 ) , clinical ( 0 % versus 31.25 % ; p < 0.05 ) and live births rates ( 0 % versus 25 % ; p = 0.1 ) were lower in the experimental group compared with controls . Conclusion : Our RCT did not find any benefit from local injury to the endometrium in women with a high number of RIFs . Further studies are warranted to better define the target population of patients who may benefit from this procedure OBJECTIVES To investigate the effect of endometrial scratching , performed during oral contraceptive pill ( OCP ) pretreatment , on reproductive outcome and on ultrasound markers of endometrial receptivity , and to assess the pain involved in the procedure , in unselected women undergoing assisted reproductive techniques ( ART ) . METHODS Women undergoing ART were r and omly allocated to undergo either endometrial scratching with a pipelle de Cornier or a sham procedure , 7 - 14 days before starting controlled ovarian stimulation ( COS ) . We evaluated subsequent rates of clinical pregnancy , live birth , implantation , miscarriage and multiple pregnancy . Pain during the procedure was evaluated using a 10-cm visual analog scale . Endometrial thickness and volume and three-dimensional power Doppler ( 3D-PD ) indices ( vascularization index ( VI ) , flow index ( FI ) and vascularization flow index ( VFI ) ) were assessed during COS when there was at least one follicle ≥ 17 mm in diameter . RESULTS We included 158 women . Endometrial scratching was associated with higher rates of live birth ( 41.8 % vs 22.8 % , P = 0.01 ) and clinical pregnancy ( 49.4 % vs 29.1 % , P = 0.01 ) and higher pain score ( 6.42 ± 2.35 cm vs 1.82 ± 1.52 cm , P < 0.001 ) , endometrial VI ( 3.71 ± 1.77 vs 2.95 ± 1.56 , P < 0.01 ) and VFI ( 0.97 ± 0.51 vs 0.76 ± 0.40 , P < 0.01 ) . There was no significant effect of endometrial scratching on rate of miscarriage ( 15.4 % vs 21.7 % , P = 0.53 ) or multiple pregnancy ( 22.5 % vs 25.0 % , P = 0.79 ) , or on endometrial thickness ( 10.12 ± 1.55 mm vs 9.98 ± 1.62 mm , P = 0.59 ) , endometrial volume ( 6.18 ± 1.63 cm(3 ) vs 6.01 ± 1.48 cm(3 ) , P = 0.51 ) or FI ( 26.12 ± 2.82 vs 25.91 ± 2.72 , P = 0.65 ) . CONCLUSIONS Endometrial scratching performed once , during OCP pretreatment 7 - 14 days before starting COS , increases the chance of live birth and clinical pregnancy , but might cause considerable pain OBJECTIVE To evaluate the effect of a single endometrial biopsy regimen ( S-EBR ) in the cycle preceding the ICSI cycle in patients with repeated implantation failure . STUDY DESIGN This was a prospect i ve r and omized controlled trial which included two-hundred infertile women with a history of repeated implantation failure . The subjects were r and omly divided into two groups . Group A subjects underwent hysteroscopy and endometrial scraping by Novak curette in the cycle preceding the ICSI cycle , while group B subjects underwent hysteroscopy without endometrial scraping . Implantation rate , clinical pregnancy rate , abortion rate and live birth rate were compared between both groups . RESULTS The number of retrieved oocytes in group A was 11.6 ± 3 and in group B was 11.6 ± 2.8 with no statistically significant difference ( p=0.787 ) . There were statistically significant differences regarding the implantation rate , the clinical pregnancy rate and live birth rate . The implantation rate in group A was 12 % while in group B it was 7 % ( p=0.015 ) , the clinical pregnancy rate was 32 % in group A while it was only 18 % in group B ( p=0.034 ) and the live birth rate was 28 % in group A while it was 14 % in group B ( p=0.024 ) . CONCLUSIONS The single endometrial biopsy regimen ( S-EBR ) performed during hysteroscopy has statistically significant higher implantation rate , clinical pregnancy rate and live birth rate than hysteroscopy without endometrial scraping
Output:
| But , as the critics rightfully point out , studies that include meta-analyses are often not without biases . |
MS212758 | ***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 To prospect ively evaluate peri-implant bone and soft tissue dimension changes around adjacent implants placed at different horizontal interimplant distances . MATERIAL S AND METHODS Thirty partially edentulous patients , who underwent rehabilitation with two adjacent implant-supported crowns as part of their treatment plan , were assigned to three groups based on their prosthetic needs . Patients in group A ( 10 patients , 20 implants ) were to have two implants placed at a 2-mm interimplant distance , patients in group B ( 10 patients , 20 implants ) were to have two implants placed at a 3-mm interimplant distance , and patients in group C ( 10 patients , 20 implants ) were to have two implants placed at an interimplant distance of > 4 mm according to their prosthetic needs . All patients received single-crown restorations after 3 months . Clinical examinations were performed at the time of crown placement ( T3 ) , and 6 months ( T6 ) , 12 months ( T12 ) , and 24 months ( T24 ) after implant placement . Peri-implant bone levels were assessed radiographically at the time of implant placement ( T0 ) , and at T3 , T12 , and T24 . RESULTS One patient from group C did not return for follow-up examinations after implant placement . The mean ( ± st and ard deviation ) horizontal interimplant distance was 1.97 ± 0.44 mm for implants in group A , 3.12 ± 0.15 mm for implants in group B , and 5.3 ± 0.64 mm for implants in group C. For group A , the mean marginal bone loss was 0.29 ± 0.51 mm at the T0-T3 interval , 0.31 ± 0.36 mm at the T0-T12 interval , and 0.27 ± 0.33 mm at the T0-T24 interval . For group B , the mean marginal bone loss was 0.16 ± 0.29 mm at the T0-T3 interval , 0.20 ± 0.28 mm at the T0-T12 interval , and 0.23 ± 0.28 mm at the T0-T24 interval . For group C , the mean marginal bone loss was 0.51 ± 0.84 mm at the T0-T3 interval , 0.45 ± 0.72 mm at the T0-T12 interval , and 0.44 ± 0.74 mm at the T0-T24 interval . For group A , the mean midproximal bone loss was 0.33 ± 0.50 mm at the T0-T3 interval , 0.45 ± 0.35 mm at the T0-T12 interval , and 0.40 ± 0.32 mm at the T0-T24 interval . For group B , the mean midproximal loss was 0.31 ± 0.37 mm at the T0-T3 interval , 0.32 ± 0.39 mm at the T0-T12 interval , and 0.33 ± 0.42 mm at the T0-T24 interval . For group C , the mean midproximal bone loss was 0.40 ± 0.44 mm at the T0-T3 interval and 0.41 ± 0.50 mm at both the T0-T12 and T0-T24 intervals . There were no statistically significant differences in marginal and midproximal bone crest loss between the different groups at any time point . CONCLUSION The study failed to support the hypothesis that horizontal interimplant distance has an effect on peri-implant bone and soft tissue dimension changes for implants with internal conical implant-abutment interface connection and platform-switching characteristics PURPOSE The aim of this pilot study was to determine what effect thin mucosal tissues can have on crestal bone stability around implants with platform switching . MATERIAL S AND METHODS Twelve 2-piece implants , consisting of 6 implants with horizontally matching implant-abutment connection ( control ) and 6 implants with platform switching ( test ) were placed in 4 patients . The mean age of the patients was 43 years ( range , 37 to 56 yrs ) . Mucosal tissue thickness at implant sites was measured to be 2 mm or less . Implants were restored with 5 splinted crowns and single 3-unit fixed partial denture . Intraoral radiographs were obtained and crestal bone changes were measured at implant placement and after a 1-year follow-up post-treatment . The statistical significance level was set to P less than .05 . RESULTS Bone loss around the test implants was 1.81 + /- 0.39 mm on the mesial site and 1.70 + /- 0.35 mm on the distal aspect . Control implants overcame marginal bone resorption equaling 1.60 + /- 0.46 mm on the mesial site and 1.76 + /- 0.45 mm on distal measurement . No statistically significant difference was found between control and test implants either mesially ( F([1,10 ] ) = 0.746 ; P = .408 ) or distally ( F([1,10 ] ) = 0.080 ; P = .783 ) . CONCLUSION Within the limitations of this pilot study it can be concluded that implants with platform switching did not preserve crestal bone better in comparison with implants with traditional implant-abutment connection if , at the time of implant placement , thin mucosal tissues were present AIM To evaluate the peri-implant tissues in patients with two adjacent implant crowns in the aesthetic zone , treated with either two adjacent implants with a scalloped platform or with a flat platform . MATERIAL AND METHODS Forty patients were r and omly allocated to : ( 1 ) a " scalloped implant group " : 20 patients treated with two adjacent implants with a scalloped platform , and ( 2 ) a " flat implant group " : 20 patients treated with two adjacent implants with a flat platform . Clinical and radiographic examinations were performed during a 1-year follow-up period to assess hard and soft tissue changes . RESULTS The scalloped implant group showed significantly more marginal bone loss ( scalloped : 2.7±1.4 mm , flat : 0.9±0.8 mm ) and more inter-implant bone crest loss ( scalloped : 1.8±1.4 , flat : 1.0±0.9 mm ) than the flat implant group . There was no significant difference between the groups with regard to the papilla index and patients ' satisfaction . CONCLUSION After 1 year of function , there was more bone loss around scalloped implants than around flat implants . With regard to the presence of papilla , there were no differences between the groups . With both applied implant design s , it is difficult to establish a predictable and harmonious aesthetic result , especially regarding the peri-implant mucosa . Patients were very satisfied with the aesthetic outcome of the adjacent implants irrespective of the treatment concept applied PURPOSE The aim of this clinical trial was to evaluate the influence of gingival tissue thickness on crestal bone loss around dental implants after a 1-year follow-up . MATERIAL S AND METHODS Forty-six implants ( 23 test and 23 control ) were placed in 19 patients . The test implants were placed about 2 mm supracrestally , whereas the control implants were positioned at the bone level . Before implant placement , the tissue thickness at implant sites was measured with a periodontal probe . After healing , metal-ceramic cement-retained prostheses were constructed . According to tissue thickness , the test implants were divided into A ( thin ) and B ( thick ) groups . Intraoral radiographs were performed and crestal bone changes were measured at implant placement and after 1 year . RESULTS Mean bone loss around the test implants in group A ( thin mucosa ) was 1.61 + /- 0.24 mm ( SE ; range , 0.9 to 3.3 mm ) on the mesial and 1.28 + /- 0.167 mm ( range , 0.8 to 2.1 mm ) on the distal . Mean bone loss in test group B ( thick mucosa ) implants was 0.26 + /- 0.08 mm ( range , 0.2 to 0.9 mm ) on the mesial aspect and 0.09 + /- 0.05 mm ( range , 0.2 to 0.6 mm ) on the distal aspect . Mean bone loss around control implants was 1.8 + /- 0.164 mm ( range , 0.6 to 4.0 mm ) and 1.87 + /- 0.166 mm ( range , 0.0 to 4.1 mm ) on the mesial and distal aspects , respectively . Analysis of variance revealed a significant difference in terms of bone loss between test A ( thin ) and B ( thick ) groups on both the mesial and the distal . CONCLUSION Initial gingival tissue thickness at the crest may be considered as a significant influence on marginal bone stability around implants . If the tissue thickness is 2.0 mm or less , crestal bone loss up to 1.45 mm may occur , despite a supracrestal position of the implant-abutment interface
Output:
| Based on the available evidence , it is not possible to define a precise threshold for the optimal horizontal distance between two adjacent implants |
MS212759 | ***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 Thimerosal is an organic-mercury (Hg)-containing compound ( 49.55 % Hg by weight ) historically added to many multi-dose vials of vaccine as a preservative and still added to some vaccines today . Concerns about the toxic effects from Thimerosal-containing childhood vaccines and the risk of an atypical autism diagnosis were evaluated in this study . METHODS A hypothesis-testing , prospect i ve longitudinal , case-control study assessed exposure to Hg from Thimerosal-containing hepatitis B vaccines ( TM-HepB ) among cases diagnosed with atypical autism ( n=164 ) and controls ( n=15,216 ) . Automated medical records for subjects born from 1991 to 2000 and continuously enrolled in the Vaccine Safety Data link ( VSD ) data base were examined . RESULTS Cases diagnosed with atypical autism were statistically significantly more likely to have received greater overall and dose-dependent exposures to Hg from TM-HepB vaccines administered within the first month of life , first two months of life , and first six months of life than the controls . Similar phenomena were observed when cases and controls were separated by gender . CONCLUSIONS Routine childhood vaccination is an important public health tool to reduce infectious diseases . The present study provides important epidemiological evidence significantly associating increasing Hg exposure from Thimerosal-containing childhood vaccines and the subsequent risk of atypical autism diagnosis , and suggests that Thimerosal should be eliminated from vaccines
Output:
| Results of the current meta- analysis revealed that mercury is an important causal factor in the etiology of ASD .
It seems that the detoxification and excretory mechanisms are impaired in ASD patients which lead to accumulation of mercury in the body . |
MS212760 | ***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: Rationale Buprenorphine may be a useful alternative option to methadone in addicts . Opioids can produce severe changes in the immune system . Objectives The objectives of this study are to compare the effect of sublingual buprenorphine and methadone on the immune system and to compare the two substances on the drying-out program compliance . Methods We studied 62 r and omized out patients for a period of 12 months . Subjects ( 55 males and 7 females ; mean age 25±4 years ; average history of heroin abuse being 2 years ) on maintenance treatment were assigned in two groups ( A and B ) . Methadone chloride ( medium dose 100 mg/day ) was administered to group A , whereas group B received sublingual buprenorphine ( 32.40±2.8 mg/day ) . Urine toxicological screening , plasma levels of TNF-alpha interleukin-1 , interleukin-beta , lymphocyte CD14 and a self-rating depression question naire were measured . Results Urine screening was negative for opiates in 17.6 % of group A and in 10.7 % of group B ( p<0.001 ; r=0.62 ) . Depression score was 62±2 in group A and 55±3 in group B ( p<0.01 ) . Cytokine and CD14 revealed higher concentrations both in groups A and B without significant differences ( p>0.05 ) between the two groups . Conclusions The effects of buprenorphine and methadone tested on the immune system were overlapping in our patients . The elevated cytokine levels observed may suggest that the two drugs stimulate immunologic hyperactivation of an immune system that was formerly inhibited by heroin . Furthermore , our data suggest that buprenorphine can be a valid alternative to methadone in maintenance treatment of chronic heroin abuse and referred a marked decline in depression Patients on methadone maintenance therapy are relatively intolerant of pain , a finding hypothesized to reflect a hyperalgesic state induced by chronic opioid administration . To explore if the intrinsic activity of the opioid maintenance agent might affect expression of hyperalgesia in this population , withdrawal latency for cold-pressor ( CP ) pain was compared between small groups of methadone-maintained ( n = 18 ) , buprenorphine-maintained ( n = 18 ) , and matched control ( n = 18 ) subjects . The opioid-maintained groups had equal and significantly shorter withdrawal latencies than controls , however it is possible that high rates of continued illicit opioid use precluded finding differences between methadone and buprenorphine groups . Differential effects of maintenance agent were found for the few subjects without illicit opioid use , such that withdrawal latencies for methadone-maintained ( n = 5 ) were less than for buprenorphine-maintained ( n = 7 ) which were less than controls ( n = 18 ) . Diminished pain tolerance in patients receiving opioid maintenance treatment has significant clinical implication s. More research is needed to determine if buprenorphine offers advantages over methadone in this regard Methadone medical maintenance ( MMM ) reduces the reporting schedule for stable and well-functioning methadone maintenance patients to once a month , with counseling provided by medical staff . We report on the 12-month outcomes of 92 highly stable methadone maintenance patients r and omly assigned to one of three study conditions : routine care , MMM at the methadone maintenance program , and MMM at a physician 's office . Methadone medical maintenance patients received a 28-day supply of methadone , whereas routine care patients received five or six take-home methadone doses each week . All patients performed a medication recall once a month and su bmi tted two urine sample s each month . An adaptive stepped-care system of treatment intensification was used for patients who failed recall or who had drug-positive urine specimens . Seventy-seven patients completed the 12-month study period . Dropout was caused primarily by problems with h and ling methadone and disliking the recall frequency . There were low rates of drug use or failed medication recall . Treatment satisfaction was high in all groups , but the MMM patients initiated more new employment or family/social activities than did routine care patients over the study period . The stepped-care approach was well tolerated and matched patients to an appropriate step of service within a continuum of treatment intensity Abstract Background Buprenorphine dependence is a relatively novel addiction . Aims To compare the treatment outcome in three groups over 12-weeks of treatment . Methods Two hundred and four intravenous (IV)-buprenorphine-dependent patients were r and omised into three groups . Subjects received 50 mg oral methadone tablet , or 5 mg sublingual buprenorphine tablet , or 50 mg oral naltrexone , and a weekly 30-minute clinical counselling session . Results The majority ( 80 % ) had a history of opium or heroin dependency before they were introduced to IV buprenorphine . The main source of buprenorphine for misusers was street sale ( 91 % ) . The mean duration of buprenorphine dependence was 1.9 years and the mean dose per day was 3.9 ampoules ( 1 ampoule contains 0.3 mg of buprenorphine in 1ml ) . Overall 59 % of the patients completed the 12-week study . Retention in the 50 mg methadone group was significantly better than the 5 mg dose buprenorphine group ( p=0.001 ) and the 50 mg dose naltrexone group ( p=0.000 ) . Retention in the 5 mg buprenorphine group was significantly better than the 50 mg naltrexone dose group ( p=0.000 ) . Conclusions These results support the efficacy and safety of oral methadone and sublingual buprenorphine tablets for injection buprenorphine-dependent patients BACKGROUND The partial opiate-receptor agonist buprenorphine has been suggested for treatment of heroin dependence , but there are few long-term and placebo-controlled studies of its effectiveness . We aim ed to assess the 1-year efficacy of buprenorphine in combination with intensive psychosocial therapy for treatment of heroin dependence . METHODS 40 individuals aged older than 20 years , who met DSM-IV criteria for opiate dependence for at least 1 year , but did not fulfil Swedish legal criteria for methadone maintenance treatment were r and omly allocated either to daily buprenorphine ( fixed dose 16 mg sublingually for 12 months ; supervised daily administration for a least 6 months , possible take-home doses thereafter ) or a tapered 6 day regimen of buprenorphine , thereafter followed by placebo . All patients participated in cognitive-behavioural group therapy to prevent relapse , received weekly individual counselling sessions , and su bmi tted thrice weekly supervised urine sample s for analysis to detect illicit drug use . Our primary endpoint was 1-year retention in treatment and analysis was by intention to treat . FINDINGS 1-year retention in treatment was 75 % and 0 % in the buprenorphine and placebo groups , respectively ( p=0.0001 ; risk ratio 58.7 [ 95 % CI 7.4 - 467.4 ] ) . Urine screens were about 75 % negative for illicit opiates , central stimulants , cannabinoids , and benzodiazepines in the patients remaining in treatment . INTERPRETATION The combination of buprenorphine and intensive psychosocial treatment is safe and highly efficacious , and should be added to the treatment options available for individuals who are dependent on heroin AIMS To evaluate the effectiveness of buprenorphine compared with methadone maintenance therapy in opiate addicts over a treatment period of 24 weeks . DESIGN Subjects were r and omized to receive either buprenorphine or methadone in an open , comparative study . SETTING Subjects were recruited and treated at the drug addiction outpatient clinic at the University of Vienna . PARTICIPANTS Sixty subjects ( 19 females and 41 males ) who met DSM-IV criteria for opioid dependence and were seeking treatment . INTERVENTION Subjects received either sublingual buprenorphine ( 2-mg or 8-mg tablets ; maximum daily dose 8 mg ) or oral methadone ( racemic D -/+ L-methadone ; maximum daily dose 80 mg ) . A stable dose was maintained following the 6-day induction phase . MEASUREMENT Assessment of treatment retention and illicit substance use ( opiates , cocaine and benzodiazepines ) was made by urinalysis . FINDINGS The retention rate was significantly better in the methadone maintained group ( p < 0.05 ) but subjects completing the study in the buprenorphine group had significantly lower rates of illicit opiate consumption ( p = 0.04 ) . CONCLUSION The results support the superiority of methadone with respect to retention rate . However , they also confirm previous reports of buprenorphine use as an alternative in maintenance therapy for opiate addiction , suggesting that a specific subgroup may be benefiting from buprenorphine . This is the first comparative trial to use sublingual buprenorphine tablets : previously published comparison studies refer to 30 % solutions of buprenorphine in alcohol BACKGROUND Prescription opioid dependence is a growing problem , but little research exists on its treatment , including patient characteristics that predict treatment outcome . METHODS A secondary analysis of data from a large multisite , r and omized clinical trial , the National Drug Abuse Treatment Clinical Trials Network Prescription Opioid Addiction Treatment Study ( POATS ) was undertaken to examine baseline patient characteristics ( N=360 ) associated with success during 12-week buprenorphine/naloxone treatment for prescription opioid dependence . Baseline predictor variables included self-reported demographic and opioid use history information , diagnoses assessed via the Composite International Diagnostic Interview , and historical opioid use and related information from the Pain And Opiate Analgesic Use History . RESULTS In bivariate analyses , pre-treatment characteristics associated with successful opioid use outcome included older age , past-year or lifetime diagnosis of major depressive disorder , initially obtaining opioids with a medical prescription to relieve pain , having only used opioids by swallowing or sublingual administration , never having used heroin , using an opioid other than extended-release oxycodone most frequently , and no prior opioid dependence treatment . In multivariate analysis , age , lifetime major depressive disorder , having only used opioids by swallowing or sublingual administration , and receiving no prior opioid dependence treatment remained as significant predictors of successful outcome . CONCLUSIONS This is the first study to examine characteristics associated with treatment outcome in patients dependent exclusively on prescription opioids . Characteristics associated with successful outcome after 12 weeks of buprenorphine/naloxone treatment include some that have previously been found to predict heroin-dependent patients ' response to methadone treatment and some specific to prescription opioid-dependent patients receiving buprenorphine/naloxone Ninety-six confirmed heroin addicts requesting a heroin maintenance prescription were r and omly allocated to treatment with injectable heroin or oral methadone . Progress was monitored throughout the next 12 months by research workers operating independently of the clinic . Heroin can be seen as maintaining the status quo , with the majority continuing to inject heroin regularly and to supplement their maintenance prescription from other sources ; it was associated with a continuing intermediate level of involvement with the drug subculture and criminal activity . Refusal to prescribe heroin while offering oral methadone constituted a more confrontational response and result ed in a higher abstinence rate , but also a greater dependence on illegal sources of drugs for these who continued to inject . Those offered oral methadone tended to polarize toward high or low categories of illegal drug use and involvement with the drug subculture , and were more likely to be arrested during the 12-month follow-up . There was no difference between the two groups in terms of employment , health , or consumption of nonopiate drugs . Refusal to prescribe heroin result ed in a significantly greater drop out from regular treatment AIMS To evaluate the safety and efficacy of an 8 mg/day sublingual dose of buprenorphine in the maintenance treatment of heroin addicts by comparison with a 1 mg/day dose over a 16-week treatment period . As a secondary objective , outcomes were determined concurrently for patients treated with two other dose levels . DESIGN Patients were r and omized to four dosage groups and treated double-blind . SETTING Twelve outpatient opiate maintenance treatment centers throughout the United States . PARTICIPANTS Two hundred and thirty-nine women and 497 men who met the DSM-III-R criteria for opioid dependence and were seeking treatment . INTERVENTION Patients received either 1 , 4 , 8 or 16 mg/day of buprenorphine and were treated in the usual clinical context , including a 1-hour weekly clinical counseling session . MEASUREMENT Retention in treatment , illicit opioid use as determined by urine toxicology , opioid craving and global ratings by patient and staff . Safety outcome measures were provided by clinical monitoring and by analysis of the reported adverse events . FINDINGS Outcomes in the 8 mg group were significantly better than in the 1 mg group in all four efficacy domains . No deaths occurred in either group . The 8 mg group did not show an increase in the frequency of adverse events . Most reported adverse effects were those commonly seen in patients treated with opioids . CONCLUSIONS The findings support the safety and efficacy of buprenorphine and suggest that an adequate dose of buprenorphine will be a useful addition to pharmacotherapy Buprenorphine at 2 mg and 6 mg daily was
Output:
| Studies evaluating illicit opioid consumption using other measures demonstrate pain to increase the risk for opioid abuse .
Conclusion CNCP may increase risk for continued opioid abuse and poor psychiatric functioning . |
MS212761 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: Background : The BioEnterics ® Intragastric Balloon ( BIB ® ) System in association with restricted diet has been used for the short-term treatment of morbid obesity . Aim of this study was to evaluate the real , short term , efficacy of the BIB for weight reduction in morbidly obese patients by using a prospect i ve , double-blind , r and omised , sham-controlled , crossover study . Methods : Patients were recruited from January 2003 to December 2003 . After selection , they were r and omly allocated into two groups : BIB followed by sham procedure after 3 months ( Group A ) , and sham procedure followed by BIB after 3 months ( Group B ) . All endoscopic procedures were performed under unconscious intravenous sedation . The BioEnterics Intragastric Balloon ( Inamed Health ; Santa Barbara , CA , USA ) was filled by using saline ( 500 ml ) and methylene blue ( 10 ml ) . Patients were discharged with omeprazole therapy and diet ( 1000 kcal ) . Patients were followed up weekly by a physician blinded to r and omisation . In both groups mortality , complications , BMI , BMI reduction and % EWL were considered . Data were expressed as mean±s.d . , except as otherwise indicated . Statistical analysis was performed by means of Student 's t-test , Fisher 's exact test or χ 2 with Yates correction ; P<0.05 was considered significant . Results : A total of 32 patients were selected and entered the study ( 8M/24F ; mean age : 36.2±5.6 years , range 25–50 years ; mean BMI 43.7±1.5 kg/m2 , range 40–45 kg/m2 ; mean % EW : 43.1±13.1 , range : 35–65 ) . All patients completed the study . Mortality was absent . Complications related to endoscopy , balloon placement and removal were absent . Mean time of BIB positioning was 15±2 min , range 10–20 min . After the first 3 months of the study , in Group A patients the mean BMI significantly ( P<0.001 ) lowered from 43.5±1.1 to 38.0±2.6 kg/m2 , while in Group B patients the decrease was not significant ( from 43.6±1.8 to 43.1±2.8 kg/m2 ) . The mean % EWL was significantly higher in Group A than in Group B ( 34.0±4.8 vs 2.1±1 % ; P<0.001 ) . After crossover , at the end of the following 3 months , the BMI lowered from 38.0±2.6 to 37.1±3.4 kg/m2 and from 43.1±2.8 to 38.8±3.1 kg/m2 in Groups A and B , respectively . Conclusions : The results of this study show that treatment of obese patients with BioEnterics Intragastric Balloon is a safe and effective procedure . In association with appropriate diet it is significantly effective in weight reduction when compared to sham procedure plus diet . The BIB ® procedure can play a role in weight reduction in morbidly obese patients or in the preoperative treatment of bariatric patients OBJECTIVES We sought to evaluate the safety and efficacy of percutaneous transmyocardial revascularization ( PTMR ) in patients with refractory angina caused by one or more chronic total occlusions ( CTOs ) of a native coronary artery . BACKGROUND Previous unblinded , r and omized trials of PTMR in patients with end-stage coronary artery disease and refractory angina have demonstrated significant relief of angina and increased exercise duration . Whether such benefits would be realized in blinded patients with less extensive coronary artery disease is unknown . METHODS A total of 141 consecutive patients with class III or IV angina caused by one or more chronically occluded native coronary arteries in which a percutaneous coronary intervention ( PCI ) had failed were prospect ively r and omized , at 17 medical centers , in the same procedure , to PTMR plus maximal medical therapy ( MMT ) ( n = 71 ) or MMT only ( n = 70 ) . Blinding was achieved through heavy sedation , dark goggles and the concurrent performance of PCI in all patients . RESULTS Baseline characteristics were similar between the two groups . A median number of 20 laser channels were created in patients r and omized to PTMR . At six months , the anginal class improved by two or more classes in 49 % of patients assigned to PTMR and in 37 % of those assigned to MMT ( p = 0.33 ) . The median increase in exercise duration from baseline to six months was 64 s with PTMR versus 52 s with MMT ( p = 0.73 ) . There were no differences in the six-month rates of death ( 8.6 % vs. 8.8 % ) , myocardial infa rct ion ( 4.3 % vs. 2.9 % ) or any revascularization ( 4.3 % vs. 5.9 % ) in the PTMR and MMT groups , respectively ( p = NS for all ) . CONCLUSIONS In patients with class III or IV angina caused by nonrecanalizable CTOs , the performance of PTMR does not result in a greater reduction in angina , improvement in exercise duration or survival free of adverse cardiac events , as compared with MMT only Background Surgical placebos are controversial . This in-depth study explored the design , acceptability , and feasibility issues relevant to design ing a surgical placebo-controlled trial for the evaluation of the clinical and cost effectiveness of arthroscopic lavage for the management of people with osteoarthritis of the knee in the UK . Methods Two surgeon focus groups at a UK national meeting for orthopaedic surgeons and one regional surgeon focus group ( 41 surgeons ) ; plenary discussion at a UK national meeting for orthopaedic anaesthetists ( 130 anaesthetists ) ; three focus groups with anaesthetists ( one national , two regional ; 58 anaesthetists ) ; two focus groups with members of the patient organisation Arthritis Care ( 7 participants ) ; telephone interviews with people on consultant waiting lists from two UK regional centres ( 15 participants ) ; interviews with Chairs of UK ethics committees ( 6 individuals ) ; postal surveys of members of the British Association of Surgeons of the Knee ( 382 surgeons ) and members of the British Society of Orthopaedic Anaesthetists ( 398 anaesthetists ) ; two centre pilot ( 49 patients assessed ) . Results There was widespread acceptance that evaluation of arthroscopic lavage had to be conducted with a placebo control if scientific rigour was not to be compromised . The choice of placebo surgical procedure ( three small incisions ) proved easier than the method of anaesthesia ( general anaesthesia ) . General anaesthesia , while an excellent mimic , was more intrusive and raised concerns among some stakeholders and caused extensive discussion with local decision-makers when seeking formal approval for the pilot . Patients were willing to participate in a pilot with a placebo arm ; although some patients when allocated to surgery became apprehensive about the possibility of receiving placebo , and withdrew . Placebo surgery was undertaken successfully . Conclusions Our study illustrated the opposing and often strongly held opinions about surgical placebos , the ethical issues underpinning this controversy , and the challenges that exist even when ethics committee approval has been granted . It showed that a placebo-controlled trial could be conducted in principle , albeit with difficulty . It also highlighted that not only does a placebo-controlled trial in surgery have to be ethically and scientifically acceptable but that it also must be a feasible course of action . The place of placebo-controlled surgical trials more generally is likely to be limited and require specific circumstances to be met . Suggested criteria are presented . Trial registration numberThe trial was assigned IS RCT N02328576 through http://controlled-trials.com/ in June 2006 . The first patient was r and omised to the pilot in July 2007 BACKGROUND & AIMS Ablation of gastric inlet patches ( GIP ) in the cervical esophagus by argon plasma coagulation ( APC ) can alleviate chronic globus sensations in the throat . We investigated the efficacy of this therapy in a r and omized , controlled multicenter trial . METHODS Patients with chronic globus sensations and GIP were r and omly assigned 1:1 to groups that were treated with APC or a sham procedure ( controls ) . Patients and their referring physicians were blinded to therapy . All patients completed a st and ardized question naire about symptoms before and 3 months after the procedure . Thereafter , control patients were eligible for cross-over therapy . Long-term efficacy was assessed in all patients > or=6 months after APC . RESULTS Improvement of symptoms was reported in 9 ( 82 % ) of 11 patients who received APC , compared with 0 ( 0 % ) of 10 patients in the control group ( P = .002 ) . Nine ( 90 % ) of 10 patients treated with APC had per protocol healing , compared with 0 ( 0 % ) of 9 controls ( P < .001 ) . Scores for symptom/globus assessment significantly improved in patients in the APC group , whereas patients in the control group did not perceive any symptom relief . Eight of the 10 patients who started in the control group crossed over to the APC group . Long-term efficacy ( after a median follow-up of 17 months ) was documented in 13 ( 76 % ) of 17 treated patients . CONCLUSIONS Ablation of gastric inlet patches appears to be an effective therapy for alleviation of associated globus sensations . This new treatment modality might change the paradigm for treatment of these patients Background : Alzheimer disease ( AD ) has been associated with abnormal cerebral clearance of macromolecules , such as amyloid and microtubule-associated-protein tau ( MAP-τ ) . We hypothesized that improving clearance of macromolecules from the CNS might slow the progression of dementia . Objective : This prospect i ve , r and omized , double-blinded , placebo-controlled trial evaluated the safety and effectiveness of a surgically implanted shunt in subjects with probable AD . Methods : A total of 215 subjects with probable AD by National Institute of Neurological Disorders and Stroke – Alzheimer ’s Disease and Related Disorders Association criteria received either a low-flow ventriculoperitoneal shunt or a sham ( occluded ) shunt for 9 months . Longitudinal CSF sampling was performed in both active and control subjects . Primary outcome measures were the Mattis Dementia Rating Scale and the Global Deterioration Scale . CSF Aβ(1 - 42 ) and MAP-τ also were assayed . Results : After a planned interim analysis , the study was halted for futility . Using the intent-to-treat population , no between-group differences were observed in the primary outcome measures . The surgical procedure and device were associated with 12 CNS infections , some temporally associated with CSF sampling . All were treated successfully . Conclusions : We found no benefit to low-flow CSF shunting in subjects with mild to severe Alzheimer disease . CSF infections , while treatable , occurred more frequently than expected , in some cases likely related to CSF sampling . GLOSSARY : Aβ = amyloid beta-peptides ; AD = Alzheimer disease ; ADCS-ADL = AD Cooperative Study Activities of Daily Living ; BBB = blood – brain barrier ; CP = choroid plexus ; FDA = Food and Drug Administration ; GDS = Global Deterioration Scale ; GEE = Generalized Estimating Equations ; IA = interim analysis ; ISF = interstitial fluid ; ITT = intent-to-treat ; LRP-1 = lipoprotein receptor-related protein-1 ; MAP-τ = microtubule-associated-protein tau ; MDRS = Mattis Dementia Rating Scale ; MMSE = Mini-Mental State Examination ; NAART = North American Adult Reading Test ; NINCDS-ADRDA = National Institutes of Neurological and Communicative Diseases and Stroke – Alzheimer ’s Disease and Related Disorders Association ; NPH = normal-pressure hydrocephalus ; PHF = perihippocampal fissures ; RAGE = receptor for advanced glycation end-products ; SADAS-Cog = St and ardized AD Assessment Scale – Cognitive ; SAE = serious adverse events OBJECTIVE To examine the effect on pain and quality of life for women with all stages of endometriosis undergoing laparoscopic surgery compared with placebo surgery . DESIGN A r and omized , blinded , crossover study . SETTING A tertiary referral unit in a district general hospital . PATIENT(S ) Thirty-nine women with histologically proven endometriosis completed the 12-month study . INTERVENTION(S ) Women were r and omized to receive initially either a diagnostic procedure ( the delayed surgical group ) or full excisional surgery ( the immediate surgery group ) . After 6 months , repeat laparoscopy was performed , with removal of any pathology present . MAIN OUTCOME MEASURE(S ) The end points were changes from baseline values of visual analogue pain scores , vali date d quality -of-life instruments ( EQ-5D and SF-12 ) , and sexual activity question naire scores . Patients and assessors of outcomes were blinded to the treatment-group assignment . RESULT ( S ) Significantly more of the 39 women operated on according to protocol reported symptomatic improvement after excisional surgery than after placebo : 16 of 20 ( 80 % ) vs. 6 of 19 ( 32 % ) ; chi(2
Output:
| The main problem reported in many trials was a very slow recruitment rate , mainly due to the difficulty in finding eligible patients .
This review demonstrated that placebo-controlled surgical trials are feasible , at least for procedures with a lower level of invasiveness , but also that recruitment is difficult .
Many of the presumed challenges to undertaking such trials , for example , funding , anaesthesia or blinding of patients and assessors , were not reported as obstacles to completion in any of the review ed trials |
MS212762 | ***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 introduction of new treatments for esophageal cancer including surgery , chemotherapy , radiotherapy , or a combination of these modalities has not only improved patient survival , but may also increase the risk of the second primary cancers . The available evidence is conflicting with most risk estimates based on sparse numbers . Here we estimated st and ardized incidence ratios ( SIRs ) of second cancer among 24,557 esophageal cancer survivors ( at least 2 months ) in the Surveillance , Epidemiology , and End Results ( SEER ) Program between 1973 and 2007 , who had been followed up for median 6.5 years ( range 2 months-29.3 years ) . Second cancer risk was statistically significantly elevated ( SIR = 1.34 , 95 % confidence interval [CI]= 1.25 - 1.42 ) among the survivors compared with the general population ; the SIRs for cancers of oral and pharynx , stomach , small intestine , larynx , lung and bronchus , thyroid and prostate cancer were 8.64 ( 95 % CI = 7.36 - 10.07 ) , 2.87 ( 95 % CI = 2.10 - 3.82 ) , 3.80 ( 95 % CI = 1.82 - 7.00 ) , 3.19 ( 95 % CI = 2.12 - 4.61 ) , 1.68 ( 95 % CI = 1.46 - 1.93 ) , 2.50 ( 95 % CI = 1.25 - 4.47 ) , and 0.77 ( 95 % CI = 0.65 - 0.90 ) , respectively . Radiotherapy raised cancer risk of larynx ( SIR = 3.98 , 95 % CI = 2.43 - 6.14 ) and thyroid ( SIR = 3.57 , 95 % CI = 1.54 - 7.03 ) among all esophageal cancer survivors . For patients who had 5 - 9 years of follow up after radiotherapy , the SIR for lung cancer was 3.46 ( 95 % CI = 2.41 - 4.82 ) . Patients with esophageal cancer are at increased risks of second cancers of oral and pharynx , larynx , lung , and thyroid , while at a decreased risk for prostate cancer . These findings indicate that radiotherapy for esophageal cancer patients may increase risk of developing second cancers of larynx , lung , and thyroid . Thus , r and omized clinical trials to address the association of radiotherapy and the risk of secondary cancer are warranted We studied the risk of the development of acute myeloid leukemia ( AML ) during initial remission in 733 consecutive children with acute lymphoid leukemia ( ALL ) who were treated with intensive chemotherapy . This complication was identified according to st and ard morphologic and cytochemical criteria in 13 patients 1.2 to 6 years ( median , 3.0 ) after the diagnosis of ALL . At three years of follow-up , the cumulative risk of secondary AML during the first bone marrow remission was 1.6 percent ( 95 percent confidence limits , 0.7 and 3.5 percent ) ; at six years , it was 4.7 percent ( 2 and 10 percent ) . The development of secondary AML was much more likely among patients with a T-cell than a non-T-cell immunophenotype ( cumulative risk , 19.1 percent [ 6 and 47 percent ] at six years ) . Sequential cytogenetic studies in 10 patients revealed entirely different karyotypes in 9 , suggesting the induction of a second neoplasm . In eight of these patients , the blast cells had abnormalities of the 11q23 chromosomal region , which has been associated with malignant transformation of a pluripotential stem cell . There was no evidence of loss of DNA from chromosome 5 or 7 , a karyotypic change commonly observed in cases of AML secondary to treatment with alkylating agents , irradiation , or both . We conclude that there is a substantial risk of AML in patients who receive intensive treatment for ALL , especially in those with a T-cell immunophenotype , and that 11q23 chromosomal abnormalities may be important in the pathogenesis of this complication IMPORTANCE Screening for lung cancer has the potential to reduce mortality , but in addition to detecting aggressive tumors , screening will also detect indolent tumors that otherwise may not cause clinical symptoms . These overdiagnosis cases represent an important potential harm of screening because they incur additional cost , anxiety , and morbidity associated with cancer treatment . OBJECTIVE To estimate overdiagnosis in the National Lung Screening Trial ( NLST ) . DESIGN , SETTING , AND PARTICIPANTS We used data from the NLST , a r and omized trial comparing screening using low-dose computed tomography ( LDCT ) vs chest radiography ( CXR ) among 53 452 persons at high risk for lung cancer observed for 6.4 years , to estimate the excess number of lung cancers in the LDCT arm of the NLST compared with the CXR arm . MAIN OUTCOMES AND MEASURES We calculated 2 measures of overdiagnosis : the probability that a lung cancer detected by screening with LDCT is an overdiagnosis ( PS ) , defined as the excess lung cancers detected by LDCT divided by all lung cancers detected by screening in the LDCT arm ; and the number of cases that were considered overdiagnosis relative to the number of persons needed to screen to prevent 1 death from lung cancer . RESULTS During follow-up , 1089 lung cancers were reported in the LDCT arm and 969 in the CXR arm of the NLST . The probability is 18.5 % ( 95 % CI , 5.4%-30.6 % ) that any lung cancer detected by screening with LDCT was an overdiagnosis , 22.5 % ( 95 % CI , 9.7%-34.3 % ) that a non-small cell lung cancer detected by LDCT was an overdiagnosis , and 78.9 % ( 95 % CI , 62.2%-93.5 % ) that a bronchioalveolar lung cancer detected by LDCT was an overdiagnosis . The number of cases of overdiagnosis found among the 320 participants who would need to be screened in the NLST to prevent 1 death from lung cancer was 1.38 . CONCLUSIONS AND RELEVANCE More than 18 % of all lung cancers detected by LDCT in the NLST seem to be indolent , and overdiagnosis should be considered when describing the risks of LDCT screening for lung cancer
Output:
| Conclusion Overall , the risk of developing MPCs appears to have increased since the 1980s when considering studies of all primary cancer sites combined from the USA and Australia but not from Europe . |
MS212763 | ***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 No data on lipopolysaccharide-binding protein ( LBP ) in newborns with sepsis have been available up to now . We therefore determined levels of LBP and soluble CD14 ( sCD14 ) in plasma of healthy and septic neonates in order to evaluate their potential diagnostic role . The study included prospect ively collected patient sample s of two recently published studies on cytokine expression in neonatal sepsis . Twenty-nine septic patients were enrolled in the present analysis . Sample s — either cord blood or peripheral blood — from patients admitted within the first 24 h of life for suspicion of sepsis and cord blood sample s of a control group of 40 healthy mature infants delivered spontaneously were analyzed . For seven patients of the septic group , a second sample collected between 24 and 48 h of life was available . Levels of sCD14 and LBP in plasma were determined by an enzyme immunoassay using recombinant CD14 and LBP as st and ards . LBP and sCD14 were correlated to cytokine plasma levels . In septic neonates , LBP ( median , 36.6 versus 7.8 μg/ml ; P < 0.001 ) and sCD14 ( median , 0.42 versus 0.28 μg/ml ; P < 0.001 ) levels were highly elevated when compared to those of healthy neonates and strongly correlated to granulocyte colony-stimulating factor ( G-CSF ) , interleukin-1β ( IL-1β ) , IL-6 , and IL-8 levels . LBP levels in septic neonates analyzed between 24 and 48 h of life even increased when compared to sample s obtained at or shortly after delivery ( median , 36.6 versus 60 μg/ml ; P = 0.038 ) . In summary , levels of LBP in plasma of neonates with early-onset sepsis are significantly elevated ; the elevated plasma levels seem to persist for more than 24 h , which could provide the clinician with a prolonged time period to identify the newborn with bacterial sepsis In a prospect i ve study , levels of interleukin-1 beta ( IL-1 beta ) , interleukin-6 ) ( IL-6 ) , and tumor necrosis factor ( TNF ) were measured in a blind fashion in cord blood plasma from 92 neonates by specific immunoassays , and were correlated with the clinical courses of the infants , including type of delivery and perinatal complications . Plasma IL-1 beta concentration was undetectable in infants born by normal vaginal delivery or elective cesarean section but was significantly increased in infants born after induced vaginal deliveries ( 142 + /- 68 pg/ml ) or urgent cesarean section ( 290 + /- 21 pg/ml ; both p less than 0.05 compared with normal deliveries ) . The IL-1 beta levels were elevated in infants with severe perinatal complications ( 282 + /- 116 pg/ml ; p less than 0.001 ) , whereas TNF and IL-6 levels were not related to these complications . Infants with isolated perinatal infectious complications had elevated levels of plasma IL-6 compared with those of sick neonates without infection ( p less than 0.001 ) . In contrast , TNF plasma levels and IL-1 beta production by cord blood leukocytes were decreased in infants with infectious complications alone ( both p less than 0.05 ) . These studies suggest that the levels of IL-1 beta , IL-6 , and TNF in the cord plasma relate differentially to clinical complications in the perinatal period The first objective of this article was to determine the diagnostic accuracy of tumor necrosis factor-alpha , interleukin-6 ( IL-6 ) , and interleukin-8 ( IL-8 ) in differentiating infected from noninfected neonates during the first 24 hours of suspected sepsis and to compare them to the currently used laboratory parameters : C-reactive protein ( CRP ) , immature-to-total neutrophil ratio , and leukocyte and platelet count . The secondary objective was to compare the cytokine levels in sub population s of neonates . Seventy-five premature and 30 term infants were enrolled . Blood sample s for the " currently used laboratory tests " and the cytokine levels were obtained at the first suspicion of sepsis ( " 0-hour " ) and 18 to 30 hours later ( " 24-hours " ) . Patients were classified as septic ( 48 ) or nonseptic ( 57 ) . Thirty-two septic patients had positive blood cultures and 16 showed clinical signs of sepsis . Twenty septic patients had early-onset and 28 had late-onset sepsis . Sensitivity , specificity , and positive and negative predictive values ( PPV and NPV ) were calculated for each test . Receiver-operating characteristic curves were analyzed to determine the optimal thresholds . A combination of CRP > 10 pg/mL plus IL-6 > 18 pg/mL ( sensitivity = 89 % , specificity = 73 % , PPV = 70 % , NPV = 90 % ) was the best " 0-hour " test , and CRP ( sensitivity = 78 % , specificity = 94 % ) was the best " 24-hours " test . Lower IL-6 at 0-hour ( p = 0.018 ) and IL-8 at 24 hours ( p = 0.023 ) were detected among the patients infected with coagulase-negative staphylococci then with other bacteria . In conclusion , a combination of CRP + IL-6 provided additional diagnostic accuracy for differentiation between septic and nonseptic patients during the first 24 hours of suspected sepsis BACKGROUND Neonatal sepsis is a common and life-threatening disorder , particularly among preterm infants . Early initiation of antibiotic therapy is frequently delayed because the first clinical signs of sepsis are non-specific and there are no reliable early laboratory indicators . We investigated the time course of expression and the prognostic power of the early inflammatory mediators interleukin-1 receptor antagonist ( IL-1ra ) , interleukin-6 ( IL-6 ) , and circulating intercellular adhesion molecule-1 ( cICAM-1 ) before clinical diagnosis of sepsis . METHODS In a prospect i ve multicentre study , we monitored 182 very-low-birthweight infants in six intensive-care units for occurrence of sepsis . During routine or clinical ly indicated blood sampling , an additional sample was collected for measurement of IL-1ra , IL-6 , cICAM-1 , and C-reactive protein ( CRP ) . Infants were grouped into those with proven sepsis , no infection , or unclassified . The mean study duration was 34 days . Whenever sepsis occurred , a study period of 10 days was defined : day 0 was the day of clinical diagnosis of sepsis ; days -4 to -1 were the 4 days before diagnosis ; days + 1 to + 5 were the 5 days after . We compared the concentrations of the immune mediators during the 10-day study period with group-specific baseline values from before day -4 . FINDINGS 101 infants were included in the analysis : 21 with proven sepsis , 20 with no infection , and 60 unclassified . We excluded 57 because of incomplete data sets and 24 who had early-onset sepsis . IL-1ra and IL-6 increased significantly 2 days before diagnosis of sepsis ; maximum median increases within the study period were 15-fold for IL-1ra and 12-fold for IL-6 . The diagnostic sensitivities of IL-1ra , IL-6 , and CRP concentrations on day 0 of diagnosis were 93 % , 86 % , and 43 % , respectively ; corresponding values on day -1 were 64 % , 57 % , and 18 % . The specificities of IL-1ra , IL-6 , and CRP concentrations were 92 % , 83 % , and 93 % . cICAM-1 had a specificity of only 64 % . INTERPRETATION IL-1ra and IL-6 are superior to cICAM-1 and CRP as predictors of sepsis 1 or more days before clinical diagnosis . Ad-hoc measurement of these cytokines could allow earlier initiation of antibiotic therapy with corresponding improvement in outcome in very-low-birthweight infants with sepsis OBJECTIVE To evaluate plasma levels of interleukin-6 ( IL-6 ) and soluble tumor necrosis factor receptors ( sTNF-R ) 55 and 75 in neonates as a contribution to the early diagnosis of infection . STUDY DESIGN We prospect ively measured IL-6 and sTNF-R 55 and sTNF-R 75 plasma levels in 157 newborn infants admitted to our regional neonatal center in a 3-month period and in cord blood of 131 newborn infants delivered in our obstetrics unit . C-reactive protein was sequentially determined after admission . Newborn infants were classified into four groups : group 0 , not infected ; group 1 , possibly infected ; group 2a , infected ( culture positive ) , and group 2b , probably infected ( culture negative ) . We looked for the optimal cutoff point of these parameters , using the receiver operating characteristics ( ROC ) curve . RESULTS IL-6 levels were significantly higher in group 2 ( n = 11 ; median level , 250 pg/ml ; range , 0 to 81,000 ) , group 2b ( n = 25 ; median level , 750 pg/ml ; range , 0 to 180,000 ) , and group 1 ( n = 35 ; median level , 160 pg/ml ; range 0 to 10,000 ) , in comparison with group 0 ( n = 217 ; median level , 0 pg/ml ; range , 0 to 3400 ) . A cutoff value of 100 pg/ml or greater obtained by the ROC method gives a sensitivity of 83.3 % and a specificity of 90.3 % . For inborn infants ( n = 220 ) sample d at birth , sensitivity is 100 % and specificity 92.3 % . This high sensitivity persists until the twelfth hour of life . The sTNF-R 55 levels are significantly higher in group 2a ( median , 12.0 ng/ml ; range , 3.2 to 24.4 ) . In group 2b ( median , 7.0 ng/ml ; range , 3.0 to 25.2 ) , and in group 1 ( median , 7.0 ng/ml ; range , 2.5 to 18.9 ) than in group 0 ( median , 3.9 ng/ml ; range , 1.5 to 15.0 ) , and with a cutoff value of 6 ng/ml , sensitivity is 75 % and specificity 69 % . The sTNF-R 75 levels are significantly higher in group 2a ( median , 17.0 ng/ml ; range , 7.2 to 48.8 ) . In group 2b ( median , 11.2 ng/ ml ; range , ( 2.0 to 31.3 ) , and in group 1 ( median , 10.6 ng/ml ; range , 2.0 to 33.0 ) ; than in group 0 ( median , 7.0 ng/ml ; range , 1 to 23.0 ) . With a cutoff value of 9 ng/ ml , sensitivity is 80 % and specificity 67 % . Sensitivity of C-reactive protein is low initially but improves with time . Combining IL-6 with C-reactive protein provides the possibility of identifying the majority of infected infants in the postnatal period . CONCLUSION A plasma IL-6 level of 100 pg/ml or greater , obtained before the twelfth hour of life , appears to be an ideal marker for detecting early-onset neonatal infection with a high degree of sensitivity and specificity . After the twelfth hour , the combined determination of IL-6 and C-reactive protein may be equally useful . The sTNF-R levels appear to be less useful in the early diagnosis of infection because of their smaller magnitude of variation Objective Late-onset sepsis is responsible for high morbidity and mortality in newborn infants in the world and in particular in developing countries . In this study , we evaluated whether clinical characteristics , laboratory parameters and measurements of serum interleukin-8 ( IL-8 ) are able to discriminate between late neonatal sepsis and normal baby . Methods This was a prospect i ve ( case-control ) study conducted between March 2007 and April 2008 , at the neonatal intensive care unit , Ghaem Hospital , Mashhad , Iran . The study comprised 93 neonates ≥72 hours of life . The infants were categorized in two groups based on the clinical presentation , and biochemical markers including complete blood count , C-reactive protein ( CRP ) and blood culture : 1 ) Control group including 42 infants with routine screening and 2 ) Case group consisting of 38 infants with definitive infection ( positive blood and /or cerebrospinal fluid culture ) or clinical sepsis ( clinical and laboratory signs of infection without positive blood or CSF culture ) . Receiver-operating characteristic curves were used for the determination of thresholds for the infection group versus healthy neonate group . Findings Eighty infants were enrolled in this study . IL-8 and CRP decreased in order of definitive infection , clinical sepsis and healthy subjects respectively ( P<0.001 ) . Sensitivity , specificity , positive predictive value , negative predict
Output:
| Meta-regression analysis showed that the diagnostic accuracy of IL-6 was not affected by confounding variables .
IL-6 seems to be a valid marker for predicting NS . |
MS212764 | ***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 Maternal and perinatal mortality are major problems for which progress in sub-Saharan Africa has been inadequate , even though childbirth services are available , even in the poorest countries . Reducing them is the aim of two of the main Millennium Development Goals . Many initiatives have been undertaken to remedy this situation , such as the Advances in Labour and Risk Management ( ALARM ) International Program , whose purpose is to improve the quality of obstetric services in low-income countries . However , few interventions have been evaluated , in this context , using rigorous methods for analyzing effectiveness in terms of health outcomes . The objective of this trial is to evaluate the effectiveness of the ALARM International Program ( AIP ) in reducing maternal mortality in referral hospitals in Senegal and Mali . Secondary goals include evaluation of the relationships between effectiveness and re source availability , service organization , medical practice s , and satisfaction among health personnel . Methods / Design This is an international , multi-centre , controlled cluster-r and omized trial of a complex intervention . The intervention is based on the concept of evidence -based practice and on a combination of two approaches aim ed at improving the performance of health personnel : 1 ) Educational outreach visits ; and 2 ) the implementation of facility-based maternal death review s . The unit of intervention is the public health facility equipped with a functional operating room . On the basis of consent provided by hospital authorities , 46 centres out of 49 eligible were selected in Mali and Senegal . Using r and omization stratified by country and by level of care , 23 centres will be allocated to the intervention group and 23 to the control group . The intervention will last two years . It will be preceded by a pre-intervention one-year period for baseline data collection . A continuous clinical data collection system has been set up in all participating centres . This , along with the inventory of re sources and the satisfaction surveys administered to the health personnel , will allow us to measure results before , during , and after the intervention . The overall rate of maternal mortality measured in hospitals during the post-intervention period ( Year 4 ) is the primary outcome . The evaluation will also include cost-effectiveness . Trial Registration The QUARITE trial is registered on the Current Controlled Trials website under the number IS RCT N46950658 Accurate , affordable , and valid measurements of clinical practice are the basis for quality -of-care assessment s ( 1 ) . However , to date , most measurement tools have relied on incomplete data sources , such as medical records or administrative data ; require highly trained and expensive personnel to implement ; and are difficult to vali date ( 2 - 5 ) . Comparisons of clinical practice across different sites and health care systems are also difficult because they require relatively complex instrument design s or statistical techniques to adjust for variations in case mix among the underlying patient population s ( 6 , 7 ) . We have developed a measurement tool , computerized clinical vignettes , that overcomes these limitations and measures physicians ' clinical practice against a predefined set of explicit quality criteria . These vignettes simulate patient visits and can be given to physicians to measure their ability to evaluate , diagnose , and treat specific medical conditions . Each vignette-simulated case contains realistic clinical detail , allowing an identical clinical scenario to be presented to many physicians . Each physician can be asked to complete several vignettes to simulate diverse clinical conditions . This instrument design obviates the need to adjust quality scores for the variation in disease severity and comorbid conditions found in actual patient population s. Our vignettes are also distinct from other quality measurements of clinical practice because they do not focus on a single task , or even a limited set of tasks , but instead comprehensively evaluate the range of skills needed to care for a patient . Vignettes are particularly well-suited for quality assessment s of clinical practice that are used for large-scale ( 8 , 9 ) , cross-system comparisons ( 10 , 11 ) or for cases in which ethical issues preclude involving patients or their records ( 7 , 12 , 13 ) . They are also ideal for evaluations that require holding patient variation constant ( 14 , 15 ) or manipulating patient-level variables ( 15 - 17 ) . The appeal of vignettes has result ed in their extensive use in medical school education ( 18 , 19 ) , as well as various studies that explicitly evaluate the quality of clinical practice in real-life setting s and comparative analysis among national health care systems ( 10 , 20 - 23 ) . Before vignette-measured quality can be used confidently in these setting s , however , 2 important questions must be answered : How valid are vignettes as a measure of actual clinical practice ? Can vignettes discriminate among variations in the quality of clinical practice ? This has led to a search to define a gold st and ard for validation ( 24 - 26 ) . We and others have used st and ardized patients as this st and ard . St and ardized patients are trained actors who present unannounced to outpatient clinics as patients with a given clinical condition . Immediately after meeting with a physician , the st and ardized patient records on a checklist what the physician did during the visit ( 26 - 28 ) . Rigorous methods , which we have described in detail elsewhere ( 29 ) , ensure that st and ardized patients can be considered a gold st and ard . In addition , we have demonstrated the validity of st and ardized patients as a gold st and ard by concealing audio recorders on st and ardized patients during visits . The overall rate of agreement between the st and ardized patients ' checklists and the independent assessment of the audio transcripts was 91 % ( 26 ) . We previously used paper- and -pen vignettes in a study limited to only 1 health care system , the Veterans Administration , and found that they seemed to be a valid measure of the quality of clinical practice according to their rate of agreement with st and ardized patient checklists ( 26 ) . For this study , we wanted to confirm the validity of vignettes by using a more complex study design that introduced many more r and omly assigned physicians , a broader range of clinical cases , and several sites representing different health care systems . We also wanted to test a refined , computerized version of vignettes , which we believe are more realistic and streamline data collection and scoring . We were particularly interested in determining whether the vignettes accurately capture variation in the quality of clinical practice , which has become increasingly prominent in the national debate on quality of care ( 30 , 31 ) . We hoped that vignettes could contribute to this debate by providing a low-cost measure of variation across different health care systems . Methods Sites The study was conducted in 4 general internal medicine clinics : 2 Veterans Affairs ( VA ) medical centers and 2 large , private medical centers . One private site is a closed group model , and the other , primarily staffed by employed physicians , contracts with managed care plans . All sites are located in California , and each has an internal medicine residency training program . One VA medical center and 1 private site are located in 1 of 2 cities . The 2 VA medical centers are large , academically affiliated hospitals with large primary care general internal medicine practice s. We chose the 2 private sites that were generally similar to the VA medical centers and to each other ; each had large primary care practice s and capitated reimbursement systems that provide primary care general internists with a broad scope of clinical decision-making authority . Study Design At each site , all attending physicians and second- and third-year residents who were actively engaged in the care of general internal medicine out patients were eligible to participate in the study . We excluded only interns . Of 163 eligible physicians , 144 agreed to participate . We informed consenting physicians that 6 to 10 st and ardized patients might be introduced unannounced into their clinics over the course of a year and that they might be asked to complete an equal number of vignettes . Sixty physicians were r and omly selected to see st and ardized patients : 5 physicians from each of the 3 training levels at each of the 4 sites ( Figure 1 ) . We assigned st and ardized patients to each selected physician for 8 clinical casessimple and complex cases of chronic obstructive pulmonary disease , diabetes , vascular disease , and depression . We abstract ed the medical records from the 480 st and ardized patient visits . Each selected physician also completed a computerized clinical vignette for each of the 8 cases . For st and ardized patient visits that a selected physician did not complete , a replacement physician , who was r and omly selected from the same training level at the same site , completed the visit . Eleven physicians required replacements . The 11 replacement physicians completed 24 st and ardized patient visits . Each replacement physician completed vignettes for all 8 cases . Finally , we r and omly selected 45 additional physicians to serve as controls and complete vignettes ( only ) for all 8 cases . A total of 116 physicians participated in the study by seeing st and ardized patients , completing vignettes , or both . St and ardized patients presented to the clinics between March and July 2000 , and physicians completed vignettes between May and August 2000 . Figure 1 . Planned study design showing sites and physician sample by level of training and clinical case for the 3 quality measurement methods . Vignette Data Collection We developed the vignettes by using a st and ardized protocol . We first selected relatively common medical conditions frequently seen by internists . All selected conditions had explicit , evidence -based quality criteria and accepted st and ards of practice that could be used to score the vignettes , as well as be measured by st and ardized patients and chart abstract ion . We developed written scenarios that described a typical patient with 1 of the same 4 diseases ( chronic obstructive pulmonary disease , diabetes , vascular disease , or depression ) . For each disease , we developed a simple ( uncomplicated ) case and a more complex case with a comorbid condition of either hypertension or hypercholesterolemia . This yielded a total of 8 clinical cases . ( A sample vignette and scoring sheet are available online . ) Supplement . Appendix Figure : Vignette scoring sheet . Published online with permission from John W. Peabody , MD , PhD The physician completing the vignette sees the patient on a computer . Each vignette is organized into 5 sections , or domains , which , when completed in sequential order , recreate the normal sequence of events in an actual patient visit : taking the patient 's history , performing the physical examination , ordering radiologic or laboratory tests , making a diagnosis , and administering a treatment plan . For example , the computerized vignette first states the presenting problem to the physician and prompts the physician to take the patient 's history ( that is , ask questions that would determine the history of the present illness ; past medical history , including prevention ; and social history ) . Physicians can record components of the history in any order without penalty . The entire format is open-ended : The physician enters the history questions directly into the computer and , in the most recent computerized versions , receives realtime responses . When the history is completed , the computer confirms that the physician has finished and then provides key responses typical of a patient with the specific case . The same process is repeated for the 4 remaining domains . In addition to the open-ended format , we have taken 3 steps to avoid potential inflation of vignette scores . First , physicians are not allowed to return to a previous domain and change their queries after they have seen the computerized response . Second , the number of queries is limited in the history and physical examination domains . For example , in the physical examination domain , physicians are asked to list only the 6 to 10 essential elements of the examination that they would perform . Third , they are given limited time to complete the vignette ( just as time is limited during an actual patient visit OBJECTIVE To determine whether clinical vignettes can measure variations in the quality of clinical care in two economically divergent countries . DATA SOURCE / STUDY SETTING Primary data collected between February 1997 and February 1998 at two Veterans Affairs facilities in the United States and four government-run outpatient facilities in Macedonia . STUDY DESIGN R and omly selected , eligible Macedonian and U.S. physicians ( > 97 percent participation rate ) completed vignettes for four common outpatient conditions . Responses were judged against a master list of explicit quality criteria and scored as percent correct . DATA COLLECTION / EXTRACTION : An ANOVA model and two-tailed t-tests were used to compare overall scores by case , study site , and country . Principal Findings . The mean score for U.S. physicians was 67 percent ( + /-11 percent ) compared to 48 percent ( + /-11 percent ) for Macedonian physicians . The quality of clinical practice , which emphasizes basic skills , varied greatly in both sites , but more so in Macedonia . However , the top Macedonian physicians in all sites approached or-in one case-exceeded the median score in the U.S. sites . CONCLUSIONS Vignettes are a useful method for making cross-national comparisons of the quality of care provided in very different setting s. The vignette measurements revealed that some physicians in Macedonia performed at a st and ard comparable to that of their counterparts in the United States , despite the disparity of the two health systems . We infer that in poorer countries , policy that promotes improvements in the quality of clinical practice -not just structural inputs-could lead to rapid improvements in health
Output:
| Re source availability positively correlated with mean hospital CBCA scores and maternal and perinatal mortality were inversely correlated with hospital CBCA scores .
Conclusion Our CBCA has substantial inter-rater reliability and there is compelling evidence of its validity as the tool performs according to theory . |
MS212765 | ***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 / AIM We report on survival data of 595 patients with stage I-III lung cancer with respect to TNM classification . MATERIAL S AND METHODS We constructed a basic model consisting of stage and grade , and assessed the improvement of survival prediction after adding comorbidity data , spirometric data , clinical and laboratory parameters . RESULTS Body mass index ( BMI ) and presence of a cardiac disease reached statistical significance for prediction of overall survival in a Cox regression model . In addition to BMI ( < 25 kg/m(2 ) ) and the presence of cardiovascular disease , the spirometric variable ( FEV1 ) predicted early death ( less than five months postoperatively ) . When the survival r and om forest method was employed to predict disease outcome , creatinine levels and VO2 max became additional variables of interest for predicting survival . CONCLUSION We propose that our lung cancer data base may help to identify variables ( aside from histomorphological variables ) that are suitable for identifying patients at risk of death after surgical treatment of lung cancer Physical activity has been associated with lower lung cancer incidence and mortality in several population s. We investigated these relationships in the Women 's Health Initiative Observational Study ( WHI-OS ) and Clinical Trial ( WHI-CT ) prospect i ve cohort of postmenopausal women . The WHI study enrolled 161,808 women aged 50 - 79 years between 1993 and 1998 at 40 U.S. clinical centers ; 129,401 were eligible for these analyses . Cox proportional hazards models were used to assess the association of baseline physical activity levels [ metabolic equivalent (MET)-min/week : none < 100 ( reference ) , low 100 to < 500 , medium 500 to < 1,200 , high 1,200 + ] and sedentary behavior with total lung cancer incidence and mortality . Over 11.8 mean follow-up years , 2,148 incident lung cancer cases and 1,365 lung cancer deaths were identified . Compared with no activity , higher physical activity levels at study entry were associated with lower lung cancer incidence [ p = 0.009 ; hazard ratios ( 95 % confidence intervals ) for each physical activity category : low , HR : 0.86 ( 0.76 - 0.96 ) ; medium , HR : 0.82 ( 0.73 - 0.93 ) ; and high , HR : 0.90 ( 0.79 - 1.03 ) ] , and mortality [ p < 0.0001 ; low , HR : 0.80 ( 0.69 - 0.92 ) ; medium , HR : 0.68 ( 0.59 - 0.80 ) ; and high , HR : 0.78 ( 0.66 - 0.93 ) ] . Body mass index ( BMI ) modified the association with lung cancer incidence ( p = 0.01 ) , with a stronger association in women with BMI < 30 kg/m(2 ) . Significant associations with sedentary behavior were not observed . In analyses by lung cancer subtype , higher total physical activity levels were associated with lower lung cancer mortality for both overall NSCLC and adenocarcinoma . In conclusion , physical activity may be protective for lung cancer incidence and mortality in postmenopausal women , particularly in non-obese women Lung cancer is the most common cause of cancer death with unchanged mortality for 50 years . Only localized nonsmall-cell lung cancer ( NSCLC ) is curable . In these patients it is essential to accurately predict survival to help identify those that will benefit from treatment and those at risk of relapse . Despite needing this clinical information , prospect i ve data are lacking . We therefore prospect ively identified prognostic factors in patients with potentially curable lung cancer . Over 2 years , 110 consecutive patients with confirmed localized NSCLC ( stages 1–3A ) were recruited from a single tertiary center . Prognostic factors investigated included age , gender , body mass index ( BMI ) , performance status , comorbidity , disease stage , quality of life , and respiratory physiology . Patients were followed up for 3 - 5 years and mortality recorded . The data were analyzed using survival analysis methods . Twenty-eight patients died within 1 year , 15 patients died within 2 years , and 11 patients died within 3 years postsurgery . Kaplan-Meier survival estimates show a survival rate of 51 % at 3 years . Factors significantly ( p < 0.05 ) associated with poor overall survival were age at assessment , diabetes , serum albumin , peak VO2 max , shuttle walk distance , and predicted postoperative transfer factor . In multiple-variable survival models , the strongest predictors of survival overall were diabetes and shuttle walk distance . The results show that potentially curable lung cancer patients should not be discriminated against with respect to weight and smoking history . Careful attention is required when managing patients with diabetes . Respiratory physiologic measurements were of limited value in predicting long-term survival after lung cancer surgery Background Whether waist circumference provides clinical ly meaningful information not delivered by body-mass index regarding prediction of cause-specific death is uncertain . Methods We prospect ively examined waist circumference ( WC ) and body-mass index ( BMI ) in relation to cause-specific death in 225,712 U.S. women and men . Cox regression was used to estimate relative risks and 95 % confidence intervals ( CI ) . Statistical analyses were conducted using SAS version 9.1 . Results During follow-up from 1996 through 2005 , we documented 20,977 deaths . Increased WC consistently predicted risk of death due to any cause as well as major causes of death , including deaths from cancer , cardiovascular disease , and non-cancer/non-cardiovascular diseases , independent of BMI , age , sex , race/ethnicity , smoking status , and alcohol intake . When WC and BMI were mutually adjusted in a model , WC was related to 1.37 fold increased risk of death from any cancer and 1.82 fold increase risk of death from cardiovascular disease , comparing the highest versus lowest WC categories . Importantly , WC , but not BMI showed statistically significant positive associations with deaths from lung cancer and chronic respiratory disease . Participants in the highest versus lowest WC category had a relative risk of death from lung cancer of 1.77 ( 95 % CI , 1.41 to 2.23 ) and of death from chronic respiratory disease of 2.77 ( 95 % CI , 1.95 to 3.95 ) . In contrast , subjects in the highest versus lowest BMI category had a relative risk of death from lung cancer of 0.94 ( 95 % CI , 0.75 to 1.17 ) and of death from chronic respiratory disease of 1.18 ( 95 % CI , 0.89 to 1.56 ) . Conclusions Increased abdominal fat measured by WC was related to a higher risk of deaths from major specific causes , including deaths from lung cancer and chronic respiratory disease , independent of BMI BACKGROUND In China , there have been few large prospect i ve studies of the associations of body mass index ( BMI ) with overall and cause-specific mortality that have simultaneously controlled for biases that can be caused by pre-existing disease and smoking . METHODS Prospect i ve cohort study of 224 064 men , of whom 40 700 died during follow-up between 1990 - 91 and 2006 . Analyses restricted to 142 214 men aged 40 - 79 years at baseline with no disease history and , to further reduce bias from pre-existing disease , at least 5 years of subsequent follow-up , leaving 17 800 deaths [ including 4165 stroke , 1297 coronary heart disease ( CHD ) , 3121 chronic obstructive pulmonary disease ( COPD ) ] . Adjusted hazard ratios ( HRs ) and 95 % confidence intervals ( 95 % CIs ) per 5 kg/m(2 ) calculated within either a lower ( 15 to < 23.5 kg/m(2 ) ) or higher ( 23.5 to < 35 kg/m(2 ) ) range . RESULTS The association between BMI and all-cause mortality was U-shaped with the lowest mortality at ∼22.5 - 25 kg/m(2 ) . In the lower range , 5 kg/m(2 ) higher BMI was associated with 14 % lower mortality ( HR 0.86 , 95 % CI 0.82 - 0.91 ) ; in the upper range , it was associated with 27 % higher mortality ( HR 1.27 , 95 % CI 1.15 - 1.40 ) . The absolute excess mortality in the lower range was largely accounted for by excess mortality from specific smoking-related diseases : 54 % by that for COPD , 12 % other respiratory disease , 13 % lung cancer , 11 % stomach cancer . The excess mortality in the upper BMI range was largely accounted for by excess mortality from specific vascular diseases : 55 % by that for stroke , 16 % CHD . In this range , 5 kg/m(2 ) higher BMI was associated with ∼50 % higher mortality from stroke ( HR 1.61 , 95 % CI 1.36 - 1.92 ) and CHD ( HR 1.48 , 95 % CI 1.12 - 1.95 ) . CONCLUSIONS For China , previous evidence may have overestimated the excess mortality at low BMI but underestimated that at high BMI . The main way obesity kills in China appears to be stroke Introduction : Traditional tumor-based staging systems provide limited information on the best treatment option for individual patients with advanced inoperable non-small cell lung cancer ( NSCLC ) . The Glasgow prognostic score ( GPS ) reflects the host systemic inflammatory response and is a vali date d independent prognostic factor in these patients . The aim of this study was to examine the clinical application of the pretreatment GPS in a mature cohort of patients with inoperable NSCLC . Methods : The data of 261 patients with inoperable NSCLC were collected prospect ively and before treatment . Information on patient demographics , body mass index , performance status ( PS ) , the modified Glasgow prognostic score ( mGPS ) , the prognostic index , and treatment received were included . Results : The majority of patients were aged 65 years or older ( 68 % ) , were men ( 59 % ) , had a body mass index more than 20 ( 89 % ) , and an Eastern Cooperative Oncology Group performance status ( ECOG-PS ) 0 or 1 ( 54 % ) . Most patients had a pretreatment mGPS = 1 ( 62 % ) and pretreatment prognostic index = 1 ( 56 % ) . During the follow-up period , 248 ( 95 % ) patients died , 246 from their disease . The median survival was 8 months . On multivariate analysis , age ( p = 0.001 ) , ECOG-PS ( p < 0.05 ) , mGPS ( p < 0.0001 ) , and tumor stage ( p < 0.0001 ) were independently associated with cancer-specific survival . Using 5-year cancer-specific mortality as an end point , the area under the receiver operator curve was 0.735 ( 95 % confidence interval [ CI ] , 0.566–0.903 ; p = 0.024 ) for the mGPS , 0.669 ( 95 % CI , 0.489–0.848 ; p = 0.106 ) for ECOG-PS , and 0.622 ( 95 % CI , 0.437–0.807 ; p = 0.240 ) for tumor , node , metastasis stage . Patients with an increased mGPS were more likely to have a poorer ECOG-PS ( p < 0.05 ) , an increased white cell count ( p < 0.05 ) , and received palliative treatment ( p < 0.05 ) . Conclusion : The pretreatment mGPS is a useful and important predictor of cancer-specific survival in patients with inoperable NSCLC . Basing clinical assessment on the mGPS has implication s for the routine monitoring and treatment of the patients OBJECTIVE Previous studies have suggested that marital status is associated with survival from lung cancer ; however , its association is not conclusive . The association between marital status and survival in Japanese patients with non-small cell lung cancer ( NSCLC ) was prospect ively investigated . METHODS Between July 1999 and July 2004 , a total of 1230 NSCLC patients were enrolled . The baseline survey consisted of the collection of clinical information and various demographic data , including marital status . A Cox regression model was used to estimate the hazards ratio ( HR ) of all-cause mortality adjustments for age , BMI , education level , performance status , histology type , clinical stage , smoking status , choice of definitive treatment , and depression . RESULTS The multivariable adjusted HR of male widowed patients versus male married patients was 1.7 ( 95 % confidence interval=1.2 - 2.5 , p=0.005 ) . However , no significant increased risk of death in female widowed patients compared with female married patients was observed ( HR=0.7 , 95 % confidence interval=0.5 - 1.1 , p=0.15 ) . With regard to separated/divorced and single patients no significant increased risk of death in male and /or female compared with married patients was observed . CONCLUSIONS The present data suggest that male widowed patients with NSCLC have a higher mortality
Output:
| In conclusion , lung cancer patients with a higher BMI have a longer survival than those with a lower BMI . |
MS212766 | ***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: Chronic inflammation has been consistently associated with cancers of several sites , including the breast , and inhibition of inflammation through the use of non-steroidal anti-inflammatory drugs ( NSAIDs ) has been inversely associated with risk . As NSAIDs bind with cyclooxygenase-2 ( COX-2 ) , genetic variation in COX-2 may influence breast cancer risk by affecting inflammatory response and response to NSAID use . We identified eight single nucleotide polymorphisms ( SNPs ) for COX-2 and examined their association with risk of breast cancer in a population -based case – control study in Western New York . Cases had incident , first primary , histologically confirmed breast cancer ( n = 1077 ) . Controls ( n = 1910 ) were r and omly selected from NY Department of Motor Vehicles records ( < 65 ) or Medicare rolls ( ≥65 ) . Participants were queried on adult lifetime use of aspirin and recent use of ibuprofen . Unconditional logistic regression was used to estimate odds ratios ( OR ) and 95 % confidence intervals ( 95 % CI ) . One SNP , rs2745559 , was associated with an increased risk of breast cancer ( OR 1.23 , 95 % CI 1.03–1.46 ) . Associations with other variants were not evident . Significant interaction ( P interaction = 0.04 ) between recent aspirin use and rs4648261 was also observed . Variation in COX-2 was modestly associated with breast cancer risk , indicating that COX-2 may play a role in breast carcinogenesis . Better underst and ing of the role of COX-2 genetic variation and interaction with NSAID use in breast carcinogenesis has potential to inform prevention strategies OBJECTIVE Previous epidemiological studies have suggested that use of aspirin or other nonsteroidal anti-inflammatory drugs ( NSAIDs ) may be associated with reduced risk of breast cancer , but some studies have been limited in their ability to separate the effects of aspirin from other NSAIDs or to account for breast cancer risk factors . METHODS We examined the incidence of breast cancer in association with self-reported aspirin , as well as other nonaspirin NSAID use in a large prospect i ve cohort of postmenopausal women ( n = 27,616 ) . Over 6 years of follow-up , 938 incident breast cancers were identified . RESULTS After adjustment for other breast cancer risk factors , any current use of aspirin or other NSAIDs compared with no use was associated with a reduction in risk of breast cancer [ relative risk ( RR ) = 0.80 , 95 % confidence interval ( CI ) 0.67 - 0.95 ] . There was a trend of decreasing risk of incident breast cancer with increasing frequency of aspirin use ( P(trend ) = 0.0011 ) . The multivariate-adjusted RR of breast cancer was 0.71 ( 95 % CI 0.58 - 0.87 ) for women who reported using aspirin six or more times per week compared with women who reported no use . These results did not depend on whether women had early or late stage breast cancer . No association was found between nonaspirin NSAID use and incident breast cancer . The adjusted RR of using other NSAIDs six or more times per week compared with no use was 1.01 ( 95 % CI 0.83 - 1.25 ) . CONCLUSION This prospect i ve study corroborates other reports that use of aspirin might reduce risk of breast cancer BACKGROUND The use of aspirin and other nonsteroidal anti-inflammatory drugs ( NSAIDs ) is widespread for treatment of common symptoms such as headaches , muscular pain , and inflammation . In addition , the chemopreventive use of NSAIDs is increasingly common for heart disease and colon cancer . Evidence of a protective association with breast cancer risk has been inconsistent , and few data exist for premenopausal women . METHODS We assessed the associations for use of aspirin , other NSAIDs , and acetaminophen with breast cancer risk among premenopausal women in the prospect i ve Nurses ' Health Study II . In total , 112,292 women , aged 25 to 42 years and free of cancer in 1989 , were followed up until June 2003 . Multivariate relative risks and 95 % confidence intervals were calculated by Cox proportional hazards models , adjusting for age and other important breast cancer risk factors . RESULTS Overall , 1345 cases of invasive premenopausal breast cancer were documented . Regular use of aspirin ( > or = 2 times per week ) was not significantly associated with breast cancer risk ( relative risk , 1.07 ; 95 % confidence interval , 0.89 - 1.29 ) . Regular use of either nonaspirin NSAIDs or acetaminophen also was not consistently associated with breast cancer risk . Results did not vary by frequency ( days per week ) , dose ( tablets per week ) , or duration of use . Furthermore , associations with each drug category did not vary substantially by estrogen and progesterone receptor status of the tumor . CONCLUSION These data suggest that the use of aspirin , other NSAIDs , and acetaminophen is not associated with a reduced risk of breast cancer among premenopausal women UNLABELLED There is evidence that use of aspirin offers several potential health benefits including cancer prevention and cardiovascular disease prevention . The purpose of this study was to assess the association between aspirin use and death from cancer and cardiovascular diseases with a special emphasis on cancer mortality . MATERIAL S AND METHODS The baseline data for this prospect i ve cohort study were collected in 1971 - -1975 for the first National Health and Nutrition Examination Study ( NHANES I ) and 1976 - -1980 as part of the second NHANES ( NHANES II ) with mortality follow-up using the National Death Index ( NDI ) through December 31 , 1992 . The main analyses were the relative risks of total mortality and cause-specific mortality for persons who used aspirin compared to persons who did not use aspirin adjusted for confounding using Cox proportional hazards . RESULTS The proportion of aspirin users was lower among cancer cases than non-cases ( 58 % versus 66 % ) and use of aspirin decreased with age . Consequently , age was a negative confounder attenuating the protective association between aspirin use and cancer and cardiovascular mortality . After adjusting for age , BMI , sex , race , poverty index , education and smoking , we observed a significant association of reduced all cause mortality among all aspirin users ( relative risk [ RR ] = 0.88 ; 95 % confidence interval [ CI ] 0.85 - 0.99 ) and lung cancer mortality among male aspirin users ( RR = 0.69 ; CI 0.49 - 0.96 ) . However , for women we observed adverse associations between aspirin use and bladder ( RR=12.31 ; CI 2.98 - 50.80 ) and brain cancer mortality ( RR=3.13 ; CI 1.09 - 9.00 ) , although case numbers were small . CONCLUSION Aspirin use appears to offer protection from all causes of mortality and lung cancer among men . In women aspirin use is associated with increased risk of bladder and brain cancer . Because of the small number of female bladder ( n=15 ) and brain ( n=20 ) cancer cases in this cohort the findings require confirmation BACKGROUND The cancer chemopreventive benefits of aspirin and nonaspirin nonsteroidal anti-inflammatory drugs ( NSAIDs ) are incompletely defined and may vary by smoking history . We evaluated associations between aspirin and nonaspirin NSAID use with cancer incidence and mortality stratified by smoking history in the Iowa Women 's Health Study , a prospect i ve cohort of postmenopausal women . METHODS Aspirin and nonaspirin NSAID use was self-reported by question naire in 1992 . Cancer incidence and mortality were ascertained by annual linkage to the Iowa Surveillance , Epidemiology , and End Results Cancer Registry and death certificates . Cox proportional hazards models were used to estimate multivariable relative risks ( RRs ) and 95 % confidence intervals ( CIs ) . All statistical tests were two-sided . RESULTS During an average of 10 years of follow-up , 3487 incident cancer cases and 3581 deaths were observed in the cohort of 22,507 women . Compared with nonuse , aspirin use was inversely associated with total cancer incidence ( multivariable-adjusted RR = 0.84 , 95 % CI = 0.77 to 0.90 ) , with age-adjusted incidence rates of 147 and 170 per 10,000 person-years for ever and never users , respectively , and was inversely associated with cancer mortality ( multivariable-adjusted RR = 0.87 , 95 % CI = 0.76 to 0.99 ) , with age-adjusted rates of 47 and 52 per 10,000 person-years . The inverse relationship was stronger among former and never smokers than current smokers , although not statistically significantly ( P = .28 ) . Aspirin use was also inversely associated with coronary heart disease mortality ( multivariable-adjusted RR = 0.75 , 95 % CI = 0.64 to 0.89 ) , with age-adjusted rates of 23 and 30 per 10,000 person-years for ever and never users , respectively , and with all-cause mortality ( multivariable-adjusted RR = 0.82 , 95 % CI = 0.76 to 0.89 ) , with age-adjusted rates of 126 and 155 per 10,000 person-years . Nonaspirin NSAID use was not associated with cancer incidence or mortality , coronary heart disease mortality , or all-cause mortality . CONCLUSIONS Aspirin use , but not nonaspirin NSAID use , was associated with lower risks of cancer incidence and mortality , which was more pronounced among former and never smokers than current smokers Nonsteroidal antiinflammatory drugs ( NSAIDs ) may play a role in breast cancer prevention ; however , breast cancer subtypes and lifestyle/host factors may influence their impact . During 1996 - 1998 in Canada , the authors examined the association between regular NSAID use ( defined as daily use for at least 2 months ) and breast cancer risk by estrogen receptor ( ER ) and progesterone receptor ( PR ) status , cigarette smoking exposure , and history of arthritis . Breast cancer cases ( n = 3,125 , including 1,600 ER+PR+ and 591 ER-PR- ) and an age-matched , r and om sample of controls ( n = 3,062 ) completed a general risk factor question naire , including detailed questions on prescription and nonprescription NSAID use . NSAID use was associated with reduced risk of breast cancer ( odds ratio = 0.76 , 95 % confidence interval : 0.66 , 0.88 ) . The association was not significantly different for ER+PR+ ( odds ratio = 0.71 , 95 % confidence interval : 0.60 , 0.84 ) and ER-PR- cancers ( odds ratio = 0.80 , 95 % confidence interval : 0.62 , 1.03 ) ( p(heterogeneity ) = 0.66 ) . The magnitude of the NSAID inverse association was similar for women with and without arthritis and across smoking strata ( risk estimates ranged from 0.74 to 0.84 ) . Breast cancer risk tended to decrease with increasing duration of NSAID use and was generally lowest for > or=7 years of use , and both acetylsalicylic acid and non-acetylsalicylic acid use were associated with reduced risks We carried out a nested case – control study to measure the rate ratio ( RR ) for invasive female breast cancer in relation to non-steroidal anti-inflammatory drug ( NSAID ) use . The source population consisted of the female beneficiaries of the Saskatchewan Prescription Drug Plan from 1981 to 1995 with no history of cancer since 1970 . Four controls/case , matched on age and sampling time , were r and omly selected . Dispensing rates during successive time periods characterized NSAID exposure . RRs associated with exposure during each period were adjusted for exposure during the others . Confounding by other determinants was studied in analyses adjusted with data obtained by interviewing sample s of subjects accrued from mid-1991 to mid-1995 . We accrued 5882 cases and 23 517 controls . Increasing NSAID exposure 2–5 years preceding diagnosis was associated with a trend towards a decreasing RR ( P -trend = 0.003 ) ; for the highest exposure level RR = 0.76 , 95 % confidence interval 0.63–0.92 . This protective effect could not be attributed to confounding by other determinants . In analyses involving only the cases , NSAID exposure 2–5 and 6–10 years preceding diagnosis was associated with significantly reduced risks of presenting with a large tumour ( > 5 cm diameter ) or distant metastasis , but not regional lymph node metastasis . The use of NSAIDs may retard the growth of breast cancers and prevent distant metastasis . © 2000 Cancer Research Use of non-steroidal anti-inflammatory drugs ( NSAIDs )
Output:
| A similar effect was found for aspirin , acetaminophen , COX-2 inhibitors and , to a lesser extent , ibuprofen .
The effect of aspirin was similar in preventing hormone-receptor-positive breast cancer .
This meta- analysis suggests a slightly protective effect of NSAIDs-especially aspirin and COX-2 inhibitors- against breast cancer , which seems to be restricted to ER/PR+tumors |
MS212767 | ***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 This study 's purpose was to test silver diammine fluoride ( SDF ) in arresting incipient occlusal caries in erupting permanent first molars and to compare it with other approaches . METHODS Sixty-six first erupting permanent molars were r and omly divided into 3 groups : cross tooth-brushing technique ( CTT ) , application of SDF , and glass ionomer fissure sealant ( GIC ) . The clinical procedures were conducted by the same dentist . Teeth were assessed clinical ly by 1 blinded examiner using visual inspection at baseline and after 3 , 6 , 12 , 18 , and 30 months and radiographically at 6- , 12- , and 30-month follow-up evaluations . The Kruskall-Wallis test was used to compare noninvasive treatments , and the Friedman test was performed to evaluate differences for each group during different follow-up periods . RESULTS A reduced number of active caries lesions was noted in all groups . After 3 and 6 months , SDF showed a significantly greater capacity for arresting caries lesions than CTT and GIC . At 18- and 30-month evaluations , no differences were observed among the 3 groups . All groups showed differences between baseline and all follow-up re-examinations . CONCLUSIONS All the tested techniques are equally efficient in controlling initial occlusal caries in erupting permanent first molars after 30-months of follow-up Objective : Considering the minimally invasive approach to dentistry , the scientific community has focused on non-invasive treatments for caries lesions . The aim of this study was to evaluate the efficacy of a nonsurgical approach to arrest occlusal non-cavitated dentin lesions through glass ionomer sealing . Methods : In this controlled clinical trial , 51 teeth with clinical ly non-cavitated occlusal caries radiographically located beneath the enamel-dentine junction ( radiolucent area ) were selected among patients presenting a moderate to high risk of caries . The teeth were r and omly divided into two groups : an experimental group receiving an application of Vidrion-R ( SS White ) glass ionomer and a control group not su bmi tted to any clinical intervention . Caries progression was monitored by clinical and radiographic examination at 4-monthly intervals over a period of one year . In addition , marginal integrity of the sealant was evaluated in the experimental group . Results : Clinical examination showed no statistical difference between the groups ( P=.13 ) . On the other h and , sealed teeth presented lower caries progression when analyzed by radiographic examination ( P=.004 ) . Conclusion : A glass ionomer sealant over non-cavitated occlusal caries lesions in dentin may not be sufficiently effective in arresting their progression The aim of this double-blind r and omized clinical trial was to evaluate the efficacy of 1.23 % APF gel application on the arrest of active incipient carious lesions in children . Sixty 7- to 12-year-old children , with active incipient lesions were included in the study . Children were divided r and omly into 2 groups : 1.23 % APF gel and placebo gel applications . Each group received 8 weekly applications of treatment . The lesions were re-evaluated at the 4th and 8th appointments . Poisson regression analysis was used to estimate relative risks of the presence of active white spot lesions . Groups showed similar results ( PR = 1.67 ; CI 95 % 0.69 - 3.98 ) . The persistence of at least 1 active lesion was associated with a higher number of lesions in the baseline ( PR = 2.67 ; CI 95 % 1.19 - 6.03 ) , but not with sugar intake ( PR = 1.06 ; CI 95 % 0.56 - 2.86 ) and previous exposure to fluoride dentifrice ( PR = 1.26 ; CI 95 % 0.49 - 2.29 ) . The trial demonstrates the equivalence of the treatments . The use of the APF gel showed no additional benefits in this sample of children exposed to fluori date d water and dentifrice . The professional dental plaque removal in both groups may also account for the result ing equivalence of the treatments This 12-week clinical study evaluated the impact of 10 % CPP-ACP and 5 % sodium fluoride varnish regimes on the regression of nonorthodontic white spot lesions ( WSLs ) . The study included 21 children with 101 WSLs who were r and omised into four treatment regimes : weekly clinical applications of fluoride varnish for the first month ( FV ) ; twice daily self-applications of CPP-ACP paste ( CPP-ACP ) ; weekly applications of fluoride varnish for the first month and twice daily self-applications of CPP-ACP paste ( CPP-ACP-FV ) ; and no intervention ( control ) . All groups undertook a st and ard oral hygiene protocol and weekly consultation . Visual appraisal s and laser fluorescence ( LF ) measurements were made in weeks one and twelve . The majority of WSLs in the control and FV groups exhibited no shift in appearance , whereas , in the CPP-ACP and CPP-ACP-FV groups , the lesions predominantly regressed . The visual and LF assessment s indicated that the extent of remineralisation afforded by the treatments was of the following order : control ~ FV < CPP-ACP ~ CPP-ACP-FV . Self-applications of CPP-ACP paste as an adjunct to st and ard oral hygiene significantly improved the appearance and remineralisation of WSLs . No advantage was observed for the use of fluoride varnish as a supplement to either the st and ard or CPP-ACP-enhanced oral hygiene regimes OBJECTIVE To compare the effectiveness of annual topical application of silver diamine fluoride ( SDF ) solution , semi-annual topical application of SDF solution , and annual application of a flowable high fluoride-releasing glass ionomer in arresting active dentine caries in primary teeth . METHODS A total of 212 children , aged 3 - 4 years , were r and omly allocated to one of three groups for treatment of carious dentine cavities in their primary teeth : Gp1-annual application of SDF , Gp2-semi-annual application of SDF , and Gp3-annual application of glass ionomer . Follow-up examinations were carried out every six months to assess whether the treated caries lesions had become arrested . RESULTS After 24 months , 181 ( 85 % ) children remained in the study . The caries arrest rates were 79 % , 91 % and 82 % for Gp1 , Gp2 and Gp3 , respectively ( p=0.007 ) . In the logistic regression model using GEE to adjust for clustering effect , higher caries arrest rates were found in lesions treated in Gp2 ( OR=2.98 , p=0.007 ) , those in anterior teeth ( OR=5.55 , p<0.001 ) , and those in buccal/lingual smooth surfaces ( OR=15.6 , p=0.004 ) . CONCLUSION Annual application of either SDF solution or high fluoride-releasing glass ionomer can arrest active dentine caries . Increasing the frequency of application to every 6 months can increase the caries arrest rate of SDF application . CLINICAL SIGNIFICANCE Arrest of active dentine caries in primary teeth by topical application of SDF solution can be enhanced by increasing the frequency of application from annually to every 6 months , whereas annual paint-on of a flowable glass ionomer can also arrest active dentine caries and may provide a more aesthetic outcome The possibility of achieving a caries-reducing effect by a combination of fortnightly mouthrinsings with 0.2 % NaF-solutions and topical painting with solutions containing Al- , Fe- , and Mn-ions was examined in a 4-year clinical study . In addition to the fluoride rinses one of two r and omized groups was given three paintings per year with a 0.2 % NaF-solution . The other group was painted three times per year with a potassium fluoride solution containing Al- , Fe- , and Mn-ions . This group developed significantly less caries during the study than the NaF-group . The results indicate that certain metal ions can enhance the caries-prophylactic action of the fluoride ions Objectives The hypothesis was that the daily use of a high dose of a xylitol chewing gum for 6 months would reduce the increment of decayed permanent first molar surfaces ( ΔD6S ) in high-risk schoolchildren after 2 years . Methods In this r and omised , clinical trial , 204 schoolchildren with a high caries risk were assigned to two experimental groups , xylitol and non-xylitol . Caries status , salivary mutans streptococci , and lactobacilli were re-evaluated 2 years later in 74 xylitol-treated and 83 non-xylitol-treated schoolchildren . Differences in mean ∆D6S between groups registered at baseline and at follow-up were evaluated using the nonparametric Mann – Whitney U test . Results Outcome was the development of detectable carious lesions initial ( D1–D2 ) and manifest ( D3 ) in the permanent first molars . In the xylitol group , the difference in proportion of children with decayed first permanent molars at baseline and follow-up was 1.43 % for manifest lesion and 2.86 % for initial lesions ; while in the non-xylitol group was 10.26 % ( p < 0.01 ) and 16.66 % ( p < 0.01 ) , respectively . A statistically significant difference regarding means was also observed in the non-xylitol group : the ∆D6S for manifest lesion was 0.18 ( p = 0.03 ) and 0.67 ( p = 0.02 ) for initial lesion . Conclusion The use of a chewing gum containing a high dose of xylitol for a period of 6 months has been shown to produce a long-term effect on caries development in high caries-risk children . Clinical relevance A school-based preventive programme based on 6 months ’ administration of a high dose of xylitol via chewing gum proved to be efficacious in controlling caries increment in high-risk children OBJECTIVES Little is known about the effect of Cervitec , a chlorhexidine-thymol varnish , on root caries . Our objective was to determine whether a 3-monthly application of Cervitec over 1 year would limit the progress of existing root caries lesions and reduce the incidence of dental root caries in a group of dentate institutionalized elderly , as a complement to their usual oral hygiene practice s. METHODS A double-blind r and omized clinical trial was conducted in 68 subjects ( 34 per group ) in two residences in Almería ( Spain ) . Twenty-one subjects with 60 root caries lesions and 25 with 65 lesions , in the Cervitec and placebo groups , respectively , completed the study . Varnishes were applied twice in the first week , 1 month later , and every 3 months until the end of the study . Clinical parameters associated with established lesions were determined at baseline and after 6 and 12 months , as was the incidence of root caries lesions . RESULTS The clinical evolution of lesions was significantly better in the Cervitec group as opposed to the placebo group in terms of width , height , color , and texture . The increase in root caries was significantly lower ( p=0.039 ) in the Cervitec group . CONCLUSION According to these results , Cervitec may help to control established root lesions and reduce the incidence of root caries lesion among institutionalized elderly Sound evidence on the effectiveness of fluoride varnishes ( FV ) to reduce caries incidence in preschool children is lacking . Objective : To assess whether the application of FV in preschool children at 6-month intervals decreases the incidence of caries and produces any adverse effects . Methods : A r and omized , examiner- and patient-blind , placebo-controlled , parallel-group design , clinical trial , comprising 1- to 4-year-old children , 100 in each group ( FV or placebo varnish , PV ) , was conducted in Rio de Janeiro , Brazil . Two trained pediatric dentists performed the clinical examinations ( kappa = 0.85 ) . Dental caries was recorded at the d2 ( cavitated enamel ) and d3 ( dentine ) levels using the International Caries Diagnosis and Assessment System . Results : At baseline , the mean age of the participants was 2.4 years ( SD 0.9 ) and the mean d3mfs was 0.8 ( SD 1.9 ) . Most of the children brushed their teeth with fluoride toothpaste and consumed fluori date d tap water . After 24 months , 89 and 92 children of the test and the control groups were analyzed , respectively . A total of 32 ( 35.9 % ) children in the FV group and 43 ( 46.7 % ) in the PV group presented new dentine caries lesions ( χ2 test ; p = 0.14 ) , showing relative and absolute risk reductions of 23 % ( 95 % CI : -9.5 to 45.9 ) and 11 % ( 95 % CI : -3.5 to 25.0 ) . The mean caries increment differences between the test and control groups were -0.8 ( 95 % CI : -2.0 to 0.4 ) at the d2 level and -0.7 ( 95 % CI : -1.9 to 0.4 ) at the d3 level . Only 2 minor complaints regarding the intervention were reported . Conclusion : Although safe and well accepted , twice-yearly professional FV application , during 2 years , did not result in a significant decrease in caries incidence
Output:
| Study -level data indicated that 5 % NaF varnish was the most effective for arresting or reversing noncavitated facial/lingual carious lesions ( low certainty ) and that 38 % silver diamine fluoride solution applied biannually was the most effective for arresting advanced cavitated carious lesions on any coronal surface ( moderate to high certainty ) . |
MS212768 | ***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 Preliminary evidence suggests that meditative exercise may have benefits for patients with chronic systolic heart failure ( HF ) ; this has not been rigorously tested in a large clinical sample . We sought to investigate whether tai chi , as an adjunct to st and ard care , improves functional capacity and quality of life in patients with HF . METHODS A single-blind , multisite , parallel-group , r and omized controlled trial evaluated 100 out patients with systolic HF ( New York Heart Association class I-III , left ventricular ejection fraction ≤40 % ) who were recruited between May 1 , 2005 , and September 30 , 2008 . A group-based 12-week tai chi exercise program ( n = 50 ) or time-matched education ( n = 50 , control group ) was conducted . Outcome measures included exercise capacity ( 6- minute walk test and peak oxygen uptake ) and disease-specific quality of life ( Minnesota Living With Heart Failure Question naire ) . RESULTS Mean ( SD ) age of patients was 67 ( 11 ) years ; baseline values were left ventricular ejection fraction , 29 % ( 8 % ) and peak oxygen uptake , 13.5 mL/kg/min ; the median New York Heart Association class of HF was class II . At completion of the study , there were no significant differences in change in 6-minute walk distance and peak oxygen uptake ( median change [ first quartile , third quartile ] , 35 [ -2 , 51 ] vs 2 [ -7 , 54 ] meters , P = .95 ; and 1.1 [ -1.1 , 1.5 ] vs -0.5 [ -1.2 , 1.8 ] mL/kg/min , P = .81 ) when comparing tai chi and control groups ; however , patients in the tai chi group had greater improvements in quality of life ( Minnesota Living With Heart Failure Question naire , -19 [ -23 , -3 ] vs 1 [ -16 , 3 ] , P = .02 ) . Improvements with tai chi were also seen in exercise self-efficacy ( Cardiac Exercise Self-efficacy Instrument , 0.1 [ 0.1 , 0.6 ] vs -0.3 [ -0.5 , 0.2 ] , P < .001 ) and mood ( Profile of Mood States total mood disturbance , -6 [ -17 , 1 ] vs -1 [ -13 , 10 ] , P = .01 ) . CONCLUSION Tai chi exercise may improve quality of life , mood , and exercise self-efficacy in patients with HF . Trial Registration clinical trials.gov Identifier : NCT00110227 Background : Capacity to exercise may not be fully restored in patients with heart failure even in the long term after ventricular assist device ( VAD ) implantation . The benefits of exercise training in patients with VAD are unknown . Design and methods : Fifteen patients , aged 38.3 ± 15.9 years , bridged to heart transplantation with left ventricular assist device or biventricular assist device were r and omized at a ratio of 2 : 1 to a training group ( TG , n = 10 ) or a control group ( n = 5 ) , 6.3 ± 4 months after implantation . Both the groups were advised to walk 30–45 min/day . TG also underwent moderate-intensity aerobic exercise using a bike or treadmill for 45 min , three to five times a week , combined with high-intensity inspiratory muscle training using a computer- design ed software to respiratory exhaustion , two to three times a week for 10 weeks . The patients were tested using cardiopulmonary exercise testing , 6-min walk test , spirometry and electronic pressure manometer for inspiratory muscle strength ( Pimax ) and endurance ( sustained Pimax ) measurement . Quality of life was assessed with the Minnesota Living with Heart Failure question naire . Results : TG improved peak oxygen consumption ( 19.3 ± 4.5 vs. 16.8 ± 3.7 ml/kg per min , P = 0.008 ) and VO2 at ventilatory threshold ( 15.1 ± 4.2 vs. 12 ± 5.6 ml/kg per min , P = 0.01 ) , whereas the ventilation/carbon dioxide slope decreased ( 35.9 ± 5.6 vs. 40 ± 6.5 , P = 0.009 ) . The 6-min walk test distance increased ( 527 ± 76 vs. 462 ± 88 m , P = 0.005 ) and quality of life was improved ( 38.2 ± 11.6 vs. 48.9 ± 12.8 , P = 0.005 ) , as well as Pimax ( 131.8 ± 33 vs. 95.5 ± 28cmH2O , P = 0.005 ) , sustained Pimax ( 484 ± 195 vs. 340 ± 193cmH2O/s/10 3 , P = 0.005 ) , and inspiratoty lung capacity ( 2.4 ± 0.9 vs. 1.7 ± 0.7 L , P = 0.008 ) were improved . No significant changes were noted in the control group . Conclusion : Our findings indicate that exercise training may improve the functional status of VAD recipients even at a later period after implantation and thus , may have additional importance in cases of destination therapy BACKGROUND We hypothesised that combined aerobic training ( AT ) with resistance training ( RT ) and inspiratory muscle training ( IMT ) could result in additional benefits over AT alone in patients with chronic heart failure ( CHF ) . METHODS Twenty-seven patients , age 58 ± 9 years , NYHA II/III and LVEF 29 ± 7 % were r and omly assigned to a 12-week AT ( n=14 ) or a combined AT/RT/IMT ( ARIS ) ( n=13 ) exercise program . AT consisted of bike exercise at 70 - 80 % of max heart rate . ARIS training consisted of AT with RT of the quadriceps at 50 % of 1 repetition maximum ( 1RM ) and upper limb exercises using dumbbells of 1 - 2 kg as well as IMT at 60 % of sustained maximal inspiratory pressure ( SPI(max ) ) . At baseline and after intervention patients underwent cardiopulmonary exercise testing , echocardiography , evaluation of dyspnea , muscle function and quality of life ( QoL ) scores . RESULTS The ARIS program as compared to AT alone , result ed in additional improvement in quadriceps muscle strength ( 1RM , p=0.005 ) and endurance ( 50%1 RM × number of max repetitions , p=0.01 ) , SPI(max ) ( p<0.001 ) , exercise time ( p=0.01 ) , circulatory power ( peak oxygen consumption × peak systolic blood pressure , p=0.05 ) , dyspnea ( p=0.03 ) and QoL ( p=0.03 ) . CONCLUSIONS ARIS training was safe and result ed in incremental benefits in both peripheral and respiratory muscle weakness , cardiopulmonary function and QoL compared to that of AT . The present findings may add a new prospect i ve to cardiac rehabilitation programs of heart failure patients whilst the clinical significance of these outcomes need to be addressed in larger r and omised studies BACKGROUND The effects of mind-body interventions ( MBIs ) ( eg , Tai Chi , yoga , meditation ) for individuals with heart failure ( HF ) have not been systematic ally evaluated . METHODS AND RESULTS We performed a systematic review of r and omized controlled trials ( RCTs ) examining the effects of MBIs in HF . We extracted participant characteristics , MBI procedure , outcomes assessed , and main results of English- language RCTs before October 2016 . We identified 24 RCTs ( n = 1314 participants ) of 9 MBI types : Tai Chi ( n = 7 ) , yoga ( n = 4 ) , relaxation ( n = 4 ) , meditation ( n = 2 ) , acupuncture ( n = 2 ) , biofeedback ( n = 2 ) , stress management ( n = 1 ) , Pilates ( n = 1 ) , and reflexology ( n = 1 ) . Most ( n = 22 , 95.8 % ) reported small-to-moderate improvements in quality of life ( 14/14 studies ) , exercise capacity ( 8/9 studies ) , depression ( 5/5 studies ) , anxiety and fatigue ( 4/4 studies ) , blood pressure ( 3/5 studies ) , heart rate ( 5/6 studies ) , heart rate variability ( 7/9 studies ) , and B-type natriuretic peptide ( 3/4 studies ) . Studies ranged from 4 minutes to 26 weeks and group sizes ranged from 8 to 65 patients per study arm . CONCLUSIONS Although wide variability exists in the types and delivery , RCTs of MBIs have demonstrated small-to-moderate positive effects on HF patients ' objective and subjective outcomes . Future research should examine the mechanisms by which different MBIs exert their effects Aims : The aims of this study were to determine whether yoga and hydrotherapy training had an equal effect on the health-related quality of life in patients with heart failure and to compare the effects on exercise capacity , clinical outcomes , and symptoms of anxiety and depression between and within the two groups . Methods : The design was a r and omized controlled non-inferiority study . A total of 40 patients , 30 % women ( mean±SD age 64.9±8.9 years ) with heart failure were r and omized to an intervention of 12 weeks , either performing yoga or training with hydrotherapy for 45–60 minutes twice a week . Evaluation at baseline and after 12 weeks included self-reported health-related quality of life , a six-minute walk test , a sit-to-st and test , clinical variables , and symptoms of anxiety and depression . Results : Yoga and hydrotherapy had an equal impact on quality of life , exercise capacity , clinical outcomes , and symptoms of anxiety and depression . Within both groups , exercise capacity significantly improved ( hydrotherapy p=0.02 ; yoga p=0.008 ) and symptoms of anxiety decreased ( hydrotherapy p=0.03 ; yoga p=0.01 ) . Patients in the yoga group significantly improved their health as rated by EQ-VAS ( p=0.004 ) and disease-specific quality of life in the domains symptom frequency ( p=0.03 ) , self-efficacy ( p=0.01 ) , clinical summary as a combined measure of symptoms and social factors ( p=0.05 ) , and overall summary score ( p=0.04 ) . Symptoms of depression were decreased in this group ( p=0.005 ) . In the hydrotherapy group , lower limb muscle strength improved significantly ( p=0.01 ) . Conclusions : Yoga may be an alternative or complementary option to established forms of exercise training such as hydrotherapy for improvement in health-related quality of life and may decrease depressive symptoms in patients with heart failure BACKGROUND Despite recent advances in pharmacologic and device therapy , morbidity and mortality from heart failure ( HF ) remain high . Yoga combines physical and breathing exercises that may benefit patients with HF . We hypothesized that an 8-week regimen of yoga in addition to st and ard medical therapy would improve exercise capacity , inflammatory markers , and quality of life ( QoL ) in patients with HF . METHODS AND RESULTS New York Heart Association Class I-III HF patients were r and omized to yoga treatment ( YT ) or st and ard medical therapy ( MT ) . Measurements included a grade d exercise test ( GXT ) to V O(2Peak ) and the following serum biomarkers : interleukin-6 ( IL-6 ) , high-sensitivity C-reactive protein ( hsCRP ) , and extracellular superoxide dismutase ( EC-SOD ) . The Minnesota Living with Heart Failure Question naire ( MLHFQ ) was administered to assess changes in QoL. A total of 19 patients were enrolled after the initial screening . Of the 19 patients , 9 were r and omized to YT and 10 to MT . Patients had a mean EF of 25 % . GXT time and V O(2Peak ) were significantly improved in the YT versus MT groups ( + 18 % in the YT and -7.5 % in MT ; P = .03 vs. control and + 17 in YT and -7.1 in MT ; P = .02 , respectively ) . There were statistically significant reductions in serum levels of IL-6 and hsCRP and an increase in EC-SOD in the YT group ( all P < .005 vs. MT ) . MLHFQ scores improved by 25.7 % in the YT group and by 2.9 % in the MT group . CONCLUSIONS Yoga improved exercise tolerance and positively affected levels of inflammatory markers in patients with HF , and there was also a trend toward improvements in Background Heart failure with preserved ejection fraction ( HFpEF ) is remarkably common in elderly people with highly prevalent comorbid conditions . Despite its increasing in prevalence , there is no evidence -based effective therapy for HFpEF . We sought to evaluate whether inspiratory muscle training ( IMT ) improves exercise capacity , as well as left ventricular diastolic function , biomarker profile and quality of life ( QoL ) in patients with advanced HFpEF and nonreduced maximal inspiratory pressure ( MIP ) . Design and methods A total of 26 patients with HFpEF ( median ( interquartile range )
Output:
| IMT_Ph had the highest effect sizes for VO2 peak and 6MWT , IMT_Pm highest for QoL , and Qi_Ex highest for heart rate .
Aerobics had the second highest for VO2 peak , Qi_Ex second highest for 6MWT , and IMT_Ph second highest for heart rate and QoL. CONCLUSION This study supports that high- and medium-intensity machine-assisted training improves exercise capacity and QoL in hospital-based heart failure patients .
After hospital discharge , non-machine-assisted training continuously improves cardiac function |
MS212769 | ***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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***EXAMPLES***
Input: Objectives The main purpose of this study is the detection of amoxicillin and clindamycin concentrations in teeth . Material s and methods Eleven patients received 2 g of amoxicillin , and 11 patients received 600 mg of clindamycin in a single dose of oral medication at least 60 min prior to tooth extraction due to systemic diseases . The concentrations were determined in crowns and roots separately using liquid chromatography – t and em mass spectrometry ( LC-MS-MS ) . Results Amoxicillin ( 13 sample s ) and clindamycin ( 12 sample s ) were detected in the sample s of the root and crown preparations of the extracted teeth . The mean concentration of amoxicillin was 0.502 μg/g in the roots and 0.171 μg/g in the crowns . The mean concentration of clindamycin was 0.270 μg/g in the roots and 0.064 μg/g in the crowns . Conclusions A single dose of oral amoxicillin and clindamycin leads to concentrations of both antibiotics in teeth which exceed the minimal inhibition concentration of some oral bacteria . Clinical relevance The proof of antibacterial activity in dental hard tissue after oral single-dose application is new . The antimicrobial effect of amoxicillin and clindamycin concentrations in roots of teeth may be of clinical relevance to bacterial reinfection from dentinal tubules The objective of this prospect i ve study was to estimate the incidence of early loss of dental implants and the potential risk factors . The predictive variables were classified as being patient , implant , anatomical , or operation-specific . The outcome variable was early failure of the implant . The significance of differences was assessed using bivariate analyses , and then a multivariate logistic regression model to identify independent predictors for early loss of implants . A total of 169 patients , 116 women and 53 men , mean age 47 ( range 16 - 80 ) years , had 399 implants inserted . Fifteen implants were lost in 14 patients ( 8 % ) . The early loss of dental implants was significantly associated with width of keratinised gingiva ( p=0.008 ) , the use polyglactin sutures ( p=0.048 ) , and the use of narrow implants ( p=0.035 ) . Multivariate logistic regression analysis established the significance of narrow keratinised gingiva ( OR=4.7 , p=0.005 ) and the use of polyglactin sutures ( OR=3.8 , p=0.042 ) , which we conclude are probably the strongest predictors of early failure of implants The purpose of this study was to compare the efficacy of two antibiotic regimens in reducing early dental implant failure . A preoperative single-dose regimen and a 3-day antibiotic course were compared . Eighty subjects needing dental implant placement were r and omly allocated to one of the two antibiotic prophylaxis regimen groups . In the first group , dental implants were placed after the administration of a single preoperative dose of antibiotic ( 1 g of amoxicillin ) ; no postoperative antibiotics were given . In the second group , dental implants were inserted in patients who received the same preoperative dose of antibiotic as the first group , but the antibiotic was then continued postoperatively for 3 days . Patients returned for postoperative evaluation at 3 days , 7 days , and 12 weeks . The surgical sites were assessed for pain , swelling , wound dehiscence , and pus formation . No statistically significant difference was observed between the two groups , probably because of the limited number of patients . Although minor complications were seen in a few patients , all implants were successfully osseointegrated . Until a study with a larger population rules definitively on the role of antibiotics in implant surgery , a single dose of antibiotic before implant placement may be sufficient PURPOSE The purpose of this prospect i ve study was to compare the efficacy of prophylactic antibiotic regimens commonly used in dental implant surgery . Preoperative single-dose and long-term prophylactic antibiotic regimens were compared . MATERIAL S AND METHODS This was a 2-center prospect i ve study in which 215 patients underwent ambulatory endosseous implant placement . In the first group , 445 dental implants were placed in 125 patients after the administration of a single preoperative dose of prophylactic antibiotic with no postoperative antibiotics . In the second group , 302 dental implants were placed in 90 patients who received a preoperative dose of antibiotics and were instructed to take antibiotics postoperatively for 7 days . In both groups , 0.12 % chlorhexidine pre- and postoperative mouth rinses were used . Patients returned for postoperative evaluation at 1 week , 2 weeks , and just prior to surgical uncovering . The surgical sites were assessed for pain , swelling , erythema , and purulence . RESULTS In the first group , 3 patients developed wound dehiscence at 5 implant sites and 1 developed a minor inflammatory response . None of the patients in this group received further antibiotics . In the second group , 3 patients developed wound dehiscence , 2 developed an inflammatory response , and 1 was diagnosed with infection , for which another course of antibiotics was required . There was no statistical difference between the 2 groups according to the Fisher 2 x 4 exact test ( P = .56 ) . DISCUSSION Indiscriminate use of antibiotics is unacceptable in clinical practice today . Surgeons must adhere to basic principles to gain the most benefit from the use of prophylactic antibiotics . CONCLUSION Long-term prophylactic antibiotic use in implant surgery was of no advantage or benefit over a single-dose preoperative antibiotic regimen in this patient population Peri-implantitis is a biofilm-induced destructive inflammatory process that , over time , results in loss of supporting bone around an osseointegrated dental implant . Biofilms at peri-implantitis sites have been reported to be dominated by Gram-negative anaerobic rods with a proteolytic metabolism such as , Fusobacterium , Porphyromonas , Prevotella and Tannerella , as well as anaerobic Gram-positive cocci . In this study , we hypothesized that protease activity is instrumental in driving bone destruction and we therefore compared the microbial composition and level of protease activity in sample s of peri-implant biofluid ( PIBF ) from 25 healthy subjects ( H group ) and 25 subjects with peri-implantitis ( PI group ) . Microbial composition was investigated using culture techniques and protease activity was determined using a FITC-labelled casein substrate . The microbial composition was highly variable in subjects both in the H and PI groups but one prominent difference was the prevalence of Porphyromonas/Prevotella and anaerobic Gram positive cocci which was significantly higher in the PI than in the H group . A subgroup of subjects with peri-implantitis displayed a high level of protease activity in the PIBF compared to healthy subjects . However , this activity could not be related to the presence of specific bacterial species . We propose that a high level of protease activity may be a predictive factor for disease progression in peri-implantitis . Further longitudinal studies are however required to determine whether assessment of protease activity could serve as a useful method to identify patients at risk for progressive tissue destruction The aim of this study was to attempt to determine the minimum effective regimen of amoxicillin antibiotic prophylaxis for dental implant surgery . One hundred patients were r and omly allocated to 4 different antibiotic prophylactic treatment groups . At second-stage surgery , only 2 implants failed in the nonantibiotic group . No statistically significant differences were found in the 4 groups , probably because of the limited number of the sample s. Until a study with a larger population may definitely rule on the role of antibiotics in oral implant surgery , in may be prudent for the practitioner to adopt the single preoperative antibiotic dose as the minimal effective regimen The aim of the present r and omized controlled clinical trial was to investigate the adjunctive effect of systemic antibiotics and the local use of chlorhexidine for implant surface decontamination in the surgical treatment of peri-implantitis . One hundred patients with severe peri-implantitis were recruited . Surgical therapy was performed with or without adjunctive systemic antibiotics or the local use of chlorhexidine for implant surface decontamination . Treatment outcomes were evaluated at 1 y. A binary logistic regression analysis was used to identify factors influencing the probability of treatment success , that is , probing pocket depth ≤5 mm , absence of bleeding/suppuration on probing , and no additional bone loss . Treatment success was obtained in 45 % of all implants but was higher in implants with a nonmodified surface ( 79 % ) than those with a modified surface ( 34 % ) . The local use of chlorhexidine had no overall effect on treatment outcomes . While adjunctive systemic antibiotics had no impact on treatment success at implants with a nonmodified surface , a positive effect on treatment success was observed at implants with a modified surface . The likelihood for treatment success using adjunctive systemic antibiotics in patients with implants with a modified surface , however , was low . As the effect of adjunctive systemic antibiotics depended on implant surface characteristics , recommendations for their use in the surgical treatment of peri-implantitis should be based on careful assessment s of the targeted implant ( Clinical Trials.gov NCT01857804 )
Output:
| These findings demonstrate that plasma concentrations of a prophylactic dose of amoxicillin are higher than the minimum inhibitory concentration needed to prevent the common dental bacteria involved in peri-implantitis and periodontal diseases |
MS212770 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: AIMS : To compare the efficacy of and tolerance to oral fluconazole and intraconazole in preventing fungal infection in neutropenic patients with haematological malignancies . PATIENTS : 213 consecutive , afebrile adult patients treated with or without autologous stem cell transplantation for haematological malignancies . METHODS : A r and omised , double blind , single centre study . Patients were r and omly assigned to receive fluconazole 50 mg or itraconazole 100 mg , both twice daily in identical capsules . An intention to treat analysis was performed on 202 patients , 101 in each group . RESULTS : Microbiologically documented systemic fungal infections occurred in four patients in each group . Clinical fungal infection was thought to be present in seven recipients of fluconazole and four of itraconazole . In all 202 patients , 29 proceeded to intravenous amphotericin ( amphotericin B ) , 16 in the fluconazole group and 13 in the itraconazole group . Superficial fungal infection was seen only in three non-compliant patients in the fluconazole group . All these infections were oral . No major differences were noted in the isolates of fungi in mouth washes and fecal sample s. Overall mortality was 8.9 % ( 18 deaths ; seven in the fluconazole group , 11 in the itraconazole group ) . Mortality from microbiologically and clinical ly documented fungal infection was 4.5 % ( nine deaths ; three in the fluconazole group , six in the itraconazole group ) . Median time to suspected or proven fungal infection was 16 days in both groups . None of these comparisons reached statistical significance ( p < 0.05 ) . No major clinical toxicity was noted and compliance was excellent . CONCLUSIONS : In neutropenic patients treated for haematological malignancies with or without autologous stem cell transplantation , fluconazole and itraconazole in low doses result in a similar low frequency of fungal disease . Fluconazole may be the preferable drug because of the smaller number of capsules and lack of need for timing relative to meals Goal of workThe aim of the study is to evaluate the effect of fluconazole antifungal prophylaxis on the severity of mucositis in head and neck cancer patients receiving radiotherapy . Patients and methods Sixty-three patients , with malignant head and neck tumor , eligible to receive radiotherapy , entered the study . Thirty-four patients ( group A ) received 100 mg/day of fluconazole prophylaxis during radiotherapy and were compared with 29 patients , who received radiotherapy alone ( group B ) . The two groups were similar in terms of patients and radiotherapy characteristics . Smear to test for C and ida carriage was taken before and after radiotherapy . Oral c and idiasis was diagnosed using the criteria described before . Oral mucositis was recorded according to EORTC/RTOG criteria .Main results A significant reduction of severe mucositis at the end of radiotherapy ( 14.7 vs 44.8 % , p=0.018 ) and of interruptions ( 0 vs 17.2 % , p=0.017 ) was observed in group A. C and idiasis was prevented ( 0 vs 34.5 % , p=0.001 ) , with a significant reduction of C and ida carriage of 40.7 % ( p=0.001 ) . Conclusion Fluconazole prophylaxis showed a significant beneficial impact on the severity of mucositis and on radiotherapy interruptions in this group of patients . The current study provides data on the build of a r and omized controlled trial on the effect of fluconazole prophylaxis on treatment schedule and quality of life of the patients during head and neck radiotherapy The aim of this study was to investigate oral yeast colonization and oral yeast strain diversity in irradiated ( head and neck ) , dentate , xerostomic individuals . Subjects were recruited from a nasopharyngeal carcinoma clinic and were segregated into group A ( age , < 60 years [ n = 25 ; average age + /- st and ard deviation ( SD ) , 48 + /- 6 years ; average postirradiation time + /- SD , 5 + /- 5 years ] ) and group B ( age , > /=60 years [ n = 8 ; average age + /- SD , 67 + /- 4 years ; average postirradiation time + /- SD , 2 + /- 2 years ] ) and were compared with age- and sex-matched healthy individuals in group C ( age , < 60 years [ n = 20 ; average age + /- SD , 44 + /- 12 years ] and group D ( age , > /=60 years [ n = 10 ; average age , 70 + /- 3 years ] ) . Selective culture of oral rinse sample s was carried out to isolate , quantify , and speciate yeast recovery . All test subjects underwent a 3-month comprehensive oral and preventive care regimen plus topical antifungal therapy , if indicated . A total of 12 subjects from group A and 5 subjects from group B were recalled for re assessment of yeast colonization . Sequential ( pre- and posttherapy ) C and ida isolate pairs from patients were phenotypically ( all isolate pairs ; biotyping and resistotyping profiles ) and genotypically ( C and ida albicans isolate pairs only ; electrophoretic karyotyping by pulsed-field gel electrophoresis , restriction fragment length polymorphism [ RFLP ] , and r and omly amplified polymorphic DNA [ RAPD ] assays ) evaluated . All isolates were C and ida species . Irradiated individuals were found to have a significantly increased yeast carriage compared with the controls . The isolation rate of C and ida posttherapy remained unchanged . A total of 9 of the 12 subjects in group A and 3 of the 5 subjects in group B harbored the same C. albicans or C and ida tropicalis phenotype at recall . Varying degrees of congruence in the molecular profiles were observed when these sequential isolate pairs of C. albicans were analyzed by RFLP and RAPD assays . Variations in the genotype were complementary to those in the phenotypic characteristics for some isolates . In conclusion , irradiation-induced xerostomia seems to favor intraoral colonization of C and ida species , particularly C. albicans , which appeared to undergo temporal modifications in clonal profiles both phenotypically and genotypically following hygienic and preventive oral care which included topical antifungal therapy , if indicated . We postulate that the observed ability of C and ida species to undergo genetic and phenotypic adaptation could strategically enhance its survival in the human oral cavity , particularly when salivary defenses are impaired Guidelines for the management of patients with invasive c and idiasis and mucosal c and idiasis were prepared by an Expert Panel of the Infectious Diseases Society of America . These up date d guidelines replace the previous guidelines published in the 15 January 2004 issue of Clinical Infectious Diseases and are intended for use by health care providers who care for patients who either have or are at risk of these infections . Since 2004 , several new antifungal agents have become available , and several new studies have been published relating to the treatment of c and idemia , other forms of invasive c and idiasis , and mucosal disease , including oropharyngeal and esophageal c and idiasis . There are also recent prospect i ve data on the prevention of invasive c and idiasis in high-risk neonates and adults and on the empiric treatment of suspected invasive c and idiasis in adults . This new information is incorporated into this revised document To evaluate the efficacy of itraconazole capsules in prophylaxis for fungal infections in neutropenic patients , we conducted a prospect i ve , double-blind , placebo-controlled , r and omized trial . Patients with hematologic malignancies or those who received autologous bone marrow transplants were assigned either a regimen of itraconazole ( 100 mg orally twice daily ; n=104 ) or of placebo ( n=106 ) . Overall , fungal infections ( superficial or systemic ) occurred more frequently in the placebo group ( 15 % vs. 6 % ; P=.03 ) . There were no differences in the empirical use of amphotericin B or systemic fungal infections . Among patients with neutropenia that was profound ( < 100 neutrophils/mm3 ) and prolonged ( for at least 7 days ) , those receiving itraconazole used less empirical amphotericin B ( 22 % vs. 61 % ; P=.0001 ) and developed fewer systemic fungal infections ( 6 % vs. 19 % ; P=.04 ) . For patients with profound and prolonged neutropenia , itraconazole capsules at the dosage of 100 mg every 12 h reduce the frequency of systemic fungal infections and the use of empirical amphotericin Fungal infections are a major problem in patients with hematologic malignancy . Attempts to reduce their frequency with antifungal agents have not been successful . A double-blind , controlled , single-center trial was conducted with 96 consecutive patients undergoing 154 episodes of chemotherapy . Patients received 400 mg of fluconazole or placebo until bone marrow recovery or initiation of intravenous amphotericin B infusions . End points were amphotericin B use , fungal infection , stable neutrophil count > 0.5 x 10(9)/L , toxicity precluding further fluconazole use , and death . By Kaplan-Meier estimation , the time to initiation of amphotericin B therapy was shorter in 76 patients treated with placebo than in 75 treated with fluconazole ( P = .003 ) . Also , fluconazole reduced the number of febrile days by 20 % ( P = .002 ) and prevented oropharyngeal c and idiasis ( 1/75 vs. 9/76 , P = .018 ) . The frequency of deep mycoses ( 8/76 vs. 8/75 ) and outcome were unaffected . Fluconazole did not have a favorable effect on infection-related health care costs and was associated with prolonged severe neutropenia ( P = .01 ) In a prospect i ve r and omized study the efficacy of fluconazole ( 50 mg in one single daily dose ) was compared with oral amphotericin B in suspension and tablets ( each 200 mg four times daily ) for prevention of colonization and subsequent infection by yeasts in 50 patients undergoing remission induction treatment for acute leukaemia . All patients received ciprofloxacin for prevention of bacterial infections . Fluconazole was as effective as amphotericin B in preventing severe local and disseminated fungal disease ( one documented and one highly suspected infection in each group of patients ) . Fluconazole effectively prevented yeast colonization of the oropharynx but was less effective than amphotericin B in preventing colonization of the lower alimentary tract . Fifty-two percent of patients receiving fluconazole had persistent positive stool cultures as compared to 4 % in the amphotericin B group ( P less than 0.01 ) . Fluconazole was better tolerated than amphotericin B. One patient developed an extended rash leading to the termination of fluconazole PURPOSE To identify predictors of oral mucositis and gastrointestinal toxicity after high-dose therapy . PATIENTS AND METHODS Mucositis and gastrointestinal toxicity were prospect ively evaluated in 202 recipients of high-dose therapy and autologous or allogeneic stem-cell rescue . Of 10 outcome variables , three were selected as end points : the peak value for the University of Nebraska Oral Assessment Score ( MUCPEAK ) , the duration of parenteral nutritional support , and the peak daily output of diarrhea . Potential covariates included patient age , sex , diagnosis , treatment protocol , transplantation type , stem-cell source , and rate of neutrophil recovery . The three selected end points were also examined for correlation with blood infections and transplant-related mortality . RESULTS A diagnosis of leukemia , use of total body irradiation , allogeneic transplantation , and delayed neutrophil recovery were associated with increased oral mucositis and longer parenteral nutritional support . No factors were associated with diarrhea . Also , moderate to severe oral mucositis ( MUCPEAK > or = 18 on a scale of 8 to 24 ) was correlated with blood infections and transplant-related mortality : 60 % of patients with MUCPEAK > or = 18 had positive blood cultures versus 30 % of patients with MUCPEAK less than 18 ( P = .001 ) ; 24 % of patients with MUCPEAK > or = 8 died during the transplantation procedure versus 4 % of patients with MUCPEAK less than 18 ( P = .001 ) . CONCLUSION Gastrointestinal toxicity is a major cause of transplant-related morbidity and mortality , emphasizing the need for corrective strategies . The peak oral mucositis score and the duration of parenteral nutritional support are useful indices of gastrointestinal toxicity because these end points are correlated with clinical ly significant events , including blood infections and treatment-related mortality The goal of this prospect i ve r and omized single-center study was the comparison of safety and efficacy of high-dose oral/intravenous fluconazole ( 400
Output:
| Conclusions There is an increased risk of clinical ly significant oral fungal infection during cancer therapy .
Systemic antifungals are effective in the prevention of clinical oral fungal infection in patients receiving cancer therapy . |
MS212771 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
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Input: OBJECTIVE Joint protection aims to reduce pain and local inflammation , preserve the integrity of joint structures and improve function . There is evidence that it can improve pain and function in the short term , but the long-term effects are uncertain . This study evaluated the effects of joint protection in early rheumatoid arthritis ( RA ) . METHODS A r and omized , controlled , assessor-blinded trial of duration 1 yr was conducted . Two interventions ( both 8 h ) were compared : st and ard arthritis education , including 2.5 h of joint protection education based on typical UK practice ; and a joint protection arthritis education programme , using educational-behavioural teaching methods . Assessment s were made at entry and 6 and 12 months . RESULTS Sixty-five people with RA attended the joint protection programme and 62 the st and ard programme . The groups were matched for age ( 51 and 49 yr ) , disease duration ( 21 and 17.5 months ) and use of non-steroidal anti-inflammatory drugs and disease-modifying anti-rheumatic drugs . In comparison with the st and ard group , the joint protection group significantly improved with respect to adherence to the joint protection programme ( P=0.001 ) , h and pain ( P=0.02 ) , general pain ( P=0.05 ) , early morning stiffness ( P=0.01 ) , self-reported number of disease flare-ups ( P=0.004 ) , visits to the doctor for arthritis ( P<0.01 ) , and the AIMS 2 ( Arthritis Impact Measurement Scales ) activities of daily living scale ( P=0.04 ) . A trend to improved swollen joint counts was identified ( P=0.07 ) . Within-group analyses also showed improvements in arthritis self-efficacy and perceived control . H and deformity scores continued to increase in both groups . CONCLUSION We found significant improvements in adherence , pain , disease status and functional ability amongst those attending the joint protection programme . Benefits became more apparent with time , suggesting that joint protection can help slow the progression of the effects of RA over and above the effects of drug therapy The present study examined the efficacy of a behavioral intervention design ed to increase adherence to fluid-intake restrictions among hemodialysis patients . Twenty intervention-group patients were compared with 20 matched control patients on an indicator of fluid-intake adherence at 3 time points . The Group x Time interaction was significant , indicating that patients in the 2 groups exhibited a differential pattern of change in fluid-intake adherence across the follow-up period . The intervention and control groups did not differ significantly in terms of adherence at the initial postintervention period but did differ at the 8-week follow-up . The observed group differences were , in part , due to a trend toward increasingly better adherence in the intervention group and poorer adherence in the control group across the follow-up period Developing more effective behavioural interventions requires an underst and ing of the mechanisms of behaviour change , and methods to rigorously test their theoretical basis . The delivery and theoretical basis of an intervention protocol were assessed in ProActive , a UK trial of an intervention to increase the physical activity of those at risk of Type 2 diabetes ( N = 365 ) . In 108 intervention sessions , behaviours of facilitators were mapped to four theories that informed intervention development and behaviours of participants were mapped to 17 theoretical components of these four theories . The theory base of the intervention specified by the protocol was different than that delivered by facilitators , and that received by participants . Of the intervention techniques delivered , 25 % were associated with theory of planned behaviour ( TPB ) , 42 % with self-regulation theory ( SRT ) , 24 % with operant learning theory ( OLT ) and 9 % with relapse prevention theory ( RPT ) . The theoretical classification of participant talk showed a different pattern , with twice the proportion associated with OLT ( 48 % ) , 21 % associated with TPB , 31 % with SRT and no talk associated with RPT . This study demonstrates one approach to assessing the extent to which the theories used to guide intervention development account for any changes observed OBJECTIVE In rheumatoid arthritis , education programmes successfully impart knowledge but , notwithst and ing issues of empowerment , this knowledge has to be translated into behavioural change to have a chance of improving disease outcome . Arguably , behavioural change must also occur early if outcomes are to be improved . For these reasons , we planned a study of patient education in early disease , with radiological damage and quality of life as the main outcome variables . METHODS We performed a r and omized controlled trial in people with rheumatoid arthritis of < 5 yr duration . The main intervention was a 4 week education programme , each weekly session lasting 2 h. Assessment s were made at entry , at 4 weeks and at 12 months . The main outcome variables were the modified Larsen radiological score for the h and s and the SF-36 quality of life question naire . Secondary outcome variables were the Health Assessment Question naire ( HAQ ) , Ritchie Articular Index ( RAI ) , Patient Knowledge Question naire ( PKQ ) , Compliance Question naire ( CQ ) , plasma viscosity ( PV ) , pharmaceutical changes and consulting behaviour . RESULTS The patient numbers were 34 ( 10 male , 24 female ) for the control group and 43 ( 16 male , 27 female ) for the education group . The groups were matched for age ( 56.5 yr for control , 55 yr for education ) , disease duration ( 3.5 yr vs 3.0 yr ) and duration of second-line drug therapy ( 14 months vs 12 months ) . We found no significant difference between the groups for Larsen scores at 12 months , although scores for the education group were lower ( 39.5 vs 43.0 , P = 0.13 ) . The ' social functioning ' and ' general health perception ' subscales of the SF-36 showed a significant improvement in the education group , but no significant differences between groups were seen . No significant differences were found for the HAQ , RAI , PV and CQ , but the education group had more disease-specific knowledge than the control group at 12 months ( PKQ scores : 17 vs 21 , P = 0.0002 ) . No differences were found for out-patient visits and in-patient admissions , but the education group had slightly more changes in second-line drugs during the study ( 0.43 changes/person in the control group , 0.51 changes/person in the education group ) . CONCLUSIONS We found no significant difference between the groups in our primary outcome measures , but a trend in favour of the education group was found in radiological progression . Further studies of this kind , using larger patient numbers , are required since the difference may result from improved self-care , better compliance with joint protection strategies and , possibly , improved drug compliance Group counseling and education were studied in patients with rheumatoid arthritis ( RA ) . Patients were matched and r and omly assigned to a control ( CG ) or experimental ( EG ) group . Each group attended an educational session but only the EG participated in 12 weekly group counseling sessions . A test of knowledge about RA and psychological tests were administered before and after these sessions . The EG improved their scores in 2 areas of self-concept and in factual knowledge . There was no increase in depression level . These results provide evidence that formal educational sessions and group counseling may be important in the management of patients with RA The purpose of the study was to investigate the effects of supervised muscle relaxation training in individuals with rheumatoid arthritis ( RA ) . Sixty-eight participants were allocated at r and om either to a muscle relaxation training group or to a control group . Every participant was evaluated for health-related quality of life , muscle function , pain , and disease activity . The training group exercised 30 minutes , twice a week for 10 weeks , while no intervention was made in the control group . The results indicated improvements in the training group regarding self-care according to the Arthritis Impact Measurement Scales 2 , and in recreation and pastimes according to the Sickness Impact Profile-RA ( p < 0.05 ) directly after the intervention . Mobility and arm function ( p < 0.01 ) according to the Arthritis Impact Measurement Scales 2 , and muscle function of the lower limbs ( p < 0.05 ) were improved after six months . No improvements remained after twelve months . It thus seems that 10 weeks ' relaxation training might have some short-term influence in individuals with RA OBJECTIVE To investigate the effects of a 21-week concurrent strength and endurance training protocol on physical fitness profile in women with early or longst and ing rheumatoid arthritis ( RA ) compared with healthy subjects . METHODS Twenty-three female patients with RA volunteered for the study . Twelve had early RA and eleven had longst and ing RA . Twelve healthy women served as controls . Maximal strength of different muscle groups was measured by dynamometers , walking speed with light cells , and vertical squat jump on the force platform to mirror explosive force . Maximal oxygen uptake was measured by gas analyzer . Six training sessions ( 3 strength training and 3 endurance training ) were carried out in a 2-week period for 21 weeks . RESULTS The training led to large gains in maximal strength both in women with RA and in healthy women ( P < 0.043 - 0.001 ) . The strength gains were accompanied by increases in walking speed ( P < 0.034 - 0.001 ) and vertical squat jump ( P < 0.034 - 0.001 ) . Significant improvements also occurred in maximal aerobic capacity in all groups ( P < 0.023 - 0.014 ) . CONCLUSIONS Both early and longst and ing RA patients with stable disease can safely improve all characteristics of their physical fitness profile using a progressive concurrent strength and endurance training protocol & NA ; This study examined the efficacy of a cognitive and behavioural intervention ( CBT ) for patients with recent onset , seropositive rheumatoid arthritis . Fifty‐three participants with a diagnosis of classical or definite rheumatoid arthritis , who were seropositive and had less than 2 years of disease history were recruited into the trial . All participants received routine medical management during the study , although half were r and omly allocated to receive an adjunctive psychological intervention . All pre‐ and post‐treatment assessment s were conducted blind to the allocation . Analyses were conducted of treatment completers and also by intention‐to‐treat . Significant differences were found between the groups at both post‐treatment and 6‐month follow‐up in depressive symptoms . While the CBT group showed a reduction in depressive symptoms , the same symptoms increased in the St and ard group . At outcome but not follow‐up , the CBT group also showed reduction in C‐reactive protein levels . However , the CBT group did show significant improvement in joint involvement at 6‐month follow‐up compared with the St and ard group , indicating physical improvements above those achieved with st and ard care . These results indicate that cognitive‐behavioural intervention offered as an adjunct to st and ard clinical management early in the course of RA is efficacious in producing reductions in both psychological and physical To examine the effectiveness of a cognitive-behavioral pain management program for patients with rheumatoid arthritis , three patient groups were studied : a cognitive-behavioral group ( CB ) , an attention-placebo group , and a control group . The CB group received a comprehensive , 12-month pain management program that taught coping strategies such as problem-solving techniques , relaxation training , strategies for attention diversion , and training in family dynamics and communication . Dependent measures included pain , coping strategies , psychological status , functional status , and disease status . Data analysis at 12 months revealed benefits for the CB group in the area of enhanced coping strategies . Specifically , the CB subjects showed significantly greater use of coping strategies and significantly more confidence in their ability to manage pain . The findings are discussed in terms of the importance of enhanced self-efficacy and personal control for patients with rheumatoid arthritis The objective of this study was to determine whether the Arthritis Self-Management Programme ( ASMP ) improves perceptions of control , health behaviours and health status , and changes use of health care re sources . The design was a pragmatic r and omized controlled study ; participants were allocated to ASMP ( Intervention Group ) or a 4-month waiting-list Control Group . The Intervention Group completed a 12-month follow-up . In total , 544 people with arthritis were recruited from the community--311 in the Intervention Group and 233 in the Control Group . Main outcome measures included : arthritis self-efficacy , health behaviours ( exercise , cognitive symptom management , diet and relaxation ) and health status ( pain , fatigue , anxiety , depression and positive affect ) . At 4 months follow-up , the ASMP had a significant effect on arthritis self-efficacy for other symptoms and pain subscales . Performance of a range of health behaviours ( cognitive symptom management , communication with physicians , dietary habit , exercise and relaxation ) was significantly greater among the Intervention Group . The Intervention Group were significantly less depressed and had greater positive mood . In addition , trends towards decreases on fatigue and anxiety were noted . Physical functioning , pain and GP visits remained stable at 4 months . A similar pattern of findings was found at 12 months follow-up for the Intervention Group . Furthermore , a significant improvement was found on pain and visits to GPs had decreased . Apart from a small improvement on physical functioning among the Intervention Group participants with osteoarthritis 12 months , all effects were independent of the type of arthritis . The findings suggest that the ASMP is effective in promoting improvements in perception of control , health behaviours and health status , when delivered in UK setting OBJECTIVE To examine relationships among changes in self-efficacy and changes in other clinical ly relevant outcome measures . METHOD Subjects ( n = 44 ) were participants in a prospect i ve , r
Output:
| Comparative analyses revealed that interventions utilizing more self-regulation techniques reduced depressive symptoms and anxiety significantly more than interventions utilizing fewer such techniques .
Additionally , depressive symptoms were reduced significantly more among recently diagnosed RA patients than among those with longst and ing RA .
Psychological interventions are beneficial for many patients with RA , particularly when it comes to increasing physical activity levels .
Intervention techniques derived from self-regulation theory appear to play a role in reducing depressive symptoms and anxiety among patients with RA |
MS212772 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
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Input: Objective : The underlying changes in biological processes that are associated with reported changes in mental and physical health in response to meditation have not been systematic ally explored . We performed a r and omized , controlled study on the effects on brain and immune function of a well‐known and widely used 8‐week clinical training program in mindfulness meditation applied in a work environment with healthy employees . Methods : We measured brain electrical activity before and immediately after , and then 4 months after an 8‐week training program in mindfulness meditation . Twenty‐five subjects were tested in the meditation group . A wait‐list control group ( N = 16 ) was tested at the same points in time as the meditators . At the end of the 8‐week period , subjects in both groups were vaccinated with influenza vaccine . Results : We report for the first time significant increases in left‐sided anterior activation , a pattern previously associated with positive affect , in the meditators compared with the nonmeditators . We also found significant increases in antibody titers to influenza vaccine among subjects in the meditation compared with those in the wait‐list control group . Finally , the magnitude of increase in left‐sided activation predicted the magnitude of antibody titer rise to the vaccine . Conclusions : These findings demonstrate that a short program in mindfulness meditation produces demonstrable effects on brain and immune function . These findings suggest that meditation may change brain and immune function in positive ways and underscore the need for additional research Using a quasiexperimental design , in an intensive outpatient chemical dependency treatment program , this research compared a psychoeducational addiction treatment group with an intervention that combined progressive relaxation and visualization in a group setting . The progressive relaxation and visualization treatment consisted of six hour-long sessions that replaced psychoeducation treatment groups over the space of a 3-week period . The visualization group and the psychoeducation treatment groups were compared via pretest and posttest instruments to examine the impact of treatments on levels of emotional arousal , self-efficacy , and coping re sources . The State-Trait Anxiety Inventory ( STAI ) , the Situational Confidence Question naire ( SCQ ) , and the Coping Re sources Inventory ( CRI ) were used as part of the st and ardized measures . A total of 76 participants were involved in this study , which was conducted over an 8-month period . ( As they entered treatment , participants were assigned to groups in a fashion that would maintain equivalency of group size . ) Statistical tests determined that the nonr and omly assigned treatment groups were not significantly different from each other at the outset of the treatment interventions , t-tests and multivariate analysis of variance and covariance ( MANOVA/MANCOVA ) were used to examine the results of the study . The t-tests revealed that there were significant pretest/posttest differences ( p < .05 ) for both groups on almost all the dependent measures . MANCOVA , using pretest levels of the dependent measures as the covariate , did not reveal significant differences between the two groups ( i.e. , both groups showed equal levels of improvement on the posttest measures ) . Also , there were outcome differences for individuals who achieved greater degrees of relaxation and increased involvement in visualization session . In conclusion , both psychoeducation and visualization treatments were equally effective in producing positive effects . Although there is little empirical research that evaluates the effectiveness of psychoeducation treatment provided by chemical dependency treatment programs , these findings support that psychoeducation treatment is producing positive treatment effects . Further research is needed to assess the incremental benefit of using visualization as an adjunct to psychoeducation treatment BACKGROUND : Night eating syndrome ( NES ) is characterized by a lack of appetite in the morning , consumption of 50 % or more of daily food intake after 6:00 p.m. , and difficulty falling and /or staying asleep . It has been associated with stress and with poor results at attempts to lose weight . OBJECTIVE : The purpose of this study was to determine whether a relaxation intervention ( Abbreviated Progressive Muscle Relaxation Therapy , APRT ) that has been shown to significantly reduce stress levels in normal , healthy adults would also benefit an NES sample . RESEARCH METHODS AND PROCEDURES : A total of 20 adults with NES were r and omly assigned to either a relaxation training ( APRT ) or a Control ( quietly sitting for the same amount of time ) group , and all subjects attended two laboratory sessions 1 week apart . Pre- and postsession indices of stress , anxiety , relaxation , and salivary cortisol were obtained , as well as Day 1 and Day 8 indices of mood . Food diaries and hunger ratings were also obtained . RESULTS : The results indicated that 20 min of a muscle relaxation exercise significantly reduced stress , anxiety , and salivary cortisol immediately postsession . After practicing these exercises daily for a week , subjects exhibited lowered stress , anxiety , fatigue , anger , and depression on Day 8 . APRT was also associated with significantly higher a.m. and lower p.m. ratings of hunger , and a trend of both more breakfast and less night-time eating . DISCUSSION : These data support the role of stress and anxiety in NES and suggest that practicing relaxation may be an important component of treatment for this condition BACKGROUND Lost productivity from attending work when unwell , or " presenteeism " , is a largely hidden cost of mental disorders in the workplace . Sensitive measures are needed for clinical and policy applications , however there is no consensus on the optimal self-report measure to use . This paper examines the sensitivity of four alternative measures of presenteeism to depression and anxiety in an Australian employed cohort . METHODS A prospect i ve single-group study in ten call centres examined the association of presenteeism ( presenteeism days , inefficiency days , Work Limitations Question naire , Stanford Presenteeism Scale ) with Patient Health Question naire depression and anxiety syndromes . RESULTS At baseline , all presenteeism measures were sensitive to differences between those with ( N=69 ) and without ( N=363 ) depression/anxiety . Only the Work Limitations Question naire consistently showed worse productivity as depression severity increased , and sensitivity to remission and onset of depression/anxiety over the 6-month follow-up ( N=231 ) . There was some evidence of individual depressive symptoms having a differential association with different types of job dem and s. LIMITATIONS The study findings may not generalise to other occupational setting s with different job dem and s. We were unable to compare responders with non-responders at baseline due to anonymity . CONCLUSIONS In this community sample the Work Limitations Question naire offered additional sensitivity to depression severity , change over time , and individual symptoms . The comprehensive assessment of work performance offers significant advantages in demonstrating both the individual and economic burden of common mental disorders , and the potential gains from early intervention and treatment The purpose of this project was to investigate the psychological and physical effects of training of body awareness and slow stretching on persons with chronic toxic encephalopathy ( CTE ) . In the present study , a method of self-regulation , a body-mind training , is presented . The body-mind training used was a guided relaxation technique combined with meditative stretching . The techniques are introduced and the psychological and physiological effects of the training is presented . Eight subjects with CTE , 48.5 years , were trained for 8 weeks . Outcome measures were percentage alpha brain waves ( alpha% ) , electromyography ( EMG ) on the frontalis muscle , state-trait anxiety ( STAI ) , creativity ( RAT ) , and mood measured as anxiousness , humour and mental fatigue . The mean alpha% increased 52 % during the training period ( P < 0.01 ) , and the EMG decreased 31 % ( P < 0.001 . State anxiety decreased 22 % during the training period ( P < 0.01 ) , but no changes were observed in trait anxiety and in the creativity score . The level of anxiousness and fatigue before a training session decreased during the training period . In conclusion , the body-mind training result ed in an improved ability for physical and mental relaxation as indicated from the lower EMG , the higher alpha% and the decrease in state anxiety OBJECTIVES : Psychological treatments are considered to be useful in the irritable bowel syndrome ( IBS ) , although the evidence is based on small , often flawed trials . Although cognitive behavior therapy ( CBT ) and relaxation therapy have both been promising , we hypothesized that CBT would be superior to relaxation and st and ard care alone in IBS patients . The objective of this study was to test this assumption by comparing the effects of cognitive behavior therapy with relaxation therapy and routine clinical care alone in individuals with IBS . METHODS : Patients ( n = 105 ) with Rome I criteria for IBS were recruited from advertisement ( n = 51 ) and outpatient clinics ( n = 54 ) ; those patients with resistant IBS were not included . A r and omized controlled trial with three arms ( st and ard care for all groups plus either CBT or relaxation ) for 8 wk was conducted , which applied blinded outcome assessment s using vali date d measures with 1 yr of follow-up . The primary outcome for this study was bowel symptom severity . RESULTS : Of 105 patients at the commencement of treatment , the mean bowel symptom frequency score for the whole sample was 21.1 and at the end of treatment had fallen to 18.1 ; this persisted at the 52-wk follow-up , with a significant linear trend for scores to change over time ( F= 39.57 p < 0.001 ) . However , there were no significant differences among the three treatment conditions . Significant changes over time were found for physical functioning ( F= 4.37 , p < 0.001 ) , pain ( F= 3.12 , p < 0.05 ) , general health ( F= 2.71 , p < 0.05 ) , vitality ( F= 2.94 , p < 0.05 ) , and the social functioning scales on the Medical Outcomes Study Short Form 36 ( F= 4.08 , p < 0.05 ) ; however , all three arms showed similar improvement . There were significant reductions in anxiety , depression , and locus of control scales , but no significant differences among the treatment groups were detected . CONCLUSION : Cognitive behavior and relaxation therapy seem not to be superior to st and ard care alone in IBS Poppen ( Behavior Relaxation Training and Assessment , 1988 ) has developed an observational method of assessing the degree to which individuals show a relaxation response . Although promising , this method , the Behavioral Rating Scale ( BRS ) , has yet to be thoroughly investigated . Subjects in this study were r and omly assigned to a progressive relaxation training group or an attention-control group . Following a training period , subjects participated in a laboratory session in which self-report measures of relaxation were obtained , physiological measures were monitored , and behavioral observations were made using the BRS . Results supported the use of the BRS as a valid , observable measure of an individual 's relaxation response . Discriminant validity was demonstrated by between-group differences on the BRS and construct validity was shown by significant correlations between changes on the BRS and changes on self-report and physiological measures . It is argued that , though alternative explanations are feasible , this study 's results support the use of the BRS as an effective assessment tool when measuring an individual 's response to progressive muscle relaxation Cognitive therapy ( CT ) and applied relaxation ( AR ) as treatments of generalized anxiety disorder ( GAD ) were compared in a sample of 45 patients of a community mental health center , r and omly allocated to condition . Patients were assessed before and after a 12-session treatment , and at one and six months follow-ups . There was a 20 % drop out from CT and 15 % from AR ( NS ) , with some drop outs being considerably improved . Both completers and intention-to-treat analyses revealed that both treatments were effective ( ESs of composite and specific measures ranging from 0.53 to 1.14 ) . At one-month follow-up AR tended to do better than CT , with CT catching up with AR at six months . Recovery rates and proportions of patients showing reliable change were comparable to other studies on AR and CT , with 55 % of CT and 53.3 % of AR patients recovered on the STAI-trait at six-month follow-up . These results confirm that both CT and AR are effective treatments for GAD , and also that there is still room for improvement Background The aim of this open trial was to examine the influence of acute bright light exposure on anxiety in older and young adults . Methods This study was ancillary to a complex 5-day laboratory experiment testing phase-responses to light at all times of the day . On 3 consecutive days , participants were exposed to bright light ( 3,000 lux ) for 3 hours . The Spielberger State-Trait Anxiety Inventory ( Form Y1 ) was administered 5 minutes before and 20 minutes after each treatment . Mean state anxiety before and after treatment were analyzed by age , sex , and time ANOVA . To avoid floor effects , only participants with baseline STAI levels of ≥ 25 were included . Results A significant anxiolytic effect of bright light was found for the mean data , as well as for each of the three days . No significant main effect of age , sex , or interaction of these factors with STAI change were found . Conclusion The results show consistent and significant ( albeit modest ) anxiolytic effects following acute bright light exposure in low anxiety adults . Further r and omized , controlled trials in clinical ly anxious individuals are needed The present study examined the effects of progressive relaxation training and EMG biofeedback on acute glucose disposal in diabetic subjects , as measured by glucose tolerance and three other measures of diabetic metabolic control . Twenty subjects with non-insulin-using Type II diabetes took part in progressive relaxation training and EMG biofeedback in a pre-post treatment versus wait-list experimental design . Treatment effects were assessed on glucose tolerance along with three measures of diabetic control : fasting blood glucose , two-hour postpr and ial blood glucose , and fructosamine . Stress reduction and relax
Output:
| Efficacy was higher for meditation , among volunteers and for longer treatments .
Conclusion The results show consistent and significant efficacy of relaxation training in reducing anxiety .
This meta- analysis extends the existing literature through facilitation of a better underst and ing of the variability and clinical significance of anxiety improvement subsequent to relaxation training |
MS212773 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
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Input: Abstract Objectives : To present the first experience in Iraq of autologous rectus fascia sling ( RFS ) procedures and transobturator tape ( TOT ) for treating female stress urinary incontinence ( SUI ) , and to review the validity of the RFS in the era of synthetic tapes . Patients and methods : From December 2004 to July 2012 , 80 female patients with SUI were enrolled in the study , and r and omly assigned into two types of surgery , with 40 treated by RFS ( retropubic route ) and 40 by TOT . The surgical results were compared between the groups and with those from previous studies . Results : The mean operative duration was 80 min for RFS vs. 20 min for TOT . The early cure rate was 98 % for RFS ( with one failure due to prolonged urinary retention ) and 95 % for TOT ( with two failures due to persistent incontinence ) . The early complications were mainly abdominal wound problems ( 20 % ) for RFS , and groin and upper thigh pain ( 13 % ) for TOT . The late complications were the development of postvoid residual urine ( 8 % in RFS vs. 5 % in TOT ) and de novo detrusor overactivity ( 5 % in each group ) . There were no vaginal or urethral erosions up to the end of the study . Conclusions : RFS and TOT have comparable efficacy and safety in treating SUI . Nevertheless RFS , with its more invasive nature and long operative duration , should only be used when synthetic tapes are not available or not preferable Introduction and hypothesisSynthetic mid-urethral slings are currently considered the treatment of choice for stress urinary incontinence ( SUI ) . In this study , two types of slings are compared : TVT vs. TOT . Methods In a prospect i ve r and omized study , 40 patients underwent either TVT ( 19 patients ) or TOT ( 21 patients ) . Stress-specific and overall success was evaluated . Perioperative complications were classified according to Clavien ’s classification . Results Mean duration of follow-up was 20 months . At last follow-up , stress-specific success rate was 94.6 % in TVT vs. 81 % in TOT . No significant difference was detected in terms of post-void residual urine , symptom score , and filling and voiding parameters . Thigh pain represented the main complication in the TOT group . Conclusions Both TVT and TOT are effective procedures for treatment of SUI . When compared to each other , TOT seems to be inferior to TVT in terms of efficacy , causing less serious complications BACKGROUND There is a lack of information on the long-term outcomes of transobturator tension-free vaginal tape ( TO-TVT ) in the surgical treatment of female stress urinary incontinence ( SUI ) . OBJECTIVES To assess the 3-yr outcomes following TO-TVT and to compare the effectiveness of inside-out versus outside-in approaches . DESIGN , SETTING , AND PARTICIPANTS A 3-yr follow-up study of the Evaluation of Transobturator Tapes ( E-TOT ) trial , a r and omised controlled trial ( RCT ) conducted with women undergoing TO-TVT as a sole procedure between April 2005 and April 2007 in a tertiary urogynaecology centre in the United Kingdom . INTERVENTION Patients ( n=341 ) were r and omised to undergo either TVT-O ( Ethicon Inc. , Somerville , NJ , USA ) for the inside-out approach or TOT-Aris ( Coloplast Corp. , Minneapolis , MN , USA ) for the outside-in approach . OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS The primary outcome was patient-reported success rate . Secondary outcomes included further treatment for SUI , improvement in quality of life , late complications , and risk factors for late failures . Categorical variables were compared using the chi-square or Fisher exact test . Within-group comparison was undertaken using Wilcoxon and Mann-Whitney tests . Risk factors for late failures were assessed in a multivariate regression model . All statistical analysis was performed using SPSS v.18.0 ( IBM Corp. , Armonk , NY , USA ) . RESULTS AND LIMITATIONS The 3-yr follow-up was completed by 238 of the 341 women ( 70 % ) . The overall success rate , based on Patient 's Global Impression of Improvement response , was 73.1 % , with no significant difference between the inside-out and the outside-in TO-TVT ( 73.18 % vs 72.3 % ; odds ratio : 0.927 ; 95 % confidence interval , 0.552 - 1.645 ; p=0.796 ) . Compared with the 1-yr follow-up , there was a significant reduction in the patient-reported success rate ( p=0.005 ) ; however , no independent risk factors were identified . A clinical ly significant improvement ( ≥10 points ) was seen in 80 % ( n=191 ) of women , with no significant difference between both groups ( p=0.113 ) . Twenty-two women ( 6 % ) underwent further surgical treatment within 3 yr . The lack of an objective outcome assessment is a potential limitation of this RCT . CONCLUSIONS The E-TOT RCT showed a 73 % patient-reported success rate for TO-TVT at 3-yr follow-up , with no significant differences between inside-out and outside-in approaches . There was a significant drop in patient-reported success rates between 1 and 3 yr Purpose To evaluate in a comprehensive way TVT in comparison with TOT , the results of a single-center RCT are presented . Many studies addressed efficacy and safety of TVT and TOT . Methods Women included were adults having predominant SUI with positive stress test . They were r and omized to get either TVT ( Gynecare ® ) or TOT ( Aris ® ) . All women were seen 1 week , 3 , 6 , 12 , 18 , and 24 months . Results Seventy-one women completed 2-year follow-up . Median age was 47 ( range 33–60 years ) . Mean ± SD BMI in TVT group was 34 ± 5 while in TOT group was 32 ± 5 kg/m2 . POP of any degree was seen in 50 % ( 35 women ) . At 1 year , pad test – negative women were 31 and 29 for TVT and TOT , respectively . At 2 years , figures became 28 in TVT group and 27 in TOT . At 1 year , UDI 6 and IIQ 7 decreased by 78.5 and 81 % for TVT and by 69 % and 75 % for TOT group . At 2 year , comparable percentages were 73 and 79 % for TVT and 69 and 82 % for TOT . Fifteen unique patients had adverse events , 10 of them had TOT . Conclusions Both tapes have similar efficacy , regarding cure of incontinence . TVT is more effective , albeit insignificantly , than TOT at 2 years . However , serious adverse events were more frequent with TVT , yet TOT has more unique adverse events Purpose Transobturator approaches to midurethral sling surgery are one of the most commonly performed operations for female stress urinary incontinence throughout the world . However , very few results of r and omized clinical trials of transobturator midurethral sling surgery ( MONARC vs. TVT-O ) for the treatment of female urinary incontinence have been reported . In this study , we compared the 3-year follow-up cure rates of these two procedures . Material s and Methods From July 2006 to June 2008 , 74 patients who had undergone MONARC ( 35 patients ) or TVT-O ( 39 patients ) were included in the study and were analyzed prospect ively . The mean follow-up duration of both groups was 39.2 months . Preoperative and postoperative evaluations included physical examination , uroflowmetry and postvoid residual measurement , involuntary urine loss with physical activity , and urinary symptoms . Cure of female urinary incontinence was defined as patient report of no loss of urine upon physical activity . The patients ' satisfaction after treatment was rated as very satisfied , satisfied , equivocal , and unsatisfied . Very satisfied and satisfied were considered as the satisfied rate . Results There were no significant differences in preoperative patient characteristics , postoperative complications , or success rate between the two groups . The cure rate of the MONARC and TVT-O groups was 85.7 % and 84.6 % , respectively . The patient satisfaction ( very satisfied , satisfied ) rate of the MONARC and TVT-O groups was 82.8 % and 82.1 % , respectively . Conclusions The MONARC and TVT-O procedures were equally efficient for the treatment of female urinary incontinence , with maintenance of high cure rates for 3 years . Longer follow-up is needed to confirm these results Introduction and hypothesisA prospect i ve study comparing the effect of the tension-free vaginal tape ( TVT ) to the Monarc sling on sexual function in women with urodynamic stress incontinence ( USI ) and intrinsic sphincter deficiency ( ISD ) is presented . Methods Eighty-seven sexually active women with USI and ISD were enrolled . Sexual function was assessed pre-operatively and at 6 and 12 months post-operatively by history , PISQ-12 , UDI-6 and IIQ-7 question naires . Results A significant increase was detected in PISQ-12 score following both TVT and Monarc insertion . This score was greater in the TVT group at 6 months but not at 12 months when compared to the Monarc group . A significant decrease in UDI-6 and IIQ-7 score was detected . Specifically , coital incontinence and fear of leakage were reduced in both groups , and no change in dyspareunia or orgasm intensity was found . Conclusions Sexual function improves 6 months after TVT or Monarc sling , and this benefit is maintained at 12 months BACKGROUND Many studies have assessed the equivalent effectiveness of tension-free vaginal tape ( TVT ) and transobturator suburethral tape ( TVT-O ) at short- to medium-term follow-up , but no long-term r and omised trials appear in the literature . OBJECTIVE We compared the use of TVT to TVT-O , providing a longer follow-up than currently appears in the literature . DESIGN , SETTING , AND PARTICIPANTS Seventy-two consecutive patients affected by stress urinary incontinence ( SUI ) were included in this r and omised , controlled trial . Patients were r and omly allocated to the TVT or TVT-O procedure using a predetermined , computer-generated r and omisation code . INTERVENTION After preoperative assessment , patients were r and omly allocated to the TVT or TVT-O procedure . MEASUREMENTS This 5-yr study represents the extension of our original r and omised trial , which was design ed to assess the incidence of long-term complications ( primary end point ) and successes ( secondary end point ) for both techniques . RESULTS AND LIMITATIONS At 60-mo follow-up , 52 patients ( 72 % ) were objective ly cured of SUI ( 72.9 % after TVT-O and 71.4 % after TVT ) , but only 44 patients ( 61 % ) were satisfied . The late complication rate was 16.6 % ( 10 women ) : five women ( 16.1 % ) in the TVT-O group and five women ( 17.2 % ) in the TVT group ( p=1 ) . In this follow-up , 62 % of the patients from the TVT-O group and 60 % from the TVT group ( p=1 ) expressed that they were satisfied or very satisfied with the results . The mean cause of dissatisfaction was the development of sexual dysfunction result ing from dyspareunia or incontinence during intercourse , which was found in 6 of 16 dissatisfied patients ( 37.5 % ) . The limitations of our study included the adequate but small sample size and the lack of question naires . CONCLUSIONS Both surgical techniques are safe , with similar results ( 72.9 % and 71 % of patients objective ly cured after TVT-O and TVT , respectively ) and low complication rates ( 16.6 % : 16.1 % and 17.2 % , respectively , for TVT-0 and TVT ) , even after 5-yr follow-up Purpose To evaluate long-term ( over 4 years ) functional outcomes and quality of life of transobturator ( TOR ) and retropubic ( RPR ) routes in the cure of stress urinary incontinence ( SUI ) . Methods Prospect i ve , r and omized multicentre study involving 88 women with SUI from March 2004 to May 2005 ( RPR group ( n = 42 ) , TOR group ( n = 46 ) ) . Long-term functional results and quality of life were evaluated using vali date d question naires and compared with those observed at the first year . Results Eight patients ( 19 % ) in the RPR group and 9 patients ( 19.5 % ) in the TOR group were lost to follow-up ( NS ) . The mean follow-up in the RPR and the TOR groups was 52.7 months and 53.1 months , respectively . In intention to treat , the success rate at 4 years was 64.3 % in the RPR group and 69.5 % in the TOR group ( NS ) . At 4 years , no significant differences in the IIQ scores were observed in either group compared to the preoperative scores with no difference between the groups ( RPR group : 32 vs. 14.9 ( NS ) , TOR group : 25.7 vs. 21.4 ( NS ) ) . Compared to 1 year UDIQ and IIQ scores , a
Output:
| The present analysis confirms the superiority of MUS over Burch colposuspension .
The studies comparing insertion of RT-TVT and TO-TVT showed higher subjective and objective cure rates for the RP-TVT but at the cost of higher risks of some complications and voiding lower urinary tract symptoms .
Efficacy of inside-out and outside-in techniques of TO-TVT insertion was similar , although the risk of vaginal perforation was lower in the inside-to-out TO-TVT .
PATIENT SUMMARY Retropubic and transobturator midurethral slings are a popular treatment for female stress urinary incontinence .
The available literature suggest that those slings are either more effective or safer than other older surgical procedures .
Retropubic tapes are followed with slightly higher continence rates as compared with the transobturator tapes but are associated with higher risk of intra- and postoperative complications |
MS212774 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
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Input: Introduction Critically ill patients are characterized by increased loss of muscle mass , partially attributed to sepsis and multiple organ failure , as well as immobilization . Recent studies have shown that electrical muscle stimulation ( EMS ) may be an alternative to active exercise in chronic obstructive pulmonary disease ( COPD ) and chronic heart failure ( CHF ) patients with myopathy . The aim of our study was to investigate the EMS effects on muscle mass preservation of critically ill patients with the use of ultrasonography ( US ) . Methods Forty-nine critically ill patients ( age : 59 ± 21 years ) with an APACHE II admission score ≥13 were r and omly assigned after stratification upon admission to receive daily EMS sessions of both lower extremities ( EMS-group ) or to the control group ( control group ) . Muscle mass was evaluated with US , by measuring the cross sectional diameter ( CSD ) of the vastus intermedius and the rectus femoris of the quadriceps muscle . Results Twenty-six patients were finally evaluated . Right rectus femoris and right vastus intermedius CSD decreased in both groups ( EMS group : from 1.42 ± 0.48 to 1.31 ± 0.45 cm , P = 0.001 control group : from 1.59 ± 0.53 to 1.37 ± 0.5 cm , P = 0.002 ; EMS group : from 0.91 ± 0.39 to 0.81 ± 0.38 cm , P = 0.001 control group : from 1.40 ± 0.64 to 1.11 ± 0.56 cm , P = 0.004 , respectively ) . However , the CSD of the right rectus femoris decreased significantly less in the EMS group ( -0.11 ± 0.06 cm , -8 ± 3.9 % ) as compared to the control group ( -0.21 ± 0.10 cm , -13.9 ± 6.4 % ; P < 0.05 ) and the CSD of the right vastus intermedius decreased significantly less in the EMS group ( -0.10 ± 0.05 cm , -12.5 ± 7.4 % ) as compared to the control group ( -0.29 ± 0.28 cm , -21.5 ± 15.3 % ; P < 0.05 ) . Conclusions EMS is well tolerated and seems to preserve the muscle mass of critically ill patients . The potential use of EMS as a preventive and rehabilitation tool in ICU patients with polyneuromyopathy needs to be further investigated . Trial Registration clinical trials.gov : Objective : To determine whether early activity is feasible and safe in respiratory failure patients . Design : Prospect i ve cohort study . Setting : From June 1 , 2003 , through December 31 , 2003 , we assessed safety and feasibility of early activity in all consecutive respiratory failure patients who required mechanical ventilation for > 4 days admitted to our respiratory intensive care unit ( RICU ) . A majority of patients were treated in another intensive care unit ( ICU ) before RICU admission . We excluded patients who required mechanical ventilation for ≤4 days . Patients : Eight‐bed RICU at LDS Hospital . Interventions : We assessed patients for early activity as part of routine respiratory ICU care . We prospect ively recorded activity events and adverse events . We defined three activity events as sit on bed , sit in chair , and ambulate . We defined six activity‐related adverse events as fall to knees , tube removal , systolic blood pressure > 200 mm Hg , systolic blood pressure < 90 mm Hg , oxygen desaturation < 80 % , and extubation . Measurements and Main Results : During the study period , we conducted a total of 1,449 activity events in 103 patients . The activity events included 233 ( 16 % ) sit on bed , 454 ( 31 % ) sit in chair , and 762 ( 53 % ) ambulate . In patients with an endotracheal tube in place , there were a total of 593 activity events , of which 249 ( 42 % ) were ambulation . There were < 1 % activity‐related adverse events , including fall to the knees without injury , feeding tube removal , systolic blood pressure > 200 mm Hg , systolic blood pressure < 90 mm Hg , and desaturation < 80 % . No patient was extubated during activity . Conclusions : We conclude that early activity is feasible and safe in respiratory failure patients . A majority of survivors ( 69 % ) were able to ambulate > 100 feet at RICU discharge . Early activity is a c and i date therapy to prevent or treat the neuromuscular complications of critical illness Objectives : To investigate whether a daily exercise session , using a bedside cycle ergometer , is a safe and effective intervention in preventing or attenuating the decrease in functional exercise capacity , functional status , and quadriceps force that is associated with prolonged intensive care unit stay . A prolonged stay in the intensive care unit is associated with muscle dysfunction , which may contribute to an impaired functional status up to 1 yr after hospital discharge . No evidence is available concerning the effectiveness of an early exercise training intervention to prevent these detrimental complications . Design : R and omized controlled trial . Setting : Medical and surgical intensive care unit at University Hospital Gasthuisberg . Patients : Ninety critically ill patients were included as soon as their cardiorespiratory condition allowed bedside cycling exercise ( starting from day 5 ) , given they still had an expected prolonged intensive care unit stay of at least 7 more days . Interventions : Both groups received respiratory physiotherapy and a daily st and ardized passive or active motion session of upper and lower limbs . In addition , the treatment group performed a passive or active exercise training session for 20 mins/day , using a bedside ergometer . Measurements and Main Results : All outcome data are reflective for survivors . Quadriceps force and functional status were assessed at intensive care unit discharge and hospital discharge . Six-minute walking distance was measured at hospital discharge . No adverse events were identified during and immediately after the exercise training . At intensive care unit discharge , quadriceps force and functional status were not different between groups . At hospital discharge , 6-min walking distance , isometric quadriceps force , and the subjective feeling of functional well-being ( as measured with “ Physical Functioning ” item of the Short Form 36 Health Survey question naire ) were significantly higher in the treatment group ( p < .05 ) . Conclusions : Early exercise training in critically ill intensive care unit survivors enhanced recovery of functional exercise capacity , self-perceived functional status , and muscle force at hospital discharge STUDY OBJECTIVES To evaluate the effects of early exercise training in patients recovering from acute respiratory failure needing mechanical ventilation ( MV ) . DESIGN Prospect i ve , r and omized , and controlled study . SETTING Three respiratory intermediate ICUs ( RIICUs ) . PATIENTS Of 228 patients admitted to an RIICU , 66 patients weaned from MV from > 48 to < 96 h were considered eligible and enrolled in the study . INTERVENTION Sixty-six patients were r and omized to either supported arm exercise training plus general physiotherapy ( gPT ) [ group 1 , 32 patients ] or to gPT alone ( group 2 , 34 patients ) . MEASUREMENTS AND RESULTS Twenty-five patients in each group completed the protocol . Group 1 showed a greater improvement in exercise capacity , as assessed by an arm incremental test ( IT ) [ p = 0.003 ] and an endurance test ( ET ) [ p = 0.021 ] , compared to group 2 . Posttraining maximal inspiratory pressure ( MIP ) significantly improved in both groups ( p < 0.001 and p = 0.003 in groups 1 and 2 respectively ; not significant ) . IT isoworkload dyspnea improved significantly in both groups ( p = 0.005 and p = 0.009 in groups 1 and 2 , respectively ; not significant between groups ) , whereas IT isoworkload peripheral muscle fatigue ( p < 0.001 ) , ET isotime dyspnea ( p < 0.01 ) , and ET isotime muscular fatigue ( p < 0.005 ) improved significantly in group 1 but not in group 2 . IT improvers ( chi2 = 0.004 ) and ET improvers ( chi2 = 0.047 ) were more frequently observed in group 1 than in group 2 . Baseline MIP could discriminate for IT ( p = 0.013 ; odds ratio [ OR ] , 1.116 ) and ET improvers ( p = 0.022 ; OR , 1.067 ) . CONCLUSION Early upper-limb exercise training is feasible in RIICU patients recently weaned from MV and can enhance the effects of gPT . Baseline inspiratory muscle function is related to exercise capacity improvement OBJECTIVE It is known that patients in the intensive care unit show an enormous loss of muscle mass . Neuromuscular electrical stimulation is effective in enhancing strength and endurance in immobilized patients . The aim of this study was to evaluate the effects of neuromuscular electrical stimulation on muscle layer thickness of knee extensor muscles in intensive care unit patients . DESIGN R and omized , controlled , double-blind , pilot trial . PATIENTS Thirty-three patients , male to female ratio 26:7 , mean age 55 years ( st and ard deviation 15 ) . METHODS After enrolment in the study , intensive care unit patients ( main diagnoses : polytrauma , cardiovascular diseases , transplantation , pneumonia , cancer ) were stratified ( based on the length of their stay in hospital ) into 2 groups : 17 acute patients ( < 7 days ) and 16 long-term patients ( > 14 days ) . Both groups were r and omized to a stimulation group or a sham-stimulation group . Neuromuscular electrical stimulation was applied to knee extensor muscles for a period of 4 weeks ( session time 30 - 60 minutes , 5 days/week ) . Ultrasound measurements were performed before and after the stimulation period to quantify muscle layer thickness of knee extensor muscles . RESULTS Only stimulated long-term patients ( + 4.9 % ) showed a significant ( p = 0.013 ) increase in muscle layer thickness compared with sham-stimulated patients ( -3.2 % ) . CONCLUSION Neuromuscular electrical stimulation appears to be a useful adjunct to revert muscle wasting in intensive care unit long-term patients ; however , larger studies with a larger sample size are needed to confirm these promising , but preliminary , results OBJECTIVE Patients in intensive care exhibit a high degree of loss of muscle mass . Appropriate instruments are needed to document muscle wasting in these patients . The aim of this pilot study was to describe muscle wasting in patients in the intensive care unit . DESIGN Two-fold study setting : prospect i ve longitudinal and cross-sectional single-blind . PATIENTS A total of 118 patients in the intensive care unit ( length of stay 1 - 98 days ; male : female ratio 88:30 ; age 55 + /- 17 years ) were included in a two-fold study setting . METHODS Muscle layer thickness of the M. quadriceps femoris was documented using ultrasound measurement at well-defined points . Seventeen pilot- patients were measured twice ; at baseline and after 28 days . In another group of 101 patients , muscle layer thickness was determined once after a r and om length of stay . The results of both groups were compared and correlated . RESULTS In both groups , M. quadriceps femoris thickness showed a significant negative correlation with length of stay in the intensive care unit ( p < 0.01 ) . Furthermore , muscle wasting in intensive care patients could be described using a logarithmic function . CONCLUSION Loss of muscle mass shows a negative correlation with length of stay , and seems to be higher during the first 2 - 3 weeks of immobilization/intensive care unit stay . Ultrasound is a valid and practical measurement tool for documenting muscle mass ( e.g. muscle layer thickness ) as part of the daily routine at an intensive care unit STUDY OBJECTIVE To compare the effects of active limb mobilization ( ALM ) with or without electrical stimulation ( ES ) on muscle strength , respiratory rate ( RR ) , heart rate , oxygen saturation , and time needed to transfer from bed to chair in two groups of patients with COPD . DESIGN R and omized , controlled study . SETTING Respiratory high-dependency care unit . PATIENTS Twenty-four bed-bound patients with chronic hypercapnic respiratory failure due to COPD who were receiving mechanical ventilation , with marked peripheral muscle hypotonia and atrophy . METHODS Patients were r and omly assigned either to ALM alone or to ALM plus ES ( ALM/ES ) . ES was applied using square-wave alternate , symmetric , and compensated impulses for 30 min bid . The duration of treatment was 28 days for all patients . RESULTS Muscle strength improved significantly in the overall group of patients ( from 1.75 + /- 0.73 to 3.44 + /- 0.65 , p < 0.05 ) . Comparing the change ( end minus beginning ) of the analyzed variables , ALM/ES significantly improved muscle strength ( 2.16 + /- 1.02 vs 1.25 + /- 0.75 , p = 0.02 ) and RR ( - 1.91 + /- 1.72 vs 0.41 + /- 1.88 , p = 0.004 ) , and decreased the number of days needed to transfer from bed to chair ( 10.75 + /-
Output:
| CONCLUSION With this systematic review , it is possible to conclude that motor physical therapy is a feasible and safe therapy for critically ill patients and can minimize the deleterious effects of prolonged immobilization .
Approaches involving electrostimulation , cycle ergometry and kinesiotherapy showed positive responses in patients under intensive care . |
MS212775 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
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Input: Abstract Objective To estimate the effect of adding exercise classes , spinal manipulation delivered in NHS or private premises , or manipulation followed by exercise to “ best care ” in general practice for patients consulting with back pain . Fig 1 Progress of the UK BEAM trial Design Pragmatic r and omised trial with factorial design . Setting 181 general practice s in Medical Research Council General Practice Research Framework ; 63 community setting s around 14 centres across the United Kingdom . Participants 1334 patients consulting their general practice s about low back pain . Main outcome measures Scores on the Rol and Morris disability question naire at three and 12 months , adjusted for centre and baseline scores . Results All groups improved over time . Exercise improved mean disability question naire scores at three months by 1.4 ( 95 % confidence interval 0.6 to 2.1 ) more than “ best care . ” For manipulation the additional improvement was 1.6 ( 0.8 to 2.3 ) at three months and 1.0 ( 0.2 to 1.8 ) at 12 months . For manipulation followed by exercise the additional improvement was 1.9 ( 1.2 to 2.6 ) at three months and 1.3 ( 0.5 to 2.1 ) at 12 months . No significant differences in outcome occurred between manipulation in NHS premises and in private premises . No serious adverse events occurred . Conclusions Relative to “ best care ” in general practice , manipulation followed by exercise achieved a moderate benefit at three months and a small benefit at 12 months ; spinal manipulation achieved a small to moderate benefit at three months and a small benefit at 12 months ; and exercise achieved a small benefit at three months but not 12 months BACKGROUND Spinal pain is common and frequently disabling . Management guidelines have encouraged referral from primary care for spinal manipulation . However , the evidence base for these recommendations is weak . More pragmatic trials and economic evaluations have been recommended . OBJECTIVES Our aim was to assess the effectiveness and health care costs of a practice -based osteopathy clinic for subacute spinal pain . METHODS A pragmatic r and omized controlled trial was carried out in a primary care osteopathy clinic accepting referrals from 14 neighbouring practice s in North West Wales . A total of 201 patients with neck or back pain of 2 - 12 weeks duration were allocated at r and om between usual GP care and an additional three sessions of osteopathic spinal manipulation . The primary outcome measure was the Extended Aberdeen Spine Pain Scale ( EASPS ) . Secondary measures included SF-12 , EuroQol and Short-form McGill Pain Question naire . Health care costs were estimated from the records of referring GPs . RESULTS Outcomes improved more in the osteopathy group than the usual care group . At 2 months , this improvement was significantly greater in EASPS [ 95 % confidence interval ( CI ) 0.7 - 9.8 ] and SF-12 mental score ( 95 % CI 2.7 - 10.7 ) . At 6 months , this difference was no longer significant for EASPS ( 95 % CI -1.5 to 10.4 ) , but remained significant for SF-12 mental score ( 95 % CI 1.0 - 9.9 ) . Mean health care costs attributed to spinal pain were significantly greater by 65 UK pounds in the osteopathy group ( 95 % CI 32 - 155 UK pounds ) . Though osteopathy also cost 22 UK pounds more in mean total health care cost , this was not significant ( 95 % CI - 159 to 142 UK pounds ) . CONCLUSION A primary care osteopathy clinic improved short-term physical and longer term psychological outcomes , at little extra cost . Rigorous multicentre studies are now needed to assess the generalizability of this approach A national telephone survey was conducted in 1998 using r and om-digit dialing and the first Osteopathic Survey of Healthcare in America ( OSTEOSURV-I ) instrument to determine patients ' satisfaction with their healthcare , as well as their perceptions of osteopathic medicine . Of the 1106 respondents , 243 ( 22.0 % ) had received medical care from an osteopathic physician , and another 307 ( 27.8 % ) cl aim ed to be aware of osteopathic physicians . Patients of osteopathic physicians reported the highest levels of satisfaction in 8 of the 11 elements studied when compared with patients of allopathic physicians , chiropractors , and nonphysician clinicians other than chiropractors . Respondents perceived osteopathic manipulative treatment ( OMT ) to be beneficial for musculoskeletal disorders ( P < .001 ) . In addition , respondents perceived that healthcare services provided by osteopathic physicians were similar to those provided by allopathic physicians ( P < .001 ) , but not to those provided by chiropractors ( P = .01 ) . A total of 97.9 % of current patients of osteopathic physicians agreed with the statement that osteopathic physicians practice d in their local community , compared with 80.6 % of former patients of osteopathic physicians and 67.8 % of patients who had never visited osteopathic physicians ( P < .001 ) . In general , the most favorable perceptions of osteopathic medicine were reported by current patients of osteopathic physicians , followed by former patients of such physicians . The least favorable perceptions came from patients who had never been patients of osteopathic physicians . The perception that OMT should be covered by health insurance was significantly associated with the use of osteopathic physicians ( odds ratio , 3.2 ; 95 % confidence interval , 1.5 to 6.7 , among patients who had ever been to an osteopathic physician ) . The results of our survey suggest that greater access to osteopathic services , including OMT , is desirable and that promotional efforts aim ed at encouraging the use of osteopathic medical services among the general population are warranted Abstract This single-blind r and omised clinical trial compared osteopathic manipulative treatment with chemonucleolysis ( used as a control of known efficacy ) for symptomatic lumbar disc herniation . Forty patients with sciatica due to this diagnosis ( confirmed by imaging ) were treated either by chemonucleolysis or manipulation . Outcomes ( leg pain , back pain and self-reported disability ) were measured at 2 weeks , 6 weeks and 12 months . The mean values for all outcomes improved in both groups . By 12 months , there was no statistically significant difference in outcome between the treatments , but manipulation produced a statistically significant greater improvement for back pain and disability in the first few weeks . A similar number from both groups required additional orthopaedic intervention ; there were no serious complications . Crude cost analysis suggested an overall financial advantage from manipulation . Because osteopathic manipulation produced a 12-month outcome that was equivalent to chemonucleolysis , it can be considered as an option for the treatment of symptomatic lumbar disc herniation , at least in the absence of clear indications for surgery . Further study into the value of manipulation at a more acute stage is warranted Abstract Objective To assess the cost effectiveness of adding spinal manipulation , exercise classes , or manipulation followed by exercise ( “ combined treatment ” ) to “ best care ” in general practice for patients consulting with low back pain . Design Stochastic cost utility analysis alongside pragmatic r and omised trial with factorial design . Setting 181 general practice s and 63 community setting s for physical treatments around 14 centres across the United Kingdom . Participants 1287 ( 96 % ) of 1334 trial participants . Main outcome measures Healthcare costs , quality adjusted life years ( QALYs ) , and cost per QALY over 12 months . Results Over one year , mean treatment costs relative to “ best care ” were £ 195 ( $ 360 ; € 279 ; 95 % credibility interval £ 85 to £ 308 ) for manipulation , £ 140 ( £ 3 to £ 278 ) for exercise , and £ 125 ( £ 21 to £ 228 ) for combined treatment . All three active treatments increased participants ' average QALYs compared with best care alone . Each extra QALY that combined treatment yielded relative to best care cost £ 3800 ; in economic terms it had an “ incremental cost effectiveness ratio ” of £ 3800 . Manipulation alone had a ratio of £ 8700 relative to combined treatment . If the NHS was prepared to pay at least £ 10 000 for each extra QALY ( lower than previous recommendations in the United Kingdom ) , manipulation alone would probably be the best strategy . If manipulation was not available , exercise would have an incremental cost effectiveness ratio of £ 8300 relative to best care . Conclusions Spinal manipulation is a cost effective addition to “ best care ” for back pain in general practice . Manipulation alone probably gives better value for money than manipulation followed by exercise Back pain is a common illness and chiropractors provide a large proportion of back pain care in the United States . This is the first study to systematic ally compare chiropractic patients with those who saw other providers for back pain . The authors analyzed data from the R AND Health Insurance Experiment , a community-based study of the use of health services . Insurance cl aims forms were examined for all visits specified by the patient as occurring for back pain . Visits were grouped into episodes using decision rules and clinical judgment . The primary provider of back pain care was defined as the provider who delivered most of the services . Sociodemographic and health status and attitudes variables of patients were examined for association with the choice of chiropractor . Multivariate logistic regression models were constructed to calculate adjusted odds ratios for independent predictors . There were 1020 episodes of back pain care made by 686 different persons and encompassing 8825 visits . Results indicated that chiropractors were the primary provider for 40 % of episodes , and retained as primary provider a greater percentage of their patients ( 92 % ) who had a second episode of back pain care than did medical doctors . Health insurance experiment site , white race , male sex , and high school education were independent predictors of choosing a chiropractor . Conclusions suggested that chiropractors were the choice of one third of all patients who sought back pain care , and provided care for 40 % of all episodes of care . Geographic site , education , gender , and income were independent patient factors predicting chiropractic use Fifty-four subjects volunteered to participate in a controlled study contrasting spinal manipulation with spinal mobilization without the rotational forces and leverage required to move facet joints . All suffered from regional low-back pain for less than 1 month , were ages 18–40 , had never previously undergone any form of spinal manipulation , and denied a prior episode of backache within the previous 6 months . R and omization was stratified at outset into those who suffered for less than 2 weeks and those whose discomfort had persisted for 2–4 weeks . Outcome was monitored by a question naire assessing functional impairment . A treatment effect of manipulation was demonstrated only in the strata with more prolonged illness at entry . In the first week following manipulation , these patients improved to a greater degree ( P=.009 , t test ) and more rapidly ( P < .025 , Wilcoxon rank-sum test ) The effectiveness of spinal manipulation carried out by a non-medical qualified osteopath was compared with that of short-wave diathermy ( SWD ) and a placebo ( detuned SWD ) in 109 patients with low back pain . More than half the subjects in each of the 3 treatment groups benefited immediately from therapy . Significant improvements were observed in the 3 groups at the end of 2 weeks ' treatment , and these were still apparent at 12 weeks . The outcome of treatment was unrelated to the initial severity or duration of pain or to the trend of pain towards deterioration or improvement . It is , therefore , unlikely that the results simply reflect the natural history of low back pain . Benefits obtained with osteopathy and SWD in this study may have been achieved through a placebo effect Previous studies have shown that dysmenorrhea produces low-back pain and an electromyographic ( EMG ) pattern typical of trauma-induced low-back pain . To determine the effects of high-velocity low-amplitude osteopathic manipulative treatment ( OMT ) on this type of low-back pain , 12 dysmenorrheic subjects were assigned to a group receiving OMT or to a group not receiving OMT ( or both ) . Eight subjects participated in both groups , the other four being equally distributed between groups . Osteopathic manipulative treatment significantly decreased EMG activity during extension of the lumbar spinae erector muscles and abolished the spontaneous EMG activity . These EMG changes coincided with the patient 's report of alleviated low-back pain and menstrual cramping . Osteopathic manipulative treatment did not change the creatinine kinase , lactate dehydrogenase or lactate-dehydrogenase isoenzyme activity , or myoglobin concentration A r and omized clinical trial of rotational manipulation was conducted on 95 patients with low back pain selected for ( 1 ) the absence of any contraindications for vertebral manipulation , ( 2 ) the absence of any psychosocial problems that might affect the outcome of treatment , ( 3 ) the absence of any previous experience with manipulative therapy , and ( 4 ) the presence of palpatory cues indicating that manipulation might be successful . Patients were r and omly assigned to one of two groups : an experimental group receiving manipulation therapy and a control group receiving soft-tissue massage . Comparison of the two groups indicated that ( 1 ) patients who received manipulative treatment were much more likely to report immediate relief after the first treatment , and ( 2 ) at discharge , there was no significant difference between the two groups because both showed substantial improvement In a multicentre trial 456 selected patients with low back pain were r and omly allocated to one of four treatments-manipulation , definitive physiotherapy , corset , or analgesic tablets . Patients were reassessed clinical ly after three weeks ' treatment and again after a further three weeks . Question naires were used to find out
Output:
| There were significant pain reductions with OMT regardless of whether trials were performed in the United Kingdom or the United States .
Significant pain reductions were also observed during short- , intermediate- , and long-term follow-up .
Conclusion OMT significantly reduces low back pain .
The level of pain reduction is greater than expected from placebo effects alone and persists for at least three months . |
MS212776 | ***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 goal of this study was to examine the association of the antiinflammatory interleukin-10 ( IL-10 ) with risk of cardiovascular disease ( CVD ) . Methods and Results —In the PROSPER ( PROspect i ve Study of Pravastatin in the Elderly at Risk ) cohort , we related baseline concentrations of circulating IL-10 to risk of CVD events in a nested case (n=819)-control ( n=1618 ) study of 3.2 years of follow-up . Circulating IL-10 showed few strong associations with classical risk factors but was positively correlated with IL-6 and C-reactive protein . IL-10 was positively associated with risk of CVD events ( odds ratio [ OR ] 1.17 , 95 % CI 1.05 to 1.31 per unit increase in log IL-10 ) after adjusting for classical risk factors and C-reactive protein . Furthermore , IL-10 was associated more strongly with CVD risk among those with no previous history of CVD ( OR 1.42 , 95 % CI 1.18 to 1.70 ) , compared with those with previous CVD ( OR 1.04 , 95 % CI 0.90 to 1.19 ; P=0.018 ) . Overall , IL-10 showed a modest ability to add discrimination to classical risk factors ( C-statistic + 0.005 , P=0.002 ) . Conclusion —Baseline circulating levels of the antiinflammatory IL-10 are positively associated with risk of CVD among the elderly without prior CVD events , although the association is less evident in those with a history of CVD . Additional epidemiological and mechanistic studies investigating the role of IL-10 in CVD are warranted The Healthy Eating Index-2005 ( HEI-2005 ) measures adherence to the 2005 Dietary Guidelines for Americans , but the association between the HEI-2005 and risk of chronic disease is not known . The Alternative Healthy Eating Index ( AHEI ) , which is based on foods and nutrients predictive of chronic disease risk , was associated inversely with chronic disease risk previously . We up date d the AHEI , including additional dietary factors involved in the development of chronic disease , and assessed the associations between the AHEI-2010 and the HEI-2005 and risk of major chronic disease prospect ively among 71,495 women from the Nurses ' Health Study and 41,029 men from the Health Professionals Follow-Up Study who were free of chronic disease at baseline . During ≥24 y of follow-up , we documented 26,759 and 15,558 incident chronic diseases ( cardiovascular disease , diabetes , cancer , or nontrauma death ) among women and men , respectively . The RR ( 95 % CI ) of chronic disease comparing the highest with the lowest quintile was 0.84 ( 0.81 , 0.87 ) for the HEI-2005 and 0.81 ( 0.77 , 0.85 ) for the AHEI-2010 . The AHEI-2010 and HEI-2005 were most strongly associated with coronary heart disease ( CHD ) and diabetes , and for both outcomes the AHEI-2010 was more strongly associated with risk than the HEI-2005 ( P-difference = 0.002 and < 0.001 , respectively ) . The 2 indices were similarly associated with risk of stroke and cancer . These findings suggest that closer adherence to the 2005 Dietary Guidelines may lower risk of major chronic disease . However , the AHEI-2010 , which included additional dietary information , was more strongly associated with chronic disease risk , particularly CHD and diabetes BACKGROUND Adherence to a Mediterranean diet may improve longevity , but relevant data are limited . METHODS We conducted a population -based , prospect i ve investigation involving 22,043 adults in Greece who completed an extensive , vali date d , food-frequency question naire at base line . Adherence to the traditional Mediterranean diet was assessed by a 10-point Mediterranean-diet scale that incorporated the salient characteristics of this diet ( range of scores , 0 to 9 , with higher scores indicating greater adherence ) . We used proportional-hazards regression to assess the relation between adherence to the Mediterranean diet and total mortality , as well as mortality due to coronary heart disease and mortality due to cancer , with adjustment for age , sex , body-mass index , physical-activity level , and other potential confounders . RESULTS During a median of 44 months of follow-up , there were 275 deaths . A higher degree of adherence to the Mediterranean diet was associated with a reduction in total mortality ( adjusted hazard ratio for death associated with a two-point increment in the Mediterranean-diet score , 0.75 [ 95 percent confidence interval , 0.64 to 0.87 ] ) . An inverse association with greater adherence to this diet was evident for both death due to coronary heart disease ( adjusted hazard ratio , 0.67 [ 95 percent confidence interval , 0.47 to 0.94 ] ) and death due to cancer ( adjusted hazard ratio , 0.76 [ 95 percent confidence interval , 0.59 to 0.98 ] ) . Associations between individual food groups contributing to the Mediterranean-diet score and total mortality were generally not significant . CONCLUSIONS Greater adherence to the traditional Mediterranean diet is associated with a significant reduction in total mortality BACKGROUND Dietary factors can affect telomere length ( TL ) , a biomarker of aging , through oxidation and inflammation-related mechanisms . A Dietary Inflammatory Index ( DII ) could help to underst and the effect of the inflammatory potential of the diet on telomere shortening . OBJECTIVE This study aim ed to determine the association of the DII with TL and to examine whether diet-associated inflammation could modify the telomere attrition rate after a 5-y follow-up of a Mediterranean dietary intervention . DESIGN This was a prospect i ve study of 520 participants at high cardiovascular disease risk ( mean ± SD age : 67.0 ± 6.0 y , 45 % males ) from the PREDIMED-NAVARRA ( PREvención con DIeta MEDiterránea-NAVARRA ) trial . Leukocyte TL was measured by quantitative real-time polymerase chain reaction at baseline and after 5 y of follow-up . The DII was calculated from self-reported data by using a vali date d 137-item food-frequency question naire . RESULTS Longer telomeres at baseline were found in participants who had a more anti-inflammatory diet ( lowest DII score ) ( P-trend = 0.012 ) . Longitudinal analyses further showed that a greater anti-inflammatory potential of the diet ( i.e. , a decrease in the DII ) could significantly slow down the rate of telomere shortening . Moreover , the multivariable-adjusted OR for short telomeres ( z score ≤20th percentile ) was 1.80 ( 95 % CI : 1.03 , 3.17 ) in a comparison between the highest ( proinflammatory ) and the lowest ( anti-inflammatory ) DII tertiles . Similarly , a greater DII ( greatest proinflammatory values ) after a 5-y follow-up was associated with almost a 2-fold higher risk of accelerated telomere attrition compared with the highest decrease in DII ( greatest anti-inflammatory values ) during this period ( P-trend = 0.025 ) . CONCLUSIONS This study showed both cross-sectional and longitudinal associations between the inflammatory potential of the diet and telomere shortening in subjects with a high cardiovascular disease risk . Our findings are consistent with , but do not show , a beneficial effect of adherence to an anti-inflammatory diet on aging and health by slowing down telomere shortening . These results suggest that diet might play a key role as a determinant of TL through proinflammatory or anti-inflammatory mechanisms . This trial was registered at controlled-trials.com as IS RCT N35739639 Background Diet is known to play a key role in atherogenesis and in the development of cardiovascular events . Dietary factors may mediate these processes acting as potential modulators of inflammation . Potential Links between inflammatory properties of diet and the occurrence of cardiovascular events have not been tested previously . Objective We aim ed to assess the association between the dietary inflammatory index ( DII ) , a method to assess the inflammatory potential of the diet , and incident cardiovascular disease . Methods In the prospect i ve , dynamic SUN cohort , 18,794 middle-aged , Spanish university graduates were followed up for 8.9 years ( median ) . A vali date d 136-item food-frequency question naire was used to calculate the DII . The DII is based on scientific evidence about the relationship between diet and inflammatory biomarkers ( C-reactive protein , IL-1β , IL-4 , IL-6 , IL-10 and TNF-α ) . Cox proportional hazard models were used to estimate hazard ratios ( HR ) and 95 % confidence intervals ( CI ) for the association between the DII and incident cardiovascular disease ( myocardial infa rct ion , stroke or cardiovascular death ) . Results The risk for cardiovascular events progressively increased with each increasing quartile of DII ( ptrend = 0.017 ) . The multivariable-adjusted HR for participants in the highest ( most pro-inflammatory ) vs. the lowest quartile of the DII was 2.03 ( 95 % CI 1.06–3.88 ) . Conclusions A pro-inflammatory diet was associated with a significantly higher risk for developing cardiovascular events CONTEXT Associations between adiposity and circulating inflammation markers are assumed to be causal , although the direction of the relationship has not been proven . OBJECTIVE The aim of the study was to explore the causal direction of the relationship between adiposity and inflammation using a bidirectional Mendelian r and omization approach . METHODS In the PROSPER study of 5804 elderly patients , we related C-reactive protein ( CRP ) single nucleotide polymorphisms ( SNPs ) ( rs1800947 and rs1205 ) and adiposity SNPs ( FTO and MC4R ) to body mass index ( BMI ) as well as circulating levels of CRP and leptin . We gave each individual two allele scores ranging from zero to 4 , counting each pair of alleles related to CRP levels or BMI . RESULTS With increasing CRP allele score , there was a stepwise decrease in CRP levels ( P for trend < 0.0001 ) and a 1.98 mg/liter difference between extremes of the allele score distribution , but there was no associated change in BMI or leptin levels ( P > or= 0.89 ) . By contrast , adiposity allele score was associated with 1 ) an increase in BMI ( 1.2 kg/m(2 ) difference between extremes ; P for trend 0.002 ) ; 2 ) an increase in circulating leptin ( 5.77 ng/ml difference between extremes ; P for trend 0.0027 ) ; and 3 ) increased CRP levels ( 1.24 mg/liter difference between extremes ; P for trend 0.002 ) . CONCLUSIONS Greater adiposity conferred by FTO and MC4R SNPs led to higher CRP levels , with no evidence for any reverse pathway . Future studies should extend our findings to other circulating inflammatory parameters . This study illustrates the potential power of Mendelian r and omization to dissect directions of causality between intercorrelated metabolic factors BACKGROUND Because of the high density of fat , high-fat diets are perceived as likely to lead to increased bodyweight , hence health-care providers are reluctant to recommend them to overweight or obese individuals . We assessed the long-term effects of ad libitum , high-fat , high-vegetable-fat Mediterranean diets on bodyweight and waist circumference in older people at risk of cardiovascular disease , most of whom were overweight or obese . METHODS PREDIMED was a 5 year parallel-group , multicentre , r and omised , controlled clinical trial done in primary care centres affiliated to 11 hospitals in Spain . 7447 asymptomatic men ( aged 55 - 80 years ) and women ( aged 60 - 80 years ) who had type 2 diabetes or three or more cardiovascular risk factors were r and omly assigned ( 1:1:1 ) with a computer-generated number sequence to one of three interventions : Mediterranean diet supplemented with extra-virgin olive oil ( n=2543 ) ; Mediterranean diet supplemented with nuts ( n=2454 ) ; or a control diet ( advice to reduce dietary fat ; n=2450 ) . Energy restriction was not advised , nor was physical activity promoted . In this analysis of the trial , we measured bodyweight and waist circumference at baseline and yearly for 5 years in the intention-to-treat population . The PREDIMED trial is registered with IS RCT N.com , number IS RCT N35739639 . FINDINGS After a median 4·8 years ( IQR 2·8 - 5·8 ) of follow-up , participants in all three groups had marginally reduced bodyweight and increased waist circumference . The adjusted difference in 5 year changes in bodyweight in the Mediterranean diet with o
Output:
| We conclude that the DII score seems to be a useful tool to appraise the inflammatory capacity of the diet and to better underst and the relationships between diet , inflammation , and cardio-metabolic diseases |
MS212777 | ***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 Occupational low back pain ( OLBP ) is widespread in industrialized societies . We present a model to estimate the net economic costs of investments in ergonomic interventions at the company level to reduce work-related low back pain . METHODS Costs of interventions are defined by incorporating not only the costs of investment of equipment and labor , but also by taking into account the avoided costs of lost work time , medical care costs , and productivity improvements . In the net-cost model , all costs are annualized and are calculated at the level of an individual organization . Three case studies have been performed based on data from three companies in the manufacturing sector of the United States using the above approach . RESULTS The net-cost estimates for the three case studies consistently show that ergonomic interventions applied appropriately can result in substantial cost savings for the companies . CONCLUSIONS Although generalizing on the basis of three case studies is not ideal , our analyses show that it might be in the economic interest of management to play a more active role to prevent back pain . Gathering useful retrospective cost data , even on interventions deemed effective by corporate innovators , proved to be extremely difficult . We conclude that it is essential to incorporate a protocol for collecting cost and effectiveness data in the st and ard operating procedures of ergonomists and companies introducing such innovation . We intend to vali date the net-cost model for the monitoring and reporting of such data through prospect i ve studies in a variety of industrial setting s and in countries at various stages of economic development BACKGROUND High rates of work-related injuries are seen among health care workers involved in lifting and transferring patients . We studied the effects of a participatory worker-management ergonomics team among hospital orderlies . METHODS This prospect i ve intervention trial examined work injuries and other outcomes before and after the intervention , with other hospital employees used as a concurrent control . All orderlies in a 1,200-bed urban hospital were studied using passively collected data ( mean employment during study period 100 - 110 orderlies ) ; 67 orderlies ( preintervention ) and 88 orderlies ( postintervention ) also completed a question naire . The intervention was the formation of a participatory ergonomics team with three orderlies , one supervisor , and technical advisors . This team design ed and implemented changes in training and work practice s. RESULTS The 2-year postintervention period was marked by decreased risks of work injury ( RR = 0.50 , 95 % CI 0.35 - 0.72 ) , lost time injury ( RR = 0.26 , 95 % CI 0.14 - 0.48 ) , and injury with three or more days of time loss ( RR = 0.19 , 95 % CI 0.07 - 0.53 ) . Total lost days declined from 136.2 to 23.0 annually per 100 full-time worker equivalents ( FTE ) . Annual workers ' compensation costs declined from $ 237/FTE to $ 139/FTE . The proportion of workers with musculoskeletal symptoms declined and there were statistically significant improvements in job satisfaction , perceived psychosocial stressors , and social support among the orderlies . CONCLUSION Substantial improvements in health and safety were seen following implementation of a participatory ergonomics program Background : Call centre work with computers is associated with increased rates of upper body pain and musculoskeletal disorders . Methods : This one year , r and omised controlled intervention trial evaluated the effects of a wide forearm support surface and a trackball on upper body pain severity and incident musculoskeletal disorders among 182 call centre operators at a large healthcare company . Participants were r and omised to receive ( 1 ) ergonomics training only , ( 2 ) training plus a trackball , ( 3 ) training plus a forearm support , or ( 4 ) training plus a trackball and forearm support . Outcome measures were weekly pain severity scores and diagnosis of incident musculoskeletal disorder in the upper extremities or the neck/shoulder region based on physical examination performed by a physician blinded to intervention . Analyses using Cox proportional hazard models and linear regression models adjusted for demographic factors , baseline pain levels , and psychosocial job factors . Results : Post-intervention , 63 participants were diagnosed with one or more incident musculoskeletal disorders . Hazard rate ratios showed a protective effect of the armboard for neck/shoulder disorders ( HR = 0.49 , 95 % CI 0.24 to 0.97 ) after adjusting for baseline pain levels and demographic and psychosocial factors . The armboard also significantly reduced neck/shoulder pain ( p = 0.01 ) and right upper extremity pain ( p = 0.002 ) in comparison to the control group . A return-on-investment model predicted a full return of armboard and installation costs within 10.6 months . Conclusion : Providing a large forearm support combined with ergonomic training is an effective intervention to prevent upper body musculoskeletal disorders and reduce upper body pain associated with computer work among call centre employees BACKGROUND Low back injuries are common and costly , accounting for 15 to 25 percent of injuries covered by workers ' compensation and 30 to 40 percent of the payments made under that program . The high costs of injury , the lack of effective treatment . and the evidence that there are behavioral risk factors have led to widespread use of employee education programs that teach safe lifting and h and ling . The effectiveness of those programs , however , has received little rigorous evaluation . METHODS We evaluated an educational program design ed to prevent low back injury in a r and omized , controlled trial involving about 4000 postal workers . The program , similar to that in wide use in so-called back schools , was taught by experienced physical therapists . Work units of workers and supervisors were trained in a two-session back school ( three hours of training ) , followed by three to four reinforcement sessions over the succeeding few years . Injured subjects ( from both the intervention and the control groups ) were r and omized a second time to receive either training or no training after their return to work . RESULTS Physical therapists trained 2534 postal workers and 134 supervisors . Over 5.5 years of follow-up , 360 workers reported low back injuries , for a rate of 21.2 injuries per 1000 worker-years of risk . The median time off from work per injury was 14 days ( range , 0 to 1717 ) ; the median cost was $ 204 ( range , zero to $ 190,380 ) . After their return to work , 75 workers were injured again . Our comparison of the intervention and control groups found that the education program did not reduce the rate of low back injury , the median cost per injury , the time off from work per injury , the rate of related musculoskeletal injuries , or the rate of repeated injury after return to work ; only the subjects ' knowledge of safe behavior was increased by the training . CONCLUSIONS A large-scale , r and omized , controlled trial of an educational program to prevent work-associated low back injury found no long-term benefits associated with training To define the cost-effectiveness of a back school program in industry , a controlled longitudinal field study was carried out in a Dutch bus company . The experimental group received a program consisting of information on back care , physical fitness , nutrition , stress , and relaxation . Objective data on absenteeism were collected and compared during a 6-year period for the control and experimental groups . Results showed that a tailor-made back school program reduced absenteeism by at least 5 days per year per employee , therefore being cost-effective to industry . A reduction was not observed in incidence , but in mean length of absenteeism . This effect turned out to be persistent during a 2-year period following the program
Output:
| Results In the manufacturing and warehousing sector strong evidence was found in support of the financial merits of ergonomic interventions from a firm perspective .
In the administrative support and health care sectors moderate evidence was found , in the transportation sector limited evidence , and in remaining sectors insufficient evidence .
Conclusions Most intervention studies focus on effectiveness .
Few consider their financial merits .
Often only a small part of the overall evaluation of many studies focused on evaluating their cost-effectiveness |
MS212778 | ***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 Long-term effects of lamivudine treatment on chronic hepatitis B patients without advanced disease remain unknown . Our aim was to investigate the effects of long-term lamivudine treatment and lamivudine-resistant virus ( YMDD ) on the development of cirrhosis and hepatocellular carcinoma ( HCC ) in asymptomatic patients without advanced disease . METHODS One hundred and forty-two hepatitis B e antigen (HBeAg)-positive patients ( median age : 33.9 years ) on long-term lamivudine ( median treatment duration : 89.9 months ) and 124 HBeAg-positive controls ( median age : 33.4 years ) were prospect ively followed up . Patients were monitored for the development of cirrhosis and HCC , liver biochemistry , hepatitis B virus ( HBV ) DNA levels , HBeAg seroconversion and hepatitis flares . YMDD mutations ( YMDD-MT ) were determined annually . RESULTS Lamivudine-treated patients had a significantly lower cumulative rate of development of cirrhosis and /or HCC compared with controls ( P = 0.005 ) . YMDD-MT occurred in 76.3 % of patients after 8 years of lamivudine treatment . When compared with controls and patients with YMDD-MT , patients without YMDD-MT had the greatest reduction of HBV DNA and bilirubin levels , slowest decline of albumin level , highest rate of HBeAg seroconversion and lowest risk of hepatitis flare . Patients with YMDD-MT still had a lower risk for developing cirrhosis and /or HCC ( P = 0.024 ) and a greater HBV DNA reduction ( P = 0.001 ) in comparison with controls . Patients with YMDD-MT and controls had a similar chance of hepatitis flares and hepatic decompensation . CONCLUSIONS Long-term lamivudine treatment was associated with a reduced chance of developing cirrhosis and HCC in patients without advanced disease . Although YMDD-MT reduced the benefits from lamivudine therapy , the outcome of these patients was still better than untreated patients BACKGROUND The effectiveness of antiviral therapy in preventing disease progression in patients with chronic hepatitis B and advanced fibrosis or cirrhosis is unknown . METHODS Patients with chronic hepatitis B who had histologically confirmed cirrhosis or advanced fibrosis were r and omly assigned in a 2:1 ratio to receive lamivudine ( 100 mg per day ) or placebo for a maximum of five years . Of 651 patients , 436 were assigned to receive lamivudine and 215 to receive placebo . The primary end point was time to disease progression , defined by hepatic decompensation , hepatocellular carcinoma , spontaneous bacterial peritonitis , bleeding gastroesophageal varices , or death related to liver disease . An independent data and safety monitoring board monitored the progress of the study and performed interim analyses of the data . RESULTS We r and omly assigned 651 patients ( 98 percent Asian and 85 percent male ) to receive lamivudine or placebo . The study was terminated after a median duration of treatment of 32.4 months ( range , 0 to 42 ) owing to a significant difference between treatment groups in the number of end points reached . End points were reached by 7.8 percent of the patients receiving lamivudine and 17.7 percent of those receiving placebo ( hazard ratio for disease progression , 0.45 ; P=0.001 ) . The Child-Pugh score increased in 3.4 percent of the patients receiving lamivudine and 8.8 percent of those receiving placebo ( hazard ratio , 0.45 ; P=0.02 ) , whereas hepatocellular carcinoma occurred in 3.9 percent of those in the lamivudine group and 7.4 percent of those in the placebo group ( hazard ratio , 0.49 ; P=0.047 ) . Genotypic resistance YMDD mutations developed in 49 percent of the patients treated with lamivudine , and the Child-Pugh score was more likely to increase in patients with these mutations than in the other patients treated with lamivudine ( 7 percent vs. < 1 percent ) . Overall , 12 percent of the patients in the lamivudine group and 18 percent of the patients in the placebo group reported serious adverse events . CONCLUSIONS Continuous treatment with lamivudine delays clinical progression in patients with chronic hepatitis B and advanced fibrosis or cirrhosis by significantly reducing the incidence of hepatic decompensation and the risk of hepatocellular carcinoma BACKGROUND The long-term efficacy of lamivudine treatment for patients suffering from severe acute exacerbation of hepatitis B e antigen (HBeAg)-positive chronic hepatitis B is unknown . METHODS Consecutive patients with severe acute exacerbation of HBeAg-positive chronic hepatitis B were prospect ively recruited from 1999 to 2004 and treated with lamivudine . All patients had alanine aminotransferase ( ALT ) and serum bilirubin levels 10x and 3x above the upper limit of normal , respectively . HBeAg-positive patients without severe acute exacerbation served as controls . RESULTS Forty-five patients with severe acute exacerbation and 31 controls were treated with lamivudine for a median of 2.8 ( range 1.0 - 7.1 ) years and 3.8 ( range 3.5 - 8.4 ) years , respectively . Compared with controls , patients with severe acute exacerbation had higher HBeAg seroconversion rates ( 78 % versus 52 % ; P=0.02 ) and lower risk of virological breakthrough . However , 33 % of patients with severe acute exacerbation still developed lamivudine resistance and virological breakthrough by year 5 . HBV DNA levels at week 4 and prolonged baseline prothrombin time were independent factors associated with virological breakthrough . All patients with week 4 HBV DNA <3 log10 copies/ml had maintained virological response . Among 15 patients who stopped lamivudine after sustained HBeAg seroconversion for > or = 6 months , 11 ( 73 % ) had virological relapse at a median of 1.4 ( 0.2 - 3.9 ) years . ALT increased beyond 10x the upper limit of normal in six ( 38 % ) patients who stopped lamivudine and two ( 7 % ) patients on maintained lamivudine treatment ( P=0.02 ) . CONCLUSION Among patients with severe acute exacerbation of HBeAg-positive chronic hepatitis B treated with lamivudine , virological breakthrough and post-treatment relapse are common despite a high rate of HBeAg seroconversion . Severe hepatitis flare is also common particularly among patients developing virological relapse after discontinuation of lamivudine CONTEXT Serum hepatitis B virus ( HBV ) DNA level is a marker of viral replication and efficacy of antiviral treatment in individuals with chronic hepatitis B. OBJECTIVE To evaluate the relationship between serum HBV DNA level and risk of hepatocellular carcinoma . DESIGN , SETTING , AND PARTICIPANTS Prospect i ve cohort study of 3653 participants ( aged 30 - 65 years ) , who were seropositive for the hepatitis B surface antigen and seronegative for antibodies against the hepatitis C virus , recruited to a community-based cancer screening program in Taiwan between 1991 and 1992 . MAIN OUTCOME MEASURE Incidence of hepatocellular carcinoma during follow-up examination and by data linkage with the national cancer registry and the death certification systems . RESULTS There were 164 incident cases of hepatocellular carcinoma and 346 deaths during a mean follow-up of 11.4 years and 41,779 person-years of follow-up . The incidence of hepatocellular carcinoma increased with serum HBV DNA level at study entry in a dose-response relationship ranging from 108 per 100,000 person-years for an HBV DNA level of less than 300 copies/mL to 1152 per 100,000 person-years for an HBV DNA level of 1 million copies/mL or greater . The corresponding cumulative incidence rates of hepatocellular carcinoma were 1.3 % and 14.9 % , respectively . The biological gradient of hepatocellular carcinoma by serum HBV DNA levels remained significant ( P<.001 ) after adjustment for sex , age , cigarette smoking , alcohol consumption , serostatus for the hepatitis B e antigen ( HBeAg ) , serum alanine aminotransferase level , and liver cirrhosis at study entry . The dose-response relationship was most prominent for participants who were seronegative for HBeAg with normal serum alanine aminotransferase levels and no liver cirrhosis at study entry . Participants with persistent elevation of serum HBV DNA level during follow-up had the highest hepatocellular carcinoma risk . CONCLUSION Elevated serum HBV DNA level ( > or = 10,000 copies/mL ) is a strong risk predictor of hepatocellular carcinoma independent of HBeAg , serum alanine aminotransferase level , and liver cirrhosis BACKGROUND & AIMS Data on the long-term safety of lamivudine are limited . The aim of this analysis was to determine the incidence of hepatitis flares , hepatic decompensation , and liver-disease-related ( LDR ) serious adverse events ( SAE ) during long-term lamivudine treatment . METHODS We review ed data on 998 patients with HBeAg-positive compensated chronic hepatitis B who received lamivudine for up to 6 years ( median , 4 years ) and 200 patients who received placebo for 1 year . RESULTS Hepatitis flares occurred in 10 % of the lamivudine-treated patients in year 1 and in 18%-21 % in years 2 - 5 . A temporal association between hepatitis flares and lamivudine-resistant mutations increased from 43 % in year 1 to > 80 % in year 3 . Ten hepatic decompensation events occurred in 8 ( < 1 % ) lamivudine-treated patients . Fifty-three ( 5 % ) lamivudine-treated patients experienced a total of 60 LDR SAEs . Four patients died , 2 from liver-related causes . The proportion of patients with a documented lamivudine-resistant mutation increased from 23 % in year 1 to 65 % in year 5 . During each year of the study , patients with lamivudine-resistant mutations experienced significantly more hepatitis flares than patients without lamivudine-resistant mutations ( P < 0.005 ) . The occurrence of hepatic decompensation ( 0%-2 % ) and LDR SAEs ( 1%-10 % ) among patients with lamivudine resistance remained stable during the first 4 years with mutations and increased afterward to 6 % ( P = 0.03 ) and 20 % ( P = 0.009 ) , respectively . CONCLUSIONS This study demonstrated that lamivudine treatment for up to 6 years has an excellent safety profile in patients with HBeAg-positive compensated liver disease , but patients with long-st and ing lamivudine-resistant mutations may experience worsening liver disease BACKGROUND / AIMS This study aim ed to evaluate the effect of interferon-alpha therapy on the long-term outcome of HBeAg-negative chronic hepatitis B. METHODS A cohort of 209 interferon-alpha treated and 195 untreated patients with histologically documented HBeAg-negative chronic hepatitis B were closely followed for a mean of 6 ( 1 - 13.5 ) years . Patients with decompensated liver disease and /or hepatocellular carcinoma at presentation were excluded . RESULTS Survival and complication ( liver decompensation and /or hepatocellular carcinoma ) -free survival were significantly worse in patients with compared to those without baseline cirrhosis and in patients older compared to those younger than 45 years ( P < 10(-4 ) ) . Sustained biochemical remission was achieved in 57 treated patients . Sustained responders had significantly better survival and complication-free survival than non-sustained responders ( P = 0.027 and P = 0.019 , respectively ) or than untreated patients ( P = 0.048 and P = 0.012 , respectively ) . Multivariate analysis showed that absence of baseline cirrhosis , younger age , and sustained biochemical remission were independently associated with an improved outcome . CONCLUSION In patients with HBeAg-negative chronic hepatitis B , sustained biochemical remission induced by interferon-alpha is associated with improved long-term outcome , even in the presence of cirrhosis and old age , both known factors associated with worse survival . Therefore , long-term biochemical remission appears to represent a satisfactory therapeutic target in this setting To assess whether extended treatment with interferon improves the outcome of hepatitis B e antigen (HBeAg)-negative chronic hepatitis B , 101 consecutive patients were treated with 6 MU of interferon alfa 2b 3 times weekly for 24 months . During the 68-month study , 30 patients ( 30 % ) had a sustained response
Output:
| Chronic hepatitis B patients receiving medium-term nucleos(t)ide analogue therapy had a significantly lower incidence of HCC compared to untreated patients but treatment does not completely eliminate the risk of HCC .
Among the treated patients , cirrhosis , HBeAg negative at baseline and failure to remain in virological remission were associated with an increased risk of HCC |
MS212779 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: This study was performed to investigate the effects of the co-administration of proton pump inhibitor ( PPI ) on the efficacy of bisphosphonate ( BP ) treatment for osteoporosis . A total of 180 women with low bone mineral density were r and omly divided into four groups , one in which sodium risedronate was administered with sodium rabeprazole and one in which only risedronate was administered ( BP + PPI and BP groups , respectively ) . The biomarkers were measured at the baseline and every 3 months , inlcuding : N-terminal telopeptide of type I collagen corrected for creatinine , bone-specific alkaline phosphatase ( BAP ) , parathyroid hormone , bone mineral density ( BMD ) of the lumbar spine and physical parameters evaluated according to the SF-36v2 ™ Health Survey . Statistical comparisons of these parameters were performed after 9 months . Data were available for a total of 137 patients ( 62 in the BP group and 75 in the BP + PPI group ) . The Δ % value of increase in BMD and improvement of physical functioning in the BP + PPI group were significantly larger , and its decrease in BAP in the BP + PPI group was significantly smaller than that in the BP group . It is expected that risedronate administration in combination with a PPI may be more effective not only for treating osteoporosis but also improving physical fitness than treatment with risedronate alone We studied the effect of proton pump inhibitors , histamine H2 receptor antagonists , and other types of antacid drugs on fracture risk . All cases were subjects with any fracture sustained during the year 2000 ( n = 124,655 ) . For each case , three controls ( n = 373,962 ) matched on age and gender were r and omly drawn from the background population . The primary exposure variables were use of proton pump inhibitors , histamine H2 antagonists , and other antacid drugs . Adjustments were made for several confounders , including diagnosis of an ulcer , nonsteroidal anti-inflammatory drug use , use of histamine H1 antagonists , stomach resection , previous fracture , and use of corticosteroids . The effect of dose was examined by stratifying for cumulated dose ( defined daily dose ) . Use of proton pump inhibitors was associated with an increase in fracture risk for use within the last year [ odds ratio ( OR ) = 1.18 , 95 % confidence interval ( CI ) 1.12–1.43 for overall fracture risk ; OR = 1.45 , 95 % CI 1.28–1.65 for hip fractures ; and OR = 1.60 , 95 % CI 1.25–2.04 for spine fractures ) . Histamine H2 antagonists were associated with a decreased fracture risk if they had been used within the last year ( OR = 0.88 , 95 % CI 0.82–0.95 for any fracture , OR = 0.69 , 95 % CI 0.57–0.84 for hip fractures ) . Other antacids were not associated with overall fracture risk but were associated with hip and spine fractures . Proton pump inhibitors appeared to be associated with a limited increase in fracture risk , in contrast to histamine H2 antagonists , which seemed to be associated with a small decrease in fracture risk . In all cases , the changes in risk estimates were small and the clinical significance was limited BACKGROUND No studies have estimated disability-adjusted life-years ( DALYs ) lost due to hip fractures using real-life follow-up cohort data . We aim ed to quantify the burden of disease due to incident hip fracture using DALYs in prospect i ve cohorts in the CHANCES consortium , and to calculate population attributable fractions based on DALYs for specific risk factors . METHODS We used data from six cohorts of participants aged 50 years or older at recruitment to calculate DALYs . We applied disability weights proposed by the National Osteoporosis Foundation and did a series of sensitivity analyses to examine the robustness of DALY estimates . We calculated population attributable fractions for smoking , body-mass index ( BMI ) , physical activity , alcohol intake , type 2 diabetes and parity , use of hormone replacement therapy , and oral contraceptives in women . We calculated summary risk estimates across cohorts with pooled analysis and r and om-effects meta- analysis methods . FINDINGS 223 880 men and women were followed up for a mean of 13 years ( SD 6 ) . 7724 ( 3·5 % ) participants developed an incident hip fracture , of whom 413 ( 5·3 % ) died as a result . 5964 DALYs ( 27 per 1000 individuals ) were lost due to hip fractures , 1230 ( 20·6 % ) of which were in the group aged 75 - 79 years . 4150 ( 69·6 % ) DALYs were attributed to disability . Current smoking was the risk factor responsible for the greatest hip fracture burden ( 7·5 % , 95 % CI 5·2 - 9·7 ) followed by physical inactivity ( 5·5 % , 2·1 - 8·5 ) , history of diabetes ( 2·8 % , 2·1 - 4·0 ) , and low to average BMI ( 2·0 % , 1·4 - 2·7 ) , whereas low alcohol consumption ( 0·01 - 2·5 g per day ) and high BMI had a protective effect . INTERPRETATION Hip fracture can lead to a substantial loss of healthy life-years in elderly people . National public health policies should be strengthened to reduce hip fracture incidence and mortality . Primary prevention measures should be strengthened to prevent falls , and reduce smoking and a sedentary lifestyle . FUNDING European Community 's Seventh Framework Programme Proton pump inhibitors are taken by millions of patients for prevention and treatment of gastroesophageal diseases . Case-control studies have suggested that use of omeprazole is associated with an increased risk of hip fractures . The aim of this prospect i ve study was to assess the risk of vertebral fractures in postmenopausal women using omeprazole . We studied 1,211 postmenopausal women enrolled in the Osteoporosis and Ultrasound Study from the general population . Information on omeprazole and other risk factors for fractures including prevalent fractures and bone mineral density was obtained at baseline . Vertebral fractures were assessed on X-rays obtained at baseline and at the end of the 6-year follow-up and analyzed central ly . At baseline , 5 % of this population was using omeprazole . Age-adjusted rates for vertebral fractures were 1.89 and 0.60 for 100 person-years for omeprazole users and nonusers , respectively ( P = 0.009 ) . In the multivariate analysis , omeprazole use was a significant and independent predictor of vertebral fractures ( RR = 3.50 , 95 % CI 1.14–8.44 ) . The other predictors were age higher than 65 years ( RR = 2.34 , 95 % CI 1.02–5.34 ) , prevalent vertebral fractures ( RR = 3.62 , 95 % CI 1.63–8.08 ) , and lumbar spine T score ≤ −2.5 ( RR = 2.38 , 95 % CI 1.03–5.49 ) . Omeprazole use is associated with an increased risk of vertebral fractures in postmenopausal women . Further studies are required to determine the mechanism of the association between the underlying gastric disease , omeprazole use , and risk of osteoporotic fractures 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 examine the association between chronic use of proton pump inhibitors ( PPIs ) and risk of hip fracture . Design Prospect i ve cohort study . Setting Nurses ’ Health Study , which originally recruited from the 11 most populous states in the US . Participants 79 899 postmenopausal women enrolled in the Nurses ’ Health Study who provided data on the use of PPIs and other risk factors biennially since 2000 and were followed up to 1 June 2008 . Main outcome measure Incident hip fracture Results During 565 786 person years of follow-up , we documented 893 incident hip fractures . The absolute risk of hip fracture among regular users of PPIs was 2.02 events per 1000 person years , compared with 1.51 events per 1000 person years among non-users . Compared with non-users , the risk of hip fracture among women who regularly used PPIs for at least two years was 35 % higher ( age adjusted hazard ratio 1.35 ( 95 % confidence interval 1.13 to 1.62 ) ) , with longer use associated with increasing risk ( Ptrend<0.01 ) . Adjustment for risk factors , including body mass index , physical activity , and intake of calcium did not material ly alter this association ( hazard ratio 1.36 ( 1.13 to 1.63 ) ) . These associations were also not changed after accounting for reasons for PPI use . The relation between PPI use and fracture differed by smoking history ( Pinteraction=0.03 ) . Among current and former smokers , PPI use was associated with greater than 50 % increase in risk of fracture , with a multivariate hazard ratio for fracture of 1.51 ( 1.20 to 1.91 ) . In contrast , among women who never smoked there was no association ( multivariate hazard ratio 1.06 ( 0.77 to 1.46 ) ) . In a meta- analysis of these results with 10 prior studies , the pooled odds ratio of hip fracture associated with PPI use was 1.30 ( 1.25 to 1.36 ) . Conclusion Chronic use of PPIs is associated with increased risk of hip fracture , particularly among women with a history of smoking Summary A large Canadian cohort was studied over 10 years to see if proton pump inhibitor ( PPI ) use increased the risk of sustaining a fragility fracture . We found an increased risk of fracture in individuals who used PPIs . The risk remained after controlling for other known fracture risk factors . Introduction Multiple retrospective studies have linked proton pump inhibitor use with increased risk of fragility fracture . We prospect ively studied the association between PPI use and fracture in a large cohort over a 10-year period while controlling for known fracture risk factors . Methods We studied 9,423 participants in the Canadian Multicenter Osteoporosis Study . The cohort was formed in 1995–1997 and followed for 10 years with monitoring for incident nontraumatic fracture and PPI use . Cox regression analyses were used to assess the association between PPI use and incident fracture risk . Results PPI use , coded as a time-dependent variable , was associated with a shorter time to first nontraumatic fracture , hazard ratio ( HR ) = 1.75 ( 95 % confidence interval ( CI ) 1.41–2.17 , p < 0.001 ) . After controlling for multiple risk factors , including femoral neck bone density , the association remained significant , HR = 1.40 ( 95 % CI 1.11–1.77 , p = 0.004 ) . Similar results were obtained after controlling for bisphosphonate use , using PPI “ ever ” use , or when the outcome was restricted to hip fracture . Conclusions In this large prospect i ve population -based cohort study , we found an association between PPI use and increased risk of fragility fracture . Although the increased risk found was modest , this finding is important , given the high prevalence of PPI use and the excess morbidity and mortality associated with osteoporosis-related fractures BACKGROUND Proton pump inhibitor ( PPI ) medications have been inconsistently shown to be associated with osteoporotic fractures . We examined the association of PPI use with bone outcomes ( fracture , bone mineral density [ BMD ] ) . METHODS This prospect i ve analysis included 161 806 postmenopausal women 50 to 79 years old , without history of hip fracture , enrolled in the Women 's Health Initiative ( WHI ) Observational Study and Clinical Trials with a mean ( SD ) follow-up of 7.8 ( 1.6 ) years . Analyses were conducted for 130 487 women with complete information . Medication information was taken directly from drug containers during in-person interviews ( baseline , year 3 ) . The main outcome measures were self-reported fractures ( hip [ adjudicated ] , clinical spine , forearm or wrist , and total fractures ) and for a sub sample ( 3 densitometry sites ) , 3-year change in BMD . RESULTS During 1 005 126 person-years of follow-up , 1500 hip fractures , 4881 forearm or wrist fractures , 2315 clinical spine fractures , and 21 247 total fractures occurred . The
Output:
| This meta- analysis suggests that PPI user have a 26 % increased risk of hip fracture as compared to non-PPI user . |
MS212780 | ***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: Solutions are employed to support clinical research trial tasks in community-based practice setting s. Using the IT Implementation Framework ( ITIF ) , an integrative framework intended to guide the synthesis of theoretical perspectives for planning multi-level interventions to enhance IT use , we sought to underst and the barriers and facilitators to clinical research in community-based practice setting s preliminary to implementing new informatics solutions for improving clinical research infrastructure . The studies were conducted in practice s within the Columbia University Clinical Trials Network . A mixed- method approach , including surveys , interviews , time-motion studies , and observations was used . The data collected , which incorporates predisposing , enabling , and reinforcing factors in IT use , were analyzed according to each phase of ITIF . Themes identified in the first phase of ITIF were 1 ) processes and tools to support clinical trial research and 2 ) clinical research peripheral to patient care processes . Not all of the problems under these themes were found to be amenable to IT solutions . Using the multi-level orientation of the ITIF , we set forth strategies beyond IT solutions that can have an impact on reengineering clinical research tasks in practice -based setting s. Developing strategies to target enabling and reinforcing factors , which focus on organizational factors , and the motivation of the practice at large to use IT solutions to integrate clinical research tasks with patient care processes , is most challenging . The ITIF should be used to consider both IT and non-IT solutions concurrently for reengineering of clinical research in community-based practice setting Background The feasibility of r and omized trials often depends on successful patient recruitment . Although numerous recruitment barriers have been identified it is unclear which of them complicate recruitment most . Also , most surveys have focused on the patients ' perspective of recruitment barriers whereas the perspective of recruiting physicians has received less attention . Therefore , our aim was to conduct a postal survey among recruiting physicians of a multi-center trial to weigh barriers according to their impact on recruitment . Methods We identified any potential recruitment barriers from the literature and from our own experience with a multi-center trial of respiratory rehabilitation in patients with chronic obstructive pulmonary disease . We developed and pilot-tested a self-administered question naire where recruiting physicians were asked to express their agreement with statements about recruitment barriers on a Likert-type scale from 1 ( full agreement with statement = very substantial recruitment barrier ) to 7 ( no agreement with statement = no recruitment barrier ) . Results 38 of 55 recruiting physicians returned question naires ( 69 % response rate ) , of which 35 could be analyzed ( 64 % useable response rate ) . Recruiting physicians reported that " time constraints " ( median agreement of 3 , interquartile range 2–5 ) had the most negative impact on recruitment followed by " difficulties including identified eligible patients " ( median agreement of 5 , IQR 3–6 ) . Other barriers such as " trial design barriers " , " lack of access to treatment " , " individual barriers of recruiting physicians " or " insufficient training of recruiting physicians " were perceived to have little or no impact on patient recruitment . Conclusion Physicians perceived time constraints as the most relevant recruitment barrier in a r and omized trial . To overcome recruitment barriers interventions , that are affordable for both industry- and investigator-driven trials , need to be developed and tested in r and omized trials . Trial registration IS RCT 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 Recent cohort studies of r and omised controlled trials have provided evidence of within- study selective reporting bias ; where statistically significant outcomes are more likely to be more completely reported compared to non-significant outcomes . Bias result ing from selective reporting can impact on meta-analyses , influencing the conclusions of systematic review s , and in turn , evidence based clinical practice guidelines .In 2006 we received funding to investigate if there was evidence of within- study selective reporting in a cohort of RCTs su bmi tted to New Zeal and Regional Ethics Committees in 1998/99 . This research involved accessing ethics applications , their amendments and annual reports , and comparing these with corresponding publications . We did not plan to obtain informed consent from trialists to view their ethics applications for practical and scientific reasons .In November 2006 we sought ethical approval to undertake the research from our institutional ethics committee . The Committee declined our application on the grounds that we were not obtaining informed consent from the trialists to view their ethics application . This initiated a seventeen month process to obtain ethical approval . This publication outlines what we planned to do , the issues we encountered , discusses the legal and ethical issues , and presents some potential solutions . Discussion and conclusion Method ological research such as this has the potential for public benefit and there is little or no harm for the participants ( trialists ) in undertaking it . Further , in New Zeal and , there is freedom of information legislation , which in this circumstance , unambiguously provided rights of access and use of the information in the ethics applications . The decision of our institutional ethics committee defeated this right and did not recognise the nature of this observational research . Method ological research , such as this , can be used to develop processes to improve quality in research reporting . Recognition of the potential benefit of this research in the broader research community , and those who sit on ethics committees , is perhaps needed . In addition , changes to the ethical review process which involve separation between those who review proposals to undertake method ological research using ethics applications , and those with responsibility for review ing ethics applications for trials , should be considered . Finally , we contend that the research community could benefit from quality improvement approaches used in allied sectors Public health interventions usually operate at the level of groups rather than individuals , and cluster r and omized controlled trials ( RCTs ) are one means of evaluating their effectiveness . Using examples from six such trials in Bangladesh , India , Malawi and Nepal , we discuss our experience of the ethical issues that arise in their conduct . We set cluster RCTs in the broader context of public health research , highlighting debates about the need to reconcile individual autonomy with the common good and about the ethics of public health research in low-income setting s in general . After a brief introduction to cluster RCTs , we discuss particular challenges we have faced . These include the nature of - and responsibility for - group consent , and the need for consent by individuals within groups to intervention and data collection . We discuss the timing of consent in relation to the implementation of public health strategies , and the problem of securing ethical review and approval in a complex domain . Finally , we consider the debate about benefits to control groups and the st and ard of care that they should receive , and the issue of post-trial adoption of the intervention under test Background Excessive protocol violations ( PV ) , which can be defined as preventable mistakes in study conduct , may result in patient harm and introduce errors into a clinical trial 's results leading to flawed trial conclusions .The purpose of this project was to gain a better underst and ing of reported PVs , to describe current practice with regards to the use of methods for the reduction of PVs and to investigate relationships between clinical trial characteristics and PVs . Methods We review ed 80 clinical trials conducted across a broad range of medical specialties published in four major general medical journals ( The Lancet , NEJM , JAMA , BMJ ) . Eligible papers were identified using a PubMed search . For each included trial , two authors independently abstract ed information on trial characteristics , PV reporting and PV rates and interventions used to reduce PVs . PVs were categorised into one of five distinct types : enrolment , r and omisation , study intervention , patient compliance and data collection errors . Associations between PVs and study characteristics were investigated using logistic regression . Results Eighty clinical trials ( 20 from each journal ) were identified from 101 consecutive PubMed abstract s. The median number of participants was 701 ( range : 20 to 162 , 367 ) and the median number of participating sites was 15 ( range : 1 to 701 ) . Nineteen percent ( 15/80 ) of included trials were single centre trials . The median study duration was 24 months ( range : 5.81 - 127 months ) and 74 % ( 59/80 ) of included trials were primarily academic funded . Thirty two percent ( 26/80 ) of included trials failed to provide explicit reporting of any type of PV and none ( 0/80 ) of the trials provided explicit reporting of all five types of PVs . Larger clinical trials ( more patients , more sites , longer duration , more complex management structure ) were more likely to have more complete reporting of PV's . Only 9 % ( 7/80 ) of trials reported the use of a specific study method to prevent PVs . Use of a run-in phase was the only method reported . Conclusions PVs are under-reported . Although the CONSORT statement provides guidance on the reporting of PVs , reporting requirements are not explicit for all types of PVs . As a first step towards improved reporting by authors , we recommend the CONSORT statement highlight the importance of PVs by making reporting requirements more explicit Blinding embodies a rich history spanning over two centuries . Most research ers worldwide underst and blinding terminology , but confusion lurks beyond a general comprehension . Terms such as single blind , double blind , and triple blind mean different things to different people . Moreover , many medical research ers confuse blinding with allocation concealment . Such confusion indicates misunderst and ings of both . The term blinding refers to keeping trial participants , investigators ( usually health-care providers ) , or assessors ( those collecting outcome data ) unaware of the assigned intervention , so that they will not be influenced by that knowledge . Blinding usually reduces differential assessment of outcomes ( information bias ) , but can also improve compliance and retention of trial participants while reducing biased supplemental care or treatment ( sometimes called co-intervention ) . Many investigators and readers naïvely consider a r and omised trial as high quality simply because it is double blind , as if double-blinding is the sine qua non of a r and omised controlled trial . Although double blinding ( blinding investigators , participants , and outcome assessors ) indicates a strong design , trials that are not double blinded should not automatically be deemed inferior . Rather than solely relying on terminology like double blinding , research ers should explicitly state who was blinded , and how . We recommend placing greater credence in results when investigators at least blind outcome assessment s , except with objective outcomes , such as death , which leave little room for bias . If investigators properly report their blinding efforts , readers can judge them . Unfortunately , many articles do not contain proper reporting . If an article cl aims blinding without any accompanying clarification , readers should remain sceptical about its effect on bias reduction OBJECTIVE Latinas are underrepresented in clinical trials despite the rise in Hispanic population . This study examines the factors associated with Latinas ' willingness to participate in preventive breast cancer r and omized clinical trials ( RCTs ) . METHODS Women self-identifying as Latina , over age 40 , with no prior history of breast cancer were eligible . Using the Behavior Model for Vulnerable Population s , we administered a survey ( n=168 ) to assess predisposing ( e.g. , knowledge ) , enabling ( e.g. , trust ) and need factors ( e.g. , risk perception ) . Intention to participate was defined using a lenient ( maybe , probably or definitely ) and a stringent criterion ( probably and definitely ) . Chi-square tests and logistic regression models examined the associations of predisposing , enabling , and need factors with women 's intentions to participate in RCTs . RESULTS Most participants ( 74.9 % ) were monolingual Spanish-speaking immigrants . Most ( 83.9 % ) reported willing to participate in clinical trials using the lenient definition ( vs. 43.1 % under the stringent definition ) . Using the lenient definition , the odds of willing to participate in RCTs were significantly lower for unmarried women ( OR=.25 , 95 % CI=.08-.79 ) and those with lower cancer risk perceptions ( OR=.20 , 95 % CI=.06-.63 ) , while being significantly higher for women with lower language acculturation ( OR=6.2 , 95 % CI=1.
Output:
| The challenge related to design was poor planning .
Conclusion : Based on the results of this systematic review , the most important challenges were barriers related to h and ling ethical and regulatory systems , patient recruitment , and lack of budget and skilled staff for conducting clinical trials . |
MS212781 | ***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: HYPOTHESIS Stapled hemorrhoidectomy offers several advantages over excision hemorrhoidectomy , including reduced postoperative pain , a reduced hospital stay , and an earlier recovery time . Furthermore , stapled hemorrhoidectomy is associated with lower hemorrhoidal recurrence on long-term follow-up . DESIGN A r and omized prospect i ve trial . Patients were blinded to the operation technique used . Follow-up occurred at 1 and 3 weeks and 12 months postoperatively . SETTING A university hospital providing primary , secondary , and tertiary care . PATIENTS Forty patients with second- and third-degree hemorrhoid disease were r and omized to undergo either stapled or excision hemorrhoidectomy . Two patients were excluded . All patients were subject to a follow-up examination . INTERVENTIONS Stapled hemorrhoidectomy ( Longo technique ) vs excision hemorrhoidectomy ( Ferguson technique ) . MAIN OUTCOME MEASURES Operating time , postoperative pain ( measured by the visual analog scale ) , hospital stay , histologic features , morbidity , defecation habit , continence , recovery time ( return to work ) , and hemorrhoid recurrence at 1 year . RESULTS Stapled vs excision hemorrhoidectomy was associated with a significantly reduced operating time ( 30 vs 43.25 minutes ; P<.001 ) , reduced postoperative pain scores ( visual analog score ) on the first 4 postoperative days ( day 1 : 2.7 vs 6.3 ; day 2 : 1.7 vs 6.3 ; day 3 : 0.8 vs 5.4 ; and day 4 : 0.5 vs 4.8 , where 0 indicates no pain , and 10 , maximum pain ; P < or = .001 ) , and an earlier return to work ( 6.7 vs 20.7 days;P = .001 ) . There were no differences for stapled vs excision hemorrhoidectomy in length of hospital stay ( 2.4 vs 2.1 days ) , complications ( 3 [ 15 % ] of 20 patients vs 5 [ 25 % ] of 20 patients ) , and recurrence rate ( 1 [ 5 % ] of 20 patients vs 1 [ 5 % ] of 20 patients ) . CONCLUSIONS Stapled hemorrhoidectomy is associated with reduced postoperative pain , earlier recovery time and return to work , and a similar recurrence rate compared with the excision technique . Provided further clinical trials confirm these findings , stapled hemorrhoidectomy may become a future gold st and ard Abstract Purpose : To compare the postoperative evolution and the long-term efficacy after stapled haemorrhoidopexy ( PPH ) and Milligan-Morgan haemorrhoidectomy ( MM ) . Methods : In a prospect i ve r and omized study , 40 patients requiring surgical treatment for prolapsing haemorrhoids grade II or III were assigned to either MM or PPH ( 20 each ) . Postoperative pain , wound healing were evaluated , as well as anal pressures and sphincter anatomy . Mean follow-up is 46 months . Results : Postoperative pain at rest and during defecation was less important after PPH if no resection of external piles or skin tags was associated ( P < 0.0001 ) . Healing time was shorter after PPH ( P < 0.0001 ) . Endoanal ultrasound remained unchanged postoperatively . Resting and squeeze pressures decreased after MM , but not after PPH ( P < 0.01 ) . After a mean follow-up of 46 months ( 12 - 56 ) , persistent or recurrent symptoms , mostly mild and temporary , were observed after both MM and PPH , in 7 and 11 patients respectively ( NS ) . After PPH , five patients ( 25 % ) complained of recurrent external swelling and /or prolapse ( P = 0.047 vs. MM ) requiring redo surgery in four of them , after 10 , 13 , 14 and 21 months . No redo-surgery was required after MM . Long term patient satisfaction after PPH was not better than after MM . Conclusions : Postoperative pain is less important after PPH . This advantage disappears if any resection is associated with the stapling . At medium to long-term follow-up , PPH seems to carry a higher risk of symptomatic external haem-orrhoidal disease , needing further surgery PURPOSE It has been shown that for hemorrhoidal surgery both LigaSure ™ and stapler cause less pain than diathermy or scissor dissection . This study has attempted to establish which of the less painful alternatives proves best in an unselected series of patients with hemorrhoidal disease . METHODS Fifty patients were r and omized to undergo stapling hemorrhoidopexy or LigaSure ™ hemorrhoidectomy . Parameters investigated were pain ( primary parameter ) , patient satisfaction with treatment , and recovery of personal activity . Other factors investigated were operative result , ease of h and ling , analgesic requirements , and postoperative course . RESULTS Both methods were found to be equivalent in all major aspects analyzed . Postoperative pain scores ( P = 0.99 ) , patient satisfaction ( P = 1 ) , and self- assessment of activity ( P = 0.99 ) were almost identical in both groups of patients . Significant differences were found in none of the numerous factors investigated . CONCLUSION Both methods can be used safely and without major disadvantage for the patient regardless of stage and extent of hemorrhoidal disease Background and aims Stapled hemorrhoidectomy is a relatively new procedure , and studies on long-term outcomes are few . We present the results of a 5-year follow-up on patients recruited to a r and omized controlled trial comparing stapled and Milligan – Morgan hemorrhoidectomy . Patients and methods We performed telephone interviews and office visits between May and July 2005 on patients who had taken part in a r and omized controlled trial from May 1999 to December 2000 . Results Occasional pain and bleeding were referred by the patients with no difference between the two groups . The patients were also equally satisfied with both procedures . No recurrent hemorrhoidal prolapse or stenosis was detected at anorectal exploration and rigid sigmoidoscopy . Conclusion Both stapled and Milligan – Morgan techniques guarantee satisfactory long-term results . Larger studies are needed to assess the durability of stapled hemorrhoidectomy Advantages of the stapling procedure for haemorrhoids include reduced postoperative pain and shortened convalescence ; however , there are few data with respect to functional and symptomatic outcome . At a dedicated clinic , we review ed patients between Dec , 2001 , and March , 2002 , who had taken part in a r and omised controlled trial undertaken at the unit in 1999 , which compared outcomes after open or stapled haemorrhoidectomy . We noted the presence or absence of haemorrhoid specific symptoms , and assessed overall satisfaction , continence , and quality of life . Rigid sigmoidoscopy and an anorectal examination were also used to examine symptomatic recurrence and disease activity . At minimum follow-up of 33 months since surgery , both techniques seem to be equally effective PURPOSE A r and omized trial was undertaken to evaluate and compare stapled hemorrhoidopexy with excisional hemorrhoidectomy in which the Harmonic Scalpel ™ was used . METHODS Patients with Grade III hemorrhoids who were employed during the trial period were recruited and r and omized into two groups : ( 1 ) Harmonic Scalpel ™ hemorrhoidectomy , and ( 2 ) stapled hemorrhoidopexy . All operations were performed by a single surgeon . In the stapled group , the doughnut obtained was sent for histopathologic examination to determine whether smooth muscles were included in the specimen . Operative data and complications were recorded , and patients were followed up through a structured pro forma protocol . An independent assessor was assigned to obtain postoperative pain scores and satisfaction scores at six-month follow-up . Patients were also administered a simple question naire at follow-up to assess continence functions . RESULTS Over a 20-month period , 88 patients were recruited . The two groups were matched for age and gender distribution . No significant difference was identified between the two groups in terms of operation time , blood loss , day of first bowel movement after surgery , and complication rates . Despite a similar parenteral and oral analgesic requirement , the stapled group had a significantly better pain score ( P = 0.002 ) ; these patients also had a significantly shorter length of stay ( P = 0.02 ) , and on average resumed work nine days earlier than the group treated with the Harmonic Scalpel ™ ( 6.7 vs. 15.6 , P = 0.002 ) . Although 88 percent of doughnuts obtained in the stapled group contained some smooth muscle fibers , no association was found between smooth muscle incorporation and postoperative continence function , and as a whole the continence outcomes of the stapled group were similar to those after Harmonic Scalpel ™ hemorrhoidectomy . Finally , at six-month follow-up , patients who underwent the stapled procedure had significantly better satisfaction scores ( P = 0.001 ) . CONCLUSIONS tapled hemorrhoidopexy is a safe and effective procedure for Grade III hemorrhoidal disease . Patients derive greater short-term benefits of reduced pain , shorter length of stay , and earlier resumption to work . Long-term follow-up is necessary to determine whether these initial results are lasting The aim of this study was to assess the short- and long-term results of treatment for haemorrhoids by prospect ively comparing two techniques , namely , stapled rectal prolapse mucosectomy according to Longo and open hemorrhoidectomy . One hundred consecutive patients were r and omised to stapled ( 50 patients ) or manual hemorrhoidectomy ( 50 patients ) . We analysed postoperative pain , preoperative and postoperative anorectal function , intraoperative and postoperative complications , time needed to return to work and to normal social activities , and costs . Long-term follow data were obtained by means of an outpatient visit . The operative time of the stapled technique was less than that of open haemorrhoidectomy ( 22 vs 35 minutes ) . Two cases of early postoperative bleeding occurred after the stapled technique . The mean pain score on a visual scale was significantly less in patients undergoing the stapled technique . In addition , the time needed to return to work and to normal social activities was significantly less after the stapled technique , which , however , proved to be a more expensive procedure . Stapled mucosectomy of the prolapsed rectal mucosa is a safe , rapid , and relatively painless technique , which has a low incidence of complications . It can be performed in a day surgery unit . Patient satisfaction , early return to normal activities and good long-term results counterbalance the high cost of the procedure PURPOSE Stapled hemorrhoidectomy may be associated with less pain and faster recovery than conventional hemorrhoidectomy for prolapsing hemorrhoids . Therefore , the outcome of stapled hemorrhoidectomy was compared with that of diathermy hemorrhoidectomy in a r and omized , controlled trial . METHODS Sixty patients with third-degree hemorrhoids were r and omly assigned to stapled hemorrhoidectomy ( n = 30 ) or to diathermy hemorrhoidectomy in a day-case setting . Visual analog scale was used for postoperative pain scoring . Surgical and functional outcome was assessed at six weeks and one year after surgery . RESULTS Operation time was a median of 21 ( range , 11–59 ) minutes in the stapled group vs. 22 ( range , 14–40 ) minutes in the diathermy group . Day-case surgery was successful in 24 patients ( 80 percent ) in the stapled group vs. 29 patients ( 97 percent ) in the diathermy group . Average pain in the stapled group was significantly lower than in the diathermy group ( median , 1.8 ( 0.1–4.8 ) vs. 4.3 ( 1.4–6.2 ) , 95 percent confidence interval difference medians , 1.15–3.85 , P = 0.0002 , Mann-Whitney U test ) as was the average pain expected by the patients ( median −2.7 ( −0.15–0.8 ) vs. 0.006 ( −4.05–0.5 ) respectively , 95 percent confidence interval difference medians , 0.5–3.55 , P = 0.0018 , Mann-Whitney U test ) . Postoperative morbidity and time off work were not significantly different between the diathermy and stapled groups . Seven treatment failures in the stapled group and one in the diathermy group necessitated other treatments at a later date . Patient satisfaction scores in the stapled and diathermy group were similar . Symptoms attributed to difficult rectal evacuation decreased significantly after surgery . CONCLUSIONS Stapled hemorrhoidectomy is a significantly less painful operation than diathermy hemorrhoidectomy , but does not seem to offer significant advantages in terms of hospital stay or symptom control in the long term . Hemorrhoidectomy may improve symptoms of difficult rectal evacuation PURPOSE : Stapled hemorrhoidectomy is performed without leaving painful perianal wounds . The aim of this study was to assess any benefits , compared with a conventional open diathermy technique . METHODS : A total of 119 consecutive patients with prolapsed irreducible hemorrhoids were r and omly assigned ( conventional open diathermy technique=62 ; stapled hemorrhoidectomy=57 ) . Preoperative fecal incontinence scoring , anorectal manometry , and endoanal ultrasound were performed . Postoperatively , these were repeated at up to three months with pain scores , analgesic requirements , quality of life assessment , and total related medical costs . RESULTS : Conventional open diathermy technique was
Output:
| No significant difference was noted between the two techniques in terms of the total incidence of complications .
Stapled haemorrhoidopexy offers some short-term benefits over conventional operation but the total complication rates are similar for both techniques .
Stapled haemorrhoidopexy is associated with a higher rate of recurrent disease |
MS212782 | ***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: Study Design . Cross sectional Objective . To investigate the ability of the neurological examination to identify the specific level of a disc herniation in patients with sciatica and confirmed disc herniation . Summary of Background Data . Tests included in a neurological examination theoretically provide accurate diagnostic information about the level of the herniated disc . However , there is currently very little evidence about the diagnostic accuracy of individual tests or combinations of tests . Methods . The study included 283 patients with sciatica and confirmed disc herniation from a previous r and omized controlled trial . The reference test for the current study was the MRI scan , reported for level of disc herniation . Index tests investigated were a neurologist 's overall impression of the level of disc herniation , individual neurological tests ( e.g. , sensation testing ) and multiple test findings ( i.e. , the number of positive tests ) . The index tests were performed blinded to the MRI results . The diagnostic accuracy of the index tests in predicting herniations at the lower three lumbar discs was investigated using area under the curve ( AUC ) , sensitivity and specificity . Results . None of the individual neurological tests from the clinical examination were highly accurate for identifying the level of disc herniation ( AUC < 0.75 ) . The outcome of multiple test findings was slightly more accurate but did not produce high sensitivity and specificity . The dermatomal pain location was generally the most informative individual neurological test . The overall suspected level of disc herniation rated by the neurologist after a full examination of the patient was more accurate than individual tests . At L4/5 and L5/S1 herniations the AUC for neurologist ratings was 0.79 and 0.80 respectively . Conclusion . The current study did not find evidence to support the accuracy of individual tests from the neurological examination in identifying the level of disc herniation demonstrated on MRI . A neurologist 's overall impression was moderately accurate in identifying the level of disc herniation Summary The diagnostic power or clinical parameters in the diagnosis of lumbar disc herniation in patients with monoradicular pain was evaluated in a prospect i ve study with a 100 % verification of the diagnosis . Eighty patients with monoradicular pain corresponding to the fifth lumbar or the first sacral nerve root were included . Pre-operatively a number of clinical parameters were recorded and compared to the intra-operative finding of a disc herniation . The parameters were analysed by receiver operating characteristic ( ROC ) curves . Results from the available literature were analysed by ROC curves for comparison . In 76 % of the cases a disc herniation was discovered . The level of the disc herniation was correctly predicted in 93 % of these cases by the location of the pain alone or supplemented by neurological signs . Apart from radicularly distributed pain , all parameters in the present study and in the literature had no or low diagnostic accuracy . Thus , in patients with monoradicular sciatica further clinical parameters do not add to the diagnosis of lumbar disc herniation OBJECTIVE To establish the level of cardiorespiratory fitness and the rate of decrease in maximal aerobic capacity according to age in patients with chronic low back pain and compare these with normative data . DESIGN Prospect i ve case series with historical controls . SUBJECTS/ PATIENTS Seventy patients with chronic low back pain . METHODS A maximal cycle ergometer protocol was used to measure VO2max , heart rate , respiratory exchange ratio and blood lactate levels . RESULTS Seventy patients achieved absolute and normalized for weight VO2max values of 2.17 ( st and ard deviation ( SD ) 0.65 ) l/min and 30.79 ( SD 7.77 ) ml/kg/min , respectively . Absolute VO2max was poorly related to age in both men and women with chronic low back pain ( r = -0.22 and r = -0.28 , respectively ) . VO2max normalized for weight was also inversely related to age in both men and women ( r = -0.36 and r = -0.42 , respectively ) . The rate of VO2max decline between 20 and 59 years was -3.3 ml/kg/min/decade for the entire population and -1.2 and -5.4 ml/kg/min/decade in men and women , respectively . CONCLUSION The level of physical fitness of patients with chronic low back pain is comparable to the physical fitness of healthy , but poorly conditioned subjects . Patients with chronic low back pain show a VO2max decline with ageing that is slower than of active subjects This prospect i ve and consecutive study was design ed to evaluate the validity of different clinical tests , e.g. lumbar extension in lying and slump test for patients with suspected herniated nucleus pulposus , in comparison with findings on computed tomography ( CT ) and /or magnetic resonance imaging ( MRI ) scan . There were 105 patients who were seen and examined by the senior author ( for the sake of the study ) at the Orthopaedic Physiotherapy Department , on an average of 5.5 days ( range 0 - 21 days ) before CT and /or MRI examination were carried out . There were 36 women and 69 men with an average age of 42.7 + /- 9.8 ( range 19 - 64 ) years . According to the radiological findings on CT and /or MRI , the patients were divided into three groups : 52 patients with disc hernia , 41 patients with bulging discs and 12 patients without positive findings . The mean values with st and ard deviations of 25 variables of three diagnostic groups were studied . Multiple comparison adjustment according to Bonferroni showed significant differences for three variables that were of diagnostic value ( lumbar range of motion for forward flexion , left side-bending in st and ing , and pain distribution during extension in st and ing ) . The agreement between clinical and radiological findings for type and level of diagnosis of disc herniation was accurate in 72 patients ( 69 % ) . The diagnostic sensitivity for disc herniation was 82.6 % and the specificity 54.7 % Summary In a prospect i ve , consecutive study of patients with lumbar back pain and sciatica , various clinical features and surgical findings were evaluated in order to analyse the predictive value regarding ( 1 ) level of diseased interspace ( 2 ) presence and type of lesion responsible for root compression ( 3 ) outcome after surgery . One hundred patients underwent surgery solely on clinical grounds . Fifty-eight had disc herniation . The level of disc herniation was correctly predicted in three quarters of patients with aprolapsed disc . The outcome after surgery was good in 77 patients .Only few clinical features , namely male sex and scoliosis were predictors of a good outcome . Lasegue 's sign was indicative of root compression in 90 % , but only two-thirds had disc herniation . Conversely one-third had disc herniation in spite of a “ negative ” test . Lasegue 's sign was not superior to other clinical tests in predicting outcome .The most important indicator of a good outcome was the presence of disc herniation at surgery . Patients with disc pathology other than true disc herniation fared equally with patients , who had normal discs disclosed at surgery . Myelography was undertaken in all patients prior to surgery , the results of which are analysed in the following paper . ( Espersenet al. : Predictive value of radiculography in patients with lumbago-sciatica . A prospect i ve Currently , there are over 300,000 lumbar discectomies performed in the US annually without an objective st and ard for patient selection . A prospect i ve clinical outcome study of 200 cases with 5-year follow-up was used to develop and vali date an MRI-based classification scheme to eliminate as much ambiguity as possible . 100 consecutive lumbar microdiscectomies were performed between 1992 and 1995 based on the criteria for “ substantial ” herniation on MRI . This series was used to develop the MSU Classification as an objective measure of lumbar disc herniation on MRI to define “ substantial ” . It simply classifies herniation size as 1 - 2 - 3 and location as A-B-C , with inter-examiner reliability of 98 % . A second prospect i ve series of 100 discectomies was performed between 2000 and 2002 , based on the new criteria , to vali date this classification scheme . All patients with size-1 lesions were electively excluded from surgical consideration in our study . The Oswestry Disability Index from both series was better than most published outcome norms for lumbar microdiscectomy . The two series reported 96 and 90 % good to excellent outcomes , respectively , at 1 year , and 84 and 80 % at 5 years . The most frequent types of herniation selected for surgery in each series were types 2-B and 2-AB , suggesting the combined importance of both size and location . The MSU Classification is a simple and reliable method to objective ly measure herniated lumbar disc . When used in correlation with appropriate clinical findings , the MSU Classification can provide objective criteria for surgery that may lead to a higher percentage of good to excellent outcomes Study Design . A cross-sectional study of interobserver variability in primary care patients . Objective . To investigate the consistency of signs and symptoms of nerve root compression in primary care patients with pain irradiating pain into the leg ( sciatica ) . Summary of Background Data . The literature does not report on all the clinical tests for nerve root compression . In previous studies , most patients had low back pain with no irradiation . Often , little information on examination technique , proportion of positive test results , or clinical patient characteristics was provided . Methods . A r and om selection of 91 patients was investigated by a neurologist-resident couple . Agreement percentages , proportions of positive test results , and kappas were calculated . Results . The kappa of the overall conclusion after the history taking was 0.40 , increasing to 0.66 after physical examination . Kappas were good for decreased muscle strength and sensory loss ( 0.57–0.82 ) , intermediate for reflex changes ( 0.42–0.53 ) , and poor for the examination of the lumbar spine ( 0.16–0.33 ) . The straight leg raising , crossed straight leg raising , Bragard ’s sign , and Naffziger ’s sign were the most consistent nerve root tension signs ( > 0.66 ) . Conclusions . Two clinicians disagreed on the presence of nerve root involvement in one of four patients after history taking , and in one of five patients after physical examination . For a more consistent overall diagnosis , the physician probably should put more emphasis on the history of pain on coughing – straining – sneezing , a feeling of coldness in the legs , and urinary incontinence . The investigation of paresis , sensory loss , reflex changes , straight leg raising , and Bragard ’s sign provide the most consistent results OBJECTIVE To determine the extent to which the history and physical examination predict the outcome of the electrodiagnostic ( EDX ) evaluation in patients with suspected lumbosacral radiculopathy . DESIGN Data for 170 subjects referred for low-back and lower limb symptoms were prospect ively collected at five EDX laboratories . The sensitivity , specificity , positive and negative predictive values , and odds ratios were determined for symptoms and neurologic signs . RESULTS Symptoms were not significantly associated with an EDX study or a lumbosacral radiculopathy . The physical examination was better at predicting that an EDX study would be abnormal in general than it was at predicting a lumbosacral radiculopathy in particular . Of those subjects with normal physical examinations , 15%-18 % still had abnormal EDX findings . CONCLUSIONS In a population of patients referred for an EDX study , the history and physical examination alone can not reliably predict electrodiagnostic outcome & NA ; Chronic low back pain ( CLBP ) is a major clinical problem with a substantial socio‐economical impact . Today , diagnosis and therapy are insufficient , and knowledge concerning interaction between musculoskeletal pain and motor performance is lacking . Most studies in this field have been performed under static conditions which may not represent CLBP patients ' daily‐life routines . A st and ardized way to study the sensory‐motor interaction under controlled motor performance is to induce experimental muscle pain by i.m . injection of hypertonic saline . The aim of the present controlled study was to analyze and compare electromyographic ( EMG ) activity of and coordination between lumbar muscles ( 8 paraspinal recordings ) during gait in 10 patients with CLBP and in 10 volunteers exposed to experimental back muscle pain induced by bolus injection of 5 % hypertonic saline . When the results are compared to sex‐ and age‐matched controls , the CLBP patients showed significantly increased EMG activity in the swing phase ; a phase where the lumbar muscles are normally silent . These changes correlated significantly to the intensity of the back pain . Similar EMG patterns were found in the experimental study together with a reduced peak EMG activity in the period during double stance where the back muscles are normally active . Generally , these changes were localized ipsilaterally to the site of pain induction . The clinical and experimental findings indicate that musculoskeletal pain modulates motor performance during gait probably via reflex pathways . Initially , these EMG changes may be interpreted as a functional adaptation to muscle pain , but the consequences of chronic altered muscle performance are not known . New possibilities to monitor and investigate altered motor performance may help to develop more rational therapies for CLBP patients In a prospect i ve study of 163 consecutive patients operated on because they were thought to have lumbar disc hernia , the authors investigated whether physical signs could predict the degree of hernia ( complete hernia , incomplete hernia , protruded disc , and normal disc ) found at surgery . Stepwise discriminant analysis showed that there were only 2 physical signs of diagnostic value : lumbar range of motion and crossed Lasegue sign . By these signs , 74 % of the uncontained hernias and 68 % of the contained hernias could be correctly classified . Discrimination also was made between intact annuli ( negative exploration and protruded disc ) versus ruptured annuli ( incomplete h
Output:
| This systematic review and meta- analysis demonstrate that neurological testing procedures have limited overall diagnostic accuracy in detecting disc herniation with suspected radiculopathy .
Pooled diagnostic accuracy values of the tests were poor , whereby all tests demonstrated low sensitivity , moderate specificity , and limited diagnostic accuracy independent of the disc herniation reference st and ard or the specific level of herniation . |
MS212783 | ***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 — Observational studies suggest that skeletonization of the internal thoracic artery ( ITA ) can improve conduit flow and length and reduce deep sternal infections and postoperative pain . We performed a r and omized , double-blind , within-patient comparison of skeletonized and nonskeletonized ITAs in patients undergoing coronary surgery . Methods and Results — Patients ( n=48 ) undergoing bilateral ITA harvest were r and omized to receive 1 skeletonized and 1 nonskeletonized ITA . Intraoperatively , ITA flow was assessed directly and with a Doppler flow probe before and after topical application of papaverine . ITA harvest time and conduit length were recorded . A blinded assessment of pain ( visual analog scale ) and dysesthesia ( physical examination ) was performed at discharge , at 2 weeks , and at a 3-month follow-up . Sternal perfusion was assessed with nuclear imaging ( n=7 ) . Skeletonization required longer ITA harvest times ( 27±1 versus 24±1 minutes ; P=0.04 ) . There was a trend toward increased ITA length in the skeletonized group ( 18.2±0.3 versus 17.7±0.3 cm ; P=0.09 ) . In situ ITA flow was lower in skeletonized arteries ( 7.4±0.9 versus 10.1±1.0 mL/min ; P=0.01 ) and increased significantly after ITA division and papaverine application . Postanastomotic flows were similar between groups . Skeletonization was associated with decreased pain at the 3-month follow-up and a reduction in major sensory deficits at the 4-week and 3-month ( 17 % versus 50 % ; P=0.002 ) follow-ups . Baseline adjusted sternal perfusion was significantly greater by 17±6 % ( P=0.03 ) on the skeletonized side . Conclusions — Skeletonization results in reduced postoperative pain and dysesthesia and increased sternal perfusion at follow-up but does not produce increased conduit flow . ITA skeletonization may be a strategy for reducing morbidity after CABG BACKGROUND This study was conceived to evaluate the effect of internal thoracic artery ( ITA ) skeletonization on vessel wall integrity . METHODS Forty consecutive patients undergoing coronary artery bypass were r and omized to receive a skeletonized ( n = 22 ) or a pedicled ( n = 18 ) ITA graft . ITA harvesting was performed by 2 experienced surgeons using the same instrumentation and technique . Specimens were examined by light and electron microscope in order to assess vascular wall integrity . A specific immunohistochemical staining and a computerized method were used to quantify the degree of endothelial integrity after surgical preparation . RESULTS Morphologic analysis revealed 2 cases of limited subadventitial hemorrhage ( one for each group ) and no case of major arterial damage . Immunohistochemical staining demonstrated an extremely high degree of maintenance of the endothelial integrity in both groups ( 97.2 % + /- 1.9 % in the skeletonized and 96.8 % + /- 2.1 % in the pedicled one ; p = 0.53 ) . CONCLUSIONS Skeletonization does not affect ITA wall integrity in humans su bmi tted to coronary artery bypass procedures BACKGROUND The skeletonization of internal thoracic artery is postulated to improve graft length , early blood flow , sternal blood supply , and postoperative respiratory function . Concern exists that skeletonization may injure internal thoracic artery , precluding good results of surgery . Reports on endothelial function of skeletonized internal thoracic artery are lacking . METHODS A prospect i ve assessment of early clinical outcomes of 357 consecutive patients undergoing coronary artery bypass grafting was performed : 287 patients with nonskeletonized and 70 with skeletonized left internal thoracic artery ( LITA ) . The lengths of LITA and of its discarded distal segment , as well as free LITA blood flow , were measured . The dose-effect relationship for relaxation to acetylcholine was studied in the organ bath . RESULTS Apart from a higher incidence of breaching the pleura with nonskeletonized LITA the clinical outcomes were comparable . The length of skeletonized LITA was 17.8+/-1.14 cm versus 20.3+/-0.52 cm skeletonized ( p = 0.11 ) . The length of discarded LITA was shorter in nonskeletonized artery ( 0.8+/-0.28 cm versus 2.6+/-0.49 cm ; p = 0.022 ) . The free LITA blood flow was 66.3+/-7.42 mL/min in nonskeletonized vessel versus 100.3+/-14.84 mL/min in skeletonized ( p = 0.048 ) . The acetylcholine-induced relaxation was similar in both groups ( maximal relaxation , 80.7%+/-5.95 % in nonskeletonized versus 72.9%+/-9.11 % in skeletonized ; not significant ; negative logarithm of half-maximal effect , 7.43+/-0.18 versus 7.1+/-0.10 , respectively ; p = 0.063 ) . CONCLUSIONS Skeletonization does not damage the endothelial function of the LITA . Higher free blood flow and available LITA length should encourage the use of skeletonized LITA in clinical practice BACKGROUND Skeletonization of the internal thoracic artery ( ITA ) has advantages , but the variation of ITA preparation may be traumatic for the arterial wall . We sought to compare intraoperative results and endothelial nitric oxide synthase ( e-NOS ) expression on the vessel wall after left ITA harvesting with skeletonization and the conventional technique . METHODS A prospect i ve evaluation of 84 consecutive patients undergoing coronary artery bypass grafting was performed : 40 patients with skeletonized and 44 patients with pedicled left ITA . The lengths of ITA and free ITA blood flow were measured . Distal ITA segments were analyzed histopathologically and stained by antibodies against e-NOS . RESULTS In the skeletonized group , the length of the ITA were significantly longer than in the pedicled group ( 15.7 + /- 0.4 cm versus 19.0 + /- 0.6 cm ; P = .001 ) . Also , the free-flow capacity of the ITA was significantly higher than in the pedicled group ( 62.4 + /- 4.8 mL/min versus 88.6 + /- 6.9 mL/min ; P = .001 ) . e-NOS expressions on endothelial cells were similar between the groups . Dense e-NOS immunostaining was observed in vaso vasorum of the adventitia in the pedicled group . However , there was not any e-NOS immunostaining in vaso vasorum of the adventitia in the skeletonized group . CONCLUSIONS Although skeletonization of the ITA is a more technically dem and ing procedure , it provides some advantages such as increased available graft length and reduced sternal devascularization . This technique did not have any detrimental effects on the endothelial cell lining and e-NOS expressions on the endothelial layer . To reach a definitive judgment for using skeletonized ITA , we need information about the long-term angiographic patency rates OBJECTIVE To compare the free blood flow , caliber , and length of the left internal thoracic artery ( LITA ) , dissected in the pedicled ( P ) and skeletonized ( S ) manners , during surgery before and after topical vasodilator ( TV ) application . METHODS A r and omized , blind , clinical trial was carried out with 50 patients undergoing elective myocardial revascularization to assess the use of the LITA in situ in its pedicled or skeletonized form . The 25 patients in the pedicled group ( GP ) had NYHA class II or III angina , ejection fraction ( EF ) of 50.8+/-9.2 % , and 16 were of the male sex . The patients in the skeletonized group ( SG ) had NYHA class II angina , EF of 46.8+/-9.3 % , and 19 were of the male sex . The measurements were performed before extracorporeal circulation and divided into 2 phases : phase 1 ( before topical papaverine application ) and phase 2 ( 15 min after topical application of papaverine , 2.5 mg/mL , at 37 degrees C ) . During the measurements , mean blood pressure , central venous pressure , and heart rate were monitored . RESULTS The phase 1 and 2 results are as follows : 1 ) PG : blood flow , 46+/-16 and 77+/-28 mL/min ; caliber , 1.4+/-0.1 and 1.7+/-0.1 mm , respectively ; 2 ) SG : blood flow , 57+/-27 and 97+/-35 mL/min ; and caliber , 1.4+/-0.1 and 1.8+/-0.2 mm , respectively . No significant differences were observed in length . CONCLUSION The LITA in SG had a significant increase in blood flow and caliber after the use of TV compared with blood flow and caliber in PG ( P=0.03 and P=0.01 , respectively ) BACKGROUND We examined the hypothesis that complete skeletonization of an internal thoracic artery ( ITA ) results in increased diameter of the graft for anastomosis and therefore improves graft flow in coronary artery bypass grafting . METHODS We studied 65 consecutive patients who underwent coronary artery bypass grafting , in which the left ITA was anastomosed to the left anterior descending artery . The first 20 consecutive ITA were harvested as a pedicle ( group P ) and later 45 consecutive ITAs were harvested as an ultrasonically skeletonized graft ( group S ) . Intraoperative ITA graft mean flows were obtained with a transit-time flowmeter . Three diameters of the ITA graft were measured quantitatively in postoperative angiograms performed 14 + /- 5 days after the coronary artery bypass grafting ; D1 , at the origin from the subclavian artery ; D2 , at the level of the second intercostal space ; and D3 , just proximal to the anastomosis . RESULTS Intraoperative mean flow was significantly greater in group S than in group P ( S : 42.6 + /- 29.1 mL/min versus P : 26.4 + /- 16.1 mL/min , p = 0.03 ) . Although the diameters D1 and D2 were not significantly different between groups , D3 was significantly larger in group S than in group p ( S : 1.77 + /- 0.28 mm versus P : 1.57 + /- 0.17 mm , p = 0.02 ) . CONCLUSIONS Compared with pedicle harvesting , complete skeletonization of ITA may make it possible to anastomose an ITA with a larger diameter in coronary artery bypass grafting , which leads to increased graft flow by decreasing vascular resistance BACKGROUND The preferential harvesting technique of the internal mammary artery has been periodically debated . This r and omized study evaluated the flow outcome of the skeletonized versus pedicled left internal mammary artery . METHODS Two hundred patients undergoing surgery for left anterior descending coronary artery revascularization were enrolled and r and omized to pedicled ( n=100 ) or skeletonized ( n=100 ) harvesting . Intraoperative baseline flow and post adenosine infusion into the left ventricle , hospital outcome , echocardiographic results , and troponin I leakage were analyzed . Noninvasive periodic evaluation of flow was carried out at rest and during intravenous adenosine infusion by transthoracic Doppler ultrasound , and was stratified according to the harvesting technique . Final angiographic evaluation was performed by 64-slice multidetector computed tomography . RESULTS Skeletonized left internal mammary arteries demonstrated better flow capacity at rest and during adenosine recruitment perioperatively and at all time points of follow-up . Troponin I leakage was significantly higher in the pedicled group ( 59 vs 42 , p=0.02 ) . Pedicled harvesting ( hazard ratio [ HR ] 3.6 , 95 % confidence interval [ CI ] 2.5 to 6.9 , p<0.001 ) ; indexed left ventricular mass greater than 150 g/m2 ( HR 4.6 , 95 % CI 3.1 to 7.5 , p<0.001 ) ; and baseline corrected thrombolysis in myocardial infa rct ion frame count greater than 30 ( HR 4.4 , 95 % CI , 3.8 to 7.2 , p<0.001 ) were the most powerful multivariable predictors of graft flow reserve less than 2.0 . Postoperative echocardiographic results and clinical and angiographic outcomes were comparable between the two groups . CONCLUSIONS Skeletonization of the left internal mammary artery , beyond traditional proven advantages , provided significantly higher flow capacity and better graft flow reserve
Output:
| Meta-regression demonstrated some modulation influence by female gender , age and diabetes on the flow capacity of grafts .
In summary , in terms of flow capacity , a skeletonized ITA appears to be superior in comparison with a pedicled ITA during CABG |
MS212784 | ***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 Few Iranian women take the Papanicolaou test despite its important role in preventing cervical cancer . This study aim ed to determine the effectiveness of an educational intervention based on the protection motivation theory ( PMT ) variables and implementation intentions in the first and second Pap test practice among Iranian women . MATERIAL S AND METHODS In this quasi-r and omized controlled trial , 200 women who were referred to 30 primary health care clinics in Tehran were r and omly selected . PMT variables and Pap test practice were measured at baseline and again after 3 and 15 months . The 4-week educational intervention program was conducted for the intervention group . RESULTS Following the intervention , the mean scores of self-efficacy , perceived vulnerability , and behavior intention variables were significantly higher in the intervention group when compared to the control group ( p<0.05 ) . No significant differences were found in the perceived severity , response efficacy , response cost , and fear between the two groups following the intervention . Higher percent of women in the intervention group had obtained first and second Pap test compared to the controls . CONCLUSIONS The PMT and implementation intentions provide a suitable theory-based framework for developing educational interventions regarding Pap test practice in Iran BACKGROUND Low-income African American women are more likely to die of breast cancer than their Caucasian counterparts , and at least part of the difference in mortality results from differential screening adherence . The purpose of this study was to identify more efficacious methods of promoting routine mammography screening in underserved population s. METHODS A prospect i ve r and omized intervention study of 344 low income African American women compared the impact of three interventions on mammography adherence and stage of readiness : ( 1 ) pamphlet only ; ( 2 ) culturally appropriate video ; and ( 3 ) interactive computer-assisted instruction program . RESULTS The interactive computer intervention program produced the greatest level of adherence to mammography ( 40.0 % ) compared to the video group ( 24.6 % ) and the pamphlet group ( 32.1 % ) . When subjects in the pamphlet and video groups were combined to form a non-interactive group , this group had a significantly lower adherence than the group who received the interactive computer intervention ( 27.0 % versus 40.0 % ) . There was also significantly more forward movement in mammography stage of readiness among participants in the computer group ( 52.0 % ) compared to those in the pamphlet group ( 46.4 % ) or the video group ( 31.3 % ) . When combining the non-interactive technology ( pamphlet and video ) there was also more forward movement in mammography stage of readiness for those in the interactive intervention group ( 52.0 % moved 1 or 2 stages ) compared to those in the non-interactive group ( 36.2 % ) . CONCLUSIONS These data indicate that tailored approaches are more effective than targeted messages either in print or video format . Another finding of this study is that interactive interventions are more effective than non-interactive interventions in increasing adherence and moving African American women forward in their mammogram stage of readiness The Pap smear test is recommended for early diagnosis of cervical cancer . The aim of this study was to assess knowledge and behavior regarding the Pap smear test based on the Health Belief Model ( HBM ) in women referred to premarital counseling classes , Hamadan , Iran . This quasi-experimental study was conducted on 330 women , who were allocated r and omly to two case and control groups ( n=165 ) . Two educational session classes were performed in the case group . Two stages in before and after intervention groups were evaluated . Analysis of data was performed by SPSS/16.0 , using t-test , x2 , and McNemar 's test . P-values < 0.05 were regarded as significant . There was no significant difference between the mean scores of the various structures of this model in two groups before the intervention . However , after the intervention there were significant increase in mean score of knowledge and all variables of HBM in the intervention group(<0.001 ) . The findings of this study highlight the important role of education about cervical cancer on changing women 's beliefs about cervical screening Under-screening may increase the risk of cervical cancer in middle-aged women . This study aim ed to investigate cervical cancer screening behaviour and its predictors among women aged 50 years or above . A population -based sample of 959 women was recruited by telephone from domestic households in Hong Kong , using r and om methods , and a structured question naire developed to survey participants . Multivariable logistic regressions were performed to examine the factors independently associated with cervical screening behaviour . Nearly half the sample ( 48 % ) had never had a cervical smear test . Multivariable analyses showed that age , educational level , marital status , family history of cancer , smoking status , use of complementary therapy , recommendation from health professionals , and believing that regular visits to a doctor or a Chinese herbalist were good for their health were predictors of cervical screening behaviour . Misconceptions concerned with menopause may reduce women ’s perceived susceptibility to cervical cancer , especially if they are 50 or above , and exert a negative effect on their screening behaviour . Healthcare professionals should actively approach these high-risk groups – older unmarried women , smokers , those less educated and who are generally not much concerned with their health Background Cervical cancer is the second most common form of cancer observed among women in Turkey . The participation of women in cervical cancer screening programs is strongly affected by Turkish attitudes , beliefs , and sociocultural structure . Aim This study was conducted to assess the effectiveness of health education that aim ed to raise awareness about Papanicolaou testing and to emphasize the importance of the early diagnosis of cervical cancer . Material s and Methods The study was conducted as a prospect i ve , r and omized , controlled trial and was carried out in 148 women . Seventy-five women in the control group were asked to fill out question naire forms . A 45-minute conference-style training was given to 73 women in the study group , and all of the subjects were asked to fill out the forms after the training . The sociodemographic characteristics of the 2 groups and the mean “ Health Belief Model Scale for Cervical Cancer and Pap Smear Test ” scores of the 2 groups were statistically analyzed by Statistical Package of Social Sciences ( SPSS ) , version 15 . Results There was no statistically significant difference noticed between the sociodemographic characteristics of the 2 groups ( P > 0.05 ) . The difference in test scores , which represented knowledge about cervical cancer and Papanicolaou testing , was statistically significant between the control group and the study group ( t = 10.122 , P < 0.05 ) . In the Health Belief Model Scale for Cervical Cancer and Pap Smear Test , there were statistically significant differences in the following measures : lower levels of susceptibility to cervical cancer score ( t = −2.035 , P < 0.05 ) , lower levels of perceived benefit from a Papanicolaou test score ( t = 3.278 , P < 0.05 ) and lower levels of perceived barriers to Papanicolaou test score ( t = −3.182 , P < 0.05 ) . Conclusion Nurses should be involved in educating women about cervical cancer and Papanicolaou testing . By doing so , they can change the attitudes , knowledge , and beliefs of the women Background Cervical cancer is a disease of public health importance affecting many women and contributing to avoidably high levels of cancer deaths in Nigeria . In spite of the relative ease of prevention , the incidence is on the increase . This study aim ed to determine the effect of health education on the awareness , knowledge and perception of cervical cancer and screening among women in rural Nigerian communities . Methods The study design was quasi-experimental . The study was carried out among adult women in Odogbolu ( intervention ) and Ikenne ( control ) local government areas ( LGA ) of Ogun state . Three hundred and fifty ( 350 ) women were selected per group by multistage r and om sampling technique . Data was collected by semi structured interviews with the aid of question naire . The intervention consisted of structured health education based on a movie . Result The intervention raised the level of awareness of cervical cancer and screening to 100 % ( p < 0.0001 ) . The proportion of women with very good knowledge of cervical cancer and screening rose from 2 % to 70.5 % ( χ2 = 503.7 , p < 0.0001 ) while the proportion of those with good perception rose from 5.1 % to 95.1 % ( p < 0.0001 ) . The mean knowledge and mean perception scores were also increased ( p < 0.0001 ) . There was increase in the proportion of women who had undertaken cervical screening from 4.3 % to 8.3 % ( p = 0.038 ) . The major reason stated by the women for not having had cervical screening done was lack of awareness about cervical cancer and screening . There was statistically significant difference between the intervention and control groups concerning their knowledge attitude and practice towards cervical and screening ( p < 0.05 ) after the intervention . Conclusion Multiple media health education based on a movie is effective in creating awareness for and improving the knowledge and perception of adult women about cervical cancer and screening . It also improves the uptake of cervical cancer screening . The creation of awareness is very crucial to the success of a cervical cancer prevention programme BACKGROUND Cervical cancer is one of the most common forms of carcinoma among women worldwide , accounting for about 12 % of all cancers . Tragically , studies have shown generally low awareness levels on its symptoms , risk factors and prevention . This study evaluated the effect of a health education program on knowledge of cervical cancer amongst women at risk in Africa . METHOD This study was conducted in the city of Lagos , Nigeria , using a multistage sampling technique . Two model markets were chosen by simple r and om sampling method from a total of 10 local governments with model markets . One was design ated the intervention/experimental group while the other was the control . Systematic sampling method was used in selecting 350 women comprising of 175 participants from each model market . A baseline survey on cervical cancer awareness and screening practice s was carried out in both sample groups with the aid of interviewer-administered , structured and pre-tested question naires . Thereafter , respondents in the intervention group received sessions of community-based educational messages on cervical cancer and its prevention . Subsequently , participants in both groups were reassessed to evaluate the effect of the educational program . Data analysis was conducted with Epi-info statistical software . RESULTS Knowledge level was low on cervical cancer at baseline ; only about 15 % and 6.9 % of participants in the intervention and control groups respectively had heard of cervical cancer . The most common sources of information were friends and media prior to the intervention . Significant increase in proportions were found in the intervention/experimental group on awareness of cervical cancer ( 61.7 % ) , associated symptoms and risk factors such as early sexual debut , promiscuity and smoking . CONCLUSION It is apparent that efforts must be put in place by all stakeholders in reaching women at risk of cervical cancer through well organized educational campaigns using culturally sensitive information , education and communication BACKGROUND North American Chinese women have lower levels of Papanicolaou ( Pap ) testing than other population subgroups . We conducted a r and omized controlled trial to evaluate the effectiveness of two alternative cervical cancer screening interventions for Chinese women living in North America . METHODS Four hundred and eighty-two Pap testing underutilizers were identified from community-based surveys of Chinese women conducted in Seattle , Washington , and Vancouver , British Columbia . These women were r and omly assigned to one of two experimental arms or control status . Several Chinese- language material s were used in both experimental arms : an education-entertainment video , a motivational pamphlet , an educational brochure , and a fact sheet . Women in the first experimental group ( outreach worker intervention ) received the material s , as well as tailored counseling and logistic assistance , during home visits by trilingual , bicultural outreach workers . Those in the second experimental group ( direct mail intervention ) received the material s by mail . The control group received usual care . Follow-up surveys were completed 6 months after r and omization to ascertain participants ' Pap testing behavior . All statistical tests were two-sided . RESULTS A total of 402 women responded to the follow-up survey ( 83 % response rate ) . Of these women , 50 ( 39 % ) of the 129 women in the outreach group , 35 ( 25 % ) of the 139 women in the direct mail group , and 20 ( 15 % ) of the 134 women in the control group reported Pap testing in the interval between r and omization and follow-up data collection ( P<.001 for outreach worker versus control , P = .03 for direct mail versus control , and P = .02 for outreach worker versus direct mail ) . Intervention effects were greater in Vancouver than in Seattle . CONCLUSION Culturally and linguistically appropriate interventions may improve Pap testing levels among Chinese women in North America Despite declines in cervical cancer mortality in developed countries , cervical cancer incidence and mortality rates remain high in Jamaica due to low levels of screening . Effective interventions are needed to decrease barriers to preventive behaviors and increase adoption of behaviors and services to improve prospect s of survival . We enrolled 225 women attending health facilities in an intervention consisting of a pre-test , educational presentation and post-test . The question naires assessed attitudes , knowledge , risk factors , and symptoms of cervical cancer among women . Changes in knowledge and intention to screen were assessed using paired t-tests and tests for correlated proportions . Participants were followed approximately six months post-intervention to determine cervical cancer screening rates . We found statistically significant increases from pre-test to post-test in the percentage of questions correctly answered and in participants ’ intention to screen for cervical cancer . The greatest improvements were observed in responses to questions on knowledge , symptoms and prevention , with some items increasing up to 62 % from pre-test to post-test
Output:
| The heath belief model is the most popular used framework for cervical cancer screening interventions .
The results of our study showed that different health education methods ( such as calls , mailed postcards , mother/daughter education .
consultation sessions , picture books , videos , PowerPoint slides , small group discussion s , educational brochures , radio broadcast education , lecture presentations , tailored counseling and a fact sheet , Self-learning package , face-to- face interviews and etc ) are effective in modifying cervical cancer screening behavior of women .
Conclusions : Our results showed that the different interventions and health behavior change frameworks provide an effective base for cervical cancer prevention . |
MS212785 | ***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 Pancreatic enzyme replacement therapy ( PERT ) is essential for maintaining adequate nutrition in children with exocrine pancreatic insufficiency ( EPI ) due to cystic fibrosis ( CF ) . The US Food and Drug Administration regulations now require all PERT products to undergo clinical efficacy and safety studies before they can be considered for marketing approval . OBJECTIVE This study was conducted to compare the efficacy of a new formulation of pancrelipase ( pancreatin ) delayed-release 12,000-lipase unit capsules with placebo in children with EPI due to CF . METHODS This was a multicenter , r and omized , double-blind , placebo-controlled , 2-period crossover , superiority study of the new formulation of pancrelipase delayed-release 12,000-lipase unit capsules in children aged 7 to 11 years with CF and EPI . In each period , pancrelipase or identical placebo capsules were taken for 5 days . The primary outcome measure was the coefficient of fat absorption ( CFA ) ; secondary outcome measures were the coefficient of nitrogen absorption ( CNA ) and clinical symptoms . The latter were assessed based on patient-reported daily stool frequency , stool consistency ( hard , formed/normal , soft , or watery ) , flatulence ( none , mild , moderate , or severe ) , and abdominal pain ( none , mild , moderate , or severe ) . Safety measures included vital signs , physical examinations , st and ard laboratory safety tests ( hematology and biochemistry ) , and adverse events . RESULTS Seventeen patients were r and omized to treatment and 16 completed the study ; 1 patient withdrew consent during the first treatment period and was not included in the efficacy analysis . Patients ' median age was 8.0 years ( range , 7 - 11 years ) ; 12 patients ( 70.6 % ) were male . CFA values were significantly greater for pancrelipase compared with placebo , with least squares mean ( SE ) values of 82.8 % ( 2.7 % ) and 47.4 % ( 2.7 % ) , respectively ( P < 0.001 ) . The results were similar for CNA , with mean values of 80.3 % ( 3.2 % ) and 45.0 % ( 3.2 % ) ( P < 0.001 ) . Pancrelipase treatment had significantly greater effects on CFA and CNA in patients with a placebo CFA < 50 % than in those with a placebo CFA > 50 % ( both parameters , P < 0.001 and P = 0.008 , respectively ) . Significant improvements in stool fat , weight , and nitrogen and a significant reduction in daily stool frequency were observed with pancrelipase compared with placebo ( all , P < 0.001 ) . Symptoms of EPI were less severe and remained relatively stable during pancrelipase treatment , but worsened slightly during receipt of placebo . Treatment-emergent adverse events were reported in 5 patients ( 29.4 % ) during receipt of pancrelipase and in 9 patients ( 56.3 % ) during receipt of placebo ; these were predominantly gastrointestinal events . There were no discontinuations due to treatment-emergent adverse events and no serious adverse events . CONCLUSIONS In this study in children with EPI due to CF , the new formulation of pancrelipase delayedrelease capsules was associated with improvements in CFA , CNA , stool properties , and EPI symptoms compared with placebo . Pancrelipase delayed-release capsules appeared to be well tolerated . Clinical Trials.gov identifier : NCT00690820 . ( Clin Ther ABSTRACT . In order to compare the efficacy of pancreatic enzyme supplementation as pH‐sensitive enteric‐coated microspheres Pancrease ® to that of conventional supplementation with enteric‐coated Pancreatin ® in cystic fibrosis , a double blind cross‐over study was conducted . Eleven patients under 12 years of age received each of the enzyme preparations for four weeks . Treatment efficacy was evaluated by means of a symptom score card recording stool frequency , consistency , colour , odour , abdominal cramps and appetite as well as a 3 days fat absorption test . Weight increments were recorded 3 months before the study when patients were on Pancreatin , and 3 months after the study when patients were on Pancrease . In eight of the patients fat absorption was improved on Pancrease , but the difference did not reach statistical significance . However , the patients experienced significantly less dyspeptic symptoms , decreased stool frequency , better appetite and increments in weight were significantly higher on Pancrease compared to Pancreatin OBJECTIVES to compare the efficacy and tolerance of Creon and Pancrease in children and young adults with cystic fibrosis . METHODS a double blind , crossover study of two pH sensitive microsphere preparations of pancreatin ( Creon , Pancrease ) , given in equivalent lipase dosage to 27 children with cystic fibrosis , was conducted . RESULTS at similar lipase activity no significant difference was found in the following : coefficient of fat absorption ( CFA ) , coefficient of nitrogen absorption ( CNA ) , weight gain , mean adequate daily intake for energy , and subjective symptoms . Three children who had a CFA less than 70 % while receiving Pancrease all improved on Creon . No children had a CFA less than 70 % while receiving Creon . A significant reduction in the number of capsules required daily to achieve similar control was possible when changing from Pancrease ( mean 25/day ) to Creon ( mean 15/day ) . Seventy percent of patients preferred Creon and this was likely to be related to a perceived reduction in abdominal pain and stool frequency , and need for less capsules per day . CONCLUSION Creon and Pancrease are equally effective at doses providing equal lipase activity , however , the reduced number of capsules , fewer symptoms , and possible improvement of more severe steatorrhoea result in an increased patient preference for Creon Abstract The failure of conventional pancreatic enzyme supplements to correct completely the malabsorption that is caused by pancreatic insufficiency in cystic fibrosis ( CF ) is partly due to acid-peptic inactivation of ingested enzymes . To compare various methods of preventing acid-peptic inactivation we studied 10 CF patients during four r and omised crossover 14-day treatment periods : ( i ) conventional supplements of pancrelipase ( 68±5 capsules daily ) ; ( ii ) pH-sensitive enteric-coated microspheres of pancrelipase ( ECMP ; 31±3 capsules/day ) ; ( iii ) ECMP plus cimetidine ( 20 mg/kg/day ) ; and ( iv ) ECMP plus antacid suspension . Faecal fat excretion , measured as mmol/24 h and as a percentage of recorded ad-libitum intake , faecal nitrogen excretion , measured as g/24h and as a percentage of intake , and faecal weight/24 h were measured during each treatment period . During the ECMP treatment period there were significant decreases in faecal fat excretion ( A comparative study of the efficacy of pH sensitive enteric coated microspheres ( ECM ) with an enteric coated tablet ( ECT ) pancreatic enzyme preparation was carried out in 20 children with cystic fibrosis in a double-blind doubleplacebo crossover manner . Steatorrhoea was assessed by 3 day faecal fat analysis and dosage of medication , stool frequency and consistency ; abdominal pain and appetite were documented by a patient-kept diary card . ECM controlled steatorrhoea ( 11.8±9.2 g vs 23.2±18.9 g , P<0.02 ) , stool frequency ( 1.7±0.6 vs 2.1±0.9,P<0.01 ) and abdominal pain ( 8.8±13.8 vs 23.4±24.1,P<0.05 ) significantly better than ECT . Out of 20 patients 17 preferred ECM to ECT ( P<0.00036 ) . ECM preparations should allow more satisfactory dietary management of patients with cystic fibrosis with longterm beneficial effect This study compared the relative effectiveness of a st and ard pancreatic enzyme supplement ( ‘ Creon ’ , Duphar ) and a new preparation ( ‘ Pancrease HL ’ , Cilag ) containing about 3 times the lipase and more than 5 times the protease activity . Capsule dosage was adjusted to a ratio of approximately 3:1 . Fat balances showed that absorption of fat did not change significantly on conversion to the new high‐lipase product , and the coefficient of absorption of total energy was similarly maintained . The coefficient of protein absorption was significantly enhanced with the high enzyme preparation ( P < 0.01 ) , which may explain the reported subjective improvement in stool odour . No adverse effects were recorded . Patient acceptability of the new compound was high ; the great reduction in the number of capsules required at each meal was cited by all patients as the reason for their preference BACKGROUND Zenpep ( APT-1008 ) is a pancreatic enzyme product for the treatment of exocrine pancreatic insufficiency ( EPI ) associated with cystic fibrosis ( CF ) . METHODS Zenpep and Kreon , both containing 25,000 lipase units , were compared in a r and omised , double-blind , crossover , non-inferiority study for CF-associated EPI in patients aged ≥12years . Patients on a st and ardised diet and stabilised treatment were r and omised to two treatment sequences : Zenpep/Kreon or Kreon/Zenpep . The primary efficacy endpoint was the coefficient of fat absorption over 72h ( CFA-72h ) . RESULTS 96 patients ( mean age 19.2years , 60.4 % males ) were r and omised with 83 completers of both sequences comprising the efficacy population . Zenpep demonstrated non-inferiority and equivalence to Kreon in fat absorption ( LS mean CFA-72h : Zenpep , 84.1 % [ SE 1.1 ] vs. Kreon , 85.3 % [ SE 1.1 ] ; p=0.297 ) . Safety and tolerability were similar . CONCLUSIONS Zenpep is comparable with Kreon in efficacy and safety for the treatment of adolescents and adults with CF-associated EPI . NCT01641393 Fifteen patients with cystic fibrosis and pancreatic insufficiency were studied during four r and omised seven day treatment periods in which they received only pancreatic supplement ( Pancrelipase , 27 capsules per day ) or supplement plus cimetidine ( 20 mg/kg body weight/24 h ) or sodium bicarbonate ( 15 g/m2/24 h ) alone or in combination . Dietary intake was not fixed but was restricted to foods of known fat and nitrogen content from which daily intakes could be computed . Faecal fat and nitrogen were calculated as g/24 h and percentage of intake . Addition of either cimetidine or bicarbonate result ed in significant improvement in fat and nitrogen excretion , which was not greater with the combination of both drugs . Cimetidine and sodium bicarbonate in these doses are therefore sufficient to produce maximal improvement in digestive activity of pancreatic supplements . Fat excretion per gram of intake fell with cimetidine and bicarbonate from 12 times the normal level , to normal , in patients consuming less than 120 g fat daily . Above this intake the dose of pancreatic supplement appeared to be inadequate . Faecal nitrogen excretion increased with nitrogen intake in all four periods , but , in contrast with fat excretion , the response to cimetidine and bicarbonate was not affected by the level of intake . Dietary intake appears to be a significant factor in determining the faecal output of fat and nitrogen in patients with pancreatic insufficiency and should be considered when determining the optimum amount of pancreatic supplementation Enteric‐coated microspheres of pancreatin were compared with non‐enteric‐coated pancreatin combined with cimetidine taken 40 min before meals in the treatment of patients with cystic fibrosis . Fourteen adults with steatorrhoea due to cystic fibrosis were investigated in an open , r and omized crossover study , over two consecutive 28‐day treatment periods . Lipase intake was adjusted to each patient 's previous requirements and was the same during both months ; they were instructed to continue with their normal diet . Patients collected faeces for 72 h at the end of each month and completed diary cards daily throughout . Bowel actions were less frequent on enteric‐coated microspheres of pancreatin than on non‐enteric‐coated pancreatin/cimetidine ( 1.7 vs. 2.4/day ; P < 0.001 ) and stool character was improved ( P < 0.001 ) . Mean daily faecal weight was similar on enteric‐coated microspheres of pancreatin to that on the combination ( 254 g vs. 291 g ; N.S. ) , whereas daily faecal fat excretion tended to be less on enteric‐coated microspheres of pancreatin ( 21 g vs. 27 g ; N.S. ) , and percentage fat absorption tended to be greater ( 81%vs . 73 % ; N.S. ) . Mean body weight increased by 0.3 kg on enteric‐coated microspheres of pancreatin and fell by 0.1 kg on the combination ( N.S. ) . These data indicate that enteric‐coated microspheres of pancreatin are at least as effective as non‐enteric‐coated pancreatin with
Output:
| There is limited evidence of benefit from enteric-coated microspheres when compared to non-enteric coated pancreatic enzyme preparations up to one month .
In the only comparison where we could combine any data , the fact that these were cross-over studies is likely to underestimate the level of inconsistency between the results of the studies due to over-inflation of confidence intervals from the individual studies .There is no evidence on the long-term effectiveness and risks associated with pancreatic enzyme replacement therapy .
There is also no evidence on the relative dosages of enzymes needed for people with different levels of severity of pancreatic insufficiency , optimum time to start treatment and variations based on differences in meals and meal sizes . |
MS212786 | ***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: AIM The purpose of the present study is to evaluate the healing of periapical lesions of teeth with positive and negative canal cultures at the time of obturation , and to evaluate the periapical healing of teeth treated in one visit ( without ) or in two visits with an interappointment dressing of calcium hydroxide . METHODOLOGY Thirty-nine patients received root-canal treatment . In the first visit , teeth were instrumented , and 18 of these teeth were filled ( after microbiological sampling ) with calcium hydroxide in sterile saline . The other 21 teeth were obturated with gutta-percha and AH-26 sealer after microbiological sampling . Four weeks later , the teeth with calcium hydroxide were accessed again and after microbiological sampling they were obturated with gutta-percha and AH-26 sealer . Healing of periapical radiolucency was recorded over a period up to 4.5 years . RESULTS In both the treatment groups , the size of the periapical lesions reduced significantly during the follow-up period . Complete radiographic healing was observed in 81 % of the cases in the one-visit group , and in 71 % of the cases in the two-visit group . The probability of success increased continuously over time for both treatment groups . Seven out of eight cases ( 87.5 % ) that showed a positive root-canal culture at the time of obturation healed . The number of colony forming units ( CFU ) in six out of eight positive canals was < 10(2 ) CFU mL(-1 ) . CONCLUSIONS Within the limitations of this study , no significant differences in healing of periapical radiolucency was observed between teeth that were treated in one visit ( without ) and two visits with inclusion of calcium hydroxide for 4 weeks . The presence of a positive bacterial culture ( CFU<10(2 ) ) at the time of filling did not influence the outcome of treatment AIM This prospect i ve clinical study explored the influence of calcium hydroxide as an interappointment dressing on the healing of periapical lesions associated with pulpless teeth that had not been endodontically treated previously . This was achieved by comparing the prognosis after a two-visit root canal treatment with that following a one-visit treatment . METHODOLOGY Seventy-three patients were recruited having one tooth with an endodontically induced lesion . Of these patients , 67 could be re-examined . Calcium hydroxide was placed in the instrumented root canals of 31 teeth for at least one week and the treatment finished at the second visit . Thirty-six teeth were root canal treated at one visit . The criteria for success were the absence of signs and symptoms indicating an acute phase of periapical periodontitis and radiographically a periodontal ligament space of normal width . Methods for event time analysis were used to evaluate and compare the prognosis of both treatment approaches . RESULTS The probability that complete periapical healing will take place increased continuously with the length of the observation period . In both treatment groups the likelihood that the root canal treatment yields a success within an observation time of five years exceeded 90 % . A statistically significant difference between the two treatment groups could not be detected . CONCLUSIONS From a microbiological perspective , one-visit root canal treatment created favourable environmental conditions for periapical repair similar to the two-visit therapy when calcium hydroxide was used as antimicrobial dressing . One-visit root canal treatment is an acceptable alternative to two-visit treatment for pulpless teeth associated with an endodontically induced lesion This study was performed to evaluate radiographic healing of teeth with apical periodontitis , treated in one visit or in two visits ( a ) with or ( b ) without calcium hydroxide as an intracanal disinfecting medicament . The patients were assigned one of the three treatment groups by the throwing of a die . The Periapical Index ( PAI ) Scoring Method was used to compare differences in periapical status from the beginning of treatment to a 52-wk follow-up evaluation . Overall , the periapical status of the treated teeth improved significantly after 52 wk ( p < 0.0001 ) . A PAI score of 1 or 2 was considered as representing a " good " periapical status while 3 , 4 , or 5 was a " bad " status . When base line PAI scores were controlled for , the calcium hydroxide group showed the most improvement in PAI score ( 3 , 4 , or 5 to 1 or 2 ) , followed by the one-step group ( 74 % vs. 64 % ) . The teeth that were left empty between visits had clearly inferior healing results . Power statistics were conducted to determine the numbers required for significant differences between the groups , and it was shown that large experimental groups on the order of hundreds of patients would be required to show significant differences
Output:
| The authors draw the conclusion , using defective review material , that removal of smear layer enhances the seal of the root filling . |
MS212787 | ***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 Exenatide , an incretin mimetic for adjunctive treatment of type 2 diabetes ( T2DM ) , reduced hemoglobin A(1c ) ( A1C ) and weight in clinical trials . The objective of this study was to evaluate the effects of > or = 3 years exenatide therapy on glycemic control , body weight , cardiometabolic markers , and safety . METHODS Patients from three placebo-controlled trials and their open-label extensions were enrolled into one open-ended , open-label clinical trial . Patients were r and omized to twice daily ( BID ) placebo , 5 mug exenatide , or 10 mug exenatide for 30 weeks , followed by 5 mug exenatide BID for 4 weeks , then 10 mug exenatide BID for > or = 3 years of exenatide exposure . Patients continued metformin and /or sulfonylureas . RESULTS 217 patients ( 64 % male , age 58 + /- 10 years , weight 99 + /- 18 kg , BMI 34 + /- 5 kg/m(2 ) , A1C 8.2 + /- 1.0 % [ mean + /- SD ] ) completed 3 years of exenatide exposure . Reductions in A1C from baseline to week 12 ( -1.1 + /- 0.1 % [ mean + /- SEM ] ) were sustained to 3 years ( -1.0 + /- 0.1 % ; p < 0.0001 ) , with 46 % achieving A1C < or = 7 % . Exenatide progressively reduced body weight from baseline ( -5.3 + /- 0.4 kg at 3 years ; p < 0.0001 ) . Patients with elevated serum alanine aminotransferase ( ALT ) at baseline ( n = 116 ) had reduced ALT ( -10.4 + /- 1.5 IU/L ; p < 0.0001 ) and 41 % achieved normal ALT . Patients with elevated ALT at baseline tended to lose more weight than patients with normal ALT at baseline ( -6.1 + /- 0.6 kg vs. -4.4 + /- 0.5 kg ; p = 0.03 ) , however weight change was minimally correlated with baseline ALT ( r = -0.01 ) or ALT change ( r = 0.31 ) . Homeostasis Model Assessment B ( HOMA-B ) , blood pressure , and aspartate aminotransferase ( AST ) all improved . A subset achieved 3.5 years of exenatide exposure and had serum lipids available for analysis ( n = 151 ) . Triglycerides decreased 12 % ( p = 0.0003 ) , total cholesterol decreased 5 % ( p = 0.0007 ) , LDL-C decreased 6 % ( p < 0.0001 ) , and HDL-C increased 24 % ( p < 0.0001 ) . Exenatide was generally well tolerated . The most frequent adverse event was mild-to-moderate nausea . The main limitation of this study is the open-label , uncontrolled nature of the study design which does not provide a placebo group for comparison . CONCLUSION Adjunctive exenatide treatment for > or = 3 years in T2DM patients result ed in sustained improvements in glycemic control , cardiovascular risk factors , and hepatic biomarkers , coupled with progressive weight reduction OBJECTIVE To assess the effects of exenatide on body weight and glucose tolerance in nondiabetic obese subjects with normal or impaired glucose tolerance ( IGT ) or impaired fasting glucose ( IFG ) . RESEARCH DESIGN AND METHODS Obese subjects ( n = 152 ; age 46 ± 12 years , female 82 % , weight 108.6 ± 23.0 kg , BMI 39.6 ± 7.0 kg/m2 , IGT or IFG 25 % ) were r and omized to receive exenatide ( n = 73 ) or placebo ( n = 79 ) , along with lifestyle intervention , for 24 weeks . RESULTS Exenatide-treated subjects lost 5.1 ± 0.5 kg from baseline versus 1.6 ± 0.5 kg with placebo ( exenatide − placebo , P < 0.001 ) . Placebo-subtracted difference in percent weight reduction was −3.3 ± 0.5 % ( P < 0.001 ) . Both groups reduced their daily calorie intake ( exenatide , −449 cal ; placebo , −387 cal ) . IGT or IFG normalized at end point in 77 and 56 % of exenatide and placebo subjects , respectively . CONCLUSIONS Exenatide plus lifestyle modification decreased caloric intake and result ed in weight loss in nondiabetic obesity with improved glucose tolerance in subjects with IGT and IFG OBJECTIVE The aim was to evaluate the ability of liraglutide to augment weight loss and improve insulin resistance , cardiovascular disease ( CVD ) risk factors , and inflammation in a high-risk population for type 2 diabetes ( T2DM ) and CVD . RESEARCH DESIGN AND METHODS We r and omized 68 older individuals ( mean age , 58 ± 8 years ) with overweight/obesity and prediabetes to this double-blind study of liraglutide 1.8 mg versus placebo for 14 weeks . All subjects were advised to decrease calorie intake by 500 kcal/day . Peripheral insulin resistance was quantified by measuring the steady-state plasma glucose ( SSPG ) concentration during the insulin suppression test . Traditional CVD risk factors and inflammatory markers also were assessed . RESULTS Eleven out of 35 individuals ( 31 % ) assigned to liraglutide discontinued the study compared with 6 out of 33 ( 18 % ) assigned to placebo ( P = 0.26 ) . Subjects who continued to use liraglutide ( n = 24 ) lost twice as much weight as those using placebo ( n = 27 ; 6.8 vs. 3.3 kg ; P < 0.001 ) . Liraglutide-treated subjects also had a significant improvement in SSPG concentration ( −3.2 vs. 0.2 mmol/L ; P < 0.001 ) and significantly ( P ≤ 0.04 ) greater lowering of systolic blood pressure ( −8.1 vs. −2.6 mmHg ) , fasting glucose ( −0.5 vs. 0 mmol/L ) , and triglyceride ( −0.4 vs. −0.1 mmol/L ) concentration . Inflammatory markers did not differ between the two groups , but pulse increased after liraglutide treatment ( 6.4 vs. −0.9 bpm ; P = 0.001 ) . CONCLUSIONS The addition of liraglutide to calorie restriction significantly augmented weight loss and improved insulin resistance , systolic blood pressure , glucose , and triglyceride concentration in this population at high risk for development of T2DM and CVD Objective : Having demonstrated short-term weight loss with liraglutide in this group of obese adults , we now evaluate safety/tolerability ( primary outcome ) and long-term efficacy for sustaining weight loss ( secondary outcome ) over 2 years . Design : A r and omized , double-blind , placebo-controlled 20-week study with 2-year extension ( sponsor unblinded at 20 weeks , participants /investigators at 1 year ) in 19 European clinical research centers . Subjects : A total of 564 adults ( n=90–98 per group ; body mass index 30–40 kg m−2 ) enrolled , 398 entered the extension and 268 completed the 2-year trial . Participants received diet ( 500 kcal deficit per day ) and exercise counseling during 2-week run-in , before being r and omly assigned ( with a telephone or web-based system ) to once-daily subcutaneous liraglutide ( 1.2 , 1.8 , 2.4 or 3.0 mg , n=90–95 ) , placebo ( n=98 ) or open-label orlistat ( 120 mg × 3 , n=95 ) . After 1 year , liraglutide/placebo recipients switched to liraglutide 2.4 mg , then 3.0 mg ( based on 20-week and 1-year results , respectively ) . The trial ran from January 2007–April 2009 and is registered with Clinical trials.gov , number NCT00480909 . Results : From r and omization to year 1 , liraglutide 3.0 mg recipients lost 5.8 kg ( 95 % confidence interval 3.7–8.0 ) more weight than those on placebo and 3.8 kg ( 1.6–6.0 ) more than those on orlistat ( P⩽0.0001 ; intention-to-treat , last-observation-carried-forward ) . At year 2 , participants on liraglutide 2.4/3.0 mg for the full 2 years ( pooled group , n=184 ) lost 3.0 kg ( 1.3–4.7 ) more weight than those on orlistat ( n=95 ; P<0.001 ) . Completers on liraglutide 2.4/3.0 mg ( n=92 ) maintained a 2-year weight loss of 7.8 kg from screening . With liraglutide 3.0 mg , 20-week body fat decreased by 15.4 % and lean tissue by 2.0 % . The most frequent drug-related side effects were mild to moderate , transient nausea and vomiting . With liraglutide 2.4/3.0 mg , the 2-year prevalence of prediabetes and metabolic syndrome decreased by 52 and 59 % , with improvements in blood pressure and lipids . Conclusion : Liraglutide is well tolerated , sustains weight loss over 2 years and improves cardiovascular risk factors AIM We investigated the relationship between weight change and related factors in subjects with type 2 diabetes mellitus ( T2DM ) treated with liraglutide versus comparator diabetes therapies . METHODS Twenty-six-week data from seven phase 3 , r and omized trials in the liraglutide T2DM development programme were analysed by trial and treatment group : liraglutide ( 1.2 and 1.8 mg ) , active comparator and placebo . Outcome measures included proportions of subjects in various weight change categories and their percentage weight change from baseline ; impact of body mass index ( BMI ) and gastrointestinal ( GI ) adverse events ( AEs ) on weight change and correlation of weight change with change in glycosylated haemoglobin ( HbA1c ) . RESULTS A number of subjects experienced > 5 % weight loss during the trials ( 24.4 % liraglutide 1.8 mg and 17.7 % liraglutide 1.2 mg ; 17.7 % exenatide , 10.0 % sitagliptin , 3.6 - 7.0 % sulphonylurea , 2.6 % thiazolidinedione and 2.6 % glargine ; 9.9 % placebo ) . More weight loss was seen with liraglutide 1.2 and 1.8 mg than with active comparators except exenatide . Across trials , higher initial BMI was associated with slightly greater weight loss with liraglutide . Mean weight loss increased slightly the longer GI AEs persisted . Although HbA1c reduction was slightly larger in higher weight loss categories across treatments ( including placebo ) , sample sizes were small and no clear correlation could be determined . Liraglutide-treated subjects experienced additional HbA1c reduction beyond that which appeared weight induced ; thus , not all HbA1c-lowering effect appears weight mediated . CONCLUSIONS The majority of liraglutide-treated T2DM subjects experienced weight loss in this analysis . Weight loss was greater and occurred more in glucagon-like peptide-1 receptor agonist-treated subjects than in active comparator-treated subjects OBJECTIVE To investigate the effect of treatment with the glucagon-like peptide 1 receptor agonist exenatide on weight loss and metabolic parameters in obese nondiabetic women . RESEARCH DESIGN AND METHODS Forty-one obese women ( aged 48 ± 11 years and BMI 33.1 ± 4.1 kg/m2 ) participated in a 35-week r and omized , double-blind , placebo-controlled , crossover study , including two 16-week treatment periods separated by a 3-week washout period . There was no lifestyle intervention . The primary outcome was change in body weight . RESULTS Subjects treated with exenatide lost an average of 2.49 ± 0.66 kg compared with a 0.43 ± 0.63 kg weight gain during placebo treatment . Weight loss with exenatide treatment was noted at 2 weeks . The degree of weight loss could be stratified . A total of 30 % of subjects were high responders who lost ≥5 % body weight ( −7.96 ± 0.52 % ) , 39 % were moderate responders who lost < 5 % body weight ( −2.43 ± 0.
Output:
| Participants in GLP-1RA groups achieved a larger weight loss than those in control groups ( -2.85 kg , 95%CI -3.55 to -2.14 ) , and liraglutide may work in a dose-dependent fashion .
GLP-1RAs also reduced body mass index ( BMI ) and waist circumferences ( WC ) and benefited systolic blood pressure and triglyceride regulation .
But GLP-1RAs were associated with increased nausea and vomiting events .
GLP-1 mimetics induce a weight loss in addition to BMI and WC reduction in obese/overweight adults without diabetes . |
MS212788 | ***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 Attention and interest in the use of Complementary and Alternative Medicine ( CAM ) has been reawakened globally . Evidence from studies carried out in different parts of the world has established that CAM use is very common and varies among population s. This study investigated the use of CAM among adults in Enugu urban , irrespective of their health status . It provided information on the prevalence of CAM use , forms of CAM remedies used and reasons for utilizing them Methods The study areas were three local government areas in Enugu urban of Enugu State . Cross-sectional survey using question naires were administered to r and omly selected households . All consenting participants were used for the study Results 732 participants ( 37.2 % males and 62.8 % females ) were used for the study . Ages ranged from 18 - 65 years . 620 ( 84.7 % ) of the adult population have used CAM ranging from one single type to twenty different types while 112 ( 15.3 % ) have not used any form of CAM . The most commonly used CAM product was the biological products , followed by prayer/faith healing . Major reasons for using CAM include their natural state and also for health promotion and maintenance . Conclusion There is need for adequate policy formulation and regulation to ensure safety and efficacy of CAM products . Measures to ensure rational use of CAM should be instituted Summary Background . Traditional bone setting ( TBS ) practice is an important part of health care delivery in many developing countries and has been in Nigeria for long . Despite the complications that arise from the cultural practice , TBS services is still in high dem and by a significant number of people . This study was conducted to determine the factors that influence the utilization of TBS practice . Methods . A descriptive cross-sectional study was carried out using a semi structured question naire to gather information from 400 r and omly selected residents of Ilorin West LGA in north central Nigeria . Multistage sampling technique was used in selecting the respondents . Results . The respondents were between the ages of 18 - 72 years with a mean age of 36.3 ± 12.3 . Three hundred and three ( 77.3 % ) of the respondents know of TBS practice as a way of getting treatment for bone injuries . More than two third 210 ( 69.3 % ) of the respondents who know TBS practice as a form of treatment for bone injuries think that TBS therapy is preferable to Orthodox medicine in h and ling bone injuries . Reasons for preference are that it is cheap 134 ( 63.8 % ) , acceptable 123 ( 58.6 % ) and accessible 109 ( 51.9 % ) to them . More than half ( 52.3 % ) of the respondents had patronized TBS treatment at one time or the other . Main reason for patronage of TBS was influence from family members and friends ( 53.6 % ) . However , factors that influence the respondents decision to utilize TBS treatment include attitude of health workers 310 ( 77.5 % ) , delay in hospitals 284(71.0 % ) fear of amputation 272 ( 54.35 ) and fear of operation 217(54.3 % ) in hospitals . There was a statistically significant ( p < 0.05 ) relationship between respondents age , sex , marital status , occupation , ethnicity as well as the income level of the respondents and the utilization of TBS . Conclusions . Utilisation of TBS is quite popular among the studied population because it is believed to be cheap , acceptable and accessible to them and a high proportion of the respondents utilize TBS notwithst and ing that they live in a community where they have better access to orthodox medical care . Influence from family and friends is the main reason for consulting TBS . Regulations should be made concerning the advertisement of TBS practice by relevant agencies and the public should be made aware through health education on the dangers of TBS treatment Background Traditional herbal medicines are commonly used in sub-Saharan Africa and some herbs are known to be hepatotoxic . However little is known about the effect of herbal medicines on liver disease in sub-Saharan Africa . Methods 500 HIV-infected participants in a rural HIV care program in Rakai , Ug and a , were frequency matched to 500 HIV-uninfected participants . Participants were asked about traditional herbal medicine use and assessed for other potential risk factors for liver disease . All participants underwent transient elastography ( FibroScan ® ) to quantify liver fibrosis . The association between herb use and significant liver fibrosis was measured with adjusted prevalence risk ratios ( adjPRR ) and 95 % confidence intervals ( CI ) using modified Poisson multivariable logistic regression . Results 19 unique herbs from 13 plant families were used by 42/1000 of all participants , including 9/500 HIV-infected participants . The three most-used plant families were Asteraceae , Fabaceae , and Lamiaceae . Among all participants , use of any herb ( adjPRR = 2.2 , 95 % CI 1.3–3.5 , p = 0.002 ) , herbs from the Asteraceae family ( adjPRR = 5.0 , 95 % CI 2.9–8.7 , p<0.001 ) , and herbs from the Lamiaceae family ( adjPRR = 3.4 , 95 % CI 1.2–9.2 , p = 0.017 ) were associated with significant liver fibrosis . Among HIV infected participants , use of any herb ( adjPRR = 2.3 , 95 % CI 1.0–5.0 , p = 0.044 ) and use of herbs from the Asteraceae family ( adjPRR = 5.0 , 95 % CI 1.7–14.7 , p = 0.004 ) were associated with increased liver fibrosis . Conclusions Traditional herbal medicine use was independently associated with a substantial increase in significant liver fibrosis in both HIV-infected and HIV-uninfected study participants . Pharmacokinetic and prospect i ve clinical studies are needed to inform herb safety recommendations in sub-Saharan Africa . Counseling about herb use should be part of routine health counseling and counseling of HIV-infected persons in Ug and OBJECTIVES Use of complementary and alternative medicines ( CAMs ) is widespread . Several studies have explored why individuals chose to use CAM but there are fewer data to explain how its use ' dovetails ' with conventional medicine . This study aim ed to determine the prevalence of CAM use in the adult population in Australia and the proportion that seek advice or tell their primary care physician after CAM use , and also to investigate which demographic characteristics , health behaviours and health status are associated with CAM use and disclosure . DESIGN A cross sectional survey . METHODS a r and om sample of 1261 adults was interviewed as part of 2010 Queensl and Social Survey , which contained questions about CAM use , frequency of use , types of CAM used , reasons for use , discussing and reporting CAM use with the doctor and confidence in CAM use . Relationships were explored using bivariate and multiple logistic regression . MAIN OUTCOME MEASURES use of CAM ; sought advice from doctor before CAM use ; informed doctor after CAM use . RESULTS 61.7 % of respondents had used self-prescribed CAM or visited a CAM practitioner . Being female and being younger predicted CAM use . Being male and in better health predicted seeking advice from the doctor before and also after CAM use . CONCLUSION Our results confirm the relatively high use of CAM in Queensl and , Australia and found that a significant proportion of people did not seek advice from their primary care physician before using CAM , or disclose its use afterwards . These factors should be taken into account in the doctor-patient consultation Background In Africa , herbal medicines are often used as primary treatment for Human immunodeficiency virus ( HIV ) related problems . Concurrent use of traditional herbal medicines ( THM ) with antiretroviral drugs ( ARVs ) is widespread among HIV infected patients . However , the extent of THM use is not known in most setting s in Sub-Saharan Africa . This study aim ed at determining the prevalence and factors associated with THM use among HIV infected patients on highly active antiretroviral therapy ( HAART ) attending The AIDS Support Organization ( TASO ) in Ug and a. TASO is a non-governmental organization devoted to offering HIV/AIDS care and treatment services in the population . Methods This was a cross-sectional study carried out in two TASO treatment centres in Ug and a among 401 r and omly selected eligible participants . We included participants who were 18 years and above , were enrolled on HAART , and consented to participate in the study . Data was collected using an interviewer-administered semi-structured question naire . THM use referred to someone who had ever used or was currently using herbal medicine while on highly active antiretroviral therapy ( HAART ) by the time of the study . Data was captured in Epi- data version 3.1 and exported to STATA version 9.0 for analysis . Results The prevalence of THM use was 33.7 % . Patients on HAART for < 4 years were more likely to use THM ( OR = 5.98 , 95 % CI 1.13 - 31.73 ) as well as those who experienced HAART side effects ( OR = 3.66 , 95 % CI : 1.15 - 11.68 ) . Older patients ( ≥39 years ) were less likely to use THM ( OR = 0.26 95 % CI : 0.08 - 0.83 ) . Participants with HAART adherence levels > 95 % were less likely to use THM ( OR = 0.09 , 95 % CI 0.01 - 0.65 ) . Conclusion The prevalence of THM use among participants on HAART was high . This raises clinical and pharmacological concerns that need attention by the health care service providers INTRODUCTION Traditional medicines are an important part of healthcare in sub-Saharan Africa , and building successful disease treatment programs that are sensitive to traditional medicine practice s will require an underst and ing of their current use and roles , including from a biomedical perspective . Therefore , we conducted a mixed- method study in Northern Tanzania in order to characterize the extent of and reasons for the use of traditional medicines among the general population so that we can better inform public health efforts in the region . METHODS Between December 2013 and June 2014 in Kilimanjaro , Tanzania , we conducted 5 focus group discussion s and 27 in-depth interviews of key informants . The data from these sessions were analyzed using an inductive framework method with cultural insider-outsider coding . From these results , we developed a structured survey design ed to test different aspects of traditional medicine use and administered it to a r and om sample of 655 adults from the community . The results were triangulated to explore converging and diverging themes . RESULTS Most structured survey participants ( 68 % ) reported knowing someone who frequently used traditional medicines , and the majority ( 56 % ) reported using them themselves in the previous year . The most common uses were for symptomatic ailments ( 42 % ) , chronic diseases ( 15 % ) , reproductive problems ( 11 % ) , and malaria/febrile illnesses ( 11 % ) . We identified five major determinants for traditional medicine use in Northern Tanzania : biomedical healthcare delivery , credibility of traditional practice s , strong cultural identities , individual health status , and disease underst and ing . CONCLUSIONS In order to better formulate effective local disease management programs that are sensitive to TM practice s , we described the determinants of TM use . Additionally , we found TM use to be high in Northern Tanzania and that its use is not limited to lower-income areas or rural setting s. After symptomatic ailments , chronic diseases were reported as the most common reason for TM use which may be particularly important in Northern Tanzania where non-communicable diseases are a rapidly growing burden OBJECTIVE To investigate the prevalence of use of traditional medicines amongst patients with HIV infection receiving therapies of antiretroviral ( ARV ) drugs at the Aminu Kano Teaching Hospital ( AKTH ) , Kano , Northwest Nigeria , and to assess the attitude of these patients to their ARV therapy . METHODS A cross sectional prospect i ve study using pretested structured question naires administered on 430 patients with antiretroviral therapy attending the AKTH between April and June 2009 . Data was collected on socio-demographic characteristics , use of traditional medicine and attitude to antiretroviral therapy . RESULTS A mean age of ( 33.6#20381;8.4 ) years old was found with 67.2 % females and 32.8 % males . A total of 29 % had no formal education while 10.5 % had postgraduate education ; 12 % earned above 35,000 naira ( 230 USD ) per month ; 63.8 % were married ; 39.8 % had at least 2 sexual partners ; 27.5 % used traditional medicine before commencement of antiretroviral therapy ( ART ) , but only 4.25 % of patients used ARV and traditional medicine concurrently . There was no significant difference in most of the socio-demographic indices between the concurrent users and other patients ( P>0.05 ) . A total of 28.8 % HIV patients , 14.6 % patients used traditional medicine before ART and 29.4 % concurrent users had missed at least a dose of their ARVs since commencement of therapy . 148 ( 37 % ) of the patients had their drug regimen changed at least once while 23 ( 20.90 % ) patients receiving traditional medicine before ART and 5 ( 29.41 % ) patients having two treatments had their drug regimen changed .
Output:
| Results Despite the heterogeneity and general low quality of the identified literature , the review highlights a relatively high use of TCAM alone or in combination with orthodox medicine , in both general population and in specific health conditions in SSA .
TCAM users compared with non-TCAM users are more likely to be of low socioeconomic and educational status , while there were inconsistencies in age , sex , spatial location and religious affiliation between TCAM users and non-TCAM users .
Conclusion TCAM use in SSA is significant , although most studies emerge from a few countries . |
MS212789 | ***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: Objective : To assess the value of spectroscopic and perfusion MRI for glioma grading and for distinguishing glioblastomas from metastases and from CNS lymphomas . Methods : The authors examined 79 consecutive patients with first detection of a brain neoplasm on nonenhanced CT scans and no therapy prior to evaluation . Spectroscopic MRI ; arterial spin-labeling MRI for measuring cerebral blood flow ( CBF ) ; first-pass dynamic , susceptibility-weighted , contrast-enhanced MRI for measuring cerebral blood volume ; and T1-weighted dynamic contrast-enhanced MRI were performed . Receiver operating characteristic analysis was performed , and optimum thresholds for tumor classification and glioma grading were determined . Results : Perfusion MRI had a higher diagnostic performance than spectroscopic MRI . Because of a significantly higher tumor blood flow in glioblastomas compared with CNS lymphomas , a threshold value of 1.2 for CBF provided sensitivity of 97 % , specificity of 80 % , positive predictive value ( PPV ) of 94 % , and negative predictive value ( NPV ) of 89 % . Because CBF was significantly higher in peritumoral nonenhancing T2-hyperintense regions of glioblastomas compared with metastases , a threshold value of 0.5 for CBF provided sensitivity , specificity , PPV , and NPV of 100 % , 71 % , 94 % , and 100 % . Glioblastomas had the highest tumor blood flow values among all other glioma grade s. For discrimination of glioblastomas from grade 3 gliomas , sensitivity was 97 % , specificity was 50 % , PPV was 84 % , and NPV was 86 % ( CBF threshold value of 1.4 ) , and for discrimination of glioblastomas from grade 2 gliomas , sensitivity was 94 % , specificity was 78 % , PPV was 94 % , and NPV was 78 % ( CBF threshold value of 1.6 ) . Conclusion : Perfusion MRI is predictive in distinguishing glioblastomas from metastases , CNS lymphomas and other gliomas vs. MRI and magnetic resonance spectroscopy Background The treatment goal for recurrent malignant gliomas centers on disease stabilization while minimizing therapy-related side effects . Metronomic dosing of cytotoxic chemotherapy has emerged as a promising option to achieve this objective . Methods This phase I study was performed using metronomic temozolomide ( mTMZ ) at 25 or 50 mg/m2/day continuously in 42-day cycles . Correlative studies were incorporated using arterial spin labeling MRI to assess tumor blood flow , analysis of matrix metalloproteinase-2 ( MMP-2 ) and MMP-9 activities in the cerebrospinal fluid ( CSF ) as surrogates for tumor angiogenesis and invasion , as well as determination of CSF soluble interleukin-2 receptor alpha ( sIL-2Rα ) levels as a marker of immune modulation . Results Nine subjects were enrolled and toxicity consisted of primarily grade 1 or 2 hematological and gastrointestinal side effects ; only one patient had a grade 3 elevated liver enzyme level that was reversible . Tumor blood flow was variable across subjects and time , with two experiencing a transient increase before a decrease to below baseline level while one exhibited a gradual drop in blood flow over time . MMP-2 activity correlated with overall survival but not with progression free survival , while MMP-9 activity did not correlate with either outcome parameters . Baseline CSF sIL-2Rα level was inversely correlated with time from initial diagnosis to first progression , suggesting that subjects with higher sIL-2Rα may have more aggressive disease . But they lived longer when treated with mTMZ , probably due to drug-related changes in T-cell constituency . Conclusions mTMZ possesses efficacy against recurrent malignant gliomas by altering blood flow , slowing invasion and modulating antitumor immune function BACKGROUND AND PURPOSE : The purpose of this study was to determine whether qualitative and quantitative measures obtained with pulsed arterial spin-labeling ( PASL ) and apparent diffusion coefficients ( ADC ) improve glioma grading compared with conventional MR images . MATERIAL S AND METHODS : We prospect ively performed 2 qualitative consensus review s in 33 suspected gliomas : 1 ) conventional MR images alone and 2 ) conventional MR images with PASL and ADC . To calculate the diagnostic performance parameters of PASL and ADC , we used a qualitative scoring system on the basis of the tumor perfusion signal intensity ( sTP ) and visual ADC scoring ( sADC ) . We then analyzed quantitative regions of interest and calculated the ratio of the maximum tumor perfusion signal intensity ( rTPmax ) and the minimum ADC value ( mADC ) . RESULTS : Two observers diagnosed accurate tumor grade s in 23 of 33 ( 70 % ) lesions in the first review and in 29 of 33 ( 88 % ) lesions in the second review . The sensitivity , specificity , positive predictive value ( PPV ) , and negative predictive value ( NPV ) for determining a glioma grading by using combined sTP and sADC scoring were 90.9 , 90.9 , 95.2 , and 83.3 % , respectively . Statistical analysis gave a threshold value of 1.24 for rTPmax and 0.98 × 10–3 mm/s2 for mADC to provide a sensitivity , specificity , PPV , and NPV of 95.5 , 81.8 , 91.3 , and 90.1 % and 90.9 , 81.8 , 90.9 , and 81.8 % , respectively . The receiver operator characteristic curve analyses showed no significant difference between the quantitative and combined qualitative parameters . CONCLUSION : PASL and ADC significantly improve the diagnostic accuracy of glioma grading compared with conventional imaging
Output:
| The absolute tumour blood flow ( TBF ) values can differentiate high- grade gliomas ( HGGs ) from low- grade gliomas ( LGGs ) and grade II from grade IV tumours .
However , it lacked the capacity to differentiate grade II from grade III tumours and grade III from grade IV tumours .
In contrast , the relative TBF ( rTBF ) is effective in differentiating HGG from LGG and in glioma grading .
The maximum rTBF ( rTBFmax ) demonstrated the best results in glioma grading .
Sensitivity and specificity analysis replicate these results as well .
This meta- analysis suggests that ASL is useful for glioma grading , especially when considering the rTBFmax parameter |
MS212790 | ***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 Glutathione ( GSH ) deficiency is common in HIV-infected individuals and is associated with impaired T cell function and impaired survival . N-acetylcysteine ( NAC ) is used to replenish GSH that has been depleted by acetaminophen overdose . Studies here test oral administration of NAC for safe and effective GSH replenishment in HIV infection . DESIGN Oral NAC administration in a r and omized , 8-week double-blind , placebo-controlled trial followed by optional open-label drug for up to 24 weeks . SUBJECTS HIV-infected , low GSH , CD4 T cells < 500 micro L(-1 ) , no active opportunistic infections or other debilitation ; n = 81 . Study conducted prior to introduction of protease inhibitors . RESULTS Whole blood GSH levels in NAC arm subjects significantly increased from 0.88 mM to 0.98 mM , bringing GSH levels in NAC-treated subjects to 89 % of uninfected controls ( P = 0.03 ) . Baseline GSH levels in the placebo group ( 0.91 ) remained essentially the same during the 8 week placebo-controlled trial . T cell GSH , adjusted for CD4 T cell count and beta2-microglobulin levels , also increased in the NAC-treated subjects ( P = 0.04 ) . Adverse effects were minimal and not significantly associated with NAC ingestion . CONCLUSION NAC treatment for 8 weeks safely replenishes whole blood GSH and T cell GSH in HIV-infected individuals . Thus , NAC offers useful adjunct therapy to increase protection against oxidative stress , improve immune system function and increase detoxification of acetaminophen and other drugs . These findings suggest that NAC therapy could be valuable in other clinical situations in which GSH deficiency or oxidative stress plays a role in disease pathology , e.g. rheumatoid arthritis , Parkinson 's disease , hepatitis , liver cirrhosis , septic shock and diabetes OBJECTIVE We aim ed to evaluate the efficacy of low dose N-acetylcysteine ( NAC ) against myocardial ischemia-reperfusion damage in coronary artery bypass surgery accompanied by cardiopulmonary bypass ( CPB ) . METHODS Thirty patients operated due to triple coronary artery disease were enrolled into this prospect i ve r and omized study ( control group -n=15 and NAC group - n=15 ) . N-acetylcysteine was added to induction cardioplegia solution in dose of 4 mmol/l and in dose of 2 mmol/l to maintenance cardioplegia solution in the NAC group . Hemodynamic measurements were performed before and after anesthesia with different intervals . Creatine kinase-MB ( CK-MB ) levels were analyzed during 24 hours postoperatively . Blood sample s were obtained from coronary sinus before CPB ( T1 ) , just before the cross-clamp removed ( T2 ) and 30 minutes later ( T3 ) . Malondialdehyde ( MDA ) , glutathione peroxidase ( GSH-Px ) , nitric oxide ( NO ) levels and neutrophil percentage were determined . Statistical analysis was performed using student 's t test , Chi-square and two-way ANOVA tests . RESULTS There were no significant differences between the two groups with regard to the hemodynamic parameters , and CK-MB levels . The MDA levels were significantly lower in NAC group than in control group during reperfusion period ( 0.75 nmol/l vs 0.88 nmol/l , p<0.05 ) . Neutrophil percentage in coronary sinus blood was significantly lower in NAC group than in control group during the reperfusion period ( 77.6 % vs 82.7 % , p<0.05 ) . The GSH-Px and NO levels were also not statistically different between groups . CONCLUSION Low dose NAC as an adjunct to cardioplegic solutions effectively reduces myocardial oxidative stress in coronary bypass surgery with cardiopulmonary bypass , but may not restore the myocardial injury In a r and omized , double – blind study , 131 consecutive patients , subjected to elective upper laparotomy , were prophylactically given the recommended dose of N – acetylcysteine ( NAC ) ( Mucomyst , ASTRA ) ( 200 mg × 3 ) or placebo against postoperative pulmonary complications . The effect was evaluated by lung function tests ( VC and FEV1 ) , arterial blood gas analyses and chest x – ray . No benefit could be demonstrated , either to postoperative pulmonary function or in the frequency of atelectasis in the recommended dose . However , no patients with preoperative bronchopulmonary disease dem and ing treatment with bronchodilatators were included in the study . A positive effect of NAC in this category of patients could not be excluded OBJECTIVE --To see whether intravenous acetylcysteine would improve outcome in patients with fulminant hepatic failure after paracetamol overdose . DESIGN --A prospect i ve r and omised controlled study . SETTING --The Institute of Liver Studies , King 's College Hospital , London . PATIENTS --50 consecutive patients ( 21 male ) aged 16 - 60 with fulminant hepatic failure after paracetamol overdose who had not previously received acetylcysteine . INTERVENTIONS --Conventional intensive liver care plus either acetylcysteine ( 25 patients ) in the same dose regimen as used early after a paracetamol overdose , except that the infusion was continued until recovery from encephalopathy or death , or an equivalent volume of 5 % dextrose ( 25 patients ) . MAIN OUTCOME MEASURES --Survival ; incidence of cerebral oedema , renal failure , and hypotension requiring inotropic support ; liver function as assessed by prolongation of the prothrombin time ; and degree of encephalopathy . RESULTS --The rate of survival was significantly higher in the acetylcysteine treated group than in the controls ( 48 % ( 12/25 patients ) v 20 % ( 5/25 ) ; p = 0.037 , 95 % confidence interval for difference in proportions surviving 3 % to 53 % ) . Acetylcysteine treated patients had a lower incidence of cerebral oedema ( 40 % ( 10/25 ) v 68 % ( 17/25 ) ; p = 0.047 , 95 % confidence interval for difference in incidence 2 % to 54 % ) , and fewer developed hypotension requiring inotropic support ( 48 % ( 12/25 ) v 80 % ( 20/25 ) ; p = 0.018 , 95 % confidence interval 7 % to 57 % ) . Rates of deterioration and recovery of liver function , however , were similar in the two groups . No adverse reactions to acetylcysteine were seen . CONCLUSIONS --Acetylcysteine is safe and effective in fulminant hepatic failure after paracetamol overdose The role of N-acetylcystein ( NAC ) administration on the oxidative response of neutrophils during cardiopulmonary bypass ( CPB ) was evaluated in a double-blind study . Twenty-four adult patients undergoing coronary artery bypass were included in the study . Twelve patients received NAC as a bolus of 100 mg/kg followed by a continuous infusion of 20 mg/kg/h in the bypass circuit from the beginning to the end of bypass . A further 12 patients received placebo . Citrated blood sample s for measurement of oxidative burst response of neutrophils were obtained at different time points during bypass . The oxidative burst response of neutrophils in the patients receiving NAC was significantly low at all times during bypass . Based on these findings NAC appears to act as an oxygen free radical scavenger during open-heart surgery BACKGROUND & AIMS N-acetylcysteine ( NAC ) , an antidote for acetaminophen poisoning , might benefit patients with non-acetaminophen-related acute liver failure . METHODS In a prospect i ve , double-blind trial , acute liver failure patients without clinical or historical evidence of acetaminophen overdose were stratified by site and coma grade and assigned r and omly to groups that were given NAC or placebo ( dextrose ) infusion for 72 hours . The primary outcome was overall survival at 3 weeks . Secondary outcomes included transplant-free survival and rate of transplantation . RESULTS A total of 173 patients received NAC ( n = 81 ) or placebo ( n = 92 ) . Overall survival at 3 weeks was 70 % for patients given NAC and 66 % for patients given placebo ( 1-sided P = .283 ) . Transplant-free survival was significantly better for NAC patients ( 40 % ) than for those given placebo ( 27 % ; 1-sided P = .043 ) . The benefits of transplant-free survival were confined to the 114 patients with coma grade s I-II who received NAC ( 52 % compared with 30 % for placebo ; 1-sided P = .010 ) ; transplant-free survival for the 59 patients with coma grade s III-IV was 9 % in those given NAC and 22 % in those given placebo ( 1-sided P = .912 ) . The transplantation rate was lower in the NAC group but was not significantly different between groups ( 32 % vs 45 % ; P = .093 ) . Intravenous NAC generally was well tolerated ; only nausea and vomiting occurred significantly more frequently in the NAC group ( 14 % vs 4 % ; P = .031 ) . CONCLUSIONS Intravenous NAC improves transplant-free survival in patients with early stage non-acetaminophen-related acute liver failure . Patients with advanced coma grade s do not benefit from NAC and typically require emergency liver transplantation Objective : Markers of oxidative stress are reported to be increased in severe malaria . It has been suggested that the antioxidant N-acetylcysteine ( NAC ) may be beneficial in treatment . We studied the efficacy and safety of parenteral NAC as an adjunct to artesunate treatment of severe falciparum malaria . Design : A r and omized , double-blind , placebo-controlled trial on the use of high-dose intravenous NAC as adjunctive treatment to artesunate . Setting : A provincial hospital in Western Thail and and a tertiary referral hospital in Chittagong , Bangladesh . Patients : One hundred eight adult patients with severe falciparum malaria . Interventions : Patients were r and omized to receive NAC or placebo as an adjunctive treatment to intravenous artesunate . Measurements and Main Results : A total of 56 patients were treated with NAC and 52 received placebo . NAC had no significant effect on mortality , lactate clearance times ( p = 0.74 ) , or coma recovery times ( p = 0.46 ) . Parasite clearance time was increased from 30 hours ( range , 6–144 hours ) to 36 hours ( range , 6–120 hours ) ( p = 0.03 ) , but this could be explained by differences in admission parasitemia . Urinary F2-isoprostane metabolites , measured as a marker of oxidative stress , were increased in severe malaria compared with patients with uncomplicated malaria and healthy volunteers . Admission red cell rigidity correlated with mortality , but did not improve with NAC . Conclusion : Systemic oxidative stress is increased in severe malaria . Treatment with NAC had no effect on outcome in patients with severe falciparum malaria in this setting OBJECTIVE To determine the effects of intravenous N-acetylcysteine ( NAC ) on the development of severe adult respiratory distress syndrome ( ARDS ) and mortality rate in patients with mild-to-moderate acute lung injury and to analyze the duration of ventilatory support and FIO2 required as well as the evolution of the lung injury score . SETTING Three university hospital ICUs and one regional ICU in Switzerl and . PATIENTS Sixty-one adult patients presenting with mild-to-moderate acute lung injury and various predisposing factors for ARDS received either NAC , 40 mg/kg/d , or placebo intravenously for 3 days . MEASUREMENTS Respiratory dysfunction was assessed daily according to the need for mechanical ventilation and FIO2 , the evolution of the lung injury score , and the PaO2/FIO2 ratio . The cardiovascular state , liver function , and kidney function were also monitored . Data were collected at admission ( day 0 ) , during the first 3 days , and on the day of discharge from the ICU . RESULTS The NAC and placebo groups ( 32 and 29 patients , respectively ) were comparable at ICU admission for severity of illness assessed by the simplified acute physiology score ( SAPS ) ( 10.8 + /- 4.6 vs 10.9 + /- 4.8 ) and lung injury score ( LIS ) ( 1.39 + /- 0.95 vs 1.11 + /- 1.08 ) ( mean + /- SD ) . Three patients in each group developed ARDS . The 1-month mortality rate was 22 percent for the NAC group and 35 percent for the placebo group ( difference not statistically significant ) . At admission , 22 of 32 patients ( 69 percent ) in the NAC group were mechanically ventilated compared with 22 of 29 ( 76 percent ) in the place
Output:
| Early application of N-acetylcysteine to prevent the development of an oxidato-inflammatory response did not affect the outcome , nor did late application that is after 24 hours of developing symptoms .
Late application was associated with cardiovascular instability .
AUTHORS ' CONCLUSIONS Overall , this meta- analysis puts doubt on the safety and utility of intravenous N-acetylcysteine as an adjuvant therapy in SIRS and sepsis .
At best , N-acetylcysteine is ineffective in reducing mortality and complications in this patient population .
At worst , it can be harmful , especially when administered later than 24 hours after the onset of symptoms , by causing cardiovascular depression . |
MS212791 | ***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 analyse the factors affecting the clinical performance and those influencing the survival of resin-retained bridgework provided at a UK dental teaching hospital between 1994 and 2001 . Design A prospect i ve analysis of restorations provided at a single centre using case notes with all patients invited for review to corroborate findings . Setting Department of Restorative Dentistry , University of Bristol Dental Hospital and School , Bristol , United Kingdom . Subjects and methods Between January 1994 and December 2001 , data regarding 1,000 consecutive resin-retained bridges provided at Bristol Dental Hospital and School were recorded . Data was available for 805 patients at the time of the study . Following invitation , 621 patients attended for a review appointment . Life table and Kaplan-Meir survival analysis were carried out for all restorations provided . Results The five-year and ten-year survival rates estimated by the life-table method are 80.8 % ( 95 % confidence interval 78.0–83.6 % ) and 80.4 % ( 95 % confidence interval 77.6–83.2 % ) respectively . The median survival can not be estimated for this study as the survival probability remains above 80 % even at the longest follow-up . Analysis of clinical variables influencing survival revealed that design of the restoration and experience of the operator providing the restoration were significant factors . Resin-retained bridges made with minimal tooth preparation are shown to be superior in terms of longevity than those for which other types of tooth preparation is made . Patient satisfaction with their treatment was high In a multicentre r and omised trial ( German Research Association , grants DFG WA 831/2 - 1 to 2 - 6 , WO 677/2 - 1.1 to 2 - 2.1 . ; controlled-trials.com IS RCT N97265367 ) , patients with complete molar loss in one jaw received either a partial removable dental prosthesis ( PRDP ) with precision attachments or treatment according to the SDA concept aim ing at pre-molar occlusion . The objective of this current analysis was to evaluate the influence of different treatments on periodontal health . Linear mixed regression models were fitted to quantify the differences between the treatment groups . The assessment at 5 years encompassed 59 patients ( PRDP group ) and 46 patients ( SDA group ) . For the distal measuring sites of the posterior-most teeth of the study jaw , significant differences were found for the plaque index according to Silness and Löe , vertical clinical attachment loss ( CAL-V ) , probing pocket depth ( PPD ) and bleeding on probing . These differences were small and showed a slightly more unfavourable course in the PRDP group . With CAL-V and PPD , significant differences were also found for the study jaw as a whole . For CAL-V , the estimated group differences over 5 years amounted to 0.27 mm ( 95 % CI 0.05 ; 0.48 ; P = 0.016 ) for the study jaw and 0.25 mm ( 95 % CI 0.05 ; 0.45 ; P = 0.014 ) for the distal sites of the posterior-most teeth . The respective values for PPD were 0.22 mm ( 95 % CI 0.03 ; 0.41 ; P = 0.023 ) and 0.32 mm ( 95 % CI 0.13 ; 0.5 ; P = 0.001 ) . It can be concluded that even in a well-maintained.patient group statistically significant although minor detrimental effects of PRDPs on periodontal health are measurable BACKGROUND The aim of this study was the evaluation , from a clinical point of view , of implants subjected to immediate functional loading ( IFL ) and to immediate non-functional loading ( INFL ) in various anatomical configurations . METHODS The study included 152 patients who had given their informed consent . A total of 646 implants were inserted . The implants were placed in 39 totally edentulous m and ibles , 14 edentulous maxillae , 23 edentulous posterior m and ibles , 16 edentulous anterior m and ibles , 16 edentulous anterior maxillae , and 15 edentulous posterior maxillae . Fifty-eight implants were used to replace single missing teeth . In 65 cases , IFL was carried out for 422 implants . INFL was carried out in 116 cases , ( 224 implants ) . RESULTS In the IFL group 6 of 422 implants failed ( 1.4 % ) ; in the INFL group 2 of 224 implants failed ( 0.9 % ) . All the other implants appeared , from clinical and radiographic observations , to have successfully osseointegrated and have been functioning satisfactorily since insertion . All failures were observed in the first few months after implant loading . CONCLUSION Immediate functional and non-functional loading seems to be a technique that gives satisfactory results in selected cases BACKGROUND General dental care can effectively control disease and restore damaged tissue , yet little is known about its impact on patients ' subjective oral health , namely treatment goals and oral health-related quality of life ( OHRQoL ) . This study aim ed to evaluate change in both aspects of subjective oral health among elderly adults receiving publicly-funded , general dental care . METHODS We conducted a prospect i ve , single-group intervention study of adults aged 75 + years receiving care through the South Australian Dental Service ( SADS ) . Before receiving dental care , subjects completed the Oral Health Impact Profile ( OHIP-14 ) question naire which evaluates OHRQoL. In this question naire , subjects rated the extent to which they had attained a self-nominated oral health goal . Dentists provided st and ard-of-care treatment and six months later the OHIP-14 and goal attainment questions were re-administered . RESULTS Among the 253 adults studied , overall improvements in OHRQoL were observed ( p < 0.05 ) , although the effect was dependent on pre-treatment goal : mean OHIP-14 scores did not change significantly for subjects whose goal was less pain/discomfort while significant improvements were observed for subjects with other treatment goals . In contrast , mean goal attainment ratings improved significantly ( P < 0.05 ) , regardless of treatment goal categories . CONCLUSIONS Dental care was associated with improvements in subjective oral health , although different patterns of improvement were observed for OHRQoL compared with goal attainment ratings OBJECTIVES This study aim ed to compare two different tooth replacement strategies for partially dentate older patients ; namely functionally orientated treatment according to the principles of the shortened dental arch ( SDA ) and conventional treatment using removable partial dentures ( RPDs ) using a r and omised controlled clinical trial . The primary outcome measure for this study was impact on oral health-related quality of life ( OHRQoL ) measured using the short form of the oral health impact profile ( OHIP-14 ) . METHODS Patients aged 65 years and older were r and omly allocated to two different treatment groups : the RPD group and the SDA group . For the RPD group each patient was restored to complete arches with cobalt-chromium RPDs used to replace missing teeth . For the SDA group , patients were restored to a premolar occlusion of 10 occluding pairs of natural and replacement teeth using resin bonded bridgework ( RBB ) . OHRQoL was measured using the OHIP-14 question naire administered at baseline , 1 month , 6 months and 12 months after treatment intervention . RESULTS In total , 89 patients completed the RCT : 44 from the RPD group and 45 from the SDA group . Analysis using a mixed model of covariance ( ANCOVA ) illustrated that treatment according to the SDA concept result ed in significantly better mean OHIP-14 scores compared with RPD treatment ( p<0.05 ) . This result was replicated in both treatment centres used in the study . CONCLUSIONS In terms of impact on OHRQoL , treatment based on the SDA concept achieved significantly better results than that based on RPDs 12 months after treatment intervention ( trial registration no. IS RCT N26302774 ) . CLINICAL SIGNIFICANCE Functionally orientated treatment delivery result ed in significantly better outcomes compared to removable dentures in terms of impact on Objectives Although the shortened dental arch ( SDA ) concept is a widely accepted strategy to avoid overtreatment , little is known on its impact on oral health-related quality of life ( OHRQoL ) . This multicenter r and omized controlled trial aim ed to investigate the OHRQoL for removable partial dental prostheses ( RPDP ) with molar replacement versus the SDA concept . Material and methods In both groups , missing anterior teeth were replaced with fixed dental prosthesis . Two hundred fifteen patients with bilateral molar loss in at least one jaw were included . The Oral Health Impact Profile ( OHIP-49 ) was completed before ; 6 weeks ( baseline ) , 6 months , and 12 months after treatment ; and thereafter annually until 5 years . Results Of the initial cohort , 81 patients were assigned to the RPDP group and 71 to the SDA group ( age , 34 to 86 years ) . Before treatment , the median OHIP score was similar in both groups ( RPDP , 38.0 ; SDA , 40.0 ; n.s . ) . Results indicate marked improvements in OHRQoL in both groups between pretreatment and baseline ( RPDP , 27.0 ; SDA , 19.0 ; p ≤ 0.0001 ) which continued in the RPDP group until the 1-year follow-up ( p = 0.0002 ) . These significant reductions in OHIP scores are reflected in its subscales . No further differences were seen within and between groups during the remainder observation period . Conclusion Both treatments show a significant improvement in OHRQoL which continued in the RPDP group until the 1-year follow-up . No significant differences were seen between groups . Clinical relevance For improving OHRQoL , it is not necessary to replace missing molars with a RPDP OBJECTIVE To conduct a cost-effectiveness analysis comparing two different tooth replacement strategies for partially dentate older patients , namely partial removable dental prostheses ( RDP ) and functionally orientated treatment based on the shortened dental arch concept ( SDA ) . METHODS Ninety-two partially dentate older patients completed a r and omized controlled clinical trial . Patients were r and omly allocated to two treatment groups : the RDP group and the SDA group . Treatment effect was measured using impact on oral health-related quality of life ( OHrQOL ) , and the costs involved in providing and maintaining care were recorded for all patients . Patients were followed for 12 months after treatment intervention . All treatment was provided by a single operator . RESULTS The total cost of achieving the minimally important clinical difference ( MID ) in OHrQOL for an average patient in the RDP group was € 464.64 . For the SDA group , the cost of achieving the MID for an average patient was € 252.00 . The cost-effectiveness ratio was therefore 1:1.84 in favour of SDA treatment . CONCLUSION With an increasingly ageing population , many patients will continue to benefit from removable prostheses to replace their missing natural teeth . From a purely economic st and point , the results from this analysis suggest that the treatment of partially dentate older adults should be focused on functionally orientated treatment because it is simply more cost-effective PURPOSE Removable partial dentures ( RPD ) used to restore the severely shortened m and ible may adversely affect the remaining natural teeth and are associated with a low prevalence of use . This pilot study investigated patient satisfaction following restoration of m and ibular shortened dental arches . MATERIAL S AND METHODS Sixty subjects with m and ibular shortened dental arches entered a r and omized controlled trial comparing two types of m and ibular prostheses : bilateral free-end saddle RPDs and distal cantilever resin-bonded fixed partial dentures ( FPD ) . Patient satisfaction was assessed using self-administered question naires before ( baseline ) , 3 months after , and 1 year after provision of new prostheses . RESULTS Improvements in levels of general satisfaction with teeth , appearance of teeth , and perceived masticatory ability were significant for the FPD group . Significant improvements in perceived masticatory ability were noted for both groups . There were also significant improvements in perceived levels of comfort of m and ibular prostheses in both groups . Changes in summary satisfaction scores indicated improved satisfaction for both treatment groups but suggested a larger clinical effect for the FPD group . Significant differences between treatment groups were not established . CONCLUSION Patient-based outcomes reported suggested that resin-bonded cantilever FPDs are an effective means of restoring the shortened m and ibular dental arch in terms of patient comfort and acceptance A multi-centre r and omized clinical trial is under way at 14 university dental schools in Germany to compare prosthodontic treatments for the shortened dental arch ( SDA ) . One of the aims of this pilot- study was to measure the effect of two treatment options of the SDA on oral health-related quality of life and on the Research Diagnostic Criteria ( RDC ) for temporom and ibular disorders ( TMD ) . Thirty-four patients participated in the pilot- study . Inclusion criteria were : all molars were missing and the presence of at least both canines and one premolar in each quadrant . Participants were r and omly assigned to receive either removable partial dentures including molar replacement ( RPD_group ) or retain a premolar occlusion ( PROC_group ) . The Oral Health Impact Profile ( OHIP-49 ) and the RDC for TMD were completed by participants before treatment ( pre-treatment ) , 6 weeks ( 6 wks ) , 6 months ( 6 m ) and 12 months ( 12 m ) after treatment . At the 12-month follow up , data of 10 women and 11 men ( mean
Output:
| The remaining articles were reports of prospect i ve cohort studies from Denmark and the Netherl and s. CONCLUSIONS there is currently insufficient evidence to recommend one tooth replacement strategy over another in adult patients with reduced dentitions . |
MS212792 | ***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 Wide-awake , local anesthesia , no tourniquet ( WALANT ) h and surgery was developed to improve access to h and surgery care while optimizing medical re sources . H and surgery in the clinic setting may result in substantial cost savings for the United States Military Health Care System ( MHS ) and provide a safe alternative to performing similar procedures in the operating room . METHODS A prospect i ve cohort study was performed on the first 100 consecutive clinic-based WALANT h and surgery procedures performed at a military medical center from January 2014 to September 2015 by a single h and surgeon . Cost savings analysis was performed by using the Medical Expense and Performance Reporting System , the st and ard cost accounting system for the MHS , to compare procedures performed in the clinic versus the operating room during the study period . A study specific question naire was obtained for 66 procedures to evaluate the patient 's experience . RESULTS For carpal tunnel release ( n = 34 ) and A1 pulley release ( n = 33 ) , there were 85 % and 70 % cost savings by having the procedures performed in clinic under WALANT compared with the main operating room , respectively . During the study period , carpal tunnel release , A1 pulley release , and de Quervain release performed in the clinic instead of the operating room amounted to $ 393,100 in cost savings for the MHS . There were no adverse events during the WALANT procedure . CONCLUSIONS A clinic-based WALANT h and surgery program at a military medical center results in considerable cost savings for the MHS . TYPE OF STUDY /LEVEL OF EVIDENCE Economic/Decision Analysis IV Background The purpose of this study was to provide prospect i ve independently analyzed evidence on how patients feel about a carpal tunnel release ( CTR ) performed under local anesthesia only ( no sedation or tourniquet ) versus with local anesthesia , intravenous ( IV ) sedation , and a tourniquet . Methods This prospect i ve cohort study compared 100 consecutive CTRs done with only lidocaine and epinephrine in Saint John , New Brunswick to 100 consecutive CTRs done with IV sedation in Davenport , Iowa . Patient perspectives on the anesthesia were captured in a blinded question naire 1 week postoperatively . Results For subsequent surgery , 93 % of wide awake patients would choose local anesthesia only and 93 % of se date d patients would choose sedation . Wide awake patients spent less time at the hospital ( M = 2.6 h ) than se date d patients ( M = 4.0 h ; p < .001 ) . Preoperative blood work , electrocardiograms , and /or chest radiographs were done for 3 % of wide awake patients and 48 % of se date d patients ( p < 0.001 ) . Preoperative anxiety levels for wide awake patients were lower than for se date d patients ( p = 0.007 ) ; postoperative anxiety was similar . There were no anesthesia complications in either group . Narcotics were used by 5 % of unse date d patients and 67 % of se date d patients ( p < 0.001 ) . Adequate pain control was reported by 89 % and 90 % of patients , respectively . Conclusions The majority of patients from both cohorts liked whichever method of anesthesia they received and would choose it again . However , se date d patients spent more time at the hospital , required more preoperative testing , and reported greater preoperative anxiety Purpose : Minor h and surgeries can be done under field sterility in procedure rooms . Surgeons are still sceptical about the usage of wide awake local anaesthesia no tourniquet ( WALANT ) technique . They perceive that patients can tolerate tourniquet for a brief period while they perform minor surgeries under local anaesthesia ( LA ) . We compared the perceived comfort experienced by patients during minor h and surgeries with WALANT and LA/tourniquet . We investigated the difference in preoperative preparation time , operating time and blood loss between the two groups . Methods : Between July and October 2016 , a total of 72 patients were diagnosed with carpal tunnel syndrome , trigger finger or ganglion , at the University Malaya Medical Centre . Forty patients consented to participate in this study and were r and omized into WALANT and LA/tourniquet groups . Anaesthesia was administered accordingly and tourniquet was applied . The time taken for preoperative preparation and surgery was recorded . Each surgeon estimated the blood loss . The perceived comfort level of each patient was quantified using a visual analogue score ( VAS ) . Data were analysed using SPSS . Results : The mean VAS for the WALANT group was 2.33 ± 1.94 , whereas it was 4.72 ± 3.05 for the LA/tourniquet group , and the difference was statistically significant ( p < 0.05 ) . The mean time for preoperative preparation in WALANT group was 19.17 ± 12.61 min and LA/tourniquet group was 7.05 ± 3.44 min . The difference between these groups was statistically significant ( p < 0.01 ) . There was no significant difference in operating time and blood loss . Conclusion : WALANT technique was associated with better patient comfort . Tourniquet was the main reason for discomfort during surgeries . WALANT is an alternative in minor h and surgeries for a bloodless surgical field without the discomfort of tourniquet application Background : We prospect ively evaluated opioid consumption postoperatively following trigger finger release ( TFR ) and open carpal tunnel release ( CTR ) , and hypothesized that cases performed wide awake with local anesthesia and no tourniquet ( WALANT ) would result in increased opioid consumption compared with cases performed under monitored anesthesia care ( MAC ) . Methods : Postoperative opioid consumption following CTR and TFR was prospect ively collected over 6 months . The primary end points of the study were : ( 1 ) total opioid consumption ; and ( 2 ) the number of days an opioid was used for both groups . Results : Mean opioid use and number of days the opioid was used for all MAC cases were 3.95 pills and 1.8 days , respectively . The results for WALANT were 3.85 pills and 1.6 days . Conclusions : These results suggest that effective pain control postoperatively may be independent of anesthesia type for soft tissue procedures of the h and . Specifically , average opioid consumption and days of utilization were similar in both the MAC and WALANT groups . Average postoperative opioid consumption was approximately only 4 opioid pills . Consideration should be given to prescribing fewer opioids for surgeries such as CTR and TFR BACKGROUND Most minor h and operations can be performed with local anesthesia and tourniquet . Some literature supports this concept based on the believe that the " patient can tolerate it " . Nowadays , the wide-awake technique with epinephrine- contained lidocaine is safe . This technique does not need a tourniquet because epinephrine provides local vasoconstriction . OBJECTIVE The present study was design ed to compare patients ' comfort and effectiveness of local anesthesia as well as bleeding at the surgical site between wide-awake anesthesia and local lidocaine with tourniquet application . MATERIAL AND METHOD Prospect i ve Clinical Trial was performed in 60 patients who received outpatient surgery for common h and problems at Maharaj Nakorn Chiang Mai Hospital . With r and omization , 30 patients were in wide-awake group , who received adrenaline-contained lidocaine as a local anesthetic agent , with tourniquet wrapping but with no pressure applied ( group 1 ) . The other 30 patients were in the conventional group that received lidocaine ( no adrenaline ) and a 250-mmHg tourniquet application ( group 2 ) . Operations were performed with st and ard methods . Visual analog scores , surgical field bleeding , amount of bleeding , any complications within 4 weeks were recorded . RESULTS There are no significant differences between the two groups in terms of patient profiles ( sex , age and diseases ) , injected site pain and surgeon 's opinion of surgical site bleeding . Tourniquet 's pain and the amount of blood loss in the conventional group were significantly higher than the wide-awake group . CONCLUSION Wide-awake technique ( no tourniquet applied ) offers better comfort for patients and less total blood loss while providing effective anesthesia and patient safety as with the conventional technique We conducted a prospect i ve r and omized controlled trial to investigate carpal tunnel decompression under local anaesthesia . Carpal tunnel decompression was performed in 37 wrists using local anaesthesia and an arm tourniquet and 36 without tourniquet but with a local anaesthetic mixture containing adrenaline . Patients who underwent carpal tunnel decompression using a tourniquet experienced a significantly greater degree of pain when compared with those who did not have a tourniquet . Pain and h and function improved to a similar degree in both groups . We conclude that carpal tunnel decompression performed with a tourniquet causes patients unnecessary pain with no additional benefit as compared with the wide-awake carpal tunnel decompression without use of a tourniquet . Level of evidence :
Output:
| All study design s defined by the Oxford Centre for Evidence -Based Medicine will be included in the search . " |
MS212793 | ***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 SAD PERSONS scale is a widely used risk assessment tool for suicidal behavior despite a paucity of supporting data . The objective of this study was to examine the ability of the scale in predicting suicide attempts . METHOD Participants consisted of consecutive referrals ( N=4,019 ) over 2 years ( January 1 , 2009 to December 31 , 2010 ) to psychiatric services in the emergency departments of the 2 largest tertiary care hospitals in the province of Manitoba , Canada . SAD PERSONS and Modified SAD PERSONS ( MSPS ) scale scores were recorded for individuals at their index and all subsequent presentations . The 2 main outcome measures in the study included current suicide attempts ( at index presentation ) and future suicide attempts ( within the next 6 months ) . The ability of the scales to predict suicide attempts was evaluated with logistic regression , sensitivity and specificity analyses , and receiver operating characteristic curves . RESULTS 566 people presented with suicide attempts ( 14.1 % of the sample ) . Both SAD PERSONS and MSPS showed poor predictive ability for future suicide attempts . Compared to low risk scores , high risk baseline scores had low sensitivity ( 19.6 % and 40.0 % , respectively ) and low positive predictive value ( 5.3 % and 7.4 % , respectively ) . SAD PERSONS did not predict suicide attempts better than chance ( area under the curve = 0.572 ; 95 % confidence interval [ CI ] , 0.51 - 0.64 ; P value nonsignificant ) . Stepwise regression identified 5 original scale items that accounted for the greatest proportion of future suicide attempt variance . High risk scores using this model had high sensitivity ( 93.5 % ) and were associated with a 5-fold higher likelihood of future suicide attempt presentation ( odds ratio = 5.58 ; 95 % CI , 2.24 - 13.86 ; P<.001 ) . CONCLUSION In their current form , SAD PERSONS and MSPS do not accurately predict future suicide attempts 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 Rates of self-harm are high and have recently increased . This trend and the repetitive nature of self-harm pose a significant challenge to mental health services . AIMS To determine the efficacy of a structured group problem-solving skills training ( PST ) programme as an intervention approach for self-harm in addition to treatment as usual ( TAU ) as offered by mental health services . METHOD A total of 433 participants ( aged 18 - 64 years ) were r and omly assigned to TAU plus PST or TAU alone . Assessment s were carried out at baseline and at 6-week and 6-month follow-up and repeated hospital-treated self-harm was ascertained at 12-month follow-up . RESULTS The treatment groups did not differ in rates of repeated self-harm at 6-week , 6-month and 12-month follow-up . Both treatment groups showed significant improvements in psychological and social functioning at follow-up . Only one measure ( needing and receiving practical help from those closest to them ) showed a positive treatment effect at 6-week ( P = 0.004 ) and 6-month ( P = 0.01 ) follow-up . Repetition was not associated with waiting time in the PST group . CONCLUSIONS This brief intervention for self-harm is no more effective than treatment as usual . Further work is required to establish whether a modified , more intensive programme delivered sooner after the index episode would be effective The 2013 US Veterans Administration/Department of Defense Clinical Practice Guidelines ( VA/DoD CPG ) require comprehensive suicide risk assessment s for VA/DoD patients with mental disorders but provide minimal guidance on how to carry out these assessment s. Given that clinician-based assessment s are not known to be strong predictors of suicide , we investigated whether a precision medicine model using administrative data after outpatient mental health specialty visits could be developed to predict suicides among out patients . We focused on male nondeployed Regular US Army soldiers because they account for the vast majority of such suicides . Four machine learning classifiers ( naive Bayes , r and om forests , support vector regression and elastic net penalized regression ) were explored . Of the Army suicides in 2004–2009 , 41.5 % occurred among 12.0 % of soldiers seen as outpatient by mental health specialists , with risk especially high within 26 weeks of visits . An elastic net classifier with 10–14 predictors optimized sensitivity ( 45.6 % of suicide deaths occurring after the 15 % of visits with highest predicted risk ) . Good model stability was found for a model using 2004–2007 data to predict 2008–2009 suicides , although stability decreased in a model using 2008–2009 data to predict 2010–2012 suicides . The 5 % of visits with highest risk included only 0.1 % of soldiers ( 1047.1 suicides/100 000 person-years in the 5 weeks after the visit ) . This is a high enough concentration of risk to have implication s for targeting preventive interventions . An even better model might be developed in the future by including the enriched information on clinician-evaluated suicide risk m and ated by the VA/DoD CPG to be recorded OBJECTIVE The authors evaluated the effectiveness of brief cognitive-be
Output:
| Risk assessment methods have been shown to be sensitive predictors of suicide and suicide attempts , but the frequency of false positives limits their clinical utility . |
MS212794 | ***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 Increases in both the portion size and energy density of food have both been shown to increase energy intake , but the combined effects of such increases have not been investigated . OBJECTIVE The objective was to determine the combined effects of energy density and portion size on energy intake in women . DESIGN This study used a within-subjects design . Once a week for 6 wk , 39 women were served breakfast , lunch , and dinner ad libitum . The main entrée at lunch was formulated in 2 versions that varied in energy density ( 5.23 or 7.32 kJ/g ) , each of which was served in 3 different portion sizes ( 500 , 700 , or 900 g ) . The 2 versions were matched for macronutrient composition and palatability . Breakfast and dinner were st and ard meals . RESULTS Increases in portion size and energy density led to independent and additive increases in energy intake ( P < 0.0001 ) . Subjects consumed 56 % more energy ( 925 kJ ) when served the largest portion of the higher energy-dense entrée than when served the smallest portion of the lower energy-dense entrée . Subjects did not compensate for the additional intake by eating less at the subsequent meal . Despite substantial differences in energy intake , no systematic differences in ratings of hunger and fullness across conditions were observed . CONCLUSIONS The energy density and the portion size of a food act independently to affect energy intake . The findings indicate that large portions of foods with a high energy density may facilitate the overconsumption of energy BACKGROUND An impaired ability to compensate for calories and increased eating in the absence of hunger ( EAH ) has been associated with increased energy intake and weight gain in unrelated children . OBJECTIVE The aims of this study were to compare caloric compensation [ the percentage compensation index ( % COMPX ) ] and EAH in weight-discordant siblings aged 5 - 12 y. DESIGN In a crossover , behavioral genetics design , 47 same-sex sibling pairs ( 53 % female , 55 % full siblings ) were served dinner once a week for 3 wk . Across conditions , siblings were served the same dinner , but 25 min before dinner , they either consumed in full or did not consume 1 of 2 preloads that varied in energy density ( ED ; 0.57 or 0.97 kcal/g ) . On the day when no preload was consumed , EAH was assessed after dinner and defined as the number of calories consumed from snacks . RESULTS Overweight/obese siblings undercompensated [ % COMPX : -48.8 ± 56.3 ( mean ± SEM ) ] and therefore overate after the high-ED preload , whereas normal-weight siblings showed accurate compensation ( % COMPX : 101.3 ± 51.9 ; P = 0.03 ) . Furthermore , overweight/obese siblings consumed 34 % more calories ( 93 kcal ) in the absence of hunger than did normal-weight siblings ( P = 0.01 ) . Within-pair resemblances for % COMPX and EAH were stronger for full siblings ( P < 0.049 ) than for half siblings ( P > 0.23 ) . CONCLUSIONS An impaired ability to regulate short-term energy intake , which includes incomplete adjustment for calorie differences in a preload and eating when satiated , may represent a behavioral phenotype for obesity in children . Future studies should test whether teaching children to focus on internal satiety cues may prevent at-risk children from overeating Background The purpose of this study was to determine whether a high-protein afternoon yogurt snack improves appetite control , satiety , and reduces subsequent food intake compared to other commonly-consumed , energy dense , high-fat snacks . Findings Twenty , healthy women ( age : 27 ± 2 y ; BMI : 23.4 ± 0.7 kg/m2 ) completed the r and omized crossover design study which included 3 , 8-h testing days comparing the following 160 kcal afternoon snacks : high-protein yogurt ( 14 g protein/25 g CHO/0 g fat ) ; high-fat crackers ( 0 g protein/19 g CHO/9 g fat ) ; and high-fat chocolate ( 2 g protein/19 g CHO/9 g fat ) . Participants were acclimated to each snack for 3 consecutive days . On day 4 , the participants consumed a st and ardized breakfast and lunch ; the respective snack was consumed 3-h post-lunch . Perceived hunger and fullness were assessed throughout the afternoon until dinner was voluntarily requested . An ad libitum dinner was then provided . The consumption of the yogurt snack led to greater reductions in afternoon hunger vs. chocolate ( p < 0.01 ) . No differences in afternoon fullness were detected . The yogurt snack also delayed eating initiation by approximately 30 min compared to the chocolate snack ( p < 0.01 ) and approximately 20 min vs. crackers ( p = 0.07 ) . The yogurt snack led to approximately 100 fewer kcals consumed at dinner vs. the crackers ( p = 0.08 ) and chocolate ( p < 0.05 ) . No other differences were detected . Conclusion These data suggest that , when compared to high-fat snacks , eating less energy dense , high-protein snacks like yogurt improves appetite control , satiety , and reduces subsequent food intake in healthy women This study tested the hypothesis that the amount ( weight or volume ) of food consumed affects the satiating potency of a food , independent of its energy content . Normal-weight young men ( n = 20 ) were tested in a within-subjects design . Subjects were served a milk-based drink or no drink ( control ) , followed 30 min later by a self-selected lunch and > 4 h later by a self-selected dinner . Milk drinks were equal in energy content ( 2088 kJ , or 499 kcal ) and had similar proportions of fat ( 30.3 % ) , carbohydrate ( 54.7 % ) , and protein ( 15 % ) across three volumes : 300 , 450 , and 600 mL. Ratings of palatability , sensory properties , and energy content of the drinks and of hunger completed before consumption of the preloads were not significantly different among conditions . The results showed that preload volume affected energy intake at lunch ( P < or = 0.009 ) such that energy intake was less after the 600-mL preload than after the 300-mL preload . This effect was still present when energy intake at dinner was included ( P < or = 0.022 ) . At lunch , including energy from the preload , subjects overate relative to the control condition ( 4323 + /- 322 kJ ) after the 300- ( 5263 + /- 321 kJ ) and 450-mL ( 5011 + /- 300 kJ ) preloads but not after the 600-mL ( 4703 + /- 353 kJ ) preload . Thus , the best adjustment for the energy in the preloads was with the largest , least energy-dense drink . Consistent with the effects on intake , the volume of the drinks affected ratings of hunger and fullness . These results indicate that the volume consumed is an important determinant of satiety after milk drinks under these conditions BACKGROUND The results of previous studies indicated that energy density , independent of fat content , influences energy intake . In most studies , however , both fat content and energy density were lower than in typical American diets . OBJECTIVE We examined the influence of energy density on intake when fat content was above , below , or similar to the amount of fat typically consumed and when energy density was closer to that of American diets . DESIGN Lean ( n = 19 ) and obese ( n = 17 ) women consumed all meals daily in our laboratory during 6 experimental sessions . The main entrées , consumed ad libitum , were formulated to vary in fat content ( 25 % , 35 % , and 45 % of energy ) and energy density ( 5.23 kJ/g , or low energy density , and 7.32 kJ/g , or high energy density ) but to have similar palatability . RESULTS Energy density influenced energy intake across all fat contents in both lean and obese women ( P < 0.0001 ) . Women consumed less energy in the low ( 7531 kJ ) than in the high ( 9414 kJ ) energy density condition . Despite this 20 % lower energy intake , there were only small differences in hunger ( 7 % ) and fullness ( 5 % ) . Women consumed a similar volume , but not weight , of food daily across conditions . Differences in intake by weight , but not volume , occurred because for some versions of manipulated foods , weight and volume were not directly proportional . CONCLUSIONS Energy density affected energy intake across different fat contents and at levels of energy density comparable with those in typical diets . Furthermore , our findings suggest that cues related to the amount of food consumed have a greater influence on short-term intake than does the amount of energy consumed BACKGROUND Studies have shown that energy intake increases when both the fat content and energy density of the entire diet increases . When the fat content and energy density vary independently of one another , however , energy density , but not fat content , influences intake . OBJECTIVE The present study examined whether energy intake in lean and obese women is affected when either the energy density or the fat content of a portion of the diet is manipulated and palatability is held constant . DESIGN In a within-subjects design , 17 lean and 17 obese women consumed meals in the laboratory for four , 4-d test periods . In 3 of these test periods the energy density ( 4.4 and 6.7 kJ/g ) or the fat content ( 16 % and 36 % of energy ) of compulsory entrees representing 50 % of each subject 's usual energy intake was manipulated . Additional self-selected foods were consumed ad libitum at meals and as snacks . RESULTS There were no systematic differences in palatability of the manipulated foods across conditions . Obese and lean participants responded similarly to the dietary manipulations . Intake of self-selected foods at meals was reduced significantly by 16 % for both lean and obese subjects in the low- compared with the high-energy-density condition . The fat content of the compulsory foods had no significant effect on energy intake . Ratings of hunger did not differ between diets . CONCLUSION These results indicate that when a portion of the diet was manipulated , the energy density , but not the fat content , of the foods affected total energy intake at meals in both lean and obese women BACKGROUND Little is known about the long-term effects of dietary energy density ( ED ) on weight gain . OBJECTIVE The objective was to assess the long-term relation between changes in dietary ED and age-related weight gain . DESIGN We conducted a prospect i ve study of 50 026 women ( x + /- SD age : 36.5 + /- 4.6 y ) in the Nurses ' Health Study II followed from 1991 to 1999 . Dietary ED and body weight were ascertained in 1991 , 1995 , and 1999 . Total dietary ED was calculated by dividing each subject 's daily energy intake ( kcal ) by the reported weight ( g ) of all foods consumed . RESULTS Dietary ED was positively correlated with saturated fat ( r = 0.16 ) , trans fat ( r = 0.15 ) , and the glycemic index ( r = 0.16 ) , but was inversely correlated with vegetable protein ( r = -0.30 ) , vegetables ( r = -0.27 ) , and fruit ( r = -0.17 ) . ED was not significantly correlated with total fat intake as a percentage of energy ( r = 0.08 ) . Women who increased their dietary ED during follow-up the most ( 5th quintile ) had a significantly greater multivariate-adjusted weight gain than did those who decreased their dietary ED ( 1st quintile ) ( 8-y time period : 6.42 kg compared with 4.57 kg ; P for trend < 0.001 ) . However , the amount of weight change over time varied considerably according to the ED values of individual foods and beverages . CONCLUSION A high dietary ED reflects a dietary pattern higher in saturated and trans fats and refined carbohydrates . Increases in dietary ED were associated with greater weight gain among middle-aged women during 8 y of follow-up . However , public health recommendations can not be made simply on the basis of ED values of individual foods and beverages Although several studies have assessed the influence of the glycemic index on body weight and blood pressure among adults , limited evidence exists for the pediatric age population . In the current study , we compared the effects of low glycemic index ( LGI ) diet to the healthy nutritional recommendation (HNR)-based diet on obesity and blood pressure among adolescent girls in pubertal ages . This 10-week parallel r and omized clinical trial comprised of 50 overweight or obese and sexually mature girls less than 18 years of age years , who were r and omly assigned to LGI or HNR-based diet . Macronutrient distribution was equivalently prescribed in both groups . Blood pressure , weight and waist circumference were measured at baseline and after intervention . Of the 50 participants , 41 subjects ( include 82 % ) completed the study . The GI of the diet in the LGI group was 42.67 ± 0.067 . A within-group analysis illustrated that in comparison to the baseline values , the body weight and body mass index ( not waist circumference and blood pressure ) decreased significantly after the intervention in both groups ( P =
Output:
| In summary , the current analysis revealed that we can restrict the energy intake by consuming an LED preload .
Moreover , consuming an LED preload could favorably affect preload+meal energy intake |
MS212795 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: CONTEXT Attention-deficit/hyperactivity disorder ( ADHD ) is a highly prevalent and impairing psychiatric disorder that affects both children and adults . There are Food and Drug Administration-approved stimulant and nonstimulant medications for treating ADHD ; however , little is known about the mechanisms by which these different treatments exert their therapeutic effects . OBJECTIVE To contrast changes in brain activation related to symptomatic improvement with use of the stimulant methylpheni date hydrochloride vs the nonstimulant atomoxetine hydrochloride . DESIGN Functional magnetic resonance imaging before and after 6 to 8 weeks of treatment with methylpheni date ( n = 18 ) or atomoxetine ( n = 18 ) using a parallel-groups design . SETTING Specialized ADHD clinical research program at Mount Sinai School of Medicine , New York , New York . PARTICIPANTS Thirty-six youth with ADHD ( mean [ SD ] age , 11.2 [ 2.7 ] years ; 27 boys ) recruited from r and omized clinical trials . MAIN OUTCOME MEASURES Changes in brain activation during a go/no-go test of response inhibition and investigator-completed ratings on the ADHD Rating Scale-IV-Parent Version . RESULTS Treatment with methylpheni date vs atomoxetine was associated with comparable improvements in both response inhibition on the go/no-go test and mean ( SD ) improvements in ratings of ADHD symptoms ( 55 % [ 30 % ] vs 57 % [ 25 % ] ) . Improvement in ADHD symptoms was associated with common reductions in bilateral motor cortex activation for both treatments . Symptomatic improvement was also differentially related to gains in task-related activation for atomoxetine and reductions in activation for methylpheni date in the right inferior frontal gyrus , left anterior cingulate/supplementary motor area , and bilateral posterior cingulate cortex . These findings were not attributable to baseline differences in activation . CONCLUSIONS Treatment with methylpheni date and atomoxetine produces symptomatic improvement via both common and divergent neurophysiologic actions in frontoparietal regions that have been implicated in the pathophysiology of ADHD . These results represent a first step in delineating the neurobiological basis of differential response to stimulant and nonstimulant medications for ADHD This study examined effects of reward and response costs on the ability of 19 attention-deficit hyperactivity disorder ( ADHD ) and 17 control children to inhibit responding . Children were tested under 4 reinforcement conditions on a go/no-go learning task developed by J. P. Newman , C. S. Widom , and S. Nathan ( 1985 ) . Two conditions involved both reward and response costs . 1 response costs only , and 1 reward only . ADHD children made more commission errors than controls across the 4 conditions . Analyses of learning curves indicated that group differences became larger on later trials . Thus , impaired inhibition was more generalized in ADHD children than in the psychopaths and extraverts studied by Newman and colleagues , and it became most evident when the children were required to improve learning across trials A disturbed functioning of the prefrontal cortex , the anterior cingulate cortex , and an accordingly reduced P300 presumably underlies executive function deficits of children with attention deficit hyperactivity disorder ( ADHD ) . Using a combined classification and Go/NoGo task paradigm , the present study investigated whether medication with methylpheni date ( MPH ) modulates the P300 as measured by a high-density electroencephalogram ( EEG ) and facilitates response inhibition in children with ADHD . Further , effects of MPH were compared with effects of self-regulation by if-then plans ( Gollwitzer in Am Psychol 54 : 493–503 , 1999 ) . MPH as well as if-then plans modulated the P300 and improved inhibition of an unwanted response on a Go/NoGo task to the same level observed in children without ADHD . Importantly , self-regulation strategies might be a valuable alternative to medication with MPH in children with ADHD The go-no go test requires a subject to emit a simple motor response to one cue while inhibiting the response in the presence of another cue . This test has been effective in demonstrating impulsivity ( elevated commission error rate ) in children with attention deficit disorder ( ADD ) . In this study , we examined the effects on go-no go test performance of two doses of methylpheni date ( 0.15 mg/kg and 0.3 mg/kg ) administered in double-blind placebo-controlled fashion to children with ADD . Our results indicate that even modest doses of methylpheni date improve the go-no go performance of these children by decreasing their tendency to make impulsive commission errors . Thus the test is sensitive to the effects of methylpheni date and can be used to monitor a response to therapy . ( J Child Neurol 1991 ; 6(Suppl):S126-S129 )
Output:
| Results indicate that deficits in withholding are insufficiently sensitive or specific to be used individually as a diagnostic measure or biomarker in most disorders |
MS212796 | ***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 OBJECTIVE To develop a checklist of items measuring the quality of reports of r and omized clinical trials ( RCTs ) assessing nonpharmacological treatments ( NPTs ) . STUDY DESIGN AND SETTING The Delphi consensus method was used to select and reduce the number of items in the checklist . A total of 154 individuals were invited to participate : epidemiologists and statisticians involved in the field of methodology of RCTs ( n = 55 ) , members of the Cochrane Collaboration ( n = 41 ) , and clinicians involved in planning NPT clinical trials ( n = 58 ) . Participants ranked on a 10-point Likert scale whether an item should be included in the checklist . RESULTS Fifty-five experts ( 36 % ) participated in the survey . They were experienced in systematic review s ( 68 % were involved in the Cochrane Collaboration ) and in planning RCTs ( 76 % ) . Three rounds of the Delphi method were conducted to achieve consensus . The final checklist contains 10 items and 5 subitems , with items related to the st and ardization of the intervention , care provider influence , and additional measures to minimize the potential bias from lack of blinding of participants , care providers , and outcome assessors . CONCLUSIONS This tool can be used to critically appraise the medical literature , design NPT studies , and assess the quality of trial reports included in systematic review A comparison of pressure reducing properties of alternating air , static air , and water mattress overlays was conducted with 57 patients in a surgical intensive care unit . Sacral and heel pressures in both recumbent and semi-Fowler 's positions were tested for each surface using a repeated measures design . Mean pressures for the alternating air mattress were significantly higher than pressures with other surfaces , regardless of position or site . There were significant main effects for position and site , with higher pressures in the semi-Fowler 's position and at the sacral site . A significant interaction between surface , site , and position was found . Pressure sores developed in eight patients , but the incidence was not significantly different across groups . A pressure measuring device constructed from available clinical material s proved to be both sensitive and reliable . The findings suggest alternating air overlays should be avoided , and that positioning and periodic position change to reduce sacral pressures for patients requiring prolonged upper body elevation is important OBJECTIVE To estimate the effectiveness of a new high-performance Australian medical sheepskin ( meeting Australian St and ard 4480.1 - 1998 ) in preventing pressure ulcers in a general hospital population at low to moderate risk of these ulcers . DESIGN Open-label r and omised controlled clinical trial . SETTING A large metropolitan teaching hospital in Melbourne , Victoria , in 2000 . PARTICIPANTS 441 patients aged over 18 years admitted between 12 June and 30 November 2000 , with expected length of stay over 2 days and assessed as at low to moderate risk of developing pressure ulcers . INTERVENTION Patients were r and omly allocated to receive a sheepskin mattress overlay for the duration of their hospital stay ( 218 patients ) or usual treatment , as determined by ward staff ( referent group , 223 patients ) . MAIN OUTCOME MEASURES Incidence rate and cumulative incidence of pressure ulcers , assessed daily throughout hospital stay . RESULTS 58 patients developed pressure ulcers ( sheepskin group , 21 ; referent group , 37 ) . Cumulative incidence risk was 9.6 % in the sheepskin group ( 95 % CI , 6.1%-14.3 % ) versus 16.6 % in the referent group ( 95 % CI , 12.0%-22.1 % ) . Patients in the sheepskin group developed new pressure ulcers at a rate less than half that of referent patients ( rate ratio , 0.42 ; 95 % CI , 0.26 - 0.67 ) . CONCLUSIONS The Australian Medical Sheepskin is effective in reducing the incidence of pressure ulcers in general hospital in patients at low to moderate risk of these ulcers Pressure sores are a frequent problem , especially in elderly patients . Nutritional status may influence the incidence , progression and severity of pressure sores , data , however , are contradictory ( 1 ) . The purpose of this study was to determine the effect of supplemental feeding on the nutritional status and the development and severity of pressure sores . The effect of supplemental feeding overnight ( tube + ) on patients with a fracture of the hip and a high pressure-sore risk score , was studied in a r and omized clinical trial . The control group ( tube - ) had no supplemental feeding . After informed consent , 140 patients were r and omized , and 129 of these took part in the trial ( 62 tube + , and 67 tube - ) . Protein and energy intake , haemoglobin , serum albumin , total serum protein and pressure-sore grade were measured at admission and after 1 and 2 weeks . Of the 62 patients r and omized for tube feeding ( tube + ) , only 25 tolerated their tube for more than 1 week and 16 for 2 weeks . Nevertheless , energy and protein intake was significantly higher in the tube + group ( P < 0.001 ) . This , however , did not significantly influence total serum protein , serum albumin and development and severity of pressure sores after 1 and 2 weeks . Comparison of the actually tube fed group ( n=25 at 1 week , n = 16 at 2 weeks ) and the control group showed a 2 - 3 times higher protein and energy intake ( P < 0.0001 ) , and a significantly higher total serum protein and serum albumin after 1 and 2 weeks in the actually tube fed group ( all P < 0.001 ) . Pressure-sore development and severity were not significantly influenced in the actually tube fed group . We conclude that we were not able to show a significant decrease in development and severity of pressure sores , because the nasogastric tube for supplemental feeding was not well tolerated in this patient group . Nevertheless , tube feeding overnight does result in a significant higher protein and energy intake , and has a significant effect on nutritional status in the actually tube-fed group . Other means of supplemental feeding will have to be used in order to answer the question of whether supplemental feeding can decrease development and severity of pressure sores 59 elderly patients ( mean age 82 ) with femoral neck fractures were r and omised into two groups . 27 patients received daily an oral nutrition supplement ( 250 ml , 20 g protein , 254 kcal ) for a mean of 32 days ; 32 patients acted as controls . On admission most patients had nutritional deficiencies . Despite being offered adequate quantities , nutritional requirements were not met during the hospital stay . Clinical outcome was significantly better in the supplemented group ( 56 % favourable course vs 13 % in controls ) during the stay in the convalescent hospital . The rates of complications and deaths were also significantly lower in supplemented patients ( 44 % vs 87 % ) . 6 months after the fracture the rates of complications and mortality were significantly lower in supplemented patients ( 40 % vs 74 % ) . The median duration of hospital stay was significantly shorter in the supplemented group ( 24 vs 40 days ) . Thus the clinical outcome of elderly patients with femoral neck fracture can be improved by once daily dietary oral supplementation Six hundred patients at risk for pressure sores were r and omized in either a control group or one of two experimental groups placed on alternating-pressure air-mattresses and water-mattresses . The groups remained comparable throughout the 10-day study period . Twenty-one patients from the control group developed decubitus ulcers , compared with 7 in each of the other groups . Patient and ward personnel opinions on the acceptability of the three types of mattresses were registered OBJECTIVES To examine skin health outcomes of an exercise and incontinence intervention . DESIGN R and omized controlled trial with blinded assessment s of outcomes at three points over 8 months . SETTING Four nursing homes ( NHs ) . PARTICIPANTS One hundred ninety incontinent NH residents . INTERVENTION In the intervention group , research staff provided exercise and incontinence care every 2 hours from 8:00 a.m. to 4:30 p.m. ( total of four daily care episodes ) 5 days a week for 32 weeks . The control group received usual care from NH staff . MEASUREMENTS Perineal skin wetness and skin health outcomes ( primarily blanchable erythema and pressure ulcers ) as measured by direct assessment s by research staff , urinary and fecal incontinence frequency , and percentage of behavioral observations with resident engaged in st and ing or walking . RESULTS Intervention subjects were significantly better in urinary and fecal incontinence , physical activity , and skin wetness outcome measures than the control group . However , despite these improvements , differences in skin health measures were limited to the back distal perineal area , which included the sacral and trochanter regions . There was no difference between groups in the incidence rate of pressure ulcers as measured by research staff , even though those residents who improved the most on fecal incontinence showed improvement in pressure ulcers in one area . CONCLUSION A multifaceted intervention improved four risk factors related to skin health but did not translate into significant improvements in most measures of skin health . Even if they had adequate staffing re sources , NHs might not be able to improve skin health quality indicators significantly if they attempt to implement preventive interventions on all residents who are judged at risk because of their incontinence status Pressure sores are a problem , especially in elderly patients . Our study was design ed to determine the effectiveness in pressure-sore prevention of a new interface-pressure decreasing mattress . In a prospect i ve r and omised controlled clinical trial we tested the Comfortex DeCube mattress ( Comfortex , Winona , USA ) against our st and ard hospital mattress in 44 patients with femoral-neck fracture and concomitant high pressure-sore risk score . In addition both groups were treated according to the Dutch consensus protocol for the prevention of pressure sores . On admission and 1 and 2 weeks after admission , pressure sores were grade d. The two groups were similar in patient characteristics and pressure-sore risk factors . At 1 week , 25 % of the patients nursed on the DeCube mattress and 64 % of the patients nursed on the st and ard mattress had clinical ly relevant pressure sores ( grade 2 or more ) . At 2 weeks the figures were 24 % and 68 % , respectively . The maximum score over the several body regions of the pressure-sore grading , measured on a 5-point sale , was significantly different in favour of the DeCube mattress at 1 week ( p = 0.0043 ) and 2 weeks ( p = 0.0067 ) postoperatively . We show that the occurrence of pressure sores and their severity can be significantly reduced when patients at risk are nursed on an interface-pressure decreasing mattress OBJECTIVE To evaluate the impact of in-hospital pressure ulcer development on mortality among older , high-risk , hospitalized patients up to 1 year post-hospital discharge , after adjusting for baseline patient characteristics , disease severity , hospital complications , and discharge activity level . DESIGN A prospect i ve , inception , cohort study . SETTING An urban , tertiary , acute care , university teaching hospital . PATIENTS A total of 286 patients aged 55 or older , expected to be confined to bed or chair for at least 5 days , who were admitted to the hospital without a Stage 2 or greater pressure ulcer . MEASUREMENTS The primary outcome measurement was time to death from admission to 1-year post-hospital discharge . Baseline information included demographic , medical , functional , and nutritional variables known to be associated with increased mortality . Measures of global disease severity and co-morbidity included the admitting physician 's estimate of illness severity and life expectancy , the acute physiology score of APACHE II , the Co-morbidity Damage Index , and the Medicus Nursing Classification Score . Baseline infections , incident infections , and noninfectious hospital complications were determined . Functional activity level was determined at hospital discharge . Post-discharge vital status was determined by telephone interviews at 3,6,9 , and 12 months after discharge and confirmed by death certificate review . MAIN RESULTS Development of an in-hospital pressure ulcer was associated with greater risk of death at 1 year ( 59.5 % vs 38.2 % , P = .02 ) . However , pressure ulcer development did not remain independently associated with decreased survival after adjusting for other predictors of mortality . Predictors of mortality at hospital admission by multivariate Cox regression analysis included weight loss in the 6 months before admission ( RR 2.4 , CI 1.6 , 3.6 ) , physician estimate of life expectancy ( RR 2.1 , CI 1.7 , 2.6 ) , and the Co-morbidity Damage Index ( RR 1.1 , CI 1.0 , 1.2 ) . Multivariate predictors of 1-year mortality at discharge included physician estimate of life expectancy ( RR 2.2 , CI 1.8,2.6 ) , weight loss in the 6 months before admission ( RR 2.2 , CI 1.5,3.2 ) , remaining confined to bed or chair ( RR 1.9 , CI 1.2,3.1 ) , and the total number of hospital complications ( RR 1.3 , CI 1.2,1.5 ) . CONCLUSIONS Pressure ulcers that develop during acute hospitalization are not associated with reduced 1-year survival among high risk older persons after adjusting for nutritional and functional status , global measures of disease severity and co-morbidity , and noninfectious hospital complications This study had three aims : to investigate if visco-elastic foam mattresses are more effective
Output:
| Effective strategies that addressed impaired mobility included the use of support surfaces , mattress overlays on operating tables , and specialized foam and specialized sheepskin overlays .
While repositioning is a mainstay in most pressure ulcer prevention protocol s , there is insufficient evidence to recommend specific turning regimens for patients with impaired mobility .
In patients with nutritional impairments , dietary supplements may be beneficial .
The incremental benefit of specific topical agents over simple moisturizers for patients with impaired skin health is unclear .
Given current evidence , using support surfaces , repositioning the patient , optimizing nutritional status , and moisturizing sacral skin are appropriate strategies to prevent pressure ulcers . |
MS212797 | ***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 daily supplementation of 800 mg dl alpha-tocopheryl acetate for 30 d on general health , nutrient status , hepatic and renal function , intermediary metabolism , hematological status , plasma nutrients and antioxidant status , thyroid hormones , and urinary creatinine concentrations was studied in 32 healthy elderly ( > 60 y ) people who participated in a double-blind , placebo-controlled , residential trial . The subjects reported no side effects due to the supplements . Supplementation had no effect on body weight , plasma total protein , albumin , glucose , total cholesterol and triglycerides , conjugated and unconjugated bilirubin , alkaline phosphatase , indicators of hepatic and renal function , hematologic status , thyroid hormones , or serum and urinary creatinine concentrations and creatinine clearance . Supplementation did cause a significant increase in serum vitamin E , and a small ( 5 % ) but significant ( P < 0.05 ) increase in plasma zinc in the vitamin E-supplemented group . Thus , short-term supplementation with 800 mg vitamin E/d has no adverse effect on healthy older adults BACKGROUND It has been suggested that vitamin E can counteract the age-associated decline in cellular immune responsiveness ( CIR ) . Particularly , T helper cell type 1 ( Th1 ) activity , ie , interferon ( IFN ) gamma-producing Th1 activity and , hence , delayed-type hypersensitivity ( DTH ) would be enhanced by vitamin E supplementation . OBJECTIVE Our aim was to study the effects of 6 mo supplementation with 50 and 100 mg vitamin E on CIR in the elderly . DESIGN A double-blind , placebo-controlled trial was conducted in 161 healthy elderly subjects aged 65 - 80 y. CIR was measured in vivo by means of DTH skin tests and in vitro by assessing the production of interleukin ( IL ) 2 , IFN-gamma ( a typical Th1 cytokine ) , and IL-4 ( a typical Th2 cytokine ) by peripheral blood mononuclear cells after stimulation with phytohemagglutinin . RESULTS Both DTH and IL-2 production showed a trend toward increased responsiveness with increasing dose of vitamin E. However , IFN-gamma production decreased whereas IL-4 production increased in the groups receiving vitamin E. Only the change in the number of positive DTH reactions was borderline significantly larger in the 100-mg vitamin E group than in the placebo group ( P = 0.06 , Bonferroni adjusted ) . Subjects receiving 100 mg vitamin E with low baseline DTH reactivity or who were physically less active had a significantly larger increase in the cumulative diameter of the skin in duration result ing from the DTH test than did the placebo group ( P = 0.03 ) , although this difference was not significant after Bonferroni correction ( P = 0.07 ) . CONCLUSION Possible beneficial effects of 100-mg vitamin E supplementation may be more pronounced in particular subgroups of elderly subjects AIM To evaluate the safety and efficacy of Vitamin E in children with chronic hepatitis B. METHODS We r and omly assigned patients with chronic hepatitis B , positive for hepatitis B e antigen ( HBeAg ) , to receive either Vitamin E or placebo once daily for 6 mo in a 3:1 ratio and double-blind manner . The primary end point was HBeAg seroconversion , defined as the loss of HBeAg , undetectable levels of serum hepatitis B virus DNA , and the appearance of antibodies against HBeAg 12 mo after therapy . RESULTS At baseline visit , 49 patients had normal and 43 had increased serum aminotransferase levels . Twenty-nine patients did not respond to previous treatment with interferon-alpha or lamivudine . Seventy-six children completed the study ; 16 were non-compliant ( n = 7 ) , lost to follow-up ( n = 7 ) , or started another antiviral treatment ( n = 3 ) . Intention-to-treat analysis showed HBeAg seroconversion in 16 children ( 23.2 % ) treated with Vitamin E and two ( 8.7 % ) in the placebo group ( P = 0.13 ) . Vitamin E was well tolerated . CONCLUSION There is only a tendency that Vitamin E may promote HBeAg seroconversion . Therefore larger studies are needed to clarify the role of antioxidants in the therapy of chronic hepatitis BACKGROUND & AIMS Insulin resistance and oxidative stress contribute to the pathogenesis of nonalcoholic steatohepatitis ( NASH ) . We conducted a pilot study for the following reasons : ( 1 ) to test the hypothesis that a combination of an antioxidant ( vitamin E ) and an insulin sensitizer ( pioglitazone ) would be superior to vitamin E alone for the treatment of NASH , and ( 2 ) to define the effects of these interventions on insulin-sensitive metabolic functions and correlate the effects with changes in liver histology . METHODS A r and omized prospect i ve trial was performed to compare the efficacy and safety of vitamin E alone ( 400 IU/day ) vs. vitamin E ( 400 IU/day ) and pioglitazone ( 30 mg/day ) in nondiabetic , noncirrhotic subjects with NASH . Metabolic functions were assessed by a 2-step , hyperinsulinemic ( 10 and 40 mU/m2/min ) euglycemic clamp . RESULTS A total of 10 patients were r and omized to each arm . Two patients on combination therapy discontinued treatment ; one because of pregnancy and the other because of hepatotoxicity . Treatment with vitamin E only produced a significant decrease in steatosis ( mean grade , 2.2 vs. 1.4 ; P < .02 ) . Compared with baseline , combination therapy produced a significant decrease in steatosis ( mean , 2.3 vs. 1 ; P < .002 ) , cytologic ballooning ( 1.3 vs. 0.2 ; P < .01 ) , Mallory 's hyaline ( 0.7 vs. 0.2 ; P < .04 ) , and pericellular fibrosis ( 1.2 vs. 0.6 ; P < .03 ) . Although vitamin E had no significant effects , combination therapy produced a significant increase in metabolic clearance of glucose and a decrease in fasting free fatty acid ( FFA ) and insulin . The decrease in fasting FFA and insulin independently predicted improvement in hepatic steatosis and cytologic ballooning . CONCLUSIONS A combination of vitamin E and pioglitazone produces a greater improvement in NASH histology . The improvement in steatosis and cytologic ballooning are related to treatment-associated decreases in fasting FFA and insulin levels CONTEXT Nonalcoholic fatty liver disease ( NAFLD ) is the most common chronic liver disease in US children and adolescents and can present with advanced fibrosis or nonalcoholic steatohepatitis ( NASH ) . No treatment has been established . OBJECTIVE To determine whether children with NAFLD would improve from therapeutic intervention with vitamin E or metformin . DESIGN , SETTING , AND PATIENTS R and omized , double-blind , double-dummy , placebo-controlled clinical trial conducted at 10 university clinical research centers in 173 patients ( aged 8 - 17 years ) with biopsy-confirmed NAFLD conducted between September 2005 and March 2010 . Interventions Daily dosing of 800 IU of vitamin E ( 58 patients ) , 1000 mg of metformin ( 57 patients ) , or placebo ( 58 patients ) for 96 weeks . MAIN OUTCOME MEASURES The primary outcome was sustained reduction in alanine aminotransferase ( ALT ) defined as 50 % or less of the baseline level or 40 U/L or less at visits every 12 weeks from 48 to 96 weeks of treatment . Improvements in histological features of NAFLD and resolution of NASH were secondary outcome measures . RESULTS Sustained reduction in ALT level was similar to placebo ( 10/58 ; 17 % ; 95 % CI , 9 % to 29 % ) in both the vitamin E ( 15/58 ; 26 % ; 95 % CI , 15 % to 39 % ; P = .26 ) and metformin treatment groups ( 9/57 ; 16 % ; 95 % CI , 7 % to 28 % ; P = .83 ) . The mean change in ALT level from baseline to 96 weeks was -35.2 U/L ( 95 % CI , -56.9 to -13.5 ) with placebo vs -48.3 U/L ( 95 % CI , -66.8 to -29.8 ) with vitamin E ( P = .07 ) and -41.7 U/L ( 95 % CI , -62.9 to -20.5 ) with metformin ( P = .40 ) . The mean change at 96 weeks in hepatocellular ballooning scores was 0.1 with placebo ( 95 % CI , -0.2 to 0.3 ) vs -0.5 with vitamin E ( 95 % CI , -0.8 to -0.3 ; P = .006 ) and -0.3 with metformin ( 95 % CI , -0.6 to -0.0 ; P = .04 ) ; and in NAFLD activity score , -0.7 with placebo ( 95 % CI , -1.3 to -0.2 ) vs -1.8 with vitamin E ( 95 % CI , -2.4 to -1.2 ; P = .02 ) and -1.1 with metformin ( 95 % CI , -1.7 to -0.5 ; P = .25 ) . Among children with NASH , the proportion who resolved at 96 weeks was 28 % with placebo ( 95 % CI , 15 % to 45 % ; 11/39 ) vs 58 % with vitamin E ( 95 % CI , 42 % to 73 % ; 25/43 ; P = .006 ) and 41 % with metformin ( 95 % CI , 26 % to 58 % ; 16/39 ; P = .23 ) . Compared with placebo , neither therapy demonstrated significant improvements in other histological features . CONCLUSION Neither vitamin E nor metformin was superior to placebo in attaining the primary outcome of sustained reduction in ALT level in patients with pediatric NAFLD . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00063635 BACKGROUND The purpose of the present paper was to investigate the efficacy of vitamin E in children with immunotolerant-phase chronic hepatitis B virus ( CHB ) infection . METHODS Fifty-eight immunotolerant children were prospect ively and r and omly recruited into two groups . Group 1 ( study group ) included 30 patients who received vitamin E at a dose of 100 mg/day throughout 3 months ; group 2 ( control group ) contained 28 patients who did not receive any medication . Comparison of serological , virologic , and biochemical response ratios were done at the end of the therapy and after 6 months of vitamin E discontinuation . RESULTS Mean alanine transaminase ( ALT ) values in group 1 at the beginning of the therapy , 3 months after the therapy initiation and 6 months after discontinuation were 30.4 + /- 7.3 IU/L , 31.3 + /- 7.8 IU/L and 32.1 + /- 8.5 IU/L , respectively . The mean hepatitis B virus (HBV)-DNA load of group 1 at onset , and at the third and ninth months of the treatment were 3106 + /- 718 pg/mL , 3530 + /- 137 pg/mL and 3364 + /- 1246 pg/mL , respectively . These changes in both ALT and HBV-DNA values did not reach significant levels ( P > 0.05 ) . In group 2 , mean ALT values at the beginning of therapy , and at the third and ninth months were 28.0 + /- 1.8 IU/L , 34.6 + /- 8.1 IU/L , and 34.1 + /- 7.0 IU/L , respectively ( P > 0.05 ) , and mean viral load of HBV-DNA was 4227 + /- 1435 pg/mL , 3368 + /- 2673 pg/mL , and 3018 + /- 2814 pg/mL , respectively ( P > 0.05 ) . There was no statistically significant difference between group 1 and group 2 at the third and ninth months in the mean ALT values and viral load of HBV-DNA ( P > 0.05 ) . Hepatitis B s antigen and hepatitis B e antigen clearance or hepatitis B s antibody and hepatitis B e antibody seroconversion were not observed in either group . CONCLUSION As a first study investigating the effect of vitamin E in children with immunotolerant CHB infection , no beneficial effect could be demonstrated . Different immunomodulator protocol s should be considered for future investigations
Output:
| Based on the clinical results obtained in VE-treated chronic HBV carriers , we provide a reliable hypothesis for the possible role of this vitamin in the modulation of host miRNA profiles perturbed by this viral pathogen and in the regulation of some cellular miRNA with a suggested potential anti-HBV activity . |
MS212798 | ***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 the use of selective decontamination of the digestive tract ( SDD ) ( polymyxin , amphotericin , tobramycin , and intravenous cefotaxime ) in a mixed intensive care unit , we performed a stratified , r and omized , prospect i ve study . The 331 patients were recruited over an 18-month period , with 256 patients remaining more than 48 hours . Stratification by acute physiology and chronic health evaluation ( APACHE II ) preceded r and omization to control ( st and ard antibiotic therapy ) or treatment ( SDD ) groups . Nosocomial infection was significantly reduced in the SDD group ( 16.7 % ; 21 of 126 patients ) compared with the control group ( 30.8 % ; 40 of 130 patients ; p = 0.008 ) . No difference was found in overall mortality rate or length of stay between the two groups . Those patients with admission APACHE II scores 10 to 19 demonstrated the most significant reduction in nosocomial infection ( 23 of 70 control vs 13 of 76 SDD ; p = 0.03 ) and mortality ( 15 of 70 control vs 8 of 76 SDD ; p = 0.07 ) . Emergence of multiresistant microorganisms was not a clinical problem , but a definite change occurred in the ecology of environmental and colonizing bacteria . With the exception of cefotaxime , a reduction was noted in systemic antibiotic usage in the SDD group . We conclude that SDD is useful in selected patients in a mixed intensive care unit Selective decontamination of the oropharynx and gastrointestinal tract with nonabsorbable antimicrobials and sucralfate , a stress ulcer prophylactic that maintains the normal gastric acid bacterial barrier , were compared for prevention of pneumonia in a cardiac surgery intensive care unit . Over 8 months , 51 patients received selective decontamination and 56 received sucralfate . The selective decontamination regimen included polymyxin , gentamicin , and nystatin given as an oral paste and as a solution ; patients also received st and ard antacid or histamine2 blocker stress ulcer prophylaxis . Patients in the selective decontamination group had significantly less colonization of the oropharynx and stomach by gram-negative bacilli ( 12 % vs. 55 % , P less than .001 ) , significantly fewer infections due to gram-negative bacilli ( 6 % vs. 20 % , P = .02 ) , and fewer infections overall ( 12 % vs. 27 % , P = .04 ) . There was one episode of pneumonia in the selective decontamination group and five in the sucralfate group . Mortality and length of stay did not differ between the groups , but those receiving selective decontamination had less than one-third as many days of systemic antibiotic therapy with no increase in colonization or infection with resistant gram-negative bacilli . Thus , selective decontamination appeared to reduce both extrapulmonary and pulmonary infections BACKGROUND Reduction of potential pathogens by selective intestinal decontamination has been proposed to improve intensive care . Despite large scientific interest in this method , little is known about its benefit in homogeneous trauma population s. METHODS In a prospect i ve , controlled study , we enrolled non-infected trauma patients ( age over 18 years , mechanical ventilation > or = 48 hours , intensive care for more than 3 days ) who primarily were admitted to our university medical center . We r and omized patients to be treated with two different topical regimens ( polymyxin , tobramycin , and amphotericin ( PTA ) or polymyxin , ciprofloxin , amphotericin ( PCA ) ) or the carrier only ( placebo ) , administered four times daily both to the oropharynx and to the gastrointestinal tract . All patients received intravenous ciprofloxacin ( 200 mg , bd ) for 4 days . FINDINGS Of 357 enrolled patients , 310 ( age 38.0 + /- 16.5 years , Injury Severity Score 35.2 + /- 12.7 ) met all inclusion criteria . Selective decontamination successfully reduced intestinal bacterial colonization . However , we did not identify significant differences between groups regarding pneumonia ( PTA 47.5 % , PCA 39.0 % , placebo 45.3 % ) , sepsis ( PTA 47.5 % , PCA 37.8 % , placebo 42.6 % ) , multiple organ failure ( PTA 56.3 % ; PCA 52.4 % , placebo 58.1 % ) , and death ( PTA 11.3 % , PCA 12.2 % , placebo 10.8 % ) . Total costs per patient were highest with the PTA regimen . CONCLUSIONS We found no benefit of selective decontamination in trauma patients . Apparently , bacterial overgrowth in the intestinal tract is not the sole link between trauma , sepsis , and organ failure STUDY OBJECTIVE To study the efficacy of intestinal decontamination by oral nonabsorbable antibiotic agents to control a nosocomial outbreak of intestinal colonization and infection with multiresistant Enterobacteriaceae , and to examine its effects on endemic nosocomial infection rates . DESIGN A 10-week prospect i ve incidence study ( group 1 ) , and then an 8-week r and omized , open trial of intestinal decontamination ( groups 2 and 3 ) . SETTING A medical intensive care unit of a tertiary care university hospital . PATIENTS Consecutive patients with unit stay of over 2 days and a severity score at admission of more than 2 ; 124 patients were included in group 1 , 50 in group 2 ( control ) , and 36 in group 3 ( intestinal decontamination ) . INTERVENTIONS Neomycin , polymyxin E , and nalidixic acid were given to group 3 patients throughout their stay in the unit . MEASUREMENTS AND MAIN RESULTS Intestinal colonization with multiresistant strains occurred in 19.6 % of patients in group 1 , at a mean of 16 days after admission , and preceded detection in clinical sample s by a mean of 11 days . During the decontamination trial , intestinal colonization rates decreased to 10 % ( group 2 ) , and 3 % ( group 3 ) ( P = 0.12 and P less than 0.01 , compared with group 1 , respectively ) . Corresponding infection rates were 9 % ( group 1 ) , 3 % ( group 2 ) , and 0 ( group 3 ) . No new cases were detected in the following 4 months . The intestinal colonization rate with gram-positive cocci was higher in group 3 than group 2 ( P less than 0.001 ) . The overall rate of nosocomial infections was at 28 % ( group 1 ) , 33 % ( group 2 ) , and 32 % ( group 3 ) . CONCLUSIONS Intestinal decontamination can help to control an outbreak of intestinal colonization and infection with multiresistant gram-negative bacilli in the intensive care unit , but should not be recommended for routine prevention of endemic nosocomial infections In a prospect i ve r and omized study to determine whether prevention of colonization of Gram-negative bacteria results in prevention of Gram-negative bacterial infections , 96 intensive care patients were r and omly allocated into a control group and a study group . The study group received oral nonabsorbable antimicrobial agents ( i.e. , tobramycin , amphotericin B , and polymyxin E ) in addition to parenteral antibiotics . Colonization with Gram-negative microorganisms in the oropharynx , and respiratory and digestive tracts increased in the control group during their stay , while the study group did not tend to colonize with Gram-negative bacteria . In the control group , 107 nosocomial infections were diagnosed , vs. 42 nosocomial infections in the study group . Nosocomial infections caused by Gram-negative bacteria were significantly less frequent in the study group . Mortality due to an acquired infection was significantly less frequent in the study group . We conclude that colonization , infection , and subsequent mortality by nosocomial Gram-negative bacteria can be prevented by a regime of topically applied nonabsorbable antibiotics Selective decontamination of the digestive tract ( SDD ) , by means of non-absorbable antibiotics , to prevent infection in intensive-care units ( ICUs ) remains controversial ; there is evidence that the regimen reduces the incidence of secondary infection , but no convincing reduction in morbidity or mortality has been shown and the costs and effect on microbial resistance patterns need further study . In a double-blind , placebo-controlled trial , we have tried to find out whether SDD should be used routinely in all ICU patients at high risk of secondary infection . All patients admitted to the ICU who were thought likely to stay in the unit for at least 5 days and to need intubation for longer than 48 h were enrolled and r and omly allocated to groups receiving placebo or SDD ( amphotericin , colistin , and tobramycin applied to the oropharynx and enterally ) ; all patients received intravenous cefotaxime for 72 h. Of 322 patients r and omised , 83 were withdrawn ( 80 ICU stay or duration of intubation too short , 3 protocol violations ) . 239 medical , trauma , and surgical patients completed the trial period ( 114 SDD , 125 placebo ) . There were no differences between SDD and placebo groups in incidence of infection ( 30 [ 26 % ] vs 43 [ 34 % ] patients ; p = 0.22 ) , duration of ICU stay ( mean 16.2 [ 14.3 ] vs 16.8 [ 12.3 ] days ) , hospital stay ( 29.9 [ SD 25.0 ] vs 31.9 [ 22.2 ] days ) , or mortality ( 21 [ 18 % ] vs 21 [ 17 % ] ) . SDD substantially increased the costs of intensive care . Mechanisms other than bacterial colonisation of the gut may bring about substantial numbers of secondary infections in ICUs . Routine use of SDD in multidisciplinary ICUs can not be recommended A comparative , prospect i ve study was made of the incidence of infection in the lower airway ( purulent tracheobronchitis and pneumonia ) in long-term patients who were mechanically ventilated due to respiratory failure of noninfectious origin . Twenty-eight patients were r and omly allocated into a study group ( A , n = 13 ) in which a nonabsorbable paste containing 2 % tobramycin , 2 % amphotericin B , and 2 % polymyxin E was administered locally to decontaminate the oropharynx , and a control group ( B , n = 15 ) in which a paste without antibiotics was also applied to the oropharynx . We studied the effectiveness of the prophylactic technique in decontaminating the oropharynx and trachea of organisms potentially pathogenic for the respiratory system . Decontamination was successful in ten of 13 patients in group A vs. one of 15 patients in group B ( p less than .001 ) . The results demonstrated a lower rate of infection in the lower respiratory tract in the study group ( three patients with tracheobronchitis and no pneumonias ) than in the control group ( three patients with tracheobronchitis and 11 with pneumonia ) , the difference between both being highly significant ( p less than .001 ) . Two ( 15 % ) patients in group B developed sepsis of pulmonary origin . None of the patients on prophylactic treatment developed this complication . Although the overall mortality was similar in both groups ( group A , 30 % vs. group B , 33 % ) , we believe that infection contributed to a great extent to the death of two of five patients in group B. We conclude that nosocomial pneumonia , which is a frequent complication in critically ill patients on mechanical ventilation , could be prevented by local application of nonabsorbable antibiotics to the oropharynx Suppression of the gut luminal aerobic flora to reduce nosocomial infections was tested in a prospect i ve , r and omized , double-blind , placebo-controlled clinical trial in patients in a surgical intensive care unit who had persistent hypermetabolism . Forty-six patients were r and omized to receive either norfloxacin , 500-mg suspension every 8 hours , together with nystatin , 1 million units every 6 hours , or matching placebo solutions administered through a nasogastric tube within 48 hours of surgical intensive care unit admission . Selective gut decontamination with the experimental therapy or placebo solutions continued for at least 5 days or until the time of surgical intensive care unit discharge . Patients were monitored with routine surveillance cultures for the development of nosocomial infections , as defined by criteria from the Centers for Disease Control . All other therapy was given as clinical ly indicated , including systemic antibiotics . The selective gut decontamination group experienced a significant reduction in the incidence of nosocomial infections and a reduced length of stay . However , these results were not associated with a concomitant decrease in progressive multiple organ failure syndrome , adult respiratory distress syndrome , or mortality Nosocomial pneumonia is a frequent complication of prolonged mechanical ventilation [ 1 - 3 ] . Oropharyngeal and gastric colonization ,
Output:
| This meta- analysis of 15 years of clinical research suggests that antibiotic prophylaxis with a combination of topical and systemic drugs can reduce respiratory tract infections and overall mortality in critically ill patients . |
MS212799 | ***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 Closure of ileostomy is considered a contaminated operation . The infection rate of the stoma wound is ≥30 % . Several ileostomy – closure techniques intended to reduce the high rate of infection have been described in the literature . Among them , delayed primary closure of the stoma wound is a commonly used method that was reported to reduce the infection rate according to several retrospective studies . We therefore conducted the first prospect i ve r and omized trial comparing primary with delayed primary closure of a stoma wound . Methods During 2003 , 40 patients were admitted to our ward for closure of ileostomy . The ileostomies were taken down by the same team using the same surgical technique except for the technique of wound closure . We r and omly divided the patients into two groups . In Group 1 ( n = 20 ) , the wound was left open for delayed primary closure and not closed until postoperative day 4 . In Group 2 , the wound was primarily closed at the end of the procedure . Results The total wound infection rate was relatively low ( 15 % ) . Infection occurred more frequently ( 4 cases , 20 % ) in Group 1 than in Group 2 ( 2 cases , 10 % ) . The length of hospital stay was similar for both groups . Conclusions In this first prospect i ve comparison of two techniques during ileostomy take down , primary closure unexpectedly produced less wound infection than delayed primary closure Background : It is still a matter of debate whether delayed primary closure ( DPC ) of contaminated abdominal incisions reduces surgical site infections compared with a primary closure ( PC ) . The aim of this study was to determine the optimal method of wound closure for patients with perforated appendicitis . Methods : A total of 70 patients with perforated appendicitis were included . They were r and omized to have their surgical incisions ( skin and subcutaneous tissue ) either PC or left open with Betadine‐soaked gauze packing for DPC on the fifth postoperative day or later if the wound conditions were inappropriate for closure . A wound was considered infected if pus discharged from the incision site . The main outcome measures were the incidence of wound infection and the length of hospital stay ( LOS ) . Results : In the entire series , wound infection developed after incision closure in 21.4 % of the patients . The PC group had a higher incidence of wound infection ( 38.9 % vs. 2.9 % , p < 0.001 ) and longer LOS ( 8.4 days vs. 6.3 days , p = 0.038 ) . Conclusion : Delayed primary closure is the optimal management strategy for perforated appendicitis wounds . It significantly reduces the wound infection rate and length of stay BACKGROUND AND PURPOSE It is still a matter of debate whether delayed primary closure ( DPC ) of dirty abdominal incisions reduces surgical site infections ( SSIs ) compared with primary closure ( PC ) . Our objective was to determine whether DPC of dirty abdominal incisions reduces SSIs . METHOD A controlled r and omized study was conducted at an academic tertiary care 1,500-bed university hospital in Western India involving 81 consecutive patients with dirty abdominal incisions . Only 77 patients ( DPC = 37 , PC = 40 ) were evaluable because of the deaths of four patients . A total of 52 patients had peptic or typhoid perforations , whereas the rest had appendicular perforations/abscesses , penetrating or blunt abdominal injuries with gastrointestinal perforation , or intra-peritoneal abscesses . Patients were r and omized to have their surgical incisions ( skin and subcutaneous tissue ) either closed primarily ( PC ) or left open with saline-soaked gauze dressings for DPC on the 3(rd ) postoperative day or later if the incision conditions were inappropriate for closure . The main outcome measure was the incidence of postoperative SSI . RESULTS In the entire series , SSI developed after incision closure in 23 % of the patients . Infections were significantly more common in the PC group ( 42.5 % vs. 2.7 % for DPC ; p = 0.0000375 ) . There also were significantly more cases of abdominal dehiscence in the PC group ( DPC 1 [ 2.7 % ] vs. PC 10 [ 25 % ] ; p = 0.005 ) . The mean complete incision healing ( CIH ) time and length of hospital stay ( LOS ) were longer after PC ( 18.52 days ) than DPC ( 13.86 days ) , result ing in a significant difference in the end point of healing and LOS ( p = 0.0207 ) . Short-term cosmetic results for PC incisions were significantly inferior to those for DPC ( p = 0.03349 ) . CONCLUSIONS Delayed primary closure is a sound incision management technique that should be utilized for dirty abdominal incisions . It significantly lowers the rate of superficial SSI as well as fascial dehiscence and reduces the mean CIH time and hospitalization . The short-term cosmetic appearance is superior A prospect i ve r and omized trial was performed on 122 patients with perforated or gangrenous appendicitis to determine whether delayed primary wound closure lowered morbidity from wound infection . The 54 per cent wound infection rate with delayed primary closure was significantly inferior to the 18 per cent infection rate for primary closure with topical ampicillin powder ( P = 0.0082 ) , but not significantly different from the 37 per cent infection rate for primary closure alone . Furthermore , patients disliked delayed primary closure , their hospital stay was prolonged and 17 per cent of their wounds became contaminated with Staphylococci before being closed . Delayed primary wound closure should not be used in treating perforated and gangrenous appendicitis wounds OBJECTIVE To compare the difference in the rate of surgical wound infection , patient 's convenience and length of hospital stay between Primary Closure and Delayed Primary Closure in cases of complicated appendicitis in adults . METHODS This r and omised control trial was conducted at the Combined Military Hospital , Kharian and Malir from June 5 , 2006 , to September 10 , 2009 . Patients > or = 15 years of both gender who underwent appendectomy through grid iron or Lanz incision and having complicated appendicitis were included . The 100 patients who were included in the study out of the initial size of 393 , were r and omised into two equal groups of 50 each ( Group A : Primary Closure ; Group B : Delayed Primary Closure ) using a computer-generated table . All the surgeries were done by the same surgeon and the operative steps and antibiotic coverage were st and ardised . The rate of surgical wound infection , patient 's convenience ( on visual analogue scale in mm ) and the length of hospital stay were recorded . Data was analysed using SPSS version 11 , and p value was calculated . RESULTS Demographic data , comorbids and medication of both the groups was comparable . There was no significant difference in rate of surgical wound infection ( p > 0.05 ) . The difference in patient 's convenience and length of hospital stay were significant ( p < 0.05 ) , showing superiority of Primary Closure over Delayed Primary Closure with no added morbidity/mortality . CONCLUSION Primary Closure in complicated appendicitis not only reduces the cost of treatment , but is also more convenient and satisfying for the patients , with no added risk of surgical wound infection Objective To determine the optimal method of wound closure for dirty abdominal wounds . Summary Background Data The rate of wound infection for dirty abdominal wounds is approximately 40 % , but the optimal method of wound closure remains controversial . Three r and omized studies comparing delayed primary closure ( DPC ) with primary closure ( PC ) have not conclusively shown any advantage of one method over the other in terms of wound infection . Methods Fifty-one patients with dirty abdominal wounds related to perforated appendicitis , other perforated viscus , traumatic injuries more than 4 hours old , or intraabdominal abscesses were enrolled . Patients were stratified by cause ( appendicitis vs. all other causes ) and prospect ively r and omized to one of two wound management strategies : E/DPC ( wound packed with saline-soaked gauze , evaluated 3 days after surgery for closure the next day if appropriate ) or PC . In the E/DPC group , wounds that were not pristine when examined on postoperative day 3 were not closed and daily dressing changes were instituted . Wounds were considered infected if purulence discharged from the wound , or possibly infected if signs of inflammation or a serous discharge developed . Results Two patients were withdrawn because they died less than 72 hours after surgery . The wound infection rate was greater in the PC group than in the E/DPC group . Lengths of hospital stay and hospital charges were similar between the two groups . Conclusion A strategy of DPC for appropriate dirty abdominal wounds 4 days after surgery produced a decreased wound infection rate compared with PC without increasing the length of stay or cost OBJECTIVE To compare the rate of wound infection of perforated appendicitis in children between primary wound closure and delayed primary wound closure . STUDY DESIGN Prospect i ve clinical trial . MATERIAL AND METHOD Children diagnosed with perforated appendicitis between January 1999 and December 1999 received gentamicin and metronidazole pre- and post-operatively . Intra-abdominal fluid cultured and tested for sensitivity . The rate of wound infection , skin closure for patients were compared between primary wound closure and delayed primary wound closure . RESULTS Among 198 children diagnosed with appendicitis , 44 cases were perforated ( 22.22 % ) . Of these 44 cases , 8 cases had wound infection ( 18.18 % ) , 2 of 8 Infected cases ( 9.1 % ) were in the primary wound closure group , 6 of 8 ( 27.3 % ) were in the delayed primary wound closure group . CONCLUSION The rate of wound infection from perforated appendicitis in children is still high . Primary wound closure has a significantly lower rate of wound infection compared with delayed primary wound closure In a 3-year period , 63 consecutive patients with advanced perforated ( n=53 ) and gangrenous ( n=10 ) appendicitis were allocated to undergo either immediate wound closure or delayed primary wound closure after emergency appendectomy . The incidence of wound infection between delayed primary wound closure and immediate wound closure was similar ( 24.0 % and 21.1 % , respectively ) . The duration for complete healing of infected wounds was slightly shorter in the group undergoing delayed primary wound closure ( mean + /- SD , 24.3 + /- 9.2 days ) than in the group undergoing immediate wound closure ( mean + /- SD , 32.6 + /- 16.5 days ) , but the difference was not significant . However , healing of noninfected wounds was significantly prolonged in the group undergoing delayed primary wound closure ( mean + /- SD , 19.3 + /- 10.1 days ) compared with the group undergoing immediate wound closure ( mean + /- SD , 7.0 + /- 0 days ) . The latter had been shown to associate with more nonseptic wound complications and therefore required longer rehabilitation . Our study showed that delayed primary closure did not offer additional advantage over immediate closure in the treatment of wounds associated with advanced appendicitis in children
Output:
| Our evidence suggested there might be no advantage of DPC over PC in reducing SSI in complicated appendicitis . |
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