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MS211500 | ***TASK*** the task is to summarize an input biomedical literature 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 : Poor cancer survival rates in the United Kingdom are often blamed on delayed medical care . A local audit of endometrial cancer revealed a variety of preventable delays . We surveyed practice in the South West of Engl and to see if this was an isolated or widespread problem . Methods : All 15 hospitals in the South West of Engl and collected information prospect ively from all women with endometrial cancer over 3 months in the spring of 2009 . Results : There were delays in all stages of the uterine cancer pathway . Excluding extraneous cases , 52 % of women waited more than a month and 12 % waited more than 6 months to see their GP from the onset of symptoms . Almost half the cases said they were unaware that abnormal bleeding was a symptom of cancer . Only a quarter of women had treatment within 31 days from the outpatient visit to first definitive treatment and 18 % waited more than the target of 62 days for their treatment . Conclusions : Significant treatment delays occur because women do not report bleeding . If this is replicated throughout Britain , approximately 1000 women per year will delay presentation for at least 3 months and 600 will wait for more than 6 months OBJECTIVE To describe why , when and to whom general practitioners refer women with symptoms possibly attributable to cervical , endometrial or ovarian cancers , and to identify patient and GP factors that predict referral to either a gynaecologist or a gynaecological oncologist . DESIGN AND SETTING A national survey of GPs between 1 April and 31 August 2009 using a r and omised incomplete block design based on case vignettes , and using a self-completed postal or online question naire . PARTICIPANTS A sample of GPs , stratified by location and r and omly selected from a data base of GPs maintained by the Australasian Medical Publishing Company . MAIN OUTCOME MEASURES Proportion of vignettes that were deemed to reflect a high probability of cancer being referred ; and the patient and clinician factors that were the strongest predictors of referral . RESULTS Of the 3082 GPs who were selected for participation , 1402 responded , giving a response rate of 45.5 % . Overall , for vignettes identified as describing women with a high probability of cancer , 75 % were referred by metropolitan GPs and 73 % by rural practitioners . Metropolitan GPs were significantly more likely to refer women in scenarios indicative of endometrial cancer than rural GPs . For all three cancers , GPs were significantly more likely to refer a patient to a gynaecologist ( between 70.8 % and 95.4 % ) than a gynaecological oncologist . Metropolitan GPs had significantly greater access to both private and public gynaecological oncologists than their rural counterparts . Referral rates were higher for ovarian and cervical cancer ( 83 % and 80 % , respectively ) and lower for endometrial cancer ( 68 % ) . For all three cancers , patient factors were stronger predictors of referral than the demographic factors of participating GPs . CONCLUSION There appears to be significant variation in referral practice s among GPs and this variation is greater for endometrial cancer , for which there are currently no evidence -based clinical practice guidelines in Australia . There is a need for further research into underst and ing the basis of these differences , including a review of the existing guidelines for ovarian and cervical cancer and the development of guidelines for endometrial cancer Background Disadvantaged population s face many barriers to cancer care , including limited support in navigating through the complexities of the healthcare system . Family members play an integral role in caring for patients and provide valuable care coordination ; however , the effect of family navigators on adherence to cancer screening has not previously been evaluated . Training and evaluating trusted family members and other support persons may improve cancer outcomes for vulnerable patients . Methods Guided by principles of community based participatory research ( CBPR ) , “ Evaluating Coaches of Older Adults for Cancer Care and Healthy Behaviors ( COACH ) ” is a community-based r and omized controlled trial to assess the effectiveness of a trained participant- design ated coach ( support person or care giver ) in navigating cancer-screening for older African American adults , 50–74 years old . Participants are r and omly assigned as dyads ( participant + coach pair ) to receiving either printed educational material s only ( PEM — control group ) or educational material s plus coach training ( COACH — intervention group ) . We defined a coach as family member , friend , or other lay support person design ated by the older adult . The coach training is design ed as a one-time , 35- to 40-minute training consisting of : 1 ) a didactic session that covers the role of the coach , basic facts about colorectal , breast and cervical cancers ( including risk factors , signs and symptoms and screening modalities ) , engaging the healthcare provider in cancer screening , insurance coverage for screening , and related healthcare issues , 2 ) three video skits addressing misconceptions about and planning for cancer screening , and 3 ) an interactive role-play session with the trainer to reinforce and practice strategies for encouraging the participant to get screened . The primary study outcome is the difference in the proportion of participants completing at least one of the recommended screenings ( for breast , cervix or colorectal cancer ) between the control and intervention groups . Discussion Building on trusted patient contacts to encourage cancer screening , COACH is a highly sustainable intervention in a high-risk population . It has the potential to minimize the effect of mistrust of the medical establishment on screening behaviors by mobilizing participants ’ existing support networks . If effective , the intervention could have a high impact on health care disparities research across multiple diseases . Trial registration Clinical Trials.gov ( NCT01613430 ) . Registered June 5 , Non-r and omised studies of the effects of interventions are critical to many areas of healthcare evaluation , but their results may be biased . It is therefore important to underst and and appraise their strengths and weaknesses . We developed ROBINS-I ( “ Risk Of Bias In Non-r and omised Studies - of Interventions ” ) , a new tool for evaluating risk of bias in estimates of the comparative effectiveness ( harm or benefit ) of interventions from studies that did not use r and omisation to allocate units ( individuals or clusters of individuals ) to comparison groups . The tool will be particularly useful to those undertaking systematic review s that include non-r and omised studies Background The grading of recommendation , assessment , development and evaluation ( GRADE ) approach is widely implemented in health technology assessment and guideline development organisations throughout the world . GRADE provides a transparent approach to reaching judgements about the quality of evidence on the effects of a health care intervention , but is complex and therefore challenging to apply in a consistent manner . Methods We developed a checklist to guide the research er to extract the data required to make a GRADE assessment . We applied the checklist to 29 meta-analyses of r and omised controlled trials on the effectiveness of health care interventions . Two review ers used the checklist for each paper and used these data to rate the quality of evidence for a particular outcome . Results For most ( 70 % ) checklist items , there was good agreement between review ers . The main problems were for items relating to indirectness where considerable judgement is required . Conclusions There was consistent agreement between review ers on most items in the checklist . The use of this checklist may be an aid to improving the consistency and reproducibility of GRADE assessment s , particularly for inexperienced users or in rapid review s without the re sources to conduct assessment s by two research ers independently A postmenopausal bleeding ( PMB ) clinic was set up to provide quicker access for consultation , transvaginal ultrasound ( TVS ) and pipelle endometrial sampling in one visit . The aim of the study was to evaluate the impact of a one-stop PMB clinic on reaching a diagnosis and initiating treatment . One hundred and seven women have been referred to PMB clinic since the service started . We analysed the prospect i ve findings of 80 patients who met the criteria of direct GP referral to PMB clinic . The mean time from GP referral to consultation at PMB clinic was 14.8 days ( range : 2 - 24 days ) ; 97.5 % of women had TVS and abnormal findings were reported in 67.5 % . Pipelle endometrial sampling was performed in 31 patients and a sample obtained successfully in 21 women . Ten women were referred directly for diagnostic hysteroscopy and another 10 had hysteroscopy after a failed pipelle sampling . Twenty-four women ( 30 % ) were discharged back to their general practitioners ( GPs ) after reassurance by consultation and normal TVS . Seventy women ( 87.5 % ) considered a single PMB clinic visit was satisfactory . This study demonstrates the effective role of the one-stop PMB clinic to provide quick reassurance , arrive at a diagnosis and initiate plan of management during a single outpatient visit The value of any new therapeutic strategy or treatment is determined by the magnitude of its clinical benefit balanced against its cost . Evidence for clinical benefit from new treatment options is derived from clinical research , in particular phase III r and omised trials , which generate unbiased data regarding the efficacy , benefit and safety of new therapeutic approaches . To date , there is no st and ard tool for grading the magnitude of clinical benefit of cancer therapies , which may range from trivial ( median progression-free survival advantage of only a few weeks ) to substantial ( improved long-term survival ) . Indeed , in the absence of a st and ardised approach for grading the magnitude of clinical benefit , conclusions and recommendations derived from studies are often hotly disputed and very modest incremental advances have often been presented , discussed and promoted as major advances or ' breakthroughs ' . Recognising the importance of presenting clear and unbiased statements regarding the magnitude of the clinical benefit from new therapeutic approaches derived from high- quality clinical trials , the European Society for Medical Oncology ( ESMO ) has developed a vali date d and reproducible tool to assess the magnitude of clinical benefit for cancer medicines , the ESMO Magnitude of Clinical Benefit Scale ( ESMO-MCBS ) . This tool uses a rational , structured and consistent approach to derive a relative ranking of the magnitude of clinical ly meaningful benefit that can be expected from a new anti-cancer treatment . The ESMO-MCBS is an important first step to the critical public policy issue of value in cancer care , helping to frame the appropriate use of limited public and personal re sources to deliver cost-effective and affordable cancer care . The ESMO-MCBS will be a dynamic tool and its criteria will be revised on a regular basis The cluster r and omized trial with a concurrent economic evaluation is considered the gold st and ard evaluative design for the conduct of implementation research evaluating different strategies to promote the transfer of research findings into clinical practice . This has implication s for the planning of such studies , as information is needed on the effects of clustering on both effectiveness and efficiency outcomes . This paper describes the design considerations specific to implementation research studies , focusing particularly on the estimation of sample size requirements and on the need for reliable information on intracluster correlation coefficients for both effectiveness and efficiency outcomes OBJECTIVE To evaluate endometrial cancer ( EC ) risk assessment and early detection strategies in high-risk population s , we design ed a large , prospect i ve cohort study of women undergoing endometrial evaluation to assess risk factors and collect novel biospecimens for future testing of emerging EC biomarkers . Here we report on the baseline findings of this study . METHODS Women aged ≥45 years were enrolled at the Mayo Clinic from February 2013-June 2018 . Risk factors included age , body mass index ( BMI ) , smoking , oral contraceptive and hormone therapy use , and parity . We collected vaginal tampons , endometrial biopsies , and Tao brush sample s. We estimated mutually-adjusted odds ratios ( OR ) and 95 % confidence intervals ( CI ) using multinomial logistic regression ; outcomes included EC , atypical hyperplasia , hyperplasia without atypia , disordered proliferative endometrium , and polyps , versus normal endometrium . RESULTS Subjects included 1205 women with a mean age of 55 years ; 55 % were postmenopausal , and 90 % had abnormal uterine bleeding . The prevalence of EC was 4.1 % ( n = 49 ) , predominantly diagnosed in postmenopausal women ( 85.7 % ) . Tampons and Tao brushings were obtained from 99 % and 68 % of women , respectively . Age ( OR 1.14 , 95 % CI 1.1 - 1.2 ) and BMI ( OR 1.39 , 95 % CI 1.1 - 1.7 ) were positively associated with EC ; atypical hyperplasia ( OR 1.07 , 95 % CI 1.0 - 1.1 ; OR 2.00 , 95 % CI 1.5 - 2.6 , respectively ) , and polyps ( OR 1.06 , 95 % CI 1.0 - 1.1 ; OR 1.17 , 95 % CI 1.0 - 1.3 , respectively ) ; hormone therapy use and smoking were inversely associated with EC ( OR 0.42 , 95 % , 0.2 - 0.9 ; OR 0.43 , 95 % CI , 0.2 - 0.9 , respectively ) . Parity and past oral contraception use were not associated with EC . CONCLUSIONS Well-established EC risk factors may have less discriminatory accuracy in high-risk population s. Future analyses will integrate risk factor assessment with biomarker testing for EC detection
Output:
| There is currently an absence of evidence to indicate the effectiveness of health education interventions involving healthcare providers or individuals or both to promote early presentation and referral for women with endometrial cancer symptoms . |
MS211501 | ***TASK*** the task is to summarize an input biomedical literature 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 pilot aims to better underst and the market for childcare in Saudi Arabia – both the supply and dem and sides – and to design a r and omized controlled experiment to test whether access to affordable day care ( in the form of subsidies , for example ) would incentivize Saudi mothers to search actively for employment and to remain employed once they are hired . In addition , the study seeks to underst and the degree to which employment early on in one ’s life impacts employment in later stages . The pilot will provide information on the groups of women the experiment should target , appropriate levels for the childcare subsidy , and the quality and current geographic locations of daycare sites . Expected Impact Determine the effects of facilitating childcare access on Saudi women ’s employment . PRINCIPAL INVESTIGATORS Boston University Patricia Cortes Harvard University Claudia Goldin Swarthmore College Jennifer BACKGROUND School-based body mass index screenings ( S BMI S ) have been controversial . We aim ed to determine if parents would indicate improved utility with S BMI S when the report included parent education and whether parental intent to modify obesity risk factors would vary with report type or child weight . METHODS A cluster-controlled trial was conducted with 31 elementary schools r and omized to distribute a st and ard S BMI S report or the st and ard report plus education ( S BMI S+ ) . A r and om sub sample of parents completed a mailed survey ( 731 S BMI S , 738 S BMI S+ ) . Using a two-stage cluster sampling design , logistic regression models with school-level r and om effect were used to assess differences between conditions and by weight category . RESULTS Parents in the S BMI S+ condition vs. the st and ard condition were more likely to indicate that the report provided useful information ( not significant ) and an intent to help their child get enough sleep ( p < 0.001 ) . Parents of children who were overweight or obese were less likely than parents of children who were not to indicate that the report provided useful information about their child 's weight status ( p < 0.001 ) or access to re sources ( p < 0.05 ) . However , these parents were more likely to plan a visit to healthcare provider ( p < 0.001 ) and to intend to limit sugar-sweetened beverages ( p < 0.05 ) . CONCLUSIONS Parental education can enhance the utility of the S BMI S report and parental intention to modify at least one obesity risk factor . S BMI S reports prompted parents of children with overweight and obesity to seek clinical care and limit sugar-sweetened drinks Objectives As parents of young children are often unaware their child is overweight , screening provides the opportunity to inform parents and provide the impetus for behaviour change . We aim ed to determine if parents could recall and underst and the information they received about their overweight child after weight screening . Design R and omised controlled trial of different methods of feedback . Setting Participants were recruited through primary and secondary care but appointments took place at a University research clinic . Participants and intervention 1093 children aged 4–8 years were screened . Only overweight children ( n=271 , 24.7 % ) are included in this study . Parents of overweight children were r and omised to receive feedback regarding their child 's weight using best practice care ( BPC ) or motivational interviewing ( MI ) at face-to-face interviews typically lasting 20–40 min . 244 ( 90 % ) parents participated in a follow-up interview 2 weeks later to assess recall and underst and ing of information from the feedback session . Primary and secondary outcome measures Interviews were audio-taped and transcribed verbatim before coding for amount and accuracy of recall . Scores were calculated for total recall and sub-categories of interest . Results Overall , 39 % of the information was recalled ( mean score 6.3 from possible score of 16 ) . Parents given feedback via BPC recalled more than those in the MI group ( difference in total score 0.48 ; 95 % CI 0.05 to 0.92 ) . Although 94 % of parents were able to correctly recall their child 's weight status , fewer than 10 parents could accurately describe what the measurements meant . Maternal education ( 0.81 ; 0.25 to 1.37 ) and parental ratings of how useful they found the information ( 0.19 ; 0.04 to 0.35 ) were significant predictors of recall score in multivariate analyses . Conclusions While parents remember that their child 's body mass index is higher than recommended , they are unable to remember much of the information and advice provided about the result . Trial registration number Australian New Zeal and Clinical Trials Registry ACTRN12609000749202 Background Because parental recognition of overweight in young children is poor , we need to determine how best to inform parents that their child is overweight in a way that enhances their acceptance and supports motivation for positive change . This study will assess 1 ) whether weight feedback delivered using motivational interviewing increases parental acceptance of their child 's weight status and enhances motivation for behaviour change , and 2 ) whether a family-based individualised lifestyle intervention , delivered primarily by a MInT mentor with limited support from " expert " consultants in psychology , nutrition and physical activity , can improve weight outcomes after 12 and 24 months in young overweight children , compared with usual care . Methods / Design 1500 children aged 4 - 8 years will be screened for overweight ( height , weight , waist , blood pressure , body composition ) . Parents will complete question naires on feeding practice s , physical activity , diet , parenting , motivation for healthy lifestyles , and demographics . Parents of children classified as overweight ( BMI ≥ CDC 85th ) will receive feedback about the results using Motivational interviewing or Usual care . Parental responses to feedback will be assessed two weeks later and participants will be invited into the intervention . Additional baseline measurements ( accelerometry , diet , quality of life , child behaviour ) will be collected and families will be r and omised to Tailored package or Usual care . Parents in the Usual care condition will meet once with an advisor who will offer general advice regarding healthy eating and activity . Parents in the Tailored package condition will attend a single session with an " expert team " ( MInT mentor , dietitian , physical activity advisor , clinical psychologist ) to identify current challenges for the family , develop tailored goals for change , and plan behavioural strategies that best suit each family . The mentor will continue to provide support to the family via telephone and in-person consultations , decreasing in frequency over the two-year intervention . Outcome measures will be obtained at baseline , 12 and 24 months . Discussion This trial offers a unique opportunity to identify effective ways of providing feedback to parents about their child 's weight status and to assess the efficacy of a supportive , individualised early intervention to improve weight outcomes in young children . Trial registration Australian New Zeal and Clinical Trials Registry Background The National Child Measurement Programme was established to measure the height and weight of children at primary school in Engl and and provides parents with feedback about their child ’s weight status . In this study we will evaluate the impact of the National Child Measurement Programme feedback on parental risk perceptions of overweight , lifestyle behaviour and health service use . Methods The study will be a prospect i ve cohort study of parents of children enrolled in the National Child Measurement Programme and key service providers from 5 primary care trusts ( administrative bodies responsible for providing primary and secondary care services ) . We will conduct baseline question naires , followed by provision of weight feedback and 3 follow up question naires over the course of a year . Question naires will measure change in parental risk perception of overweight , health behaviours and health service use . Qualitative interviews will be used to identify barriers and facilitators to change . This study will produce preliminary data on National Health Service costs associated with weight feedback and determine which feedback approach ( letter and letter plus telephone ) is more effective . Discussion This study will provide the first large scale evaluation of the National Child Measurement Programme feedback . Findings from this evaluation will inform future planning of the National Child Measurement Programme AIM To determine whether a single session of motivational interviewing ( MI ) for feedback of a child 's overweight status promotes engagement in treatment following screening . METHODS One thous and ninety-three children aged 4 - 8 years were recruited through primary and secondary care to attend health screening , including assessment of parenting practice s and motivation ( question naire ) . Families with normal-weight children were informed about their child 's weight but had no further involvement . Parents of overweight ( body mass index ≥ 85th percentile ) children ( n = 271 ) were r and omised to receive weight feedback via MI or best practice care ( BPC ) using a traffic light concept to indicate degree of health risk . Follow-up interviews were held 2 weeks later to examine intervention uptake , changes to motivation and behaviour , and parental response to feedback . RESULTS Recruitment into the intervention was high ( 76 % ) and not altered by feedback condition ( percentage difference 6.6 ( 95 % confidence interval -2.9 , 16.0 ) . High scores on the Health Care Climate Question naire ( rating of the interviewer ) indicated satisfaction with how the information was provided to parents . No differences were observed in multiple indicators of harm . However , self-determined motivation for healthy life-styles was significantly higher in the MI condition at follow-up ( 0.18 : 0.00 , 0.35 ) , after only a single session of MI . CONCLUSIONS MI and BPC were both successful in encouraging parents to participate in a family-based intervention , with MI offering little significant benefit over BPC . A traffic light approach to weight feedback is a suitable way of providing sensitive information to parents not expecting such news School-based body mass index ( BMI ) screening and reporting could have a positive impact on student health , but best practice s for writing a report are unknown . Building on previous qualitative work , 8 focus groups were conducted with a diverse group of California parents ( n = 79 ) to elicit feedback on report content and design . Results indicate that parents want a visually appealing , picture-heavy report that clearly defines BMI , avoids stigmatizing language , and includes recommendations for appropriate actions whole families can take . Next steps involve using the final report in a statewide , r and omized trial to determine the effectiveness of school-based BMI screening and reporting in reducing childhood obesity
Output:
| Studies of effect found that the format of feedback made little or no difference in parents attending further treatment , recognising their child as overweight or obese , reactions to the way the weight notification is given , motivation for lifestyle change , underst and ing how to reduce the risk of overweight , or taking any action .
However , parents receiving feedback with motivational interviewing have somewhat greater satisfaction with the way the healthcare provider supports them .
Qualitative studies found that parents had clear preferences for the format , timing , content and amount of information they wanted to receive in relation to both the weighing process and weight notification .
They also had clear preferences for how they wanted health care providers to interact and communicate with them and their children .
Both parents and children often felt that they were not receiving enough information and worried about how their results would be kept private .
Many parents experienced an emotional response when told about their child ’s weight ranging from positive , disbelief and negative feelings .
Those who reacted with disbelief or negatively were less likely to accept their child ’s weight status and /or act upon the notification letter . |
MS211502 | ***TASK*** the task is to summarize an input biomedical literature 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 AIM Interferon-alpha treatment of chronic hepatitis C is beneficial in only 20 - 30 % of patients . This study evaluates if combination therapy with Interferon-alfa plus ribavirin is effective in inducing a response in patients who did not respond to , or relapsed after , a st and ard Interferon-alfa treatment . PATIENTS AND METHODS A total of 88 patients , 49 non-responders and 39 relapsers to previous Interferon-alfa therapy , were r and omized to receive either natural Interferon-alfa ( 6 MU t.i.w . ) plus ribavirin ( 1000 mg/daily ) or natural Interferon-alfa alone ( 6 MU t.i.w . ) for 6 months . All were followed for 12 months after stopping therapy . Serum aminotransferase levels were assessed monthly and HCV RNA was evaluated by RT-PCR ( Amplicor , Roche ) at end of therapy and the end of follow-up . RESULTS After treatment , a higher response rate defined as return to normal of aminotransferases and absence of serum HCV RNA was observed among patients treated with Interferon-alfa-ribavirin : 4/28 ( 14 % ) vs 1/21 ( 5 % ) non-responder patients and 9/19 ( 47 % ) vs 5/20 ( 25 % ) in the relapsers group . At the end of follow-up , a sustained response was found only in the combination treatment group : 4 % and 32 % in non-responder and relapser patients , respectively . CONCLUSIONS Our results suggest that retreatment with natural Interferon-alfa plus ribavirin is more effective than Interferon-alfa alone in increasing the response rate in patients with chronic hepatitis C who relapse after a previous st and ard IFN treatment whereas it is less effective in non-responder patients A r and om-primed complementary DNA library was constructed from plasma containing the uncharacterized non-A , non-B hepatitis ( NANBH ) agent and screened with serum from a patient diagnosed with NANBH . A complementary DNA clone was isolated that was shown to encode an antigen associated specifically with NANBH infections . This clone is not derived from host DNA but from an RNA molecule present in NANBH infections that consists of at least 10,000 nucleotides and that is positive-str and ed with respect to the encoded NANBH antigen . These data indicate that this clone is derived from the genome of the NANBH agent and are consistent with the agent being similar to the togaviridae or flaviviridae . This molecular approach should be of great value in the isolation and characterization of other unidentified infectious agents The coadministration of ribavirin with recombinant interferon alfa-2b ( rIFN-alpha 2b ) compared with rIFN-alpha 2b alone markedly enhanced sustained virologic response rates in relapsed and treatment-naive chronic hepatitis C patients . The potential for ribavirin to likewise exacerbate the adverse events associated with the alpha interferons is review ed . The overall safety and tolerability of combination rIFN-alpha 2b/ribavirin therapy was evaluated in 2,089 patients treated in phase III clinical studies conducted in the United States and internationally . Serious adverse events were also evaluated on an interim basis in > 25,000 patients --a majority of whom were treated with combination therapy ( open label)--treated worldwide in investigator-initiated studies . Patients in the phase III studies received 3 million International Units rIFN-alpha 2b three times per week by subcutaneous injection plus either ribavirin or placebo orally in divided daily doses of 1,000 or 1,200 mg for patients weighing < or = 75 or > 75 kg , respectively . Adverse event frequency and severity and dose modifications were recorded throughout the 24-week ( relapse ) or 48-week ( naive ) treatment period and 24-week follow-up period . Clinical ly significant adverse events included anemia and depression . There was no evidence that the adverse effects of alpha interferon ( e.g. , fatigue , depression , neutropenia ) were exacerbated by ribavirin . Severe adverse events were limited due to strict adherence to dose-modification criteria ; approximately 6 % to 9 % of patients discontinued combination therapy because of an adverse event . Clinical ly serious adverse events , dose reductions and discontinuations , and potential mechanisms of toxicity associated with rIFN-alpha 2b and ribavirin are examined Chronic active hepatitis due to HCV represents a severe progressive disorder of the liver , At present , Interferon seems to be the most efficacious treatment available , however , only 20 - 25 % of the patients treated achieve complete remission . The efficacy has , therefore , been evaluated of Ribavirin , a nucleoside analogue active both on DNA and RNA viruses , in the treatment of non responders to a previous course of interferon . Twenty patients were r and omly assigned to two groups : A ) received the association R ( 800 mg/day for 2 months)+interferon ( 9 Mu/week for 6 months ) ; B ) received IFN ( 9 Mu/week for 6 months ) . All patients completed the study without important side effects . Four patients in group A presented reduced ALT and loss of viraemia during treatment with Ribavirin . Only one patient in group B had reduced indices of cell lysis and was negative for HCV-RNA during the course of the study . However , viremia and an increase of ALT values were observed in all of these subjects once treatment was interrupted . The results emerging from this study indicate that Ribavirin therapy , at the dose and duration of treatment employed , is not sufficient to change the natural course of events of chronic active hepatitis from HCV BACKGROUND More than 70 % of patients with chronic hepatitis C are resistant to interferon therapy . Ribavirin , in association with interferon , has been demonstrated as effective , at a dose of 800 - 1200 mg/day , but the efficacy of a lower dose has not been established . METHODS We assessed the effectiveness of the combination of 600 mg/day of ribavirin plus 3 MU of interferon over a period of 6 months , in a group of patients previously resistant to interferon . Sixty-two patients with chronic hepatitis C with serum and hepatic HCV RNA relapsers or non-responders to interferon , were r and omly divided into two groups : group A received 3 MU of interferon alpha-2b , three times a week for 6 months ; group B was given the same dose plus 600 mg per day of ribavirin for 6 months . Two patients from each group dropped from therapy . One patient from group A and two from group B withdrew from treatment because of adverse effects . RESULTS Mean alanine aminotransferase levels were similar in both groups throughout the study . A sustained response was observed in 7 % and 7.4 % of groups A and B with short-term response in 39 % and 59 % , and no response in 54 % and 34 % from both groups respectively ( non-significant ) . At 12 months , 4 and 7 patients from groups A and B respectively , cleared serum HCV RNA however , only one sustained responder from each group cleared HCV RNA from peripheral blood mononuclear cells . At 18 months , 3 patients remained serum HCV RNA negative . Adverse effects were similar . Only haemoglobin values were lower in group B in the first month of therapy ( p<0.05 ) . CONCLUSION In conclusion , the combination of 3 MU of interferon plus 600 mg of ribavirin is not effective in chronic hepatitis C resistant to interferon Although evidence of virologic elimination , normalization of serum alanine aminotransferase levels , and reduction in liver inflammation are the principal therapeutic outcome goals in chronic hepatitis C patients , improvement in health-related quality of life ( HQL ) is also an important aspect of therapeutic outcome . In a recent report of chronic hepatitis C patients treated for 24 weeks with interferon , sustained virologic response ( 24 weeks post-treatment ) was associated with improvement in HQL compared with nonresponse . We report on the relationship between sustained virologic response and Hepatitis Quality -of-Life Question naire ( HQLQ ) survey results of patients who relapsed after a previous course of interferon alfa who were subsequently treated with recombinant interferon alfa-2b ( rIFN-alpha 2b ) either alone or in combination with ribavirin . The HQLQ was administered at baseline , at treatment Weeks 12 and 24 , and at follow-up Weeks 12 and 24 . All patients received rIFN-alpha 2b 3 million International Units by subcutaneous injection three times weekly plus either oral ribavirin ( 1,000 or 1,200 mg ) or placebo daily for 24 weeks . At baseline , patients scored lower than adjusted population norms in HQL . Relative to patients treated with rIFN-alpha 2b monotherapy , patients receiving combination therapy showed better HQL in 6 of 13 domains . Furthermore , sustained virologic response in either treatment group was associated with improvement in the scores of both generic and hepatitis-specific HQL survey domains . These results indicate that successful therapeutic resolution of hepatitis C infection improves HQL as assessed by generic and hepatitis C-specific measures of functional health and well-being . Furthermore , improvements in HQL outcome measures may predict reduced dem and for health care re sources and greater productivity in the workplace BACKGROUND & AIMS Sustained response to interferon treatment for chronic hepatitis C is unsatisfactory . This study examined whether combining interferon alfa with ribavirin induces a better sustained efficacy than interferon alone in the treatment of chronic hepatitis C. METHODS Sixty noncirrhotic patients with chronic hepatitis C were r and omly assigned to three groups . Group 1 received 1200 mg oral ribavirin daily plus 3 million units of recombinant interferon alfa 2a thrice weekly for 24 weeks , group 2 received the same dose of interferon alfa 2a alone for 24 weeks , and group 3 received no treatment . The patients were then followed up for an additional 96 weeks . RESULTS At the end of treatment , a complete response ( normal serum alanine aminotransferase level and undetectable serum hepatitis C virus RNA ) was achieved in 16 of the 21 patients in group 1 ( 76 % ) , as compared with 6 of 19 in group 2 ( 32 % ) and none in group 3 . At 96 weeks after the end of treatment , patients in group 1 sustained a higher complete response rate than patients in group 2 ( 43 % vs. 6 % ) . CONCLUSIONS Combined treatment with ribavirin and interferon alfa 2a for 24 weeks is more effective than interferon alfa 2a alone for the treatment of chronic hepatitis C. The biochemical and virological responses were sustained in about one half of the treated patients for at least 2 years after cessation of the therapy We evaluated oral ribavirin as therapy for chronic hepatitis C infection in a pilot study including 10 patients . Patients ( 7 men , 3 women ; mean age 40 years , range 23 - 54 ) all had biopsy-proven chronic non-A , non-B hepatitis and were repeatedly positive for antibodies to hepatitis C virus . Treatment was with oral ribavirin 1000 - 1200 mg per day in two divided doses for 12 weeks . The median serum alanine aminotransferase concentration for all patients at enrollment was 3.15 mu kat/l ( range 1.22 - 7.79 ) and decreased significantly ( p less than 0.005 ) to 1.25 mu kat/l ( 0.78 - 2.04 ) after 12 weeks of treatment . Within 6 weeks of the end of treatment the median serum alanine aminotransferase concentration was not significantly different from that before treatment . Side-effects were mild and fully reversible after cessation of therapy . We conclude that ribavirin is the first drug to offer a potentially effective oral treatment for chronic hepatitis C. It should be further evaluated in controlled trials , possibly in combination with interferon alpha BACKGROUND / AIMS A sustained biochemical and virologic response to st and ard interferon therapy for chronic hepatitis C is seen in no more than 25 % of patients , and the efficacy of re-treatment or of higher doses in non-responders and relapsers has not been established . A more effective therapy for interferon alfa-resistant hepatitis C is needed . METHODS A study of ribavirin plus interferon alfa combination therapy was conducted in 30 patients with chronic hepatitis C resistant to a previous st and ard course of interferon alfa ( 14 interferon non-responders , 16 interferon relapsers ) . Patients were r and omly assigned to receive either ribavirin , 800 mg daily , and interferon alfa , 3 MU thrice weekly ( n = 15 ) , or interferon alfa alone , 3 MU thrice weekly ( n = 15 ) , for 6 months . RESULTS At the end of treatment , normal alanine aminotransferase levels were observed in eight patients in the combination therapy group : one ( 14 % ) interferon non-responder and seven ( 87 % ) interferon relapsers ( p = 0.01 ) . Six months post-ther
Output:
| Results of these trials indicate that combination therapy produces larger sustained response rates than monotherapy .
Thus , ribavirin substantially increases drug costs compared with interferon monotherapy .
This shows it is worth treating all patients with combination therapy as first-line treatment for 6 months , but only worth treating those with one or two response factors for a further 6 months .
Those with three or four factors do well by 6 months , but gain very little from |
MS211503 | ***TASK*** the task is to summarize an input biomedical literature 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 Adherence to evidence based medicines in patients who have experienced a myocardial infa rct ion remains low . Individual ’s beliefs towards their medicines are a strong predictor of adherence and may influence other factors that impact on adherence . Objective To investigate if community pharmacists discussing patients ’ beliefs about their medicines improved medication adherence at 12 months post myocardial infa rct ion . Setting This study included 200 patients discharged from a public teaching hospital in Queensl and , Australia , following a myocardial infa rct ion . Patients were r and omised into intervention ( n = 100 ) and control groups ( n = 100 ) and followed for 12 months . Method All patients were interviewed between 5 to 6 weeks , at 6 and 12 months post discharge by the research er using the repertory grid technique . This technique was used to elicit the patient ’s individualised beliefs about their medicines for their myocardial infa rct ion . In the intervention group , patients ’ beliefs about their medicines were communicated by the research er to their community pharmacist . The pharmacist used this information to tailor their discussion with the patient about their medication beliefs at design ated time points ( 3 and 6 months post discharge ) . The control group was provided with usual care . Main outcome measure The difference in non-adherence measured using a medication possession ratio between the intervention and control groups at 12 months post myocardial infa rct ion . Results There were 137 patients remaining in the study ( intervention group n = 72 , control group n = 65 ) at 12 months . In the intervention group 29 % ( n = 20 ) of patients were non-adherent compared to 25 % ( n = 16 ) of patients in control group . Conclusion Discussing patients ’ beliefs about their medicines for their myocardial infa rct ion did not improve medication adherence . Further research on patients beliefs should focus on targeting non-adherent patients whose reasons for their non-adherence is driven by their medication beliefs BACKGROUND Adherence to drugs and healthy lifestyles is low after acute coronary syndrome . We assessed whether trained community health workers could improve adherence to drugs , lifestyle changes , and clinical risk markers in patients with acute coronary syndrome in India . METHODS In this study done at 14 hospitals in India we r and omly assigned ( 1:1 ) patients with acute coronary syndrome 1 or 2 days before discharge from hospital to a community health worker-based intervention group or a st and ard care group . Patients were r and omly assigned with a telephone r and omisation service . In the intervention group , during four in-hospital and two home visits , community health workers used unstructured discussion s , visual methods , and patient diaries to educate patients on healthy lifestyle and drugs , and measures to enhance adherence . The primary outcome was adherence to proven secondary prevention drugs ( antiplatelet drugs , β blockers , angiotensin-converting enzyme inhibitors or angiotensin receptor blockers , and statins ) estimated using a Composite Medication Adherence Scale at 1 year . The secondary outcomes were difference in lifestyle factors ( diet , exercise , and tobacco and alcohol use ) , and clinical risk markers ( blood pressure , bodyweight , BMI , heart rate , and lipids ) . All analyses were by intention to treat . This trial is registered with the Clinical Trial Registry of India , number REF/2013/03/004737 , and Clinical Trials.gov , number NCT01207700 . RESULTS Between Aug 23 , 2011 , and June 25 , 2012 , 806 participants were r and omly assigned ( 405 to a community health worker-based intervention group and 401 to a st and ard care group ) . At 1 year , 40 patients had died and 15 had discontinued or been lost to follow-up , so 750 ( 93 % ) were included in the analyses ( 375 in each group ) . Secondary prevention drugs prescribed at discharge were 98 % ( 786/803 ) for any antiplatelet drug , 79 % ( 638/803 ) for dual antiplatelet drugs , 69 % ( 555/803 ) for β blockers , 69 % ( 552/803 ) for angiotensin-converting enzyme inhibitors and angiotensin receptor blockers , and 95 % ( 762/803 ) for statins . At one year , overall adherence ( ≥80 % ) to prescribed evidence -based drugs was higher in the intervention group than in the control group ( 97 % vs 92 % , odds ratio [ OR ] 2·62 , 95 % CI 1·32 - 5·19 ; p=0·006 ) . For individual drugs , we recorded significant differences for angiotensin-converting enzyme inhibitors and angiotensin receptor blockers ( 97 % [ 233/240 ] in the intervention group vs 93 % [ 223/240 ] in the control group ; p=0·036 ) and statins ( 97 % [ 346/356 ] vs 93 % [ 321/345 ] ; p=0·011 ) . The intervention group had significantly greater adherence to smoking cessation ( 85 % [ 110/129 ] vs 52 % [ 71/138 ] , OR 5·46 , 95 % CI 3·03 - 9·86 ; p<0·0001 ) , regular physical activity ( 89 % [ 333/375 ] vs 60 % [ 226/375 ] , OR 5·23 , 95 % CI 3·57 - 7·66 ; p<0·0001 ) , and healthy diet ( score 5·0 vs 3·0 , OR 2·47 , 95 % CI 1·88 - 3·25 ; p<0·0001 ) . More patients in the intervention group had stopped alcohol use at 1 year ( 87 % [ 64/74 ] vs 46 % [ 46/67 ] , OR 2·92 , 95 % CI 1·26 - 6·79 ; p = 0·010 ) . At 1 year , the mean systolic blood pressure ( 124·4 mm Hg [ SD 13·5 ] vs 128·0 mm Hg [ 15·9 ] ; p=0·002 ) , weight ( 65·0 kg [ 11·0 ] vs 66·5 kg [ 11·5 ] ; p<0·0001 ) , cholesterol ( 157·0 [ 40·2 ] vs 166·9 [ 48·4 ] ; p=0·184 ) , LDL ( 81·0 [ 20·6 ] vs 87·3 [ 29·9 ] ; p=0·191 ) , HDL ( 42·0 [ 11·4 ] vs 38·2 [ 6·5 ] ; p=0·042 ) , and BMI ( 24·4 kg/m(2 ) [ SD 3·7 ] vs 25·0 kg/m(2 ) [ 3·8 ] ; p<0·0001 ) were lower in the intervention group than in the control group . However , we noted no significant difference in diastolic blood pressure and heart rate . INTERPRETATION A community health worker-based personalised intervention strategy in patients with acute coronary syndrome improved adherence to evidence -based drugs and healthy lifestyles , and result ed in an improvement in clinical risk markers . Integration of trained community health workers can improve secondary prevention in coronary artery disease . FUNDING US National Heart , Lung , and Blood Institute ( NHLBI ) , National Institutes of Health , Department of Health and Human Services , and the UnitedHealth group , USA Background : Adherence to dietary and medication regimen plays an important role in successful treatment and reduces the negative complications and severity of the disease . Therefore , the present study aim ed to investigate the effect of nurse-led telephone follow-up on the level of adherence to dietary and medication regimen among patients after Myocardial Infa rct ion ( MI ) . Methods : This non-blinded r and omized controlled clinical trial was conducted on 100 elderly patients with MI who had referred to the cardiovascular clinics in Shiraz . Participants were selected and r and omly assigned to intervention and control groups using balanced block r and omization method . The intervention group received a nurse-led telephone follow-up . The data were collected using a demographic question naire , Morisky ’s 8-item medication adherence question naire , and dietary adherence question naire before and three months after the intervention . Data analysis was done by the SPSS statistical software ( version 21 ) , using paired t-test for intra-group and Chi-square and t-test for between groups comparisons . Significance level was set at<0.05 . Results : The results of Chi-square test showed no statistically significant difference between the intervention and control groups with respect to their adherence to dietary and medication regimen before the intervention ( P>0.05 ) . However , a statistically significant difference was found between the two groups in this regard after the intervention ( P<0.05 ) . The mean differences of dietary and medication adherence scores between pre- and post-tests were significantly different between the two groups . Independent t-test showed these differences ( P=0.001 ) . Conclusion : The results of the present study confirmed the positive effects of nurse-led telephone follow-up as a method of tele-nursing on improvement of adherence to dietary and medication regimen in the patients with MI . Trial Registration Number : I RCT 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 We investigated whether an intervention mainly consisting of a signed agreement between patient and physician on the objectives to be reached , improves reaching these secondary prevention objectives in modifiable cardiovascular risk factors six-months after discharge following an acute coronary syndrome . Background There is room to improve mid-term adherence to clinical guidelines ' recommendations in coronary heart disease secondary prevention , specially non-pharmacological ones , often neglected . Methods In CAM-2 , patients discharged after an acute coronary syndrome were r and omly assigned to the intervention or the usual care group . The primary outcome was reaching therapeutic objectives in various secondary prevention variables : smoking , obesity , blood lipids , blood pressure control , exercise and taking of medication . Results 1757 patients were recruited in 64 hospitals and 1510 ( 762 in the intervention and 748 in the control group ) attended the six-months follow-up visit . After adjustment for potentially important variables , there were , between the intervention and control group , differences in the mean reduction of body mass index ( 0.5 vs. 0.2 ; p < 0.001 ) and waist circumference ( 1.6 cm vs. 0.6 cm ; p = 0.05 ) , proportion of patients who exercise regularly and those with total cholesterol below 175 mg/dl ( 64.7 % vs. 56.5 % ; p = 0.001 ) . The reported intake of medications was high in both groups for all the drugs considered with no differences except for statins ( 98.1 % vs. 95.9 % ; p = 0.029 ) . Conclusions At least in the short term , lifestyle changes among coronary heart disease patients are achievable by intensifying the responsibility of the patient himself by means of a simple and feasible intervention AIM AND BACKGROUND Studies have reported that adherence to medications after hospital discharge for myocardial infa rct ion is poor with about 12 % to 20 % of patients discontinue their medications six months after discharge . This study aim ed to examine the effect of self-efficacy enhancement program on medication adherence in post-acute myocardial infa rct ion patients . METHODS A total 44 patient with post-acute myocardial infa rct ion were recruited from the in-patient department , Police General Hospital . The participants were r and om assigned into control group and experimental group . The control group received conventional care while the experimental group attended a four-week self-efficacy enhancement program , which included motivation , skill practice , and monitoring skills . The mean self-efficacy score between groups was assessed . The pill count was used to measure medication adherence . Correlations between self-efficacy and medication adherence were examined . Data were analyzed using descriptive statistic , Pearson 's correlation , and t-test . RESULTS The mean score on medication adherence of the experiment group who attended the self-efficacy enhancement program was significantly greater than the control group ( t=-2.77 ; df=21 ; p=0.01 ) . The mean scores of self-efficacy between the experimental and control group were 35.73 ( SD=4.11 ) and 35.41 ( SD=3.78 ) . The correlations between self-efficacy and medication adherence were significantly ( r=1.00 , p=0.00 ) . CONCLUSION The effectiveness of self-efficacy enhancement program was effective in improving medication adherence in Thai post-acute myocardial infa rct ion Background : Short hospital stays for patients with acute coronary syndromes ( A
Output:
| HCP-led interventions for ACS patients appear to have a small positive impact on medication adherence .
While we were able to identify BCTs among interventions , data were insufficient to determine the impact of particular BCTs on study effectiveness . |
MS211504 | ***TASK*** the task is to summarize an input biomedical literature 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 Home detoxification is a recognized method of treating problem drinkers within their own home environment . The aim of this research is to determine whether a relatively brief psychological intervention adds to its effectiveness . METHODS A pragmatic trial with 91 participants r and omly assigned to either the psychological intervention or treatment as usual . Community Psychiatric Nurses were trained to administer the brief psychological intervention involving motivational interviewing , coping skills training and social support . A manual was developed in order to st and ardize the training and implementation . RESULTS At the 3 month and 12 month follow-up the psychological intervention result ed in significant positive changes in alcohol consumption , abstinent days , social satisfaction , self-esteem and alcohol-related problems . Further , a cost analysis confirmed that the psychological intervention was a ninth of the cost of inpatient treatment . CONCLUSIONS Adding a psychological intervention to a home detoxification programme was successful and cost-effective The purpose of this study was to compare the cost-effectiveness of conventional outpatient treatment for alcoholic patients ( CT ) with this same conventional treatment plus home visits ( HV ) , a new proposal for intervention within the Brazilian outpatient treatment system . A cost-effectiveness evaluation alongside a 12-week r and omized clinical trial was performed . We identified the re sources utilized by each intervention , as well as the cost according to National Health System ( SUS ) , Brazilian Medical Association ( AMB ) tables of fees , and others based on 2005 data . The incremental cost-effectiveness ratio ( ICER ) was estimated as the main outcome measure – abstinent cases at the end of treatment . There were 51.8 % abstinent cases for HV and 43.1 % for CT , a clinical ly relevant finding . Other outcome measures , such as quality of life , also showed significant improvements that favored HV . The baseline scenario presented an ICER of USD 1,852 . Sensitivity analysis showed an ICER of USD 689 ( scenario favoring HV ) and USD 2,334 ( scenario favoring CT ) . The HV treatment was found to be cost-effective according to the WHO Commission on Macroeconomics and Health The Home Detoxification Service ( HDS ) established in central Scotl and was introduced in response to a high admission rate of problem drinkers to the acute psychiatric wards in Bellsdyke Hospital . This paper reports the results of a comparison of two types of management for people referred to the HDS by local general practitioners ( family doctors ) . Ninety-five patients referred to the HDS were r and omly allocated to two groups of differing treatment intensities . With one group , the home detoxification ( HD ) programme was utilized and with the other , minimal intervention ( MI ) strategies were employed . Post-treatment outcome information collected after 6 months was examined in relation to drinking behaviour , changes in levels of alcohol-related problems and uptake of on-going support from other alcohol agencies . The majority of patients in both treatment groups demonstrated some degree of improvement in relation to these criteria and the most striking factor was that patients in the HD group remained abstinent twice as long after treatment as those in the MI group In this study , 20 subjects who had home detoxification with supervision and support from the Western Australian Alcohol and Drug Authority Community Nursing Service were matched with 20 subjects who had inpatient detoxification in the Authority 's detoxification facility . Subjects were interviewed between nine and 22 months ( mean 15.5 months ) after detoxification to compare client outcomes and the costs of home and inpatient detoxification . The results indicate that , for suitable clients , home detoxification was at least as beneficial as inpatient detoxification and that it was achieved at a much lower cost than inpatient care
Output:
| Community detoxification had high completion rates and was reported to be safe .
Compared to patients undergoing facility based detoxification , those who underwent community detoxification had better drinking outcomes .
Community detoxification was cheaper than facility based detoxification and generally had good acceptability by various stakeholders .
IMPLICATION S For certain patients , community detoxification should be considered as a viable option to increase access to care . |
MS211505 | ***TASK*** the task is to summarize an input biomedical literature 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 examined the effectiveness of ingesting a carbohydrate or carbohydrate + medium-chain triglycerides ( MCT ) on metabolism and cycling performance . Eight endurance-trained men [ peak O(2 ) uptake = 4.71 + /- 0.09 ( SE ) l/min ] completed 35 kJ/kg as quickly as possible [ time trial ( TT ) ] while consuming 250 ml/15 min of either a 6 % ( wt/vol ) carbohydrate solution ( C ) , a 6 % carbohydrate + 4.2 % MCT solution ( C+M ) , or a sweet placebo ( P ) . Time to complete the set amount of work was reduced in both C and C+M compared with P by 7 and 5 % , respectively ( C : 166 + /- 7 min ; C+M : 169 + /- 7 min ; P : 178 + /- 11 min ; P < 0.01 ) . Plasma glucose concentration was maintained at or above resting values throughout both C and C+M trials but decreased ( P < 0.05 ) below resting values in P at the completion of the TT . The estimated rate of carbohydrate oxidation was not different during the first 90 min of exercise but thereafter was reduced ( P < 0.05 ) in P and was maintained in both C and C+M. These data demonstrate that carbohydrate ingestion during exercise improves 100-km TT performance compared with a sweet placebo , but the addition of MCT does not provide any further performance enhancement This study analyzed the effect of caffeine ingestion on performance during a repeated- measures , 100-km , laboratory cycling time trial that included bouts of 1- and 4-km high intensity epochs ( HIE ) . Eight highly trained cyclists participated in 3 separate trials ' placebo ingestion before exercise with a placebo carbohydrate solution and placebo tablets during exercise ( Pl ) , or placebo ingestion before exercise with a 7 % carbohydrate drink and placebo tablets during exercise ( Cho ) , or caffeine tablet ingestion before and during exercise with 7 % carbohydrate ( Caf ) . Placebo ( twice ) or 6 mg.kg(-1 ) caffeine was ingested 60 min prior to starting 1 of the 3 cycling trials , during which subjects ingested either additional placebos or a caffeine maintenance dose of 0.33 mg.kg(-1 ) every 15 min to trial completion . The 100-km time trial consisted of five 1-km HIE after 10 , 32 , 52 , 72 , and 99 km , as well as four 4-km HIE after 20 , 40 , 60 , and 80 km . Subjects were instructed to complete the time trial and all HIE as fast as possible . Plasma ( caffeine ) was significantly higher during Caf ( 0.43 + /- 0.56 and 1.11 + /- 1.78 mM pre vs. post Pl ; and 47.32 + /- 12.01 and 72.43 + /- 29.08 mM pre vs. post Caf ) . Average power , HIE time to completion , and 100-km time to completion were not different between trials . Mean heart rates during both the 1-km HIE ( 184.0 + /- 9.8 Caf ; 177.0 + /- 5.8 Pl ; 177.4 + /- 8.9 Cho ) and 4-km HIE ( 181.7 + /- 5.7 Caf ; 174.3 + /- 7.2 Pl ; 175.6 + /- 7.6 Cho ; p < .05 ) was higher in Caf than in the other groups . No significant differences were found between groups for either EMG amplitude ( IEMG ) or mean power frequency spectrum ( MPFS ) . IEMG activity and performance were not different between groups but were both higher in the 1-km HIE , indicating the absence of peripheral fatigue and the presence of a central ly-regulated pacing strategy that is not altered by caffeine ingestion . Caffeine may be without ergogenic benefit during endurance exercise in which the athlete begins exercise with a defined , predetermined goal measured as speed or distance Most studies investigating the effects of acute carbohydrate ( CHO ) ingestion on post-exercise cytokine responses have involved fasted athletes . This study characterised the effects of acute CHO beverage ingestion preceded by consumption of a CHO-containing pre-exercise meal . Sixteen highly-trained male cyclists/triathletes ( age : 30.6 + /- 5.6 y ; V O ( 2max ) : 64.8 + /- 4.7 ml . kg . min ( -1 ) [ mean + /- SD ] ) undertook two cycle ergometry trials involving r and omised consumption of a 10 % CHO beverage ( 15 mL . kg ( -1 ) . hr ( -1 ) ) or water ( H (2)O ) . Trials were undertaken 2 h after a breakfast providing 2.1 g CHO . kg ( -1 ) body mass ( BM ) ( 48 kJ . kg ( -1 ) BM ) and consisted of 100 min steady state cycle ergometry at 70 % V O ( 2max ) followed by a time trial of approximately 30 min duration . Blood sample s were collected pre- , post- and 1 h post-exercise for measurement of Interleukin (IL)-6 , IL-8 , IL-10 and IL-1ra . Time-trial performance was not substantially different between CHO and H (2)O trials ( 4.5 % , p = 0.42 ) . Neither IL-6 nor IL-8 responses were substantially reduced in the CHO compared to the H (2)O trial . There was a substantial reduction in IL-10 ( 32 % , p = 0.05 ) and IL-1ra ( 43 % , p = 0.02 ) responses at 1 h post-exercise with CHO compared to H (2)O ingestion . In conclusion , the previously shown attenuating effects of CHO ingestion during exercise on cytokine responses appear reduced when athletes consume a CHO-containing pre-exercise meal The study examined the effect of carbohydrate ingestion on exercise performance capacity . Nine male cyclists performed two separate trials at 70 % VO2max for 60 min followed by a maximal ride for 10 min . During trials subjects were fed either an 8 % glucose solution ( CHO ) or a placebo solution ( PL ) , which were administered at rest and during and immediately after submaximal exercise . Statistical analyses indicated that glucose levels at rest increased significantly 15 min after the ingestion of CHO compared to PL . At 30 and 60 min during submaximal exercise , plasma glucose levels decreased significantly in the CHO but not in the PL trial . Following the performance ride , glucose levels increased significantly only during the CHO test trial . Free fatty acids did not change significantly during testing trials . The maximal performance ride results showed that in the CHO trial , a significantly greater external work load was accomplished compared to the PL trial . It is concluded that CHO ingestion improves maximal exercise performance after prolonged exercise PURPOSE Five days of a high-fat diet produce metabolic adaptations that increase the rate of fat oxidation during prolonged exercise . We investigated whether enhanced rates of fat oxidation during submaximal exercise after 5 d of a high-fat diet would persist in the face of increased carbohydrate ( CHO ) availability before and during exercise . METHODS Eight well-trained subjects consumed either a high-CHO ( 9.3 g x kg(-1 ) x d(-1 ) CHO , 1.1 g x kg(-1 ) x d(-1 ) fat ; HCHO ) or an isoenergetic high-fat diet ( 2.5 g x kg(-1 ) x d(-1 ) CHO , 4.3 g x kg(-1 ) x d(-1 ) fat ; FAT-adapt ) for 5 d followed by a high-CHO diet and rest on day 6 . On day 7 , performance testing ( 2 h steady-state ( SS ) cycling at 70 % peak O(2 ) uptake [ VO(2peak ) ] + time trial [ TT ] ) of 7 kJ x kg(-1 ) ) was undertaken after a CHO breakfast ( CHO 2 g x kg(-1 ) ) and intake of CHO during cycling ( 0.8 g x kg(-1 ) x h(-1 ) ) . RESULTS FAT-adapt reduced respiratory exchange ratio ( RER ) values before and during cycling at 70 % VO(2peak ) ; RER was restored by 1 d CHO and CHO intake during cycling ( 0.90 + /- 0.01 , 0.80 + /- 0.01 , 0.91 + /- 0.01 , for days 1 , 6 , and 7 , respectively ) . RER values were higher with HCHO ( 0.90 + /- 0.01 , 0.88 + /- 0.01 ( HCHO > FAT-adapt , P < 0.05 ) , 0.95 + /- 0.01 ( HCHO > FAT-adapt , P < 0.05 ) ) . On day 7 , fat oxidation remained elevated ( 73 + /- 4 g vs 45 + /- 3 g , P < 0.05 ) , whereas CHO oxidation was reduced ( 354 + /- 11 g vs 419 + /- 13 g , P < 0.05 ) throughout SS in FAT-adapt versus HCHO . TT performance was similar for both trials ( 25.53 + /- 0.67 min vs 25.45 + /- 0.96 min , NS ) . CONCLUSION Adaptations to a short-term high-fat diet persisted in the face of high CHO availability before and during exercise , but failed to confer a performance advantage during a TT lasting approximately 25 min undertaken after 2 h of submaximal cycling We evaluated the effect of carbohydrate ( CHO ) loading on cycling performance that was design ed to be similar to the dem and s of competitive road racing . Seven well-trained cyclists performed two 100-km time trials ( TTs ) on separate occasions , 3 days after either a CHO-loading ( 9 g CHO . kg body mass(-1 ) . day(-1 ) ) or placebo-controlled moderate-CHO diet ( 6 g CHO . kg body mass(-1 ) . day(-1 ) ) . A CHO breakfast ( 2 g CHO/kg body mass ) was consumed 2 h before each TT , and a CHO drink ( 1 g CHO . kg(.)body mass(-1 ) . h(-1 ) ) was consumed during the TTs to optimize CHO availability . The 100-km TT was interspersed with four 4-km and five 1-km sprints . CHO loading significantly increased muscle glycogen concentrations ( 572 + /- 107 vs. 485 + /- 128 mmol/kg dry wt for CHO loading and placebo , respectively ; P < 0.05 ) . Total muscle glycogen utilization did not differ between trials , nor did time to complete the TTs ( 147.5 + /- 10.0 and 149.1 + /- 11.0 min ; P = 0.4 ) or the mean power output during the TTs ( 259 + /- 40 and 253 + /- 40 W , P = 0.4 ) . This placebo-controlled study shows that CHO loading did not improve performance of a 100-km cycling TT during which CHO was consumed . By preventing any fall in blood glucose concentration , CHO ingestion during exercise may offset any detrimental effects on performance of lower preexercise muscle and liver glycogen concentrations . Alternatively , part of the reported benefit of CHO loading on subsequent athletic performance could have result ed from a placebo effect It is presently unclear whether the reported ergogenic effect of a carbohydrate ( CHO ) mouth rinse on cycling time-trial performance is affected by the acute nutritional status of an individual . Hence , the aim of this study was to investigate the effect of a CHO mouth rinse on a 60-min simulated cycling time-trial performance commenced in a fed or fasted state . Twelve competitive male cyclists each completed 4 experimental trials using a double-blinded Latin square design . Two trials were commenced 2 h after a meal that contained 2.5 g·kg(-1 ) body mass of CHO ( FED ) and 2 after an overnight fast ( FST ) . Prior to and after every 12.5 % of total time during a performance ride , either a 10 % maltodextrin ( CHO ) or a taste-matched placebo ( PLB ) solution was mouth rinsed for 10 s then immediately expectorated . There were significant main effects for both pre-ride nutritional status ( FED vs. FST ; p < 0.01 ) and CHO mouth rinse ( CHO vs. PLB ; p < 0.01 ) on power output with an interaction evident between the interventions ( p < 0.05 ) . The CHO mouth rinse improved mean power to a greater extent after an overnight fast ( 282 vs. 273 W , 3.4 % ; p < 0.01 ) compared with a fed state ( 286 vs. 281 W , 1.8 % ; p < 0.05 ) . We concluded that a CHO mouth rinse improved performance to a greater extent in a fasted compared with a fed state ; however , optimal performance was achieved in a fed state with the addition of a CHO mouth rinse The effects of
Output:
| Conclusion Due to the limitations of this systematic review , results can only be applied to a subset of athletes ( trained male cyclists ) .
For those , we could observe a potential ergogenic benefit of carbohydrate supplementation especially in a concentration range between 6 and 8 % when exercising longer than 90 min |
MS211506 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: OBJECTIVE --To assess the efficacy of a single intra-articular injection of triamcinolone hexacetonide ( THA ) in knee osteoarthritis ( OA ) and examine factors which may relate to treatment efficacy . METHODS --Eighty four patients with clinical and radiographic evidence of knee OA were recruited and r and omly allocated to receive either THA ( 20 mg in 1 ml ) or placebo ( 0.9 % normal saline , 1 ml ) . Follow up assessment s evaluated the following outcome variables : patient opinion of overall change in the treated knee , visual analogue pain score ( VAS ) , distance walked in one minute ( WD ) , and Health Assessment Question naire modified for lower limb function ( HAQ ) . RESULTS --Seventy eight percent of THA and 49 % of placebo treated patients reported overall improvement at week 1 ( p < 0.05 ) . At week 6 , improvement was reported in 57 % and 55 % of patient groups , respectively . VAS improved in both groups at week 1 ( THA , p < 0.001 ; placebo , p < 0.05 ) and week 6 ( both p < 0.01 ) . Improvement in VAS was significantly greater among THA treated patients at week 1 only ( p < 0.01 ) . Subgroup analysis of THA treated patients revealed greater improvement in VAS among patients with clinical evidence of an effusion ( p < 0.05 ) , and those who had synovial fluid successfully aspirated at the time of injection ( p < 0.01 ) . WD improved in THA treated patients at week 1 ( p < 0.001 ) , and in both groups at week 6 ( THA , p < 0.001 ; placebo , p < 0.01 ) . Improvements in HAQ were seen in THA patients only at weeks 1 and 6 ( p < 0.05 ) . Regression analysis did not identify any additional clinical , radiographic , or synovial fluid characteristics which influenced the response . CONCLUSIONS --THA provided short term pain relief in knee OA . Increased benefit was associated with both clinical evidence of joint effusion and successful aspiration of synovial fluid at the time of injection Background : Since the good effect of intra‐articular injections of the 5‐HT3 receptor antagonist tropisetron in patients with arthritides and activated osteoarthritis has already been demonstrated in pilot studies , the effect of tropisetron is compared with that of methylprednisolone here . Objectives : In a double‐blind study , 34 patients with gonarthritides or activated osteoarthritis ( 18 patients with rheumatoid arthritis , 16 patients with osteoarthritis ) were treated with a single intra‐articular injection of 10 mg tropisetron ( 18 patients ) or 40 mg methylprednisolone ( 16 patients ) . Before treatment as well as one and three weeks later , the intensity of rest pain and pain following exercise was measured with the visual analog scale ( VAS ) for pain and the clinical findings in the knee joint were recorded . Results : By means of the intra‐articular tropisetron treatment , the inflammatory joint process with arthritides and activated arthroses could be influenced in a similar way as with corticosteroid treatment . No significant differences were detected . Conclusion : According to the results presented here , the intra‐articular treatment with the 5‐HT3 receptor antagonist tropisetron in patients with gonarthritides and activated arthroses was about equally effective as those for treatment with corticosteroids . Therefore , it can be used as an alternative in patients for whom concomitant diseases like diabetes and hypertension make it difficult to use corticosteroids . Whether increasing the tropisetron dose may further improve the results remains to be determined in future studies OBJECTIVES : To show whether intra-articular steroid injections are effective in osteoarthritis ; to determine factors that predict response ; and to determine whether injection has a beneficial effect on muscle strength . METHODS : Double blind , placebo controlled , crossover study in 59 patients with symptomatic osteoarthritis of the knee . Outcome measure- Primary outcome measure : change in visual analogue score for pain at three weeks . Predictors of response analysed using logistic regression with a 15 % decrease in pain score at three weeks defining response . RESULTS : Intra-articular methyl prednisolone acetate produced a significant reduction in visual analogue pain score at three weeks compared to both baseline ( median change -2.0 mm , interquartile range -16.25 to 4.0 ) and placebo ( median 0.0 mm , interquartile range -9.0 to 6.25 ) . No clinical predictors of response could be identified . Muscle strength was not significantly improved in the short term by intra-articular injection . CONCLUSIONS : Intra-articular corticosteroids are effective for short term relief of pain in osteoarthritis but predicting responders is not possible . There may be a place for their more widespread use Hyaluronic acid is a natural component of cartilage and is considered not only as a lubricant in joints but also as playing a physiological role in the trophic status of cartilage . Hyalectin , a selected fraction of hyaluronic acid extracted from cocks ' combs , has exhibited efficacy in animal models of osteoarthritis . To assess the efficacy and tolerability of intra-articular injections of hyalectin , we conducted a prospect i ve , r and omized , placebo-controlled trial of 1 years ' duration in 110 patients with painful hydarthrodial osteoarthritis of the knee . At entry and once a week for 3 weeks , aspiration of the knee effusion and intra-articular injections of either hyalectin 20 mg ( H ) or its vehicle ( C ) were performed . The vehicle acted as the control treatment . Four weeks after the last injection , the improvement was greater in the H group compared with the C group ( pain : -35.5 + /- 26.4 mm vs -25.8 + /- 21.4 , P = 0.03 , Lequesne 's functional index : -3.8 + /- 4.3 vs -2.3 + /- 3.3 , P = 0.03 ) . During the 1 year follow-up , the need to perform supplementary local therapies ( joint fluid aspiration because of painful hydarthrodial episodes and /or local corticosteroid injections ) was more frequent in group C ( 44 % vs 30 % , P = 0.03 ) . Moreover , at the final visit , the physician 's overall assessment of efficacy was in favor of H ( 77 % vs 54 % , P = 0.01 ) and the improvement in the functional index was greater in group H ( -4.4 + /- 5.1 vs -2.7 + /- 4.1 , P = 0.05 ) . This study suggests that intra-articular injections of hyalectin may ( 1 ) improve clinical condition and ( 2 ) have a long-term beneficial effect in patients with osteoarthritis of the knee Background : Although both corticosteroid and hyaluronic acid injections are widely used to palliate the symptoms of knee osteoarthritis , little research involving a comparison of the two interventions has been done . We tested the hypothesis that there are no significant differences between Hylan G-F 20 ( Synvisc ) and the corticosteroid betamethasone sodium phosphate-betamethasone acetate ( Celestone Soluspan ) in terms of pain relief or improvement in function , as determined by vali date d scoring instruments . Methods : One hundred patients with knee osteoarthritis were r and omized to receive intra-articular injection of either Hylan G-F 20 or the corticosteroid , and they were followed for six months . The patients treated with Hylan G-F 20 received one course of three weekly injections . The patients treated with the corticosteroid received one injection at the time of enrollment in the study , and they could request one more injection any time during the study . An independent , blinded evaluator assessed the patients with the Western Ontario and McMaster University Osteoarthritis Index ( WOMAC ) , a modification of the Knee Society rating system , and the visual analog pain scale . Results : Both the group treated with the corticosteroid and the group treated with Hylan G-F 20 demonstrated improvements from baseline WOMAC scores ( a median decrease from 55 to 40 points and from 54 to 44 points , respectively ; p < 0.01 for both ) . The scores according to the Knee Society system did not significantly improve for the patients who received the corticosteroid ( median , 58 to 70 points ; p = 0.06 ) or for those who received Hylan G-F 20 ( median , 58 to 68 points ; p = 0.15 ) . The scores on the visual analog scale improved for patients receiving Hylan G-F 20 ( median , 70 to 52 mm ; p < 0.01 ) but not for the patients who received the corticosteroid ( median , 64 to 52 mm ; p = 0.28 ) . However , no significant differences between the two treatment groups were found with respect to the WOMAC , Knee Society system , or visual analog scale results . Women demonstrated a significant improvement in only one of the six possible outcome -treatment combinations ( the WOMAC scale ) , whereas men demonstrated significant improvements in five of the six outcomes ( all measures except the Knee Society rating system ) . Conclusions : No differences were detected between patients treated with intra-articular injections of Hylan G-F 20 and those treated with the corticosteroid with respect to pain relief or function at six months of follow-up . Women demonstrated significantly less response to treatment than men did for both treatments on all three outcome scales . Such significant gender-related differences warrant further investigation . Level of Evidence : Therapeutic study , Level I-1b ( r and omized controlled trial [ no significant difference but narrow confidence intervals ] ) . See Instructions to Authors for a complete description of levels of evidence OBJECTIVE To evaluate the efficacy of joint lavage and intraarticular steroid injection , alone and in combination , in the treatment of patients with symptomatic knee osteoarthritis ( OA ) . METHODS Ninety-eight patients with painful tibiofemoral OA were enrolled in a prospect i ve , r and omized , controlled , 2 x 2 factorial- design trial of 6 months ' duration . The 4 treatment groups consisted of 1 ) intraarticular placebo ( 1.5 ml of 0.9 % normal saline ) , 2 ) intraarticular corticosteroids ( 3.75 mg of cortivazol in 1.5 ml ) , 3 ) joint lavage and intraarticular placebo , and 4 ) joint lavage and intraarticular corticosteroid . Outcome measures evaluated at baseline , week 1 , week 4 , week 12 , and week 24 included severity of pain ( 100-mm visual analog scale [ VAS ] ) , global status ( 100-mm VAS ) , and Lequesne 's functional index . RESULTS No interaction between steroid injection and joint lavage was demonstrated . Patients who had undergone joint lavage had significantly improved pain VAS scores at week 24 ( P = 0.020 ) . In contrast , corticosteroid injection had no long-term effect ( P = 0.313 ) ; corticosteroid injection was associated with a decrease in pain only at week 1 ( P = 0.003 ) and week 4 ( P = 0.020 ) . After week 4 , Lequesne 's functional index was not significantly improved regardless of the assigned treatment . CONCLUSION Compared with placebo , both treatments significantly relieved pain but did not improve functional impairment . The effects of the 2 treatments were additive . Cortivazol provided short-term relief of pain ( up to week 4 ) . The effects of joint lavage persisted up to week 24 OBJECTIVE To evaluate the safety and efficacy of long-term intraarticular ( IA ) steroid injections for knee pain related to osteoarthritis ( OA ) . METHODS In a r and omized , double-blind trial , 68 patients with OA of the knee received IA injections of triamcinolone acetonide 40 mg ( 34 patients ) or saline ( 34 patients ) into the study knee every 3 months for up to 2 years . The primary outcome variable was radiologic progression of joint space narrowing of the injected knee after 2 years . Measurements of minimum joint space width were performed by an automated computerized method on st and ardized fluoroscopically guided radiographs taken with the patient st and ing and with the knee in a semiflexed position . The clinical efficacy measure of primary interest was the pain subscale from the Western Ontario and McMaster Universities OA Index ( WOMAC ) . Efficacy measures of secondary interest were the total score on the WOMAC , physician 's global assessment , patient 's global assessment , patient 's assessment of pain , range of motion ( ROM ) of the affected knee , and 50-foot walking time . Clinical symptoms were assessed just before each injection . RESULTS At the 1-year and 2-year followup evaluations , no difference was noted between the two treatment groups with respect to loss of joint space over time . The steroid-injected knees showed a trend toward greater symptom improvement , especially at 1 year , for the WOMAC pain subscale , night pain , and ROM values ( P = 0.05 ) compared with the saline-injected knees . Using area under the curve analyses , knee pain and stiffness were significantly improved throughout the 2-year study by repeated injections of triamcinolone acetonide , but not saline ( P < 0.05 ) . CONCLUSION Our findings support the long-term safety of IA steroid
Output:
| We concluded that intra-articular corticosteroids reduce knee pain for at least 1 week and that intra-articular corticosteroid injection is a short-term treatment of a chronic problem |
MS211507 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: OBJECTIVE To test whether pre-electroconvulsive therapy ( ECT ) medication resistance is associated with post-ECT relapse rates . METHOD In a post hoc analysis of data from a large multicenter trial of post-ECT relapse prevention strategies ( conducted from May 1997 to July 2004 ) , we assessed whether response to antidepressant medications prior to ECT for a unipolar nonpsychotic depressive episode ( DSM-IV ) was associated with differential relapse rates after remission with ECT . Baseline ( i.e. , pre-ECT ) medication use was assessed with the Antidepressant Treatment History Form . Following remission with ECT that was stable for 1 week , patients were r and omly assigned to receive 6 months of treatment with either combination lithium carbonate/nortriptyline or continuation ECT . Relapse was assessed with the 24-item Hamilton Rating Scale for Depression . There were 146 patients followed in the first week after remission ( termed the interim week in this study ) , and 73 in the r and omized phase of the study . For the purpose s of this trial , medication resistance is defined as not having responded to at least 1 adequate trial of an antidepressant medication before ECT . RESULTS In the first week after acute remission , 9.8 % of patients not having at least 1 antidepressant medication trial met relapse criteria , while 31.4 % of medication-resistant patients met relapse criteria , a difference that was statistically significant ( p = .026 ) . In the r and omized phase of the study , 34.6 % of non-medication-resistant patients relapsed , while 50.0 % of medication-resistant patients relapsed , a difference that was not significant ( p = .434 ) . CONCLUSION We conclude that nonpsychotic patients who had at least 1 adequate antidepressant medication trial before ECT may be especially prone to early relapse after successful acute remission with ECT BACKGROUND While electroconvulsive therapy ( ECT ) in major depression is effective , cognitive effects limit its use . Reducing the width of the electrical pulse and using the right unilateral electrode placement may decrease adverse cognitive effects , while preserving efficacy . METHODS In a double-masked study , we r and omly assigned 90 depressed patients to right unilateral ECT at 6 times seizure threshold or bilateral ECT at 2.5 times seizure threshold , using either a traditional brief pulse ( 1.5 ms ) or an ultrabrief pulse ( 0.3 ms ) . Depressive symptoms and cognition were assessed before , during , and immediately , two , and six months after therapy . Patients who responded were followed for a one-year period . RESULTS The final remission rate for ultrabrief bilateral ECT was 35 percent , compared with 73 percent for ultrabrief unilateral ECT , 65 percent for st and ard pulse width bilateral ECT , and 59 percent for st and ard pulse width unilateral ECT ( all P's<0.05 after covariate adjustment ) . The ultrabrief right unilateral group had less severe cognitive side effects than the other 3 groups in virtually all primary outcome measures assessed in the acute postictal period , and during and immediately following therapy . Both the ultrabrief stimulus and right unilateral electrode placement produced less short- and long-term retro grade amnesia . Patients rated their memory deficits as less severe following ultrabrief right unilateral ECT compared to each of the other three conditions ( P<0.001 ) . CONCLUSIONS The use of an ultrabrief stimulus markedly reduces adverse cognitive effects , and when coupled with markedly suprathreshold right unilateral ECT , also preserves efficacy . ( Clinical Trials.gov number , NCT00487500 . ) CONTEXT Electroconvulsive therapy ( ECT ) is the most effective biological treatment for major depression . However , there is little agreement about clinical ly useful predictors of acute ECT outcomes . OBJECTIVE To assess whether age , sex , burden of comorbid physical illness , age at onset , history of recurrence , episode duration , chronic depression or comorbid dysthymia , melancholic features , episode severity , and medication resistance are predictors of remission after an acute course of ECT . DESIGN We performed an analysis using data gathered prospect ively in 328 patients with unipolar major depression ( according to Research Diagnostic Criteria ) treated with ECT . The study was conducted from 1993 through 1999 . Patients had a pretreatment score of 21 or higher on the 24-item Hamilton Rating Scale for Depression ( HAM-D ) . Treatment history was assessed using the Antidepressant Treatment History Form . Remission was defined as a 24-item HAM-D score of 10 or less and a 60 % or more relative reduction of the HAM-D score . RESULTS On univariate logistic regression , statistically significant predictors of nonremission were chronic depression/dysthymia , medication resistance , longer episode duration , and younger age . On backward elimination logistic regression , only medication resistance ( OR = 1.67 , 95 % CI = 1.05 to 2.67 ) and chronic depression/ dysthymia ( OR = 1.84 , 95 % CI = 1.06 to 3.21 ) were statistically significant predictors of nonremission . CONCLUSIONS In patients with major depression , lower rates of remission after acute ECT are associated with medication resistance and chronicity , but not with age or burden of physical illness Objective To compare the relative efficacy of electroconvulsive therapy ( ECT ) in psychotic and nonpsychotic patients with unipolar major depression . Methods The outcome of an acute ECT course in 253 patients with nonpsychotic ( n = 176 ) and psychotic ( n = 77 ) unipolar major depression was assessed in the first phase of an ongoing National Institute of Mental Health-supported four-hospital collaborative study of continuation treatments after successful ECT courses . ECT was administered with bilateral electrode placement at 50 % above the titrated seizure threshold . The remission criteria were rigorous : a score ≤10 on the 24-item Hamilton Rating Scale for Depression ( HRSD ) after 2 consecutive treatments , and a decrease of at least 60 % from baseline . Results The overall remission rate was 87 % for study completers . Among these , patients with psychotic depression had a remission rate of 95 % and those with nonpsychotic depression , 83 % . Improvement in symptomatology , measured by the HRSD , was more robust and appeared sooner in the psychotic patients compared with the nonpsychotic patients . Conclusion Bilateral ECT is effective in relieving severe major depression . Remission rates are higher and occur earlier in psychotic depressed patients than in nonpsychotic depressed patients . These data support the argument that psychotic depression is a distinguishable nosological entity that warrants separate treatment algorithms Abstract : This prospect i ve study assessed the influence of resistance to antidepressant pharmacotherapy on the short-term response to subsequent electroconvulsive therapy ( ECT ) . Previous research has shown that patients with medication resistance were less likely to respond to ECT . This finding may be applicable to the population of depressed in patients in The Netherl and s , where ECT is often preceded by several medication trials . Eighty-five patients ( 61 female and 24 male patients ) with DSM-IV criteria for depressive disorder , both with and without mood congruent psychotic features , were included for analysis . Medication resistance was rated with the Antidepressant Treatment History Form . Medication resistance was predefined in accordance with the previous research in this field . When a reduction of at least 50 % on the 17-item version of the Hamilton Rating Scale for Depression ( HRSD ) between pre- and post-ECT is used as response criterion , medication-resistant patients were equally likely to respond to subsequent ECT ( 30/48 = 82.5 % ) than patients without medication resistance ( 30/37 = 81.1 % ) . Even when post-ECT HRSD score ≤7 was used ( full remission ) , there was no significant difference between medication-resistant patients ( 21/48 = 43.8 % ) and patients without medication resistance ( 15/37 = 40.5 % ) . When potential confounding variables were taken into account , these differences remain nonsignificant . In contrast to earlier research , medication resistance does not influence short-term response to subsequent ECT and it can still be of considerable efficacy CONTEXT Electroconvulsive therapy ( ECT ) is highly effective for treatment of major depression , but naturalistic studies show a high rate of relapse after discontinuation of ECT . OBJECTIVE To determine the efficacy of continuation pharmacotherapy with nortriptyline hydrochloride or combination nortriptyline and lithium carbonate in preventing post-ECT relapse . DESIGN R and omized , double-blind , placebo-controlled trial conducted from 1993 to 1998 , stratified by medication resistance or presence of psychotic depression in the index episode . SETTING Two university-based hospitals and 1 private psychiatric hospital . PATIENTS Of 290 patients with unipolar major depression recruited through clinical referral who completed an open ECT treatment phase , 159 patients met remitter criteria ; 84 remitting patients were eligible and agreed to participate in the continuation study . INTERVENTIONS Patients were r and omly assigned to receive continuation treatment for 24 weeks with placebo ( n = 29 ) , nortriptyline ( target steady-state level , 75 - 125 ng/mL ) ( n = 27 ) , or combination nortriptyline and lithium ( target steady-state level , 0.5 - 0.9 mEq/L ) ( n = 28 ) . MAIN OUTCOME MEASURE Relapse of major depressive episode , compared among the 3 continuation groups . RESULTS Nortriptyline-lithium combination therapy had a marked advantage in time to relapse , superior to both placebo and nortriptyline alone . Over the 24-week trial , the relapse rate for placebo was 84 % ( 95 % confidence interval [ CI ] , 70%-99 % ) ; for nortriptyline , 60 % ( 95 % CI , 41%-79 % ) ; and for nortriptyline-lithium , 39 % ( 95 % CI , 19%-59 % ) . All but 1 instance of relapse with nortriptyline-lithium occurred within 5 weeks of ECT termination , while relapse continued throughout treatment with placebo or nortriptyline alone . Medication-resistant patients , female patients , and those with more severe depressive symptoms following ECT had more rapid relapse . CONCLUSIONS Our study indicates that without active treatment , virtually all remitted patients relapse within 6 months of stopping ECT . Monotherapy with nortriptyline has limited efficacy . The combination of nortriptyline and lithium is more effective , but the relapse rate is still high , particularly during the first month of continuation therapy OBJECTIVE To examine the predictive value of resistance to a tricyclic antidepressant ( TCA ) and lithium with respect to the efficacy of subsequent electroconvulsive therapy ( ECT ) . METHOD This open prospect i ve study was conducted in the inpatient depression unit of a university hospital in The Netherl and s. Patients were enrolled in the study from October 1996 to June 2002 and had to meet DSM-IV criteria for major depressive disorder . Eighty-six patients were treated twice weekly with ECT until recovery or no progress during at least 10 bilateral treatments . Patients were maintained drug free during the ECT treatment . Clinical evaluation of depressive symptoms was performed each week ; scores on the 17-item version of the Hamilton Rating Scale for Depression ( HAM-D ) were obtained 1 to 3 days prior to ECT and 1 to 3 days after treatment termination . The primary outcome criterion was defined as the mean difference in HAM-D score before and after ECT for patients who had received adequate treatment with a TCA and lithium compared with patients who had not received adequate treatment with a TCA and lithium . Adequate treatment was defined as 4 weeks taking a predefined plasma level of a TCA ; nonresponders had lithium added to the medication , and the minimal duration of the lithium addition was 3 weeks with a plasma level of at least 0.6 mmol/L. Independent sample s t test was used to analyze this primary outcome criterion . RESULTS According to the primary outcome criterion , patients who had received adequate treatment with a TCA and lithium ( N = 56 ) had a mean difference in HAM-D score pre-ECT and post-ECT of 16.4 compared to a HAM-D score difference of 19.5 in the patient group who had received inadequate treatment with a TCA and lithium ( N = 30 ) . This ine quality in differences in mean HAM-D scores is not significant ( p = .2 ) . CONCLUSION In the present study sample , treatment failure with adequate pharmacotherapy with a TCA and lithium addition appears to be unrelated to outcome following subsequent ECT BACKGROUND Antidepressant medication resistance is the commonest indication for electroconvulsive therapy ( ECT ) in Scotl and . Evidence from the USA suggests that clinical response is reduced for medication resistant patients . The aim of the present study was to establish if the American results were generalisable to routine clinical practice in Edinburgh . METHOD Fifty eligible depressed patients consecutively referred for a new course of bilateral ECT at the Royal Edinburgh Hospital were prospect ively assessed as part of
Output:
| In conclusion , the efficacy of ECT is significantly superior in patients without previous pharmacotherapy failure as compared with medication-resistant patients .
Because this finding is based on observational studies , it might be caused by a confounding factor , for example , the presence of psychotic features or the duration of the index episode .
Electroconvulsive therapy seems to be an effective treatment for severely depressed patients as well as for patients with previous pharmacotherapy failure |
MS211508 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
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Input: We previously reported that the Charlson Comorbidity Index ( CCI ) was useful for predicting outcomes in patients undergoing allogeneic hematopoietic cell transplantation ( HCT ) . However , the sample size of patients with scores of 1 or more , captured by the CCI , did not exceed 35 % . Further , some comorbidities were rarely found among patients who underwent HCT . Therefore , the current study was design ed to ( 1 ) better define previously identified comorbidities using pretransplant laboratory data , ( 2 ) investigate additional HCT-related comorbidities , and ( 3 ) establish comorbidity scores that were suited for HCT . Data were collected from 1055 patients , and then r and omly divided into training and validation sets . Weights were assigned to individual comorbidities according to their prognostic significance in Cox proportional hazard models . The new index was then vali date d. The new index proved to be more sensitive than the CCI since it captured 62 % of patients with scores more than 0 compared with 12 % , respectively . Further , the new index showed better survival prediction than the CCI ( likelihood ratio of 23.7 versus 7.1 and c statistics of 0.661 versus 0.561 , respectively , P < .001 ) . In conclusion , the new simple index provided valid and reliable scoring of pretransplant comorbidities that predicted nonrelapse mortality and survival . This index will be useful for clinical trials and patient counseling before HCT Chemotherapy is associated with toxicity in elderly patients with potentially curable malignancies , posing the dilemma of whether to intensify therapy , thereby improving the cure rate , or de-escalate therapy , thereby reducing toxicity , with consequent risks for under- or overtreatment . Adequate tools to define doses and combinations have not been identified for lymphoma patients . We conducted a prospect i ve trial aim ed to evaluate the feasibility and efficacy of chemotherapy modulated according to a modified comprehensive geriatric assessment ( CGA ) in elderly ( aged ≥70 years ) patients with diffuse large B-cell lymphoma ( DLBCL ) . In June 2000 to March 2006 , 100 patients were stratified using a CGA into three groups ( fit , unfit , and frail ) , and they received a rituximab plus cyclophosphamide , doxorubicin , vincristine , and prednisone modulated in dose and drugs according to comorbidities and activities of daily living ( ADL ) and instrumental ADL scores . Treatment was associated with a complete response rate of 81 % and mild toxicity : grade 4 neutropenia in 14 % , anemia in 1 % , and neurological and cardiac toxicity in 2 % of patients . At a median follow-up of 64 months , 51 patients were alive , with 5-year disease-free , overall , and cause-specific survival rates of 80 % , 60 % , and 74 % , respectively . Chemoimmunotherapy adjustments based on a CGA are associated with manageable toxicity and excellent outcomes in elderly patients with DLBCL . Wide use of this CGA-driven treatment may result in better cure rates , especially in fit and unfit patients The objective of this study was to develop a prospect ively applicable method for classifying comorbid conditions which might alter the risk of mortality for use in longitudinal studies . A weighted index that takes into account the number and the seriousness of comorbid disease was developed in a cohort of 559 medical patients . The 1-yr mortality rates for the different scores were : " 0 " , 12 % ( 181 ) ; " 1 - 2 " , 26 % ( 225 ) ; " 3 - 4 " , 52 % ( 71 ) ; and " greater than or equal to 5 " , 85 % ( 82 ) . The index was tested for its ability to predict risk of death from comorbid disease in the second cohort of 685 patients during a 10-yr follow-up . The percent of patients who died of comorbid disease for the different scores were : " 0 " , 8 % ( 588 ) ; " 1 " , 25 % ( 54 ) ; " 2 " , 48 % ( 25 ) ; " greater than or equal to 3 " , 59 % ( 18 ) . With each increased level of the comorbidity index , there were stepwise increases in the cumulative mortality attributable to comorbid disease ( log rank chi 2 = 165 ; p less than 0.0001 ) . In this longer follow-up , age was also a predictor of mortality ( p less than 0.001 ) . The new index performed similarly to a previous system devised by Kaplan and Feinstein . The method of classifying comorbidity provides a simple , readily applicable and valid method of estimating risk of death from comorbid disease for use in longitudinal studies . Further work in larger population s is still required to refine the approach because the number of patients with any given condition in this study was relatively small CONTEXT Patients with cancer often have other medical ailments , referred to as comorbidity . Comorbidity may impact treatment decision-making , prognosis , and quality of care assessment . OBJECTIVE To assess whether comorbidity information can provide important prognostic information in a hospital-based cancer registry . DESIGN , SETTING , AND PARTICIPANTS An observational prospect i ve cohort study using comorbidity data collected by trained hospital-based cancer registrars . Comorbidity was obtained through medical record review using the Adult Comorbidity Evaluation 27 , a vali date d chart-based comorbidity instrument . A total of 17,712 patients receiving care between January 1 , 1995 , and January 31 , 2001 , for the primary diagnosis of new cancer of the prostate , lung ( nonsmall cell ) , breast , digestive system , gynecological , urinary system , or head and neck were included . MAIN OUTCOME MEASURE Duration in months of overall survival . RESULTS A total of 19,268 patients were included in the study ; median duration of follow-up was 31 months . Of these patients , 1556 ( 8.0 % ) were excluded due to missing or unknown data . Severity of comorbidity strongly influenced survival in a dose-dependent fashion and the impact of comorbidity was independent of cancer stage . Compared with patients without comorbidity , the adjusted hazard ratio associated with mild comorbidity was 1.21 ( 95 % confidence interval [ CI ] , 1.13 - 1.30 ) , moderate comorbidity was 1.86 ( 95 % CI , 1.73 - 2.00 ) , and severe comorbidity was 2.56 ( 95 % CI , 2.35 - 2.81 ) . Adjusted Kaplan-Meier survival curves revealed that at any point in time the patients with more severe levels of comorbidity had worse survival ( partial chi2(3 ) due to comorbidity , 523.54 ; P<.001 ) . Model discrimination ranged from 0.71 for head and neck to 0.86 for prostate cancers . CONCLUSIONS Comorbidity is an important independent prognostic factor for patients with cancer . The inclusion of comorbidity in hospital-based cancer registries will increase the value and use of observational research High-dose chemotherapy followed by autologous peripheral blood stem cell transplantation is a widely applied treatment for advanced non-Hodgkin lymphoma ( NHL ) , but few studies have analyzed the tolerability and outcomes in older patients compared with younger patients treated in a homogeneous manner . We retrospectively review ed 152 consecutive patients who underwent autologous stem cell transplantation ( ASCT ) following BEAM conditioning ( carmustine , etoposide , cytarabine , and melphalan ) for NHL from January 2000 through August 2004 at our institution . We compared 59 patients age > or = 60 years and 93 patients age < 60 years . Supportive care was identical for all patients . The frequency of comorbidities was similar between both groups . CD34 + cell doses , days to neutrophil recovery , and days to platelet count > 20,000/mm3 were similar in younger and older patients , although days to platelet count > 50,000/mm3 were longer in the older patients ( median 30.0 days versus 22.5 days , P = .01 ) . Patients over the age of 60 were more likely to develop grade III/IV mucositis than their younger counterparts ( 37.7 % versus17.4 % , P = .0063 ) . Otherwise , the frequency of other grade III/IV toxicities were similar between younger and older patients . Treatment-related mortality ( TRM ) was similar between older and younger patients ( 8.5 % versus 5.4 % , P = .45 ) . Although age was not associated with TRM , the Charlson Comorbidity Index Score was significantly correlated with TRM ( P = .03 ) . Median disease-free survival was similar between older and younger patients ( 21.8 months versus 29.9 months , P = .93 ) , as was overall survival ( OS ) ( 47.7 months versus 62.5 months , P = .20 ) . After controlling for age , the Charlson Comorbidity Index Score influenced OS [ P = .013 ] . Overall , our cohort of patients with NHL over the age of 60 who underwent ASCT following BEAM conditioning experienced toxicities and survival similar to their younger counterparts . Comorbidities significantly influenced TRM and OS in this retrospective cohort . Future study should focus on improving tolerability of conditioning and careful prospect i ve evaluation of comorbidities and their association with outcomes Over 60 % of patients aged over 70 years , diagnosed with non‐Hodgkin 's lymphoma ( NHL ) in the Netherl and s have serious comorbidity . We studied the independent influence of comorbidity on choice of treatment , dose reductions , treatment‐related toxicity and prognosis , using data from a r and om sample of 381 patients from the population ‐based Eindhoven Cancer Registry . About 45 % of patients over 60 years of age with NHL had high impact comorbidity at the time of cancer diagnosis . The proportion of patients with aggressive NHL who received chemotherapy decreased from 85 % in patients aged 40–60 years to 70 % in those over 60 years . About 65 % of systematic ally treated patients with aggressive NHL suffered from treatment‐related toxicity . Toxicity appeared to be more common among females and those with high‐intermediate or high International Prognostic Index ( IPI ) risk . Among patients with aggressive NHL , the chance of dying for those with high impact comorbidity was twice as high compared with those without comorbidity . This was independent of the IPI risk . Dose reductions are frequently unavoidable for patients with severe comorbidity , poor performance status or chemotherapy‐related toxicity . Whether the less frequent prescription of ( full dose ) chemotherapy for patients with advanced age and /or with comorbidity is justified remains a question for debate Data on outcome , prognostic factors , and treatment for very elderly non‐Hodgkin lymphomas ( NHL ) is sparse . We conducted a multicentre retrospective analysis of NHL patients ≥80 years ( at diagnosis ) treated between 1999 and 2009 . Detailed characteristics were obtained including geriatric syndromes , activities of daily living ( ADLs ) , and co‐morbidities using the Cumulative Illness Rating Scale‐Geriatrics ( CIRS‐G ) . We identified 303 patients : 170 aggressive NHL ( 84 % B cell/16 % T cell ) and 133 indolent NHL ( 82 % B cell/18 % T cell ) . Median age was 84 years ( 80–95 ) . A geriatric syndrome was present in 26 % of patients , 18 % had ≥1 grade 4 CIRS‐G , and 14 % had loss of ADLs . At 49‐month median follow‐up , 4‐year progression‐free ( PFS ) and overall survival ( OS ) for aggressive NHLs were 31 % and 44 % respectively ( stage I/II : PFS 53 % and OS 66 % ; stage III/IV : PFS 20 % and OS 32 % ; P < 0·0001 and 0·0002 , respectively ) . Four‐year PFS and OS for indolent NHL were 44 % and 66 % respectively , regardless of stage . Multivariate regression analysis identified two key factors that predicted inferior PFS and OS for both NHL groups : lack of CR and loss of ADLs . Prospect i ve studies for very elderly NHL that incorporate geriatric tools , especially ADLs , are warranted PURPOSE The treatment of patients with diffuse large B-cell lymphoma ( DLBCL ) with cardiac comorbidity is problematic , because this group may not be able to receive anthracycline-containing chemoimmunotherapy . We design ed a single-arm phase II multicenter trial of rituximab , gemcitabine , cyclophosphamide , vincristine , and prednisolone ( R-GCVP ) in patients considered unfit for anthracycline-containing chemoimmunotherapy because of cardiac comorbidity . PATIENTS AND METHODS Sixty-one of 62 patients received R-GCVP , administered on day 1 with gemcitabine repeated on day 8 of a 21-day cycle . Median age was 76.5 years . All patients had advanced disease ; 27 ( 43.5 % ) had left ventricular ejection fraction of ≤ 50 % , and 35 ( 56.5 % ) had an ejection fraction of > 50 % and comorb
Output:
| The majority of studies demonstrated significant impact of comorbidity on survival , reporting poorer survival rates for patients with comorbidities compared to those with no comorbidities . |
MS211509 | ***TASK*** the task is to summarize an input biomedical literature 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 insulin tolerance test ( ITT ) is considered the test of choice for the diagnosis of GH deficiency ( GHD ) . However , in patients with contraindications to ITT , alternative provocative tests must be used with appropriate cut-offs . The glucagon stimulation test has proved to be a safe , low-cost and effective means of stimulating GH secretion , and therefore can be considered as a suitable alternative to the ITT . We have studied the GH response to the glucagon test in 33 patients with known pituitary disease , 12 males and 21 females , aged between 21 and 60 yr ( 41.18±9.47 yr ) ; 5 had isolated GHD and 28 had panhypopituitarism . We also evaluated a control group of 25 individuals , matched for age and sex ( 8 males and 17 females ) , aged between 20 and 60 yr ( 39.28±12.10 yr ) . They were selected via the ITT if their peak GH response was > 5.0 ng/ml . GH peak after glucagon was significantly lower in the group of patients compared to the control group ( 0.49±0.85 vs 8.69±5.85 ng/ml , p=0.0001 ) . Receiver-operating characteristic ( ROC ) plot analyses of the control and GHD group showed an area under the curve of 0.982 for GH peak response to glucagon . The response value of 3.0 ng/ml showed the best pair of sensitivity (97%)/specificity ( 88 % ) , and was chosen as the cut-off defining GHD . After evaluation of positive predictive values ( PPV ) and negative predictive values ( NPV ) through simulation of different prevalences of the disease , we concluded that the cut-off point of 3.00 ng/ml maximizes both PPV and NPV ( 100 % ) . In conclusion , we have shown that the glucagon stimulation test has a good performance and great diagnostic accuracy for the diagnosis of GHD OBJECTIVE The glucagon stimulation test ( GST ) like the insulin tolerance test ( ITT ) stimulates both ACTH and GH secretion . However , there are limited data with modern assays on sensitivity and specificity for GST in comparison to ITT . The aim of this study was to evaluate the diagnostic utility of the GST for GH deficiency ( GHD ) and adrenal insufficiency ( AI ) in patients following pituitary surgery . DESIGN AND PATIENTS ITT and GST were performed within 7 days in 49 patients at least 3 months after transsphenoidal surgery . Serum GH and cortisol were measured by Immulite 2000 assay ( Siemens AG ) . Receiver-operating characteristic ( ROC ) analysis was performed to identify the thresholds for GST . RESULTS In ITT , 18/49 cases were classified as AI . ROC analysis revealed a peak cortisol value > 599 nmol/l in GST for adrenal sufficiency with 100 % specificity and 32 % sensitivity , and a peak cortisol < 277 nmol/l with > 95 % specificity and 72 % sensitivity for AI . Of the 49 subjects , 25 ( 51 % ) demonstrated levels between these cut-offs and could not be diagnosed by GST alone with sufficient accuracy . Regarding GHD , 21/49 cases were classified as insufficient by ITT . ROC analysis revealed a cut-off of 2.5 ng/ml with 95 % sensitivity and 79 % specificity . Of the 49 cases , seven ( 14 % ) were discordant in terms of defining GHD , with six subjects being treated for GHD according to GST although being sufficient in ITT . CONCLUSION In our prospect i ve series of patients with pituitary disease , GST is a potential alternative test for the assessment of GH reserve , but is a poor test for ACTH reserve . Test-specific cut-offs should be applied to avoid misinterpretation objective Reduction of plasma free fatty acids leads to enhanced GH response after stimulation by GH‐releasing hormone ( GHRH ) . We studied the clinical usefulness of combined administration of acipimox and GHRH for the diagnosis of GH deficiency In the attempt to define a GH stimulation test with high specificity and reproductibility , few studies have addressed the influence of potential interfering external factors on the test result . We therefore tested the influence of physical activity ( admission to hospital on test morning ) and mild heat exposure on the GH response to l‐arginine stimulation test ( Arg ) and insulin‐tolerance test ( ITT ) BACKGROUND AND OBJECTIVE Publication bias and other sample size effects are issues for meta-analyses of test accuracy , as for r and omized trials . We investigate limitations of st and ard funnel plots and tests when applied to meta-analyses of test accuracy and look for improved methods . METHODS Type I and type II error rates for existing and alternative tests of sample size effects were estimated and compared in simulated meta-analyses of test accuracy . RESULTS Type I error rates for the Begg , Egger , and Macaskill tests are inflated for typical diagnostic odds ratios ( DOR ) , when disease prevalence differs from 50 % and when thresholds favor sensitivity over specificity or vice versa . Regression and correlation tests based on functions of effective sample size are valid , if occasionally conservative , tests for sample size effects . Empirical evidence suggests that they have adequate power to be useful tests . When DORs are heterogeneous , however , all tests of funnel plot asymmetry have low power . CONCLUSION Existing tests that use st and ard errors of odds ratios are likely to be seriously misleading if applied to meta-analyses of test accuracy . The effective sample size funnel plot and associated regression test of asymmetry should be used to detect publication bias and other sample size related effects BACKGROUND Adult growth hormone ( GH ) deficiency must be diagnosed before prescribing therapeutic recombinant human GH . We studied the clinical relevance of a diagnostic strategy for growth hormone deficiency ( GHD ) using IGF-1 determination as a first step . METHODS In 2000 and 2001 , we tested 142 adult patients with hypothalamo-pituitary disorders for somatotropic function using Insulin Tolerance Test ( ITT ) , the reference test for the diagnosis of GHD , with concomitant Insulin-like growth factor-1 ( IGF-1 ) determination , a marker of somatotropic function . Patients were classified as GHD ( peak GH concentration<3 ng/ml with the ITT ) or normal . SETTING Monocenter prospect i ve study in a tertiary referral center . RESULTS GHD was diagnosed in 61 subjects . Using a ROC curve , a threshold IGF-1 concentration of 175 ng/ml yielded a negative predictive value of 89+/-5 % . A diagnostic strategy with IGF-1 determination as the first step followed by ITT for patients with an IGF-1 concentration below 175 ng/ml missed five of the 61 GHD patients , avoided 46/142 ITT and reduced the cost of diagnosis by 15 % . CONCLUSION We propose the use of a strategy consisting of IGF-1 determination followed , if below 175 ng/ml by confirmatory ITT to diagnose GHD in adults Although the use of the insulin tolerance test ( ITT ) for the diagnosis of adult GH deficiency is well established , diagnostic peak GH cut-points for other commonly used GH stimulation tests are less clearly established . Despite that fact , the majority of patients in the United States who are evaluated for GH deficiency do not undergo insulin tolerance testing . The aim of this study was to evaluate the relative utility of six different methods of testing for adult GH deficiency currently used in practice in the United States and to develop diagnostic cut-points for each of these tests . Thirty-nine patients ( 26 male , 13 female ) with adult-onset hypothalamic-pituitary disease and multiple pituitary hormone deficiencies were studied in comparison with age- , sex- , estrogen status- , and body mass index-matched control subjects ( n = 34 ; 20 male , 14 female ) . A third group of patients ( n = 21 ) with adult-onset hypothalamic-pituitary disease and no more than one additional pituitary hormone deficiency was also studied . The primary end-point was peak serum GH response to five GH stimulation tests administered in r and om order at five separate visits : ITT , arginine ( ARG ) , levodopa ( L-DOPA ) , ARG plus L-DOPA , and ARG plus GHRH . Serum IGF-I concentrations were also measured on two occasions . For purpose s of analysis , patients with multiple pituitary hormone deficiencies were assumed to be GH deficient . Three diagnostic cut-points were calculated for each test to provide optimal separation of multiple pituitary hormone deficient and control subjects according to three criteria : 1 ) to minimize misclassification of control subjects and deficient patients ( balance between high sensitivity and high specificity ) ; 2 ) to provide 95 % sensitivity for GH deficiency ; and 3 ) to provide 95 % specificity for GH deficiency . The greatest diagnostic accuracy occurred with the ITT and the ARG plus GHRH test , although patients preferred the latter ( P = 0.001 ) . Using peak serum GH cut-points of 5.1 microg/liter for the ITT and 4.1 microg/liter for the ARG plus GHRH test , high sensitivity ( 96 and 95 % , respectively ) and specificity ( 92 and 91 % , respectively ) for GH deficiency were achieved . To obtain 95 % specificity , the peak serum GH cut-points were lower at 3.3 microg/liter and 1.5 microg/liter for the ITT and ARG plus GHRH test , respectively . There was substantial overlap between patients and control subjects for the ARG plus L-DOPA , ARG , and L-DOPA tests , but test-specific cut-points could be defined for all three tests to provide 95 % sensitivity for GH deficiency ( peak GH cut-points : 1.5 , 1.4 and 0.64 microg/liter , respectively ) . However , 95 % specificity could be achieved with the ARG plus L-DOPA and ARG tests only with very low peak GH cut-points ( 0.25 and 0.21 microg/liter , respectively ) and not at all with the L-DOPA test . Although serum IGF-I levels provided less diagnostic discrimination than all five GH stimulation tests , a value below 77.2 microg/liter was 95 % specific for GH deficiency . In conclusion , the diagnosis of adult GH deficiency can be made without performing an ITT , provided that test-specific cut-points are used . The ARG plus GHRH test represents an excellent alternative to the ITT for the diagnosis of GH deficiency in adults This is the second in a series of five articles Considerable effort has been expended at the interface between clinical medicine and scientific methods to achieve the maximum validity and usefulness of diagnostic tests . This article focuses on the specific kinds of questions that arise in diagnostic research and the study architectures ( the conversions of these clinical questions into appropriate research design s ) used to answer them . As an example we shall take shall take assessment of the value of the plasma concentration of B-type natriuretic peptide ( BNP ) in the diagnosis of left ventricular dysfunction.1 R and omised controlled trials are dealt with elsewhere . As in other forms of clinical research , there are several different ways study ing the potential or real diagnostic value of a physical sign or laboratory test , and each is appropriate to one kind of question and inappropriate for others . Among the possible questions about the relation between a putative diagnostic test and a target disorder ( for example , the concentration of BNP and left ventricular dysfunction ) , four are most relevant . # # # # Summary points Diagnostic studies should match methods to diagnostic questions The keys to validity in diagnostic test studies are Both specificity and sensitivity may change as the same diagnostic test is applied in primary ,
Output:
| Serum levels of GH or IGF1 had low diagnostic accuracy .
Several tests with reasonable diagnostic accuracy are available for the diagnosis of GHD in adults . |
MS211510 | ***TASK*** the task is to summarize an input biomedical literature 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: This project , started in 1985 by Dr Infante , is based on theory of the use of the clinical laboratory in nursing education . It fully recognizes the complementary roles of nursing education and nursing service by having practitioners participate as preceptors , role models , and mentors . Six clinical agencies participated in this innovative clinical teaching project with the goal of improving the effectiveness and efficiency of nursing education and nursing practice . It is hypothesized that the synchronization of clinical laboratory experiences with instruction in nursing theory and science and a closer collaboration among faculty , students , and nurse practitioners will give students an appropriate balance of academic and clinical practice perspectives and skills to prepare them effectively to meet the complex health care needs of patients . The subjects were 173 undergraduate baccalaureate nursing students enrolled in an upper-division generic program . For the purpose of testing Infante 's clinical model , the students were r and omly assigned to a control or experimental group for two successive incoming classes of nursing students . Each student 's academic and clinical progression was monitored . Data were gathered using grade point average , a st and ardized test for nursing knowledge ( Mosby Assesstest ; Mosby , St Louis ) , college laboratory practicum , and simulated testing for clinical application skills.2 + Data were analyzed using independent t tests . The findings indicate that the students in the experimental group , who used the experimental clinical model , achieved higher grade point averages , higher scores on the Mosby Assesstest , and higher college laboratory practicum scores than the students in the control group . The findings support the need for further investigation of innovative clinical teaching models BACKGROUND Educational approaches are thought to have facilitative or hindering effects on students ' critical thinking development . The aim of this study was to compare the effects of problem-based learning ( PBL ) and lecturing approaches on the development of students ' critical thinking . METHODS All 79 Year 1 undergraduate nursing students at a university in Hong Kong were r and omly assigned to 1 of 2 parallel courses delivered by either PBL ( n = 40 ) or lecturing ( n = 39 ) over 1 academic year . The primary outcome measure was students ' critical thinking disposition as measured by the California Critical Thinking Disposition Inventory ( CCTDI ) . Individual interviews were also conducted to elicit the students ' perceptions of their learning experience . Data were collected at 4 timepoints spanning 3 years . RESULTS The overall CCTDI and subscale scores for the PBL group were not significantly different from those of the lecture group at the first timepoint ( pretest ) . Compared with lecture students , PBL students showed significantly greater improvement in overall CCTDI ( P = 0.0048 ) , Truthseeking ( P = 0.0008 ) , Analyticity ( P = 0.0368 ) and Critical Thinking Self-confidence ( P = 0.0342 ) subscale scores from the first to the second timepoints ; in overall CCTDI ( P = 0.0083 ) , Truthseeking ( P = 0.0090 ) and Analyticity ( P = 0.0354 ) subscale scores from the first to the third timepoints ; and in Truthseeking ( P = 0.0173 ) and Systematic ity ( P = 0.0440 ) subscale scores from the first to the fourth timepoints . CONCLUSIONS There were significant differences in the development of students ' critical thinking dispositions between those who undertook the PBL and lecture courses , respectively AIMS This paper reports a study examining the effects of adopting concept mapping in problem-based learning scenario discussion s on the improvement of students ' learning outcomes in a nursing course . BACKGROUND Students in Taiwan usually have a high degree of anxiety about whether or not they have learned enough . Problem-based learning is a method of teaching that uses a patient situation or scenario to stimulate students to acquire and apply information to solve problems . Concept mapping can promote problem-solving and critical thinking to help students organize complex patient data , process complex relationships and offer holistic care to patients . METHODS An experimental design was used , with participants r and omly assigned either to a control or experimental group . The experimental group participated in six problem-based learning scenario discussion s during the 16-week semester , while the control group attended a traditional course . RESULTS The experimental group had significantly higher proposition and hierarchy scores for their concept maps compared with the control group . There were no significant differences in the cross-link and example scores between the two groups . In general , the total score difference between the groups did not reach statistical significance levels . Only one student in the experimental group obtained a high score ; most participants in both groups ( over 50 % ) obtained low scores . CONCLUSIONS Concept mapping strategies may be useful for analysis of individual student 's thinking processes for ( 1 ) emphasizing key concepts or main ideas , ( 2 ) underst and ing relationships between different concepts , including cause-effect and part-whole relationships , ( 3 ) review ing propositions , hierarchies and cross-links in a logically scientific way , and ( 4 ) revising concept structures to agree with theory and experience BACKGROUND The importance of critical thinking is well-documented by the American Association of Colleges of Nursing and the National League for Nursing . Reflective writing is often used to increase underst and ing and analytical ability . The lack of empirical evidence about the effect of reflective writing interventions on critical thinking supports the examination of this concept . OBJECTIVES Study objectives were : DESIGN This study used an experimental , pretest-posttest design . SETTING S The setting was two schools of nursing at universities in the southern United States . PARTICIPANTS The convenience sample included 70 fourth-semester students in baccalaureate nursing programs . METHODS R and omly assigned control and experimental groups completed the California Critical Thinking Skills Test ( CCTST ) and the California Critical Thinking Dispositions Inventory Test ( CCTDI ) . The experimental group completed six reflective writing assignments . Both groups completed the two tests again . RESULTS Results showed that the experimental group had a significant increase ( p=0.03 ) on the truthseeking subscale of the CCTDI when compared to the control group . The experimental group 's scores increased on four CCTST subscales and were higher than the control group 's on three CCTST subscales . CONCLUSIONS The results of this study make it imperative for nursing schools to consider including reflective writing-especially assignments based on Paul 's ( 1993 ) model-in nursing courses . If future studies , testing over longer periods of time , show significant increases in critical thinking , those interventions could be incorporated into nursing curriculum and change the way nurse educators evaluate students BACKGROUND Italian Nursing Faculties use a range of tutorial strategies ( laboratory sessions , intensive clinical tutoring , weekly tutoring ) aim ed to enhance nursing students ' diagnostic reasoning : these strategies have different impacts on promoting student critical thinking . By using critical thinking methods , students develop abilities to check , monitor and constantly evaluate the accuracy of the diagnostic reasoning process . However , there is little evidence to show how effective tutorial strategies are on the accuracy of diagnostic reasoning . There is also very little known about the complexity of tutorial strategies because these are made up of several components ( e.g. tutor question ing abilities , the value of the setting , the impact of the environment , the expertise of the tutor and the impact of the Faculty 's philosophy of learning ) , tutorial strategies can not be st and ardised and depend on multiple factors which are difficult to control . OBJECTIVES The objective was to establish a relationship between tutorial strategies orientated to enhance critical thinking and the accuracy of diagnostic reasoning ( i.e. the number of correct answers given by students on simulated cases in two different nursing education context s ) . It was hypothesised that students who had had one laboratory session using intensive tutorial strategies had less probability of making reasoning errors in diagnosing a simulated case than a control group that had weekly tutorials or routine tutoring . DESIGN A double pragmatic experimental study was adopted involving two Italian Nursing Faculties at universities in Verona and Udine . PARTICIPANTS A total of 144 students in the first year of their Nursing Science Degree course were involved ; in Verona , two r and om groups of 41 students were taken ( an intervention group and a control group ) . R and om selection s of 39 students for the intervention group and 29 students for a control group were made from the second campus in Udine . Data analysis was conducted comparing student outcomes in the same faculty ( intra-trial analysis ) and between the two campuses involved ( inter-trial analysis ) . RESULTS The students doing laboratory sessions and intensive clinical tutorials demonstrated fewer errors compared to the control group [ OR 3.75 ; IC 95 % 1.77 - 7.88 ] , although the students who receive routine tutoring , demonstrated higher risk of mistaking the problems of the patient [ OR 0.22 ; IC 0.95 % 0.07 - 0.65 ] . CONCLUSION From intra- and inter-trial analysis of the results , it can be concluded within limits , that those students who had had intensive tutorial strategies aim ed developing critical thinking abilities , formulated fewer wrong hypotheses in the first list they made when confronted with a new nursing case . Faculties should consider these outcomes and develop strategies including intensive tutorial strategies for improving the accuracy of nursing students ' clinical reasoning
Output:
| All selected studies were in English , with significant conceptual similarity of Critical Thinking and dominance in choosing the approached theme during strategies in clinical nursing education with an emphasis on the nursing process .
The most widely used teaching intervention was Problem-Based Learning .
Nursing education mediated by strategies that stimulate CT is considered a positive difference in undergraduate curriculums |
MS211511 | ***TASK*** the task is to summarize an input biomedical literature 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 & AIMS Upper gastrointestinal bleeding ( UGIB ) is a severe and frequent complication of cirrhosis . Recombinant coagulation factor VIIa ( rFVIIa ) has been shown to correct the prolonged prothrombin time in patients with cirrhosis and UGIB . This trial aim ed to determine efficacy and safety of rFVIIa in cirrhotic patients with variceal and nonvariceal UGIB . METHODS A total of 245 cirrhotic patients ( Child-Pugh < 13 ; Child-Pugh A = 20 % , B = 52 % , C = 28 % ) with UGIB ( variceal = 66 % , nonvariceal = 29 % , bleeding source unknown = 5 % ) were r and omized equally to receive 8 doses of 100 microg/kg rFVIIa or placebo in addition to pharmacologic and endoscopic treatment . The primary end point was a composite including : ( 1 ) failure to control UGIB within 24 hours after first dose , or ( 2 ) failure to prevent rebleeding between 24 hours and day 5 , or ( 3 ) death within 5 days . RESULTS Baseline characteristics were similar between rFVIIa and placebo groups . rFVIIa showed no advantage over st and ard treatment in the whole trial population . Exploratory analyses , however , showed that rFVIIa significantly decreased the number of failures on the composite end point ( P = 0.03 ) and the 24-hour bleeding control end point ( P = 0.01 ) in the subgroup of Child-Pugh B and C variceal bleeders . There were no significant differences between rFVIIa and placebo groups in mortality ( 5- or 42-day ) or incidence of adverse events including thromboembolic events . CONCLUSIONS Although no overall effect of rFVIIa was observed , exploratory analyses in Child-Pugh B and C cirrhotic patients indicated that administration of rFVIIa significantly decreased the proportion of patients who failed to control variceal bleeding . Dosing with rFVIIa appeared safe . Further studies are needed to verify these findings Background — Blood loss is a common complication of cardiac surgery . Evidence suggests that recombinant activated factor VII ( rFVIIa ) can decrease intractable bleeding in patients after cardiac surgery . Our objective was to investigate the safety and possible benefits of rFVIIa in patients who bleed after cardiac surgery . Methods and Results — In this phase II dose-escalation study , patients who had undergone cardiac surgery and were bleeding were r and omized to receive placebo ( n=68 ) , 40 & mgr;g/kg rFVIIa ( n=35 ) , or 80 & mgr;g/kg rFVIIa ( n=69 ) . The primary end points were the number of patients suffering critical serious adverse events . Secondary end points included rates of reoperation , amount of blood loss , and transfusion of allogeneic blood . There were more critical serious adverse events in the rFVIIa groups . These differences did not reach statistical significance ( placebo , 7 % ; 40 & mgr;g/kg , 14 % ; P=0.25 ; 80 & mgr;g/kg , 12 % ; P=0.43 ) . After r and omization , significantly fewer patients in the rFVIIa group underwent a reoperation as a result of bleeding ( P=0.03 ) or required allogeneic transfusions ( P=0.01 ) . Conclusions — On the basis of this preliminary evidence , rFVIIa may be beneficial for treating bleeding after cardiac surgery , but caution should be applied and further clinical trials are required because there is an increase in the number of critical serious adverse events , including stroke , in those patients r and omized to receive rFVIIa BACKGROUND Coagulopathy caused by cirrhosis may contribute to excessive bleeding during hepatectomy . We evaluated the hemostatic effect and safety of recombinant factor VIIa ( rFVIIa ) in cirrhotic patients undergoing partial hepatectomy . METHODS Patients were r and omized to rFVIIa 50 or 100 mug/kg or placebo , administered intravenously 10 minutes before surgery and every second hour during surgery . The primary efficacy end points were the proportion of patients receiving red blood cell ( RBC ) transfusions and the amount of RBCs transfused . The RBC transfusion trigger was blood loss of 500 mL. Safety end points included thromboembolic and adverse events . RESULTS No statistically significant effect of rFVIIa treatment on efficacy end points was observed . Serious and thromboembolic adverse events occurred at similar incidences in the study groups . CONCLUSIONS Using blood loss as a transfusion trigger , the efficacy of rFVIIa in reducing the requirement for RBC transfusion was not established in this study . No safety concerns were identified Patients undergoing orthotopic liver transplantation ( OLT ) have excessive blood loss during surgery that requires blood transfusions , leading to increased postoperative morbidity and mortality . We studied the efficacy and safety of activated recombinant factor VII ( rFVIIa ) in reducing transfusion requirements in OLT . This multicenter , r and omized , double-blind , placebo-controlled trial enrolled patients undergoing OLT because of cirrhosis ( Child-Turcotte-Pugh class B or C ) . Patients received a repeated intravenous bolus regimen of rFVIIa 60 or 120 microg/kg or placebo . The primary efficacy endpoint was the total number of red blood cell ( RBC ) units transfused during the perioperative period . A total of 182 patients were analyzed for efficacy and 183 for safety . No significant effect of rFVIIa was observed on the number of RBC units transfused or intraoperative blood loss compared with the placebo group . A significantly higher number of patients in the rFVIIa study groups avoided RBC transfusion . Administration of rFVIIa but not placebo restored the preoperative prolonged prothrombin time to normal value during surgery . Patients receiving rFVIIa and placebo did not experience a significant difference in rate of thromboembolic events . Additionally , there was no statistically significant effect of rFVIIa treatment on hospitalization rate , total surgery time , and the proportion of patients undergoing retransplantation . In conclusion , use of rFVIIa during OLT significantly reduced the number of patients requiring RBC transfusion . There was no increase in thromboembolic events with rFVIIa administration compared with placebo Background and Purpose — Hematoma growth occurs in 38 % of intracerebral hemorrhage ( ICH ) patients scanned by computed tomography ( CT ) within 3 hours of onset . Activated recombinant factor VII ( rFVIIa ) promotes hemostasis at sites of vascular injury and may minimize hematoma growth after ICH . Methods — In this r and omized , double-blind , placebo-controlled , dose-escalation trial , 48 subjects with ICH diagnosed within 3 hours of onset were treated with placebo ( n=12 ) or rFVIIa ( 10 , 20 , 40 , 80 , 120 , or 160 & mgr;g/kg ; n=6 per group ) . The primary endpoint was the frequency of adverse events ( AEs ) . Safety assessment s included serial electrocardiography ( ECG ) , troponin I and coagulation testing , lower extremity Doppler ultrasonography , and calculation of edema : ICH volume ratios . Results — Mean age was 61 years ( range , 30 to 93 ) and 57 % were male . At admission , mean National Institutes of Health Stroke Scale ( NIHSS ) score was 14 ( range , 1 to 26 ) , median Glasgow Coma Scale score was 14 ( range , 6 to 15 ) , and mean ICH volume was 21 mL ( range , 1 to 151 ) . Mean time from onset to treatment was 181 minutes ( range , 120 to 265 ) . Twelve serious AEs occurred , including 5 deaths ( mortality 11 % ) . Six AEs were considered possibly treatment-related , including rash , vomiting , fever , ECG T-wave inversion , and 2 cases of deep vein thrombosis ( placebo and 20-&mgr;g/kg groups ) . No myocardial ischemia , consumption coagulopathy , or dose-related increase in edema : ICH volume occurred . Conclusion — This small phase II trial evaluated a wide range of rFVIIa doses in acute ICH and raised no major safety concerns . Larger studies are justified to determine whether rFVIIa can safely and effectively limit ICH growth BACKGROUND Activated recombinant coagulation factor VII ( rFVIIa ) effectively prevents and controls bleeding in patients with coagulopathy . Data show that rFVIIa may reduce blood loss and eliminate the need for transfusion in patients with normal haemostasis undergoing major surgery . We assessed the efficacy of rFVIIa in patients with normal haemostasis undergoing repair surgery of major traumatic fracture of the pelvis or the pelvis and acetabulum , who were expected to have a large volume of blood loss . METHODS We performed a double-blind , r and omized , placebo-controlled trial involving 48 patients undergoing major pelvic-acetabular surgery . Patients were r and omized to receive an i.v . bolus injection of rFVIIa 90 microg kg(-1 ) or placebo as add-on therapy at the time of the first skin incision . All patients also received intraoperative salvaged red blood cells ( RBC ) . RESULTS There was no significant difference in the total volume of perioperative blood loss , the primary outcome variable , between the rFVIIa and placebo groups . In addition , there were no differences between the two groups in the total volume of blood components , including salvaged RBC transfused , number of patients requiring allogeneic blood components , total volume of fluids infused , total operating time , time taken after entry to the intensive care unit to reach normal body temperature and acid-base status , and time spent in hospital . No adverse events , in particular thromboembolic events , were reported in either group . CONCLUSIONS In patients with normal haemostasis undergoing repair surgery of traumatic pelvic-acetabular fracture , the prophylactic use of rFVIIa does not decrease the volume of perioperative blood loss Orthotopic liver transplantation ( OLT ) can be associated with excessive blood loss . As a result , there may be increased risk of adverse outcomes . Activated recombinant factor VII ( rFVIIa ) has demonstrated the ability to improve hemostasis in a variety of disorders ; however , there has been a limited amount of research into its use in OLT . The purpose of this dose-finding study was to examine the efficacy and safety of rFVIIa in the reduction of bleeding in patients undergoing OLT . In this double-blind trial , patients with end-stage liver disease scheduled for OLT were r and omized to 1 of 4 parallel study groups . They received a single intravenous bolus of rFVIIa ( 20 , 40 , or 80 microg/kg ) or placebo prior to surgery . The primary assessment endpoint was the total number of red blood cell ( RBC ) units transfused perioperatively . Safety was evaluated by adverse events reported . Eighty-three comparable patients were r and omized to receive study product , with 82 ultimately undergoing OLT . There were no significant differences in required RBC units between the placebo and rFVIIa study groups . The number of adverse events was comparable between study groups . In conclusion , rFVIIa has a good safety profile in patients undergoing OLT . However , the doses studied did not have any effect on the number of RBC transfusions required BACKGROUND Recombinant activated factor VII ( factor VIIa ) has prohaemostatic effects in bleeding patients with coagulation abnormalities . We aim ed to test the hypothesis that recombinant factor VIIa could reduce perioperative blood loss in patients with normal coagulation systems . Therefore , we assessed safety and efficacy of this drug in patients undergoing retropubic prostatectomy , which is often associated with major blood loss and need for transfusion . METHODS In a double-blind , r and omised placebo-controlled trial , we recorded blood loss and transfusion requirements in 36 patients undergoing retropubic prostatectomy , who were r and omised to receive an intravenous bolus of recombinant factor VIIa ( 20 microg/kg or 40 microg/kg ) or placebo in the early operative phase . FINDINGS Median perioperative blood loss was 1235 mL ( IQR 1025 - 1407 ) and 1089 mL ( 928 - 1320 ) in groups given recombinant factor VIIa 20 microg/kg and 40 microg/kg , respectively , compared with 2688 mL ( 1707 - 3565 ) in the placebo group ( p=0.001 ) . Seven of twelve placebo-treated patients were transfused , whereas no patients who received 40 microg/kg recombinant factor VIIa needed transfusion . The odds ratio for receiving any blood product in patients treated with recombinant factor VIIa compared with control patients was 0 ( 95 % CI 0.00 - 0.33 ) No adverse events arose . INTERPRETATION An injection of recombinant factor VIIa can reduce perioperative blood loss and eliminate the need for transfusion in patients undergoing major surgery BACKGROUND & AIMS Activated recombinant factor VII ( rFVIIa ) has been shown to be effective in correcting prolonged prothrombin time ( PT ) in cirrhotic patients . The main objective of this study
Output:
| INTERPRETATION Clinical ly significant benefits of recombinant factor VIIa as a general hemostatic agent in patients without hemophilia remain unproven . |
MS211512 | ***TASK*** the task is to summarize an input biomedical literature 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 . Regular clinic attendance for antiretroviral ( ARV ) drug refills is important for successful clinical outcomes in HIV management . Methods . Clinic attendance for ARV drug refills and medication adherence using a clinic-based pill count in 392 adult patients receiving antiretroviral therapy ( ART ) in a district hospital in Ug and a were prospect ively monitored over a 28-week period . Results . Of the 2267 total scheduled clinic visits , 40 ( 1.8 % ) were missed visits . Among the 392 clients , 361 ( 92 % ) attended all appointments for their refills ( regular attendance ) . Clinic attendance for refills was statistically significantly associated with medication adherence with regular attendant clients having about fourfold greater odds of achieving optimal ( ≥95 % ) medication adherence [ odds ratio ( OR ) = 3.89 , 95 % CI : 1.48 to 10.25 , exact P = .013 ] . In multivariate analysis , clients in age category 35 years and below were less likely to achieve regular clinic attendance . Conclusion . Monitoring of clinic attendance may be an objective and effective measure and could be a useful adjunct to an adherence measure such as pill counting in re source -constrained setting s. Where human re source constraints do not allow pill counts or other time-consuming measures , then monitoring clinic attendance and acting on missed appointments may be an effective proxy measure Objectives : Antiretroviral treatment ( ART ) scale-up in sub-Saharan Africa has made it possible to investigate the maintenance of adherence to HIV medications . We describe here adherence to ART and identify its correlates in the Cameroonian context . Design : Prospect i ve cohort study in 9 rural district hospitals . Methods : A mixed logistic regression model was used to identify factors associated with adherence to ART in 401 patients with data prospect ively collected on adherence . Results : Although 73 % of patients were adherent after the first month on ART , this proportion decreased to 61 % after 24 months . After adjustment for known factors of adherence to ART ( such as knowledge , motivation and side-effects ) , patients who reported willingness to start ART before initiation , those who were satisfied with information provided by their physicians , and those who implemented reminder methods for ART intake { eg , using an alarm clock , mobile phone , or watch [ odds ratio ( 95 % confidence interval ) ] = 2.45 ( 1.58 to 3.79 ) , but also the help of a relative to remind them or other methods } were more likely to be adherent to ART . Conclusions : Besides highlighting some correlates already known to have an impact on adherence to ART , our findings also underline the need to reinforce the counseling component of follow-up through innovative methods . Accordingly , training and implementation research should encourage the use of medication reminder methods , such as mobile phones , to assure adherence over time and improve long-term response to ART Background . Large-scale , government-based antiretroviral therapy ( ART ) programs in rural areas of re source -poor countries remain largely unevaluated . Methods . We conducted a retrospective review of all patients receiving ART ( n = 399 ) to assess survival and retention in care and a prospect i ve evaluation of patients on ART for at least 6 months ( n = 175 ) . We used 3-day self-report to measure adherence . Results . The probability ( 95 % confidence interval [ CI ] ) of surviving and remaining in care was 0.76 ( 0.72 , 0.81 ) at 1 year . Men and patients with advanced disease were more likely to die or be lost to follow-up . At baseline , 149 ( 85 % ) reported 100 % adherence . Nonadherence was associated with lack of suppression of viral replication ( odds ratio [ OR ] = 4.5 ; 95 % CI : 1.8 , 11.5 ) . Missing a scheduled clinic visit and lack of disclosure of HIV status were associated with nonadherence . Conclusion . Viral suppression was high , but counseling to include HIV disclosure to family and keeping scheduled clinic appointments may improve long-term adherence and treatment outcomes We conducted a prospect i ve cohort study of 496 adults starting antiretroviral treatment ( ART ) to determine the impact of neuropsychiatric symptoms and socioeconomic status on adherence and mortality . Almost 60 % had good adherence based upon pharmacy records . Poor adherence was associated with being divorced , poorer , food insecure , and less educated . Longer travel time to clinic , concealing one 's human immunodeficiency virus ( HIV ) status , and experiencing side effects predicted poor adherence . Over a third of the patients had cognitive impairment and poorer cognitive function was also associated with poor adherence . During follow-up ( mean 275 days ) , 20 % died-usually within 90 days of starting ART . Neuropsychiatric symptoms , advanced HIV , peripheral neuropathy symptoms , food insecurity , and poverty were associated with death . Neuropsychiatric symptoms , advanced HIV , and poverty remained significant independent predictors of death in a multivariate model adjusting for other significant factors . Social , economic , cognitive , and psychiatric problems impact adherence and survival for people receiving ART in rural Zambia Background Access to programmes providing highly active antiretroviral therapy ( HAART ) is recent in Africa . In Senegal , a national initiative was launched in 1998 . The capacity of African patients to adhere to complex antiretroviral treatments ( ARV ) is largely unknown . Methods We assessed adherence and identified the main reasons for treatment interruption in a prospect i ve observational cohort of patients participating in an ARV access programme in Dakar , Senegal . Adherence was estimated each month on the basis of the patients ' stated consumption and on the proportion of the prescribed dose returned unused to the dispensing pharmacy . A total of 158 patients were studied between November 1999 and October 2001 . Results A cross-section analysis showed that the stated level of adherence was high : on average , over the study period , the patients said they had taken 91 % of each monthly dose and that they had taken the full monthly dose during two-thirds of the months studied . Adherence tended to be better among patients who were required to make little or no contribution to the cost of their treatment , through an appropriate pricing structure . Adherence was also better with efavirenz-containing regimens than with indinavir-containing regimens . Conclusion These results show that adherence to HAART can be as high in Africa as that generally observed in industrialized countries , and that the cost and type of drug regimen must be taken into account when design ing ARV access programmes for poor communities Background Participant non-adherence and loss to follow-up can compromise the validity of clinical trial results . An assessment of these issues was made in a 3-year tuberculosis prevention trial among HIV-infected adults in Botswana . Methods and Findings Between 11/2004–07/2006 , 1995 participants were enrolled at eight public health clinics . They returned monthly to receive bottles of medication and were expected to take daily tablets of isoniazid or placebo for three years . Non-adherence was defined as refusing tablet ingestion but agreeing to quarterly physical examinations . Loss to follow-up was defined as not having returned for appointments in ≥60 days . Between 10/2008–04/2009 , survey interviews were conducted with 83 participants identified as lost to follow-up and 127 identified as non-adherent . As a comparison , 252 r and omly selected adherent participants were also surveyed . Multivariate logistic regression analysis was used to identify associations with selected risk factors . Men had higher odds of being non-adherent ( adjusted odds ratio ( AOR ) , 2.24 ; 95 % confidence interval [ 95%CI ] 1.24–4.04 ) and lost to follow-up ( AOR 3.08 ; 95%CI 1.50–6.33 ) . Non-adherent participants had higher odds of reporting difficulties taking the regimen or not knowing if they had difficulties ( AOR 3.40 ; 95%CI 1.75–6.60 ) and lower odds associated with each year of age ( AOR 0.95 ; 95%CI 0.91–0.98 ) , but other variables such as employment , distance from clinic , alcohol use , and underst and ing study requirements were not significantly different than controls . Among participants who were non-adherent or lost to follow-up , 40/210 ( 19.0 % ) reported that they stopped the medication because of work commitments and 33/210 ( 15.7 % ) said they thought they had completed the study . Conclusions Men had higher odds of non-adherence and loss to follow-up than women . Potential interventions that might improve adherence in trial participants may include : targeting health education for men , reducing barriers , clarifying study expectations , educating employers about HIV/AIDS to help reduce stigma in the workplace , and encouraging employers to support employee health . Trial Registration Clinical Trials.gov The anti-retroviral ( ARV ) treatment programme in Nigeria is delivered through selected teaching and mission hospitals at a free/subsidized rate . The government aims to scale up ARV treatment in the country . However , non-adherence to ARV medication can lead to viral resistance , treatment failure , toxicities and waste of financial re sources . This study examined the factors responsible for non-adherence to free/subsidized ARV treatment in south-east Nigeria . The study was cross-sectional and descriptive . Information was collected from 174 patients selected by simple r and om sampling from the register of all patients who had been on anti-retroviral therapy ( ART ) for at least 12 months at the beginning of the study period . Patients were identified during their clinic visits . Information on their socio-demographic profile , ARV treatment and determinants of non-adherence to ARV treatment was obtained from those who gave consent , using pre-tested interviewer-administered question naires . All patients clearly understood the need to take ARV drugs throughout their lives , and what the costs entailed . They understood the need for periodic testing , the probability that complications would develop , cost of transportation to treatment site and the daily treatment regimen . Seventy-five per cent of respondents were not adhering fully to their drug regimen ; the mean number of days that respondents had been off drugs was 3.57 days the preceding month . Reasons for non-adherence included : physical discomfort ( side effects ) ; non-availability of drugs at treatment site ; forgetting to carry drugs during the day ; fear of social rejection ; treatment being a reminder of HIV status ; and selling of own drugs to those unable to enrol in the projects . Being female , under 35 years , single , and having higher educational status were significantly associated with non-adherence . It is important that policy makers and programme managers address the factors responsible for non-adherence when scaling up subsidized ARV treatment in Nigeria and other parts of sub-Saharan Africa The aim of this prospect i ve study ( 20 months ) was to assess HIV patients ' use of Traditional , Complementary and Alternative Medicine ( TCAM ) and its effect on ARV adherence at three public hospitals in KwaZulu-Natal , South Africa . Seven hundred and thirty-five ( 29.8 % male and 70.2 % female ) patients who consecutively attended three HIV clinics completed assessment s prior to ARV initiation , 519 after 6 months , 557 after 12 and 499 after 20 months on antiretroviral therapy ( ART ) . Results indicate that following initiation of ARV therapy the use of herbal therapies for HIV declined significantly from 36.6 % prior to ARV therapy to 8.0 % after 6 months , 4.1 % after 12 months and 0.6 % after 20 months on ARVs . Faith healing methods ( including spiritual practice s and prayer ) declined from 35.8 % to 22.1 % , 20.8 % and 15.5 % , respectively . In contrast , the use of micronutrients ( vitamins , etc . ) significantly increased from 42.6 % to 78.2 % . The major herbal remedies that were used prior to ART were unnamed traditional medicine , followed by imbiza ( Scilla natalensis planch ) , canova ( immune booster ) , izifozonke ( essential vitamins mixed with herbs ) , African potato ( Hypoxis hemerocallidea ) , stametta ( aloe mixed with vitamins and herbs ) and ingwe ( tonic ) . Herbal remedies were mainly used for pain relief , as immune booster and for stopping diarrhea . As herbal treatment for HIV was associated with reduced ARV adherence , patient 's use of TCAM should be considered in ARV adherence management Background Seventy percent of urban population s in sub-Saharan Africa live in slums . Sustaining HIV patients in these high-risk and highly mobile setting s is a major future challenge . This study seeks to assess program retention and to find determinants for low adherence to antiretroviral treatment ( ART ) and drop-out from an established HIV/ART program in Kibera , Nairobi , one of Africa 's largest informal urban settlements . Methods and Findings A prospect i ve open cohort study of 800 patients was performed at the African Medical Research Foundation ( AMREF ) clinic in the Kibera slum . Adherence to ART and drop-out from the ART program were independent outcomes . Two different adherence measures were used : ( 1 ) “ dose adherence ” ( the proportion of a prescribed dose taken
Output:
| The systematic review of the available evidence does not provide conclusive support for the existence of a clear association between SES and adherence to ART among adult patients infected with HIV/ AIDS in low- and middle-income countries . |
MS211513 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: OBJECTIVE The aim of this study was to compare perinatal outcomes of patients with second-trimester ultrasonographic evidence of preterm dilatation of the internal os treated with cerclage versus those of patients not treated with cerclage . STUDY DESIGN From May 1998 through June 1999 patients with ultrasonographic evidence of preterm dilatation of the internal os between 16 and 24 weeks ' gestation were r and omly assigned to receive a McDonald cerclage or no cerclage . Before r and om assignment all patients underwent amniocentesis and urogenital cultures and then received 48 hours of therapy with indomethacin and antibiotics . After treatment each patient was followed up as an outpatient with bed rest and weekly ultrasonographic evaluation . RESULTS Of the 61 patients 31 were r and omly assigned to cerclage and 30 were r and omly assigned to no cerclage . There were no differences between groups with respect to maternal demographic characteristics , risk factors for preterm birth , cervical measurements , rescue procedures , readmission , chorioamnionitis , and abruptio placentae . The mean gestational age at delivery ( 33.5 + /- 6.3 weeks ) and the perinatal death rate ( 12 . 9 % ) in the cerclage group were similar to the mean gestational age at delivery ( 34.7 + /- 4.7 weeks ; P = .4 ) and the perinatal death rate ( 10.0 % ; P = .9 ) in the no-cerclage group . CONCLUSION Treatment with McDonald cerclage of preterm dilatation of the cervix detected ultrasonographically during the second trimester did not improve perinatal outcomes Internal os cerclage for cervical incompetence was performed in 90 patients who had previous McDonald procedure failure ( 70 patients ) or had unfavorable cervical anatomy ( short or lacerated cervix ) for primary McDonald type cerclage ( 20 patients ) . Two different techniques were used : the Shirodkar operation ( n = 44 ) with Mersilene b and , and a simpler new technique ( n = 46 ) . The new technique is characterized by anterior colpotomy for exposure of the internal os , and a 0.6 mm nylon suture encircling the cervix to be tied high in the posterior fornix . The pregnancy outcome for both groups was similar . Late abortions of 8.7 and 11 % and premature deliveries of 13 and 18 % occurred in the new technique and the Shirodkar groups , respectively . The removal of the suture was generally difficult in the Shirodkar group and in eight patients analgesia and sedation were required . In the new technique group , the removal was easier and in only one patient was sedation required ( p less than 0.0001 ) . Severe vaginal discharge was found in 52 % of the Shirodkar patients and none in the other group . Apparently the monofilament nylon suture prevented this side effect . It seems that the new technique is simpler to perform , involves fewer side effects , the removal of the suture is easier , and it is as effective as the Shirodkar procedure OBJECTIVE To compare preterm delivery rates ( before 34 weeks of gestation ) and neonatal morbidity and mortality in patients with risk factors or symptoms of cervical incompetence managed with therapeutic McDonald cerclage and bed rest versus bed rest alone . STUDY DESIGN Cervical length was measured in patients with risk factors or symptoms of cervical incompetence . Risk factors for cervical incompetence included previous preterm delivery before 34 weeks of gestation that met clinical criteria for the diagnosis of cervical incompetence , previous preterm premature rupture of membranes before 32 weeks of gestation , history of cold knife conization , diethylstilbestrol exposure , and uterine anomaly . When a cervical length of < 25 mm was measured before a gestational age of 27 weeks , a r and omization for therapeutic cerclage and bed rest ( cerclage group ) or bed rest alone ( bed rest group ) was performed . The analysis is based on intention to treat . RESULTS Of the 35 women who met the inclusion criteria , 19 were allocated r and omly to the cerclage group and 16 to the bed rest group . Both groups were comparable for mean cervical length and mean gestational age at time of r and omization , mean overall 20 mm and 21 weeks . Preterm delivery before 34 weeks was significantly more frequent in the bed rest group than in the cerclage group ( 7 of 16 vs none , respectively ; P = .002 ) . There was no statistically significant difference in neonatal survival between the groups ( 13 neonates survived in the bed rest group vs all in the cerclage group ) . The compound neonatal morbidity , defined as admission to the neonatal intensive care unit or neonatal death , was significantly higher in the bed rest group than in the cerclage group ( 8 of 16 vs 1 of 19 , respectively ; P = .005 ; RR = 9.5 , 95 % CI , 1.3 - 68.1 ) . CONCLUSIONS Therapeutic cerclage with bed rest reduces preterm delivery before 34 weeks of gestation and compound neonatal morbidity in women with risk factors and /or symptoms of cervical incompetence and a cervical length of < 25 mm before 27 weeks of gestation OBJECTIVE The purpose of this study was to determine the efficacy of cerclage and bed rest versus bed rest-only for the prevention of preterm birth in women with a short cervix found on transvaginal ultrasound examination . STUDY DESIGN Women with > or = 1 of high-risk factors for preterm birth ( > or = 1 preterm birth at < 35 weeks of gestation , > or = 2 curettages , diethylstilbestrol exposure , cone biopsy , Mullerian anomaly , or twin gestation ) were screened with transvaginal ultrasonography of the cervix every 2 weeks from 14 weeks of gestation to 23 weeks 6 days of gestation . Enrollment was offered to both asymptomatic women who were at high risk and who were identified to have short cervix ( < 25 mm ) or significant funneling ( > 25 % ) and nonscreened women who were at low risk and who were identified incidentally . The women who gave written consent were assigned r and omly to receive either McDonald cerclage or bed rest-only . Both groups received similar counseling and treatment . Primary outcome was preterm birth at < 35 weeks of gestation . RESULTS Sixty-one women were assigned r and omly . Forty-seven pregnancies ( 77 % ) were high-risk singleton gestations . Thirty-one women ( 51 % ) were allocated to cerclage , and 30 women ( 49 % ) were allocated to bed rest . There were no differences between the groups in demographic characteristics , risk factors , and cervical variables . Preterm birth at < 35 weeks of gestation occurred in 14 women ( 45 % ) in the cerclage group and in 14 women ( 47 % ) in the bed rest group ( relative risk , 0.94 ; 95 % CI , 0.34 - 2.58 ) . There was no difference in any obstetric or neonatal outcomes . A sub analysis of singleton pregnancies with previous preterm birth at < 35 weeks of gestation and a short cervix of < 25 mm ( n = 31 women ) also revealed no significant difference in recurrent preterm birth at < 35 weeks of gestation ( 40 % vs 56 % ; relative risk , 0.52 ; 95 % CI , 0.12 - 2.17 ) . CONCLUSION Cerclage did not prevent preterm birth in women with a short cervix . These results should be confirmed by larger trials To determine the value of transvaginal sonography in women with a previous history of second trimester miscarriage due to cervical incompetence , 55 patients were subjected to either elective cervical cerclage or follow-up ( every second patient ) with weekly evaluations of the cervix by transvaginal ultrasonography . Emergency cerclage was applied when significant cervical changes were noted . All patients were evaluated with cervical cultures and ultrasound . Women with infection , fibroids , uterine malformations and multiple pregnancies were excluded from the study . The study population was divided in two groups . In group I ( n=27 ) elective cerclage was applied during the 14th week . Women in group II ( n=28 ) were subjected to serial weekly evaluations of the cervix by transvaginal ultrasonograms . In 18 cases emergency cerclage was applied due to significant cervical changes . In group I , labor started before the 33rd week in two cases ( 7.4 % ) , between 33 and 37 weeks in nine ( 33.3 % ) and after the 37th week in 16 cases ( 59.2 % ) . Out of the 18 patients in group II who had cervical cerclage after ultrasonographic evaluation , four ( 22.2 % ) delivered before the 33rd week , three ( 16.6 % ) between 33 and 37 weeks and 11 ( 61.1 % ) after the 37th week . No statistical difference was noted between the two groups referring to pregnancy outcome ( p<0.1 ) . We concluded that ultrasound-guided management despite cervical shortening , does not result in unfavorable pregnancy outcome . A significant number of patients can avoid the operation BACKGROUND Cervical cerclage has been widely used in the past 50 years to prevent early preterm birth and its associated neonatal mortality and morbidity . Results of r and omised trials have not generally lent support to this practice , but this absence of benefit may be due to suboptimum patient selection , which was essentially based on obstetric history . A more effective way of identifying the high-risk group for early preterm delivery might be by transvaginal sonographic measurement of cervical length . We undertook a multicentre r and omised controlled trial to investigate whether , in women with a short cervix identified by routine transvaginal scanning at 22 - 24 weeks ' gestation , the insertion of a Shirodkar suture reduces early preterm delivery . METHODS Cervical length was measured in 47?123 women . The cervix was 15 mm or less in 470 , and 253 ( 54 % ) of these women participated in the study and were r and omised to cervical cerclage ( 127 ) or to expectant management ( 126 ) . Primary outcome was the frequency of delivery before 33 completed weeks ( 231 days ) of pregnancy . FINDINGS The proportion of preterm delivery before 33 weeks was similar in both groups , 22 % ( 28 of 127 ) in the cerclage group versus 26 % ( 33 of 126 ) in the control group ( relative risk=0.84 , 95 % CI 0.54 - 1.31 , p=0.44 ) , with no significant differences in perinatal or maternal morbidity or mortality . INTERPRETATION The insertion of a Shirodkar suture in women with a short cervix does not substantially reduce the risk of early preterm delivery . Routine sonographic measurement of cervical length at 22 - 24 weeks identifies a group at high risk of early preterm birth OBJECTIVE The purpose of this study was to identify the risk factors that are associated with increased neonatal morbidity in patients who were treated for sonographic evidence of internal os dilation and distal cervical shortening during the second trimester . STUDY DESIGN From May 1998 to June 2000 patients between 16 and 24 weeks of gestation with the following sonographic criteria were r and omly assigned to McDonald cerclage or no cerclage : internal os dilation and either membrane prolapse into the endocervical canal at least 25 % of the total cervical length but not beyond the external os or a shortened distal cervix < 2.5 cm . Before r and omization , all patients were treated identically with an amniocentesis , multiple urogenital cultures , and therapy with indomethacin and clindamycin for 48 to 72 hours . Except for the cerclage , all patients were treated identically after r and omization . Multiple variables of perinatal outcome were analyzed . A regression model with gestational age at delivery as the dependent variable was constructed and repeated with neonatal morbidity as the dependent variable . This model was applied to 3 population s : the cerclage group , the no cerclage group , and both groups combined . RESULTS Of the 135 patients , 20 patients declined r and omization , and 2 patients were diagnosed with acute chorioamnionitis . Of the 113 patients remaining , 55 patients were r and omly assigned to the cerclage group , and 58 patients were r and omly assigned to the no cerclage group . There were 8 rescue cerclage procedures ( 4 in each group ) . Regression analysis showed that readmission for preterm labor , chorioamnionitis , and abruption were consistently associated with early gestational age at delivery and increased morbidity . Cerclage did not affect perinatal outcome . CONCLUSION The sonographic findings of second trimester internal os dilation , membrane prolapse , and distal cervical shortening likely represent a common pathway of several pathophysiologic processes . Use of cerclage does not alter any perinatal outcome variables . Increased neonatal morbidity in these patients appears to be associated with sub clinical infection , preterm labor , and abruption OBJECTIVE The objective of this study was to compare different management strategies for women at risk for cervical incompetence . STUDY DESIGN In an ongoing r and omized trial patients with a previous preterm delivery at < 34 weeks ' gestation who met clin
Output:
| Cervical cerclage was associated with mild pyrexia , increased use of tocolytic therapy and hospital admissions but no serious morbidity .
REVIEW ER 'S CONCLUSIONS The use of a cervical stitch should not be offered to women at low or medium risk of mid trimester loss , regardless of cervical length by ultrasound . |
MS211514 | ***TASK*** the task is to summarize an input biomedical literature 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 Wong-Baker FACES Pain Rating Scale ( WBS ) , used in children to rate pain severity , has been vali date d outside the emergency department ( ED ) , mostly for chronic pain . The authors vali date d the WBS in children presenting to the ED with pain by identifying a corresponding mean value of the visual analog scale ( VAS ) for each face of the WBS and determined the relationship between the WBS and VAS . The hypothesis was that the pain severity ratings on the WBS would be highly correlated ( Spearman 's rho > 0.80 ) with those on a VAS . METHODS This was a prospect i ve , observational study of children ages 8 - 17 years with pain presenting to a suburban , academic pediatric ED . Children rated their pain severity on a six-item ordinal faces scale ( WBS ) from none to worst and a 100-mm VAS from least to most . Analysis of variance ( ANOVA ) was used to compare mean VAS scores across the six ordinal categories . Spearman 's correlation ( rho ) was used to measure agreement between the continuous and ordinal scales . RESULTS A total of 120 patients were assessed : the median age was 13 years ( interquartile range [ IQR ] = 10 - 15 years ) , 50 % were female , 78 % were white , and six patients ( 5 % ) used a language other than English at home . The most commonly specified locations of pain were extremity ( 37 % ) , abdomen ( 19 % ) , and back/neck ( 11 % ) . The mean VAS increased uniformly across WBS categories in increments of about 17 mm . ANOVA demonstrated significant differences in mean VAS across face groups . Post hoc testing demonstrated that each mean VAS was significantly different from every other mean VAS . Agreement between the WBS and VAS was excellent ( rho = 0.90 ; 95 % confidence interval [ CI ] = 0.86 to 0.93 ) . There was no association between age , sex , or pain location with either pain score . CONCLUSIONS The VAS was found to have an excellent correlation in older children with acute pain in the ED and had a uniformly increasing relationship with WBS . This finding has implication s for research on pain management using the WBS as an assessment tool 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 a r and omized double-blind study of 57 children ( aged 6 months-6 yr ) , pain following lateral thoracotomy was relieved with repeated i.v . doses of morphine 100 or 50 micrograms kg-1 , or buprenorphine 3.0 or 1.5 micrograms kg-1 . The same drug and dosage were continued and cardioventilatory indices , pain intensity and sedation measured for an observation period of 24 h. The sums of the pain intensity differences were equal in all groups . The mean doses for the complete initial analgesia were 230 and 180 micrograms kg-1 with the larger and the smaller bolus doses of morphine and 5.8 and 3.7 micrograms kg-1 with buprenorphine , respectively . The mean duration of action of buprenorphine was slightly but not significantly longer than that of morphine . The total consumption of both morphine and buprenorphine was less when the smaller bolus doses were used . Two patients developed a degree of ventilatory depression following repeated doses of buprenorphine . Buprenorphine was equal to morphine as a postoperative analgesic This study was a prospect i ve , r and omized comparison of the ventilatory effects of equianalgesic single‐doses of morphine , 100 μg/kg , and buprenorphine , 3.0 μg/kg , administered intravenously to 20 children ( 5–8 years of age ) after elective ophthalmic surgery . The decrease in ventilatory rate and acute change in the arteriolar oxygen saturation and the increase in end‐tidal CO2 levels were statistically significantly greater in magnitude and duration after buprenorphine than after morphine . For both drugs , the time , duration and magnitude of ventilatory changes varied appreciably between individuals . No child had apnea or hypoventilation requiring assistance . The authors conclude that acutely administered buprenorphine depresses ventilation to a greater degree than morphine . The maximal ventilatory effect of buprenorphine occurs later than with morphine , and ventilatory depression after buprenorphine may develop late . For safety , all children given opioids intravenously should be observed until they are fully responsive and ventilatory control has stabilized The safety and efficacy of buprenorphine and morphine as postoperative analgesicsfor children were compared in 60 boys and girls 4 to 14 years old having elective orthopedic operations on upper or lower extremities . The drugs were given in a double-blind manner initially intravenously and thereafter by sublingual buprenorphine or intramuscular morphine administered as required to relieve pain until the third postoperative morning . The IV dose needed to achieve complete initial analgesia was 5.2 ± 2.8 μg/kg buprenorphine and 166 ± 100 μg/kg morphine . The duration of effect was significantly longer with buprenorphine than with morphine , 248 ± 314 and 114 ± 109 minutes , respectively ( P = 0.03 ) . The most common side effects were nausea and vomiting ( 28 and 16 % ) and urinary retention ( 21 and 19 % ) in the buprenorphine and morphine groups , respectively . Analgesia with sublingual buprenorphine was as effective and reliable as with intramuscular morphine but a longer duration of action could not be demonstrated The study describes long term ventilatory effects of 50 or 100 micrograms.kg-1 of morphine or 1.5 or 3.0 micrograms.kg-1 of buprenorphine when given in repeated intravenous ( i.v . ) doses , in a double blind fashion , to achieve equal levels of analgesia after thoracotomy . The patients were 56 children , six months to six years of age . Ventilatory rate ( VR ) was measured over the 24 h study period , and arterial carbon dioxide tension ( PaCO2 ) was measured on arrival in the Paediatric Intensive Care Unit ( PICU ) and at 1 , 6 , 12 and 18 h. In the buprenorphine groups VRs progressively decreased during the first 2 h and remained significantly lower ( P < 0.05 ) than in the morphine groups for 7 h. For the rest of the study period there were no differences . The PaCO2 values did not differ significantly at any point . For safety , prolonged observation of children is needed after intravenous administration of buprenorphine to ensure the ventilatory rate has stabilized
Output:
| There was no significant difference in the rates of adverse effects .
Conclusions Buprenorphine provided a longer duration of analgesia than morphine .
This in combination with its unique sublingual preparation could prove particularly advantageous in the paediatric population . |
MS211515 | ***TASK*** the task is to summarize an input biomedical literature 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 Suicide attempts and completed suicides are common , yet there are no proven acute medication or device treatments for treating a suicidal crisis . Repeated daily left prefrontal repetitive transcranial magnetic stimulation ( rTMS ) for 4 - 6 weeks is a new FDA -approved treatment for acute depression . Some open-label rTMS studies have found rapid reductions in suicidality . DESIGN This study tests whether a high dose of rTMS to suicidal in patients is feasible and safe , and also whether this higher dosing might rapidly improve suicidal thinking . This prospect i ve , 2-site , r and omized , active sham-controlled ( 1:1 r and omization ) design incorporated 9 sessions of rTMS over 3 days as adjunctive to usual inpatient suicidality treatment . The setting was two inpatient military hospital wards ( one VA , the other DOD ) . PATIENTS Research staff screened approximately 377 in patients , yielding 41 adults admitted for suicidal crisis . Because of the funding source , all patients also had either post-traumatic stress disorder , mild traumatic brain injury , or both . TMS METHODS Repetitive TMS ( rTMS ) was delivered to the left prefrontal cortex with a figure-eight solid core coil at 120 % motor threshold , 10 Hertz ( Hz ) , 5 second ( s ) train duration , 10 s intertrain interval for 30 minutes ( 6000 pulses ) 3 times daily for 3 days ( total 9 sessions ; 54,000 stimuli ) . Sham rTMS used a similar coil that contained a metal insert blocking the magnetic field and utilized electrodes on the scalp , which delivered a matched somatosensory sensation . MAIN OUTCOME MEASURE Primary outcomes were the daily change in severity of suicidal thinking as measured by the Beck Scale of Suicidal Ideation ( SSI ) administered at baseline and then daily , as well as subjective visual analog scale measures before and after each TMS session . Mixed model repeated measures ( MMRM ) analysis was performed on modified intent to treat ( mITT ) and completer population s. RESULTS This intense schedule of rTMS with suicidal in patients was feasible and safe . Minimal side effects occurred , none differing by arm , and the 3-day retention rate was 88 % . No one died of suicide within the 6 month followup . From the mITT analyses , SSI scores declined rapidly over the 3 days for both groups ( sham change -15.3 points , active change -15.4 points ) , with a trend for more rapid decline on the first day with active rTMS ( sham change -6.4 points , active -10.7 points , P = 0.12 ) . This decline was more pronounced in the completers subgroup [ sham change -5.9 ( 95 % CI : -10.1 , -1.7 ) , active -13 points ( 95 % CI : -18.7 , -7.4 ) ; P = 0.054 ] . Subjective ratings of ' being bothered by thoughts of suicide ' declined non-significantly more with active rTMS than with sham at the end of 9 sessions of treatment in the mITT analysis [ sham change -31.9 ( 95 % CI : -41.7 , -22.0 ) , active change -42.5 ( 95 % CI : -53.8 , -31.2 ) ; P = 0.17 ] . There was a significant decrease in the completers sample [ sham change -24.9 ( 95 % CI : -34.4 , -15.3 ) , active change -43.8 ( 95 % CI : -57.2 , -30.3 ) ; P = 0.028 ] . CONCLUSIONS Delivering high doses of left prefrontal rTMS over three days ( 54,000 stimuli ) to suicidal in patients is possible and safe , with few side effects and no worsening of suicidal thinking . The suggestions of a rapid anti-suicide effect ( day 1 SSI data , Visual Analogue Scale data over the 3 days ) need to be tested for replication in a larger sample . TRIAL REGISTRATION Clinical Trials.gov Identifier : NCT01212848 , TMS for suicidal ideation BACKGROUND Theta-burst transcranial magnetic stimulation ( TBS ) has been shown to induce potent and long lasting effects on cortical excitability . In a previous open study , we demonstrated safety , tolerability and antidepressant properties of continuous TBS ( cTBS ) in major depression ( MD ) . The present study was aim ed to evaluate the therapeutic efficacy of cTBS in depressed patients using a double-blind , sham-controlled design . METHODS Twenty nine patients with MD were r and omized to receive either active cTBS to the right dorsolateral prefrontal cortex ( n=15 ) or sham cTBS ( n=14 ) for 10 consecutive work days . After the 10th session , patients who received sham TBS were crossed over to active cTBS which consisted of 10 daily sessions . Patients who received active cTBS continued with the same treatment protocol for additional 10 treatments . Each treatment session consisted of 3600 stimuli at an intensity of 100 % of the active motor threshold . Severity of depression was assessed weekly . RESULTS Overall , there was no significant difference in the degree of clinical improvement between active and sham cTBS groups . However , in patients whose medication status remained unchanged before the trial ( n=8 ) and in those who were medication-free ( n=3 ) , active cTBS result ed in a significantly greater reduction of Hamilton depression scores as compared to sham cTBS . LIMITATIONS A small sample size , confounding effect of medication and short treatment period . CONCLUSIONS Our results suggest that the antidepressant effect of cTBS is modest , yet it might be beneficial to patients nonresponsive to ongoing pharmacological treatment . A direct comparison between cTBS and conventional rTMS protocol s is warranted BACKGROUND Repetitive transcranial magnetic stimulation ( rTMS ) has been shown to be an effective treatment for depression . However , there has been little research to determine optimal parameters for treatment . METHOD This study compared two rTMS treatment regimes for the treatment of major depression . Seventy-seven participants were r and omized to either spaced or daily treatment . Spaced rTMS was given 3 days/week for 6 weeks ( 18 treatments in total ) and daily rTMS was given 5 days/week for 4 weeks ( 20 treatments in total ) . All participants were assessed at baseline and after 4 weeks of treatment . Participants in the spaced treatment group were also assessed after 6 weeks of treatment . All participants were treated at 110 % of the resting motor threshold with high-frequency rTMS ( 10 Hz ) to the left dorsolateral prefrontal cortex ( DLPFC ) followed by low-frequency rTMS to the right DLPFC . RESULTS Participants in the daily treatment group showed more improvement by week 4 than those in the spaced treatment group ; however , both groups had similar improvement by treatment completion . There was significant improvement in both groups in ratings of depression and anxiety , with no significant differences between groups . CONCLUSIONS Our study indicates that the efficacy of rTMS is related to the number of treatments given and that spacing the treatments neither improves nor reduces efficacy BACKGROUND Major depressive disorder ( MDD ) is a significant cause of worldwide disability and treatment resistance is common . High-frequency repetitive transcranial magnetic stimulation ( HF-rTMS ) has emerged as a treatment for MDD , and while efficacious , the daily commitment for typical 4 - 6 weeks of treatment poses a significant challenge . We aim ed to determine the effectiveness and acceptability of an accelerated rTMS protocol for MDD . METHODS In this naturalistic trial , 27 patients with moderate to severe chronic and treatment-resistant MDD were treated with twice-daily HF-rTMS ( 10 Hz ) applied over the left dorsolateral prefrontal cortex for 2 consecutive weeks ( 60,000 pulses ) . The primary outcomes were rates of clinical remission and response ( 16-item Quick Inventory of Depressive Symptomatology post-treatment score ≤ 6 , and ≥ 50 % reduction , respectively ) . Secondary outcomes were self-reported anxious symptoms , depressive symptoms and quality of life , and dropout rates as a proxy for acceptability . RESULTS Ten ( 37.0 % ) patients met criteria for clinical remission and 15 ( 55.6 % ) were classified as responders , with comparable outcomes for both moderate and severe MDD . Clinician-rated improvements in depressive symptoms were paralleled in self-reported depressive and anxious symptoms , as well as quality of life . No patient discontinued treatment . LIMITATIONS This study is limited by short treatment duration that might be lengthened with corresponding improvements in effectiveness , limited duration of follow-up , small sample size , and an open-label design requiring r and omized controlled replication . CONCLUSION An accelerated protocol involving twice-daily sessions of HF-rTMS over the left DLPFC for 2 weeks was effective in treatment-resistant MDD , and had excellent acceptability . Additional research is required to optimize accelerated rTMS treatment protocol s and determine efficacy using sham-controlled trials Ultrabrief pulse width stimulation electroconvulsive therapy ( ECT ) results in less cognitive side-effects than brief pulse ECT , but recent work suggests that more treatment sessions may be required to achieve similar efficacy . In this retrospective analysis of subjects pooled from three research studies , time to improvement was analysed in 150 depressed subjects who received right unilateral ECT with a brief pulse width ( at five times seizure threshold ) or ultrabrief pulse width ( at six times seizure threshold ) . Multivariate Cox regression analyses compared the number of treatments required for 50 % reduction in depression scores ( i.e. speed of response ) in these two sample s. The analyses controlled for clinical , demographic and treatment variables that differed between the sample s or that were found to be significant predictors of speed of response in univariate analyses . In the multivariate analysis , older age predicted faster speed of response . There was a non-significant trend for faster time to 50 % improvement with brief pulse ECT ( p = 0.067 ) . Remission rates were higher after brief pulse ECT than ultrabrief pulse ECT ( p = 0.007 ) but response rates were similar . This study , the largest of its kind reported to date , suggests that fewer treatments may be needed to attain response with brief than ultrabrief pulse ECT and that remission rates are higher with brief pulse ECT . Further research with a larger r and omized and blinded study is recommended The objective of this study was to explore the response rate to high-frequency left-sided repetitive transcranial magnetic stimulation ( rTMS ) in patients who had failed to respond to right-sided low-frequency stimulation , and to investigate whether there was differential efficacy between stimulation at 5 or 10 Hz . Data from two r and omized controlled trials were pooled . In both studies a group of patients were r and omized to receive either 5- or 10-Hz left prefrontal rTMS after failing to respond to right-sided stimulation . These patients received blinded 5- or 10-Hz stimulation ( but without a sham control ) for a period of up to 4 weeks and outcomes were compared . There was a small but significant overall response to left-sided rTMS but no difference in response between the 5- and 10-Hz treatment conditions . There appears to be a significant but modest likelihood of response to left-sided TMS in patients who fail right-sided stimulation , but there is no difference in efficacy between 5- and 10-Hz stimulation CONTEXT Electroconvulsive therapy ( ECT ) is highly effective for treatment of major depression , but naturalistic studies show a high rate of relapse after discontinuation of ECT . OBJECTIVE To determine the efficacy of continuation pharmacotherapy with nortriptyline hydrochloride or combination nortriptyline and lithium carbonate in preventing post-ECT relapse . DESIGN R and omized , double-blind , placebo-controlled trial conducted from 1993 to 1998 , stratified by medication resistance or presence of psychotic depression in the index episode . SETTING Two university-based hospitals and 1 private psychiatric hospital . PATIENTS Of 290 patients with unipolar major depression recruited through clinical referral who completed an open ECT treatment phase , 159 patients met remitter criteria ; 84 remitting patients were eligible and agreed to participate in the continuation study . INTERVENTIONS Patients were r and omly assigned to receive continuation treatment for 24 weeks with placebo ( n = 29 ) , nortriptyline ( target steady-state level , 75 - 125 ng/mL ) ( n = 27 ) , or combination nortriptyline and lithium ( target steady-state level , 0.5 - 0.9 mEq/L ) ( n = 28 ) . MAIN OUTCOME MEASURE Relapse of major depressive episode , compared among the 3 continuation groups . RESULTS Nortriptyline-lithium combination therapy had a marked advantage in time to relapse , superior to both placebo and nortriptyline alone . Over the 24-week trial , the relapse rate for placebo was 84 % ( 95 % confidence interval [ CI ] , 70%-99 % ) ; for nortriptyline , 60 % ( 95 % CI , 41%-79 % ) ; and for nortriptyline-lithium , 39 % ( 95 % CI , 19%-59 % ) . All but 1 instance of relapse with nortriptyline-lithium occurred within 5 weeks of
Output:
| Conclusions : There is increasing evidence for efficacy , tolerability , and safety of neurostimulation treatments .
rTMS is now a first-line recommendation for patients with MDD who have failed at least 1 antidepressant .
ECT remains a second-line treatment for patients with treatment-resistant depression , although in some situations , it may be considered first line . |
MS211516 | ***TASK*** the task is to summarize an input biomedical literature 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 : Dysphagia is common after stroke . The onset time of swallowing rehabilitation following stroke has an important role in the recovery of dysphagia and preventing of its complications , but it was either highly variable or was not stated in previous trials . The aim of this study was investigation effects of onset time of swallowing therapy on recovery from dysphagia following stroke . Methods : Sixty dysphagia patients due to stroke range of age 60 - 74 ( 67.1 ± 3.8 ) , participated in this r and omized clinical trial study . The patients allocated in Early , Medium and Late groups , on the base of initiation of swallowing therapy after the stroke . After basic clinical and video fluoroscopic swallowing study assessment s , traditional swallowing therapy was initiated 3 times per week for 3 months . The outcome measures were North-Western dysphagia patient check sheet , functional oral intake scale , video fluoroscopy , and frequency of pneumonia . Statistical analysis was done by repeated measure ANOVA , Bonferroni and χ2 tests . Results : Three groups of patients in terms of demographic and clinical characteristics were similar in the pre-treatment P > 0.050 . Onset time of swallowing therapy after stroke was effective on swallowing recovery on the main outcome variables . So that in first group patients , recovery was rather than other groups P < 0.050 . Furthermore , the frequency of pneumonia in the early group was less than other groups and in the early group no patients experienced pneumonia P = 0.002 . Conclusion : Our data suggested that early interventions for dysphagia in stroke have an important role in recovery from dysphagia and prevention of complications like aspiration pneumonia Background — Outpatient cardiac rehabilitation ( CR ) decreases mortality rates but is underutilized . Current median time from hospital discharge to enrollment is 35 days . We hypothesized that an appointment within 10 days would improve attendance at CR orientation . Methods and Results — At hospital discharge , 148 patients with a nonsurgical qualifying diagnosis for CR were r and omized to receive a CR orientation appointment either within 10 days ( early ) or at 35 days ( st and ard ) . The primary end point was attendance at CR orientation . Secondary outcome measures were attendance at ≥1 exercise session , the total number of exercise sessions attended , completion of CR , and change in exercise training workload while in CR . Average age was 60±12 years ; 56 % of participants were male and 49 % were black , with balanced baseline characteristics between groups . Median time ( 95 % confidence interval ) to orientation was 8.5 ( 7–13 ) versus 42 ( 35 to NA [ not applicable ] ) days for the early and st and ard appointment groups , respectively ( P<0.001 ) . Attendance rates at the orientation session were 77 % ( 57/74 ) versus 59 % ( 44/74 ) in the early and st and ard appointment groups , respectively , which demonstrates a significant 18 % absolute and 56 % relative improvement ( relative risk , 1.56 ; 95 % confidence interval , 1.03–2.37 ; P=0.022 ) . The number needed to treat was 5.7 . There was no difference ( P>0.05 ) in any of the secondary outcome measures , but statistical power for these end points was low . Safety analysis demonstrated no difference between groups in CR-related adverse events . Conclusions — Early appointments for CR significantly improve attendance at orientation . This simple technique could potentially increase initial CR participation nationwide . Clinical Trial Registration — URL : http://www . clinical trials.gov . Unique identifier : NCT01596036 BACKGROUND Triage liaison physicians ( TLPs ) have been employed in overcrowded emergency departments ( EDs ) ; however , their effectiveness remains unclear . OBJECTIVES To evaluate the implementation of TLP shifts at an academic tertiary care adult ED using comprehensive outcome reporting . METHODS A six-week TLP clinical research project was conducted between December 9 , 2005 , and February 9 , 2006 . A TLP was deployed for nine hours ( 11 AM to 8 PM ) daily to initiate patient management , assist triage nurses , answer all medical consult or transfer calls , and manage ED administrative matters . The study was divided into three two-week blocks ; within each block , seven days were r and omized to TLP shifts and the other seven to control shifts . Outcomes included patient length of stay , proportion of patients who left without complete assessment , staff satisfaction , and episodes of ambulance diversion . RESULTS TLPs assessed a median of 14 patients per shift ( interquartile range , 13 - 17 ) , received 15 telephone calls per shift ( interquartile range , 14 - 20 ) , and spent 17 - 81 minutes per shift consulting on the telephone . The number of patients and their age , gender , and triage score during the TLP and control shifts were similar . Overall , length of stay was decreased by 36 minutes compared with control days ( 4:21 vs. 4:57 ; p = 0.001 ) . Left without complete assessment cases decreased from 6.6 % to 5.4 % ( a 20 % relative decrease ) during the TLP coverage . The ambulance wait time and number of episodes of ambulance diversion were similar on TLP and control days . CONCLUSIONS A TLP improved important outcomes in an overcrowded ED and could improve delivery of emergency medical care in similar tertiary care EDs Study Design . A single blind r and omized controlled trial comparing two models of care for patients with acute simple low back pain . Objectives . To compare two research -based models of care for acute low back pain and investigate the effect of the timing of physical intervention . Summary of Background Data . National guidelines offer conflicting information on the delivery of physical treatment in the management of acute low back pain . The guidelines suggest two different models of care . Direct comparisons between these models are lacking in the literature . The present study aims to compare these approaches to the management of acute low back pain . Methods . Among 804 referred patients , 102 subjects met the specific admission criteria and were r and omly assigned to an “ assess/advise/treat ” group or an “ assess/advise/wait ” group . The intervention consisted of biopsychosocial education , manual therapy , and exercise . Assessment of short-term outcome enables comparison to be made between intervention and advice to stay active . Assessment of long-term outcome enables comparison to be made between early and late intervention . Study outcomes of reported pain ( Visual Analogue Scale ) , functional disability ( the Rol and and Morris Disability Question naire ) , mood ( Modified Zung Self Rated Depression Score , Modified Somatic Perception Question naire , State-Trait Anxiety Inventory ) , general health ( Euroqol ) , and quality of life ( Short Form 36 ) were assessed at baseline , 6 weeks , 3 months , and 6 months . Results . At 6 weeks , the assess/advise/treat group demonstrated greater improvements in disability , mood , general health , and quality of life than patients in the assess/advise/wait group ( P < 0.05 ) . Disability and pain were not significantly different between the groups at long-term follow up ( P > 0.05 ) . However , mood , general health , and quality of life remained significantly better in the assess/advise/treat group ( P < 0.05 ) . Conclusions . At short-term , intervention is more effective than advice on staying active , leading to more rapid improvement in function , mood , quality of life , and general health . The timing of intervention affects the development of psychosocial features . If treatment is provided later , the same psychosocial benefits are not achieved . Therefore , an assess/advise/treat model of care seems to offer better outcomes than an assess/advise/wait model of care Objectives : To assess whether initial patient consult by senior clinicians reduces numbers of patients waiting to be seen as an indirect measure of waiting time throughout the emergency department ( ED ) . Methods : An emergency medicine consultant and a senior ED nurse ( G or F grade ) , known as the IMPACT team , staffed the triage area for four periods of four hours per week , Monday to Friday between 9 am to 5 pm for three months between December 2001 and February 2002 when staffing levels permitted . Patients normally triaged by a nurse in this area instead had an early consultation with the IMPACT team . Data were collected prospect ively on all patients seen by the IMPACT team . The number of patients waiting to be seen ( for triage , in majors and in minors ) was assessed every two hours during the IMPACT sessions and at corresponding times when no IMPACT team was operational . Results : There was an overall reduction in the number of patients waiting to be seen in the department from 18.3 to 5.5 ( p<0.0001 ) at formal two hourly assessment s. The largest difference was seen in minors . Of the patients seen at triage by the IMPACT team , 48.9 % were discharged home immediately after assessment and treatment . With the IMPACT team present , no patient waited more than four hours for initial clinical consult . Conclusions : By using a senior clinical team for initial patient consultation , the numbers of patients waiting fell dramatically throughout the ED . Many patients can be effectively treated and discharged after initial consult by the IMPACT team Objective To evaluate the effectiveness of a structured group education programme on biomedical , psychosocial , and lifestyle measures in people with newly diagnosed type 2 diabetes . Design Multicentre cluster r and omised controlled trial in primary care with r and omisation at practice level . Setting 207 general practice s in 13 primary care sites in the United Kingdom . Participants 824 adults ( 55 % men , mean age 59.5 years ) . Intervention A structured group education programme for six hours delivered in the community by two trained healthcare professional educators compared with usual care . Main outcome measures Haemoglobin A1c levels , blood pressure , weight , blood lipid levels , smoking status , physical activity , quality of life , beliefs about illness , depression , and emotional impact of diabetes at baseline and up to 12 months . Main results Haemoglobin A1c levels at 12 months had decreased by 1.49 % in the intervention group compared with 1.21 % in the control group . After adjusting for baseline and cluster , the difference was not significant : 0.05 % ( 95 % confidence interval −0.10 % to 0.20 % ) . The intervention group showed a greater weight loss : −2.98 kg ( 95 % confidence interval −3.54 to −2.41 ) compared with 1.86 kg ( −2.44 to −1.28 ) , P=0.027 at 12 months . The odds of not smoking were 3.56 ( 95 % confidence interval 1.11 to 11.45 ) , P=0.033 higher in the intervention group at 12 months . The intervention group showed significantly greater changes in illness belief scores ( P=0.001 ) ; directions of change were positive indicating greater underst and ing of diabetes . The intervention group had a lower depression score at 12 months : mean difference was −0.50 ( 95 % confidence interval −0.96 to −0.04 ) ; P=0.032 . A positive association was found between change in perceived personal responsibility and weight loss at 12 months ( β=0.12 ; P=0.008 ) . Conclusion A structured group education programme for patients with newly diagnosed type 2 diabetes result ed in greater improvements in weight loss and smoking cessation and positive improvements in beliefs about illness but no difference in haemoglobin A1c levels up to 12 months after diagnosis . Trial registration Current Controlled Trials IS RCT N17844016 Background : Although effective treatment of depressed patients requires regular follow-up contacts and symptom monitoring , an efficient method for assessing treatment outcome is lacking . We investigated responsiveness to treatment , reproducibility , and minimal clinical ly important difference of the Patient Health Question naire-9 ( PHQ-9 ) , a st and ard instrument for diagnosing depression in primary care . Methods : This study included 434 intervention subjects from the IMPACT study , a multisite treatment trial of late-life depression ( 63 % female , mean age 71 years ) . Changes in PHQ-9 scores over the course of time were evaluated with respect to change scores of the SCL-20 depression scale as well as 2 independent structured diagnostic interviews for depression during a 6-month period . Test-retest reliability and minimal clinical ly important difference were assessed in 2 subgroups of patients who completed the PHQ-9 twice exactly 7 days apart . Results : The PHQ-9 responsiveness as measured by effect size was significantly greater than the SCL-20 at 3 months ( −1.3 versus −0.9 ) and equivalent at 6 months ( −1.3 versus −1.2 ) . With respect to structured diagnostic interviews , both the PHQ-9 and the SCL-20 change scores accurately discriminated patients with persistent major depression , partial remission , and full remission . Test-retest reliability of the PHQ-9 was excellent , and its minimal clinical ly important difference for individual change , estimated as 2 st and ard errors of measurement , was 5 points on the 0 to 27 point PHQ-9 scale . Conclusions : Well-vali date d as a diagnostic measure , the PHQ-9 has now proven to be a responsive and reliable measure of depression treatment outcomes . Its responsiveness to treatment coupled with its brevity makes the PHQ-9 an attractive tool for gauging response to treatment in individual patient care as well as in clinical research Study Design An inception cohort design was used in which 421 patients were evaluated systematic ally with a st and ard battery of psychosocial assessment tests ( Structured Interview for DSM-III-R Diagnosis , Minnesota Multiphasic Personality Inventory , and Million Visual Pain Analog Scale ) within 6 weeks of acute back pain onset . Objectives
Output:
| There was low-level evidence that reduced wait time is associated with moderate improvement in workplace participation for patients seeking care for musculoskeletal conditions ; and moderate improvement in exercise tolerance for patients referred to cardiac rehabilitation .
There was inconsistent evidence that improvements in quality of life , patient satisfaction and psychological symptoms may be associated with shorter wait times .
Pain , function and physical activity outcomes were not associated with wait time .
Conclusions This review found low-level evidence suggesting an association between early access to community outpatient services and improvement of some patient outcomes .
Specifically , shorter wait times from referral to first visit for musculoskeletal pain services may improve patient work participation .
Shorter wait times for cardiac rehabilitation may improve patient exercise capacity .
The effects of a short wait time for other patient conditions and patient outcomes , including quality of life , psychological symptoms and patient experience , are inconclusive . |
MS211517 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Objectives . The prevalence of type 2 diabetes in American adolescents has increased markedly during the past generation . Although the factors that contribute to the development of type 2 diabetes are complex and not wholly eluci date d , the triad of severe obesity , hyperinsulinemia , and a family history of type 2 diabetes places a child at an increased risk for development of the disease . Current approaches to the prevention of type 2 diabetes , including dietary counseling and exercise , have had limited success . We reasoned that drugs that increase glucose tolerance in diabetic patients might prove useful in preventing the progression to glucose intolerance in high-risk patients . To that end , we conducted a double-blind , placebo-controlled study of the effects of metformin on body mass index ( BMI ) , serum leptin , glucose tolerance , and serum lipids in obese adolescents with fasting hyperinsulinemia and a family history of type 2 diabetes . Methods . The study population consisted of 29 white and black adolescents aged 12 to 19 years . All had BMI s exceeding 30 kg/m2 . Criteria for enrollment included : 1 ) a fasting insulin concentration exceeding 15 μU/mL ; and 2 ) at least 1 first- or second-degree relative with type 2 diabetes . All patients had fasting plasma glucose concentrations < 110 mg% and hemoglobin A1c concentrations ≤6.0 % . All had normal linear growth and sexual development for age , with no marked hirsutism , severe acne , or menstrual irregularities characteristic of polycystic ovary syndrome . Eight participants had acanthosis nigricans . After baseline laboratory studies including a rapidly sample d intravenous glucose tolerance test , patients were r and omized to receive metformin ( 500 mg twice daily ) or a placebo for a total of 6 months . The effects of metformin on BMI st and ard deviation score , serum leptin , glucose tolerance , and serum lipids were analyzed . The study was double-blinded and included no specific dietary restrictions . Results . Metformin caused a decline of 0.12 st and ard deviation in BMI in study participants ( −1.3 % from baseline ) , and a 5.5 % reduction in serum leptin in girls . In contrast , BMI and serum leptin rose 0.23 st and ard deviation ( 2.3 % ) and 16.2 % , respectively , in the placebo group during the treatment period . Metformin caused a progressive decline in fasting blood glucose ( from a mean of 84.9 to 75.1 mg% ) and a reduction in fasting insulin levels ( from 31.3 to 19.3 μU/mL ) . In contrast , fasting glucose levels in the placebo group rose slightly from 77.2 to 82.3 mg% , and fasting insulin levels did not change . Insulin sensitivity , as assessed by the ratio of fasting insulin to glucose concentrations and the quantitative insulin sensitivity check index ( 1/[log fasting insulin + log fasting glucose ] ) and homeostasis model assessment insulin resistance index ( fasting insulin × fasting glucose/22.5 ) indices , increased slightly in the metformin-treated participants . However , the insulin sensitivity measured using Bergman 's minimal model did not change . There were also no significant changes in glucose effectiveness , hemoglobin A1c , serum lipids , or serum lactate in the metformin or placebo groups . Metformin was tolerated well by the majority of patients . Transient abdominal discomfort or diarrhea occurred in 40 % of treated participants ; there were no episodes of vomiting or lactic acidosis . Conclusions . The treatment of obesity and insulin resistance in adults often proves ineffective because the vicious cycle leading to type 2 diabetes may have become entrenched and , to some extent , may be irreversible . Early detection and therapy of the obese adolescent with a family history of type 2 diabetes may interrupt the cycle of weight gain and insulin resistance that leads to glucose intolerance in adulthood . Through its ability to reduce fasting blood glucose and insulin concentrations and to moderate weight gain , metformin might complement the effects of dietary and exercise counseling and reduce the risk of type 2 diabetes in selected patients The present study is an evaluation of metformin ’s effect on BMI z score , insulin sensitivity , and inflammation and cardiovascular risk factors in prepubertal and pubertal children who are obese . OBJECTIVES : Metformin has shown its effectiveness in treating obesity in adults . However , little research has been conducted in children , with a lack of attention on pubertal status . The objectives were to determine whether oral metformin treatment reduces BMI z score , cardiovascular risk , and inflammation biomarkers in children who are obese depending on pubertal stage and sex . METHODS : This was a r and omized , prospect i ve , double-blind , placebo-controlled , multicenter trial , stratified according to pubertal stage and sex , conducted at 4 Spanish clinical hospitals . Eighty prepubertal and 80 pubertal nondiabetic children who were obese aged 7 to 14 years with a BMI > 95th percentiles were recruited . The intervention included 1 g/d of metformin versus placebo for 6 months . The primary outcome was a reduction in BMI z score . Secondary outcomes comprised insulin resistance , cardiovascular risk , and inflammation biomarkers . RESULTS : A total of 140 children completed the study ( 72 boys ) . Metformin decreased the BMI z score versus placebo in the prepubertal group ( −0.8 and −0.6 , respectively ; difference , 0.2 ; P = .04 ) . Significant increments were observed in prepubertal children treated with metformin versus placebo recipients in the quantitative insulin sensitivity check index ( 0.010 and −0.007 ; difference , 0.017 ; P = .01 ) and the adiponectin – leptin ratio ( 0.96 and 0.15 ; difference , 0.81 ; P = .01 ) and declines in interferon-γ ( −5.6 and 0 ; difference , 5.6 ; P = .02 ) and total plasminogen activator inhibitor-1 ( −1.7 and 2.4 ; difference , 4.1 ; P = .04 ) . No serious adverse effects were reported . CONCLUSIONS : Metformin decreased the BMI z score and improved inflammatory and cardiovascular-related obesity parameters in prepubertal children but not in pubertal children . Hence , the differential response according to puberty might be related to the dose of metformin per kilogram of weight . Further investigations are necessary INTRODUCTION Although the Diabetes Prevention Program and other clinical trials demonstrated the efficacy of intensive lifestyle interventions ( ILI ) and metformin to prevent type 2 diabetes , no studies have tested their comparative effects in pragmatic setting s. This study was design ed to compare the real-world effectiveness of ILI , metformin , and st and ard care among Hispanic women ( Latinas ) with prediabetes . STUDY DESIGN RCT . SETTING / PARTICIPANTS Ninety-two Latinas , who had a mean hemoglobin A1c of 5.9 % , BMI of 33.3 kg/m2 , and waist circumference of 97.4 cm ( 38.3 inches ) , were recruited from an urban community and r and omly assigned to ILI , metformin , or st and ard care using 1:1:1 allocation . Data were collected from 2013 - 2015 and analyzed in 2016 . INTERVENTION The 12-month ILI was adapted from the Diabetes Prevention Program 's ILI and delivered by community health workers ( promotoras ) over 24 sessions . Metformin participants received 850 mg twice daily . Those r and omized to st and ard care continued their regular medical care . MAIN OUTCOME MEASURES Weight and secondary outcomes ( waist circumference , blood pressure , hemoglobin A1c , fasting plasma glucose , insulin , and lipids ) were assessed at baseline and 12 months . RESULTS ILI participants demonstrated significantly greater mean weight loss ( -4.0 kg , 5.0 % ) than metformin ( -0.9 kg , 1.1 % ) and st and ard care participants ( + 0.8 kg , 0.9 % ) ( p<0.001 ) . The difference in weight loss between metformin and st and ard care was not significant . The ILI group experienced a greater reduction in waist circumference than st and ard care ( p=0.001 ) , and a marginal improvement in hemoglobin A1c compared with metformin and st and ard care ( p=0.063 ) . CONCLUSIONS In the first comparative effectiveness trial of diabetes prevention treatments , a 12-month ILI produced significantly greater weight loss than metformin and st and ard care among Latinas with prediabetes . These data suggest that ILI delivered by promotoras is an effective strategy for preventing diabetes in this high-risk group , which may be superior to metformin . Future pragmatic trials involving larger sample s should examine differences in diabetes incidence associated with these treatments This study assessed the efficacy of adding metformin to a structured lifestyle intervention in reducing BMI in obese adolescents with insulin resistance . Obese adolescents ( 25 ) aged 10–16 years with a body mass index ( BMI ) > 95th percentile and insulin resistance ( Homeostasis Model Assessment —HOMA ) > 3.0 were assessed in a community clinic . A structured lifestyle intervention comprising nutritional and exercise education and motivational support in both individual and group sessions was delivered over 6 months . Subjects were r and omized to lifestyle intervention alone or with metformin ( 1500 g daily ) . The primary outcome measures were a change in BMI and modification of metabolic risk factors , including insulin resistance , plasma lipids and adipocytokines . Eleven adolescents receiving lifestyle and metformin intervention and 14 receiving lifestyle alone completed the study . BMI decreased by 1.8 kg/m2 with lifestyle and metformin but did not change with lifestyle alone . HOMA was significantly decreased in the lifestyle intervention group , but not following metformin , while the adiponectin/leptin ratio improved significantly in both groups . Dyslipidemic profiles improved most significantly with metformin . We conclude that metformin in combination with a 6-month structured lifestyle intervention is effective in reducing BMI in obese adolescents but did not improve insulin resistance . Lifestyle intervention , with or without metformin , improved metabolic risk factors such as plasma lipids and adipocytokines OBJECTIVE Metformin can decrease adiposity and ameliorate obesity-related comorbid conditions , including abnormalities in glucose homeostasis in adolescents , but there are few data evaluating the efficacy of metformin among younger children . Our objective was to determine whether metformin treatment causes weight loss and improves obesity-related comorbidities in obese children , who are insulin-resistant . RESEARCH DESIGN AND METHODS This study was a r and omized double-blind placebo-controlled trial consisting of 100 severely obese ( mean BMI 34.6 ± 6.6 kg/m2 ) insulin-resistant children aged 6–12 years , r and omized to 1,000 mg metformin ( n = 53 ) or placebo ( n = 47 ) twice daily for 6 months , followed by open-label metformin treatment for 6 months . All children and their parents participated in a monthly dietitian-administered weight-reduction program . RESULTS Eighty-five percent completed the 6-month r and omized phase . Children prescribed metformin had significantly greater decreases in BMI ( difference −1.09 kg/m2 , CI −1.87 to −0.31 , P = 0.006 ) , body weight ( difference −3.38 kg , CI −5.2 to −1.57 , P < 0.001 ) , BMI Z score ( difference between metformin and placebo groups −0.07 , CI −0.12 to −0.01 , P = 0.02 ) , and fat mass ( difference −1.40 kg , CI −2.74 to −0.06 , P = 0.04 ) . Fasting plasma glucose ( P = 0.007 ) and homeostasis model assessment ( HOMA ) insulin resistance index ( P = 0.006 ) also improved more in metformin-treated children than in placebo-treated children . Gastrointestinal symptoms were significantly more prevalent in metformin-treated children , which limited maximal tolerated dosage in 17 % . During the 6-month open-label phase , children treated previously with placebo decreased their BMI Z score ; those treated continuously with metformin did not significantly change BMI Z score further . CONCLUSIONS Metformin had modest but favorable effects on body weight , body composition , and glucose homeostasis in obese insulin-resistant children participating in a low-intensity weight-reduction program Aims . To observe the rate of conversion from impaired glucose tolerance ( IGT ) to diabetes following lifestyle modification ( LSM ) or a combination of lifestyle and metformin compared to a control population with 1
Output:
| Adults using metformin experienced and maintained small decreases in weight irrespective of duration of intervention .
Conclusions The effects of metformin on weight/ BMI vary , with smaller reductions in children than in adults .
This could be because of differences in adherence , daily dosage , and insulin status .
Metformin significantly reduced the progression toward T2DM in adults . |
MS211518 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: In the last three decades , since Luft suggested a link between hospital volume and patient outcome , little has changed . Despite great efforts to formally quantify the relationship between volume and cancer survival , much uncertainty remains . It is intuitive that increased experience ( of the surgeon , the hospital or the ancillary staff ) translates to better patient care but closer analysis of the literature uncovers widespread inconsistency in study design question ing validity of conclusions . Although central isation of cancer services would seem beneficial , definitive evidence is only available regarding pancreatic and oesophageal disease and that pertaining to rectal cancer is heterogeneous and often flawed . A majority of evidence suggests better outcome for patients with rectal cancer managed in high volume centres . There are , however , many variables in data collection and interpretation rendering comparison between studies challenging . Definitions of the rectum range from distance from the anal verge ( inherent disagreement e range 10e16 cm ) , to relationship to sacral promontory ( subject to interpreter variation ) , and location of peritoneal reflection ( can not be interpreted endoscopically ) . Many authors fail to differentiate between sigmoid colon and rectum 3 and , those that do demonstrate wide variation . One of the largest studies , ( more than 7000 patients ) from the Californian Cancer Registry offered no description of tumour location . It concluded that patients undergoing surgery at high volume hospitals were less likely to have permanent colostomies and had better survival rates . The diagnosis of rectal cancer was , however , question able as it was based only on a discharge letter , often written by the most junior team member with no reference to true anatomical location . Most US studies are published from a few high volume institutions with a select patient cohort and are based on retrospective analysis of large data bases which , themselves are notoriously inaccurate . The European experience was recently explored by Ptok in a prospect i ve trial of almost 7000 patients undergoing resection for rectal cancer . This is arguably the most complete data set available to date and great effort was made to overcome common biases . A clear definition of the rectum was provided , hospital volume was Background Preoperative radiotherapy reduces recurrence rates after surgery for rectal cancer but other variables may also affect outcome . The Stockholm Rectal Cancer Study Group has conducted two prospect i ve r and omized trials on preoperative radiotherapy in rectal cancer OBJECTIVE To determine whether surgical subspecialty training in colorectal surgery or frequency of rectal cancer resection by the surgeon are independent prognostic factors for local recurrence ( LR ) and survival . SUMMARY BACKGROUND DATA Variation in patient outcome in rectal cancer has been shown among centers and among individual surgeons . However , the prognostic importance of surgeon-related factors is largely unknown . METHODS All patients undergoing potentially curative low anterior resection or abdominoperineal resection for primary adenocarcinoma of the rectum between 1983 and 1990 at the five Edmonton general hospitals were review ed in a historic- prospect i ve study design . Preoperative , intraoperative , pathologic , adjuvant therapy , and outcome variables were obtained . Outcomes of interest included LR and disease-specific survival ( DSS ) . To determine survival rates and to control both confounding and interaction , multivariate analysis was performed using Cox proportional hazards regression . RESULTS The study included 683 patients involving 52 surgeons , with > 5-year follow-up obtained on 663 ( 97 % ) patients . There were five colorectal-trained surgeons who performed 109 ( 16 % ) of the operations . Independent of surgeon training , 323 operations ( 47 % ) were done by surgeons performing < 21 rectal cancer resections over the study period . Multivariate analysis showed that the risk of LR was increased in patients of both noncolorectal trained surgeons ( hazard ratio ( HR ) = 2.5 , p = 0.001 ) and those of surgeons performing < 21 resections ( HR = 1.8 , p < 0.001 ) . Stage ( p < 0.001 ) , use of adjuvant therapy ( p = 0.002 ) , rectal perforation or tumor spill ( p < 0.001 ) , and vascular/neural invasion ( p = 0.002 ) also were significant prognostic factors for LR . Similarly , decreased disease-specific survival was found to be independently associated with noncolorectal-trained surgeons ( HR = 1.5 , p = 0.03 ) and surgeons performing < 21 resections ( HR = 1.4 , p = 0.005 ) . Stage ( p < 0.001 ) , grade ( p = 0.02 ) , age ( p = 0.02 ) , rectal perforation or tumor spill ( p < 0.001 ) , and vascular or neural invasion ( p < 0.001 ) were other significant prognostic factors for DSS . CONCLUSION Outcome is improved with both colorectal surgical subspecialty training and a higher frequency of rectal cancer surgery . Therefore , the surgical treatment of rectal cancer patients should rely exclusively on surgeons with such training or surgeons with more experience CONTEXT Hospitals that treat a relatively high volume of patients for selected surgical oncology procedures report lower surgical in-hospital mortality rates than hospitals with a low volume of the procedures , but the reports do not take into account length of stay or adjust for case mix . OBJECTIVE To determine whether hospital volume was inversely associated with 30-day operative mortality , after adjusting for case mix . DESIGN AND SETTING Retrospective cohort study using the Surveillance , Epidemiology , and End Results (SEER)-Medicare linked data base in which the hypothesis was prospect ively specified . Surgeons determined in advance the surgical oncology procedures for which the experience of treating a larger volume of patients was most likely to lead to the knowledge or technical expertise that might offset surgical fatalities . PATIENTS All 5013 patients in the SEER registry aged 65 years or older at cancer diagnosis who underwent pancreatectomy , esophagectomy , pneumonectomy , liver resection , or pelvic exenteration , using incident cancers of the pancreas , esophagus , lung , colon , and rectum , and various genitourinary cancers diagnosed between 1984 and 1993 . MAIN OUTCOME MEASURE Thirty-day mortality in relation to procedure volume , adjusted for comorbidity , patient age , and cancer stage . RESULTS Higher volume was linked with lower mortality for pancreatectomy ( P=.004 ) , esophagectomy ( P<.001 ) , liver resection ( P=.04 ) , and pelvic exenteration ( P=.04 ) , but not for pneumonectomy ( P=.32 ) . The most striking results were for esophagectomy , for which the operative mortality rose to 17.3 % in low-volume hospitals , compared with 3.4 % in high-volume hospitals , and for pancreatectomy , for which the corresponding rates were 12.9 % vs 5.8 % . Adjustments for case mix and other patient factors did not change the finding that low volume was strongly associated with excess mortality . CONCLUSIONS These data support the hypothesis that when complex surgical oncologic procedures are provided by surgical teams in hospitals with specialty expertise , mortality rates are lower A prospect i ve audit of the management of colorectal cancer was established to investigate factors associated with variation in survival observed within the former Wessex region ( population three million ) PURPOSE : The aim of this study was to analyze the impact of institutions and individual surgeons on long-term prognosis after curative resection of rectal carcinoma . METHODS : We used univariate and multivariate analysis of data from a German prospect i ve , multicenter , patient-care evaluation study . RESULTS : The locoregional recurrence rates and the observed and cancer-related survival rates showed a considerable interinstitutional and intersurgeon variability . Multivariate analysis confirmed the institution and the individual surgeon as significant independent factors influencing locoregional recurrence and survival . There was a statistically highly significant correlation between the rate of locoregional recurrence and survival rate . CONCLUSIONS : The surgeon 's technique and skill has to focus on prevention of locoregional recurrence to achieve good long-term outcome after curative resection for rectal carcinoma . New clinical trials on adjuvant treatment have to include quality assurance for surgery and pathology and documentation of the surgeon ( as local code )
Output:
| This review gives evidence that higher surgeon volume is associated with better overall survival , lower permanent stoma and APER rates |
MS211519 | ***TASK*** the task is to summarize an input biomedical literature 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 Previous research on alcohol mixed with energy drinks ( AmED ) suffers from measurement problems . Missing from the research literature are studies that assess caffeine-alcohol co-ingestion in natural drinking environments . METHODS This field study collected data in a U.S. college bar district from 328 r and omly selected patrons . Anonymous data were obtained from face-to-face interviews and self-administered surveys , and from breath tests . RESULTS Cola-caffeinated alcoholic beverage consumers left bars in a more highly intoxicated state than those who consumed alcohol only . There was no significant difference between the intoxication level of the AmED group and the cola-caffeinated alcoholic beverage group . Results from a multivariate regression model indicated that quantity of caffeinated alcoholic beverage consumption had a significant , positive association with bar patron intoxication after adjusting for potential confounders . CONCLUSIONS Findings indicate that caffeine may have a dose-dependent relationship with alcohol intoxication in the bar/nightclub setting . In addition , results revealed that cola-caffeinated alcoholic drinks may pose similar levels of risk to bar patrons as those associated with AmED beverage consumption . Product labeling requirements about alcohol risks may need to be extended not only to energy drinks , but to caffeinated soft drinks as well Background Energy drink consumption has continued to gain in popularity since the 1997 debut of Red Bull , the current leader in the energy drink market . Although energy drinks are targeted to young adult consumers , there has been little research regarding energy drink consumption patterns among college students in the United States . The purpose of this study was to determine energy drink consumption patterns among college students , prevalence and frequency of energy drink use for six situations , namely for insufficient sleep , to increase energy ( in general ) , while study ing , driving long periods of time , drinking with alcohol while partying , and to treat a hangover , and prevalence of adverse side effects and energy drink use dose effects among college energy drink users . Methods Based on the responses from a 32 member college student focus group and a field test , a 19 item survey was used to assess energy drink consumption patterns of 496 r and omly surveyed college students attending a state university in the Central Atlantic region of the United States . Results Fifty one percent of participants ( n = 253 ) reported consuming greater than one energy drink each month in an average month for the current semester ( defined as energy drink user ) . The majority of users consumed energy drinks for insufficient sleep ( 67 % ) , to increase energy ( 65 % ) , and to drink with alcohol while partying ( 54 % ) . The majority of users consumed one energy drink to treat most situations although using three or more was a common practice to drink with alcohol while partying ( 49 % ) . Weekly jolt and crash episodes were experienced by 29 % of users , 22 % reported ever having headaches , and 19 % heart palpitations from consuming energy drinks . There was a significant dose effect only for jolt and crash episodes . Conclusion Using energy drinks is a popular practice among college students for a variety of situations . Although for the majority of situations assessed , users consumed one energy drink with a reported frequency of 1 – 4 days per month , many users consumed three or more when combining with alcohol while partying . Further , side effects from consuming energy drinks are fairly common , and a significant dose effect was found with jolt and crash episodes . Future research should identify if college students recognize the amounts of caffeine that are present in the wide variety of caffeine-containing products that they are consuming , the amounts of caffeine that they are consuming in various situations , and the physical side effects associated with caffeine consumption BACKGROUND There are popular reports on the combined use of alcohol and energy drinks ( such as Red Bull and similar beverages , which contain caffeine , taurine , carbohydrates , etc . ) to reduce the depressant effects of alcohol on central nervous system , but no controlled studies have been performed . The main purpose of this study was to verify the effects of alcohol , and alcohol combined with energy drink , on the performance of volunteers in a maximal effort test ( cycle ergometer ) and also on physiological indicators ( oxygen uptake , ventilatory threshold , respiratory exchange rate , heart rate , and blood pressure ) , biochemical variables ( glucose , lactate , insulin , cortisol , ACTH , dopamine , noradrenaline , and adrenaline ) , and blood alcohol levels . METHODS Fourteen healthy subjects completed a double-blind protocol made up of four sessions : control ( water ) , alcohol ( 1.0 g/kg ) , energy drink ( 3.57 ml/kg Red Bull ) , and alcohol + energy drink , each 1 week apart . The effort test began 60 min after drug or control ingestion , and the dependent variables were measured until 60 min after the test . RESULTS Heart rate at the ventilatory threshold was higher in the alcohol and alcohol + energy drink sessions in comparison with control and energy drink sessions . Although in comparison to the control session , the peak oxygen uptake was 5.0 % smaller after alcohol ingestion , 1.4 % smaller after energy drink , and 2.7 % smaller after the combined ingestion , no significant differences were detected . Lactate levels ( 30 min after drug ingestion , 30 and 60 min after the effort test ) and noradrenaline levels ( 30 min after the effort test ) were higher in the alcohol and alcohol + energy drink sessions compared with the control session . CONCLUSIONS The performance in the maximal effort test observed after alcohol + energy drink ingestion was similar to that observed after alcohol only . No significant differences between alcohol and alcohol + energy drink were detected in the physiological and biochemical parameters analyzed . Our findings suggest that energy drinks , at least in the tested doses , did not improve performance or reduce alterations induced by acute alcohol ingestion BACKGROUND Well-known reports suggest that the use of energy drinks might reduce the intensity of the depressant effects of alcohol . However , there is little scientific evidence to support this hypothesis . OBJECTIVE AND METHODS The present study aim ed at evaluating the effects of the simultaneous ingestion of an alcohol ( vodka(37.5%v/v ) ) and an energy drink ( Red Bull-3.57 mL/kg ) , compared with those presented after the ingestion of an alcohol or an energy drink alone . Twenty-six young healthy volunteers were r and omly assigned to 2 groups that received 0.6 or 1.0 g/kg alcohol , respectively . They all completed 3 experimental sessions in r and om order , 7 days apart : alcohol alone , energy drink alone , or alcohol plus energy drink . We evaluated the volunteers ' breath alcohol concentration , subjective sensations of intoxication , objective effects on their motor coordination , and visual reaction time . RESULTS When compared with the ingestion of alcohol alone , the ingestion of alcohol plus energy drink significantly reduced subjects ' perception of headache , weakness , dry mouth , and impairment of motor coordination . However , the ingestion of the energy drink did not significantly reduce the deficits caused by alcohol on objective motor coordination and visual reaction time . The ingestion of the energy drink did not alter the breath alcohol concentration in either group . CONCLUSIONS Even though the subjective perceptions of some symptoms of alcohol intoxication were less intense after the combined ingestion of the alcohol plus energy drink , these effects were not detected in objective measures of motor coordination and visual reaction time , as well as on the breath alcohol concentration BACKGROUND Recently , Marczinski and colleagues ( 2013 ) showed that energy drinks combined with alcohol augment a person 's desire to drink more alcohol relative to drinking alcohol alone . The current study replicates the findings of Marczinski and colleagues ( 2013 ) using a robust measure of alcohol craving . METHODS Seventy-five participants aged 18 to 30 years were assigned to an alcohol only or alcohol+energy drink condition in a double-blind r and omized pre- versus posttest experiment . Participants received a cocktail containing either 60 ml of vodka and a Red Bull ( ® ) Silver Edition energy drink ( alcohol+energy drink condition ) or 60 ml of vodka with a soda water vehicle ( alcohol-only condition ) ; both cocktails contained 200 ml of fruit drink . The primary outcome measure was the Alcohol Urge Question naire taken at pretest and at 20 minutes ( posttest ) . Other measures taken at posttest were the Biphasic Alcohol Effects Question naire , the Drug Effects Question naire , and breath alcohol concentration ( BAC ) . RESULTS The alcohol+energy drink condition showed a greater pre- versus posttest increase in urge to drink alcohol compared with the alcohol-only condition ( B = 3.24 , p = 0.021 , d = 0.44 ) . Participants in the alcohol+energy drink condition had significantly higher ratings on liking the cocktail and wanting to drink more of the cocktail , and lower BACs , than the alcohol-only condition . When examined at specific BACs , the effect of the energy drink on the pre- to posttest increase in urge to drink was largest and only significant at BACs of 0.04 - 0.05 ( cf . < 0.04 g/dl).There were no significant differences in stimulation , sedation , feeling the effects of the cocktail , or feeling high . CONCLUSIONS Combining energy drinks with alcohol increased the urge to drink alcohol relative to drinking alcohol alone . More research is needed to underst and what factors mediate this effect and whether it increases subsequent alcohol consumption 1 . The dynamic and kinetic interactions of alcohol and caffeine were studied in a double-blind , placebo controlled , cross-over trial . Treatments were administered to eight healthy subjects in four experimental sessions , leaving a 1 week wash-out period between each , as follows : 1 ) placebo , 2 ) alcohol ( 0.8 g kg-1 ) , 3 ) caffeine ( 400 mg ) and 4 ) alcohol ( 0.8 g kg-1 ) + caffeine ( 400 mg ) . 2 . Evaluations were performed by means of : 1 ) objective measures : a ) psychomotor performance ( critical flicker fusion frequency , simple reaction time and tapping test ) , b ) long latency visual evoked potentials ( ' pattern reversal ' ) ; 2 ) subjective self-rated scales ( visual analogue scales and profile of mood states ) ; 3 ) caffeine and alcohol plasma concentration determinations . 3 . The battery of pharmacodynamic tests was conducted at baseline and at + 0.5 h , + 1.5 h , + 2.5 h , + 4 h and + 6 h. An analysis of variance was applied to the results , accepting a P < 0.05 as significant . The plasma-time curves for caffeine and alcohol were analysed by means of model-independent methods . 4 . Results obtained with caffeine in the objective measures demonstrated a decrease in simple reaction time and an increase in the amplitude of the evoked potentials ; the subjects ' self-ratings showed a tendency to be more active . Alcohol increased simple reaction time and decreased amplitude of the evoked potentials , although the subjects rated themselves as being active . The combination of alcohol + caffeine showed no significant difference from placebo in the objective tests ; nevertheless , the subjective feeling of drunkenness remained . The area under the curve ( AUC ) for caffeine was significantly higher when administered with alcohol . ( ABSTRACT TRUNCATED AT 250 WORDS OBJECTIVES The consumption of alcohol mixed with energy drinks ( AmED ) is popular on college campuses in the United States . Limited research suggests that energy drink consumption lessens subjective intoxication in persons who also have consumed alcohol . This study examines the relationship between energy drink use , high-risk drinking behavior , and alcohol-related consequences . METHODS In Fall 2006 , a Web-based survey was conducted in a stratified r and om sample of 4,271 college students from 10 universities in North Carolina . RESULTS A total of 697 students ( 24 % of past 30-day drinkers ) reported consuming AmED in the past 30 days . Students who were male , white , intramural athletes , fraternity or sorority members or pledges , and younger were significantly more likely to consume AmED . In multivariable analyses , consumption of AmED was associated with increased heavy episodic drinking ( 6.4 days vs. 3.4 days on average ; p < 0.001 ) and twice as many episodes of weekly drunkenness ( 1.4 days/week vs. 0.73 days/week ; p < 0.001 ) . Students who reported consuming AmED had significantly higher prevalence of alcohol-related consequences , including being taken advantage of sexually , taking advantage of another sexually , riding with an intoxicated driver , being physically hurt or injured , and requiring medical treatment ( p < 0.05 ) . The effect of consuming AmED on driving while intoxicated depended on a student 's reported typical alcohol consumption ( interaction p = 0.027 ) . CONCLUSIONS Almost one-quarter of college student current drinkers reported mixing alcohol with energy drinks . These students are at increased risk for alcohol-related consequences , even after adjusting for the amount of alcohol consumed . Further research is necessary to underst and this association and to develop targeted interventions to reduce risk AIM To assess event-level associations between energy drink consumption , alcohol intoxication , and intention to drive a motor vehicle in patrons exiting bars at night . METHOD Alcohol field study . Data collected in a U.S. college bar district from 802 r and omly selected and self-selected patrons . Anonymous interview and survey data were obtained as well as breath alcohol concentration ( BrAC ) readings . RESULTS Results from logistic regression models revealed that patrons who had consumed alcohol mixed with energy drinks were at a 3-fold increased risk of leaving a bar highly intoxicated ( BrAC > or = 0.08g/210L ) , as well as a 4-fold increased risk of intending to drive upon leaving the bar district , compared to other drinking patrons who did not consume
Output:
| Young adults who consumed AED drank more alcohol and experienced more alcohol-related harm than other drinkers .
There was insufficient evidence to conclude that AED led to increased alcohol consumption or altered the nature of alcohol-related harm .
However , AED consumers reported that AED increased stimulation and alertness , offset fatigue from drinking , and facilitated drinking .
Experimental research also found that combining ED or caffeine with alcohol increased stimulation and alertness , offset alcohol-related fatigue and increased the desire to keep drinking .
It did not change BAC , perceived intoxication , perceived impairment and it did not reverse alcohol-induced impairment on simple psychomotor tasks .
Combining ED/caffeine with alcohol reduced alcohol-induced impairment on some but not all aspects of complex tasks . |
MS211520 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: Introduction In this prospect i ve , r and omized controlled study , we aim ed to evaluate the effect of IgM-enriched immunoglobulin treatment on progression of organ failure and septic shock in patients with severe sepsis . Material s and methods Forty-two patients with severe sepsis were enrolled in the study . Patients in the study group ( n = 21 ) received an intravenous immunoglobulin preparation ( Pentaglobin ® ) in addition to st and ard therapy . Pentaglobin ® therapy was commenced on the day of diagnosis of severe sepsis : 5 ml/kg per day Pentaglobin ® ( 38 g/l IgG , 6 g/l IgM , and 6 g/l IgA ) was infused over 6 hours and repeated for 3 consecutive days . Patients in the control group ( n = 18 ) received st and ard sepsis therapy , but no immunoglobulin administration . Blood sample s for procalcitonin ( PCT ) measurements were taken daily for 8 days . Severity of critical illness and development of organ failure were assessed by obtaining daily acute physiological and chronic health evaluation ( APACHE ) II and sequential organ failure assessment ( SOFA ) scores . Results and discussion Procalcitonin levels showed a statistically significant decrease in the Pentaglobin ® group ( P < 0.001 ) ; however , an improvement in SOFA scores could not be demonstrated . Procalcitonin levels and SOFA scores did not change significantly in the control group . Septic shock incidence ( 38 % versus 57 % ) and 28-day mortality rate ( 23.8 % versus 33.3 % ) were found to be similar between the Pentaglobin ® and control groups . The evaluation of serial APACHE II scores did not demonstrate a difference between Pentaglobin ® and control groups either . Conclusion Present data could not demonstrate any beneficial effects of polyclonal immunoglobulin preparation Pentaglobin ® on organ morbidity , septic shock incidence and mortality rate in patients with severe sepsis 35 patients with septic postoperative complications entered a prospect ively r and omized study . The clinical state of these patients was daily determined using the sepsis score described by Elebute and Stoner . Endotoxin and antithrombin III were measured in the plasma using the limulus-amoebocyte-lysat test for endotoxin determination . The septic patients were treated with an immunoglobulin preparation ( Pentaglobin ) administered by the intravenous route . This preparation is enriched in IgM and IgA. Due to the immunoglobulin therapy the endotoxin titres decreased ; simultaneously a reduction of mortality and shortening of time of hospitalization and of mechanical ventilation were observed BACKGROUND It remains uncertain whether the choice of resuscitation fluid for patients in intensive care units ( ICUs ) affects survival . We conducted a multicenter , r and omized , double-blind trial to compare the effect of fluid resuscitation with albumin or saline on mortality in a heterogeneous population of patients in the ICU . METHODS We r and omly assigned patients who had been admitted to the ICU to receive either 4 percent albumin or normal saline for intravascular-fluid resuscitation during the next 28 days . The primary outcome measure was death from any cause during the 28-day period after r and omization . RESULTS Of the 6997 patients who underwent r and omization , 3497 were assigned to receive albumin and 3500 to receive saline ; the two groups had similar baseline characteristics . There were 726 deaths in the albumin group , as compared with 729 deaths in the saline group ( relative risk of death , 0.99 ; 95 percent confidence interval , 0.91 to 1.09 ; P=0.87 ) . The proportion of patients with new single-organ and multiple-organ failure was similar in the two groups ( P=0.85 ) . There were no significant differences between the groups in the mean ( + /-SD ) numbers of days spent in the ICU ( 6.5+/-6.6 in the albumin group and 6.2+/-6.2 in the saline group , P=0.44 ) , days spent in the hospital ( 15.3+/-9.6 and 15.6+/-9.6 , respectively ; P=0.30 ) , days of mechanical ventilation ( 4.5+/-6.1 and 4.3+/-5.7 , respectively ; P=0.74 ) , or days of renal-replacement therapy ( 0.5+/-2.3 and 0.4+/-2.0 , respectively ; P=0.41 ) . CONCLUSIONS In patients in the ICU , use of either 4 percent albumin or normal saline for fluid resuscitation results in similar outcomes at 28 days Objective : To evaluate the effect of intravenous IgMA-enriched immunoglobulin ( ivIGMA ) therapy on mortality in neutropenic patients with hematologic malignancies and sepsis syndrome or septic shock . Design : Multiple-center , prospect i ve r and omized , controlled study . Setting : Six university hospitals in Germany . Patients : Patients were 211 neutropenic patients with sepsis syndrome or septic shock after chemotherapy for severe hematologic disorders between 1992 and 1999 . Interventions : Patients received 1300 mL of ivIGMA ( 7.8 g IgM , 7.8 g IgA , and 49.4 g IgG ) infused intravenously within a period of 72 hrs or human albumin according to the same schedule as ivIGMA . Measurements and Main Results : All-cause mortality at 28 days , sepsis-related mortality at 28 days , all-cause mortality at 60 days , mortality from septic shock , and mortality from microbiologically proven Gram-negative sepsis and septic shock were recorded . Immunoglobulin had no benefit over human albumin . The 28-day mortality rate was 26.2 % and 28.2 % in the ivIGMA and control patients , respectively ( difference , 2.0 % [ 95 % confidence interval , −10.2 to 14.2 percentage points ] ) . Likewise , the 60-day mortality rate did not differ between both arms ( 29.6 % vs. 34.7 % in the ivIGMA and control patients , respectively ) . Mortality rates in patients with sepsis syndrome ( 17.1 % vs. 16.7 % ) and septic shock ( 51.9 % vs. 54.8 % ) were also found to be similar between both groups . Conclusions : Intravenous ivIGMA had no beneficial effects in neutropenic patients with hematologic malignancies and sepsis syndrome and septic shock Thrombocytopenia frequently complicates systemic infection and results from multiple possible mechanisms . We and others have demonstrated that platelet-associated IgG ( PAIgG ) levels are elevated in the majority of patients with septic thrombocytopenia . Corticosteroids may be undesirable as a treatment for thrombocytopenia for patients with severe infection because of their potential for suppressing the immune response . We hypothesized that septic thrombocytopenia is , in most cases , an immune disorder analogous to idiopathic thrombocytopenic purpura ( ITP ) which might respond to intravenous gamma-globulin as a treatment for increasing the platelet count in this disorder . Intravenous immune globulin ( IVIG ) , 400 mg/kg daily for 3 days , was administered in a r and omized double-blind placebo-controlled trial . Twenty-nine patients who developed thrombocytopenia during a documented , septic episode were studied . Patients with disseminated intravascular coagulation ( DIC ) , hypersplenism , or drugs known to cause thrombocytopenia were excluded . Elevated PAIgG levels were documented in 52 % of evaluable patients . Mean platelet counts in the IVIG group rose from 43 K at study entry to 178 K ( 411 % rise ) by Day 9 . In the placebo group platelets rose from 51 K to 125 K ( 261 % rise;P = 0.02 ) . Seventy-seven percent of the IVIG group had a minimum peak rise of 35 K , vs 56 % of the placebo group . Three patients in the placebo group had a serious bleeding episode , vs one in the IVIG group . The use of IVIG to treat septic thrombocytopenia not associated with DIC leads to a more rapid , more sustained , and greater increase in platelet count than placebo . Its use is recommended in the septic patient who is bleeding or is likely to need invasive or surgical procedures The objective of this study was to assess the impact on outcome of adjuvant therapy ( high-dose of immunoglobulin [ Ig ] M-enriched intravenous Ig , IVIG ) in intensive care unit ( ICU ) patients who underwent surgery by abdominal sepsis . This was a prospect i ve , r and omized , double-blind , controlled study set in the medical/surgical ICUs of seven teaching hospitals . Patients with severe sepsis and septic shock of intra-abdominal origin admitted to the ICU within 24 h after the onset of symptoms were included in the study . Polyvalent IgM-enriched Ig ( Pentaglobin ® ; IVIG group ) at a dosage of 7 mL/kg/day for 5 days or an equal amount of 5 % human albumin ( control group ) was r and omized . Fifty-six patients were enrolled . The overall mortality rate was 37.5.% . Twenty patients had shock and 36 had severe sepsis ( the mortality rate was 55.0 % and 25.0 % , respectively ) . In the intent-to-treat analysis , the mortality rate was reduced from 48.1 % in patients treated with antibiotic ( ATB ) plus albumin to 27.5 % ( P = 0.06 ) for patients with ATB plus IVIG . The organ failure score ( 1.0 ± 0.6 vs. 1.2 ± 0.9 ) , organ dysfunction score ( 1.7 ± 1.1 vs. 1.8 ± 1.0 ) , and reoperation rate ( 17.2 % vs. 29.6 % ) were not different between IVIG and control groups , respectively . Eight patients ( 14.3 % ) received inappropriate ATB initial therapy ( IAT ) , and seven died ( 87.5 % ) . IAT was the only variable independently associated with death ( odds ratio , 19.4 ) in a logistic regression model . We conclude that IVIG administration , when used in combination with adequate antibiotics , improved the survival of surgical ICU patients with intra-abdominal sepsis . The initial choice of antibiotic has a dramatic impact on outcome The efficacy and safety of high-dose intravenous polyspecific immunoglobulin G ( IVIG ) as adjunctive therapy in streptococcal toxic shock syndrome ( STSS ) were evaluated in a multicenter , r and omized , double-blind , placebo-controlled trial . The trial was prematurely terminated because of slow patient recruitment , and results were obtained from 21 enrolled patients ( 10 IVIG recipients and 11 placebo recipients ) . The primary end point was mortality at 28 days , and a 3.6-fold higher mortality rate was found in the placebo group . A significant decrease in the sepsis-related organ failure assessment score at days 2 ( P=.02 ) and 3 ( P=.04 ) was noted in the IVIG group . Furthermore , a significant increase in plasma neutralizing activity against superantigens expressed by autologous isolates was noted in the IVIG group after treatment ( P=.03 ) . Although statistical significance was not reached in the primary end point , the trial provides further support for IVIG as an efficacious adjunctive therapy in STSS Summary A multicenter r and omized controlled clinical trial , which was carried out in 10 hospitals in the Federal Republic of Germany between 1979 and 1983 , studied the influence of i.v . immunoglobulin G on the mortality in patients with diffuse acute fibrinopurulent peritonitis . Altogether 288 patients were enrolled in the trial . There was no statistically significant difference in the mortality rates within the treated group ( 46 % ) vs the control group ( 41 % ) . The power of the statistical test to detect a decrease of the mortality by 20 % was calculated to be 0.93 . This result did not change when we eliminated 50 patients not strictly obeying the entrance criteria of the analysis , or when we focused on a subgroup of patients with initial deficiency of immunoglobulin G. Factors influencing mortality were a preceding laparotomy , serum creatinine level above 2 mg/100 ml , and necessity for artificial respiration . These factors , reflecting the surgical situation and the severity of shock , essentially explain the mortality differences observed between the participating hospitals Sixty-two consecutive septic surgical patients receiving st and ard multimodal intensive care unit treatment who developed a sepsis score of 20 or greater ( day 0 ) were r and omized to receive 0.4 g/kg of either intravenous IgG ( 29 patients ) or human albumin ( controls ; 33 patients ) , repeated on days + 1 and + 5 , in a prospect i ve , double-blind , multicenter study . The two groups were similar in age , initial sepsis scores , and acute physiology and chronic health evaluation II score . A significantly lower mortality was recorded in the IgG-treated group ( 38 % ) than in controls ( 67 % ) . Septic shock was the cause of death in 7 % of IgG-treated patients and in 33 % of controls . The results of this study indicate that high
Output:
| This meta- analysis demonstrates an overall reduction in mortality with the use of ivIg for the adjunctive treatment of severe sepsis and septic shock in adults , although significant heterogeneity exists among the included trials and this result was not confirmed when only high- quality studies were analyzed . |
MS211521 | ***TASK*** the task is to summarize an input biomedical literature 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: Aqueous hydrogen peroxide ( H2O2 ) has been used clinical ly at 30 % to 35 % levels to lighten teeth for many years , but the process has required multiple visits . Heat and light have been used empirically in attempts to catalyze H2O2 decomposition and speed tooth lightening . The contribution of bleaching lights ( LumaArch , Optilux 500 , and Zoom ! ) to act as catalysts for lightening teeth was studied in 83 pairs of contralateral anterior maxillary and m and ibular teeth on 15 human subjects . Split-arch design using central s , laterals , and canines on one side treated with bleach plus light , were compared with contralateral teeth using bleach alone . Three research ers trained in the use of the Vitapan 3D-Master Shade Guide took shades with independently agreement within 0.5 value-chroma sum 89 % of the time throughout the study Laboratory tests determined bleach gel chemistry , bleach light output , and effects on the bleaches of light alone and heat alone . Results showed that the three test lights did not lighten teeth more than their bleach gels alone . All teeth lightened to nearly the same degree ( 1.7 color increments ) , but LumaArch required 60 % less time and Zoom ! used 1/3 lower H2O2 concentration . Laboratory tests indicated that the proprietary chemicals mixed into each bleach gel just before use acted as catalysts and were probably responsible for more rapid lightening produced by LumaArch gel , and need for less H2O2 in Zoom ! gel . Neither the heat produced by the accessory lights , nor the light output itself were responsible for catalytic activity with any of the three systems tested . Collectively , the data demonstrate positive effects from chemical catalysts added to bleaching gels . No output from any of the lights result ed in heat or light that catalyzed the gels This study clinical ly evaluated the alteration of color , color stability , dental sensitivity and gingival irritation on patients undergoing dental bleaching using varying bleaching methods and light-activation sources . According to pre-established criteria , 40 patients were selected and r and omly divided into four groups ( n=10 ) : Group 1 - -35 % Hydrogen Peroxide ( HP ) ; Group 2 - -35 % HP plus Halogen Curing Light XL 3000 ( 3M/ESPE ) ; Group 3 - -35 % HP plus Demetron LED ( Kerr ) and Group 4 - -35 % HP plus LED/LASER ( Bio-art ) . For all groups , there were two sessions of bleaching with 35 % HP , with a one week break between sessions . At each bleaching session , three applications of the bleaching gel were used . Two methods of shade evaluation were performed before and after the first week , second week , first month and after six months of the bleaching treatment . These methods were VITA Easyshade Spectrophotometer and Vita Classical Shade Guide . Statistical analysis using ANOVA demonstrated e quality between the participating groups when evaluating the group and time variables . The In-Office dental bleaching treatments of vital teeth with 35 % HP did not prove to be more effective when light sources were used . There was no difference in color stability between groups until the sixth month of evaluation PURPOSE To compare in vitro the bleaching effects obtained with and without the use of the various lights on power bleaching systems . METHODS 19 groups of five tooth specimens were prepared and allocated r and omly to treatments . Only specimens with shade C4 were accepted for the study . Three commercial bleaching products all based on 35 % hydrogen peroxide were used with and without four different light sources . Shade assessment s were made using a Shade Guide ( SG ) , Shade Vision System ( SVS ) and chromometer . RESULTS For SG , all but the light only treatment result ed in measurable improvement in shade ranging from 4.6 to 14.6 shade guide units . Similar findings were apparent with SVS and chromometer . No change was seen in the light only treatments by SVS or SG with very small changes by chromometer . In mean terms with all three gels , least change was noted when there was no light used . For SG , SVS and chromometer data analysis over all treatment groups , excluding light only treatments , revealed highly significant differences . Within bleach product treatment differences were only significant with one gel both with and without light activation . Differences between gels with the same light and no light revealed some significant differences in SG and chromometer data but not SVS . In mean terms the order of efficacy of gels with each light and no light was the same for the majority of data sets BACKGROUND Light-activated bleaching is a method of tooth whitening . The authors conducted a study to compare the whitening effects and tooth temperature changes induced by various combinations of peroxide bleaches and light sources . METHODS The authors r and omly assigned 250 extracted human teeth halves into experimental groups ( n = 10 ) . A placebo gel ( control ) , a 35 percent hydrogen peroxide or a 10 percent carbamide peroxide bleach was placed on the tooth surface and was irradiated with no light ( control ) ; a halogen curing light ; an infrared , or IR , light ; an argon laser ; or a carbon dioxide , or CO2 , laser . Color changes were evaluated immediately , one day and one week after treatment using a value-oriented shade guide and an electronic dental color analyzer . The outer enamel and inner dentin surface temperatures were monitored before and immediately after each 30-second application of light using a thermocouple thermometer . RESULTS Color and temperature changes were significantly affected by an interaction of the bleach and light variables . The application of lights significantly improved the whitening efficacy of some bleach material s , but it caused significant temperature increases in the outer and inner tooth surfaces . The IR and CO2 laser lights caused the highest tooth temperature increases . CONCLUSIONS Dentists performing an in-office bleaching technique with the use of an additional light source to accelerate tooth whitening should consider the specific bleaching agent being used , as well as the potential risks of heating teeth . CLINICAL IMPLICATION S A specific combination of bleach and light that demonstrates good color change and little temperature rise should be selected for in-office tooth bleaching OBJECTIVE Evaluate a light-enhanced in-office tooth whitening system in order to assess tooth color and safety . METHODS Thirty-three adults were r and omly assigned to one of three treatment groups . Professional treatment involved application of a 25 % H(2)O(2 ) gel ( Discus Dental ZOOM ! ) with light enhancement , H(2)O(2 ) gel alone , or the light alone with no peroxide . The 12 anterior teeth were treated three times for 20 minutes each . Efficacy was measured objective ly as L*a*b * color change using digital images , tooth shade was measured , and safety was evaluated immediately after treatment and at posttreatment days 7 and 30 . RESULTS After adjusting for baseline and age , immediate ( end-of-treatment ) means ( SE ) for Deltab * ( yellowness ) were -3.1 ( 0.25 ) for the gel + light , -2.0 ( 0.25 ) for the gel-only group , and -2.4 ( 0.25 ) for the light-only group . Significant ( p < 0.05 ) color rebound was evident at posttreatment day 7 . By day 30 , adjusted means (SE)for Deltab * were -1.7 ( 0.20 ) for the gel + light group , -1.1 ( 0.20 ) for the gel-only group , and -0.5 ( 0.20 ) for the light-only group . Both peroxide groups differed significantly ( p < 0.05 ) from light alone on Deltab * and DeltaL*. In the gel + light group , 91 % of subjects experienced tooth sensitivity , the majority of which was moderate or severe . Adverse events were low in the light-only group . CONCLUSION Use of light enhancement for in-office whitening leads to immediate color change , after which there was significant color and shade rebound within 7 days as well as moderate-to-severe tooth sensitivity during and after treatment . CLINICAL SIGNIFICANCE Increased tooth sensitivity during treatment and appreciable short-term color rebound after treatment may impact the utility of in-office tooth whitening with peroxide and light as a st and -alone esthetic procedure . ( J Esthet Restor Dent 21:336 - 347 , 2009 ) The objective of the present study was to assess the clinical efficacy of a dental bleaching system based on hydrogen peroxide with or without light activation . This r and omized controlled trial evaluated the effect of the light when applied to the hydrogen peroxide by using a split-mouth design with 21 patients , with light activation in one hemi-arch but not in the other . The bleaching agent was QuickWhite 35 % hydrogen peroxide and activation was conducted with a diode lamp ( Luma Cool ) . The Classic Vita Guide was used to score tooth shades . Two consecutive applications of hydrogen peroxide were made to one hemi-arch , each light-activated for 10 min . The other hemi-arch was then identically treated but without light activation . After removal of the bleaching agent , the shade was re-scored and the Wilcoxon signed ranks test was used to compare differences in tooth shade values . The bleaching treatment produced significant shade changes ( P < 0.01 ) in both hemi-arches . After treatment , there were no statistically significant differences between light-treated and non-light-treated tooth types ( central incisors , lateral incisors , and canines ) . However , taking central incisor , lateral incisor , and canine as a group , comparison between each hemi-arch showed a significant effect in the hemi-arch with light activation ( P < 0.05 ) . The use of diode light with a 35 % hydrogen peroxide gel slightly improved the dental bleaching The aim of this clinical study was to evaluate the efficiency of in-office bleaching systems with different light sources for color change and possible side effects such as tooth sensitivity and gingival irritations . Forty healthy volunteers aged 18 years and older ( average age 27.3 years ) , having all their natural healthy teeth in shade A3 or darker on the Vita shade guide , with no restorations on the buccal surfaces and no tooth sensitivity , participated in this study . Participants were r and omly assigned to four groups of ten volunteers . Group 1 received bleaching without light activation ( Opalescence Xtra Boost , Ultradent ) ; group 2 received bleaching ( Laser White 10 , Biolase ) with a diode laser ( 810 nm , 10 W/ Laser Smile , Biolase ) activation ; group 3 received bleaching treatment ( Remewhite , Remedent ) with a plasma arc lamp ( 400–490 nm , 2800 mV/cm2 , Remecure CL15 ) , and group 4 received bleaching with a light emitting diode ( LED ) lamp ( By White accelerator , Ensodent ) according to the manufacturers ’ recommendations . The shade was assessed with a classical Vita shade guide ( Vita Zahnfabrik ) and a digital spectrophotometer ( Vita Easy Shade , Vident ) . The color of teeth was scored at baseline and 1 week after bleaching . Any side effects on teeth or gingiva was recorded by visual analog scale . Results were analyzed statistically , by one-way analysis of variance ( ANOVA ) , Kruskal – Wallis , and Mann – Whitney U tests with Bonferroni correction . All the bleaching techniques result ed in shade change . No significant differences were found in the color change among the four groups with shade guide assessment ( P > 0.05 ) , but spectrophotometer readings exhibited significant differences among the groups ( P < 0.05 ) . The overall shade change values expressed as ΔL , Δa , Δb , ΔE for group 2 was significantly higher than those for the other groups ( P < 0.05 ) . Group 2 also showed lower tooth and gingival sensitivity scores than those of the other groups ( P < 0.05 ) . All techniques result ed in shade change . Although the shade guide evaluation did not exhibit any differences among the bleaching treatment groups , spectrophotometer readings showed different findings . The results obtained by the two methods of evaluation of shade change used in this study were different from each other . Bleaching with diode laser result ed in less tooth and gingival sensitivity than the other bleaching systems . Clinical relevance : in-office bleaching systems used with or without light , lead to a shade change . As bleaching with diode laser result ed in less tooth and gingival sensitivity , it might be preferred among in-office bleaching systems AIM The study aim ed to evaluate the effect of four in-office dental bleaching methods on shade change , color stability , patient satisfaction and postoperative sensitivity . METHODS AND MATERIAL S Forty patients were r and omly divided into four groups ( n=10 ) according to the method of in-office bleaching used : Group A-35 % hydrogen peroxide ( HP ) ; Group B-35 % HP plus BriteSmile and a blue curing light ; Group C-35 % HP plus QuickSmile and an LED curing light ; Group D-35 % HP and a Zoom2 metal halide curing light . For all groups , there was only one session of bleaching with three 20-minute applications of bleaching gel . The shade was evaluated before bleaching , immediately after , and one month after treatment using a VITA Classical Shade Guide . RESULTS Immediately after bleaching there was a significant difference in color change between the four groups , with Group B having the best results . At one month there was no difference between the four groups . Immediate postoperative sensitivity was the least in Group A and the highest for Group B. Patients in Group B were the most satisfied with the outcome of the bleaching procedure . CONCLUSIONS In general , the use of different lights for activation of an in-office bleaching agent did not affect the long-term results . Tooth sensitivity was mild and transient in the study . Patients were satisfied with in-office bleaching . CLINICAL SIGNIFICANCE Using light activation with in-office ble
Output:
| After combining the four components and assessing the grade of the evidence , the strength of recommendation of the intervention is established .
This expansion of the GRADE ( Ex- GRADE ) permits the creation of a new instrument that can produce tangible data and possibly bridge the gap between evidence -based research and evidence -based clinical practice |
MS211522 | ***TASK*** the task is to summarize an input biomedical literature 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 — Few prospect i ve studies have examined quantitative cigarette consumption and smoking cessation on sudden cardiac death ( SCD ) risk with long-term follow-up . Methods and Results — We prospect ively examined the association between cigarette smoking and smoking cessation on the risk of SCD among 101 018 women participating in the Nurses ’ Health Study without known coronary heart disease , stroke , and cancer at baseline 1980 . During 30 years of follow-up , we identified 351 SCD events . Compared with never smokers , current smokers had a 2.44-fold ( 95 % CI , 1.80–3.31 ) increased risk of SCD after controlling for coronary risk factors . In multivariable analyses , quantity of cigarettes smoked daily ( P value for trend , < 0.0001 ) and smoking duration ( P value for trend , < 0.0001 ) were linearly associated with SCD risk among current smokers . Small-to-moderate amounts of cigarette consumption ( 1–14 per day ) were associated with a significant 1.84-fold ( 95 % CI , 1.16–2.92 ) increase in SCD risk and every 5 years of continued smoking was associated with an 8 % increase in SCD risk ( hazard ratio , 1.08 ; 95 % CI , 1.05–1.12 ; P<0.0001 ) . The SCD risk linearly decreased over time after quitting and was equivalent to that of a never smoker after 20 years of cessation ( P value for trend , < 0.0001 ) . Conclusions — In this large prospect i ve cohort of women without coronary heart disease at baseline , a strong dose – response relationship between cigarette smoking and SCD risk was observed , and smoking cessation significantly reduced and eventually eliminated excess SCD risk . This suggests efforts to prevent SCD among women should include aggressive strategies for smoking cessation Sudden cardiac death ( SCD ) generally refers to an unexpected death from a cardiovascular cause in a person with or without preexisting heart disease . The specificity of this definition varies depending on whether the event was witnessed ; however , most studies include cases that are associated with a witnessed collapse , death occurring within 1 hour of an acute change in clinical status , or an unexpected death that occurred within the previous 24 hours.1–3 Further , sudden cardiac arrest describes SCD cases with resuscitation records or aborted SCD cases in which the individual survived the cardiac arrest . The incidence of SCD in the United States ranges between 180 000 and 450 000 cases annually.4 These estimates vary owing to differences in SCD definitions and surveillance methods for case ascertainment.4,5 In recent prospect i ve studies using multiple sources in the United States,6,7 Netherl and s,8 Irel and , 9 and China,10 SCD rates range from 50 to 100 per 100 000 in the general population .3 Despite the need for multiple sources of surveillance to provide a more accurate estimate of SCD incidence , it is clear that the overall burden in the population remains high . Although improvements in primary and secondary prevention have result ed in substantial declines in overall coronary heart disease ( CHD ) mortality over the past 30 years,11,12 SCD rates specifically have declined to a lesser extent.13–16 SCD still accounts for > 50 % of all CHD deaths and 15 % to 20 % of all deaths.17,18 For some segments of the population , rates are not decreasing19 and may actually be increasing.14,19 As a result , SCD prevention represents a major opportunity to further reduce mortality from CHD . Despite major advances in cardiopulmonary resuscitation20 and postresuscitation care , survival BACKGROUND Cigarette smoking is a known risk factor for cardiovascular disease ( CVD ) , but its relationship to the development of hypertension is unclear . Previous epidemiological studies have shown inconsistent results , having demonstrated inverse and positive associations between cigarette smoking and the development of hypertension . METHODS We analyzed 13,529 male participants from the Physicians ' Health Study free of baseline hypertension and CVD who provided information about smoking status . Smoking status was categorized as never , past , or current < 20 cigarettes/day , or current > or = 20 cigarettes/day . Incident hypertension was defined as either the initiation of antihypertensive treatment , self-reported systolic blood pressure ( BP ) > or = 140 mm Hg , or diastolic BP > or = 90 mm Hg . RESULTS Over a median follow-up of 14.5 years , 4,904 men developed hypertension . We modeled the risk of developing hypertension by baseline smoking status adjusting for known risk factors for hypertension or CVD . In a fully adjusted Cox proportional hazards model , we found that compared with never smokers , past smokers and current smokers had corresponding relative risks ( RRs ) of 1.08 and 1.15 of developing hypertension . The risk for smokers did not appear to differ based on number of cigarettes smoked daily . Further , the RR of hypertension was higher for men with normal vs. prehypertensive levels of systolic ( SBP ) or diastolic BP ( DBP ) . CONCLUSIONS This prospect i ve cohort data suggests that cigarette smoking may be a modest but important risk factor for the development of hypertension BACKGROUND Sudden death was found to share the same set of usual risk factors as coronary events and therefore could not be specifically predicted in the population . It appears , however , that parental history of sudden death has not been investigated yet as a risk factor for sudden death . Therefore , we assessed risk factors , including parental sudden death , associated with the occurrence of sudden death in a long-term cohort study . METHODS AND RESULTS We included 7746 men employed by the city of Paris who were 43 to 52 years of age in 1967 to 1972 in the Paris Prospect i ve Study I. Each subject underwent a physical examination and an ECG , provided blood for laboratory tests , and answered question naires administered by trained interviewers who paid particular attention to family medical history . Men with known ischemic cardiac disease were further excluded from analysis . For 95.5 % of the men , vital status was obtained from specific inquiries until retirement , then by death certificates . Resting heart rate , systolic or diastolic blood pressure , tobacco consumption , body mass index , diabetes status , serum cholesterol , and parental history of sudden death were independent factors associated with sudden death during follow-up ( 23 years on average ) . When adjusted for confounding variables , including parental history of myocardial infa rct ion , relative risk of sudden death associated with parental sudden death was 1.80 ( 95 % CI , 1.11 to 2.88 ) . CONCLUSIONS Parental sudden death is an independent risk factor for sudden death in middle-aged men . The existence of familial risk factors for sudden death may help provide better identification of subjects at high risk of and early prevention of sudden death Background —There are few data regarding the determinants of sudden cardiac death ( SCD ) in women , primarily because of their markedly lower rate of SCD compared with men . Nonetheless , existing data , although sparse , suggest possible gender differences in risk factors for SCD . Methods and Results —In this prospect i ve cohort of 121 701 women aged 30 to 55 years at baseline , SCD was defined as death within 1 hour of symptom onset . From 1976 to 1998 , 244 SCDs were identified . Although the risk of SCD increased markedly with age , the percentage of cardiac deaths that were sudden decreased . Most ( 69 % ) women who suffered a SCD had no history of cardiac disease before their death . However , almost all of the women who died suddenly ( 94 % ) had reported at least 1 coronary heart disease risk factor . Smoking , hypertension , and diabetes conferred markedly elevated ( 2.5- to 4.0-fold ) risk of SCD , similar to that conferred by a history of nonfatal myocardial infa rct ion ( relative risk , 4.1 ; 95 % confidence interval , 2.9 to 6.7 ) . Family history of myocardial infa rct ion before age 60 years and obesity were associated with moderate ( 1.6-fold ) elevations in risk . With regard to mechanism , 88 % of SCDs were classified as arrhythmic . In 76 % of these , the first rhythm documented was ventricular tachycardia or ventricular fibrillation . Conclusions —These prospect i ve data suggest that , as in men , coronary heart disease risk factors predict risk of SCD in women and that SCD is usually an arrhythmic death . Therefore , prevention of atherosclerosis or ventricular arrhythmias may reduce the incidence of SCD in women Summary Background Women born around 1940 in countries such as the UK and USA were the first generation in which many smoked substantial numbers of cigarettes throughout adult life . Hence , only in the 21st century can we observe directly the full effects of prolonged smoking , and of prolonged cessation , on mortality among women in the UK . Methods For this prospect i ve study , 1·3 million UK women were recruited in 1996–2001 and resurveyed postally about 3 and 8 years later . All were followed to Jan 1 , 2011 , through national mortality records ( mean 12 woman-years , SD 2 ) . Participants were asked at entry whether they were current or ex-smokers , and how many cigarettes they currently smoked . Those who were ex-smokers at both entry and the 3-year resurvey and had stopped before the age of 55 years were categorised by the age they had stopped smoking . We used Cox regression models to obtain adjusted relative risks that compared categories of smokers or ex-smokers with otherwise similar never-smokers . Findings After excluding 0·1 million women with previous disease , 1·2 million women remained , with median birth year 1943 ( IQR 1938–46 ) and age 55 years ( IQR 52–60 ) . Overall , 6 % ( 66 489/1 180 652 ) died , at mean age 65 years ( SD 6 ) . At baseline , 20 % ( 232 461 ) were current smokers , 28 % ( 328 417 ) were ex-smokers , and 52 % ( 619 774 ) were never-smokers . For 12-year mortality , those smoking at baseline had a mortality rate ratio of 2·76 ( 95 % CI 2·71–2·81 ) compared with never-smokers , even though 44 % ( 37 240/85 256 ) of the baseline smokers who responded to the 8-year resurvey had by then stopped smoking . Mortality was tripled , largely irrespective of age , in those still smoking at the 3-year resurvey ( rate ratio 2·97 , 2·88–3·07 ) . Even for women smoking fewer than ten cigarettes per day at baseline , 12-year mortality was doubled ( rate ratio 1·98 , 1·91–2·04 ) . Of the 30 most common causes of death , 23 were increased significantly in smokers ; for lung cancer , the rate ratio was 21·4 ( 19·7–23·2 ) . The excess mortality among smokers ( in comparison with never-smokers ) was mainly from diseases that , like lung cancer , can be caused by smoking . Among ex-smokers who had stopped permanently at ages 25–34 years or at ages 35–44 years , the respective relative risks were 1·05 ( 95 % CI 1·00–1·11 ) and 1·20 ( 1·14–1·26 ) for all-cause mortality and 1·84 ( 1·45–2·34 ) and 3·34 ( 2·76–4·03 ) for lung cancer mortality . Thus , although some excess mortality remains among these long-term ex-smokers , it is only 3 % and 10 % of the excess mortality among continuing smokers . If combined with 2010 UK national death rates , tripled mortality rates among smokers indicate 53 % of smokers and 22 % of never-smokers dying before age 80 years , and an 11-year lifespan difference . Interpretation Among UK women , two-thirds of all deaths of smokers in their 50s , 60s , and 70s are caused by smoking ; smokers lose at least 10 years of lifespan . Although the hazards of smoking until age 40 years and then stopping are substantial , the hazards of continuing are ten times greater . Stopping before age 40 years ( and preferably well before age 40 years ) avoids more than 90 % of the excess mortality caused by continuing smoking ; stopping before age 30 years avoids more than 97 % of it . Funding Cancer Research UK , Medical Research Council BACKGROUND Risk factors specific to sudden cardiac death ( SCD ) , ie , death within 1 hour after onset of symptoms , have been poorly identified , although recent findings from the present study incriminate heavy drinking and elevated heart rate . This paper examines the relations between a wide range of established and potential risk factors for ischemic heart disease ( IHD ) and SCD to identify independent risk factors for SCD and factors that might particularly or specifically relate to SCD . METHODS AND RESULTS We present a prospect i ve study of a cohort that was drawn from general
Output:
| These results confirm that smoking increases the risk of sudden cardiac death . |
MS211523 | ***TASK*** the task is to summarize an input biomedical literature 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 US National Institute of Neurological Disorders and Stroke convened major stakeholders in June 2012 to discuss how to improve the method ological reporting of animal studies in grant applications and publications . The main workshop recommendation is that at a minimum studies should report on sample -size estimation , whether and how animals were r and omized , whether investigators were blind to the treatment , and the h and ling of data . We recognize that achieving a meaningful improvement in the quality of reporting will require a concerted effort by investigators , review ers , funding agencies and journal editors . Requiring better reporting of animal studies will raise awareness of the importance of rigorous study design to accelerate scientific progress Background Spinal muscular atrophy is an autosomal recessive neuromuscular disorder that is caused by an insufficient level of survival motor neuron ( SMN ) protein . Nusinersen is an antisense oligonucleotide drug that modifies pre – messenger RNA splicing of the SMN2 gene and thus promotes increased production of full‐length SMN protein . Methods We conducted a r and omized , double‐blind , sham‐controlled , phase 3 efficacy and safety trial of nusinersen in infants with spinal muscular atrophy . The primary end points were a motor‐milestone response ( defined according to results on the Hammersmith Infant Neurological Examination ) and event‐free survival ( time to death or the use of permanent assisted ventilation ) . Secondary end points included overall survival and subgroup analyses of event‐free survival according to disease duration at screening . Only the first primary end point was tested in a prespecified interim analysis . To control the overall type I error rate at 0.05 , a hierarchical testing strategy was used for the second primary end point and the secondary end points in the final analysis . Results In the interim analysis , a significantly higher percentage of infants in the nusinersen group than in the control group had a motor‐milestone response ( 21 of 51 infants [ 41 % ] vs. 0 of 27 [ 0 % ] , P<0.001 ) , and this result prompted early termination of the trial . In the final analysis , a significantly higher percentage of infants in the nusinersen group than in the control group had a motor‐milestone response ( 37 of 73 infants [ 51 % ] vs. 0 of 37 [ 0 % ] ) , and the likelihood of event‐free survival was higher in the nusinersen group than in the control group ( hazard ratio for death or the use of permanent assisted ventilation , 0.53 ; P=0.005 ) . The likelihood of overall survival was higher in the nusinersen group than in the control group ( hazard ratio for death , 0.37 ; P=0.004 ) , and infants with a shorter disease duration at screening were more likely than those with a longer disease duration to benefit from nusinersen . The incidence and severity of adverse events were similar in the two groups . Conclusions Among infants with spinal muscular atrophy , those who received nusinersen were more likely to be alive and have improvements in motor function than those in the control group . Early treatment may be necessary to maximize the benefit of the drug . ( Funded by Biogen and Ionis Pharmaceuticals ; ENDEAR Clinical Trials.gov number , NCT02193074 . Objective : To examine safety , tolerability , pharmacokinetics , and preliminary clinical efficacy of intrathecal nusinersen ( previously ISIS-SMNRx ) , an antisense oligonucleotide design ed to alter splicing of SMN2 mRNA , in patients with childhood spinal muscular atrophy ( SMA ) . Methods : Nusinersen was delivered by intrathecal injection to medically stable patients with type 2 and type 3 SMA aged 2–14 years in an open-label phase 1 study and its long-term extension . Four ascending single-dose levels ( 1 , 3 , 6 , and 9 mg ) were examined in cohorts of 6–10 participants . Participants were monitored for safety and tolerability , and CSF and plasma pharmacokinetics were measured . Exploratory efficacy endpoints included the Hammersmith Functional Motor Scale Exp and ed ( HFMSE ) and Pediatric Quality of Life Inventory . Results : A total of 28 participants enrolled in the study ( n = 6 in first 3 dose cohorts ; n = 10 in the 9-mg cohort ) . Intrathecal nusinersen was well-tolerated with no safety/tolerability concerns identified . Plasma and CSF drug levels were dose-dependent , consistent with pre clinical data . Extended pharmacokinetics indicated a prolonged CSF drug half-life of 4–6 months after initial clearance . A significant increase in HFMSE scores was observed at the 9-mg dose at 3 months postdose ( 3.1 points ; p = 0.016 ) , which was further increased 9–14 months postdose ( 5.8 points ; p = 0.008 ) during the extension study . Conclusions : Results from this study support continued development of nusinersen for treatment of SMA . Classification of evidence : This study provides Class IV evidence that in children with SMA , intrathecal nusinersen is not associated with safety or tolerability concerns Nusinersen ( ISIS-SMNRx or ISIS 396443 ) is an antisense oligonucleotide drug administered intrathecally to treat spinal muscular atrophy . We summarize lumbar puncture experience in children with spinal muscular atrophy during a phase 1 open-label study of nusinersen and its extension . During the studies , 73 lumbar punctures were performed in 28 patients 2 to 14 years of age with type 2/3 spinal muscular atrophy . No complications occurred in 50 ( 68 % ) lumbar punctures ; in 23 ( 32 % ) procedures , adverse events were attributed to lumbar puncture . Most common adverse events were headache ( n = 9 ) , back pain ( n = 9 ) , and post – lumbar puncture syndrome ( n = 8) . In a subgroup analysis , adverse events were more frequent in older children , children with type 3 spinal muscular atrophy , and with a 21- or 22-gauge needle compared to a 24-gauge needle or smaller . Lumbar punctures were successfully performed in children with spinal muscular atrophy ; lumbar puncture – related adverse event frequency was similar to that previously reported in children BACKGROUND Mutations in SOD1 cause 13 % of familial amyotrophic lateral sclerosis . In the SOD1 Gly93Ala rat model of amyotrophic lateral sclerosis , the antisense oligonucleotide ISIS 333611 delivered to CSF decreased SOD1 mRNA and protein concentrations in spinal cord tissue and prolonged survival . We aim ed to assess the safety , tolerability , and pharmacokinetics of ISIS 333611 after intrathecal administration in patients with SOD1-related familial amyotrophic lateral sclerosis . METHODS In this r and omised , placebo-controlled , phase 1 trial , we delivered ISIS 333611 by intrathecal infusion using an external pump over 11·5 h at increasing doses ( 0·15 mg , 0·50 mg , 1·50 mg , 3·00 mg ) to four cohorts of eight patients with SOD1-positive amyotrophic lateral sclerosis ( six patients assigned to ISIS 333611 , two to placebo in each cohort ) . We did the r and omisation with a web-based system , assigning patients in blocks of four . Patients and investigators were masked to treatment assignment . Participants were allowed to re-enrol in subsequent cohorts . Our primary objective was to assess the safety and tolerability of ISIS 333611 . Assessment s were done during infusion and over 28 days after infusion . This study was registered with Clinical trials.gov , number NCT01041222 . FINDINGS Seven of eight ( 88 % ) patients in the placebo group versus 20 of 24 ( 83 % ) in the ISIS 333611 group had adverse events . The most common events were post-lumbar puncture syndrome ( 3/8 [ 38 % ] vs 8/24 [ 33 % ] ) , back pain ( 4/8 [ 50 % ] vs 4/24 [ 17 % ] ) , and nausea ( 0/8 [ 0 % ] vs 3/24 [ 13 % ] ) . We recorded no dose-limiting toxic effects or any safety or tolerability concerns related to ISIS 333611 . No serious adverse events occurred in patients given ISIS 333611 . Re-enrolment and re-treatment were also well tolerated . INTERPRETATION This trial is the first clinical study of intrathecal delivery of an antisense oligonucleotide . ISIS 333611 was well tolerated when administered as an intrathecal infusion . Antisense oligonucleotides delivered to the CNS might be a feasible treatment for neurological disorders . FUNDING The ALS Association , Muscular Dystrophy Association , Isis Pharmaceuticals BACKGROUND Nusinersen is a 2'-O-methoxyethyl phosphorothioate-modified antisense drug being developed to treat spinal muscular atrophy . Nusinersen is specifically design ed to alter splicing of SMN2 pre-mRNA and thus increase the amount of functional survival motor neuron ( SMN ) protein that is deficient in patients with spinal muscular atrophy . METHODS This open-label , phase 2 , escalating dose clinical study assessed the safety and tolerability , pharmacokinetics , and clinical efficacy of multiple intrathecal doses of nusinersen ( 6 mg and 12 mg dose equivalents ) in patients with infantile-onset spinal muscular atrophy . Eligible participants were of either gender aged between 3 weeks and 7 months old with onset of spinal muscular atrophy symptoms between 3 weeks and 6 months , who had SMN1 homozygous gene deletion or mutation . Safety assessment s included adverse events , physical and neurological examinations , vital signs , clinical laboratory tests , cerebrospinal fluid laboratory tests , and electrocardiographs . Clinical efficacy assessment s included event free survival , and change from baseline of two assessment s of motor function : the motor milestones portion of the Hammersmith Infant Neurological Exam-Part 2 ( HINE-2 ) and the Children 's Hospital of Philadelphia Infant Test of Neuromuscular Disorders ( CHOP-INTEND ) motor function test , and compound motor action potentials . Autopsy tissue was analysed for target engagement , drug concentrations , and pharmacological activity . HINE-2 , CHOP-INTEND , and compound motor action potential were compared between baseline and last visit using the Wilcoxon signed-rank test . Age at death or permanent ventilation was compared with natural history using the log-rank test . The study is registered at Clinical Trials.gov , number NCT01839656 . FINDINGS 20 participants were enrolled between May 3 , 2013 , and July 9 , 2014 , and assessed through to an interim analysis done on Jan 26 , 2016 . All participants experienced adverse events , with 77 serious adverse events reported in 16 participants , all considered by study investigators not related or unlikely related to the study drug . In the 12 mg dose group , incremental achievements of motor milestones ( p<0·0001 ) , improvements in CHOP-INTEND motor function scores ( p=0·0013 ) , and increased compound muscle action potential amplitude of the ulnar nerve ( p=0·0103 ) and peroneal nerve ( p<0·0001 ) , compared with baseline , were observed . Median age at death or permanent ventilation was not reached and the Kaplan-Meier survival curve diverged from a published natural history case series ( p=0·0014 ) . Analysis of autopsy tissue from patients exposed to nusinersen showed drug uptake into motor neurons throughout the spinal cord and neurons and other cell types in the brainstem and other brain regions , exposure at therapeutic concentrations , and increased SMN2 mRNA exon 7 inclusion and SMN protein concentrations in the spinal cord . INTERPRETATION Administration of multiple intrathecal doses of nusinersen showed acceptable safety and tolerability , pharmacology consistent with its intended mechanism of action , and encouraging clinical efficacy . Results informed the design of an ongoing , sham-controlled , phase 3 clinical study of nusinersen in infantile-onset spinal muscular atrophy . FUNDING Ionis Pharmaceuticals , Inc and Biogen In September 2016,theUSFood and DrugAdministration ( FDA ) approved eteplirsen ( Exondys 51 ) , a new drug for Duchenne muscular dystrophy ( DMD ) , overruling the recommendations of both its scientific staff and its external advisory committee . Duchenne muscular dystrophy is a progressive X-linked genetic disease caused by mutations in a gene that produces the protein dystrophin that helps stabilize muscle fibers . It is usually fatal by the third decade of life . No disease-modifying treatments are available . Eteplirsen offered a promising new therapeutic approach that would correct a mutation in a gene coding for dystrophin , allowing production of a truncated but functional version of the protein . In particular , eteplirsen was design ed to skip
Output:
| We found that even though the use of delivery systems provides an advantage over naked AONs , it is not yet possible to select the most promising strategies . |
MS211524 | ***TASK*** the task is to summarize an input biomedical literature 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: SETTING AND OBJECTIVE Previous reports on small numbers highlighted the need for a prospect i ve study of the clinical features and response to treatment of pulmonary disease caused by Mycobacterium avium-intracellulare ( MAC ) . DESIGN AND METHODS Patients with two positive cultures were r and omised to 2 years of rifampicin and ethambutol or of rifampicin , ethambutol and isoniazid . Clinical , bacteriological and radiological progress was monitored for 5 years . RESULTS Seventy-five patients entered the study . They had a mean age of 64 years ( range 29 - 87 ) and the sexes were balanced . Approximately two-thirds had previous/ co-existing lung disease(s ) . Sputum was positive on direct smear in 56 % , and cavitation was observed in 61 % , most having at least one large cavity . Just under half had bilateral disease and one-third extensive disease . Disease was confined to upper zone(s ) in 25 % . Twenty-seven ( 36 % ) died within 5 years , three because of MAC disease . There were 11 treatment failures and 10 relapses , with no correlation between those and in vitro resistance . Forty-five ( 60 % ) were alive at 5 years , of whom 23 were confirmed cured . CONCLUSION Pulmonary disease caused by MAC is associated with high morbidity and mortality . St and ard susceptibility tests do not correlate with the response of the disease to chemotherapy . Rifampicin and ethambutol , with or without isoniazid , cured 31 % , a result comparable with or better than that found previously with more toxic regimens , but mortality ( 36 % ) remains high . More effective regimens are needed , and management of coexisting illnesses and general health needs to be to maximised RATIONALE Patients with Mycobacterium avium complex pulmonary disease are frequently administered a combination of clarithromycin , ethambutol , and rifampicin . However , rifampicin is known to reduce the serum levels of clarithromycin . It remains unclear whether a reduction in clarithromycin serum levels influences the clinical outcome of the Mycobacterium avium complex pulmonary disease treatment regimen . OBJECTIVES To compare a three-drug regimen ( clarithromycin , ethambutol , and rifampicin ) to a two-drug regimen ( clarithromycin and ethambutol ) for the treatment of Mycobacterium avium lung disease . METHODS In a preliminary open-label study , we r and omly assigned newly diagnosed , but as-yet untreated , patients with disease caused by Mycobacterium avium complex without HIV infection to either the three-drug or the two-drug regimen for 12 months . The primary endpoint was the conversion of sputum cultures to negative after 12 months of treatment . Patient data were analyzed using the intention-to-treat method . MEASUREMENTS AND MAIN RESULTS Of 119 eligible patients , 59 were assigned to the three-drug regimen and 60 to the two-drug regimen . The rate of sputum culture conversion was 40.6 % with the three-drug regimen and 55.0 % with the two-drug regimen ( difference , -14.4 % [ 95 % confidence interval , -32.1 to 3.4 ] ) . The incidence of adverse events leading to the discontinuation of treatment was 37.2 and 26.6 % for the three-drug and the two-drug regimens , respectively . CONCLUSIONS This preliminary study suggests that treatment with clarithromycin and ethambutol is not inferior to treatment with clarithromycin , ethambutol , and rifampicin for Mycobacterium avium complex lung disease . Our findings justify a larger clinical trial to compare long-term clinical outcomes for the two treatment regimens . Clinical trial registered with http://www.umin.ac.jp/english/ ( UMIN000002819 ) SETTING An open clinical trial for the treatment of Mycobacterium avium intracellulare complex ( MAIC ) lung disease in human immunodeficiency virus (HIV)-seronegative patients . OBJECTIVE To assess the efficacy and tolerance of clarithromycin ( 0.75 - 2 g/day ) combined with minocycline ( 200 mg/day ) and clofazimine ( 100 mg/day ) for 15 months . DESIGN The study was carried out from August 1992 to June 1994 by pulmonologists of various French medical centres . The patients to be enrolled were of either sex , over 18 years of age , HIV-seronegative and suffering from MAIC lung disease , with a confirmed bacteriological and radiological diagnosis . Examinations were to be performed after 1 , 2 , 3 , 6 , 9 , 12 and 15 months of treatment . RESULTS Thirty patients were included , 16 males and 14 females . Eight did not complete the study due to deviations from protocol or adverse effects . The remainder completed the study with a post-treatment follow-up of 27 + /- 7 months . Among the 22 evaluable patients , 18 had a history of lung disease . Tolerance to the drugs was generally good , apart from three cases of hepatic disturbances and three cases of ototoxicity , which required a decrease in clarithromycin dosage after a short interruption of treatment . There were 14 treatment successes , seven treatment failures , defined by absence of bacteriologic conversion , and in one patient the disease evolution remains uncertain . CONCLUSION The combination of clarithromycin with minocycline and clofazimine proved effective with persistently negative cultures in 64 % of the patients , and an overall good drug tolerance Background : The difficulty of treatment for pulmonary Mycobacterium avium complex ( MAC ) in Japan . Objectives : To investigate the clinical and microbiological effects of treatment according to the guidelines proposed by the American Thoracic Society and the Japanese Society for Tuberculosis and prospect i ve follow-up studies after the completion of treatment of patients with pulmonary MAC disease . Methods : Analysis of the microbiological effects with regard to sputum conversion rate and the sputum relapsing rate and the clinical effects with regard to clinical symptoms and radiological findings for patients with pulmonary MAC disease treated with a regimen consisting of rifampicin , ethambutol , streptomycin , and clarithromycin over 24 months and follow-up over 12 months . Results : Sixty-five patients with pulmonary MAC disease were enrolled in this trial . In 39 patients , negative sputum conversion was observed within 6 months after the initiation of this regimen , 16 relapsed , and 20 experienced clinical worsening within 1 year after the completion of treatment . Although retreatment with the same regimen or a regimen including new quinolones was carried out for these patients , we could not achieve negative sputum conversion and /or clinical improvement . Conclusions : We believe that the dose of clarithromycin for pulmonary MAC disease may be increased and recommend surgery for patients with a localized lesion at early-stage MAC disease to prevent a high rate of relapse We initiated a prospect i ve trial of an azithromycin-containing regimen for the treatment of human immunodeficiency virus-negative patients with Mycobacterium avium complex ( MAC ) lung disease ; the initial 4 months of therapy were with azithromycin ( 600 mg/d ) alone . The primary study endpoint was microbiological response measured at 4 and 6 months of therapy . Of 29 patients enrolled in the study , 23 completed therapy . Fifty-two percent of these 23 patients were male , and 65 % were smokers . All 23 patients were older than 45 years of age ; 83 % had bilateral disease , and 48 % had fibrocavitary disease . Macrolide (clarithromycin)-susceptible MAC isolates were recovered from these 23 patients before treatment . Cultures of sputum from 38 % of these patients became negative , and the positivity of cultures of sputum from 76 % of these patients was significantly reduced . Sixty-eight percent of sputum cultures were strongly positive ( > 200 colonies ) before therapy , while only 27 % were strongly positive after therapy . Although most patients continued to receive 600 mg of azithromycin/d , the high incidence of gastrointestinal side effects ( 76 % ) and altered hearing ( 41 % ) suggests the need for lower or less frequent dosing . Macrolide ( clarithromycin ) resistance did not develop in any MAC isolates during monotherapy . These results , which demonstrate that azithromycin is active against MAC pulmonary disease , provide a rationale to include this drug in the initial multidrug regimens recommended for the treatment of this disease We initiated a prospect i ve noncomparative trial of treatment for lung disease due to Mycobacterium avium complex ( MAC ) in human immunodeficiency virus-negative patients , with a regimen of clarithromycin ( 1000 mg ) , rifabutin ( 300 - 600 mg ) , and ethambutol ( 25 mg/kg ) administered 3 times per week . Fifty-nine patients were enrolled . Twelve ( 20 % ) were lost to follow-up , and 6 ( 10 % ) developed clarithromycin intolerance . The remaining 41 patients ( 69 % ) completed the initial 6 months of therapy . The sputum of 32 of these patients ( 78 % ) converted to negative . When results were compared with the sputum response rates at 6 months in previous studies with a regimen including daily clarithromycin and regimens including intermittent ( 3 times per week ) azithromycin with the same companion drugs , no differences in treatment responses were evident . Adverse reactions related to rifabutin were a major problem , and for 24 ( 41 % ) of 59 patients the dosage was decreased or the drug was withdrawn . Intermittent ( 3 times per week ) administration of clarithromycin appears to be as effective as daily administration in effecting sputum conversion in pulmonary MAC disease OBJECTIVE To investigate whether the combined therapy according to the guideline proposed by American Thoracic Society ( ATS ) and Japanese Society for Tuberculosis ( JST ) is clinical ly appropriate for Mycobacterium avium complex ( MAC ) pulmonary disease . PATIENTS Seventy-one patients in whom MAC pulmonary disease was diagnosed at Kawasaki Medical School and our associated ten hospitals were prospect ively studied . RESULTS Seventy-one patients with Mycobacterium avium complex ( MAC ) pulmonary disease were 27 males and 44 females with a mean age of 64.4 + /- 10.2 years old . Patients received 400 mg/day or 600 mg/day of clarithromycin plus ethambutol , rifampicin , and initial streptomycin for 12 months . Among 71 patients who received more than 12 months of therapy , 41 patients ( 57.7 % ) converted their sputum to negative within six months after the initiation of this regimen , 16 of 41 patients ( 39.0 % ) relapsed , and 23 of 71 patients ( 32.4 % ) obtained clinical improvement on chest X-ray and /or clinical symptoms . The mortality rate had a comparatively good prognosis with a low incidence of 2.8 % . Although the species of pathogen ( M. avium or M. intracellulare ) did not significantly affect the conversion rate or clinical improvement , the infectious form with or without respiratory underlying disease , the characteristics and extent of lesion on chest X-ray , and the dose of clarithromycin significantly influenced the conversion rate or clinical improvement . There were no problems concerning adverse reactions for this regimen . CONCLUSION This combined therapy , according to the guideline proposed by ATS and JST , was one of the effective treatments compared to the clinical effect of only antituberculous drugs through this study . However , this combined therapy was unsatisfactory compared to the clinical effect for pulmonary tuberculosis . The development of new companion drugs for MAC pulmonary diseases is needed Intermediate results of the first 50 patients treated with clarithromycin ( CLARI ) regimens for Mycobacterium avium-intracellulare ( MAI ) lung disease were evaluated . Patients were HIV negative , and pretreatment isolates were susceptible to CLARI . Patients received CLARI 500 mg twice daily , ethambutol , rifampin ( RMP ) , or rifabutin ( RBT ) and initial streptomycin , and they were treated until culture-negative 1 yr . Eleven of 50 patients ( 22 % ) were dropped in the first 3 mo . Of the remaining 39 patients , 36 ( 92 % ) converted their sputa to negative , and 32 ( 82 % ) remain culture negative to date . This includes 11 of 16 ( 69 % ) with prior drug therapy and 21 of 23 ( 91 % ) with no prior therapy . One or more companion drugs were discontinued in 16 of 39 ( 41 % ) of patients because of adverse events . Isolates from six of 39 patients ( 15 % ) became CLARI-resistant . Of 23 patients who are alive and were culture-negative a mean of 12.0 mo while receiving therapy , all remain culture-negative without therapy a mean of 19.1 mo . Despite reduced CLARI serum levels in patients also receiving RMP , 10 of 13 patients ( 77 % ) receiving this regimen were successfully treated . Although not directly compared with previous regimens , the success of this regimen strongly suggests it is superior to previous non-CLARI-containing regimens OB
Output:
| Nevertheless , these studies showed poor sputum conversion rates in patients receiving recommended treatment regimens |
MS211525 | ***TASK*** the task is to summarize an input biomedical literature 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 highlight the contribution of the gut microbiota to the modulation of host metabolism by dietary inulin-type fructans ( ITF prebiotics ) in obese women . Methods A double blind , placebo controlled , intervention study was performed with 30 obese women treated with ITF prebiotics ( inulin/oligofructose 50/50 mix ; n=15 ) or placebo ( maltodextrin ; n=15 ) for 3 months ( 16 g/day ) . Blood , faeces and urine sampling , oral glucose tolerance test , homeostasis model assessment and impedancemetry were performed before and after treatment . The gut microbial composition in faeces was analysed by phylogenetic microarray and qPCR analysis of 16S rDNA . Plasma and urine metabolic profiles were analysed by 1H-NMR spectroscopy . Results Treatment with ITF prebiotics , but not the placebo , led to an increase in Bifidobacterium and Faecalibacterium prausnitzii ; both bacteria negatively correlated with serum lipopolysaccharide levels . ITF prebiotics also decreased Bacteroides intestinalis , Bacteroides vulgatus and Propionibacterium , an effect associated with a slight decrease in fat mass and with plasma lactate and phosphatidylcholine levels . No clear treatment clustering could be detected for gut microbial analysis or plasma and urine metabolomic profile analyses . However , ITF prebiotics led to subtle changes in the gut microbiota that may importantly impact on several key metabolites implicated in obesity and /or diabetes . Conclusions ITF prebiotics selectively changed the gut microbiota composition in obese women , leading to modest changes in host metabolism , as suggested by the correlation between some bacterial species and metabolic endotoxaemia or metabolomic signatures Background Increased exposure to intestinal bacterial products may contribute to the pathogenesis of non alcoholic steatohepatitis ( NASH ) . Bifidobacteria are predominant bacterial species in the human gut microbiota and have been considered to exert a beneficial effect on human health by maintaining the equilibrium of the resident microbiota . Aims To evaluate the effects of Bifidobacterium longum with fructo-oligosaccharides ( Fos ) in the treatment of NASH . Methods A total of 66 patients were r and omly and equally divided into two groups receiving Bifidobacterium longum with Fos and lifestyle modification ( i.e. , diet and exercise ) versus lifestyle modification alone . The following variables were assessed at −4 ( beginning of the dietary lead-in period ) , 0 ( r and omization ) , 6 , 12 , 18 , and 24 weeks : aspartate transaminase ( AST ) , alanine transaminase ( ALT ) , bilirubin , albumin , total cholesterol , high-density lipoprotein ( HDL ) cholesterol , low-density lipoprotein ( LDL ) cholesterol , triglycerides , fasting plasma glucose , insulin , C-peptide , C-reactive protein ( CRP ) , tumor necrosis factor (TNF)-α , homeostasis model assessment of insulin resistance ( HOMA-IR ) , and serum endotoxins . Liver biopsies were performed at entry and repeated after 24 weeks of treatment . Results At the end of study period , we observed that the Bifidobacterium longum with Fos and lifestyle modification group versus the lifestyle modification alone group showed significant differences in the AST −69.6 versus −45.9 IU/mL ( P < 0.05 ) , LDL cholesterol −0.84 versus −0.18 mmol/L ( P < 0.001 ) , CRP −2.9 versus −0.7 mg/L ( P < 0.05 ) , TNF-α −0.45 versus −0.12 ng/mL ( P < 0.001 ) , HOMA-IR −1.1 versus −0.6 ( P < 0.001 ) , serum endotoxin −45.2 versus −30.6 pg/mL ( P < 0.001 ) , steatosis ( P < 0.05 ) , and the NASH activity index ( P < 0.05 ) . Conclusions Bifidobacterium longum with Fos and lifestyle modification , when compared to lifestyle modification alone , significantly reduces TNF-α , CRP , serum AST levels , HOMA-IR , serum endotoxin , steatosis , and the NASH activity index High cereal fibre intake is associated with reduced risk for type 2 diabetes , but wheat fibre had little or no effect on glycaemic control or oral glucose tolerance in clinical trials lasting 4 - 12 weeks . To explain this discrepancy , we hypothesised that colonic adaptation to increased wheat fibre intake takes many months but eventually results in increased SCFA production and glucagon-like peptide-1 ( GLP-1 ) secretion . Thus , the primary objective was to determine the time-course of the effects of increased wheat fibre intake on plasma acetate , butyrate and GLP-1 concentrations in hyperinsulinaemic human subjects over 1 year . Subjects with fasting plasma insulin > or= 40 pmol/l were r and omly assigned by computer to receive either a high-wheat fibre cereal ( fibre group ; 24 g fibre/d ; twenty assigned ; six dropped out , fourteen included ) or a low-fibre cereal ( control group ; twenty assigned ; six dropped-out , fourteen included ) daily for 1 year . Acetate , butyrate and GLP-1 were measured during 8 h metabolic profiles performed every 3 months . There were no differences in body weight in the fibre group compared with the control group . After 9 months baseline-adjusted mean 8 h acetate and butyrate concentrations were higher on the high-fibre than the control cereal ( P < 0.05 ) . After 12 months on the high-fibre cereal , baseline-adjusted mean plasma GLP-1 was 1.3 ( 95 % CI 0.4 , 2.2 ) pmol/l ( P < 0.05 ) higher than at baseline ( about 25 % increase ) and 1.4 ( 95 % CI 0.1 , 2.7 ) pmol/l ( P < 0.05 ) higher than after 12 months on control . It is concluded that wheat fibre increased SCFA production and GLP-1 secretion in hyperinsulinaemic humans , but these effects took 9 - 12 months to develop . Since GLP-1 may increase insulin sensitivity and secretion , these results may provide a mechanism for the epidemiological association between high cereal fibre intake and reduced risk for diabetes Epidemiological studies have shown an inverse association between dietary intake of whole grains and the risk of chronic disease . This may be related to the ability to mediate a prebiotic modulation of gut microbiota . However , no studies have been conducted on the microbiota modulatory capability of whole-grain ( WG ) cereals . In the present study , the impact of WG wheat on the human intestinal microbiota compared to wheat bran ( WB ) was determined . A double-blind , r and omised , crossover study was carried out in thirty-one volunteers who were r and omised into two groups and consumed daily 48 g breakfast cereals , either WG or WB , in two 3-week study periods , separated by a 2-week washout period . Numbers of faecal bifidobacteria and lactobacilli ( the target genera for prebiotic intake ) , were significantly higher upon WG ingestion compared with WB . Ingestion of both breakfast cereals result ed in a significant increase in ferulic acid concentrations in blood but no discernible difference in faeces or urine . No significant differences in faecal SCFA , fasting blood glucose , insulin , total cholesterol ( TC ) , TAG or HDL-cholesterol were observed upon ingestion of WG compared with WB . However , a significant reduction in TC was observed in volunteers in the top quartile of TC concentrations upon ingestion of either cereal . No adverse intestinal symptoms were reported and WB ingestion increased stool frequency . Daily consumption of WG wheat exerted a pronounced prebiotic effect on the human gut microbiota composition . This prebiotic activity may contribute towards the beneficial physiological effects of WG wheat In rats , oligofructose has been shown to stimulate satiety hormone secretion , reduce energy intake and promote weight loss . The present study aim ed to examine the effect of oligofructose supplementation on appetite profiles , satiety hormone concentrations and energy intake in human subjects . A total of thirty-one healthy subjects ( ten men and twenty-one women ) aged 28 ( SEM 3 ) years with a BMI of 24·8 ( SEM 0·3 ) kg/m(2 ) were included in a r and omised double-blind , cross-over study . The subjects received 10 g oligofructose , 16 g oligofructose or 16 g placebo ( maltodextrin ) daily for 13 d , with a 2-week washout period between treatments . Appetite profile , active glucagon-like peptide 1 ( GLP-1 ) and peptide YY3 - 36 ( PYY ) concentrations and energy intake were assessed on days 0 and 13 of the treatment period . Time × treatment interaction revealed a trend of reduction in energy intake over days 0 - 13 by oligofructose ( P = 0·068 ) . Energy intake was significantly reduced ( 11 % ) over time on day 13 compared with day 0 with 16 g/d oligofructose ( 2801 ( SEM 301 ) v. 3217 ( SEM 320 ) kJ , P < 0·05 ) . Moreover , energy intake was significantly lower with 16 g/d oligofructose compared with 10 g/d oligofructose on day 13 ( 2801 ( SEM 301 ) v. 3177 ( SEM 276 ) kJ , P < 0·05 ) . Area under the curve ( AUC ) for GLP-1 on day 13 was significantly higher with 16 g/d oligofructose compared with 10 g/d oligofructose ( 45 ( SEM 4 ) v. 41 ( SEM 3 ) pmol/l × h , P < 0·05 ) . In the morning until lunch , AUC(0 - 230 min ) for PYY on day 13 was significantly higher with 16 g/d oligofructose compared with 10 g/d oligofructose and placebo ( 409 ( SEM 35 ) v. 222 ( SEM 19 ) and 211 ( SEM 20 ) pg/ml × h , P < 0·01 ) . In conclusion , 16 g/d and not 10 g/d oligofructose may be an effective dose to reduce energy intake , possibly supported by higher GLP-1 and PYY concentrations BACKGROUND A high-carbohydrate , low-fat diet is recommended for the prevention of atherosclerosis , because it reduces plasma cholesterol concentrations . However , such a diet can increase plasma triacylglycerol concentrations -- an undesirable side effect . The addition of nondigestible carbohydrate could reduce the risk of elevated triacylglycerol concentrations . OBJECTIVE The objective was to determine whether the addition of a moderate dose of inulin to a moderately high-carbohydrate diet would decrease hepatic lipogenesis and plasma triacylglycerol concentrations and have a cholesterol-lowering action . DESIGN Eight healthy subjects were studied twice in a double-blind , r and omized , placebo-controlled crossover study after consuming for 3 wk a moderately high-carbohydrate , low-fat diet ( 55 % of total energy ) plus an oral placebo or 10 g high-performance inulin/d . Hepatic lipogenesis and cholesterol synthesis ( deuterated water method ) , plasma lipid concentrations , fatty acid synthase , acetyl-CoA carboxylase 1 , and sterol responsive element binding protein 1c messenger RNA concentrations were measured in adipose tissue at the end of the 2 diet periods . RESULTS Plasma triacylglycerol concentrations and hepatic lipogenesis were lower after inulin than after placebo ingestion ( P < 0.05 ) , but cholesterol synthesis and plasma cholesterol concentrations were not significantly different between the 2 groups . None of the adipose tissue messenger RNA concentrations changed significantly after inulin ingestion . CONCLUSIONS The addition of high-performance inulin to a moderately high-carbohydrate , low-fat diet has a beneficial effect on plasma lipids by decreasing hepatic lipogenesis and plasma triacylglycerol concentrations . These results support the use of nondigestible carbohydrate for reducing risk factors for atherosclerosis BACKGROUND Aging is associated with reduced numbers of beneficial colonic bifidobacteria and impaired immunity . Galactooligosaccharides ( GOSs ) stimulate the growth of bifidobacteria in younger adults , but little is known about their effects in the elderly and their immunomodulatory capacity . OBJECTIVE We assessed the effect of a prebiotic GOS mixture ( B-GOS ) on immune function and fecal microflora composition in healthy elderly subjects . DESIGN In
Output:
| Dietary prebiotic consumption was found to be associated with subjective improvements in satiety and reductions in postpr and ial glucose and insulin concentrations . |
MS211526 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Objectives This study examined associations between high school students ' lunch patterns and vending machine purchases and the school food environment and policies . Methods A r and omly selected sample of 1088 high school students from 20 schools completed surveys about their lunch practice s and vending machine purchases . School food policies were assessed by principal and food director surveys . The number of vending machines and their hours of operation were assessed by trained research staff . Results Students at schools with open campus policies during lunchtime were significantly more likely to eat lunch at a fast food restaurant than students at schools with closed campus policies ( 0.7 days/week vs. 0.2 days/week , p < .001 ) . Student snack food purchases at school were significantly associated with the number of snack machines at schools ( p < .001 ) and policies about the types of food that can be sold . In schools with policies , students reported making snack food purchases an average of 0.5 ± 1.1 days/week as compared to an average of 0.9 ± 1.3 days/week in schools without policies ( p < .001 ) . In schools in which soft drink machines were turned off during lunch time , students purchased soft drinks from vending machines 1.4 ± 1.6 days/week as compared to 1.9 ± 1.8 days/week in schools in which soft drink machines were turned on during lunch ( p = .040 ) . ConclusionS chool food policies that decrease access to foods high in fats and sugars are associated with less frequent purchase of these items in school among high school students . Schools should examine their food-related policies and decrease access to foods that are low in nutrients and high in fats and sugars OBJECTIVE . To assess whether weight-related teasing predicts the development of binge eating , unhealthy weight control behaviors , and frequent dieting among male and female adolescents . METHODS . A prospect i ve study was conducted with an ethnically and socioeconomically diverse sample of 2516 adolescents who completed surveys at both time 1 ( 1998–1999 ) and time 2 ( 2003–2004 ) of the Project EAT ( Eating Among Teens ) study . RESULTS . In 1998–1999 , approximately one fourth of participants reported being teased about their weight at least a few times a year . After adjustment for age , race/ethnicity , socioeconomic status ( SES ) , and BMI , boys who were teased about their weight were more likely than their peers to initiate binge eating with loss of control and unhealthy weight control behaviors 5 years later . The predicted prevalence for incident binge eating behaviors with loss of control among boys who were teased was 4.1 % as compared with 1.4 % for those who were not teased , after adjustment for age , race/ethnicity , SES , and BMI . For unhealthy weight control behaviors at time 2 , the predicted prevalence was 27.5 % among boys who were teased and 19.3 % for boys who were not teased , after adjustment for age , race/ethnicity , SES , and BMI . Girls who were teased were more likely than their peers to become frequent dieters . The predicted prevalence for incident frequent dieting among girls who were teased was 18.2 % as compared with 11.0 % for those who were not teased , after adjustment for age , race/ethnicity , SES , and BMI . CONCLUSIONS . Weight teasing in adolescence predicts disordered eating behaviors at 5-year follow-up . The patterns of these associations differ by gender . Reducing teasing through educational interventions and policies may reduce the level of disordered eating behaviors among youths OBJECTIVES This study examined the effects of pricing and promotion strategies on purchases of low-fat snacks from vending machines . METHODS Low-fat snacks were added to 55 vending machines in a convenience sample of 12 secondary schools and 12 worksites . Four pricing levels ( equal price , 10 % reduction , 25 % reduction , 50 % reduction ) and 3 promotional conditions ( none , low-fat label , low-fat label plus promotional sign ) were crossed in a Latin square design . Sales of low-fat vending snacks were measured continuously for the 12-month intervention . RESULTS Price reductions of 10 % , 25 % , and 50 % on low-fat snacks were associated with significant increases in low-fat snack sales ; percentages of low-fat snack sales increased by 9 % , 39 % , and 93 % , respectively . Promotional signage was independently but weakly associated with increases in low-fat snack sales . Average profits per machine were not affected by the vending interventions . CONCLUSIONS Reducing relative prices on low-fat snacks was effective in promoting lower-fat snack purchases from vending machines in both adult and adolescent population BACKGROUND Our objective was to evaluate the effects of environmental , policy , and social marketing interventions on physical activity and fat intake of middle school students on campus . DESIGN Twenty-four middle schools were r and omly assigned to intervention or control conditions . Baseline measures were collected in spring 1997 , and interventions were conducted during the 1997 - 1998 and 1998 - 1999 school years SETTING /PARTICIPATION : The schools had mean enrollments of 1109 , with 44.5 % nonwhite students . Over 2 years , physical activity interventions were design ed to increase physical activity in physical education classes and throughout the school day . Nutrition interventions were design ed to provide and market low-fat foods at all school food sources , including cafeteria breakfasts and lunches , a la carte sources , school stores , and bag lunches . School staff and students were engaged in policy change efforts , but there was no classroom health education . MAIN OUTCOMES MEASURES Primary outcomes were measured by direct observation and existing records . RESULTS R and omized regression models ( N = 24 schools ) revealed a significant intervention effect for physical activity for the total group ( p < 0.009 ) and boys ( p < 0.001 ) , but not girls ( p < 0.40 ) . The intervention was not effective for total fat ( p < 0.91 ) or saturated fat ( p < 0.79 ) . Survey data indicated that the interventions reduced reported body mass index for boys ( p < 0.05 ) . CONCLUSIONS Environmental and policy interventions were effective in increasing physical activity at school among boys but not girls . The interventions were not effective in reducing fat intake at school . School environmental and policy interventions have the potential to improve health behavior of the student population , but barriers to full implementation need to be better understood and overcome OBJECTIVES We evaluated an environmental intervention intended to increase sales of lower-fat foods in secondary school cafeterias . METHODS Twenty secondary schools were r and omly assigned to either an environmental intervention or a control group for a 2-year period . The intervention increased the availability of lower-fat foods and implemented student-based promotions . RESULTS A steeper rate of increase in sales of lower-fat foods in year 1 ( 10 % intervention vs -2.8 % control , P = .002 ) and a higher percentage of sales of lower-fat foods in year 2 ( 33.6 % intervention vs 22.1 % control , P = .04 ) were observed . There were no significant changes in student self-reported food choices . CONCLUSIONS School-based environmental interventions to increase availability and promotion of lower-fat foods can increase purchase of these foods among adolescents OBJECTIVE This study examined the types and extent of competitive foods available in public high schools in Pennsylvania . DESIGN We developed , pilot tested , and distributed surveys to school foodservice directors in a r and om sample of 271 high schools in Pennsylvania . SUBJECTS Two hundred twenty-eight surveys were returned , for a response rate of 84 % . Statistical analyses were performed : Descriptive statistics were used to examine the extent of competitive food sales in Pennsylvania public high schools . The survey data were analyzed using SPSS software version 11.5.1 ( 2002 , SPSS base 11.0 for Windows , SPSS Inc , Chicago , IL ) . RESULTS A la carte sales provide almost dollar 700/day to school foodservice programs , almost 85 % of which receive no financial support from their school districts . The top-selling a la carte items are " hamburgers , pizza , and s and wiches . " Ninety-four percent of respondents indicated that vending machines are accessible to students . The item most commonly offered in vending machines is bottled water ( 71.5 % ) . While food items are less often available through school stores and club fund-raisers , c and y is the item most commonly offered through these sources . CONCLUSIONS Competitive foods are widely available in high schools . Although many of the items available are low in nutritional value , we found several of the top-selling a la carte options to be nutritious and bottled water the item most often identified as available through vending machines OBJECTIVES This study described the food environment in 20 Minnesota secondary schools . METHODS Data were collected on school food policies and the availability and nutritional content of foods in school à la carte ( ALC ) areas and vending machines ( VMs ) . RESULTS Approximately 36 % and 35 % of foods in ALC areas and in VMs , respectively , met the lower-fat criterion ( < or = 5.5 fat grams/serving ) . The chips/crackers category constituted the largest share of ALC foods ( 11.5 % ) . The median number of VMs per school was 12 ( 4 soft drink , 2 snack , 5 other ) . Few school food policies were reported . CONCLUSIONS The availability of healthful foods and beverages in schools as well as school food policies that foster healthful food choices among students needs greater attention The objectives of this study were to describe the extent , nature , and enforcement of school competitive food policies in Pennsylvania public high schools and to determine if there are differences between school foodservice directors ' and principals ' perceptions of the existence and enforcement of these policies . A survey was distributed to 271 school foodservice directors and 100 principals in a representative , r and om sample of high schools . Two hundred twenty-eight school foodservice directors ( 84 % ) and 79 principals ( 79 % ) returned surveys . Descriptive statistics , chi2 analyses , and a proportions test were done using SPSS statistical software ( SPSS base 11.5 for Windows , 2002 , SPSS Inc , Chicago , IL ) . Few nutrition policies were reported related to setting nutritional st and ards for competitive foods ( 0.5 % to 15.0 % ) . Respondents ' reporting of existence of policies not always enforced ranged from 0 % to 12.8 % . School foodservice directors reported uncertainty about existence of several policies outside their direct domain , but with potential effect on school meals participation . Differences were found between school foodservice directors ' and principals ' reporting of policies , with principals more often reporting policy existence and enforcement . These findings suggest the need for communication , both about existence of policies and chain of comm and in enforcement of policies . Given the local wellness policy provision of the Child Nutrition and WIC Reauthorization Act of 2004 , opportunities exist for nutrition professionals to contribute to development of policies that influence the nutritional quality of school foods
Output:
| RESULTS Thus far , few data exist to substantiate the concern that changes in nutrition st and ards in schools lead to a loss in total revenue .
CONCLUSIONS A renewed focus on school policies related to health provides the opportunity for research ers to investigate how nutrition-related policy change can affect , if at all , food service and overall school revenues |
MS211527 | ***TASK*** the task is to summarize an input biomedical literature 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 improved prognosis for patients with human papillomavirus (HPV)-positive head and neck squamous cell carcinoma ( HNSCC ) relative to HPV-negative HNSCC observed in retrospective analyses remains to be confirmed in a prospect i ve clinical trial . METHODS We prospect ively evaluated the association of tumor HPV status with therapeutic response and survival among 96 patients with stage III or IV HNSCC of the oropharynx or larynx who participated in an Eastern Cooperative Oncology Group ( ECOG ) phase II trial and who received two cycles of induction chemotherapy with intravenous paclitaxel and carboplatin followed by concomitant weekly intravenous paclitaxel and st and ard fractionation radiation therapy . The presence or absence of HPV oncogenic types in tumors was determined by multiplex polymerase chain reaction ( PCR ) and in situ hybridization . Two-year overall and progression-free survival for HPV-positive and HPV-negative patients were estimated by Kaplan-Meier analysis . The relative hazard of mortality and progression for HPV-positive vs HPV-negative patients after adjustment for age , ECOG performance status , stage , and other covariables was estimated by use of a multivariable Cox proportional hazards model . All statistical tests were two-sided . RESULTS Genomic DNA of oncogenic HPV types 16 , 33 , or 35 was located within tumor cell nuclei of 40 % ( 95 % confidence interval [ CI ] = 30 % to 50 % ) of patients with HNSCC of the oropharynx or larynx by in situ hybridization and PCR . Compared with patients with HPV-negative tumors , patients with HPV-positive tumors had higher response rates after induction chemotherapy ( 82 % vs 55 % , difference = 27 % , 95 % CI = 9.3 % to 44.7 % , P = .01 ) and after chemoradiation treatment ( 84 % vs 57 % , difference = 27 % , 95 % CI = 9.7 % to 44.3 % , P = .007 ) . After a median follow-up of 39.1 months , patients with HPV-positive tumors had improved overall survival ( 2-year overall survival = 95 % [ 95 % CI = 87 % to 100 % ] vs 62 % [ 95 % CI = 49 % to 74 % ] , difference = 33 % , 95 % CI = 18.6 % to 47.4 % , P = .005 , log-rank test ) and , after adjustment for age , tumor stage , and ECOG performance status , lower risks of progression ( hazard ratio [ HR ] = 0.27 , 95 % CI = 0.10 to 0.75 ) , and death from any cause ( HR = 0.36 , 95 % CI = 0.15 to 0.85 ) than those with HPV-negative tumors . CONCLUSION For patients with HNSCC of the oropharynx , tumor HPV status is strongly associated with therapeutic response and survival Background : Following chemo-radiotherapy ( CCRT ) for human papilloma virus positive ( HPV+ ) locally advanced head and neck cancer , patients frequently undergo unnecessary neck dissection ( ND ) and /or repeated biopsies for abnormal PET-CT , which causes significant morbidity . We assessed the role of circulating HPV DNA in identifying ‘ true ’ residual disease . Methods : We prospect ively recruited test ( n=55 ) and validation ( n=33 ) cohorts . HPV status was confirmed by E7 RT-PCR . We developed a novel amplicon-based next generation sequencing assay ( HPV16-detect ) to detect circulating HPV DNA . Circulating HPV DNA levels post-CCRT were correlated to disease response ( PET-CT ) . Results : In pre-CCRT plasma , HPV-detect demonstrated 100 % sensitivity and 93 % specificity , and 90 % sensitivity and 100 % specificity for the test ( 27 HPV+ ) and validation ( 20 HPV+ ) cohorts , respectively . Thirty-six out of 37 patients ( test and validation cohort ) with complete sample s-set had negative HPV-detect at end of treatment . Six patients underwent ND ( 3 ) and repeat primary site biopsies ( 3 ) for positive PET-CT but had no viable tumour . One patient had positive HPV-detect and positive PET-CT and liver biopsy , indicating 100 % agreement for HPV-detect and residual cancer . Conclusions : We demonstrate that HPV16-detect is a highly sensitive and specific test for identification of HPV DNA in plasma at diagnosis . HPV DNA post-treatment correlates with clinical response IMPORTANCE Human papillomavirus type 16 ( HPV-16 ) is a major causative factor in oropharyngeal squamous cell carcinoma ( OPSCC ) . The detection of primary OPSCC is often delayed owing to the challenging anatomy of the oropharynx . OBJECTIVE To investigate the feasibility of HPV-16 DNA detection in pretreatment and posttreatment plasma and saliva and its potential role as a marker of prognosis . DESIGN , SETTING , AND PARTICIPANTS This is a retrospective analysis of a prospect ively collected cohort . Among a cohort of patients with oropharyngeal and unknown primary squamous cell carcinoma with known HPV-16 tumor status from the Johns Hopkins Medical Institutions and Greater Baltimore Medical Center ( from 1999 through 2010 ) , 93 patients were identified with a complete set of pretreatment and posttreatment plasma or saliva sample s , of which 81 patients had HPV-16-positive tumors and 12 patients had HPV-16-negative tumors . Real-time quantitative polymerase chain reaction was used to detect HPV-16 E6 and E7 DNA in saliva and plasma sample s. MAIN OUTCOMES AND MEASURES Main outcomes included sensitivity , specificity , negative predictive value of combined saliva and plasma pretreatment HPV-16 DNA status for detecting tumor HPV-16 status , as well as the association of posttreatment HPV DNA status with clinical outcomes , including recurrence-free survival and overall survival . RESULTS The median follow-up time was 49 months ( range , 0.9 - 181.0 months ) . The sensitivity , specificity , negative predictive value , and positive predictive value of combined saliva and plasma pretreatment HPV-16 DNA status for detecting tumor HPV-16 status were 76 % , 100 % , 42 % , and 100 % , respectively . The sensitivities of pretreatment saliva or plasma alone were 52.8 % and 67.3 % , respectively . In a multivariable analysis , positive posttreatment saliva HPV status was associated with higher risk of recurrence ( hazard ratio [ HR ] , 10.7 ; 95 % CI , 2.36 - 48.50 ) ( P = .002 ) . Overall survival was reduced among those with posttreatment HPV-positive status in saliva ( HR , 25.9 ; 95 % CI , 3.23 - 208.00 ) ( P = .002 ) and those with HPV-positive status in either saliva or plasma but not among patients with HPV-positive status in plasma alone . The combined saliva and plasma posttreatment HPV-16 DNA status was 90.7 % specific and 69.5 % sensitive in predicting recurrence within 3 years . CONCLUSIONS AND RELEVANCE Using a combination of pretreatment plasma and saliva can increase the sensitivity of pretreatment HPV-16 status as a tool for screening patients with HPV-16-positive OPSCC . In addition , analysis of HPV-16 DNA in saliva and plasma after primary treatment may allow for early detection of recurrence in patients with HPV-16-positive OPSCC
Output:
| Plasma HPV-DNA is a promising tool for surveillance in patients with HPV-related HNSCC , that is , OPSCC , and has a high specificity .
By recent technical advances and by increasing follow-up blood sample s , the sensitivity could likely be improved |
MS211528 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: OBJECTIVES The purpose of this study was to test the effects of an education program in Tanzania design ed to reduce children 's risk of human immunodeficiency virus ( HIV ) infection and to improve their tolerance of and care for people with acquired immunodeficiency syndrome ( AIDS ) . METHODS A r and omized controlled community trial including baseline and 12-month follow-up surveys was employed . Public primary schools in the Arusha and Kilimanjaro regions of Tanzania were stratified according to location and r and omly assigned to intervention ( n = 6 ) or comparison ( n = 12 ) conditions . Of the 1063 sixth- grade students ( average age : 13.6 years ) who participated at baseline , 814 participated in the follow-up survey . RESULTS At follow-up , statistically significant effects favoring the intervention group were observed for exposure to AIDS information and communication , AIDS knowledge , attitudes toward people with AIDS , and subjective norms and behavioral intentions toward having sexual intercourse . A consistent positive but nonsignificant trend was seen for attitudes toward having sexual intercourse and for initiation of sexual intercourse during the previous year ( 7 % vs 17 % ) . CONCLUSIONS It is feasible and effective to train local teachers and health workers to provide HIV/AIDS education to Tanzanian primary school children PURPOSE To evaluate an intervention ( based on one which had previously been successful in reducing adolescent human immunodeficiency virus ( HIV ) risk behaviors in the United States ) among adolescents residing in Namibia , a country located in sub-Saharan Africa . METHODS A r and omized trial of a 14-session face-to-face intervention emphasizing abstinence and safer sex was conducted among 515 youth ( median age 17 years ; median grade 11 ) attending 10 secondary schools located in two districts in Namibia . Knowledge , attitudes , intentions , and HIV risk behaviors were assessed at baseline and in the immediate postintervention period . RESULTS Knowledge increased significantly among intervention compared to control youth ( 88 % vs. 82 % ; correct responses , p < .0001 ) . At postintervention follow-up , more intervention than control youth believed that they could be intimate without having sex , could have a girlfriend or boyfriend for a long time without having sex , could explain the process of impregnation , knew how to use a condom , and could ask for condoms in a clinic . Fewer intervention than control youth believed that if a girl refused to have sex with her boyfriend it was permissible for him to strike her , and that condoms took away a boy 's pleasure . More intervention than control youth anticipated using a condom when they did have sex , and fewer expected to drink alcohol . Finally , after intervention , there was a trend for increased condom use . There were significant gender-related differences at baseline , although intervention impact was generally equivalent . CONCLUSIONS These findings provide support for the judicious adaptation of successful Western HIV prevention programs in other cultural setting s. A single intervention approach appears to be effective in short-term follow-up with both genders This study investigated whether there were any changes in knowledge and normative beliefs regarding abstinence and condoms and personal risk perception of acquiring HIV among Zambian secondary -school students who were exposed to a peer sexual health intervention . Schools were r and omly assigned to intervention and control groups . A baseline assessment that measured knowledge , normative beliefs about abstinence and condoms and personal risk perception was conducted in all schools . Students in the intervention group were exposed for a 1-hour- and -45-minute-long in-class peer sexual health intervention . Students in the control schools were exposed to a 1-hour-long in-class peer water purification intervention . A follow-up assessment of students was conducted after the intervention . Logistic regression analyses were conducted to determine whether significant differences between intervention and control groups emerged at follow-up . Relative to students in the control group , knowledge was higher and normative beliefs about abstinence and condoms were significantly more positive among students in the intervention schools . Students in the intervention schools also had a higher personal risk perception of acquiring HIV than students in control schools . These findings show that a school-based peer sexual health intervention implemented in Zambia was effective in increasing knowledge , positive normative beliefs about abstinence and condoms , and personal risk perception PURPOSE The purpose of this study was to evaluate phase I of a theoretically informed media campaign design ed by youth in Zambia to encourage their peers to adopt risk-reduction practice s to protect themselves from sexually transmitted infections and human immunodeficiency virus ( HIV ) . The Helping Each other Act Responsibly Together ( HEART ) campaign conveys information for young people ages 13 to 19 years about sexually transmitted infections , HIV , and acquired immune deficiency syndrome transmission and prevention , and promotes abstinence , a return to abstinence , or consistent condom use as viable risk-reduction practice s. METHODS Separate sample baseline and follow-up design s were used to evaluate phase I of the HEART campaign among adolescents aged 13 to 19 years . The 1999 baseline survey had a sample of 368 male and 533 female adolescents ; the 2000 follow-up survey comprised 496 male and 660 female adolescents . RESULTS Controlling for age , sex , educational attainment , and urban or rural residence , logistic regression analyses demonstrated that , compared with nonviewers , campaign viewers were 1.61 times more likely to report primary or secondary abstinence and 2.38 times more likely to have ever used a condom . The odds ratio of condom use during last sex was 2.1 for respondents who recalled at least 3 television spot advertisements compared with other respondents . CONCLUSIONS The positive correlations between HEART campaign viewership and HIV risk-reduction practice s demonstrate that mediated messages can influence adolescents . The HEART campaign is among a range of programs in Zambia design ed to enable young people to protect their reproductive health . Future research should capture the independent as well as the synergistic effects of multiple campaigns and interventions PURPOSE To determine whether adolescents ' normative beliefs about abstinence and condoms , their personal risk perception , and safer sex practice s changed after the implementation of a peer sexual health education intervention implemented in Zambian secondary schools . METHODS The peer intervention was implemented during the first week of September 2000 in Lusaka , Zambia . A quasi-experimental , longitudinal panel design was used to evaluate its impact . Three schools were r and omly assigned to the intervention condition and two to the control condition . Three rounds of data from male and female adolescents in grade s 10 and 11 were collected at baseline in July 2000 , at first follow-up in the second half of September 2000 , and at second follow-up in early April 2001 . A total of 416 respondents aged 14 - 23 ( at baseline ) were interviewed in all three survey rounds . A mixed-effects logistic regression growth curve analysis was used to calculate adjusted odds ratios to compare intervention and control groups on the outcome variables . RESULTS Student self-reports showed positive changes in normative beliefs about abstinence immediately after the intervention , and these improvements were largely sustained until 6 months after the intervention . Students became more likely to approve of condom use and to intend using condoms immediately after the intervention , but these positive outcomes could not be sustained during the 6 months that followed the intervention . Normative beliefs regarding condom use took longer to develop : these were only observed at 6 months follow-up . Students reported reductions in multiple regular partnerships . There was no change in condom use . CONCLUSIONS A single session school-based peer sexual health intervention result ed in the development of normative beliefs about abstinence that were sustained over a 6-month period . Normative beliefs about condoms took longer to develop . More regular efforts may be required to sustain the approval of , and the intention to use , condoms . The intervention was successful in reducing multiple regular partnerships Objective : To evaluate an HIV risk-reduction intervention among Namibian adolescents . Methods : A r and omized trial of a 14-session face-to-face intervention emphasizing abstinence and safer sexual practice s conducted among 515 youths ( median age 17 years and median grade 11 ) attending 10 secondary schools located in two districts in Namibia . Youths were r and omly assigned to the intervention or control condition at the level of the individual . HIV risk behaviours , intentions and perceptions were assessed at baseline , immediately post-intervention and at 6 and 12 months post-intervention . Results : Among all 515 youths who enrolled in the programme , rates of either abstinence or sex with a condom were not different between control and intervention youths at baseline or in the follow-up period . However , analyses conducted among the subset of youths who were sexually inexperienced at baseline ( n = 255 ) revealed that a higher percentage of intervention youths ( 17 % ) than control youths ( 9 % , P < 0.05 ) remained sexually inexperienced one year later . Moreover , in the immediate post-intervention period , among baseline virgins who subsequently initiated sex , intervention youths were more likely than control youths to use a condom ( 18 versus 10 % , P < 0.05 ) . Additional HIV-related risk behaviours ( failure to discuss previous HIV risk exposure with one 's sexual partner and alcohol use ) , intentions to use condoms , and perceptions of the ability to use condoms were positively affected by the intervention . Conclusions : There is evidence that the ‘ My Future is My Choice ’ ( MFMC ) intervention is reducing HIV risk behaviours among sexually inexperienced participants aged 15–18 . Related risk behaviours and perceptions are also positively impacted by the intervention OBJECTIVE To describe the study design , methods and baseline findings of a behavioural intervention trial aim ed at reducing HIV incidence . METHOD A cluster r and omized-controlled trial ( RCT ) conducted in 70 villages in rural South Africa . A behavioural intervention , Stepping Stones , was implemented in 35 communities in two workshops of 20 men and 20 women in each community who met for 17 sessions ( 50 h ) over a period of 3 - 12 weeks . Individuals in the control arm communities attended a single session of about 3 h on HIV and safer sex . Impact assessment was conducted through two question naire and serological surveys at 12-month intervals . The primary outcome was HIV incidence and secondary measures included changes in knowledge , attitude and sexual behaviours . Qualitative research was also undertaken with 10 men and 10 women from two sites receiving the intervention ( one rural and one urban ) and five men and five women from one village in the control arm . They were interviewed individually three times prior to the workshops and then 9 - 12 months later . RESULTS A total of 2776 participants ( 1409 intervention and 1367 control ) were enrolled at baseline and had an interview , and HIV sero-status was established . HIV baseline prevalence rates in women were 9.8 % in the intervention arm and 12.8 % in the control arm . In men the prevalence was 1.7 % in the intervention arm and 2.1 % in the control arm . Demographic and behavioural characteristics were similar in the two arms . In the intervention groups 59.9 % of participants attended more than 75 % of the sessions . In the control group 66.3 % attended the control session . CONCLUSION This is the third RCT to be conducted in sub-Saharan Africa evaluating a behavioural intervention using HIV incidence as a primary outcome . It is of particular interest as the intervention in question is used in many developing countries . There is good baseline comparability between the study arms and the process data on the workshops suggested that the interventions were feasible and adequately implemented PURPOSE To assess the impact of exposure to life skills education by youth in KwaZulu-Natal Province ( KZN , South Africa ) on knowledge and behaviors associated with the spread of HIV/AIDS . METHODS Data come from a panel study of 2222 youth from several population subgroups in KZN . The youth were aged 14 - 24 years when interviewed in 1999 and 2001 . The intervention was a full coverage life skills education program for all students in middle and secondary schools . Impact was measured as net dose-response relationships between life skills exposure and outcomes . Econometric methods were used to control for nonr and om exposure to life skills education . Outcomes included sexual behavior and condom use indicators . RESULTS Significant effects , albeit modest in magnitude , were observed on selected areas of sexual-reproductive health knowledge and perceived condom self-efficacy , along with larger effects on condom use at first and last sex . No consistent effects on age at sexual initiation , secondary abstinence , or partnering behaviors were observed among these youth . CONCLUSIONS School-based life skills education appears capable of communicating key information and helping youth develop skills relevant to reducing HIV risk . However , the South African national program has yet to be fully implemented , and whether this initiative will result in sustained behavior modification among youth on a sufficient scale to affect the HIV/AIDS epidemic is uncertain PURPOSE To describe the implementation and evaluation of an adolescent reproductive health peer education program in West Africa . The program , known as the West African Youth Initiative ( WAYI ) , was developed to improve knowledge of sexuality and reproductive health , and promote safer sex behaviors and contraceptive use among sexually active adolescents in Nigeria and Ghana . METHODS Between November 1994 and April 1997 , two organizations , the Association for Reproductive and Family Health ( ARFH ) , based in Nigeria , and Advocates for Youth , based in Washington D.C. , supported community-based youth-serving organizations in the two countries to implement peer education projects . Consultants from the African Regional
Output:
| Sex education and condom promotion among youth did not increase sexual behaviour as well as risky sexual behaviour . |
MS211529 | ***TASK*** the task is to summarize an input biomedical literature 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 The objective of the present research was to test the efficacy of Fruit & Veg $ ense sessions in increasing fruit and vegetable consumption . DESIGN A wait-list r and omised controlled trial was conducted ( n 292 ) . Intervention participants attended a Fruit & Veg $ ense session and received newsletters at weeks 2 and 5 after attending the session . All participants completed an FFQ and a question naire measuring knowledge , attitudes , barriers and stage of change for fruit and vegetable consumption at baseline and 6 weeks . SETTING Hunter region of New South Wales , Australia . SUBJECTS Two hundred and ninety-two parents with children of primary school age . RESULTS The intervention group significantly increased its mean consumption of fruit and vegetables by 0·62 servings compared with 0·11 in the control group ( difference of 0·51 , P = 0·001 ) . Compared with the control group , there were significant increases in intervention participants ' knowledge of daily recommended servings ( for fruit and vegetables ) and serving size ( for vegetables ) , improvement in stage of change for vegetable consumption and a decrease in the number of perceived barriers to fruit and vegetable consumption . CONCLUSIONS Fruit & Veg $ ense is efficacious in increasing fruit and vegetable consumption among parents of primary -school children . The study adds significantly to the limited evidence regarding fruit and vegetable interventions and the feasibility of engaging peer educators to deliver community education sessions . A broader implementation trial to test the effectiveness of Fruit & Veg $ ense is recommended This article reports on the outcomes of the Teens Eating for Energy and Nutrition at School ( TEENS ) study , a 2-year intervention study conducted in 16 middle schools with a goal of increasing students ’ intakes of fruits , vegetables , and lower fat foods . Despite positive interim results for students r and omized to intervention schools , the positive effects of the intervention were not seen for the primary outcomes at the end of the 2nd year . Positive effects were seen only for a food choice score ( suggesting that the students usually choose lower versus higher fat foods ) and not for measures of food intake . Future studies may need to take a step back toward more controlled efficacy studies in working with this age-group . In addition , future work may consider the use of peer leaders , more intensive teacher training , ongoing formative assessment , and the testing of more powerful environmental change intervention strategies Peer education has become a popular strategy for health promotion interventions with adolescents , but it has not been used widely in school-based nutrition education . This paper describes and reports on the feasibility of the peer leader component of a school-based nutrition intervention for young adolescents design ed to increase fruit and vegetable intakes and lower fat foods . About 1,000 seventh- grade students in eight schools received the nutrition intervention . Of these , 272 were trained as peer leaders to assist the teacher in implementing the activities . Results from a multicomponent process evaluation based on peer leader and classroom student feedback , direct classroom observation , and teacher ratings and interviews are presented . Results show that peer-led nutrition education approaches in schools are feasible and have high acceptability among peer leaders , classroom students , and teachers OBJECTIVES ( 1 ) To describe promotional activities , particularly student-led , targeting lower-fat à la carte foods that were conducted in secondary schools ; and ( 2 ) to describe the relationships between the number and duration of total promotional activities for lower-fat à la carte foods and cafeteria sales of such foods over two years . DESIGN Promotional activities were implemented in schools that were r and omised to the intervention condition of a larger , two-year , school-based , r and omised , controlled nutrition intervention trial . SETTING Ten Minnesota secondary schools . SUBJECTS Students and school faculty , school food-service and research staff ( measured at the school level ) . RESULTS Over two years , 181 promotions were implemented ( n=49 in Year 1 and n=132 in Year 2 ) . In Year 1 , the number of promotions conducted in schools was significantly associated with percentage lower-fat food sales . In Year 2 , the duration of promotions was significantly associated with percentage lower-fat food sales . CONCLUSIONS Collaborative efforts among students , school food-service staff and research staff can be successful in implementing a large number of nutrition-related , school-wide promotional activities . These efforts can increase the sales of lower-fat foods in à la carte areas of school cafeterias OBJECTIVE We implemented a theory-based r and omized controlled trial ( Living Free of Tobacco , Plus ( LIFT+ ) in ten rural middle schools and assessed impact on tobacco use and fruit/vegetable ( F/V ) intake in 2008 - 2010 . Data on F/V intake at baseline , immediate post intervention , and 1-year follow-up are presented . METHODS Schools were r and omized to intervention or control groups . Goal setting , peer leaders , and class workshops with parent involvement , were intervention features ; community partners were supportive . Seventh grade rs filled out surveys on health behaviors , psycho-social variables , and demographic characteristics . Adjusted models comparing intervention and control conditions were analyzed . RESULTS Sample ( n=1119 ) was 48.5 % female , 50 % White , with a mean age of 12.7 years . Mean F/V servings were significantly higher in intervention schools at immediate post ( 3.19 servings ) and at 1-year ( 3.02 servings ) compared to controls ( 2.90 , 2.69 respectively ) . Knowledge of 5-a-day recommendation was significantly higher in intervention schools at immediate post test ( 75.0 % ) versus controls ( 53.8 % ) but not at 1-year follow-up . CONCLUSIONS Intervention schools reported significantly higher mean F/V servings at post intervention and 1-year , and for knowledge of F/V recommendations at immediate post compared to controls . Higher levels of parent and community involvement may further increase F/V intake in future interventions . Clinical Trials.gov Identifier : NCT01412697 OBJECTIVES We evaluated an environmental intervention intended to increase sales of lower-fat foods in secondary school cafeterias . METHODS Twenty secondary schools were r and omly assigned to either an environmental intervention or a control group for a 2-year period . The intervention increased the availability of lower-fat foods and implemented student-based promotions . RESULTS A steeper rate of increase in sales of lower-fat foods in year 1 ( 10 % intervention vs -2.8 % control , P = .002 ) and a higher percentage of sales of lower-fat foods in year 2 ( 33.6 % intervention vs 22.1 % control , P = .04 ) were observed . There were no significant changes in student self-reported food choices . CONCLUSIONS School-based environmental interventions to increase availability and promotion of lower-fat foods can increase purchase of these foods among adolescents PURPOSE We used principles of community-based participatory research to develop and pilot test a 5-week intervention for middle school students , Students for Nutrition and eXercise ( SNaX ) . SNaX aim ed to translate school obesity-prevention policies into practice with peer advocacy of healthy eating and school cafeteria changes . METHODS A total 425 seventh grade rs ( 63 % of all seventh grade rs ) in the intervention school were surveyed at baseline regarding cafeteria attitudes and sugar-sweetened beverage consumption ; of the 425 students , 399 ( 94 % ) were surveyed again at 1-month post-intervention . School cafeteria records were obtained from two schools : the intervention school and a nonr and omized selected comparison school with similar student socio-demographic characteristics . RESULTS A total of 140 students in the intervention school were trained as peer advocates . In the intervention school , cafeteria attitudes among peer advocates significantly improved over time ( approximately one-third of a st and ard deviation ) , whereas cafeteria attitudes of non-peer advocates remained stable ; the improvement among peer advocates was significantly greater than the pre-post-change for non-peer advocates ( b = .71 , p < .001 ) . Peer advocates significantly reduced their sugar-sweetened beverage intake ( sports and fruit drinks ) , from 33 % before intervention to 21 % after intervention ( p = .03 ) . Cafeteria records indicated that servings of fruit and healthier entrées ( salads , s and wiches , and yogurt parfaits ) significantly decreased in the comparison school and significantly increased in the intervention school ; the magnitude of changes differed significantly between the schools ( p < .001 ) . CONCLUSIONS As compared with the non-peer advocates , peer advocates appeared to benefit more from the intervention . Future research should consider engaging parents , students , and other key community stakeholders to determine acceptable and sustainable cafeteria changes HEALTHY was a multi-center primary prevention trial design ed to reduce risk factors for type 2 diabetes in adolescents . Seven centers each recruited six middle schools that were r and omized to either intervention or control . The HEALTHY intervention integrated multiple components in nutrition , physical education , behavior change and communications and promotion . The conceptual rationale as well as the design and development of the behavior intervention component are described . Pilot study data informed the development of the behavior intervention component . Principles of social learning and health-related behavior change were incorporated . One element of the behavior intervention component was a sequence of peer-led , teacher-facilitated learning activities known as FLASH ( Fun Learning Activities for Student Health ) . Five FLASH modules were implemented over five semesters of the HEALTHY study , with the first module delivered in the second semester of the sixth grade and the last module in the second semester of the eighth grade . Each module contained sessions that were design ed to be delivered on a weekly basis to foster self-awareness , knowledge , decision-making skills and peer involvement for health behavior change . FLASH behavioral practice incorporated individual and group self-monitoring challenges for eating and activity . Another element of the behavior intervention component was the family outreach strategy for extending changes in physical activity and healthy eating beyond the school day and for supporting the student 's lifestyle change choices . Family outreach strategies included the delivery of newsletters and supplemental packages with material s to promote healthy behavior in the home environment during school summer and winter holiday breaks . In conclusion , the HEALTHY behavior intervention component , when integrated with total school food and physical education environmental changes enhanced by communications and promotional campaigns , is a feasible and acceptable mechanism for delivering age-appropriate social learning for healthy eating and physical activity among an ethnically diverse group of middle school students across the United States OBJECTIVE . We design ed and tested a novel health promotion program for elementary schools that was based on peer teaching from older to younger schoolchildren ( “ Healthy Buddies ” ) . SUBJECTS AND METHODS . This prospect i ve pilot study compared the effect of our program ( 2–3 hours/week , 21 weeks ) in 2 Canadian elementary schools ( intervention : n = 232 children , the whole school implementing the program ; control : n = 151 ) . Older students ( 4th through 7th grade ) were given direct instruction from 1 intervention teacher and were paired with younger students ( kindergarten through 3rd grade ) for the whole school year . Students in 4th through 7th grade then acted as teachers for their younger “ buddies . ” All lessons included 3 components of healthy living : nutrition , physical activity , and healthy body image . The students first learned how to be positive buddies and learned the 3 components of a healthy life . Thereafter , they learned how to overcome challenges to living a healthy life . Outcome measures ( intervention and control schools at the beginning and end of the school year ) included vali date d question naires that assessed healthy-living knowledge , behavior and attitude , a 9-minute fitness run , self-competence , body satisfaction , disordered eating symptoms , and anthropometry ( BMI , blood pressure , and heart rate ) . RESULTS . Compared with control students , both older and younger intervention students showed an increase in healthy-living knowledge , behavior , and attitude scores and a smaller increase in systolic blood pressure . BMI and weight increased less in the intervention students in 4th through 7th grade and height more in the intervention students in kindergarten through 3rd grade . CONCLUSIONS . Our student-led curriculum improved knowledge not only in older schoolchildren but also in their younger buddies . It also decreased weight velocity in the older students . Student-led teaching may be an efficient , easy-to-implement way of promoting a healthy lifestyle from kindergarten to 7th grade This article describes perceptions of adolescents involved in peer-led school-based nutrition promotions encouraging lower-fat food purchases and assesses the differences by level of student involvement . Surveys were administered at schools . Data were collected from 397 high school students from 10 Minnesota schools r and omized to the intervention condition of the Trying Alternative Cafeteria Options in Schools study . Students were categorized as highly involved ( n=54 ) or less involved ( n=343 ) based on their level of involvement in promotional activity implementation . Chi 2 tests were conducted to measure the differences between highly-involved and less-involved students in perceptions and attitudes about lower-fat foods . Highly-involved students were significantly more likely than less-involved students to report more healthful eating behaviors and positive attitudes toward lower-fat foods . Student involvement in nutrition interventions should be integrated into programs aim ed at increasing healthful food choices among adolescents
Output:
| When evaluated , programs were generally well received , while the long-term maintenance of positive impacts was a challenge . |
MS211530 | ***TASK*** the task is to summarize an input biomedical literature 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: Tourette syndrome ( TS ) is characterized by chronic motor and vocal tics . Habit reversal therapy ( HR ) is a behavioral treatment for tics which has received recent empirical support . The present study compared the efficacy of HRT in reducing tics , improving life-satisfaction and psychosocial functioning in comparison with supportive psychotherapy ( SP ) in out patients with TS . In addition , we investigated whether impairments in response inhibition in patients with TS predict response to HR treatment which specifically aims to inhibit tics . Thirty adult out patients with DSM-IV TS were r and omized to 14 individual sessions of HR ( n = 15 ) ; or SP ( n = 15 ) . HR but not SP reduced tic severity over the course of the treatment . Both groups improved in life-satisfaction and psychosocial functioning during active treatment . Reductions in tic severity ( HR ) and improvements in life-satisfaction and psychosocial functioning ( HR and SP ) remained stable at the 6-month follow-up . The extent of pre-treatment response inhibition impairment in the HR group predicted reductions in tic-severity from pre- to post-treatment . Our results suggest that HR has specific tic-reducing effects although SP is effective in improving life-satisfaction and psychosocial functioning . Assessment s of response inhibition may be of value for predicting treatment response to HR OBJECTIVE Cognitive behavior therapy ( CBT ) and medication can be administered in combination in treating tic disorders but there are no studies evaluating the effectiveness of CBT with and without medication . The current study compares the efficacy of CBT in combination with medication and without medication . METHOD CBT was administered in a consecutively referred sample of 76 people diagnosed either with Gilles de la Tourette Syndrome or chronic tic disorder . The sample was divided into a medicated and a non-medicated group . Twenty three were stabilized on medication and 53 were not receiving medication . Measures administered pre- and post-CBT in both groups included : main outcome measure of Tourette Syndrome Global Scale and measures of mood . RESULTS Repeated measures analysis of variance on the initial sample revealed no difference between medicated and non-medicated groups in outcome . A further analysis comparing the 23 receiving medication with 23 not receiving medication matched on baseline clinical variables also yielded no significant group differences , either in treatment outcome on main tic outcome measures or on other clinical ly relevant question naires . DISCUSSION CBT for tic disorders is an effective treatment administered either in combination with medication or alone Comprehensive Behavioral Intervention for Tics ( CBIT ) has been shown to be effective for reducing tics in children with chronic tic disorder . Unfortunately , there remain significant barriers to dissemination . The aim of the current study was to examine the effectiveness of CBIT delivered over videoconference . Twenty children were r and omly assigned to receive CBIT over videoconference or via traditional face-to-face delivery . Results show that both treatment delivery modalities result ed in significant tic reduction with no between group differences . Furthermore , acceptability and therapist-client alliance ratings were strong for both groups . Together , these results suggest that videoconference is a viable option for disseminating CBIT The intentional nature of tics provides the opportunity to apply behavioural interventions aim ed at tic reduction through interruption of stimulus-response sequences . The aim of this study has been to evaluate the effect of exposure and response prevention ( ER ) versus habit reversal ( HR ) in 43 Tourette 's syndrome ( TS ) patients . The three outcome measures were : the Yale Global Tic Severity Scale ( YGTSS ) , 15-min tic frequency registration s monitored at the institute and 15-min home tic frequency registration s. Both treatment conditions result ed in statistically significant improvements on all outcome measures ( p < 0.001 ) . No significant differences were found between the treatment conditions on any of the outcome measures , although there was a tendency in favour of ER on the YGTSS ( p = 0.05 ) . These results suggest that , at least in the short term , TS tic symptoms can be treated effectively with both types of treatment CONTEXT Tourette disorder is a chronic and typically impairing childhood-onset neurologic condition . Antipsychotic medications , the first-line treatments for moderate to severe tics , are often associated with adverse effects . Behavioral interventions , although promising , have not been evaluated in large-scale controlled trials . OBJECTIVE To determine the efficacy of a comprehensive behavioral intervention for reducing tic severity in children and adolescents . DESIGN , SETTING , AND PARTICIPANTS R and omized , observer-blind , controlled trial of 126 children recruited from December 2004 through May 2007 and aged 9 through 17 years , with impairing Tourette or chronic tic disorder as a primary diagnosis , r and omly assigned to 8 sessions during 10 weeks of behavior therapy ( n = 61 ) or a control treatment consisting of supportive therapy and education ( n = 65 ) . Responders received 3 monthly booster treatment sessions and were reassessed at 3 and 6 months following treatment . INTERVENTION Comprehensive behavioral intervention . MAIN OUTCOME MEASURES Yale Global Tic Severity Scale ( range 0 - 50 , score > 15 indicating clinical ly significant tics ) and Clinical Global Impressions-Improvement Scale ( range 1 [ very much improved ] to 8 [ very much worse ] ) . RESULTS Behavioral intervention led to a significantly greater decrease on the Yale Global Tic Severity Scale ( 24.7 [ 95 % confidence interval { CI } , 23.1 - 26.3 ] to 17.1 [ 95 % CI , 15.1 - 19.1 ] ) from baseline to end point compared with the control treatment ( 24.6 [ 95 % CI , 23.2 - 26.0 ] to 21.1 [ 95 % CI , 19.2 - 23.0 ] ) ( P < .001 ; difference between groups , 4.1 ; 95 % CI , 2.0 - 6.2 ) ( effect size = 0.68 ) . Significantly more children receiving behavioral intervention compared with those in the control group were rated as being very much improved or much improved on the Clinical Global Impressions-Improvement scale ( 52.5 % vs 18.5 % , respectively ; P < .001 ; number needed to treat = 3 ) . Attrition was low ( 12/126 , or 9.5 % ) ; tic worsening was reported by 4 % of children ( 5/126 ) . Treatment gains were durable , with 87 % of available responders to behavior therapy exhibiting continued benefit 6 months following treatment . CONCLUSION A comprehensive behavioral intervention , compared with supportive therapy and education , result ed in greater improvement in symptom severity among children with Tourette and chronic tic disorder . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00218777 The present study evaluated the effectiveness of self-monitoring , relaxation training and habit reversal in the treatment of 6 Tourette Syndrome ( TS ) subjects with multiple motor and vocal tics . A counterbalanced design was employed and tic frequencies were measured in the clinic setting using videotapes taken through a one-way mirror . Tics were reduced by an average of 55 % with habit reversal , 44 % with self-monitoring , and 32 % with relaxation training and each behavioral procedure was the most effective treatment for at least one subject . All three treatment approaches may have some utility in the behavioral treatment of TS CONTEXT Tics in Tourette syndrome begin in childhood , peak in early adolescence , and often decrease by early adulthood . However , some adult patients continue to have impairing tics . Medications for tics are often effective but can cause adverse effects . Behavior therapy may offer an alternative but has not been examined in a large-scale controlled trial in adults . OBJECTIVE To test the efficacy of a comprehensive behavioral intervention for tics in adults with Tourette syndrome of at least moderate severity . DESIGN A r and omized controlled trial with posttreatment evaluations at 3 and 6 months for positive responders . SETTING Three outpatient research clinics . PATIENTS Patients ( N = 122 ; 78 males ; age range , 16 - 69 years ) with Tourette syndrome or chronic tic disorder were recruited between December 27 , 2005 , and May 21 , 2009 . INTERVENTIONS Patients received 8 sessions of comprehensive behavioral intervention for tics or 8 sessions of supportive treatment for 10 weeks . Patients with a positive response were given 3 monthly booster sessions . MAIN OUTCOME MEASURES Total tic score on the Yale Global Tic Severity Scale and the Clinical Global Impression-Improvement scale rated by a clinician masked to treatment assignment . RESULTS Behavior therapy was associated with a significantly greater mean ( SD ) decrease on the Yale Global Tic Severity Scale ( 24.0 [ 6.47 ] to 17.8 [ 7.32 ] ) from baseline to end point compared with the control treatment ( 21.8 [ 6.59 ] to 19.3 [ 7.40 ] ) ( P < .001 ; effect size = 0.57 ) . Twenty-four of 63 patients ( 38.1 % ) were rated as much improved or very much improved on the Clinical Global Impression-Improvement scale compared with 4 of 63 ( 6.4 % ) in the control group ( P < .001 ) . Attrition was 13.9 % , with no difference across groups . Patients receiving behavior therapy who were available for assessment at 6 months after treatment showed continued benefit . CONCLUSION Comprehensive behavior therapy is a safe and effective intervention for adults with Tourette syndrome . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00231985 Children ( n = 126 ) ages 9 to 17 years with chronic tic or Tourette disorder were r and omly assigned to receive either behavior therapy or a control treatment over 10 weeks . This study examined acute effects of behavior therapy on secondary psychiatric symptoms and psychosocial functioning and long-term effects on these measures for behavior therapy responders only . Baseline and end point assessment s conducted by a masked independent evaluator assessed several secondary psychiatric symptoms and measures of psychosocial functioning . Responders to behavior therapy at the end of the acute phase were reassessed at 3-month and 6-month follow-up . Children in the behavior therapy and control conditions did not differentially improve on secondary psychiatric or psychosocial outcome measures at the end of the acute phase . At 6-month posttreatment , positive response to behavior therapy was associated with decreased anxiety , disruptive behavior , and family strain and improved social functioning . Behavior therapy is a tic-specific treatment for children with tic disorders OBJECTIVE The authors investigated the efficacy of habit reversal for Tourette 's disorder , which is characterized by multiple motor and vocal tics . METHOD Thirty-two patients with Tourette 's disorder were r and omly assigned to 14 sessions of either habit reversal or supportive psychotherapy . Habit reversal consisted of awareness training , self-monitoring , relaxation training , competing response training , and contingency management . Changes in severity of Tourette 's disorder and psychosocial impairment were investigated over the course of the 14-session treatment for the 29 patients who completed at least eight treatment sessions . RESULTS In contrast to the 13 patients in the supportive psychotherapy group , the 16 patients in the habit reversal group improved significantly . The habit reversal patients remained significantly improved over pretreatment at 10-month follow-up . CONCLUSIONS Habit reversal may be an effective behavioral treatment for Tourette 's disorder
Output:
| This systematic review and meta- analysis demonstrates that behavior therapies based on Habit Reversal Therapy , including the Comprehensive Behavioral Intervention for Tics are effective in reducing tic severity when compared with supportive psychotherapy .
When these behavior therapies are unavailable , Exposure with Response Prevention may also be effective .
Both face-to-face and telehealth delivery methods for behavior therapy improve tic severity , and broader distribution of behavior therapy through increased training or telehealth methods is encouraged . |
MS211531 | ***TASK*** the task is to summarize an input biomedical literature 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: Anorexia nervosa ( AN ) is prevalent in adolescents and is associated with decreased bone mineral accrual at a time critical for optimizing bone mass . Low BMD in AN is a consequence of nutritional and hormonal alterations , including hypogonadism and low estradiol levels . Effective therapeutic strategies to improve BMD in adolescents with AN have not been identified . Specifically , high estrogen doses given as an oral contraceptive do not improve BMD . The impact of physiologic estrogen doses that mimic puberty on BMD has not been examined . We enrolled 110 girls with AN and 40 normal-weight controls 12 to 18 years of age of similar maturity . Subjects were studied for 18 months . Mature girls with AN ( bone age [ BA ] ≥15 years , n = 96 ) were r and omized to 100 µg of 17β-estradiol ( with cyclic progesterone ) or placebo transdermally for 18 months . Immature girls with AN ( BA < 15 years , n = 14 ) were r and omized to incremental low-dose oral ethinyl-estradiol ( 3.75 µg daily from 0 to 6 months , 7.5 µg from 6 to 12 months , 11.25 µg from 12 to 18 months ) to mimic pubertal estrogen increases or placebo for 18 months . All BMD measures assessed by dual-energy X-ray absorptiometry ( DXA ) were lower in girls with AN than in control girls . At baseline , girls with AN r and omized to estrogen ( AN E + ) did not differ from those r and omized to placebo ( AN E- ) for age , maturity , height , BMI , amenorrhea duration , and BMD parameters . Spine and hip BMD Z-scores increased over time in the AN E+ compared with the AN E- group , even after controlling for baseline age and weight . It is concluded that physiologic estradiol replacement increases spine and hip BMD in girls with AN Introduction The aim of this study was the long-term prospect i ve evaluation of the effects of estroprogestagen ( EP ) therapy on the bone mineral density ( BMD ) of girls with functional hypothalamic amenorrhea ( FHA ) carrying various PvuII and XbaI polymorphisms of ER-α . Material and methods Prospect i ve observation included 84 FHA girls and 50 controls . The FHA patients were subjected to 4-year sequential therapy with 17β estradiol ( 2 mg from the 2nd to 25th day of the menstrual cycle ) and dydrogesterone ( 10 mg from the 16th to the 25th day ) . Hormonal parameters , serum concentration of the bone fraction of alkaline phosphatase ( BALP ) , urine concentration of cross-linked n-telopeptide of type I collagen ( Ntx ) and BMD were determined before and after the treatment . Results Six-month treatment result ed in a marked increase in estradiol ( p = 0.001 ) , testosterone and prolactin levels ( p = 0.01 both ) and a significant decrease in BALP and Ntx ( p = 0.001 both ) . Patients with the PP polymorphism had significantly lower baseline BMD compared to carriers of other polymorphic variants of PvuII ( p = 0.003 ) . A significant increase in BMD was observed throughout the entire therapy period , with no significant differences in the yearly dynamics of BMD changes observed amongst various polymorphic variants and haplotypes of ER-α . Conclusions The EP therapy is effective in the treatment of BMD disorders associated with FHA , and treatment results do not depend on PvuII and XbaI polymorphisms of ER-α Abstract : There is considerable concern about the adverse effects on the skeleton of loss of menstrual function as a result of athletic activity , as well as uncertainty as to how it should be managed clinical ly . In a pilot intervention study 34 elite middle and long-distance runners , aged 18–35 years , with menstrual irregularity due to their athletic activity were r and omized to three groups : ( A ) to receive hormone replacement therapy ( HRT ) and 1000 mg calcium per day ( n= 10 ) , ( B ) to receive 1000 mg calcium per day ( n = 14 ) , ( C ) a control group who received no treatment ( n= 10 ) . Bone mineral density ( BMD ) was measured in the left hip and lumbar spine ( L2–4 ) using dual-energy X-ray absorptiometry . Results were first analyzed according to whether menstruation returned , either naturally or secondary to HRT ( EU ) , and compared with those from subjects who remained amenorrheic ( AM ) . During the first year BMD increased in the EU group in Ward ’s triangle ( 3.8 % ) and the lumbar spine ( 4.1 % ; both P<0.05 ) . BMD fell in the AM group in all regions and the between-group differences were 5.6 % ( p<0.02 ) in Ward ’s triangle , 5.8 % ( p<0.02 ) in L2–4 and 3.9 % in the trochanter ( p<0.05 ) . An ‘ intention to treat ’ analysis was then performed . It was found that the mean relative improvement at 1 year in spinal BMD was only 1.5 % , due to return of menses in some of the controls and withdrawals from treatment in the treatment group . In consequence , a trial design ed to show , with 80 % power and 5 % significance , a measurable benefit in lumbar spine BMD result ing from allocation to HRT treatment would require about 1150 athletes with amenorrhea or oligomenorrhea . These numbers could be reduced substantially to 380 subjects by confining the trial to completely amenorrheic athletes , who in this study were less likely to regain menses . For these and other logistical reasons , an HRT trial in amenorrheic athletes could only be successfully organized through international collaboration . This study illustrates the major effects of treatment withdrawals and instability of menstrual status on the design of longitudinal studies on the bony effects of menstrual dysfunction prior to menopause 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 Osteoporosis is recognized as a common medical complication of anorexia nervosa ( AN ) . The purpose of the current study was to investigate the recovery mechanism of osteoporosis in AN and the effect of medical treatment on the skeletal system . METHOD We conducted a r and omized placebo-controlled study of the effects of etidronate and calcium and vitamin D on bone loss in 41 out patients with the restricting type of AN ( AN-R ) . We measured the tibial speed of sound ( SOS ) before and after 3 months of treatment . RESULTS The bone mineral density ( BMD ) of the tibial SOS change in both the etidronate group and the calcium and vitamin D Group was significantly greater ( p < .001 ) than in the control group . Urine-N-telopeptide cross-links of type I collagen ( NTx ) before and after treatment decreased significantly ( p < .01 ) in the etidronate group . CONCLUSION These findings suggest that both etidronate and calcium and vitamin D are equally efficacious for reversing the degree of osteoporosis in patients with AN OBJECTIVES The objectives of this study were to assess ( 1 ) whether treatment with oral contraceptives , in comparison with medroxyprogesterone and placebo , improved bone mineral in women with hypothalamic amenorrhea and ( 2 ) whether treatment with medroxyprogesterone , in comparison with placebo , improved bone mineral in women with hypothalamic oligomenorrhea . STUDY DESIGN The study was a r and omized , controlled clinical trial . Twenty-four white women , aged 14 to 28 years , with hypothalamic amenorrhea or oligomenorrhea were prospect ively enrolled for a 12-month intervention period . Amenorrheic subjects were r and omized to receive oral contraceptives , medroxyprogesterone , or placebo . Oligomenorrheic subjects were r and omized to receive medroxyprogesterone or placebo . Bone mineral was measured by dual-energy x-ray absorptiometry at baseline and at 6 and 12 months . RESULTS In amenorrheic subjects spine and total body bone mineral measurements at 12 months were greater in the oral contraceptive group than in the medroxyprogesterone and placebo groups when baseline bone mineral measurements , body weight , and age were controlled for ( p < or = 0.05 ) . There were no differences in hip bone mineral calcium and bone mineral density measurements at 12 months among the three groups . In oligomenorrheic subjects there was no detectable improvement in bone mineral associated with medroxyprogesterone use . CONCLUSIONS This study supports the hypothesis that oral contraceptive use in women with hypothalamic amenorrhea will improve lumbar spine and total body bone mineral CONTEXT Anorexia nervosa is complicated by severe bone loss and clinical fractures . Mechanisms underlying bone loss in adults with anorexia nervosa include increased bone resorption and decreased formation . Estrogen administration has not been shown to prevent bone loss in this population , and to date , there are no approved , effective therapies for this comorbidity . OBJECTIVE To determine whether antiresorptive therapy with a bisphosphonate alone or in combination with low-dose transdermal testosterone replacement would increase bone mineral density ( BMD ) in women with anorexia nervosa . DESIGN AND SETTING We conducted a12-month , r and omized , placebo-controlled study at a clinical research center . STUDY PARTICIPANTS Participants included 77 ambulatory women with anorexia nervosa . INTERVENTION Subjects were r and omized to risedronate 35 mg weekly , low-dose transdermal testosterone replacement therapy , combination therapy or double placebo . MAIN OUTCOME MEASURES BMD at the spine ( primary endpoint ) , hip , and radius and body composition were measured by dual-energy x-ray absorptiometry . RESULTS Risedronate increased posteroanterior spine BMD 3 % , lateral spine BMD 4 % , and hip BMD 2 % in women with anorexia nervosa compared with placebo in a 12-month clinical trial . Testosterone administration did not improve BMD but increased lean body mass . There were few side effects associated with either therapy . CONCLUSIONS Risedronate administration for 1 yr increased spinal BMD , the primary site of bone loss in women with anorexia nervosa . Low-dose testosterone did not change BMD but increased lean body mass Anorexia nervosa ( AN ) , a psychiatric disease characterized by chronic starvation , is complicated by severe bone loss ( 1 ) , for which there is no effective , available therapy . Although bone resorption is markedly increased in these patients , estrogen is an ineffective anti-resorptive therapy in the setting of undernutrition . We hypothesized bisphosphonate administration would result in a decrease in bone resorption and an increase in bone density in women with AN and bone loss , despite undernutrition . We therefore administered risedronate 5 mg daily for nine months to 10 women with AN , all of whom had osteopenia ( mean AP spine T score : -2.7 + /- 2 ) and compared NTX and bone density with baseline values and with those from available control data prospect ively followed for the same time period . Bone density increased significantly in patients who received risedronate compared with controls and compared with baseline , despite lack of significant weight gain , for an increase of AP spine bone density of 4.1 + /- 1.6 % at six months and 4.9 + /- 1.0 % at nine months . Bone resorption , as measured by NTX , decreased 23.8 % at one month and 29.6 % at three months , from the high-normal to mid-normal range of young women . Our data suggest that risedronate 5 mg daily administered to women with AN and osteopenia may increase in bone density at the AP spine despite low weight . This is the first study to demonstrate marked increases in bone density in women with AN . Because of the lack of data regarding the safety of such medications in women of reproductive age , bisphosphonates are not approved in the U.S. for premenopausal women other than those receiving glucocorticoids . Further studies are needed to establish the efficacy and safety of bisphosphonate therapy in this population OBJECTIVE To evaluate whether decreasing doses of ethinyl estradiol affect bone loss related to hypothalamic amenorrhea . STUDY DESIGN Sixty-four women with hypothalamic oligoamenorrhea were allocated to two therapy groups : group A ( n = 24 ) received an OC containing 0.030 mg of ethinyl estradiol ( EE ) and 0.15 mg of desogestrel . Group B ( n = 22 ) received an OC containing 0.020 mg of EE and 0.15 mg of desogestrel . Eighteen women who did not wish to use hormonal therapy constituted the control group ( C ) . Calcium , phosphate and osteocalcin were measured basally and at 6 and 12 months of follow-up . Bone mineral density at the lumbar spine was determined before initiation of the study and at 12 months by dual energy X-ray absorptiometry . RESULTS Serum calcium , phosphate and osteocalcin were significantly reduced by both active treatment reg
Output:
| There was no substantial effect of receiving hormonal therapy on BMD of the femoral neck , trochanteric region , Ward triangle , or total body BMD .
Conclusion The current evidence does not support using hormonal therapy for the sole purpose of improving bone health in patients with FHA .
There are no data about bisphosphonates in this population |
MS211532 | ***TASK*** the task is to summarize an input biomedical literature 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 Concerns regarding the risk of estrogen replacement have result ed in a significant increase in the use of soy products by menopausal women who , despite the lack of evidence of the efficacy of such products , seek alternatives to menopausal hormone therapy . Our goal was to determine the efficacy of soy isoflavone tablets in preventing bone loss and menopausal symptoms . METHODS The study design was a single-center , r and omized , placebo-controlled , double-blind clinical trial conducted from July 1 , 2004 , through March 31 , 2009 . Women aged 45 to 60 years within 5 years of menopause and with a bone mineral density T score of -2.0 or higher in the lumbar spine or total hip were r and omly assigned , in equal proportions , to receive daily soy isoflavone tablets , 200 mg , or placebo . The primary outcome was changes in bone mineral density in the lumbar spine , total hip , and femoral neck at the 2-year follow-up . Secondary outcomes included changes in menopausal symptoms , vaginal cytologic characteristics , N -telopeptide of type I bone collagen , lipids , and thyroid function . RESULTS After 2 years , no significant differences were found between the participants receiving soy tablets ( n = 122 ) and those receiving placebo ( n = 126 ) regarding changes in bone mineral density in the spine ( -2.0 % and -2.3 % , respectively ) , the total hip ( -1.2 % and -1.4 % , respectively ) , or the femoral neck ( -2.2 % and -2.1 % , respectively ) . A significantly larger proportion of participants in the soy group experienced hot flashes and constipation compared with the control group . No significant differences were found between groups in other outcomes . CONCLUSIONS In this population , the daily administration of tablets containing 200 mg of soy isoflavones for 2 years did not prevent bone loss or menopausal symptoms . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00076050 Objective This study aims to evaluate the effects of soy isoflavones on breast tissue in postmenopausal women . Methods In this r and omized , double-blind , placebo-controlled study , 80 women ( aged ≥45 y and with amenorrhea > 12 mo ) with vasomotor symptoms were r and omized to receive either 250 mg of st and ardized soy extract corresponding to isoflavone 100 mg/day ( n = 40 ) or placebo ( n = 40 ) for 10 months . Breasts were evaluated through mammographic density and breast parenchyma using ultrasound ( US ) at baseline and 10-month follow-up . Independent t test , analysis of variance , Mann-Whitney U test , and & khgr;2 trend test were used in statistical analysis . Results Baseline clinical characteristics showed no significant differences between the isoflavone group and the placebo group , with mean ( SD ) age of 55.1 ( 6.0 ) and 56.2 ( 7.7 ) years , mean ( SD ) menopause duration of 6.6 ( 4.8 ) and 7.1 ( 4.2 ) years , and mean ( SD ) body mass index of 29.7 ( 5.0 ) and 28.5 ( 4.9 ) kg/m2 , respectively ( P > 0.05 ) . The study was completed by 32 women on isoflavone and 34 women on placebo . The groups did not differ in mammographic density or breast parenchyma by US ( P > 0.05 ) . Within each group , the baseline and final moments did not differ in mammography or US parameters significantly ( P > 0.05 ) . Conclusions The use of soy isoflavone extract for 10 months does not affect breast density , as assessed by mammography and US , in postmenopausal women Because soy food consumption may influence breast tissue activity , we examined its effect on the presence of epithelial cells in nipple aspirate fluid ( NAF ) . In a r and omized , crossover design , 82 premenopausal women completed a high-soy and a low-soy diet for 6 mo each , separated by a 1-mo washout period . They provided NAF sample s at baseline , 6 mo , and 13 mo during the midluteal phase of the menstrual cycle . Papanicolaou-stained cytology slides ( for 33 women at baseline , 24 at low-soy , and 36 at high-soy ) were evaluated in women with sufficient NAF . Mixed models evaluated the effect of the high-soy diet on epithelial cytology as compared to baseline and the low-soy diet . At the end of the high-soy diet , cytological subclass had decreased in 8 ( 24 % ) and increased in 3 ( 9 % ) women as compared to baseline , whereas the respective values were 3 ( 14 % ) and 6 ( 29 % ) for the low-soy diet sample s ( P = 0.32 ) . Only the change in subclass indicated a trend in lower cytological class ( P = 0.06 ) . Contrary to an earlier report , the number of NAF sample s with hyperplastic epithelial cells did not increase after a soy intervention in amounts consumed by Asians Background . Risk-benefit issues raised after the WHI have significantly increased the use of alternative treatments for the menopause . Despite this , data regarding the effect of soy isoflavones over mood and menopausal symptoms in high risk population s is still lacking . Objective . To evaluate the effect of soy derived isoflavones over hot flushes , menopausal symptoms and mood in climacteric women with increased body mass index ( BMI ) . Methods . Fifty symptomatic climacteric women aged 40 to 59 with increased BMI ( ≥25 ) were recruited to receive oral 100 mg/day of soy derived isoflavones ( Climasoy ® ) for 3 months . Hot flushes ( frequency/intensity ) , menopausal symptoms ( Menopause Rating Scale [ MRS ] ) and mood ( Hamilton Depressive Rating Scale [ HDRS ] ) were evaluated at baseline and at 90 days . Results . A total of 45 women completed the study . After 3 months of soy isoflavone supplementation hot flushes significantly decreased in percentage , number and severity ( 100 % to 31.1 % ; 3.9 ± 2.3 to 0.4 ± 0.8 and 2.6 ± 0.9 to 0.4 ± 0.8 , respectively , p < 0.001 ) . MRS scores ( total and for subscales ) reflecting general menopausal symptoms also significantly decreased compared to baseline . Regarding mood , after three months total HDRS scores and the rate of women presenting depressed mood ( scores ≥ 8) significantly decreased ( 16.3 ± 5.4 to 6.9 ± 5.2 and 93.3 % to 28.9 % , respectively , p < 0.05 ) . There was no effect on blood pressure levels or BMI values after treatment . Conclusion . In this high risk climacteric population , soy derived isoflavone treatment improved mood as well as vasomotor and general menopausal symptoms . More research is required to determine if the positive effect over mood is a direct or an indirect one through hot flush alleviation OBJECTIVE To investigate the effects of st and ardized soy extract on climacteric symptoms , lipid profiles , bone markers , and serum isoflavone concentration in healthy Taiwanese postmenopausal women . MATERIAL S AND METHODS A multicenter , open-labeled , r and omized , prospect i ve , comparative study design was used . A total of 130 out patients who had undergone natural menopause were r and omly administered either 70 mg or 35 mg soy extract daily for 24 weeks . RESULTS The evidence suggests that the soy extract treatment that was administered to both groups for 1 month could help reduce climacteric scores ( reductions of 19.66 % [ p<0.01 ] and 18.85 % [ p<0.01 ] in the 35 mg and 70 mg groups compared with baseline , respectively ) , and the efficacy was more potent after 6 months of treatment . Soy isoflavone significantly reduced the total cholesterol ( reductions of 4.50 % [ p<0.01 ] and 3.06 % [ p<0.05 ] in the 35 mg and 70 mg groups , respectively ) and low density lipoprotein cholesterol levels ( reductions of 4.67 % [ p<0.05 ] and 5.09 % [ p<0.05 ] in the 35 mg and 70 mg groups , respectively ) in patients with total cholesterol > 200 mg/dL after 6 months of treatment . In patients with high bone turnover ( urinary deoxypyridinoline/creatinine > 7.4 nM/mM ) , soy extract treatment reduced the deoxypyridinoline/creatinine level by 10.53 % ( p<0.05 ) and 11.58 % ( p<0.05 ) in the 35 mg and 70 mg groups , respectively . Serum levels of isoflavone increased in both groups after 6 months of treatment . CONCLUSION Soy extract is highly efficacious at relieving menopausal symptoms and demonstrates a positive effect on the cardiovascular system and skeleton Background and objectives : The potential of soy isoflavones to interfere with thyroid function has been reported . However , there are limited data regarding their effect on thyroid function and autoimmunity in surgical menopausal women . The present study aim ed to evaluate the effect of isoflavones on thyroid function and autoimmunity , menopausal symptoms , serum follicle stimulating hormone ( FSH ) and estradiol levels in oophorectomised women . Methods : A r and omized , double blind , placebo-controlled trial was conducted in 43 oophorectomised women to evaluate the effect of soy isoflavones ( 75 mg/day for 12 wk ) on serum thyroid profile ( free T3 , free T4 , TSH , TBG and anti-TPO antibody titres ) assessed at baseline , 6 and 12 wk after r and omization . Assessment was also done for menopause symptom score ( MSS ) three weekly , and FSH and estradiol levels at baseline and at study completion . Results : There was a significant alteration in free T 3 levels in the group receiving isoflavones ( 4.05 ± 0.36 , 4.12 ± 0.69 and 3.76 ± 0.55 pmol/l at baseline , 6 and 12 wk , respectively ; P=0.02 ) . However , the mean change in various thyroid parameters at 12 wk from baseline was not significantly different between the two groups . MSS was also significantly decreased at 9 and 12 wk from baseline with isoflavones ( 12.47 ± 8.15 , 9.35 ± 5.23 and 9 ± 5.14 at baseline , 9 and 12 wk respectively ; P=0.004 ) with significant improvement in urogenital symptoms compared to placebo . Isoflavones did not significantly affect other parameters during study period . There were no serious adverse events reported and the proportion of patients experiencing adverse events was similar between the two groups . Interpretation and conclusions : Modest reduction in serum free T3 levels in the isoflavone group in the absence of any effect on other thyroid parameters might be considered clinical ly unimportant OBJECTIVE Menopause is associated with broad , though generally not massive changes in a large number of metabolic parameters . The aim of our study was to evaluate the efficacy and tolerability of a combined nutraceutical approach on a large number of cardiometabolic risk markers and menopause symptoms in otherwise healthy , mildly dyslipidemic postmenopausal women . DESIGN / SETTING Forty women were enrolled in the context of a controlled , r and omized , prospect i ve study with parallel groups at the Lipid Clinic of the University of Bologna . INTERVENTION The women were r and omized to treatment with a nutraceuticals containing soy isoflavones ( 60 mg ) and berberine ( 500 mg ) or a placebo at a dosage of one tablet daily between meals for 12 weeks . RESULTS All patients completed the study without significant side effects . Anthropometric measures , blood pressure , HOMA index , and basal homocysteinemia significantly improved in isoflavones-berberine-treated group when compared to the baseline , but not when compared to the placebo-treated patients . Compared to placebo-treated patients , those treated with isoflavones-berberine experienced a significant improvement in plasma lipid and metalloproteinase serum levels , as well as the main menopausal symptoms . CONCLUSION The short-term consumption of a nutraceutical containing isoflavones and berberine was well-tolerated and improved menopausal symptoms , plasma lipid level , and serum levels of matrix metalloproteinases in a cohort of mildly dyslipidemic postmenopausal women when compared with a neutral control Objective This study aims to determine whether long-term isoflavone soy protein ( ISP ) supplementation affects endometrial thickness and rates of endometrial hyperplasia and cancer in postmenopausal women . Methods In this r and omized , double-blind , placebo-controlled trial , 350 postmenopausal women aged 45 to 92 years were r and
Output:
| The citation analysis revealed a growing interest for this topic and the papers on thyroid function are the most cited .
In particular , literature show that a specific dosage of isoflavones reduces cardiovascular disease ( from 20 to 100 mg/die ) , may be protective in osteoporosis and muscular fatigue ( from 20 to 80 mg/die ) , may be useful for cancer prevention on endometrium , mammary gl and s and liver ( from 50 to 100 mg/die ) , might improve menopausal symptoms , particularly in reducing the frequency of hot flashes ( from 50 to 120 mg/die ) , can reduce abdominal fat and circulating inflammatory markers ( from 80 to 160 mg/die ) , may ameliorate the possible interaction between endogenous estrogen and thyroid function ( 75 mg/die ) and improve visual memory ( from 50 to 100 mg/die ) |
MS211533 | ***TASK*** the task is to summarize an input biomedical literature 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 Lix and rão , ME , Damas , F , Chacon-Mikahil , MPT , Cavaglieri , CR , Ugrinowitsch , C , Bottaro , M , Vechin , FC , Conceição , MS , Berton , R , and Libardi , CA . Time course of resistance training – induced muscle hypertrophy in the elderly . J Strength Cond Res 30(1 ) : 159–163 , 2016—Extended periods of resistance training ( RT ) induce muscle hypertrophy . Nevertheless , to date , no study has investigated the time window necessary to observe significant changes in muscle cross-sectional area ( CSA ) in older adults . Therefore , this study investigated the time course of muscle hypertrophy after 10 weeks ( 20 sessions ) of RT in the elderly . Fourteen healthy older subjects were r and omly allocated in either the RT ( n : 6 ) or control group ( n : 8) . The RT was composed of 4 sets × 10 repetitions ( 70–80 % 1 repetition maximum [ 1RM ] ) in a leg press machine . The time course of vastus lateralis muscle hypertrophy ( CSA ) was assessed on a weekly basis by mode-B ultrasonography . Leg press muscle strength was assessed by dynamic 1RM test . Our results demonstrated that the RT group increased leg press 1RM by 42 % ( p ⩽ 0.05 ) after 10 weeks of training . Significant increases in vastus lateralis muscle CSA were observed only after 18 sessions of training ( 9 weeks ; p ⩽ 0.05 ; 7.1 % ) . In conclusion , our training protocol promoted muscle mass accrual in older subjects , and this was only observable after 18 sessions of RT ( 9 weeks ) OBJECTIVE To examine the effects of session intensity ( number of slip exposures ) and frequency on the retention of acquired adaptation for prevention of backward balance loss after repeated-slip training . DESIGN A 4-group , r and omized , and controlled study . SETTING Biomechanics research laboratory . PARTICIPANTS Healthy young subjects ( N=46 ; 21 men ) . INTERVENTIONS Twenty-four subjects experienced a high-intensity session of 24 repeated right-side slips ; 12 received additional single-slip sessions at a frequency of 1 week , 2 weeks , and 1 month , whereas the rest got no ancillary training . Another 24 subjects received a low-intensity initial session of a single slip ; 12 received the same high-frequency ancillary training , whereas the rest got none . All groups were retested with a single slip 4 months after the first session . MAIN OUTCOME MEASURES The incidence of backward balance loss , gait stability , and limb support . RESULTS The high-intensity groups , irrespective of ancillary training , displayed similar improvements in all 3 outcome measures . Remarkably , the low-intensity group receiving ancillary training also significantly improved in all measures , with retention comparable to that observed in the other 2 groups . A single-slip exposure without ancillary sessions was insufficient to yield a longer-term effect . CONCLUSIONS Frequent ancillary sessions may be unnecessary for slip-related fall prevention up to 4 months if the initial session intensity is sufficient . Furthermore , the minimum of a single slip may be as effective if the subject is exposed to frequent ancillary sessions Based on finding a strong association between number of impairments and risk of falling in earlier studies , Yale FICSIT investigators are conducting an intervention trial comparing the effectiveness of usual care plus social visits ( SV ) and a targeted risk abatement intervention ( TI ) strategy in reducing falls among at risk community elderly persons . Subjects include members of a participating HMO who are > or = 70 years of age , cognitively intact , not terminally ill , not too physically active , and possess at least one fall risk factor . The targeted risk factors include postural hypotension ; sedative use ; at least four targeted medications ; upper and lower extremity strength and range of motion impairments ; foot problems ; and balance , gait , and transfer dysfunctions . The interventions include medication adjustments , behavioral change recommendations , education and training , and home-based exercise regimens targeting the identified risk factors . The interventions are carried out by the study nurse practitioner and physical therapist in TI subjects ' homes . The SV subjects receive a comparable number of home visits as the TI subjects during which a structured life review is performed by social work students . The primary outcome is occurrence of falls during the 12-month followup . Secondary outcomes include change in mobility performance and fall-related efficacy Abstract Background Both exercise and vitamin D are recommended means to prevent falls among older adults , but their combined effects on fall-induced injuries are scarcely studied . Methods A 2-year follow-up of a previous 2-year r and omized controlled trial with vitamin D and exercise ( Ex ) of 409 older home-dwelling women using a factorial 2 × 2 design ( D−Ex− , D+Ex− , D−Ex+ , D+Ex+ ) . Besides monthly fall diaries , femoral neck bone mineral density ( fn-BMD ) , and physical functioning were assessed at 1 and 2 years after the intervention . Results After the intervention , S-25OHD concentrations declined to baseline levels in both supplement groups . The groups did not differ for change in fn-BMD or physical functioning , except for leg extensor muscle strength , which remained about 10 % greater in the exercise groups compared with the reference group ( D−Ex− ) . There were no between-group differences in the rate of all falls , but medically attended injurious falls reduced in D+Ex− and D−Ex+ groups compared with D−Ex−. However , all former treatment groups had less medically attended injured fallers , HRs ( 95 % CI ) being 0.62 ( 0.39–1.00 ) for D+Ex− , 0.46 ( 0.28–0.76 ) for D−Ex+ , and 0.55 ( 0.34–0.88 ) for D+Ex+ , compared with D−Ex−. Conclusions Exercise-induced benefits in physical functioning partly remained 2 years after cessation of supervised training . Although there was no difference in the rate of all falls , former exercise groups continued to have lower rate of medically attended injured fallers compared with referents even 2 years after the intervention . Vitamin D without exercise was associated with less injurious falls with no difference in physical functioning OBJECTIVES To primarily ascertain the effect of the Otago Exercise Program ( OEP ) on physiological falls risk , functional mobility , and executive functioning after 6 months in older adults with a recent history of falls and to ascertain the effect of the OEP on falls during a 1-year follow-up period . DESIGN R and omized controlled trial . SETTING Dedicated falls clinics . PARTICIPANTS Seventy-four adults aged 70 and older who presented to a healthcare professional after a fall . INTERVENTION The OEP , a home-based program that consists of resistance training and balance training exercises . MEASUREMENTS Physiological falls risk was assessed using the Physiological Profile Assessment . Functional mobility was assessed using the Timed Up and Go Test . Three central executive functions were assessed : set shifting , using the Trail Making Test Part B ; updating , using the verbal digits backward test ; and response inhibition , using the Stroop Color-Word Test . Falls were prospect ively monitored using daily calendars . RESULTS At 6 months , there was no significant between-group difference in physiological falls risk or functional mobility ( P > or= .33 ) . There was a significant between-group difference in response inhibition ( P=.05 ) . A falls histogram revealed two outliers . With these cases removed , using negative binomial regression , the unadjusted incidence rate ratio of falls in the OEP group compared with the control group was 0.56 . The adjusted incidence rate ratio was 0.47 . CONCLUSION The OEP may reduce falls by improving cognitive performance OBJECTIVES To evaluate the long-term effects of a multifactorial fall prevention programme on the incidence of falls requiring medical treatment . STUDY DESIGN A r and omized controlled trial . METHODS Five hundred and ninety-one community-dwelling elderly people ( > or = 65 years ) living in the town of Pori , Finl and with at least one fall during the previous 12 months were r and omized into an intervention group ( n=293 ) and a control group ( n=298 ) . Subjects in the intervention group participated in a multifactorial 12-month fall prevention programme . This study evaluated the incidence of falls requiring medical treatment during the 3-year follow-up period . RESULTS The intervention did not significantly reduce the incidence of falls requiring medical treatment during the 3-year follow-up period [ incidence rate ratio ( IRR ) for the intervention group compared with the control group 0.87 , 95 % confidence interval ( CI ) 0.63 - 1.21 ] . The number of falls requiring medical treatment was lower in the intervention group ( n=32 ) compared with the control group ( n=50 ) ( IRR 0.65 , 95%CI 0.40 - 1.07 ) during the second year of follow-up , but this was not found during the first year ( 48 and 48 falls , respectively ; IRR 1.04 , 95%CI 0.64 - 1.69 ) or the third year ( 44 and 48 falls , respectively ; IRR 0.94 , 95%CI 0.58 - 1.53 ) of follow-up . CONCLUSIONS The multifactorial fall prevention programme did not decrease the incidence of falls requiring medical treatment of fall-prone elderly people during the 3-year follow-up period . However , some positive effect was found during the second year of follow-up ( immediately after the 12-month intervention ) BACKGROUND AND OBJECTIVES To evaluate the incidence of falls according to socio-demographic and health factors , and to determine their physical , psychological and social consequences . SUBJETS AND METHOD : Population -based prospect i ve study , which included a representative cohort of 448 elderly community-dwellers , aged 65 or more living in the city of Mataró ( Spain ) . We made a baseline evaluation , which was repeated after a one-year follow up , consisting of a st and ardized question naire on socio-demographic characteristics , physical activity , tests of physical and cognitive function , history of falls during the previous year , the Falls Efficacy Scale , and associated chronic conditions . Follow-up interviews at intervals of one month over 12 months , consisting of a st and ardized question naire aim ed at detecting and describing any fall occurred during the previous month . RESULTS 25.1 % ( 95 % CI , 18.8 - 31.4 ) of males and 37.0 % ( 95 % CI , 31.2 - 42.8 ) of females fell . Multiple falls were observed in 3.8 % of men and 10.9 % of women . 203 falls were reported , providing a crude incidence rate of 30.9 falls per 100 men-years ( 95 % CI , 23.3 - 41.0 ) and 56.5 falls per 100 women-years ( 95 % CI , 46.5 - 68.8 ) . A positive association with falls was found with age , reduced physical and cognitive function , associated chronic conditions and previous falls . 71.1 % of falls had physical consequences , with 7.7 % of fractures , and 21.7 % needed medical aid . 64.4 % of fallers feared of falling again . CONCLUSIONS Our study shows a pattern of high incidence of falls among the elderly living in the Spanish non-institutionalized community . Our data confirm that adverse consequences derived from the falls are frequent and often severe , which makes falls one of the major problems of elderly people Summary This study showed that about a half of the exercise-induced gain in dynamic balance and bone strength was maintained one year after cessation of the supervised high-intensity training of home-dwelling elderly women . However , to maintain exercise-induced gains in lower limb muscle force and physical functioning , continued training seems necessary . Introduction Maintenance of exercise-induced benefits in physical functioning and bone structure was assessed one year after cessation of 12-month r and omized controlled exercise intervention . Methods Originally 149 healthy women 70–78 years of age participated in the 12-month exercise RCT and 120 ( 81 % ) of them completed the follow-up study . Self-rated physical functioning , dynamic balance , leg extensor force , and bone structure were assessed . Results During the intervention , exercise increased dynamic balance by 7 % in the combination resistance and balance-jumping training group ( COMB ) . At the follow-up , a 4 % ( 95 % CI : 1–8 % ) gain compared with the controls was still seen , while the exercise-induced isometric leg extension force and self-rated physical functioning benefits had disappeared . During the intervention , at least twice a week trained COMB subjects obtained a significant 2 % benefit in tibial shaft bone strength index compared to the controls . A half of this benefit seemed to be maintained at the follow-up . Conclusions Exercise-induced benefits in dynamic balance and rigidity in the tibial shaft may partly be maintained one year after cessation of a supervised 12-month multi-component training in initially healthy elderly women . However , to maintain the achieved gains in muscle force and physical functioning , continued training seems necessary Background : Falls in the elderly are a major health problem . Although exercise programs have been shown to reduce the risk of falls , the optimal exercise components , as well as the working mechanisms that underlie the effectiveness of these programs , have not yet been established . Objective : To test whether the Nijmegen Falls Prevention Program was effective in reducing falls and improving st and ing balance , balance confidence , and obstacle avoidance performance in community-dwelling elderly people . Method
Output:
| Interventions that applied posture-challenging exercises showed the highest effects .
Conclusions The present review and meta- analysis provide evidence that physical exercise interventions have the potential to significantly reduce fall rate and risk in healthy older adults . |
MS211534 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Objective The purpose of this study was to investigate whether a long proximal oesophageal resection margin ( PRM ) is associated with improved survival after oesophagectomy for cancer and to identify the optimal margin to aim for in this patient group . Methods A prospect ively maintained data base identified 174 patients who underwent Ivor-Lewis oesophagectomy for cancer . Demographic , clinical , and pathological data were collected . X-tile software was used to identify the optimal resection point . Two models were analysed : single point resection with comparison of two groups ( short and long ) , and two resection points with three groups ( short , medium , and long ) to provide a range . Results The median PRM was 4.0 cm ( interquartile range : 2.5–6.0 cm ) . After adjustment for significant confounders , multivariable Cox PH analysis demonstrated that the optimal resection margin was 1.7 cm , and in the three-group analysis the optimum PRM was between 1.7 and 3 cm . In the two-group analysis , the long margin had no effect on DFS ( p = 0.37 ) , but carried a significantly improved overall survival ( hazard ratio [ HR ] = 0.46 , 95 % confidence interval [ CI ] 0.25–0.87 , p = 0.02 ) . In the three-group analysis , the medium and long groups had improved OS compared with the short group ( on average 54 % , HR ≥ 0.45 , p ≤ 0.04 ) . The 5-year disease-free and overall survival rates were highest in the medium PRM group ( 48 and 57 % respectively ) . Conclusions Optimal survival following oesophagectomy for cancer is achieved with a PRM > 1.7 cm , but a PRM > 3 cm does not yield a further survival advantage . Thus , the optimal PRM is likely to be between 1.7 and 3 cm Aims Neoadjuvant chemotherapy ( NAC ) remains an important therapeutic option for advanced oesophageal cancer ( OC ) . Pathological tumour regression grade ( TRG ) may offer additional information by directing adjuvant treatment and /or follow‐up but its clinical value remains unclear . We analysed the prognostic value of TRG and associated pathological factors in OC patients enrolled in the Medical Research Council ( MRC ) OE02 trial . Methods and results Histopathology was review ed in 497 resections from OE02 trial participants r and omised to surgery ( S group ; n = 244 ) or NAC followed by surgery [ chemotherapy plus surgery ( CS ) group ; n = 253 ] . The association between TRG groups [ responders ( TRG1–3 ) versus non‐responders ( TRG4–5 ) ] , pathological lymph node ( LN ) status and overall survival ( OS ) was analysed . One hundred and ninety‐five of 253 ( 77 % ) CS patients were classified as ‘ non‐responders ’ , with a significantly higher mortality risk compared to responders [ hazard ratio ( HR ) = 1.53 , 95 % confidence interval ( CI ) = 1.05–2.24 , P = 0.026 ] . OS was significantly better in patients without LN metastases irrespective of TRG [ non‐responders HR = 1.87 , 95 % CI = 1.33–2.63 , P < 0.001 versus responders HR = 2.21 , 95 % CI = 1.11–4.10 , P = 0.024 ] . In multivariate analyses , LN status was the only independent factor predictive of OS in CS patients ( HR = 1.93 , 95 % CI = 1.42–2.62 , P < 0.001 ) . Exploratory subgroup analyses excluding radiotherapy‐exposed patients ( n = 48 ) showed similar prognostic outcomes . Conclusion Lymph node status post‐NAC is the most important prognostic factor in patients with resectable oesophageal cancer , irrespective of TRG . Potential clinical implication s , e.g. adjuvant treatment or intensified follow‐up , reinforce the importance of LN dissection for staging and prognostication OBJECTIVE To assess the clinical significance of circumferential resection margins according to current criteria of the College of American Pathologists ( CAP ) and the Royal College of Pathology ( RCP ) in esophageal and esophagogastric cancer . DESIGN Prospect i ve study . SETTING Single-surgeon data base . PATIENTS One hundred thirty-five patients ( mean age , 64 years ) with T3 tumors who underwent esophageal resection for cancer between 1991 and 2006 . Main Outcome Measure Resection margins criteria and survival . RESULTS Three hundred seventy-four consecutive patients were prospect ively identified from an institutional review board-approved data base between 1991 and 2006 . All patients with T3 tumors ( n = 135 ) had their original pathologic slides reassessed by a single gastrointestinal pathologist . Operative mortality was 0.7 % and mean follow-up was 3.1 years . Follow-up was complete in 81 % of patients . Positive margins were identified in 16 cases in the CAP group vs 83 cases in the RCP group . Five-year Kaplan-Meier survival curves in the CAP group demonstrated a significant ( P < .001 ) difference in survival , whereas the RCP group showed no difference ( P = .20 ) . In comparisons of negative vs positive margins , respectively , median survival in the CAP group ( 29.8 months [ 95 % confidence interval ( CI ) , 22.7 - 36.9 ] vs 8.33 months [ 95 % CI , 4.4 - 12.3 ] ) was significantly different from the RCP group ( 28.47 months [ 95 % CI , 19.7 - 37.2 ] vs 22.23 months [ 95 % CI , 13.6 - 30.8 ] ) . At 60-month follow-up , the positive predictive value with respect to survival was 100 % in the CAP group vs 81 % in the RCP group . Univariate and multivariate analyses identified R1 margins in the CAP group and lymph node ratio as being directly linked to survival . CONCLUSIONS Positive circumferential resection margins are prognostically important and the CAP criteria provide a more clinical ly meaningful assessment . Universal adoption of the CAP system can improve interpretation of international clinical trials and allow more accurate comparisons of outcomes SUMMARY . The failure of adjuvant therapy to significantly improve the prognosis of patients undergoing esophago-gastrectomy for cancer may be because of poor patient selection . We sought prognostic factors that would identify those patients who could benefit from adjuvant therapy . Data on 15 possible prognostic factors were prospect ively collected on 225 patients undergoing esophago-gastrectomy at a single institution , and univariate and multivariate analyzes performed . T , N , M and overall UICC stage , differentiation , involvement of the circumferential resection margin and number of metastatic of lymph nodes were identified as significant prognostic factors by univariate analysis . Multivariate analysis revealed that the completeness of resection ( R-category ) , ratio of metastatic to total nodes resected and the presence of vascular invasion were independently significant prognostic factors . Following R0 or R1 resection , patients with a metastatic to total lymph node ratio > 0.2 and ⁄or the presence of vascular invasion have a poor prognosis , and the effects of adjuvant therapy in these patients should be studied Background Controversy exists over the Sixth Edition of the International Union Against Cancer ( UICC ) TNM staging system for esophageal cancer . Inclusion of additional information such as the number of metastatic lymph nodes and extracapsular lymph node invasion may improve the current staging system and lead to optimization of patient treatment . Methods All patients in Adelaide who underwent resection for esophageal cancer between 1997 and 2007 were identified from a prospect i ve data base . Two independent observers then reexamined all pathology slides from the original resection . Univariate and multivariate analysis was performed to identify significant prognostic factors . The goodness of fit and accuracy of additional prognostic factors were assessed , and the staging system was modified according to this information . Results There were 240 patients ( mean age , 62 years ) who met the inclusion criteria . The 5-year overall survival rate was 36 % ( median , 24 months ) . Only histological grade and a refined pN stage were found to be independent prognostic factors that could then be used to improve current TNM staging . Subdivision of pN stage into three groups ( 0 , 1–2 , and > 2 positive nodes ) showed significant differences in 5-year survival between all three groups : 53 % vs 27 % vs 6 % , respectively ( P < .01 ) . The optimal staging model was the same for patients who received neoadjuvant therapy and surgery ( n = 116 ) , and those who underwent surgery alone ( n = 124 ) . Conclusion A staging model that incorporates a refined pN stage and histological grade appears to be more accurate than the current UICC-TNM staging system . This staging model is still applicable in patients who receive neoadjuvant therapy BACKGROUND For rectal carcinoma , the presence of tumour within 1 mm of the circumferential margin is an important independent prognostic factor for both local recurrence and survival . Similar prospect i ve data have not been reported for oesophageal carcinoma and we wished to ascertain the prognostic importance of this variable following potentially curative resection for oesophageal carcinoma . AIM To prospect ively assess the impact of circumferential margin involvement ( tumour within 1 mm ) following potentially curative resection for oesophageal carcinoma . PATIENTS AND METHODS In a prospect i ve study , resection specimens of 135 patients treated with potentially curative oesophageal resection alone were studied for the presence of tumour within 1 mm of the circumferential margin ( margin positive ) , using inked margins and cross sectional slicing of the specimen . All tumours were also staged using the 1987 UICC TNM classification . Patients were followed for a mean of 19 months , and overall and cancer specific survival analysed . RESULTS The finding of tumour cells within 1 mm of the circumferential margin ( CRM+ ) was a significant and independent predictor of survival following potentially curative oesophageal resection . Overall , 64 ( 47 % ) patients were CRM+ . Median survival in this group was 21 months compared with 39 months in the CRM− group ( p=0.015 ) . The impact of CRM status on survival was only seen in patients with a low nodal metastatic burden ( < 25 % nodes positive ) . The odds ratio for the risk of dying from oesophageal cancer was 2.08 when the CRM was involved ( p=0.013 ) . CONCLUSIONS The presence of tumour within 1 mm of the circumferential margin following potentially curative resection for oesophageal carcinoma is an important independent prognostic variable and should be reported routinely Objective : To evaluate prognostic factors and tumor staging in patients after esophagectomy for cancer . Summary Background Data : Several reports have question ed the appropriateness of the sixth edition of the International Union Against Cancer ( UICC ) TNM guidelines for staging esophageal cancer . Additional pathologic characteristics , besides the 3 basic facets of anatomic spread ( tumor , node , metastases ) , might also have prognostic value . Methods : All patients who underwent resection of the esophagus for carcinoma between January 1995 and March 2003 were extracted from a prospect i ve data base . Univariate and multivariate analysis was performed to identify prognostic factors for survival . The goodness of fit and accuracy of 3 staging models ( UICC-TNM , Korst classification , Rice classification ) predicting survival were assessed . Results : A total of 292 patients ( mean age , 63 years ) underwent esophagectomy . The 5-year overall survival rate was 29 % ( median , 21 months ) . pT- , pN- , pm-stage , and radicality of the resection were independent prognostic factors . Subdivision of T1 tumors into mucosal and submucosal showed significant differences in 5-year survival between both groups : 90 % versus 47 % , respectively ( P = 0.01 ) . Subdivision of pN-stage into 3 groups based on the number of positive nodes ( 0 , 1–2 , and > 3 nodes positive ) or the lymph node ratio ( 0 , 0.01–0.2 , and > 0.2 ) also refined staging ( P = 0.001 and P < 0.001 , respectively ) . The current subclassification of M1 ( M1a and M1b ) is not warranted ( P = 0.41 ) . The staging model of Rice was more accurate than the UICC-TNM classification in predicting survival . Conclusion : This study supports the view that the current ( 6th edition ) UICC-TNM staging model for esophageal cancer needs to be revised BACKGROUND A number of clinicopathological characteristics can influence survival following esophagectomy for cancer . The aim of this study was to determine the factors affecting survival in a consecutive series of patients undergoing esophagectomy for cancer at a single tertiary centre over a 7 year period . MATERIAL S & METHODS We analyzed a prospect i ve data base of 314 consecutive patients ( 247 males and
Output:
| Conclusion A positive CRM is associated with a worse prognosis regardless of classification system , T category , tumour type or neoadjuvant therapy |
MS211535 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Forty-four patients presenting for evacuation of retained products of conception were anaesthetized with either fentanyl and thiopentone , or alfentanil with etomi date , along with 70 % nitrous oxide in oxygen . There was no difference between the two techniques in indices of immediate recovery ( time to opening eyes and obeying a simple comm and ) , but the rate of return of higher mental functions ( assessed by a coin counting test ) was significantly better using the alfentanil-etomi date technique . There was no statistically significant difference between the techniques for apnoea or abnormal movements during anaesthesia , but alfentanil with etomi date was associated with significantly more pain on injection and a higher frequency of postoperative vomiting ( 40 % ) OBJECTIVE To evaluate pain relief using paracervical nerve block with 1 % lignocaine injection in patients undergoing uterine evacuation by Manual Vacuum Aspiration ( MVA ) for the treatment of incomplete abortion . DESIGN A r and omized double blind clinical trial . SETTING Marie Stopes Health Centre , Nairobi . METHODS One hundred and forty two patients were recruited between September and October 1997 . The intervention was r and om assignment to the study group ( paracervical block with 1 % lignocaine ) or the placebo group ( paracervical block with sterile water for injection ) . Intra and post operative assessment of pain was made using McGills and facial expression scales . RESULTS The untreated group experienced significantly more pain than the treated group , especially lower abdominal pain and backache . The pain was especially marked intraoperatively , less so 30 minutes post-operatively . CONCLUSION Based on the findings of this study , any patient going for manual vacuum aspiration for the treatment of incomplete abortion should be given Paracervical block as it is cost effective , easy to perform and with less side effects One hundred and fifteen patients admitted to Duke University Medical Center from January 1 , 1973 , to December 31 , 1974 inclusive , with the diagnosis of uncomplicated spontaneous incomplete or inevitable abortion were included in a r and omized prospect i ve study . All patients underwent suction curettage under either analgesia or general inhalation anesthesia . Patient response was adjudged regarding comfort and cooperativeness in the group receiving analgesia and postprocedure rehabilitation and discharge times in both groups . Fifteen of 59 patients receiving analgesia only were recorded unanimously as failures . Post-operative ambulation was no more rapid in patients receiving analgesia . Procedure-to-discharge intervals were unrelated to medication modality . There appears to be no advantage to analgesia as far as rehabilitation time , procedure-to-discharge time , and medical complications are concerned Background and objective : This study was design ed to determine which single bolus dose of remifentanil in combination with propofol and nitrous oxide is best to control the haemodynamic , autonomous and somatic responses in patients scheduled for dilatation and curettage of the uterine cervix . We evaluated the adequacy of different bolus doses of remifentanil , associated with propofol and nitrous oxide , for dilatation and curettage in a prospect i ve double-blind study . Methods : After institutional approval and informed consent , 34 healthy females undergoing curettage to remove material from the uterus after spontaneous abortion were r and omized to receive remifentanil 0.5 μg kg−1 intravenously ( i.v . ) ( Group A ; n = 4 ) , 1 μg kg−1 i.v . ( Group B ; n = 15 ) or 1.5 μg kg−1 i.v . ( Group C ; n = 15 ) , with propofol 2 mg kg−1 i.v . in all groups . Anaesthesia was maintained with 60 % nitrous oxide in oxygen . Haemodynamic , somatic and autonomic signs of light anaesthesia were registered to assess the response to surgical stress . Recovery times and Aldrete score were recorded at the end of the procedure . Results : The groups were similar with regard to biometric data and duration of surgery . The poor results using the lowest dose of remifentanil obliged us to ab and on this dose . The total dose of remifentanil was larger in Group C ( 100 ± 5.7 μg vs. 65 ± 4.1 μg in Group B ; P < 0.05 ) , but more patients required extra bolus injections in Group B ( 69 % vs. 38 % in Group C ; P < 0.01 ) . Recovery times were significantly shorter in Group C. Aldrete scores when leaving the operation room was similar . Conclusions : Remifentanil 1.5 μg kg−1 i.v . with propofol 2 mg kg−1 i.v . and 60 % nitrous oxide in oxygen provided the best anaesthetic control with the fastest recovery times OBJECTIVE To estimate the effectiveness of different methods of analgesia among women treated with manual vacuum aspiration for spontaneous abortion . MATERIAL S AND METHODS The 113 patients diagnosed with incomplete abortion and considered c and i date s for manual vacuum aspiration were r and omly assigned to 3 groups of analgesic administration : diclofenac plus paracervical block ; meperidine plus diclofenac ; and meperidine alone . Pain levels were evaluated using the Wong Scale of Pain . RESULTS The mean pain scores for the three groups were : diclofenac and paracervical block 5.4 ; meperidine plus diclofenac 5.0 ; meperidine 5.7 ( P=0.57 ) . Analysis of pain using the levels mild ( 0 - 3 ) , moderate ( 4 - 6 ) , and severe ( 7 - 10 ) showed no statistical significance among the 3 groups of analgesics . Adverse effects were more common in the groups using analgesia containing meperidine . CONCLUSIONS There was no significant difference between the analgesics used among the 3 groups . Most of the patients , regardless of the analgesic used , reported moderate pain OBJECTIVE To compare evacuation under systemic analgesia ( fentanyl and midazolam ) in a treatment room ( ward group ) with evacuation under general anaesthesia in theatre . DESIGN A prospect i ve r and omised clinical trial . SETTING A tertiary medical centre serving a black urban population . SUBJECTS One hundred and forty-two patients with uncomplicated incomplete abortions . INTERVENTION R and omisation into two groups , those for evacuation under systemic analgesia and those for evacuation under general anaesthesia . MAIN OUTCOME MEASURES Both groups were compared in terms of safety , efficacy , acceptability , blood consumption and time delay between admission and evacuation . RESULTS Significantly less blood was used in the ward group ( 37 units for 13 patients ) than in the theatre group ( 65 units for 24 patients ) ( P < 0.03 ) . Significantly less time was taken between admission and evacuation in the ward group ( median 7 hours 15 minutes ) than in the theatre group ( median 12 hours 38 minutes ) ( P < 0.0003 ) . Evacuation under fentanyl and midazolam was safe , effective and acceptable for the majority of patients compared with evacuation under general anaesthesia . CONCLUSION Patients with uncomplicated incomplete abortions ( uterine size equivalent to a pregnancy of 14 weeks ' duration or less ) can undergo evacuation safely and effectively under fentanyl and midazolam and have a significantly smaller chance of requiring a blood transfusion
Output:
| In terms of postoperative pain , PCB does not improve the control of postoperative pain when it is compared against sedation/analgesia or versus no anaesthesia/no analgesia . |
MS211536 | ***TASK*** the task is to summarize an input biomedical literature 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: Pancreatic fistula is a major form of morbidity following pancreatic resection . We conducted a nonr and omized clinical trial comparing the sealing and s and wich techniques of spraying fibrin glue to prevent pancreatic fistula following distal pancreatectomy . The pancreas was transected with a scalpel to identify and suture the main pancreatic duct and its small branches . In the sealing group , fibrin glue was sprayed over the closed pancreatic stump and sutures . Alternatively , in the s and wich group fibrin glue was sprayed so as to cover and join the cut surface of the pancreatic remnant , which was then held closed with sutures . Altogether 111 patients were included in the study ( 90 with gastric cancer , 10 with esophageal cancer , and 11 with pancreatic cancer ) . Patients were nonr and omly assigned to the s and wich or the sealing group . Morbidity was 21.8 % for the patients in the s and wich group versus 33.9 % in the sealing group . Pancreatic fistulas occurred in 9.0 % of the s and wich group versus 26.8 % of the sealing group . The incidence of fistula was thus significantly lower in the s and wich group . The incidence of fistula was also significantly lower in the s and wich group for gastric malignancy patients undergoing extended radical lymphadenectomy down to the paraaortic lymph nodes combined with left adrenalectomy . Of the patients with gastric malignancy , pancreatic fistulas occurred in 9.3 % of the s and wich group versus 25.5 % of the sealing group . The fibrin glue s and wich technique is simple and reliable and should be valuable for complementing other prophylactic methods of preventing pancreatic fistula BACKGROUND A pancreatic fistula is one of the most serious complications in distal pancreatectomy with en bloc celiac axis resection ( DP-CAR ) , because the pancreatic transection is performed on the right side of the portal vein , which results in a large cross-section surface , and because post-pancreatectomy hemorrhage is hard to treat by interventional radiology . Therefore , a procedure to decrease the incidence of postoperative pancreatic fistula is urgently needed . METHODS Twenty-six consecutive patients who underwent DP-CAR between April 2008 and August 2012 were review ed retrospectively . The first 13 consecutive patients underwent DP-CAR with no anastomosis , and the subsequent 13 consecutive patients were treated with Roux-en-Y pancreaticojejunostomy ( PJ ) in a duct-to-mucosa fashion . RESULTS Extremely high amylase levels ( > 4000 IU/l ) of all drainage fluid specimens on postoperative day ( POD ) 1 , 3 and 4 were detected more frequently in cases with no anastomosis ( n = 7 ) compared to those with PJ ( n = 1 ) ( P = 0.056 ) . CONCLUSION The incidence of grade B/C pancreatic fistulas was 15.4 % in cases with isolated Roux-en-Y anastomosis of the pancreatic stump performed in a duct-to-mucosa fashion , and we are currently examining whether this anastomosis method reduces the pancreatic fistula rate in a multicenter , r and omized controlled trial for distal pancreatectomy patients ( Clinical Trials.gov NCT01384617 ) BACKGROUND The purpose of this study was to analyze the short-term outcome and to determine risk factors after distal pancreatectomy ( DP ) . METHODS This prospect i ve single-center study included 61 patients undergoing DP with splenic preservation in 6 ( 10 % ) . The diagnoses included pancreatic adenocarcinoma ( n = 9 ) , neuroendocrine neoplasms ( n = 17 ) , benign neoplasm ( n = 26 ) , pseudocyst ( n = 4 ) , chronic pancreatitis ( n = 2 ) , and other diagnoses ( n = 3 ) . Twelve clinical factors were studied . The chi-square test was used for univariate analysis . RESULTS The median duration of the postoperative hospital stay was 10 days ( range , 5 - 155 days ) . Two patients ( 3 % ) died postoperatively ; 12 patients ( 20 % ) had one or more intra-abdominal complications with reoperation necessary in 3 patients ( 5 % ) : 6 pancreatic fistula ( 10 % ) , 11 intra-abdominal collection s ( 18 % ) , 1 postoperative hemorrhage ( 2 % ) . Univariate analysis showed that a body mass index > 25 kg/m 2 was the only risk factor for intra-abdominal complication ( P = .003 ) . CONCLUSIONS DP is associated with an intra-abdominal morbidity rate of 20 % , which is increased for patients with a body mass index > 25 kg/m 2 HYPOTHESIS Advances in specialized centers for pancreatic diseases have improved surgical morbidity and outcome . In the past , postoperative local complications ( pancreatic fistulae ) were causing most of the mortality . Now , more patients experience postoperative complications related to their comorbidity . DESIGN To report a prospect i ve audit of a single center 's experience with pancreatic resection during an 8-year period . SETTING Tertiary referral center focused on pancreatic diseases . PATIENTS AND INTERVENTIONS Six hundred seventeen consecutive patients underwent pancreatectomy between November 1 , 1993 , and August 31 , 2001 . The series included 468 pancreatic head resections ( 76 % ) , 25 total pancreatectomies ( 4 % ) , 88 left-sided resections ( 14 % ) , and 36 others ( 6 % ) . MAIN OUTCOME MEASURES Morbidity after pancreatic resection . RESULTS Postoperative in-hospital mortality was 1.6 % , and the additional operation rate was 4.1 % . Four patients died of surgical complications and 6 of systemic complications . Systemic morbidity was 18 % and consisted primarily of cardiopulmonary complications ( 13 % ) . The most frequent postoperative complication was delayed gastric emptying ( 14 % ) , which caused significant prolongation of the hospital stay . No patients died of a postoperative pancreatic fistula , which occurred in 3.2 % , and no completion pancreatectomies were necessary . CONCLUSIONS Pancreatic resections can be performed with considerable safety and a low rate of pancreatic complications . More patients die of systemic complications than in the past , which increases the dem and for precise preoperative patient selection . Completion pancreatectomy should no longer be considered in patients with a pancreatic fistula Pancreaticoduodenectomy ( PD ) is still a difficult procedure with significant morbidity . We report 150 consecutive PDs performed during a 3-year period . All the cases have been prospect ively evaluated with regard to the surgical outcome . Mortality in this series was 3/150 ( 2 % ) with a re-operation rate of 5/150 ( 3.3 % ) ; surgical complications were experienced in 57/150 ( 38 % ) . The most frequent complications were collection s in 25/150 ( 16.6 % ) and pancreatic fistulas in 16/150 ( 10.7 % ) . The majority of these complications were conservatively managed : only one abscess and one fistula due to an anastomotic dehiscence required re-operation . The complication most responsible for mortality was haemorrhage secondary to arterial pseudoaneurysms in patients with severe post-operative pancreatitis . The continued high morbidity of PDs is compensated by the ability to treat complications non-operatively , result ing in a surgical risk that should now be considered medium to low in high volume centres Background Pancreatic fistula continues to be a source of significant morbidity following distal pancreatic resections . The technique of pancreatic division varies widely among surgeons , and there is no evidence that identifies a single method as superior . In our practice , the technique of distal pancreatic resection has evolved from cut- and -sew to stapled technique with green and recently white cartridge . The aim of our study was to evaluate the rate of clinical ly significant fistulas [ International Study Group on Pancreatic Fistula ( ISGPF ) grade B or C ] following distal pancreatectomy and to identify variables associated with a low rate of fistula development . Methods Clinical records of all patients who underwent distal pancreatic resections between February 1999 and July 2010 by a single surgeon were retrospectively review ed focusing on the incidence and type of pancreatic fistula as defined by ISGPF . Study variables included age , gender , surgical approach , extent of resection , ASA classification , type of stapler cartridge , use of Seamguard ™ , and ISGPF classification . Statistical analysis was performed using Fisher ’s exact test , and univariate and multivariate logistic regression . Results Sixty-four patients ( median age 60 , range 21–85 ; 54 % male ) underwent distal pancreatic resection ( laparoscopy 50 % vs. open 50 % ) . The most common indications were pancreatic adenocarcinoma ( N = 15 ; 23 % ) and neuroendocrine neoplasms ( N = 14 ; 22 % ) . Clinical ly significant pancreatic fistula developed in 24 % ( N = 15 ) . The rate of fistula with cut- and -sew technique was 36 % ( 4/11 ) , with stapled green cartridge 31 % ( 9/29 ) and only 5 % ( 1/21 ) with stapled vascular cartridge . Univariate logistic regression identified vascular cartridge size ( p = 0.04 , OR 0.11 ) and open stapled technique ( p = 0.05 , OR 0.12 ) as variables significantly associated with a low fistula rate . Both vascular cartridge size ( p = 0.05 , OR 0.10 ) and open stapled technique ( p = 0.04 , OR 0.08 ) remained significant when analyzed by multivariate logistic regression . Division of pancreatic parenchyma with vascular cartridges result ed in significantly ( p = 0.03 , OR 9.0 ) lower fistula rate compared to green cartridges . The use of Seamguard ™ did not affect fistula rate ( 16 % vs. 27 % ; p = 0.34 ) nor did the performance of multivisceral resection vs. distal pancreatectomy/splenectomy alone ( 21 % vs. 23 % , p = 1.0 ) . Conclusion The optimal technique of pancreatic division has not been conclusively established . Dividing the pancreas utilizing vascular ( 2.5 mm ) staple cartridges significantly decreased the rate of clinical ly significant pancreatic fistula and we have changed our practice accordingly . A prospect i ve r and omized trial is necessary to vali date these results BACKGROUND We previously demonstrated that pancreatic transection with a reinforced staple line results in significantly lower fistula rates than when stapling without reinforcement . ( J Gastrointest Surg . 2007;11:345 - 349 ) . Criticism of this initial study focused on the small size of the treated group ( N = 13 ) . We report four more years of experience with this technique with a larger sample size . METHODS This was a before-after trial . Patients included had distal pancreatectomies with stapled stump closure . The main intervention analyzed was staple-line reinforcement with Seamguard . The experimental group consisted of a consecutive series of stapled pancreatectomies with reinforcement performed from 2005 to 2010 . The control group was a consecutive series of stapled pancreatectomies without reinforcement performed between 2003 and 2005 ( previously published ) . The main outcome measure was pancreatic fistula . RESULTS 54 patients were included ; 36 in the experimental group and 18 in the control group . Mean age was 62 ; 50 % were males . The most common diagnoses were adenocarcinoma ( 31 % ) , cystic neoplasm ( 24 % ) , and neuroendocrine tumor ( 22 % ) . There were no mortalities . Postoperative pancreatic leak rate was 39 % in the control group , and 8 % in the experimental group ( P = 0.01 ) . Seven of ten patients with leak required additional drain placement . Development of pancreatic leak result ed in prolonged hospital stays ( 12 vs eight days , P < 0.007 ) . CONCLUSION We demonstrate sustained success of reinforced stapling for pancreatic stump closure . Our technique is straightforward and results in reduced morbidity and cost . Our results suggest that surgical drains may not be needed when this technique is applied Background Surgery is of increasing importance in the treatment and outcome of diseases of the pancreas worldwide . The incidence of pancreatic cancer ( 7—11/ 100,000 per year ) has risen over the last years and surgical resection remains the only option for definite cure . Twenty-five percent of all resections are left of the superior mesenteric vein ( distal pancreatectomy ) and the appropriate closure technique for the pancreatic remnant remains unclear . Pancreatic fistulas are the most common ( 0—40 % ) and relevant postoperative complication . The optimal surgical strategy for pancreatic resection needs to be identified from the large number of surgical
Output:
| Neither stapler nor scalpel resection followed by h and -sewn closure of the pancreatic remnant for distal pancreatectomy showed any benefit compared to the other method in terms of postoperative pancreatic fistula , overall postoperative mortality or operation time . |
MS211537 | ***TASK*** the task is to summarize an input biomedical literature 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 Nonventilated hospital-acquired pneumonia ( NVHAP ) is a serious nosocomial infection that is increasingly attributed to antibiotic-resistant bacteria . Methods This is a retrospective case-control study comparing patients with and those without NVHAP from January 1 , 2014 to December 31 , 2014 at Barnes-Jewish Hospital , a 1,300-bed urban academic medical center in St. Louis , Missouri . Results One hundred seventy-four consecutive patients with NVHAP were enrolled . A r and om sample of 696 control patients matched by age , sex , race , and hospital admission date were selected from a total of 5,322 potential matched control subjects . NVHAP was pathogen-negative in 98 cases ( 56.3 % ) . Respiratory viruses were identified in 42 patients ( 24.1 % ) , gram-negative bacteria were seen in 25 patients ( 14.4 % ) , and gram-positive bacteria were identified in 20 patients ( 11.5 % ) . Individuals in whom NVHAP developed were more likely to die ( 15.5 % vs 1.6 % ; P < .01 ) , to require intensive care ( 56.3 % vs 22.8 % ; P < .01 ) or mechanical ventilation ( 19.0 % vs 3.9 % ; P < 0.01 ) , and to have a longer hospital length of stay ( 15.9 days [ range , 9.8 - 26.3 days ] vs 4.4 days [ range , 2.9 - 7.3 days ] ; P < 0.01 ) . This case-control study identified a strong association between hospital mortality and NVHAP , with patients who acquired NVHAP having an 8.4 times greater odds of death ( 95 % CI , 5.6 - 12.5 ) . Conclusions The occurrence of NVHAP was associated with significant increases in mortality , the use of intensive care and mechanical ventilation , and hospital length of stay . We also found that respiratory viruses were an important cause of NVHAP . These findings suggest that efforts aim ed at the successful prevention of NVHAP could improve patient outcomes and reduce health-care costs ABSTRACT Hospital-acquired pneumonia ( HAP ) contributes greatly to patient mortality and healthcare costs . Studies have shown that aggressive oral care in intensive care units ( ICUs ) can significantly reduce pneumonia rates , and hospitals have implemented stringent protocol s in this setting . However , little is known about the effectiveness of aggressive oral care in reducing HAP in non – intensive care wards , prompting us to conduct a nonr and omized controlled clinical trial . A structured toothbrushing program was provided to an experimental cohort of patients . A control group received usual care . Patient demographics , toothbrushing frequency , and pneumonia diagnosis were recorded over a 3.5-month period . Difference in pneumonia rates was computed using unadjusted and multivariate logistic regression analyses . No significant difference in pneumonia rates between control and experimental groups was found ( 1.7 % versus 1.8 % ) . Toothbrushing rates increased significantly in the experimental group ( p = .002 ) but fell short of protocol frequency . It became apparent that aggressive toothbrushing program implementation requires nursing-led interdisciplinary involvement , more intensive training , a streamlined documentation system , and efficient compliance tracking . Lessons from this study should be used for future large-scale research . A secondary analysis of these data did , however , suggests that increasing toothbrushing rates may have the potential to reduce pneumonia in the non-ICU acute care setting OBJECTIVES Aspiration of oral secretions and their bacteria is increasingly being recognized as an important factor in pneumonia . We investigated whether oral care lowers the frequency of pneumonia in institutionalized older people . DESIGN Survey . SETTING Eleven nursing homes in Japan . PARTICIPANTS Four hundred seventeen patients r and omly assigned to an oral care group or a no oral care group . INTERVENTION Nurses or caregivers cleaned the patients ' teeth by toothbrush after each meal . Swabbing with povidone iodine was additionally used in some cases . Dentists or dental hygienists provided professional care once a week . MEASUREMENTS Pneumonia , febrile days , death from pneumonia , activities of daily living , and cognitive functions . RESULTS During follow-up , pneumonia , febrile days , and death from pneumonia decreased significantly in patients with oral care . Oral care was beneficial in edentate and dentate patients . Activities of daily living and cognitive functions showed a tendency to improve with oral care . CONCLUSION We suggest that oral care may be useful in preventing pneumonia in older patients in nursing homes Flaws in the design , conduct , analysis , and reporting of r and omised trials can cause the effect of an intervention to be underestimated or overestimated . The Cochrane Collaboration ’s tool for assessing risk of bias aims to make the process clearer and more OBJECTIVE To evaluate the effectiveness of oral health promotion interventions on clinical oral health . DESIGN Single-blind r and omized controlled trial conducted over 3 weeks of in-hospital rehabilitation . SETTING Stroke rehabilitation ward in Hong Kong . PARTICIPANTS Patients with stroke ( N=102 ) admitted to the rehabilitation ward . INTERVENTIONS Patients were r and omly assigned either : ( 1 ) oral hygiene instruction , ( 2 ) oral hygiene instruction and chlorhexidine mouthrinse , or ( 3 ) oral hygiene instruction , chlorhexidine mouthrinse , and assisted brushing . MAIN OUTCOME MEASURES Dental plaque , gingival bleeding , and oral functional status were assessed at baseline and review . Development of infectious complications were also monitored during the clinical trial . RESULTS Poor oral hygiene and an overall neglect of oral hygiene practice s were observed at baseline . Reductions in dental plaque were significantly greater in the 2 groups receiving chlorhexidine compared with the group receiving oral hygiene instruction alone ( P<.001 ) . Reductions in gingival bleeding scores were 3- to 4-fold greater in groups receiving chlorhexidine . No cases of pneumonia were observed during the course of the clinical trial . CONCLUSIONS The oral health condition of patients may be safeguarded after acute stroke with the use of chlorhexidine mouthrinse in conjunction with a st and ard mechanical plaque removal tool , such as an electric toothbrush . These interventions are acceptable to the majority of patients , and their administration poses a minimal burden to rehabilitation ward staff BACKGROUND Pneumonia remains an important public health problem among elderly nursing home residents . This clinical trial sought to determine if a multicomponent intervention protocol , including manual tooth/gum brushing plus 0.12 % chlorhexidine oral rinse , twice per day , plus upright positioning during feeding , could reduce the incidence of radiographically documented pneumonia among nursing home residents , compared with usual care . METHODS This cluster-r and omized clinical trial was conducted in 36 nursing homes in Connecticut . Eligible residents > 65 years with at least 1 of 2 modifiable risk factors for pneumonia ( ie , impaired oral hygiene , swallowing difficulty ) were enrolled . Nursing homes were r and omized to the multicomponent intervention protocol or usual care . Participants were followed for up to 2.5 years for development of the primary outcome , a radiographically documented pneumonia , and secondary outcome , a lower respiratory tract infection ( LRTI ) without radiographic documentation . RESULTS A total of 834 participants were enrolled : 434 to intervention and 400 to usual care . The trial was terminated for futility . The number of participants in the intervention vs control arms with first pneumonia was 119 ( 27.4 % ) vs 94 ( 23.5 % ) , respectively , and with first LRTI , 125 ( 28.8 % ) vs 100 ( 25.0 % ) , respectively . In a multivariable Cox regression model , the hazard ratio in the intervention vs control arms , respectively , was 1.12 ( 95 % confidence interval [ CI ] , .84 - 1.50 ; P = .44 ) for first pneumonia and 1.07 ( 95 % CI , .79 - 1.46 , P = .65 ) for first LRTI . CONCLUSIONS The multicomponent intervention protocol did not significantly reduce the incidence of first radiographically confirmed pneumonia or LRTI compared with usual care in nursing home residents . CLINICAL TRIALS REGISTRATION NCT00975780 INTRODUCTION The purpose of this point-of-care study was to test the efficacy of a prevention-based oral care protocol in reducing non-ventilator-associated hospital-acquired pneumonia in a neurosurgical population outside the critical care environment . The research ers hypothesized that an enhanced oral care protocol would decrease the incidence of pneumonia . METHODS This quasi-experimental , comparative study took place on an acute neurosurgical unit at a tertiary care trauma hospital in Western Canada . Subjects were non-intubated , care-dependent adults with a primary diagnosis of neurologic injury/insult , and at high risk for pneumonia . The prospect i ve study group comprised 34 subjects ; two subjects were excluded from the study analysis . The retrospective study group comprised 51 subjects . Data were collected for both groups for a six-month period . Retrospective data were collected through chart review . The prospect i ve group were eligible neurosurgical patients who received the enhanced oral care protocol . Data collection tools were developed and diagnostic criteria for hospital-acquired pneumonia were determined . The pneumonia rates between subjects who received st and ard oral care ( retrospective group ) and those who received an enhanced , prevention-based , oral care protocol ( prospect i ve group ) were compared . RESULTS A statistically significant decrease in the pneumonia rate occurred in the prospect i ve group ( p < 0.05 ) . DISCUSSION An enhanced oral care protocol was beneficial in reducing the incidence of non-ventilator-associated hospital-acquired pneumonia . IMPLICATION S Nurses play a vital role in preventing hospital-acquired pneumonia . Foundational nursing practice s , such as regular oral hygiene , are important aspects of care in preventing nosocomial infections and related costs , optimizing health , and promoting quality care OBJECTIVE We evaluated the effectiveness of professional oral health care ( POHC ) given by dental hygienists once a week for 24 months to 141 elderly persons needing daily care and living in 2 nursing homes . STUDY DESIGN Elderly subjects with POHC and without POHC living in 2 nursing homes were examined for 24 months to detect any fevers of 37.8 degrees C or more and the prevalence of fatal aspiration pneumonia . The numbers of Staphylococcus species and C and ida albicans in swab sample s from oral cavities were compared between the POHC group and the non-POHC group . The amounts of methylmercaptan exhaled in the POHC group were determined and compared with those in the non-POHC group . RESULTS The prevalence of fevers of 37.8 degrees C or more in the subjects receiving POHC was significantly lower than in the non-POHC group ( P < .05 ) . We found that the ratio of fatal aspiration pneumonia in the POHC group during the 24 months was significantly lower than in the non-POHC group ( P < .05 ) . Numbers of C albicans species in sample s obtained from the oral cavity after 6 months of POHC were significantly lower than those in the non-POHC group ( P < .01 ) . POHC result ed in the reduction of the presence of Staphylococcus but not to a statistically significant extent . The amounts of methylmercaptan exhaled by the POHC group were significantly less than those of the non-POHC group ( P < .05 ) . CONCLUSION This study showed that POHC administered by dental hygienists to a group of elderly patients needing daily nursing care was associated with a reduction in prevalence of fever and fatal pneumonia Background A point‐prevalence survey that was conducted in the United States in 2011 showed that 4 % of hospitalized patients had a health care – associated infection . We repeated the survey in 2015 to assess changes in the prevalence of health care – associated infections during a period of national attention to the prevention of such infections . Methods At Emerging Infections Program sites in 10 states , we recruited up to 25 hospitals in each site area , prioritizing hospitals that had participated in the 2011 survey . Each hospital selected 1 day on which a r and om sample of patients was identified for assessment . Trained staff review ed medical records using the 2011 definitions of health care – associated infections . We compared the percentages of patients with health care – associated infections and performed multivariable log‐binomial regression modeling to evaluate the association of survey year with the risk of health care – associated infections . Results In 2015 , a total of 12,299 patients in 199 hospitals were surveyed , as compared with 11,282 patients in 183 hospitals in 2011 . Fewer patients had health care – associated infections in 2015 ( 394 patients [ 3.2 % ; 95 % confidence interval { CI } , 2.9 to 3.5 ] ) than in 2011 ( 452 [ 4.0 % ; 95 % CI , 3.7 to 4.4 ] ) ( P<0.001 ) , largely owing to reductions in the prevalence of surgical‐site and urinary tract infections . Pneumonia , gastro
Output:
| Conclusions Study results suggest that professional dental care may confer some benefit among NVAP patients .
The lack of consistent OCI protocol s , data in hospitalised patients and robust r and omised clinical trials do not allow definitive conclusions about the contribution of OCI in mitigating NVAP risk |
MS211538 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
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***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: The effect of pharmaceutical care on the prevention , detection , and resolution of medication-related problems in high-risk patients in a rural community was studied . Adult patients who received care at clinics in a medically underserved area of Alabama and who were identified as being at high risk of medication-related adverse events were r and omly assigned to a control group or an intervention group . The control group received st and ard medical care , and the intervention group received pharmaceutical care , including a medical record review , a medication history review , pharmacotherapeutic evaluation , and patient medication education and monitoring over a one-year period . A total of 69 patients completed the study ( 33 in the intervention group and 36 in the control group ) . The percentage of patients responding to hypertension , diabetes , dyslipidemia , and anticoagulation therapy increased significantly in the intervention group and declined in the control group . Ratings for inappropriate prescribing improved in all 10 domains evaluated in the intervention group but worsened in 5 domains in the control group . There were no significant differences between the groups at 12 months in health-related quality of life or medication misadventures . Medication compliance scores improved in the intervention group but not in the control group . Medication knowledge increased in the intervention group and decreased in the control group . Pharmaceutical care in a rural , community-based setting appeared to reduce inappropriate prescribing , enhance disease management , and improve medication compliance and knowledge without adversely affecting health-related quality of life Aim : To measure the outcomes of a harmonised , structured pharmaceutical care programme provided to elderly patients by community pharmacists . Method : A r and omised , controlled , longitudinal , clinical trial with repeated measures was performed over an 18‐month period , involving community pharmacies ( 5 intervention and 5 control ) in Northern Irel and . Elderly , ambulatory patients ( ≥ 65 years ) , taking 4 or more prescribed medications were eligible for participation . Patients attending an intervention pharmacy received education on medical conditions , implementation of compliance strategies , rationalising of drug regimens and appropriate monitoring ; patients attending control sites received normal services . A battery of clinical , humanistic and economic outcomes were assessed . Results : A significantly higher proportion of intervention patients were compliant at the end of the 18‐month study and experienced fewer problems with medication compared to control patients ( P < 0.05 ) . There was little impact on quality of life and health care utilisation . Conclusions : Pharmaceutical care provision to community‐dwelling patients result ed in an improvement in medication compliance and evidence of cost‐savings . Future pharmaceutical care studies may benefit from a more focussed selective approach to data collection and outcomes measurement Abstract Objective To investigate the effects of compliance and periodic telephone counselling by a pharmacist on mortality in patients receiving polypharmacy . Design Two year r and omised controlled trial . Setting Hospital medical clinic . Participants 502 of 1011 patients receiving five or more drugs for chronic disease found to be non-compliant at the screening visit were invited for r and omisation to either the telephone counselling group ( n = 219 ) or control group ( n = 223 ) at enrolment 12 - 16 weeks later . Main outcome measures Primary outcome was all cause mortality in r and omised patients . Associations between compliance and mortality in the entire cohort of 1011 patients were also examined . Patients were defined as compliant with a drug if they took 80 - 120 % of the prescribed daily dose . To calculate a compliance score for the whole treatment regimen , the number of drugs that the patient was fully compliant with was divided by the total number of prescribed drugs and expressed as a percentage . Only patients who complied with all recommended drugs were considered compliant ( 100 % score ) . Results 60 of the 502 eligible patients defaulted and only 442 patients were r and omised . After two years , 31 ( 52 % ) of the defaulters had died , 38 ( 17 % ) of the control group had died , and 25 ( 11 % ) of the intervention group had died . After adjustment for confounders , telephone counselling was associated with a 41 % reduction in the risk of death ( relative risk 0.59 , 95 % confidence interval 0.35 to 0.97 ; P = 0.039 ) . The number needed to treat to prevent one death at two years was 16 . Other predictors included old age , living alone , rate of admission to hospital , compliance score , number of drugs for chronic disease , and non-treatment with lipid lowering drugs at screening visit . In the cohort of 1011 patients , the adjusted relative risk for death was 1.61 ( 1.05 to 2.48 ; P = 0.029 ) and 2.87 ( 1.80 to 2.57 ; P < 0.001 ) in patients with compliance scores of 34 - 66 % and 0 - 33 % , respectively , compared with those who had a compliance score of 67 % or more . Conclusion In patients receiving polypharmacy , poor compliance was associated with increased mortality . Periodic telephone counselling by a pharmacist improved compliance and reduced mortality . Trial registration International St and ard R and omised Controlled Trial Number Register : S RCT N48076318 OBJECTIVE To compare patients ' adherence to therapy , expectations , satisfaction with pharmacy services , and health-related quality of life ( HRQOL ) after the provision of pharmaceutical care with those of patients who received traditional pharmacy care . DESIGN R and omized controlled cluster design . SETTING Sixteen community pharmacies in Alberta , Canada . PATIENTS AND OTHER PARTICIPANTS Ambulatory elderly ( > or = 65 years of age ) patients covered under Alberta Health & Wellness 's senior drug benefit plan and who were concurrently using three or more medications according to pharmacy profiles . INTERVENTION Pharmacies were r and omly assigned to either treatment ( intervention ) or control ( traditional pharmacy care ) groups . Patients at treatment pharmacies were recruited into the study , and pharmacists provided comprehensive pharmaceutical care services . Pharmacists at control pharmacies continued to provide traditional pharmacy care . MAIN OUTCOME MEASURES Study participants ' opinions , adherence to therapy , and scores on the Medical Outcomes Study 36-Item Short Form Health Survey ( SF-36 ) . RESULTS Compared with those of patients receiving traditional care , treatment patients ' expectations that their pharmacist would perform activities congruent with pharmaceutical care changed over the study period . Treatment patients ' satisfaction with the constructs " trust , " " evaluation and goal setting , " and " communicates with doctor " were also positively affected . HRQOL and patient adherence were not significantly affected by pharmaceutical care interventions . CONCLUSION Successful implementation of a pharmaceutical care practice model has the potential to increase patients ' satisfaction with their pharmacists ' activities and may increase patients ' expectations that pharmacists will work on their behalf to assist them with their health care needs . If pharmaceutical care affects patients ' HRQOL , instruments more specific than the SF-36 may be needed to detect the differences CONTEXT Poor medication adherence diminishes the health benefits of pharmacotherapies . Elderly patients with coronary risk factors frequently require treatment with multiple medications , placing them at increased risk for nonadherence . OBJECTIVE To test the efficacy of a comprehensive pharmacy care program to improve medication adherence and its associated effects on blood pressure ( BP ) and low-density lipoprotein cholesterol ( LDL-C ) . DESIGN , SETTING , AND PATIENTS A multiphase , prospect i ve study with an observational phase and a r and omized controlled trial conducted at the Walter Reed Army Medical Center of 200 community-based patients aged 65 years or older taking at least 4 chronic medications . The study was conducted from June 2004 to August 2006 . INTERVENTION After a 2-month run-in phase ( measurement of baseline adherence , BP , and LDL-C ) , patients entered a 6-month intervention phase ( st and ardized medication education , regular follow-up by pharmacists , and medications dispensed in time-specific packs ) . Following the intervention phase , patients were r and omized to continued pharmacy care vs usual care for an additional 6 months . MAIN OUTCOME MEASURES Primary end point of the observation phase was change in the proportion of pills taken vs baseline ; secondary end points were the associated changes in BP and LDL-C. Primary end point of the r and omization phase was the between-group comparison of medication persistence . RESULTS A total of 200 elderly patients ( 77.1 % men ; mean [ SD ] age , 78 [ 8.3 ] years ) , taking a mean ( SD ) of 9 ( 3 ) chronic medications were enrolled . Coronary risk factors included drug-treated hypertension in 184 patients ( 91.5 % ) and drug-treated hyperlipidemia in 162 ( 80.6 % ) . Mean ( SD ) baseline medication adherence was 61.2 % ( 13.5 % ) . After 6 months of intervention , medication adherence increased to 96.9 % ( 5.2 % ; P<.001 ) and was associated with significant improvements in systolic BP ( 133.2 [ 14.9 ] to 129.9 [ 16.0 ] mm Hg ; P = .02 ) and LDL-C ( 91.7 [ 26.1 ] to 86.8 [ 23.4 ] mg/dL ; P = .001 ) . Six months after r and omization , the persistence of medication adherence decreased to 69.1 % ( 16.4 % ) among those patients assigned to usual care , whereas it was sustained at 95.5 % ( 7.7 % ) in pharmacy care ( P<.001 ) . This was associated with significant reductions in systolic BP in the pharmacy care group ( -6.9 mm Hg ; 95 % CI , -10.7 to -3.1 mm Hg ) vs the usual care group ( -1.0 mm Hg ; 95 % CI , -5.9 to 3.9 mm Hg ; P = .04 ) , but no significant between-group differences in LDL-C levels or reductions . CONCLUSIONS A pharmacy care program led to increases in medication adherence , medication persistence , and clinical ly meaningful reductions in BP , whereas discontinuation of the program was associated with decreased medication adherence and persistence . TRIAL REGISTRATION clinical trials.gov Identifier : BACKGROUND Noncompliance is a major factor in the morbidity and unnecessary hospital readmissions for patients with heart failure . Several studies have aim ed to reduce rehospitalizations in heart failure patients through a comprehensive , multidisciplinary approach . Medication compliance was rarely measured in these studies or , when it was measured , the method employed was seldom valid . We aim ed at determining the effect of a pharmacist-led intervention on medication compliance in patients with heart failure . METHODS We conducted a r and omized controlled trial into the effect of a pharmacist-led intervention on medication compliance in patients with heart failure ( predominantly New York Heart Association [ NYHA ] II and III ) treated with loop diuretics , presenting to a cardiology outpatient clinic or admitted to hospitals in The Netherl and s. Patients in the intervention group received monthly consultations from their community pharmacist during a 6-month period . Patients in the control group received usual care . Primary endpoint was medication compliance , assessed with a medication event monitoring system , an electronic pill bottle that registers time of opening . Secondary endpoints were the number of rehospitalizations , death , and quality of life . RESULTS A total of 152 patients were r and omized : 74 patients to the intervention arm and 78 patients to the usual care arm . Over the 6-month study period , patients in the intervention group had 140/7656 days without use of loop diuretics compared with 337/6196 days in the usual care group ( relative risk 0.33 [ confidence interval ( CI ) 95 % 0.24 - 0.38 ] ) . Two consecutive days of nondosing occurred on 18/7656 days in the intervention group compared with 46/6196 days in the usual care group ( relative risk 0.32 [ CI 95 % 0.19 - 0.55 ] ) . There were no significant differences in rehospitalizations , mortality , or disease-specific quality of life between groups . CONCLUSIONS A pharmacy-led intervention can improve medication compliance in patients with moderate to severe heart failure , even in those with relatively high compliance . Future interventions should also focus at less compliant patients The objective of this systematic review was to evaluate the impact of pharmacist delivered community-based services to optimise the use of medications for mental illness . Twenty-two controlled ( r and omised and non-r and omised ) studies of pharmacists ' interventions in community and residential aged care setting s identified in international scientific literature were included for review . Papers were assessed for study design , service recipient , country of origin , intervention type , number of participating pharmacists , method ological quality and outcome measurement . Three studies showed that pharmacists ' medication counselling and treatment monitoring can improve adherence to antidepressant medications among those commencing treatment when calculated using an intention-to-treat analysis . Four trials demonstrated that pharmacist conducted medication review s may reduce the number of potentially inappropriate medications prescribed to those at high risk of medication misadventure . The results of this review provide some evidence that pharmacists can contribute to optimising the use of medications for mental illness in the community setting
Output:
| : The evidence from this review does not clearly support one single intervention to optimize medication adherence in older patients . |
MS211539 | ***TASK*** the task is to summarize an input biomedical literature 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 clinical activity and target modulation of v and etanib in women with recurrent ovarian cancer . Experimental Design : A phase II trial of orally administered v and etanib 300 mg daily was design ed to include analyses of target inhibition through paired biopsies and dynamic imaging . Core 18-gauge needle biopsies and dynamic contrast-enhanced magnetic resonance imaging were obtained before initiation of therapy and 6 weeks into therapy . Biopsy sample s were subjected to reverse-phase protein lysate array endpoint analysis . Cytokine concentrations were measured by enzyme-linked immunosorbent assay in serially collected plasma sample s. Results : Twelve patients entered the study , and accrual was terminated in the first stage because of lack of response or disease stabilization beyond 6 months . Adverse events included rash , diarrhea , and prolonged QT interval corrected for heart rate , but not hypertension . Exploratory analyses showed that epidermal growth factor receptor ( EGFR ) phosphorylation was reduced in the eight paired biopsy sets obtained ; vascular endothelial growth factor ( VEGF ) receptor-2 phosphorylation was not consistently affected nor were dynamic contrast-enhanced MRI permeability and flow parameters . Serial plasma VEGF concentrations were variable and did not significantly change in the 11 patients assessed . Conclusions : V and etanib 300 mg daily monotherapy had no significant clinical benefit in this disease setting . Proteomic analysis of paired biopsies detected both phosphorylated-EGFR and phosphorylated-VEGF receptor-2 in ovarian tumor tissue , but only phosphorylated-EGFR was measurably inhibited by v and etanib . Clin Cancer Res ; 16(2 ) ; OBJECTIVE Sorafenib ( Nexavar ) is an oral multi-kinase inhibitor that targets tumor growth and angiogenesis . This phase II study investigated efficacy , safety , and pharmacokinetics of sorafenib in Japanese patients with advanced renal cell carcinoma ( RCC ) . METHODS Nonr and omized , open-label study in Japanese patients with metastatic renal cell carcinoma who had received nephrectomy and failed > /=1 cytokine-containing therapy . The primary endpoint was response rate . Patients received sorafenib 400 mg twice daily ( b.i.d . ) on a continuous dosing schedule . RESULTS A total of 129 patients ( median age 63 years ) were valid for intention-to-treat analyses . Confirmed partial responses were observed in 16 ( 12.4 % ) patients , and investigators assessed that 19 ( 14.7 % ) of the patients achieved a partial response . Stable disease was reported in 93 ( 72.1 % ) patients , and 103 ( 80.5 % ) patients had tumor shrinkage . Median progression-free survival was 224 days and the 25th percentile of overall survival was estimated at 288 days . The most frequently occurring drug-related adverse events ( any grade ) were elevated lipase ( 56 % ) , h and -foot skin reaction ( 55 % ) , alopecia ( 39 % ) , increased amylase ( 38 % ) , rash/desquamation ( 37 % ) , and diarrhea ( 34 % ) . A total of 14 ( 10.7 % ) patients had serious sorafenib-related adverse events , including one adverse event of worst grade 5 ( dyspnea occurred 35 days after the last dose of study medication ) . The C(trough , steady state ) values in RCC patients ( n = 63 ) receiving sorafenib 400 mg b.i.d . were similar to those obtained from a Japanese phase I study involving patients with mixed solid tumors . CONCLUSION Sorafenib showed encouraging efficacy and was well tolerated in Japanese patients with metastatic RCC The objective of this phase II single-arm study was to evaluate the efficacy and safety of pazopanib , a multi-targeted tyrosine kinase inhibitor , against vascular endothelial growth factor receptor (VEGFR)-1 , -2 , and -3 , platelet-derived growth factor receptor-alpha and -beta , and c-Kit , in recurrent glioblastoma . Patients with < or = 2 relapses and no prior anti-VEGF/VEGFR therapy were treated with pazopanib 800 mg daily on 4-week cycles without planned interruptions . Brain magnetic resonance imaging and clinical re assessment were made every 8 weeks . The primary endpoint was efficacy as measured by 6-month progression-free survival ( PFS6 ) . Thirty-five GBM patients with a median age of 53 years and median Karnofsky performance scale of 90 were accrued . Grade 3/4 toxicities included leukopenia ( n = 1 ) , lymphopenia ( n = 2 ) , thrombocytopenia ( n = 1 ) , ALT elevation ( n = 3 ) , AST elevation ( n = 1 ) , CNS hemorrhage ( n = 1 ) , fatigue ( n = 1 ) , and thrombotic/embolic events ( n = 3 ) ; 8 patients required dose reduction . Two patients had a partial radiographic response by st and ard bidimensional measurements , whereas 9 patients ( 6 at the 8-week point and 3 only within the first month of treatment ) had decreased contrast enhancement , vasogenic edema , and mass effect but < 50 % reduction in tumor . The median PFS was 12 weeks ( 95 % confidence interval [ CI ] : 8 - 14 weeks ) and only 1 patient had a PFS time > or = 6 months ( PFS6 = 3 % ) . Thirty patients ( 86 % ) had died and median survival was 35 weeks ( 95 % CI : 24 - 47 weeks ) . Pazopanib was reasonably well tolerated with a spectrum of toxicities similar to other anti-VEGF/VEGFR agents . Single-agent pazopanib did not prolong PFS in this patient population but showed in situ biological activity as demonstrated by radiographic responses . Clinical Trials.gov identifier : NCT00459381 STUDY OBJECTIVE To determine if excretion of sorafenib in sweat is associated with h and -foot skin reaction in patients receiving sorafenib . DESIGN Prospect i ve pilot study . SETTING Outpatient clinic of a cancer research institution . PATIENTS Two patients who were receiving sorafenib and developed a h and -foot skin reaction of at least grade 1 and two healthy subjects ( controls ) . INTERVENTION Sweat production was stimulated in both the patients with h and -foot skin reaction and the healthy subjects by means of pilocarpine iontophoresis . MEASUREMENTS AND MAIN RESULTS Sweat sample s were collected from the patients with h and -foot skin reaction and from the healthy subjects . Using liquid chromatography-t and em mass spectrometry , sorafenib concentrations were measured in the sweat sample s. Sweat sample s from the healthy subjects were spiked with known concentrations of sorafenib to determine the lower limit of quantification of the assay , which was determined to be 5 ng/ml . Sorafenib concentrations in the sample s from the patients with h and -foot skin reaction were undetectable based on the assay 's sensitivity . CONCLUSION Our results suggest that h and -foot skin reaction in patients receiving sorafenib is not associated with excretion of sorafenib in sweat . Further studies are needed to underst and the mechanism of h and -foot skin reaction , a treatment-limiting adverse effect of multikinase inhibitors BACKGROUND We conducted a phase 3 , r and omized , double-blind , placebo-controlled trial of sorafenib , a multikinase inhibitor of tumor-cell proliferation and angiogenesis , in patients with advanced clear-cell renal-cell carcinoma . METHODS From November 2003 to March 2005 , we r and omly assigned 903 patients with renal-cell carcinoma that was resistant to st and ard therapy to receive either continuous treatment with oral sorafenib ( at a dose of 400 mg twice daily ) or placebo ; 451 patients received sorafenib and 452 received placebo . The primary end point was overall survival . A single planned analysis of progression-free survival in January 2005 showed a statistically significant benefit of sorafenib over placebo . Consequently , crossover was permitted from placebo to sorafenib , beginning in May 2005 . RESULTS At the January 2005 cutoff , the median progression-free survival was 5.5 months in the sorafenib group and 2.8 months in the placebo group ( hazard ratio for disease progression in the sorafenib group , 0.44 ; 95 % confidence interval [ CI ] , 0.35 to 0.55 ; P<0.01 ) . The first interim analysis of overall survival in May 2005 showed that sorafenib reduced the risk of death , as compared with placebo ( hazard ratio , 0.72 ; 95 % CI , 0.54 to 0.94 ; P=0.02 ) , although this benefit was not statistically significant according to the O'Brien-Fleming threshold . Partial responses were reported as the best response in 10 % of patients receiving sorafenib and in 2 % of those receiving placebo ( P<0.001 ) . Diarrhea , rash , fatigue , and h and -foot skin reactions were the most common adverse events associated with sorafenib . Hypertension and cardiac ischemia were rare serious adverse events that were more common in patients receiving sorafenib than in those receiving placebo . CONCLUSIONS As compared with placebo , treatment with sorafenib prolongs progression-free survival in patients with advanced clear-cell renal-cell carcinoma in whom previous therapy has failed ; however , treatment is associated with increased toxic effects . ( Clinical Trials.gov number , NCT00073307 [ Clinical Trials.gov ] . ) PURPOSE Given the importance of angiogenesis in soft tissue sarcoma ( STS ) , pazopanib , an oral angiogenesis inhibitor that targets vascular endothelial growth factor receptor and platelet-derived growth factor receptor , was explored in patients with advanced STS . PATIENTS AND METHODS Patients with intermediate- or high- grade advanced STS who were ineligible for chemotherapy or who had received no more than two prior cytotoxic agents for advanced disease , who had documented progression , who had adequate performance status , and who had good organ function were eligible . Pazopanib 800 mg was given daily . The primary end point was progression-free rate at 12 weeks ( PFR(12 weeks ) ) . Secondary end points were response , safety , and overall survival . Four different strata were studied : adipocytic STS , leiomyosarcomas , synovial sarcomas , and other STS types . A Simon two-stage design was applied ( P1 = 40 % ; P0 = 20 % ; alpha = beta = .1 ) for each stratum . Results One hundred forty-two patients were enrolled . The adipocytic STS stratum was closed after the first stage , given insufficient activity ( PFR(12 weeks ) , five [ 26 % ] of19 ) . PFR(12 weeks ) was 18 ( 44 % ) of 41 patients in the leiomyosarcoma cohort , 18 ( 49 % ) of 37 in the synovial sarcomas , and 16 ( 39 % ) of 41 in the other STS types . Compared with historical controls who were treated with second-line chemotherapy , progression-free and overall survivals were prolonged in the three cohorts in which the primary end point was reached . The most frequent drug-related toxicities were hypertension , fatigue , hypopigmentation , and nausea . Other toxicities included liver enzyme elevations , myelosuppression , and proteinuria , all of which were mostly grade s 1 to 2 . The most frequent grade s 3 to 4 toxicities were hyperbilirubinemia ( 6.3 % ) , hypertension ( 7.7 % ) , and fatigue ( 7.7 % ) . CONCLUSION Pazopanib is well tolerated in patients with relapsed , advanced STS and demonstrates interesting activity that warrants additional study in patients with leiomyosarcomas , synovial sarcomas , and other STS types PURPOSE Pazopanib and lapatinib are tyrosine kinase inhibitors that target vascular endothelial growth factor receptor , platelet-derived growth factor receptor , and c-Kit or epidermal growth factor receptor ( EGFR ) and human epidermal growth factor receptor 2 ( HER2/neu ) , respectively . In cervical cancer , EGFR and HER2/neu overexpression and high microvascular density correlate with survival . PATIENTS AND METHODS Patients with measurable stage IVB persistent/recurrent cervical carcinoma not amenable to curative therapy and at least one prior regimen in the metastatic setting were r and omly assigned in a ratio of 1:1:1 to pazopanib at 800 mg once daily , lapatinib at 1,500 mg once daily , or lapatinib plus pazopanib combination therapy ( lapatinib at 1,000 mg plus pazopanib at 400 mg once daily or lapatinib at 1,500 mg plus pazopanib at 800 mg once daily ) . Therapy continued until progression or withdrawal because of adverse events ( AEs ) . Primary end point was progression-free survival ( PFS ) , and secondary end points were overall survival ( OS ) , response rate ( RR ) , and safety . The fut
Output:
| Despite sharing the same spectrum of target receptors with sorafenib and sunitinib , pazopanib is associated with an unexpectedly low risk of HFSR . |
MS211540 | ***TASK*** the task is to summarize an input biomedical literature 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 Outcome measurement following surgery is increasingly the focus of attention in current health-care debates because of the rising costs of medical care and the large variety of operative options . The purpose of the present study was to correlate quality of life after volar locked plate fixation of unstable intra-articular distal radial fractures with functional and radiographic results as well as with quality -of-life data from population norms . METHODS Fifty-four consecutive patients with intra-articular distal radial fractures and a mean age of sixty-three years were managed with a volar locked plate system . Range of motion , grip strength , and radiographs were assessed at a mean of six years postoperatively . The wrist-scoring systems of Gartl and and Werley and Castaing were adopted for the assessment of objective outcomes . The Disabilities of the Arm , Shoulder and H and and Short Form-36 question naires were completed as subjective outcome measures , and the results were compared with United States and Austrian population norms . RESULTS Functional improvement continued for two years postoperatively . At the time of the latest follow-up , > 90 % of all patients had achieved good or excellent results according to the scoring systems of Gartl and and Werley and Castaing . The results of the Short Form-36 question naire were similar to the United States and Austrian population norms . The mean Disabilities of the Arm , Shoulder and H and score was 5 points at two years , and it increased to 13 points at six years . The twenty patients with radiocarpal arthritis had significantly poorer results in the physical component summary measure of the Short Form-36 question naire ( p = 0.012 ) . CONCLUSIONS The results of the present single-center study show that , following distal radial fracture fixation , wrist arthritis may affect the patient 's subjective well-being , as documented with the Short Form-36 , without influencing the functional outcome . Well- design ed longitudinal clinical trials are needed to confirm the findings of the present investigation in terms of quality of life after surgical treatment of intra-articular distal radial fractures Background Reduced muscular strength in the old age is strongly related to activity impairment and mortality . However , studies evaluating the gender-specific association between muscularity and mortality among older adults are lacking . Thus , the objective of the present study was to examine gender differences in the association between muscular strength and mortality in a prospect i ve population -based cohort study . Methods Data used in this study derived from the Cooperative Health Research in the Region of Augsburg (KORA)-Age Study . The present analysis includes 1,066 individuals ( mean age 76 ± 11 SD years ) followed up over 3 years . H and grip strength was measured using the Jamar Dynamometer . A Cox proportional hazard model was used to determine adjusted hazard ratios of mortality with 95 % confidence intervals ( 95 % CI ) for h and grip strength . Potential confounders ( i.e. age , nutritional status , number of prescribed drugs , diseases and level of physical activity ) were pre-selected according to evidence -based information . Results During the follow-up period , 56 men ( 11 % ) and 39 women ( 7 % ) died . Age-adjusted mortality rates per 1,000 person years ( 95 % CI ) were 77 ( 59–106 ) , 24 ( 13–41 ) and 14 ( 7–30 ) for men and 57 ( 39–81 ) , 14 ( 7–27 ) and 1 ( 0–19 ) for women for the first , second and third sex-specific tertile of muscular strength , respectively . Low h and grip strength was significantly associated with all-cause mortality among older men and women from the general population after controlling for significant confounders . Hazard ratios ( 95 % CI ) comparing the first and second tertile to the third tertle were 3.33 ( 1.53–7.22 ) and 1.42 ( 0.61 - 3.28 ) , respectively . Respective hazard ratios ( 95 % CI ) for mortality were higher in women than in men ( ( 5.23 ( 0.67–40.91 ) and 2.17 ( 0.27–17.68 ) versus 2.36 ( 0.97–5.75 ) and 0.97 ( 0.36–2.57 ) ) . Conclusions Grip strength is inversely associated with mortality risk in older adults , and this association is independent of age , nutritional status , number of prescribed drugs , number of chronic diseases and level of physical activity . The association between muscular strength and all-cause mortality tended to be stronger in women . It seems to be particularly important for the weakest to enhance their levels of muscular strength in order to reduce the risk of dying early A prospect i ve cohort of 120 patients with distal radius fractures completed a baseline evaluation that determined their age , sex , education level , injury compensation status , AO fracture type , prereduction radial shortening , and postreduction radial shortening . Six months later patients self-reported pain and disability using the Patient-Rated Wrist Evaluation , and were tested for physical impairment ( grip , wrist range of motion , and dexterity ) . Univariate and forward stepwise regression analyses agreed that the most influential predictor of pain and disability at 6 months was injury compensation . Patient education level and prereduction radial shortening also contributed predictive information ( R squared = 25 % ) . Wrist impairment was moderately correlated with patient reported pain and disability ( r = 0.50 ) . Both impairment and disability measures are required to fully describe outcomes . Further work is required to delineate additional factors that contribute to outcome Subchondral hematomas have been found with arthroscopy in one third of patients with dislocated distal radial fractures . The aim of the present , prospect i ve study was to determine whether these hematomas might cause radiographic osteoarthrosis . We studied 41 patients ( age 20 - 57 years , 22 women ) with a dislocated distal radial fracture . At the time of fracture , 12 patients had subchondral hematomas in a radiocarpal compartment without a fracture line , as defined by arthroscopy . The 1-year follow-up included clinical and radiographic examinations . At follow-up , radiographic subchondral bone plate changes occurred in unfractured compartments in 8 patients , of whom 7 had had a previous arthroscopically diagnosed subchondral hematoma ( p = 0.02 ) in the same compartment . Of the 8 patients with radiographic changes , 4 had also developed joint space narrowing ( osteoarthrosis ( OA ) grade 1 ) after 1 year and 6 after 3 years . All but 1 had had a hematoma in the same compartment . More importantly , 3 of the 16 patients with entirely extra-articular fractures had subchondral bone plate changes in a compartment corresponding to a previous subchondral hematoma ( p = 0.02 ) . One of these had also developed joint space narrowing . The patients with radiographic changes had a worse outcome , as measured with the Gartl and and Werley wrist score ( p = 0.06 ) . In conclusion , subchondral hematomas in distal radial fractures can lead to early onset of mild OA and worse outcome after 1 year BACKGROUND Reduced muscular strength , as measured by grip strength , has been associated with an increased risk of all-cause and cardiovascular mortality . Grip strength is appealing as a simple , quick , and inexpensive means of stratifying an individual 's risk of cardiovascular death . However , the prognostic value of grip strength with respect to the number and range of population s and confounders is unknown . The aim of this study was to assess the independent prognostic importance of grip strength measurement in socioculturally and economically diverse countries . METHODS The Prospect i ve Urban-Rural Epidemiology ( PURE ) study is a large , longitudinal population study done in 17 countries of varying incomes and sociocultural setting s. We enrolled an unbiased sample of households , which were eligible if at least one household member was aged 35 - 70 years and if household members intended to stay at that address for another 4 years . Participants were assessed for grip strength , measured using a Jamar dynamometer . During a median follow-up of 4.0 years ( IQR 2.9 - 5.1 ) , we assessed all-cause mortality , cardiovascular mortality , non-cardiovascular mortality , myocardial infa rct ion , stroke , diabetes , cancer , pneumonia , hospital admission for pneumonia or chronic obstructive pulmonary disease ( COPD ) , hospital admission for any respiratory disease ( including COPD , asthma , tuberculosis , and pneumonia ) , injury due to fall , and fracture . Study outcomes were adjudicated using source documents by a local investigator , and a subset were adjudicated central ly . FINDINGS Between January , 2003 , and December , 2009 , a total of 142,861 participants were enrolled in the PURE study , of whom 139,691 with known vital status were included in the analysis . During a median follow-up of 4.0 years ( IQR 2.9 - 5.1 ) , 3379 ( 2 % ) of 139,691 participants died . After adjustment , the association between grip strength and each outcome , with the exceptions of cancer and hospital admission due to respiratory illness , was similar across country-income strata . Grip strength was inversely associated with all-cause mortality ( hazard ratio per 5 kg reduction in grip strength 1.16 , 95 % CI 1.13 - 1.20 ; p<0.0001 ) , cardiovascular mortality ( 1.17 , 1.11 - 1.24 ; p<0.0001 ) , non-cardiovascular mortality ( 1.17 , 1.12 - 1.21 ; p<0.0001 ) , myocardial infa rct ion ( 1.07 , 1.02 - 1.11 ; p=0.002 ) , and stroke ( 1.09 , 1.05 - 1.15 ; p<0.0001 ) . Grip strength was a stronger predictor of all-cause and cardiovascular mortality than systolic blood pressure . We found no significant association between grip strength and incident diabetes , risk of hospital admission for pneumonia or COPD , injury from fall , or fracture . In high-income countries , the risk of cancer and grip strength were positively associated ( 0.916 , 0.880 - 0.953 ; p<0.0001 ) , but this association was not found in middle-income and low-income countries . INTERPRETATION This study suggests that measurement of grip strength is a simple , inexpensive risk-stratifying method for all-cause death , cardiovascular death , and cardiovascular disease . Further research is needed to identify determinants of muscular strength and to test whether improvement in strength reduces mortality and cardiovascular disease . FUNDING Full funding sources listed at end of paper ( see Acknowledgments ) Objectives Management of AO type B and C fractures of the distal radius is controversial . This study compares outcomes and complications of AO type B and C fractures of the distal radius treated with volar locked plating and nonoperative methods . Material s and methods Sixty-four patients with fractures of the distal radius ( AO type B and C ) were included in this study , according to inclusion criteria , and were allocated to the volar plating group or nonoperative group by alternate r and omization : 32 patients with odd numbers went into the nonoperative group and the other 32 with even numbers went into the volar plating group . Patients in the nonoperative group were managed with closed reduction of the fracture and plaster cast application under an image intensifier . Those in the volar plating group were managed by open reduction and fixation with a volar locked plate . Preoperative and postoperative serial clinico-radiological follow-up was done . The range of movement , grip strength , functional outcome scores and radiological parameters were compared . Student ’s t-test was used for statistical analysis with significance at p < 0.05 . Results Range of movement and functional scores were significantly ( p < 0.001 ) better in the volar plating group , but the difference in ulnar variance and radial and ulnar deviation was insignificant as compared to the nonoperative group . At 24 months follow-up , the nonoperative group had significantly more cases with malunion , articular incongruity and osteoarthritis . Conclusion In cases of AO type B or C fractures of the distal radius , volar locked plating provides anatomical stable fixation and early mobilization with better clinico-radiological outcome as compared to conservative treatment Introduction We aim ed to evaluate the influence of associated scapholunate ( SL ) and /or lunotriquetral ligament ( LT ) injury on the outcome of distal radius fractures . Material s and methods This prospect i ve study included 40 patients with surgically treated distal radius fracture . Wrist arthroscopy was used to identify associated lesions of the scapholunate and lunotriquetral ligaments and classify them according to Geissler . Patients were divided in two groups by presence ( injured group ) or absence ( intact group ) of associated injury of the SL and /or LT ligament . The patient-rated wrist evaluation ( PRWE ) and the disabilities of the arm , shoulder and h and ( DASH ) question naires were used to evaluate disability 3 and 6 months after injury . Grip strength was also evaluated . Results Wrist arthroscopy identified SL and /or LT injury in 15 patients ( 37.5 % ) . Mean total PRWE score for the intact group was
Output:
| Articular incongruence was a significant predictor for PA .
Conclusions A high prevalence of PA was found in non-osteoporotic patients following a distal radius fracture .
PA following a distal radial fracture was associated with a limited radial deviation and flexion , but not with grip strength .
Articular incongruence predicted PA . |
MS211541 | ***TASK*** the task is to summarize an input biomedical literature 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 . A prospect i ve , r and omized , single ( investigator ) blind , comparative efficacy trial was conducted . Objective . To compare the efficacy of continuous low-level heat wrap therapy ( 40 C , 8 hours/day ) with that of ibuprofen ( 1200 mg/day ) and acetaminophen ( 4000 mg/day ) in subjects with acute nonspecific low back pain . Summary of Background Data . The efficacy of topical heat methods , as compared with oral analgesic treatment of low back pain , has not been established . Methods . Subjects ( n = 371 ) were r and omly assigned to heat wrap ( n = 113 ) , acetaminophen ( n = 113 ) , or ibuprofen ( n = 106 ) for efficacy evaluation , or to oral placebo ( n = 20 ) or unheated back wrap ( n = 19 ) for blinding . Outcome measures included pain relief , muscle stiffness , lateral trunk flexibility , and disability . Efficacy was measured over two treatment days and two follow-up days . Results . Day 1 pain relief for the heat wrap ( mean , 2 ) was higher than for ibuprofen ( mean , 1.51;P = 0.0007 ) or acetaminophen ( mean , 1.32;P = 0.0001 ) . Extended mean pain relief ( Days 3 to 4 ) for the heat wrap ( mean , 2.61 ) also was higher than for ibuprofen ( mean , 1.68;P = 0.0001 ) or acetaminophen ( mean , 1.95;P = 0.0009 ) . Lateral trunk flexibility was improved with the heat wrap ( mean change , 4.28 cm ) during treatment ( P ≤ 0.009 vs acetaminophen [ mean change , 2.93 cm ] , P ≤ 0.001 vs ibuprofen [ mean change , 2.51 cm ] ) . The results were similar on Day 4 . Day 1 reduction in muscle stiffness with the heat wrap ( mean , 16.3 ) was greater than with acetaminophen ( mean , 10.5;P = 0.001 ) . Disability was reduced with the heat wrap ( mean , 4.9 ) , as compared with ibuprofen ( mean , 2.7;P = 0.01 ) and acetaminophen ( mean , 2.9;P = 0.0007 ) , on Day 4 . None of the adverse events were serious . The highest rate ( 10.4 % ) was reported in the ibuprofen group . Conclusion . Continuous low-level heat wrap therapy was superior to both acetaminophen and ibuprofen for treating low back pain A double-blind , 18-center , balanced trial of diflunisal vs. cyclobenzaprine HCl vs. these two drugs combined vs. placebo produced complete results from 175 patients . They had sought treatment at the cooperating centers for acute painful spasms of the back within a day or two of trauma or strain . Global results over the 7 to 10 days of observations revealed a clinical ly and statistically significant superiority of the combined therapy by Day 4 ( P=0.006 ) and almost all patients recovered within a week to 10 days . A combination therapy with an effective safe analgesic and a true muscle relaxant for less than a week appears to be an excellent relief measure for acute back problems Study Design . Two replicate , 4-week , r and omized , double-blind , placebo-controlled , trials of rofecoxib 25 and 50 mg versus placebo for chronic low back pain . Objectives . To determine the efficacy and safety of two doses of rofecoxib compared to placebo in the treatment of chronic low back pain . Summary of Background Data . Although nonsteroidal anti-inflammatory drugs are commonly prescribed for chronic low back pain , their efficacy is unproven and toxicity can be serious . These studies evaluated the efficacy and tolerability of rofecoxib , a selective COX-2 inhibitor , in the treatment of chronic low back pain . Methods . Patients with chronic low back pain were r and omized 1:1:1 to rofecoxib 25 mg , 50 mg , or placebo once daily . Primary endpoint : Low Back Pain Intensity . Secondary endpoints : Pain Bothersomeness , Global Assessment s of Response to Therapy , Global Assessment of Disease Status , Rol and -Morris Disability Question naire , SF-12 Health Survey , Use of Rescue Acetaminophen , and Discontinuations Due to Lack of Efficacy . Results . Combining both studies , 690 patients were r and omized to placebo ( N = 228 ) , rofecoxib 25 mg ( N = 233 ) , or rofecoxib 50 mg ( N = 229 ) . Mean ( ± SD ) age was 53.4 ( ± 12.9 ) years , pain duration 12.1 ( ± 11.8 ) years , 62.3 % female . Both rofecoxib groups improved significantly . Mean differences from placebo in pain intensity were −13.50 mm , −13.81 mm ( 25 , 50 mg doses ) respectively ( P < 0.001 ) . Both regimens were superior to placebo in eight of nine secondary endpoints . Fifty mg provided no advantage over 25 mg . Both rofecoxib regimens were well tolerated , although 25 mg had a slightly better safety profile . Conclusions . Rofecoxib significantly reduced chronic low back pain in adults and was well tolerated The study objective was to assess the efficacy and patient acceptance of ketorolac as an alternative to meperidine for the treatment of severe musculoskeletal low back pain ( LBP ) . A double blinded prospect i ve trial in a convenience sample of patients > 18 years of age presenting to an urban university hospital emergency department ( ED ) was conducted over a 19-month period . Patients were included if the pain was musculoskeletal in origin and was severe enough to warrant parenteral analgesics . Patients were r and omized to receive 1 mg/kg meperidine intramuscularly ( IM ) or 60 mg ketorolac IM . Pain intensity was measured preadministration and at 60 minutes via a 100 mm Visual Analog Scale ( VAS ) . Outcomes measured at 60 minutes were pain intensity decrease ( PID ) , patient satisfaction , rescue analgesia requirement , sedation level , and adverse effects . Clinical ly significant pain reduction was defined as a PID of at least 13 mm or a reduction in pain of least 30 % . One hundred fifty-five patients were enrolled ( meperidine = 75 , ketorolac = 80 ) and 153 patients completed the study . At 60 minutes the mean PID was 7 mm less in the ketorolac group ( 95 % confidence interval [ CI ] - 15 mm to 2.6 mm ) . Pain reduction of at least 30 % occurred in 63 % of the ketorolac group versus 67 % of the meperidine group ( 95 % CI , odds ratio [ OR ] .43 to 1.61 ) . Rescue analgesia was required in 35 % of the ketorolac group versus 37 % of the meperidine group ( 95 % CI , OR .47 to 1.74 ) . Patient satisfaction was less in the ketorolac group ( ketorolac 68 % satisfied versus meperidine 74 % satisfied ) however this was not significant ( 95 % CI , OR .66 to 2.72 ) . Sedation level and adverse effects were significantly greater in the meperidine group . Ketorolac shows comparable single dose analgesic efficacy to a single moderate dose of meperidine with less sedation and adverse effects in an ED population with severe musculoskeletal LBP . The trend for greater pain reduction and patient satisfaction with meperidine needs further investigation Abstract The efficacy and tolerability of aceclofenac was compared with diclofenac resinate in a double-blind , multicentre r and omised study in patients with acute low back pain suffering from degenerative spinal disorders . The study included 227 patients r and omised to receive either aceclofenac 2 × 100 mg daily or diclofenac resinate 2 × 75 mg daily for up to 10 days . The primary objective was to demonstrate the clinical non-inferiority of the analgesic efficacy of aceclofenac compared with diclofenac resinate , as assessed by changes from baseline in the visual analogue scale ( 0–100 mm ) pain score , at rest and at visit 3 ( final visit on day 's 8–10 ) . Secondary objectives included the time to early cure ( resolution of pain ) and global assessment of tolerability . Mean change in pain score at rest , and as visit 3 , compared with baseline , was 61.6 mm ( SD 24.5 ) for the aceclofenac group ( n = 100 ) and 57.3 mm ( SD 22.8 ) for the diclofenac resinate group ( n = 105 ) in the per- protocol population . Similar changes were observed in the intention-to-treat population . Between-group differences of 4.5 mm and 5.5 mm for the per- protocol and intention-to-treat population s , respectively , demonstrated clinical non-inferiority of aceclofenac compared with diclofenac resinate . Furthermore , there was evidence for superiority of aceclofenac over diclofenac resinate in terms of statistical significance , as the one-sided 97.5 % confidence interval was above −10 mm and 0 mm . In the intention-to treat population , a total of six aceclofenac-treated patients discontinued their medication owing to early cure , compared with only one patient receiving diclofenac resinate . Seventeen aceclofenac- ( 14.9 % ) , and 18 diclofenac resinate-treated patients ( 15.9 % ) reported at least one adverse event . However , the total number of adverse events reported was lower in patients receiving aceclofenac ( 22 versus 31 in the diclofenac resinate group ) . In conclusion , non-inferiority of the analgesic efficacy of aceclofenac compared with diclofenac resinate was demonstrated in patients with localised , uncomplicated acute lumbosacral pain . For the reduction in pain levels from baseline there was also evidence for superiority of aceclofenac compared with diclofenac resinate in terms of statistical significance , although this difference was not considered clinical ly relevant . The results also showed a trend towards a better safety and tolerability profile of aceclofenac over diclofenac resinate from a clinical point of view This study reports on 105 patients with acute low-back pain given tizanidine ( 4 mg three times daily ) plus ibuprofen ( 400 mg three times daily ) or placebo plus ibuprofen ( 400 mg three times daily ) . Patients assessed their pain using visual analogue scales in a daily diary and the doctor assessed their condition at baseline and on days 3 and 7 . Both groups were treated effectively , but earlier improvement occurred in patients given tizanidine/ibuprofen , particularly regarding pain at night and at rest . Doctors assessed the helpfulness of treatment : tizanidine/ibuprofen was significantly better than placebo/ibuprofen at day 3 ( P = 0.05 ) . Significant differences between treatments in favour of tizanidine/ibuprofen occurred in patients with moderate and severe pain at night ( P<0.05 ) , at rest ( P<0.05 ) and those with moderate or severe sciatica ( P<0.05 ) . Significantly more patients given placebo/ibuprofen had gastro-intestinal side-effects compared with tizanidine/ibuprofen ( P = 0.002 ) . This supports previous work in animals showing that tizanidine mediates gastric mucosal protection against anti-inflammatory drugs . More patients given tizanidine/ibuprofen suffered drowsiness and other central nervous system effects ( P = 0.025 ) . In patients with severe acute low-back pain , however , some sedation and bed rest is advantageous . This study shows that tizanidine/ibuprofen is more effective in the treatment of moderate or severe acute low-back pain than placebo and ibuprofen alone Two hundred and sixty patients with lumbago or sciatic pain participated in a multicenter observer-blind r and omized trial to compare the efficacy and tolerability of dipyrone 2.5 g , diclofenac 75 mg , and placebo administered as an intramuscular injection once daily for the duration of one to two days . The effectiveness of the test treatments in relieving sciatic pain was measured by a visual analog scale ( VAS ) before and 30 minutes , 1 , 2 , 3 , 6 and 24 hours after each injection . In addition , the patient 's general well-being was measured on a 5-point rating scale on day 0 , 1 and 2 . At the end of the trial , the patients evaluated the overall efficacy of the study drugs on a 5-point rating scale . Minimal finger-toe distance was measured every day of the trial . Pain intensity on VAS ( primary endpoint ) showed a significantly greater reduction with dipyrone than with diclofenac or placebo between 1 and 6 hours after application ( p < 0.01 ) and at the end of the trial ( after 48 hours ) . Improvement in general well-being and minimal finger-toe distance was greatest in the dipyrone group . 59 % of the patients with dipyrone assessed the overall efficacy as " excellent " or " very good " , compared with 30 % with diclofenac , and 18 % with placebo .
Output:
| Statistically significant effects were found in favor of NSAIDs compared with placebo , but at the cost of statistically significant more side effects .
There is moderate evidence that NSAIDs are not more effective than paracetamol for acute low back pain , but paracetamol had fewer side effects .
There is moderate evidence that NSAIDs are not more effective than other drugs for acute low back pain .
There is strong evidence that various types of NSAIDs , including COX-2 NSAIDs , are equally effective for acute low back pain .
COX-2 NSAIDs had statistically significantly fewer side effects than traditional NSAIDs .
The evidence from the 65 trials included in this review suggests that NSAIDs are effective for short-term symptomatic relief in patients with acute and chronic low back pain without sciatica .
Furthermore , there does not seem to be a specific type of NSAID , which is clearly more effective than others .
The selective COX-2 inhibitors showed fewer side effects compared with traditional NSAIDs in the r and omized controlled trials included in this review .
However , recent studies have shown that COX-2 inhibitors are associated with increased cardiovascular risks in specific patient population |
MS211542 | ***TASK*** the task is to summarize an input biomedical literature 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 & AIMS We investigated Helicobacter pylori ( H pylori)-infection as a cause of iron deficiency ( ID ) and iron-deficiency anemia ( IDA ) or treatment failure of iron supplementation . METHODS We r and omized 200 Hp-infected children ( positive urea breath test ) 2 - 5 years of age with IDA ( hemoglobin level < 110 g/L ; serum ferritin level < 12 microg/L ; and soluble transferrin receptor > 8.3 mg/L ) or ID ( serum ferritin level < 12 microg/L or soluble transferrin receptor level > 8.3 mg/L ) to 1 of 4 regimens : 2-week anti-Hp therapy ( amoxicillin , clarithromycin , and omeprazole ) plus 90-day oral ferrous sulfate ( anti-Hp plus iron ) , 2-week anti-Hp therapy alone , 90-day oral iron alone , or placebo . Sixty noninfected children with IDA received iron treatment as negative control . RESULTS Hp-infected children receiving iron had significantly less frequent treatment failure compared with those with no iron in correcting IDA ( 11 % [ 95 % confidence interval ( CI ) , 2%-20 % ] for anti-Hp plus iron , 0 % for iron alone vs 33 % [ 95 % CI , 26%-46 % ] for anti-Hp and 45 % [ 95 % CI , 31%-59 % ] for placebo ; chi(2 ) = 127 ; P < .0001 ) , ID ( 19 % [ 95 % CI , 8%-30 % ] for anti-Hp plus iron , 7 % [ 95 % CI , 0%-14 % ] for iron alone vs 65 % [ 95 % CI , 52%-78 % ] for anti-Hp alone , and 78 % [ 95 % CI , 66%-90 % ] for placebo ; chi(2 ) = 124 ; P < .0001 ) , or anemia ( 34 % [ 95 % CI , 20%-40 % ] for anti-Hp plus iron , 27 % [ 95 % CI , 14%-40 % ] for iron alone vs 65 % [ 95 % CI , 52%-78 % ] for anti-Hp alone and 78 % [ 95 % CI , 66%-90 % ] for placebo ; chi(2 ) = 46 ; P < .0001 ) . Cure rates of IDA , ID , or anemia with iron were comparable with that of the negative control group . Improvements in iron status also were significantly greater in groups with iron . CONCLUSIONS H pylori is neither a cause of IDA/ID nor a reason for treatment failure of iron supplementation in young Bangladeshi children In the present study , we investigated the prevalence of anaemia and Fe deficiency anaemia ( IDA ) and explored the relationship between Helicobacter pylori infection and IDA in adolescent girls . A total of 1037 adolescent girls from Suihua , China were enrolled . Hb , serum ferritin ( SF ) , serum transferrin receptor ( sTfR ) and serum IgG antibodies to H. pylori were measured . Participants with IDA and co-existing H. pylori infection ( n 80 ) who had an intake of > 25 mg/d of Fe were assigned r and omly to the intervention and control groups . Patients in the intervention group were administered a 12-week course of oral EDTA-Na-Fe ( 60 mg Fe/dose , three times a week ) and a 2-week course of colloidal bismuth subcitrate , amoxicillin and metronidazole . Subjects in the control group were administered EDTA-Na-Fe alone . Hb , SF and sTfR were reassessed 3 months after the 12-week regimen ended . Prevalence of anaemia , Fe deficiency ( defined as SF < 12·0 μg/l ) , IDA and H. pylori infection in the population of 1037 was 19.5 , 40.4 , 17.1 and 31.2 % , respectively . The prevalence of H. pylori infection in the IDA group was 46.9 % , while the non-anaemic group had 28.1 % prevalence . A significant increase in Hb and SF and a decrease in sTfR value were found in the intervention group and the H. pylori-negative group . Findings suggest that IDA is still one of the prominent problems in adolescent girls . There is an association between H. pylori infection and IDA . Treatment of H. pylori infection is associated with a more rapid response to oral Fe therapy OBJECTIVE To investigate the association between Helicobacter pylori infection and anaemia . DESIGN Six cross-sectional studies . H. pylori infection was assessed by the [13C]urea breath test using MS or IR analysis . Hb was measured for all countries . Ferritin and transferrin receptors were measured for Argentina , Bolivia , Mexico , and Venezuela . SETTING Health services in Argentina , Brazil and Mexico or public schools in Bolivia , Cuba and Venezuela . SUBJECTS In Argentina , 307 children aged 4 - 17 years referred to a gastroenterology unit ; in Bolivia , 424 r and omly selected schoolchildren aged 5 - 8 years ; in Brazil , 1007 adults ( 157 men , 850 women ) aged 18 - 45 years attending thirty-one primary health-care units ; in Cuba , 996 r and omly selected schoolchildren aged 6 - 14 years ; in Mexico , seventy-one pregnant women in their first trimester attending public health clinics ; in Venezuela , 418 children aged 4 - 13 years attending public schools . RESULTS The lowest prevalence of H. pylori found was among children in Argentina ( 25.1 % ) and the highest in Bolivia ( 74.0 % ) . In Bolivia , Cuba and Venezuela children showed similar prevalence of H. pylori infection as in Brazilian and Mexican adults ( range 47.5 % to 81.8 % ) . Overall anaemia prevalence was 11.3 % in Argentina , 15.4 % in Bolivia , 20.6 % in Brazil , 10.5 % in Cuba and 8.9 % in Venezuela . Adjusted analyses allowing for confounding variables showed no association between H. pylori colonization and anaemia in any study . Hb , ferritin and transferrin receptor levels were also not associated with H. pylori infection in any country . CONCLUSIONS The present study showed no evidence to support the hypothesis that H. pylori contributes to anaemia in children , adolescents , adults or pregnant women in six Latin American countries BACKGROUND Helicobacter pylori infection treatment was found not to reduce the prevalence of iron deficiency or anemia among Alaska Native children at 14 months after treatment initiation . We hypothesized that 14 months was to early to resolve H. pylori-induced gastric damage . Consequently , we conducted a 40-month follow-up . METHODS We enrolled 219 children 7 - 11 years old who had H. pylori infection ( as diagnosed by (13)C-labeled urea breath test ) and iron deficiency ( serum ferritin level , < 22.47 pmol/L ) in a controlled , household-r and omized trial of the effect of treatment of H. pylori on iron deficiency and anemia ( hemoglobin level , < 115 g/L ) . At 40 months , 176 children were evaluated . RESULTS Forty-four ( 52 % ) of 85 children in the intervention group and 53 ( 58 % ) of 91 in the control group had iron deficiency ( adjusted relative risk [ ARR ] , 0.92 [ 95 % confidence interval { CI } , 0.68 - 1.26 ] ) , versus 4 ( 5 % ) and 17(19 % ) , respectively , with both iron deficiency and anemia ( ARR , 0.25 [ 95 % CI , 0.09 - 0.73 ] ) . Reinfection occurred among 33 ( 52 % ) of 64 children who had cleared their infection . H. pylori-negative children had lower prevalences of iron deficiency ( ARR , 0.62 [ 95 % CI , 0.38 - 1.01 ] ) and iron deficiency and anemia ( ARR , 0.22 [ 95 % CI , 0.03 - 1.50 ] ) , compared with H. pylori -positive children . CONCLUSIONS The resolution of H. pylori infection for > 14 months modestly reduced the prevalence of iron deficiency and substantially reduced the prevalence of iron deficiency and anemia . H. pylori likely plays a casual role in hematological outcomes for some children ABSTRACT Iron deficiency anemia is a common public health problem in the Alaska Native population . Yet , a clear etiology has eluded research ers for decades . Previous studies suggested a link betweenHelicobacter pylori infection , gastrointestinal blood loss due to hemorrhagic gastritis , and generalized iron deficiency anemia in adult Alaska Natives . Therefore , we examined the association between the prevalence of H. pylori-specific immunoglobulin G ( IgG ) and serum ferritin levels , a marker of iron deficiency . A r and om sample of 2,080 serum sample s from Alaska Native residents drawn between 1980 and 1986 from residents in 13 regions was selected , and the sample s were stratified by age , sex , and region . Overall , 75 % were positive for H. pylori-specific IgG. The rate of H. pylori seropositivity increased with age ; by age 14 years , 78 % of the residents were positive . There were no gender differences inH. pylori seropositivity . However , marked regional differences were observed . Serum ferritin levels of < 12 ng/ml were found most commonly among persons < 20 years of age and among women of childbearing age . A significant association between low serum ferritin levels and prevalence of H. pylori-specific IgG was found , particularly for people aged less than 20 years . H. pylorimay be a factor contributing to the iron deficiency anemia in the Alaska Native population Background & objectives : Despite routine iron supplementation and promotion of diet modification , iron deficiency anaemia ( IDA ) remains widely prevalent in our antenatal population . Recent studies in pediatric population have highlighted the role of Helicobacter pylori infection in IDA . This study was undertaken to study the effect of eradication therapy in H. pylori infected pregnant women with IDA . Methods : R and omized placebo-controlled double blind clinical trial was done on 40 antenatal women between 14 - 30 wk gestation , with mild to moderate IDA and having H. pylori infection , as detected by stool antigen test . These women were r and omly divided into group I ( n=20 ) : H. pylori treatment group ( amoxicillin , clarithromycin , omeprazole for 2 wk ) and group II ( n=20 ) : placebo group . Both groups received therapeutic doses of iron and folic acid . Outcome measures were improvement in haematological parameters and serum iron profile after 6 wk of oral iron therapy . Results : The prevalence of iron deficiency in pregnant women with mild to moderate anaemia was 39.8 per cent ( 95 % CI 35.7 , 44.3 ) ; and 62.5 per cent ( 95 % CI 52 , 73 ) of these pregnant women with IDA were infected with H. pylori . After 6 wk of therapeutic oral iron and folic acid supplementation , the rise in haemoglobin , packed cell volume , serum iron and percentage transferrin saturation was significantly ( P<0.05 ) higher in the group given H. pylori eradication therapy as compared to the placebo group . Interpretation & conclusions : Our results showed a high occurrence of H. pylori infection in pregnant women with IDA . Eradication therapy result ed in significantly better response to oral iron supplementation among H. pylori infected pregnant women with IDA Ascorbic acid , the reduced form of vitamin C , may protect against gastric cancer and is secreted by the normal stomach . Secretion is impaired in Helicobacter pylori ( H pylori ) associated chronic gastritis . This study examined if eradication of H pylori improves gastric juice ascorbate values . Fasting gastric juice and plasma sample s were collected at endoscopy from patients participating in trials of H pylori eradication for duodenal ulcer disease and intestinal metaplasia before and up to 15 months after attempted eradication . Ascorbic acid and total vitamin C concentrations were determined by high performance liquid chromatography . In 12 patients in whom H pylori was successfully eradicated gastric juice ascorbate and total vitamin C concentrations and the ratio of juice to plasma vitamin C rose after treatment . Analysis after treatment suggested that the rise was greatest in patients with high final plasma vitamin C concentrations , even though these did not change with treatment . By contrast , in 22 patients in whom H pylori eradication was unsuccessful there were no significant changes in juice or plasma concentr
Output:
| Current evidence indicates increased likelihood of depleted iron stores in relation to H. pylori infection .
H. pylori eradication therapy , added to iron therapy , might be beneficial in increasing ferritin and hemoglobin levels |
MS211543 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: BACKGROUND The results of FASTACT , a r and omised , placebo-controlled , phase 2 study , showed that intercalated chemotherapy and erlotinib significantly prolonged progression-free survival ( PFS ) in patients with advanced non-small-cell lung cancer . We undertook FASTACT-2 , a phase 3 study in a similar patient population . METHODS In this phase 3 trial , patients with untreated stage IIIB/IV non-small-cell lung cancer were r and omly assigned in a 1:1 ratio by use of an interactive internet response system with minimisation algorithm ( stratified by disease stage , tumour histology , smoking status , and chemotherapy regimen ) to receive six cycles of gemcitabine ( 1250 mg/m(2 ) on days 1 and 8 , intravenously ) plus platinum ( carboplatin 5 × area under the curve or cisplatin 75 mg/m(2 ) on day 1 , intravenously ) with intercalated erlotinib ( 150 mg/day on days 15 - 28 , orally ; chemotherapy plus erlotinib ) or placebo orally ( chemotherapy plus placebo ) every 4 weeks . With the exception of an independent group responsible for monitoring data and safety monitoring board , everyone outside the interactive internet response system company was masked to treatment allocation . Patients continued to receive erlotinib or placebo until progression or unacceptable toxicity or death , and all patients in the placebo group were offered second-line erlotinib at the time of progression . The primary endpoint was PFS in the intention-to-treat population . This trial is registered with Clinical Trials.gov , number NCT00883779 . FINDINGS From April 29 , 2009 , to Sept 9 , 2010 , 451 patients were r and omly assigned to chemotherapy plus erlotinib ( n=226 ) or chemotherapy plus placebo ( n=225 ) . PFS was significantly prolonged with chemotherapy plus erlotinib versus chemotherapy plus placebo ( median PFS 7·6 months [ 95 % CI 7·2 - 8·3 ] , vs 6·0 months [ 5·6 - 7·1 ] , hazard ratio [ HR ] 0·57 [ 0·47 - 0·69 ] ; p<0·0001 ) . Median overall survival for patients in the chemotherapy plus erlotinib and chemotherapy plus placebo groups was 18·3 months ( 16·3 - 20·8 ) and 15·2 months ( 12·7 - 17·5 ) , respectively ( HR 0·79 [ 0·64 - 0·99 ] ; p=0·0420 ) . Treatment benefit was noted only in patients with an activating EGFR gene mutation ( median PFS 16·8 months [ 12·9 - 20·4 ] vs 6·9 months [ 5·3 - 7·6 ] , HR 0·25 [ 0·16 - 0·39 ] ; p<0·0001 ; median overall survival 31·4 months [ 22·2-undefined ] , vs 20·6 months [ 14·2 - 26·9 ] , HR 0·48 [ 0·27 - 0·84 ] ; p=0·0092 ) . Serious adverse events were reported by 76 ( 34 % ) of 222 patients in the chemotherapy plus placebo group and 69 ( 31 % ) of 226 in the chemotherapy plus erlotinib group . The most common grade 3 or greater adverse events were neutropenia ( 65 [ 29 % ] patients and 55 [ 25 % ] , respectively ) , thrombocytopenia ( 32 [ 14 % ] and 31 [ 14 % ] , respectively ) , and anaemia ( 26 [ 12 % ] and 21 [ 9 % ] , respectively ) . INTERPRETATION Intercalated chemotherapy and erlotinib is a viable first-line option for patients with non-small-cell lung cancer with EGFR mutation-positive disease or selected patients with unknown EGFR mutation status . FUNDING F Hoffmann-La Roche
Output:
| The pooled analyses suggested that HSP27 expression was significantly associated with the unfavorable conditions for differentiation degree , lymphatic metastasis , clinical stage , squamous cell carcinoma and tumor size .
However , HSP27 expression had no significant relationship to gender , age and smoking status .
In conclusion , our meta- analysis demonstrates that HSP27 expression may be a strong biomarker to predict both the poor clinicopathological and prognostic characteristics in patients with NSCLC |
MS211544 | ***TASK*** the task is to summarize an input biomedical literature 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 : It has been shown that camel milk consumption has a definite decreasing effect on the prevalence of diabetes . However , most of these studies were conducted on patients with type 1 diabetes , whereas studies on patients with type 2 diabetes mellitus ( T2DM ) are limited . In vitro experiments have shown that camel milk was able to decrease blood glucose concentration . Objectives : The purpose of this study was to investigate effects of camel and cow milk on blood sugar , lipid profile , and blood pressure of patients with T2DM . Patients and Methods : In a r and omized single-blinded controlled clinical trial , 20 patients with T2DM were r and omly allocated into two groups . Participants consumed 500 mL of either camel milk ( intervention group ) or cow milk ( control group ) daily for two months . Results : Mean of insulin concentration was significantly increased from 64.59 to 84.03 pmol/L in the camel milk group during the study ( P < 0.05 ) . No significant differences were shown in fasting blood sugar , lipid profile , and blood pressure between the two groups at the end of study . There was significant increase in homeostasis model assessment of insulin resistance ( HOMA-IR ) during the study in both groups , but no significant difference was seen between the two groups . Conclusions : Camel milk increased insulin level in patients with T2DM and might contribute to glycemic control in T2DM Diabetic nephropathy is originally microvascular in nature and is widely considered an important complication of diabetes . The present study was carried out to determine the efficacy of camel milk in controlling diabetic nephropathy . Twenty-four type-1 diabetic patients were r and omly recruited from the outpatient diabetic clinic in PBM Hospital , Bikaner , India . All subjects gave their written consent before participation in the study . Patients with any acute metabolic complications were not included in the study . Eligible patients entered a run-in period of 1 month in which they were oriented to achieve the best possible glycemic control through st and ardized diet , st and ardized exercise regimen and insulin administration . During this period frequent monitoring of blood sugar was performed to maintain euglycemia . At the end of the run-in period , a base line evaluation was performed , then these patients were given camel milk in addition with usual care for six months . Urine microalbumin and blood sugar was measured twice a week before breakfast and dinner . There was a significant improvement in the microalbuminuria ( 119.48 + /- 1.68 to 22.52 + /- 2.68 ; p < 0.001 ) after receiving camel milk for 6 months . A significant reduction in the mean dose of insulin for obtaining glycemic control was achieved ( 41.61 + /- 3.08 to 28.32 + /- 2.66 ; p < 0.01 ) . This study was performed to observe the role of camel milk in controlling microalbuminuria levels in type-1 diabetic patients . It was observed that after adding camel milk to the usual regimen an improvement in microalbuminuria was reached ( 119.48 + /- 1.68 to 22.52 + /- 2.68 ; p < 0.001 ) . This may be due to good glycemic control or to the direct effect of camel milk . The mechanism behind this effect is still unknown Background / Objectives : Hypoglycemic effect of camel milk supplementation in experimental rat model and significant reduction in doses of insulin in type 1 diabetic patients have been observed in our previous studies . This long-term study was undertaken to assess the efficacy , safety and acceptability of camel milk as an adjunct to insulin therapy in type 1 diabetics . Subjects/ Methods : In this 2-year r and omized clinical , parallel design study , 24 type 1 diabetics were enrolled and divided into two groups . Group I ( n=12 ) received usual care , that is , diet , exercise and insulin and Group II ( n=12 ) received 500 ml camel milk in addition to the usual care . Insulin requirement was titrated weekly by blood glucose estimation . Results were analyzed by using the regression technique . Results : In camel milk group , there was decrease in mean blood glucose ( 118.58±19–93.16±17.06 mg/dl ) , hemoglobin A1c levels ( 7.81±1.39–5.44±0.81 % ) and insulin doses ( 32.50±9.99–17.50±12.09 U/day , P<0.05 ) . Out of 12 subjects receiving camel milk , insulin requirement in 3 subjects reduced to zero . There was nonsignificant change in plasma insulin and anti-insulin antibodies in both the groups . Conclusion : It may be stated that camel milk is safe and efficacious in improving long-term glycemic control , with a significant reduction in the doses of insulin in type 1 diabetic patients Most systematic review s rely substantially on the assessment of the method ological quality of the individual trials . The aim of this study was to obtain consensus among experts about a set of generic core items for quality assessment of r and omized clinical trials ( RCTs ) . The invited participants were experts in the field of quality assessment of RCTs . The initial item pool contained all items from existing criteria lists . Subsequently , we reduced the number of items by using the Delphi consensus technique . Each Delphi round comprised a question naire , an analysis , and a feedback report . The feedback report included staff team decisions made on the basis of the analysis and their justification . A total of 33 international experts agreed to participate , of whom 21 completed all question naires . The initial item pool of 206 items was reduced to 9 items in three Delphi rounds . The final criteria list ( the Delphi list ) was satisfactory to all participants . It is a starting point on the way to a minimum reference st and ard for RCTs on many different research topics . This list is not intended to replace , but rather to be used alongside , existing criteria lists There is a traditional belief in the Middle East that regular consumption of camel milk may aid in prevention and control of diabetes . The aim of this work was to evaluate the efficacy of camel milk as an adjuvant therapy in young type 1 diabetics . This 16-week r and omized study enrolled 54 type 1 diabetic patients ( average age 20 years ) selected from those attending the outpatient diabetes clinic of the Menofia University Hospital , affiliated with Egypt 's National Cancer Institute . Subjects were r and omly divided into two groups of 27 patients : one received usual management ( diet , exercise , and insulin ) , whereas the other received 500 mL of camel milk daily in addition to st and ard management . A control group of 10 healthy subjects was also assessed . The following parameters were evaluated at baseline and at 4 and 16 weeks : hemoglobin A1c ( HbA1c ) , human C-peptide , lipid profile , serum insulin , anti-insulin antibodies , creatinine clearance , albumin in 24-hour urine , body mass index , and Diabetes Quality of Life score . The following parameters were significantly different between the usual-management group versus the camel milk group after 16 weeks : fasting blood sugar ( 227.2 + /- 17.7 vs. 98.9 + /- 16.2 mg/dL ) , HbA1c ( 9.59 + /- 2.05[% ] vs. 7.16 + /- 1.84[% ] ) , serum anti-insulin antibodies ( 26.20 + /- 7.69 vs. 20.92 + /- 5.45 microU/mL ) , urinary albumin excretion ( 25.17 + /- 5.43 vs. 14.54 + /- 5.62 mg/dL/24 hours ) , daily insulin dose ( 48.1 + /- 6.95 vs. 23 + /- 4.05 units ) , and body mass index ( 18.43 + /- 3.59 vs. 24.3 + /- 2.95 kg/m(2 ) ) . Most notably , C-peptide levels were markedly higher in the camel milk group ( 0.28 + /- 0.6 vs. 2.30 + /- 0.51 pmol/mL ) . These results suggest that , as an adjunct to st and ard management , daily ingestion of camel milk can aid metabolic control in young type 1 diabetics , at least in part by boosting endogenous insulin secretion
Output:
| Most of the studies in the current systematic review demonstrated the favorable effects of camel milk on diabetes mellitus by reducing blood sugar , decreasing insulin resistance and improving lipid profiles |
MS211545 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: OBJECTIVES To assess the optimal stroke prevention treatment for patients with atrial fibrillation ( AF ) and a low-medium risk ( < or = 4 % ) of stroke . DESIGN A total of 668 patients with persistent or permanent AF , without an indication for full dose and with adequate rate control on sotalol , were r and omized to warfarin 1.25 mg + aspirin 75 mg daily ( W/A , 334 patients ) or no anticoagulation ( C , 334 patients ) . The mean follow-up period was 33 months . The protocol intended to verify a 37 % relative risk reduction provided a 4 % stroke incidence in the C group . RESULTS The stroke incidence was less in the W/A group , although the reduction was not statistically significant ( W/A 9.6 % versus C 12.3 % ) . Four haemorrhagic strokes were identified , two in each group . Secondary end-points were transient ischaemic attacks ( TIA ) ( W/A 3.3 % versus C 4.5 % ) , all cause mortality ( W/A 9.3 % versus C 10.8 % ) , cardiovascular morbidity ( W/A 17.7 % versus C 22.2 % ) and the combination of stroke + TIA ( W/A 11.7 % versus C 16.5 % ) . Bleedings were documented in 19 versus four patients ( W/A 5.7 % versus C 1.2 % ) ( P = 0.003 ) , although none fatal . Sinus rhythm ( SR ) was recorded occasionally in 68 patients ( W/A 9.6 % versus C 10.8 % ) . The stroke incidence tended to be higher in those with SR than without , 16.2 % versus 10.4 % . CONCLUSIONS Our results were inconclusive , but consistent with a small beneficial effect of W/A for reduction of stroke and major vascular events in AF patients at moderate risk . The low-dose regiment produced , however , a significantly increased risk of bleedings . Documented SR occasionally recorded may represent a sub population that warrants full dose warfarin BACKGROUND AND PURPOSE Nonvalvular atrial fibrillation ( AF ) is a strong , independent risk factor for stroke , but the absolute rate of stroke varies widely among AF patients , importantly influencing the potential benefit of antithrombotic prophylaxis . We explore factors associated with ischemic stroke in AF patients taking aspirin . METHODS We performed multivariate logistic regression analysis of 2012 participants given aspirin alone or in combination with low , inefficacious doses of warfarin in the Stroke Prevention in Atrial Fibrillation I-III trials followed for a mean of 2.0 years , during which 130 ischemic strokes were observed . RESULTS Age ( relative risk [RR]=1.8 per decade , P<0.001 ) , female sex ( RR=1.6 , P=0.01 ) , history of hypertension ( RR=2.0 , P<0.001 ) , systolic blood pressure > 160 mm Hg ( RR=2.3 , P<0.001 ) , and prior stroke or transient ischemic attack ( RR=2.9 , P<0.001 ) were independently associated with increased stroke risk . Regular consumption of > /=14 alcohol-containing drinks per week was associated with reduced stroke risk ( adjusted RR=0.4 , P=0.04 ) . Among SPAF III participants , estrogen hormone replacement therapy was associated with a higher risk of ischemic stroke ( adjusted RR=3.2 , P=0.007 ) . With the use of these variables , a risk stratification scheme for primary prevention separated participants into those with high ( 7.1%/y , 22 % of the cohort ) , moderate ( 2.6%/y , 37 % of the cohort ) , and low ( 0.9%/y , 41 % of the cohort ) rates of stroke . Ischemic strokes in low-risk participants were less often disabling ( P<0.001 ) . CONCLUSIONS Patients with AF who have high and low rates of stroke during treatment with aspirin can be identified . However , validation of our risk stratification scheme is necessary before it can be applied with confidence to clinical management . Postmenopausal estrogen replacement therapy and moderate alcohol consumption may additionally modify the risk of stroke in AF , but these findings require confirmation Background Atrial fibrillation in the absence of rheumatic valvular disease is associated with a fivefold to sevenfold increased risk of ischemic stroke . Methods and Main Results . The Stroke Prevention in Atrial Fibrillation Study , a multicenter , r and omized trial , compared 325 mg/day aspirin ( double-blind ) or warfarin with placebo for prevention of ischemic stroke and systemic embolism ( primary events ) , and included 1,330 in patients and out patients with constant or intermittent atrial fibrillation . During a mean follow-up of 1.3 years , the rate of primary events in patients assigned to placebo was 6.3 % per year and was reduced by 42 % in those assigned to aspirin ( 3.6 % per year , p = 0.02 ; 95 % confidence interval , 9–63 % ) . In the subgroup of warfarin-eligible patients ( most less than 76 years old ) , warfarin dose-adjusted to prolong prothrombin time to 1.3-fold to 1.8-fold that of control reduced the risk of primary events by 67 % ( warfarin versus placebo , 2.3 % versus 7.4 % per year , p = 0.01 ; 95 % confidence interval , 27–85 % ) . Primary events or death were reduced 58 % ( p = 0.01 ) by warfarin and 32 % ( p = 0.02 ) by aspirin . The risk of significant bleeding was 1.5 % , 1.4 % , and 1.6%o per year in patients assigned to warfarin , aspirin , and placebo , respectively . Conclusions Aspirin and warfarin are both effective in reducing ischemic stroke and systemic embolism in patients with atrial fibrillation . Because warfarin-eligible patients composed a subset of all aspirin-eligible patients , the magnitude of reduction in events by warfarin versus aspirin can not be compared . Too few events occurred in warfarin-eligible patients to directly assess the relative benefit of aspirin compared with warfarin , and the trial is continuing to address this issue . Patients with nonrheumatic atrial fibrillation who can safely take either aspirin or warfarin should receive prophylactic antithrombotic therapy to reduce the risk of stroke BACKGROUND Atherosclerotic intracranial arterial stenosis is an important cause of stroke . Warfarin is commonly used in preference to aspirin for this disorder , but these therapies have not been compared in a r and omized trial . METHODS We r and omly assigned patients with transient ischemic attack or stroke caused by angiographically verified 50 to 99 percent stenosis of a major intracranial artery to receive warfarin ( target international normalized ratio , 2.0 to 3.0 ) or aspirin ( 1300 mg per day ) in a double-blind , multicenter clinical trial . The primary end point was ischemic stroke , brain hemorrhage , or death from vascular causes other than stroke . RESULTS After 569 patients had undergone r and omization , enrollment was stopped because of concerns about the safety of the patients who had been assigned to receive warfarin . During a mean follow-up period of 1.8 years , adverse events in the two groups included death ( 4.3 percent in the aspirin group vs. 9.7 percent in the warfarin group ; hazard ratio for aspirin relative to warfarin , 0.46 ; 95 percent confidence interval , 0.23 to 0.90 ; P=0.02 ) , major hemorrhage ( 3.2 percent vs. 8.3 percent , respectively ; hazard ratio , 0.39 ; 95 percent confidence interval , 0.18 to 0.84 ; P=0.01 ) , and myocardial infa rct ion or sudden death ( 2.9 percent vs. 7.3 percent , respectively ; hazard ratio , 0.40 ; 95 percent confidence interval , 0.18 to 0.91 ; P=0.02 ) . The rate of death from vascular causes was 3.2 percent in the aspirin group and 5.9 percent in the warfarin group ( P=0.16 ) ; the rate of death from nonvascular causes was 1.1 percent and 3.8 percent , respectively ( P=0.05 ) . The primary end point occurred in 22.1 percent of the patients in the aspirin group and 21.8 percent of those in the warfarin group ( hazard ratio , 1.04 ; 95 percent confidence interval , 0.73 to 1.48 ; P=0.83 ) . CONCLUSIONS Warfarin was associated with significantly higher rates of adverse events and provided no benefit over aspirin in this trial . Aspirin should be used in preference to warfarin for patients with intracranial arterial stenosis BACKGROUND Despite the efficacy of warfarin sodium therapy for stroke prevention in atrial fibrillation , many physicians hesitate to prescribe it to elderly patients because of the risk for bleeding complications and because of inconvenience for the patients . METHODS The Second Copenhagen Atrial Fibrillation , Aspirin , and Anticoagulation Study was a r and omized , controlled trial examining the following therapies : warfarin sodium , 1.25 mg/d ; warfarin sodium , 1.25 mg/d , plus aspirin , 300 mg/d ; and aspirin , 300 mg/d . These were compared with adjusted-dose warfarin therapy ( international normalized ratio of prothrombin time [ INR ] , 2.0 - 3.0 ) . Stroke or a systemic thromboembolic event was the primary outcome event . Transient ischemic attack , acute myocardial infa rct ion , and death were secondary events . Data were h and led as survival data , and risk factors were identified using the Cox proportional hazards model . The trial was scheduled for 6 years from May 1 , 1993 , but due to scientific evidence of inefficiency of low-intensity warfarin plus aspirin therapy from another study , our trial was prematurely terminated on October 2 , 1996 . RESULTS We included 677 patients ( median age , 74 years ) . The cumulative primary event rate after 1 year was 5.8 % in patients receiving minidose warfarin ; 7.2 % , warfarin plus aspirin ; 3.6 % , aspirin ; and 2.8 % , adjusted-dose warfarin ( P = .67 ) . After 3 years , no difference among the groups was seen . Major bleeding events were rare . CONCLUSIONS Although the difference was insignificant , adjusted-dose warfarin seemed superior to minidose warfarin and to warfarin plus aspirin after 1 year of treatment . The results do not justify a change in the current recommendation of adjusted-dose warfarin ( INR , 2.0 - 3.0 ) for stroke prevention in atrial fibrillation In patients with chronic nonrheumatic atrial fibrillation , prophylaxis of peripheral arterial embolism is strongly indicated . LMWHs may be an alternative regimen if contraindications for oral anticoagulants are present . In the present study the effect of LMWH on the incidence of embolism in atrial fibrillation has been studied in 75 consecutive patients in comparison to no specific treatment . Patients received one daily injection of the LMWH CY 216 ( n = 35 ) subcutaneously over a period of 6 months . Patients of the control group ( n = 40 ) were observed over the same period of time . In the group treated with CY 216 , three embolic events ( 8.6 % ) occurred , of which two were localized in the cerebrum . One of these two cerebral embolic events was fatal . In the control group , eight embolic events ( 20 % ) occurred , six of these were intracerebral and , of these , five were fatal . An even more pronounced difference between the groups was observed on evaluation of the patients with preceding cerebral embolism . Of 15 patients treated with LMWH , one extracerebral nonfatal embolism occurred . In the control group three of the seven patients ( 43 % ) experienced fatal reembolism . The results show that in patients with atrial fibrillation one daily subcutaneous injection of LMWH reduces the incidence of arterial embolism to about one third . No adverse effects were observed during the 6-month treatment period with LMWH The Canadian Atrial Fibrillation Anticoagulation Study was a r and omized double-blind placebo-controlled trial to assess the potential of warfarin to reduce systemic thromboembolism and its inherent risk of hemorrhage . As a result of the publication of two other " positive " studies of similar design and objective , this study was stopped early before completion of its planned recruitment of 630 patients . There were 187 patients r and omized to warfarin and 191 to placebo . Permanent discontinuation of study medication occurred in 26 % of warfarin-treated and 23 % of placebo-treated patients . The target range of the international normalized ratio was 2 to 3 . For the warfarin-treated patients , the international normalized ratio was in the target range 43.7 % of the study days , above it 16.6 % of the study days and below it 39.
Output:
| The observed rates of intracranial and extracranial hemorrhage were not significantly increased by OAC therapy , but the confidence intervals were wide .
Treatment with adjusted-dose warfarin to achieved INRs of 2 to 3 reduces stroke , disabling or fatal stroke , and death for patients with non-valvular AF .
The benefits were not substantially offset by increased bleeding among these participants in r and omized clinical trials . |
MS211546 | ***TASK*** the task is to summarize an input biomedical literature 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 female condom remains the only female-initiated method for preventing pregnancy and STDs , including HIV . Innovative methods for promoting its use , and for involving male partners in its use , are needed . METHODS A sample of 217 women and their main male sexual partners were r and omly assigned to one of three study conditions : a six-session relationship-based STD prevention intervention provided to the couple together , the same intervention provided to the woman only or a single-session education control provided to the woman only . Assessment s were conducted at baseline and three months postintervention . Contrast coding was used to examine whether the effects of the two active interventions differed from those of the control intervention , and whether the effects of the two active interventions differed from each other . Regression analyses were used to estimate treatment effects . RESULTS During follow-up , participants in either active intervention were more likely to use a female condom with their study partner and with all partners , and used female condoms at a higher rate with all partners , than individuals assigned to the control intervention ; at the end of three months , they were more likely to intend to use the condom in the next 90 days . No significant differences in outcomes were found between the active intervention groups . CONCLUSIONS Focusing on both a woman and her main male sexual partner is efficacious in increasing female condom use and intention to use among heterosexual couples at risk for HIV and other STDs The efficacy and differential effects of specialized ( S ) and traditional ( T ) AIDS education programs on cognitive , behavioral , and psychological outcomes were investigated . The sample consisted of 858 impoverished African-American and Latina women ( S = 448 , T = 410 ) . At baseline , women in the traditional group reported significantly higher distress , greater knowledge of AIDS , and less problem-focused coping . Significant improvements over the 2-week intervention interval were found for participants of both AIDS education programs for appraisal of threat , concerns , knowledge , and attitudes about AIDS , emotion-focused coping , number of sexual partners , IV and non-IV drug use , depression , and distress . However , multivariate analysis indicated that the traditional group had slightly better posttest scores on concerns , emotion-focused coping , knowledge of AIDS , and number of partners than the specialized group . The specialized group reported greater use of problem-focused coping . These differences do not detract from the substantial improvement found for both groups , but they do reinforce the conclusion that the specialized program was not more effective than its st and ard counterpart Objective : To assess effects of a combined microfinance and training intervention on HIV risk behavior among young female participants in rural South Africa . Design : Secondary analysis of quantitative and qualitative data from a cluster r and omized trial , the Intervention with Microfinance for AIDS and Gender Equity study . Methods : Eight villages were pair-matched and r and omly allocated to receive the intervention . At baseline and after 2 years , HIV risk behavior was assessed among female participants aged 14–35 years . Their responses were compared with women of the same age and poverty group from control villages . Intervention effects were calculated using adjusted risk ratios employing village level summaries . Qualitative data collected during the study explored participants ' responses to the intervention including HIV risk behavior . Results : After 2 years of follow-up , when compared with controls , young participants had higher levels of HIV-related communication ( adjusted risk ratio 1.46 , 95 % confidence interval 1.01–2.12 ) , were more likely to have accessed voluntary counseling and testing ( adjusted risk ratio 1.64 , 95 % confidence interval 1.06–2.56 ) , and less likely to have had unprotected sex at last intercourse with a nonspousal partner ( adjusted risk ratio 0.76 , 95 % confidence interval 0.60–0.96 ) . Qualitative data suggest a greater acceptance of intrahousehold communication about HIV and sexuality . Although women noted challenges associated with acceptance of condoms by men , increased confidence and skills associated with participation in the intervention supported their introduction in sexual relationships . Conclusions : In addition to impacts on economic well being , women 's empowerment and intimate partner violence , interventions addressing the economic and social vulnerability of women may contribute to reductions in HIV risk behavior The research design of the r and omised controlled trial is primarily associated today with medicine . It tends either to be ignored or regarded with suspicion by many in such disciplines as health promotion , public policy , social welfare , criminal justice , and education . However , all professional interventions in people 's lives are subject to essentially the same questions about acceptability and effectiveness . As the social reformers Sidney and Beatrice Webb pointed out in 1932 , there is far more experimentation going on in “ the world sociological laboratory in which we all live ” than in any other kind of laboratory , but most of this social experimentation is “ wrapped in secrecy ” and thus yields “ nothing to science.”1 # # # Summary points Many social scientists argue that r and omised controlled trials are inappropriate for evaluating social interventions , but they ignore a considerable history , mainly in the United States , of the use of r and omised controlled trials to assess different approaches to public policy and health promotion A tradition of experimental sociology was well established by the 1930s , built on the early use of controlled experiments in psychology and education From the early 1960s to early 1980s r and omised experiments were considered the optimal design for evaluating public policy interventions in the United States , and major evaluations using this design were carried out This approach became less popular as policy makers reacted negatively to evidence of “ near zero ” effects Lessons to be learnt about implementing r and omised controlled trials in real life setting s include the difficulty of assessing complex multi-level interventions and the challenge of integrating qualitative data The Webbs argued for a more “ scientific ” social policy , with social scientists being trained in experimental methods and evaluations of social interventions being carried out by independent investigators . They were apparently unaware that a strong tradition in experimental sociology had already been established , mainly in the United States . Investigators examined the 6-month impact of three cognitive-behavioral HIV risk-reduction programs on behavioral factors ( substance use and sexual risk behaviors ) and cognitive and psychological re sources of 325 women who resided in emergency or sober-living shelters and their 308 intimate sexual partners . Participants were r and omized by shelter to a peer-mentored , a nurse case-managed , or a st and ard care HIV risk-reduction program . Significant improvements were observed in all groups in all behavioral factors and cognitive and psychological re sources except for self-esteem . Participants in the peer-mentored and nurse case-managed groups did not differ significantly from the st and ard group in self-esteem , life satisfaction , psychological well-being , use of noninjection drugs , sex with multiple partners , and unprotected sex at 6 months ( n = 633 ) . It was concluded that a st and ard approach by health care professionals appears to effectively modify HIV risk behaviors for a majority of homeless participants and may have important economic and policy implication s. Further , the impact of short-term programs that address psychological vulnerabilities of impoverished population s needs to be studied further The purpose of this study was to document the effectiveness of small group condom motivation education in reducing new and reinfection rates of sexually transmitted diseases ( STD ) among female teenagers . Two hundred and five ( 205 ) female adolescents ( age 13 - 20 ) with a current STD were studied at two sites of a Teen Health Clinic . There were 86 teens in the Study Group and 119 in the Comparison Group . Patients were sample d from December 1992 to July 1993 . The patients in the Study Group received a condom motivation class given by the clinic STD educator in small groups of four or more adolescents . The Comparison Group , comparable in age and ethnicity , received treatment for their STD but did not participate in condom motivation classes . All teens were given treatment and condoms . The sample was followed for 6 months . The total number of patients returning with new infections was 21 ( 14.7 % ) . The total number of patients with reinfections was 14 ( 9.8 % ) . There were no significant differences between the Study and Comparison Group on return rates , new and reinfection rates or on any socio-demographic variables . The comparison of these groups suggests that a specific condom motivation class has minimal effectiveness in urban teens . However , almost 70 % of the teens returned to the clinic for their scheduled visits . It is suggested that adolescent clinics which combine family planning and STD treatment services maintain high client enrollment and therefore may be ideal locations to initiate new and continuous interventions for condom use especially for high risk teens OBJECTIVES Women in impoverished inner-city neighborhoods are at high risk for contracting HIV . A r and omized , multisite community-level HIV prevention trial was undertaken with women living in 18 low-income housing developments in 5 US cities . METHODS Baseline and 12-month follow-up population risk characteristics were assessed by surveying 690 women at both time points . In the 9 intervention condition housing developments , a community-level intervention was undertaken that included HIV risk reduction workshops and community HIV prevention events implemented by women who were popular opinion leaders among their peers . RESULTS The proportion of women in the intervention developments who had any unprotected intercourse in the past 2 months declined from 50 % to 37.6 % , and the percentage of women 's acts of intercourse protected by condoms increased from 30.2 % to 47.2 % . Among women exposed to intervention activities , the mean frequency of unprotected acts of intercourse in the past 2 months tended to be lower at follow-up ( mean = 4.0 ) than at baseline ( mean = 6.0 ) . These changes were corroborated by changes in other risk indicators . CONCLUSIONS Community-level interventions that involve and engage women in neighborhood-based HIV prevention activities can bring about reductions in high-risk sexual behaviors OBJECTIVES We evaluated the efficacy of skills training design ed to increase female condom use among women . METHODS We conducted a r and omized controlled trial of 409 women , recruited from family planning clinics in northern California , who were r and omly assigned to the experimental 4-session female condom skills training intervention or the comparison 4-session women 's general health promotion intervention . Participants received condom use instructions at baseline and male and female condoms during the study . They completed audio computer-assisted self-interviews at baseline and at 3 and 6 months . RESULTS At 3 and 6 months , women in the experimental group were more likely than those in the comparison group to have used the female condom at least once in the prior 3 months . The increase in the percentage of sexual acts protected by female condoms from baseline to the 6-month follow-up was greater for the experimental group . The percentage of sexual acts during which any condom was employed was higher in the experimental group at 6 months . There were no group differences in male condom use . CONCLUSIONS Outcomes suggest that skills training can increase female condom use and protected sexual acts without reducing male condom use among women Background : The Information-Motivation-Behavioral Skills ( IMB ) model of HIV preventive behavior ( 1–4 ) specifies that treatment effects on behavior occur largely as the result of treatment effects on behavioral skills , which follow from effects on information and motivation . Purpose : The objective was to determine whether the variables specified by the IMB model of HIV preventive behavior ( 1–4 ) accounted for the relation between an IMB-based treatment and result ing HIV preventive behavior ( condom use ) . Method : Women ( n = 557 ) living in 18 low-income housing developments in 5 geographically dispersed cities were recruited to participate in an HIV-prevention study . Women ( within housing developments ) were r and omly assigned to receive an IMB-based , HIV risk-avoidance intervention or a comparison intervention . Baseline and posttreatment ( 16 months after baseline ) data were collected on condom use information , motivation ( social norms , attitudes , intentions , and perceived risk ) , enactment of behavioral skills ( condom negotiation and procurement ) , and rates of condom use in the past 2 months . Results : The IMB intervention led to a 12 % to 16 % increase in condom use rates over the course , whereas the comparison intervention led to 2 % decrease . In addition , the IMB treatment led to greater increases in condom use information , in the intentions and social norms components of motivation and the condom procurement and condom conversations components of behavioral skills . The IMB model provided an acceptable fit to the data ( root mean square error of approximation < .05 ) and accounted for 50 % of the variance inposttreatment condom use among the sample . Treatment effects on condom use were almost entirely mediated by the IMB variables ; specifically , motivation and enactment of behavioral skills mediated the intervention ’s impact on condom use . Conclusions : These results provide supporting evidence as to how theoretical variables operate to effect change within a theory-based intervention and provide evidence as to the applicability of a prevailing theory of HIV risk behavior among low-income minority We conducted a cluster-r and omized community intervention trial at Kenyan agricultural sites to measure the impact of female condom introduction on sexually transmitted infection ( STI ) prevalence . We present male and female condom use data here . Six Intervention sites received a community risk-reduction campaign and distribution of female condoms and male condoms , while 6 Control sites received the same campaign with male condoms only . Male and female condom distribution increased throughout follow-up . Self-reported male condom use increased substantially during follow-up to over 60 % of the participants . The proportion of consistent male condom users at Control sites was higher than at Intervention sites , 23 % vs 14 % at 6 months and 24 % vs 22 % at 12 months . At Intervention sites , 11 % and 7 % of women used the female condoms all the time at 6 and 12 months , respectively , while the percentage of female condom non-users grew . Male and female condom use was hindered by male partner objections ; suspicion of
Output:
| A variety of STIs were addressed including HIV and chlamydia .
None of the trials explicitly mentioned HPV or cervical cancer prevention .
Statistically significant effects for behavioural outcomes ( e.g. increasing condom use ) were common , though not universal and varied according to the type of outcome .
There were no statistically significant effects of abstaining from or reducing sexual activity .
There were few statistically significant effects on biological ( STI ) outcomes .
Behavioural interventions for young women which aim to promote sexual behaviours protective of STI transmission can be effective , primarily at encouraging condom use . |
MS211547 | ***TASK*** the task is to summarize an input biomedical literature 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: & NA ; To increase cardiopulmonary arrest survival , the American Heart Association developed basic and advanced cardiac life support ( ACLS ) courses that expose participants to realistic learning situations . This experimental study compared results of two ACLS classes on measures of knowledge ( content exam ) and resuscitation skills ( performance exam ) . Both the control and experimental groups consisted of physicians , nurses , emergency medical technicians , respiratory therapists , and advanced health care providers . The control group used low‐fidelity simulation ( LFS ) ; the experimental group was exposed to enhanced realism via high‐fidelity simulation ( HFS ) . The findings showed a positive correlation between enhanced practice and learning but no significant correlation between posttest and skills test scores for the LFS and HFS groups . The HFS group did score higher on both cognitive and behavioral tests , but the difference was not statistically significant . Participants from both groups indicated satisfaction with their forms of simulation experience and course design . In addition , participants ' self‐confidence to care for a victim of cardiopulmonary arrest was increased after completing their course ; profession and work experience had no effect on responses . The largest difference noted was in verbal responses to course satisfaction . The experimental group stated that learning using HFS was enjoyable and adamantly recommended that ACLS should only be taught using HFS . Further study is required to assess if practicing beyond the course enhances short‐ and long‐term retention of ACLS techniques Background Virtual reality ( VR ) simulators and Web-based instructional videos are valuable supplemental training re sources in surgical programs , but it is unclear how to optimally integrate them into minimally invasive surgical training . Methods Medical students were r and omized to proficiency-based training on VR laparoscopy and endoscopy simulators by two different methods : proctored training ( automated simulator feedback plus human expert feedback ) or independent training ( simulator feedback alone ) . After achieving simulator proficiency , trainees performed a series of laparoscopic and endoscopic tasks in a live porcine model . Prior to their entry into the animal lab , all trainees watched an instructional video of the procedure and were r and omly assigned to either observe or not observe the actual procedure before performing it themselves . The joint effects of VR training method and procedure observation on time to successful task completion were evaluated with Cox regression models . Results Thirty-two students ( 16 proctored , 16 independent ) completed VR training . Cox regression modeling with adjustment for relevant covariates demonstrated no significant difference in the likelihood of successful task completion for independent versus proctored training [ Hazard Ratio ( HR ) 1.28 ; 95 % Confidence Interval ( CI ) 0.96–1.72 ; p = 0.09 ] . Trainees who observed the actual procedure were more likely to be successful than those who watched the instructional video alone ( HR 1.47 ; 95 % CI 1.09–1.98 ; p = 0.01 ) . Conclusions Proctored VR training is no more effective than independent training with respect to surgical performance . Therefore , time-consuming human expert feedback during VR training may be unnecessary . Instructional videos , while useful , may not be adequate substitutes for actual observation when trainees are learning minimally invasive surgical procedures Background With increasing pressure to use operating room time efficiently , opportunities for residents to learn fiberoptic orotracheal intubation in the operating room have declined . The purpose of this study was to determine whether fiberoptic orotracheal intubation skills learned outside the operating room on a simple model could be transferred into the clinical setting . Methods First-year anesthesiology residents and first- and second-year internal medicine residents were recruited . Subjects were r and omized to a didactic-teaching-only group ( n = 12 ) or a model-training group ( n = 12 ) . The didactic-teaching group received a detailed lecture from an expert bronchoscopist . The model-training group was guided , by experts , through tasks performed on a simple model design ed to refine fiberoptic manipulation skills . After the training session , subjects performed a fiberoptic orotracheal intubation on healthy , consenting , anesthetized , paralyzed female patients undergoing elective surgery with predicted “ easy ” laryngoscopic intubations . Two blinded anesthesiologists evaluated each subject . Results After the training session , the model group significantly outperformed the didactic group in the operating room when evaluated with a global rating scale ( P < 0.01 ) and checklist ( P < 0.05 ) . Model-trained subjects completed the fiberoptic orotracheal intubation significantly faster than didactic-trained subjects ( P < 0.01 ) . Model-trained subjects were also more successful at achieving tracheal intubation than the didactic group ( P < 0.005 ) . Conclusion Fiberoptic orotracheal intubation skills training on a simple model is more effective than conventional didactic instruction for transfer to the clinical setting . Incorporating an extraoperative model into the training of fiberoptic orotracheal intubation may greatly reduce the time and pressures that accompany teaching this skill in the operating room BACKGROUND This study compares a laparoscopic skill training protocol without proficiency targets to the same protocol with explicit targets and notification of progress . METHODS Fourteen surgery interns were r and omized into 2 groups . The intervention group received task-specific proficiency criteria to guide practice . The control group did not . After training , participants were evaluated by blinded faculty during laparoscopic cholecystectomy . RESULTS The control group met significantly fewer of the 7 LapSim ( Surgical Science Sweden AB , Gotëborg ) targets ( mean = 1.14 ) than the intervention group ( mean = 7.00 ; P = .001 ) and significantly fewer of the 5 video trainer targets ( mean = .86 ) than the intervention group ( mean = 5.00 ; P = .001 ) . Ratings of depth perception , bimanual dexterity , efficiency , tissue h and ling , autonomy , and overall competence were higher for the intervention group . Effect sizes ranged from medium to large ( .394-.981 ) , indicating an impact of the proficiency-based training protocol . CONCLUSIONS Delineation of proficiency targets with reporting of progress improves interns ' practice results , and appears to have a positive effect on their early operating room ( OR ) performance of laparoscopic cholecystectomy Training on a video trainer or computer-based minimally invasive surgery trainer leads to improved benchtop laparoscopic skill . Recently , improved operative performance from practice on a video trainer was reported . The purpose of this study was three fold : ( a ) to compare psychomotor skill improvement after training on a virtual reality ( VR ) system with that after training on a video-trainer , ( VT ) ( b ) to evaluate whether skills learned on the one training system are transferable to the other , and ( c ) to evaluate whether VR or VT training improves operative performance . For the study , 50 junior surgery residents completed baseline skill testing on both the VR and VT systems . These subjects then were r and omized to either a VR or VT structured training group . After practice , the subjects were tested again on their VR and VT skills . To assess the effect of practice on operative performance , all second-year residents ( n = 19 ) were evaluated on their operative performance during a laparoscopic cholecystectomy before and after skill training . Data are expressed as percentage of improvement in mean score/time . Analysis was performed by Student 's paired t-test . The VR training group showed improvement of 54 % on the VR posttest , as compared with 55 % improvement by the VT group . The VR training group improved more on the VT posttest tasks ( 36 % ) than the VT training group improved on the VR posttest tasks ( 17 % ) ( p < 0.05 ) . Operative performance improved only in the VR training group ( p < 0.05 ) . Psychomotor skillsimprove after training on both VR and VT , and skills may be transferable . Furthermore , training on a minimally invasive surgery trainer , virtual reality system may improve operative performance during laparoscopic cholecystectomy BACKGROUND We have previously shown that reaching expert performance on an fundamentals of laparoscopic surgery (FLS)-type simulator model for laparoscopic suturing results in measurable improvement during an actual operation ; trained novices , however , demonstrate inferior operative performance compared with experts . We hypothesized that simulator training under more difficult and realistic conditions would enhance the operative performance of novices . STUDY DESIGN Medical students ( n=32 ) participated in an IRB-approved , r and omized , controlled trial . All participants were pretested in laparoscopic suturing on a previously vali date d porcine Nissen model and were r and omized into three groups : group I ( n=6 ) received no training , group II ( n=13 ) trained on the FLS videotrainer model until a previously published proficiency score ( 512 ) was achieved on 2 consecutive and 10 additional attempts , group III ( n=13 ) trained to the same goal but had to practice in a constrained space , with a shorter suture , starting with a dropped needle , and listening to operating room noise . Training workload was measured with the vali date d NASA-TLX ( Task Load Index ) question naire after each training session . All groups were posttested on the porcine model . Results were compared using ANOVA ; p < 0.05 was considered significant . RESULTS All group II and III participants reached the training goal . At posttesting , group II and group III participants performed similarly , but substantially better than group I did ( 210+/-140 versus 218+/-139 versus 0+/-0 , respectively ; p < 0.001 ) . Compared with group II , group III participants trained longer ( 329+/-71 minutes versus 239+/-69 minutes , p < 0.001 ) , performed more repetitions ( 81+/-15 versus 59+/-14 , p < 0.001 ) , and their workload improved less by the end of training ( 5 % versus 23 % , p < 0.001 ) . CONCLUSIONS Proficiency-based simulator training reliably results in improved operative performance . Although increasing the level of training difficulty increased trainees ' workload , the strategy we used in this study did not enhance their operative performance . Other methods for curriculum optimization are needed Background The content validity of currently available inanimate simulation models is question able , because some tasks seem too far from clinical reality . The aim of this study was to vali date a simulation model with six tasks commonly used in clinical practice ( 6-TSM ) for the acquisition of psychomotor skills in minimally invasive surgery ( MIS ) . Methods This was a prospect i ve r and omized trial comparing the 6-TSM to a previously described three-task training method ( 3-TTM ) . All first , second , and third postgraduate year surgical residents were eligible . The 6-TSM included clipping and dividing of a vessel , excision of lesion , appendectomy , mesh repair , suturing perforation , and h and -sewn anastomosis . The outcome measures of 6-TSM included accuracy error , tissue damage , sliding knot , leak , operating time , and dangerous movements . After completion of training , 6-TSM and 3-TTN residents were tested by the Minimally Invasive Surgical Trainer — Virtual Reality ( MIST-VR ) . Criterion-related and construct validity , responsiveness , test – retest , and interrater reliability were assessed . Results During six months , 17 residents underwent training with the 6-TSM or the 3-TTM as allocated . The mean duration of training with 6-TSM and 3-TTM was similar ( 7.8 vs 8.1 h ) . The criterion-related validity of the 6-TSM was shown by significantly increased skill improvement in the 6-TSM residents , as compared with the 3-TTM residents at MIST-VR . Construct validity the of 6-TSM was shown by the finding that the experts ’ baseline was superior to the residents ’ baseline . The responsiveness of the 6-TSM was shown by the significantly increased skill improvement of the 6-TSM residents in sliding knot , leak , and operating time . The test – retest reliability of the 6-TSM was good ( > 0.80 ) , except for accuracy error and dangerous movements ( Cronbach ’s intraclass correlation coefficient α : 0.57 , p < 0.0001 ; 0.62 , p < 0.0001 , respectively ) . The interrater reliability of the 6-TSM was good ( > 0.80 ) except for leak ( Kendall ’s concordance coefficient tau_b:0.76 , p = 0.06 for h and -sewn anastomosis ) and dangerous movements ( tau_b:0.72 , p = 0.08 for suturing perforation and tau_b:0.68 , p = 0.10 for h and -sewn anastomosis ) . The perresident cost for 6-TSM was $ 769 . Conclusions The 6-TSM is a valid and reliable learning tool for surgical residents ’ acquisition of laparoscopic motor skills PURPOSE Repetitive practice of laparoscopic suturing and knot tying can facilitate surgeon proficiency in performing this reconstructive technique . We compared a silicone model and pelvic trainer to a virtual reality simulator in the learning of laparoscopic suturing and knot tying by laparoscopically naïve medical students , and evaluated the subsequent performance of porcine laparoscopic cystorrhaphy . MATERIAL S AND METHODS A total of 20 medical students underwent a 1-hour didactic session with video demonstration of laparoscopic suturing and knot tying by an expert laparoscopic surgeon . The students were r and omized to a pelvic trainer ( 10 ) or virtual reality simulator ( 10 ) for a minimum of 2 hours of laparoscopic suturing and knot tying training . Within 1 week of the training session the medical students performed lapar
Output:
| Pretraining and additional practice improved outcomes but , again , took longer .
Limited evidence suggests that mastery learning SBME is superior to nonmastery instruction but takes more time |
MS211548 | ***TASK*** the task is to summarize an input biomedical literature 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 As part of a continuous quality control effort to measure the interrater reliability of urodynamic studies performed at multiple centers , we compared agreement levels for urodynamic studies between central and local physician review ers . We report interrater reliability findings for the filling cystometrogram . MATERIAL S AND METHODS Following a satisfactory interrater reliability study among 4 central physician review ers in 33 tracings 36 urodynamic study tracings from 9 Urinary Incontinence Treatment Network continence treatment centers and 13 Urinary Incontinence Treatment Network certified urodynamic study testers were r and omly selected for review . These tracings were originally interpreted by 11 local physician review ers using st and ardized Urinary Incontinence Treatment Network interpretation guidelines . Each of the 4 central physician review ers review ed 9 r and omly assigned tracings and none review ed tracings from his or her center . Local and central physician review ers were instructed to categorize values as invalid if specified technical quality assurance st and ards were not met or the signal pattern suggested implausible values because of technical deficiencies . An intraclass correlation coefficient was calculated for continuous ( numerical ) variables and a kappa statistic was calculated for qualitative values with acceptable agreement defined a priori as an intraclass correlation coefficient of greater than 0.6 . RESULTS Filling cystometrogram baseline pressure , Valsalva leak point pressure , and volume and pressure measurements at maximum cystometric capacity had excellent intraclass correlation coefficients of 0.74 to 0.99 . There were no significant differences between local and central physician review er means , indicating excellent agreement . CONCLUSIONS With proper quality control measures in place and a set of st and ardized interpretive guidelines excellent interrater reliability between local and central physician review er can be achieved for numerical cystometrogram variables Abstract Objective : To compare tension-free vaginal tape with colposuspension as primary treatment for stress incontinence . Design : Multicentred r and omised comparative trial . Setting : Gynaecology or urology departments in 14 centres in the United Kingdom and Eire , including university teaching hospitals and district general hospitals . Participants : 344 women with urodynamic stress incontinence ; 175 r and omised to tension-free vaginal tape and 169 to colposuspension Main outcome measures : Assessment before treatment and at six months postoperatively with the SF-36 , the Bristol female lower urinary tract symptoms question naire , the EQ-5D health question naire , a one week urinary diary , one hour perineal pad test , cystometry , and , in some centres , urethral profilometry . Results : 23 women in the colposuspension group and 5 in the vaginal tape group withdrew before surgery . No significant difference was found between the groups for cure rates : 115 ( 66 % ) women in the vaginal tape group and 97 ( 57 % ) in the colposuspension group were objective ly cured ( 95 % confidence interval for difference in cure −4.7 % to 21.3 % ) . Bladder injury was more common during the vaginal tape procedure ; postoperative complications , in particular delayed resumption of micturition , were more common after colposuspension . Operation time , duration of hospital stay , and return to normal activity were all longer after colposuspension than after the vaginal tape procedure . Conclusion : Surgery with tension-free vaginal tape is associated with more operative complications than colposuspension , but colposuspension is associated with more postoperative complications and longer recovery . Vaginal tape shows promise for the treatment of urodynamic stress incontinence because of minimal access and rapid recovery times ; cure rates at six months were comparable with colposuspension . What is already known on this topic Few r and omised trials exist on surgery for stress incontinence Systematic review s suggest that colposuspension is associated with cure rates of up to 90 % Case series of tension-free vaginal tape suggest cure rates of about 85 % , with rapid return to normal activity What this study adds At six months the tension-free vaginal tape procedure is as effective as colposuspension for the primary treatment of stress incontinence Operative complications were more common with vaginal tape , but duration of hospital stay and return to normal activity were shorter than with colposuspension Postoperative complications were more common after OBJECTIVE To compare peri-operative complications , pain , and the immediate functional results of the sub-urethral sling procedure for urinary stress incontinence by the retropublic and transobturator routes , using a non-elastic polypropylene sub-urethral sling . PATIENTS AND METHODS This prospect i ve , multicentre study involved 88 women undergoing the sub-urethral sling procedure for stress urinary incontinence ( SUI ) . The retropubic route ( RPR ) and the transobturator route ( TOR ) were used in respectively 42 and 46 cases . The characteristics of the women in the RPR and TOR groups were as follows : mean age ( + /-st and ard deviation ) 56.8+/-12 years and 53.4+/-10 years , respectively ; mean BMI : 25+/-4 and 26+/-4 ; mean parity : 2.1+/-0.9 and 2+/-1 children ; post-menopausal status : 66.7 % and 58.7 % ; prior surgery for SUI : 7.1 % and 6.5 % ; and prior hysterectomy : 21.4 % and 26.1 % . None of these characteristics differed significantly between the groups . Likewise , pre-operative urinary functional status ( SUI stage , and pollakiuria , nocturia and urgency rates ) was similar in the two groups . RESULTS Mean hospital stay and overall morbidity rate were not significantly different between the RPR and TOR groups . Mean operating time was longer in the RPR group . Bladder injury was significantly more frequent in the RPR group and vaginal injury was significantly more frequent in the TOR group . Pain scores were significantly lower in the TOR group . The objective functional results at one month did not differ between the groups . Quality of life , evaluated with question naires and numerical rating scales , was similarly improved in the two groups . DISCUSSION The suburethral sling procedure was less painful by the TOR route than by the RPR route . Bladder injury , haematomas and abscesses were only observed in the RPR group , while vaginal injury only occurred in the TOR group . The immediate functional results of the two approaches were similar Introduction and hypothesisThis study aims to analyze comparatively the efficacy and safety of synthetic transobturatory and aponeurotic retropubic slings , in the treatment of stress urinary incontinence ( SUI ) in women . Methods Patients were separated in a r and omized way . Twenty-one patients were su bmi tted to the operatory correction by the transobturatory sling technique , whereas 20 patients were operated by the retropubic sling technique . All patients were su bmi tted to complete physical exam and urodynamic test . The “ T ” test and the Mann – Whitney U test were applied to establish comparisons between the two groups . Patients were followed-up for 12 months . Results Healing rate was 90.5 % ( 19/21 ) and 95 % ( 19/20 ) , respectively after 12 months . The transobturatory group presented lesser complications rate than the retropubic group . Conclusions The transobturatory and the aponeurotic slings techniques were equally effective for the treatment of SUI . The transobturatory sling has shown fewer complications and lesser surgical time than the aponeurotic sling technique Background : The aim of this study is to evaluate the outcome of an innovative , minimally invasive sling technique with autologous tissue in women with concomitant incontinence and anterior vaginal wall prolapse ( AVWP ) . Material s and Methods : Fifty-six women with stress urinary incontinence ( SUI ) or mixed urinary incontinence and AVWP were r and omly assigned into two groups : In Group A ( 26 patients ) , anterior colporrhaphy ( Kelly placation ) and sling placement using a strip of anterior vaginal wall were performed , and in Group B ( 30 patients ) , transvaginal mesh correction of AVWP and tension-free vaginal tape ( TVT ) insertion ( retropubic – craniocaudal route ) using polypropylene mesh were carried out . The patients were followed-up for over 18 months and were assessed objective ly using a 48 h frequency-volume chart , a 48 h pad test and a st and ardized stress test . Related surgical complications and outcomes were recorded and compared . Results : Surgical cure rates for Group A and Group B at the first ( 3 days ) and last ( 18 months ) post-operative visits were 62 % and 84 % ; and 54 % , and 72 % , respectively ( P = 0.09 and 0.31 ) . Complications occurred in 9 patients ( 44 % ) of Group B , but only 3 patients ( 12 % ) in Group A. Conclusion : Vaginal sling surgery using an anterior vaginal wall strip can improve SUI and in comparison with propylene mesh is associated with lower complication rates . Although , the surgical success rate of this technique is lower than T-Sling , larger studies with selected patients will help assess the suitable patients for this pelvic reconstructive surgery PURPOSE We examined preoperative and postoperative patient related factors associated with continence status up to 7 years after surgery for stress urinary incontinence . MATERIAL S AND METHODS Women r and omized to Burch colposuspension or fascial sling surgery and assessed for the primary outcome of urinary continence 2 years after surgery were eligible to enroll in a prospect i ve observational study . Survival analysis was used to investigate baseline and postoperative factors in the subsequent risk of stress urinary incontinence , defined as self-report of stress urinary incontinence symptoms , incontinence episodes on a 3-day diary or surgical re-treatment . RESULTS Of the women who participated in the r and omized trial 74 % ( 482 of 655 ) were enrolled in the followup study . Urinary continence rates decreased during a period of 2 to 7 years postoperatively from 42 % to 13 % in the Burch group and from 52 % to 27 % in the sling group , respectively . Among the baseline factors included in the first multivariable model age ( p = 0.03 ) , prior stress urinary incontinence surgery ( p = 0.02 ) , menopausal status ( 0.005 ) , urge index ( 0.006 ) , assigned surgery ( p = 0.01 ) and recruiting site ( p = 0.02 ) were independently associated with increased risk of incontinence . In the final multivariable model including baseline and postoperative factors , Burch surgery ( p = 0.01 ) , baseline variables of prior urinary incontinence surgery ( p = 0.04 ) , menopausal status ( p = 0.03 ) and postoperative urge index ( p < 0.001 ) were each significantly associated with a greater risk of recurrent urinary incontinence . CONCLUSIONS Preoperative and postoperative urgency incontinence symptoms , Burch urethropexy , prior stress urinary incontinence surgery and menopausal status were negatively associated with long-term continence rates . More effective treatment of urgency urinary incontinence in patients who undergo stress urinary incontinence surgery may improve long-term overall continence status Introduction and hypothesisThe purpose of this study is to describe risk factors for post-operative urinary tract infection ( UTI ) the first year after stress urinary incontinence surgery . Methods Multivariable logistic regression analyses were performed on data from 1,252 women r and omized in two surgical trials , Stress Incontinence Surgical Treatment Efficacy trial ( SISTEr ) and Trial Of Mid-Urethral Slings ( TOMUS ) . Results Baseline recurrent UTI ( rUTI ; ≥3 in 12 months ) increased the risk of UTI in the first 6 weeks in both study population s , as did sling procedure and self-catheterization in SISTEr , and bladder perforation in TOMUS . Baseline rUTI , UTI in the first 6 weeks , and PVR > 100 cc at 12 months were independent risk factors for UTI between 6 weeks and 12 months in the SISTEr population . Few ( 2.3–2.4 % ) had post-operative rUTI , precluding multivariable analysis . In women with pre-operative rUTI , successful surgery ( negative cough stress test ) at 1 year did not appear to decrease the risk of persistent rUTI . Conclusions Pre-operative rUTI is the strongest risk factor for post-operative UTI OBJECTIVE To compare the efficacy of surgically managing stress urinary incontinence ( SUI ) with tension-free vaginal tape ( TVT ) and autologous fascia lata pubovaginal sling ( Lata ) . METHODS Sixty-seven patients suffering from SUI entered this prospect i ve study . The patients were divided into two groups r and omly , 48 in TVT group and 19 in Lata group . The average follow-up time post-operation was 20 months in TVT group and 37 months in Lata group . RESULTS The operating time was ( 27 + /- 5 ) min in TVT and ( 125 + /- 13 ) min in Lata . The volume of blood loss during surgery was : ( 27 + /- 6 ) ml in TVT and ( 67 + /- 11 ) ml in Lata . The post-operative recovery period in the hospital was : TVT , 1
Output:
| Traditional slings seem to be as effective as minimally invasive slings , but had higher rates of adverse effects .
Tradional sling procedures appeared to confer a similar cure rate in comparison to open retropubic colposuspension , but the long term adverse event profile is still unclear . |
MS211549 | ***TASK*** the task is to summarize an input biomedical literature 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: Fifty three patients with asthma underwent training for two weeks in an integrated set of yoga exercises , including breathing exercises , suryanamaskar , yogasana ( physical postures ) , pranayama ( breath slowing techniques ) , dhyana ( meditation ) , and a devotional session , and were told to practise these exercises for 65 minutes daily . They were then compared with a control group of 53 patients with asthma matched for age , sex , and type and severity of asthma , who continued to take their usual drugs . There was a significantly greater improvement in the group who practised yoga in the weekly number of attacks of asthma , scores for drug treatment , and peak flow rate . This study shows the efficacy of yoga in the long term management of bronchial asthma , but the physiological basis for this beneficial effect needs to be examined in more detail Objective To examine the prevalence of outcome reporting bias — the selection for publication of a subset of the original recorded outcome variables on the basis of the results — and its impact on Cochrane review s. Design A nine point classification system for missing outcome data in r and omised trials was developed and applied to the trials assessed in a large , unselected cohort of Cochrane systematic review s. Research ers who conducted the trials were contacted and the reason sought for the non-reporting of data . A sensitivity analysis was undertaken to assess the impact of outcome reporting bias on review s that included a single meta- analysis of the review primary outcome . Results More than half ( 157/283 ( 55 % ) ) the review s did not include full data for the review primary outcome of interest from all eligible trials . The median amount of review outcome data missing for any reason was 10 % , whereas 50 % or more of the potential data were missing in 70 ( 25 % ) review s. It was clear from the publications for 155 ( 6 % ) of the 2486 assessable trials that the research ers had measured and analysed the review primary outcome but did not report or only partially reported the results . For reports that did not mention the review primary outcome , our classification regarding the presence of outcome reporting bias was shown to have a sensitivity of 88 % ( 95 % CI 65 % to 100 % ) and specificity of 80 % ( 95 % CI 69 % to 90 % ) on the basis of responses from 62 trialists . A third of Cochrane review s ( 96/283 ( 34 % ) ) contained at least one trial with high suspicion of outcome reporting bias for the review primary outcome . In a sensitivity analysis undertaken for 81 review s with a single meta- analysis of the primary outcome of interest , the treatment effect estimate was reduced by 20 % or more in 19 ( 23 % ) . Of the 42 meta-analyses with a statistically significant result only , eight ( 19 % ) became non-significant after adjustment for outcome reporting bias and 11 ( 26 % ) would have overestimated the treatment effect by 20 % or more . Conclusions Outcome reporting bias is an under-recognised problem that affects the conclusions in a substantial proportion of Cochrane review s. Individuals conducting systematic review s need to address explicitly the issue of missing outcome data for their review to be considered a reliable source of evidence . Extra care is required during data extraction , review ers should identify when a trial reports that an outcome was measured but no results were reported or events observed , and contact with trialists should be encouraged PURPOSE Psychological interventions in the treatment of epilepsy have been developed and evaluated for many years but the amount of research has hardly made an impact on how epilepsy is treated . The purpose of this study was to develop and evaluate a psychological treatment program consisting of acceptance and commitment therapy ( ACT ) together with some behavioral seizure control technology shown to be successful in earlier research . METHODS The method consisted of a r and omized controlled trial group design with repeated measures ( n=27 ) . All participants had an EEG verified epilepsy diagnosis with drug refractory seizures . Participants were r and omized into one of two conditions , ACT or supportive therapy ( ST ) . Therapeutic effects were measured by examining changes in quality of life ( SWLS and WHOQOL ) and seizure index ( frequency x duration ) . Both treatment conditions consisted of only nine hours of professional therapy distributed in two individual and two group sessions during a four-week period . RESULTS The results showed significant effects over all of the dependent variables for the ACT group as compared to the ST group at six- and twelve-month follow-ups . CONCLUSIONS The results from this study suggest that a short-term psychotherapy program combined with anticonvulsant drugs may help to prevent the long-term disability that occurs from drug refractory seizures We determined the efficacy of progressive muscle relaxation in reducing seizure frequency . Subjects were 24 people with epilepsy attending an urban neurology clinic . The experimental design consisted of an 8-week baseline period , a treatment period of six sessions of progressive relaxation training ( PRT , n = 13 ) or quiet sitting ( QS , n = 11 ) and an 8-week follow up . In the PRT group , 11 subjects reported a decrease in seizure frequency ( p less than 0.01 ) , and in the QS group , 7 reported a decrease ( p greater than 0.05 ) . The mean decrease in seizure frequency was 29 % for the PRT group ( p less than 0.01 ) but only 3 % for the QS group ( p greater than 0.05 ) . This is the fifth recent report of a controlled study documenting the success of progressive relaxation therapy in seizure reduction . PRT is inexpensive and noninvasive and facilitates patient participation . Such a technique should be incorporated into clinical practice The effects of two pranayama yoga breathing exercises on airway reactivity , airway calibre , symptom scores , and medication use in patients with mild asthma were assessed in a r and omised , double-blind , placebo-controlled , crossover trial . After baseline assessment over 1 week , 18 patients with mild asthma practised slow deep breathing for 15 min twice a day for two consecutive 2-week periods . During the active period , subjects were asked to breathe through a Pink City lung ( PCL ) exerciser -- a device which imposes slowing of breathing and a 1:2 inspiration : expiration duration ratio equivalent to pranayama breathing methods ; during the control period , subjects breathed through a matched placebo device . Mean forced expiratory volume in 1 s ( FEV1 ) , peak expiratory flow rate , symptom score , and inhaler use over the last 3 days of each treatment period were assessed in comparison with the baseline assessment period ; all improved more with the PCL exerciser than with the placebo device , but the differences were not significant . There was a statistically significant increase in the dose of histamine needed to provoke a 20 % reduction in FEV1 ( PD20 ) during pranayama breathing but not with the placebo device . The usefulness of controlled ventilation exercises in the control of asthma should be further investigated Hatha-Yoga has become increasingly popular in western countries as a method for coping with stress . However , little is known about the physiological and psychological effects of yoga practice . We measured heart rate , blood pressure , the hormones cortisol , prolactin and growth hormone and certain psychological parameters in a yoga practicing group and a control group of young female volunteers reading in a comfortable position during the experimental period . There were no substantial differences between the groups concerning endocrine parameters and blood pressure . The course of heart rate was significantly different , the yoga group had a decrease during the yoga practice . Significant differences between both groups were found in psychological parameters . In the personality inventory the yoga group showed markedly higher scores in life satisfaction and lower scores in excitability , aggressiveness , openness , emotionality and somatic complaints . Significant differences could also be observed concerning coping with stress and the mood at the end of the experiment . The yoga group had significant higher scores in high spirits and extravertedness Three children with very frequent refractory epileptic seizures underwent a behavioral intervention consisting of symptom discrimination , counter measures , contingent relaxation , and positive reinforcement for correct responses in a systematic replication series . The studies involved a 6-h nonintervention base rate , a 6-h treatment phase , and a 6-h nonintervention follow-up under laboratory conditions for each child . Neurophysiologic and behavioral measures of the effects of treatment were made using electroencephalogram (EEG)-video equipment . Effects of treatment were assessed by using a r and om sample of EEG-video sequences in base rate and follow-up . Results showed that no significant reduction of either seizure behavior or paroxysmal EEG activity was found subsequent to training in discrimination of early paroxysmal activity and /or sensations preceding seizures . Both seizure behavior and paroxysmal activity were significantly reduced in all three cases following intervention with an adapted countermeasure technique . No additional effects could be noted subsequent to the application of either contingent relaxation or positive reinforcement for correct responses . Paroxysmal EEG changes and seizure behavior were highly correlated . Reduction of the clinical manifestation or seizure response by behavioral manipulation was accompanied by a reduction of the total amount of paroxysmal activity as measured by the EEG The effect of Sahaja yoga meditation on 32 patients with primary idiopathic epilepsy on regular and maintained antiepileptic medication was studied . The patients were r and omly divided into 3 groups : group I practice d Sahaja Yoga meditation twice daily for 6 months under proper guidance ; group II practice d postural exercises mimicking the meditation for the same duration ; and group III was the control group . Visual Contrast Sensitivity ( VCS ) , Auditory Evoked Potentials ( AEP ) , Brainstem Auditory Evoked Potentials ( BAEP ) , and Mid Latency Responses ( MLR ) were recorded initially ( 0 month ) and at 3 and 6 months for each group . There was a significant improvement in VCS following meditation practice in group I participants . Na , the first prominent negative peak of MLR and Pa , the positive peak following Na did not register changes in latency . The Na-Pa amplitude of MLR also showed a significant increase . There were no significant changes in the absolute and interpeak latencies of BAEP . The reduced level of stress following meditation practice may make patients more responsive to specific stimuli . Sahaja Yoga meditation appears to bring about changes in some of the electrophysiological responses studied in epileptic patients OBJECTIVE Yoga and relaxation techniques have traditionally been used by nonmedical practitioners to help alleviate musculoskeletal symptoms . The objective of this study was to collect controlled observations of the effect of yoga on the h and s of patients with osteoarthritis ( OA ) . METHODS Patients with OA of the h and s were r and omly assigned to receive either the yoga program or no therapy . Yoga techniques were supervised by one instructor once/week for 8 weeks . Variables assessed were pain , strength , motion , joint circumference , tenderness , and h and function using the Stanford H and Assessment question naire . RESULTS The yoga treated group improved significantly more than the control group in pain during activity , tenderness and finger range of motion . Other trends also favored the yoga program . CONCLUSION This yoga derived program was effective in providing relief in h and OA . Further studies are needed to compare this with other treatments and to examine longterm effects 34 hypertensive patients were assigned at r and om either to six weeks ' treatment by yoga relaxation methods with bio-feedback or to placebo therapy ( general relaxation ) . Both groups showed a reduction in blood-pressure ( from 168/100 to 141/84 mm . Hg in the treated group and from 169/101 to 160/96 mm Hg in the control group ) . The difference was highly significant . The control group was then trained in yoga relaxation , and their blood-pressure fell to that of the other group ( now used as controls ) BACKGROUND More than 30 percent of patients with epilepsy have inadequate control of seizures with drug therapy , but why this happens and whether it can be predicted are unknown . We studied the response to antiepileptic drugs in patients with newly diagnosed epilepsy to identify factors associated with subsequent poor control of seizures . METHODS We prospect ively studied 525 patients ( age , 9 to 93 years ) who were given a diagnosis , treated , and followed up at a single center between 1984 and 1997 . Epilepsy was classified as idiopathic ( with a presumed genetic basis ) , symptomatic ( result ing from a structural abnormality ) , or cryptogenic ( result ing from an unknown underlying cause ) . Patients were considered to be seizure-free if they had not had any seizures for at least one year . RESULTS Among the 525 patients , 333 ( 63 percent ) remained seizure-free during antiepileptic-drug treatment or after treatment was stopped . The prevalence of persistent seizures was higher in patients with symptomatic or cryptogenic epilepsy than in those with idiopathic epilepsy ( 40 percent vs. 26 percent , P=0.004 ) and in patients who had had more than 20 seizures before starting treatment than in those who had had fewer ( 51 percent vs. 29 percent , P<0.001 ) . The seizure-free rate was similar in patients who were treated with a single established drug ( 67 percent ) and patients who were treated with a single new drug ( 69 percent ) . Among 470 previously untreated patients , 222 ( 47 percent ) became seizure-free during treatment with their first antiepileptic drug and 67 ( 14 percent ) became seizure-free during treatment with a second or third drug . In 12 patients ( 3 percent ) epilepsy was controlled by treatment with two drugs . Among patients who had no response to the first drug , the percentage who subsequently became seizure-free was smaller ( 11 percent ) when treatment failure was due to lack of efficacy than when it was due to intolerable side effects (
Output:
| The yoga group showed significant improvement in their quality of life according to the Satisfaction With Life Scale ( SWLS ) ( P < 0.05 ) , while the ACT group had significant improvement in the World Health Organization Quality of Life-BREF ( WHOQOL-BREF ) scale ( P < 0.01).Overall , we assessed the quality of evidence as low ; no reliable conclusions can be drawn at present regarding the efficacy of yoga as a treatment for epilepsy .
Results of the overall efficacy analysis show that yoga treatment was better when compared with no intervention or interventions other than yoga ( postural exercises mimicking yoga ) .
There was no difference between yoga and Acceptance and Commitment Therapy .
Physician blinding would normally be taken to be the person delivering the intervention , whereas we think the ' physician ' would in fact be the outcome assessor ( who could be blinded ) , so that would be a reduction in detection bias rather than performance bias . |
MS211550 | ***TASK*** the task is to summarize an input biomedical literature 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 Lack of r and omized controlled trials ( RCTs ) that compare pure laparoscopic radical prostatectomy ( LRP ) with robot-assisted laparoscopic radical prostatectomy ( RALRP ) is an important gap of the literature related to the surgical treatment of the clinical ly localized prostate cancer ( PCa ) . AIM To provide the first prospect i ve r and omized comparison on the functional and oncological outcomes of LRP and RALRP for the treatment of the clinical ly localized PCa . METHODS Between 2007 and 2008 , 128 consecutive male patients were r and omized in two groups and treated by a single experienced surgeon with traditional LRP ( Group I-64 patients ) or RALRP ( Group II-64 patients ) in all cases with intent of bilateral intrafascial nerve sparing . MAIN OUTCOME MEASURES Primary end point was to compare the 12 months erectile function ( EF ) outcomes . Complication rates , continence outcomes , and oncological results were also compared . The sample size of our study was able , with an adequate power ( 1-beta > 0.90 ) , to recognize as significant large differences ( above 0.30 ) between incidence proportions of considered outcomes . RESULTS No statistically significant differences were observed for operating time , estimated blood loss , transfusion rate , complications , rates of positive surgical margins , rates of biochemical recurrence , continence , and time to continence . However , the 12-month evaluation of capability for intercourse ( with or without phosphodiesterase type 5 inhibitors ) showed a clear and significant advantage of RALRP ( 32 % vs. 77 % , P < 0.0001 ) . Time to capability for intercourse was significantly shorter for RALRP . Rates of return to baseline International Index of Erectile Function ( IIEF-6 ) EF domain score question naires ( questions 1 - 5 and 15 ) ( 25 % vs. 58 % ) and to IIEF-6 > 17 ( 38 % vs. 63 % ) were also significantly higher for RALRP ( P = 0.0002 and P = 0.008 , respectively ) . CONCLUSIONS Our study offers the first high-level evidence that RALRP provides significantly better EF recovery than LRP without hindering the oncologic radicality of the procedure . Larger RCTs are needed to confirm if a new gold-st and ard treatment in the field of RP has risen PURPOSE Robotic assisted laparoscopic radical cystectomy for bladder cancer has been reported with potential for improvement in perioperative morbidity compared to the open approach . However , most studies are retrospective with significant selection bias . MATERIAL S AND METHODS A pilot prospect i ve r and omized trial evaluating perioperative outcomes and oncologic efficacy of open vs robotic assisted laparoscopic radical cystectomy for consecutive patients was performed from July 2009 to June 2011 . RESULTS To date 47 patients have been r and omized with data available on 40 patients for analysis . Each group was similar with regard to age , gender , race , body mass index and comorbidities , as well as previous surgeries , operative time , postoperative complications and final pathological stage . We observed no significant differences between oncologic outcomes of positive margins ( 5 % each , p = 0.50 ) or number of lymph nodes removed for open radical cystectomy ( 23 , IQR 15 - 28 ) vs robotic assisted laparoscopic radical cystectomy ( 11 , IQR 8.75 - 21.5 ) groups ( p = 0.135 ) . The robotic assisted laparoscopic radical cystectomy group ( 400 ml , IQR 300 - 762.5 ) was noted to have decreased estimated blood loss compared to the open radical cystectomy group ( 800 ml , IQR 400 - 1,100 ) and trended toward a decreased rate of excessive length of stay ( greater than 5 days ) ( 65 % vs 90 % , p = 0.11 ) compared to the open radical cystectomy group . The robotic group also trended toward fewer transfusions ( 40 % vs 50 % , p = 0.26 ) . CONCLUSIONS Our study vali date s the concept of r and omizing patients with bladder cancer undergoing radical cystectomy to an open or robotic approach . Our results suggest no significant differences in surrogates of oncologic efficacy . Robotic assisted laparoscopic radical cystectomy demonstrates potential benefits of decreased estimated blood loss and decreased hospital stay compared to open radical cystectomy . Our results need to be vali date d in a larger multicenter prospect i ve r and omized clinical trial 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 To compare health‐related quality ‐of‐life ( HRQoL ) outcomes for robot‐assisted laparoscopic radical cystectomy ( RARC ) with those of traditional open radical cystectomy ( ORC ) in a prospect i ve r and omised fashion 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 284 Background : We reported our results on a prospect i ve , r and omized trial of open vs. robotic cystectomy in 2008 . Three years later , we report our findings with regard to overall ( OS ) and disease-specific survival ( DS ) , recurrence rates and long-term complications . METHODS A prospect i ve , r and omized study comparing open vs. robotic cystectomy for bladder cancer was initiated at our institution with IRB approval in 2008 . A target accrual of 40 patients was established to evaluate for non-inferiority based upon nodal yield . Peri-operative and pathologic results were reported in 2008 . We now report our median 36-month follow-up for this patient cohort . RESULTS Of the 41 patients , 21 were r and omized to robotic and 20 to open . On surgical pathology , in the robotic group 14 patients had < = pT2 , 3 pT3/T4 , and 4 N+ disease . In the open group , 9 had < = pT2 , 5 pT3/T4 , and 7 N+ disease . No positive margins were noted . With median follow-up of 35 and 36 months in the robotic and open arms , OS was 65 % ( 13/20 ) and 81 % ( 17/21 ) respectively ( p=0.3058 ) . DSS was 68 % in the open group ( 13/19 ) and 85 % in the robotic group ( 17/20 ) ( p=0.2733 ) . There were 7 recurrences ( 35 % ) in the open cohort compared to 3 patients ( 14 % ) undergoing the robotic procedure ( p=0.1589 ) . Examining overall complications , there were no differences between the open and robotic groups when evaluating 30-day complications and > = 90 day complications ( p=0.8651 ) . The open and robotic cohorts demonstrated 2 strictures in each cohort . Two parastomal hernias were noted in the open group compared to none in the robotic group . On multivariate analysis , controlling for age , BMI and pathologic stage , cystectomy type did not predict OS or DSS , recurrences , or complications . CONCLUSIONS Median 3-year follow-up evaluating open versus robotic cystectomy demonstrates no differences with regard to OS , DSS , cancer recurrence or long-term complications . Although this study was not powered to assess survival differences , this is the first r and omized study to report such data in a non-selected population with 3-year median follow-up BACKGROUND Open radical cystectomy ( ORC ) and urinary diversion in patients with bladder cancer ( BCa ) are associated with significant perioperative complication risk . OBJECTIVE To compare perioperative complications between robot-assisted radical cystectomy ( RARC ) and ORC techniques . DESIGN , SETTING , AND PARTICIPANTS A prospect i ve r and omized controlled trial was conducted during 2010 and 2013 in BCa patients scheduled for definitive treatment by radical cystectomy ( RC ) , pelvic lymph node dissection ( PLND ) , and urinary diversion . Patients were r and omized to ORC/PLND or RARC/PLND , both with open urinary diversion . Patients were followed for 90 d postoperatively . INTERVENTION St and ard ORC or RARC with PLND ; all urinary diversions were performed via an open approach . OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS Primary outcomes were overall 90-d grade 2 - 5 complications defined by a modified Clavien system . Secondary outcomes included comparison of high- grade complications , estimated blood loss , operative time , pathologic outcomes
Output:
| Robotic surgery is comparable with laparoscopic or open surgery for oncological outcomes and overall complications , and provides somewhat better functional outcome when compared with laparoscopic and open surgery |
MS211551 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: OBJECTIVES --To compare the tolerance , efficacy , and pharmacokinetics of amphotericin deoxycholate ( Fungizone ) prepared in a parenteral fat emulsion ( Intralipid 20 % ) or glucose in HIV patients with c and idiasis . DESIGN --Non-blind r and omised controlled trial . SETTING --University hospital ; tertiary clinical care . PATIENTS --22 HIV positive patients with oral c and idiasis . INTERVENTIONS --Amphotericin 1 mg/kg/day given on four consecutive days as a one hour infusion dissolved in either 5 % glucose ( amphotericin-glucose ) or parenteral fat emulsion at a final concentration of 2 g/l fat emulsion ( amphotericin-fat emulsion ) . MAIN OUTCOME MEASURES -- Clinical tolerance ( fever , chills , sweats , nausea , arterial pressure , and pulse rate ) ; biological tolerance ( serum creatinine , electrolyte , and magnesium values ) ; clinical score of c and idiasis ; and serum concentrations of amphotericin . RESULTS --11 patients were enrolled in each group . All the amphotericin-fat emulsion infusions were given without serious problem whereas four amphotericin-glucose infusions were stopped because of renal impairment ( n = 3 ) or severe chills ( n = 2 ) , or both . For patients completing the amphotericin-glucose treatment creatine concentration increased by 42 mumol/l ; four of seven patients had at least one creatinine value > or = 133 mumol/l versus one of 11 receiving amphotericin-fat emulsion . Magnesium concentration fell significantly with amphotericin-glucose but not with amphotericin-fat emulsion . Clinical side effects were noted in 36/38 infusions with amphotericin-glucose but 10/44 with amphotericin-fat emulsion . Oral c and idiasis score was reduced similarly in both groups . Serum amphotericin concentrations were significantly lower and the volume of distribution of the drug higher after infusion of amphotericin-fat emulsion than after amphotericin-glucose . CONCLUSIONS -- Clinical and renal toxicity of amphotericin are reduced when the drug is prepared in fat emulsion . Preparation is simple and cost effective . Its efficacy is similar to that of conventional amphotericin ABSTRACT Amphotericin B deoxycholate ( AmBd ) is the recommended induction treatment for HIV-associated cryptococcal meningitis ( CM ) . Its use is hampered by toxicities that include electrolyte abnormalities , nephrotoxicity , and anemia . Protocol s to minimize toxicity are applied inconsistently . In a clinical trial cohort of AmBd-based CM induction treatment , a st and ardized protocol of preemptive hydration and electrolyte supplementation was applied . Changes in blood counts , electrolyte levels , and creatinine levels over 14 days were analyzed in relation to the AmBd dose , treatment duration ( short course of 5 to 7 days or st and ard course of 14 days ) , addition of flucytosine ( 5FC ) , and outcome . In the 368 patients studied , the hemoglobin levels dropped by a mean of 1.5 g/dl ( 95 % confidence interval [ CI ] , 1.0 to 1.9 g/dl ) following 7 days of AmBd and by a mean of 2.3 g/dl ( 95 % CI , 1.1 to 3.6 g/dl ) after 14 days . Serum creatinine levels increased by 37 μmol/liter ( 95 % CI , 30 to 45 μmol/liter ) by day 7 and by 49 μmol/liter ( 95 % CI , 35 to 64μmol/liter ) by day 14 of AmBd treatment . Overall , 33 % of patients developed grade III/IV anemia , 5.6 % developed grade III hypokalemia , 9.5 % had creatinine levels that exceeded 220 μmol , and 6 % discontinued AmBd prematurely . The addition of 5FC was associated with a slight increase in anemia but not neutropenia . Laboratory abnormalities stabilized or reversed during the second week in patients on short-course induction . Grade III/IV anemia ( adjusted odds ratio [ aOR ] , 2.2 ; 95 % CI , 1.1 to 4.3 ; P = 0.028 ) and nephrotoxicity ( aOR , 4.5 ; 95 % CI , 1.8 to 11 ; P = 0.001 ) were risk factors for 10-week mortality . In summary , routine intravenous saline hydration and preemptive electrolyte replacement during AmBd-based induction regimens for HIV-associated CM minimized the incidence of hypokalemia and nephrotoxicity . Anemia remained a concerning adverse effect . The addition of flucytosine was not associated with increased neutropenia . Shorter AmBd courses were less toxic , with rapid reversibility ABSTRACT A multicentric r and omized trial was undertaken to compare the toxicity of amphotericin B in 5 % dextrose with that of amphotericin B in a fat emulsion ( Intralipid ) in cancer patients . Group 1 ( n = 33 ) received amphotericin B diluted in 5 % dextrose with premedication consisting of promethazine plus an antipyretic . Group 2 ( n = 28 ) received amphotericin B diluted in 20 % Intralipid without premedication . Amphotericin B was infused daily at a dose of 1 mg/kg of body weight over a 1-h period to members of both groups for empirical antifungal therapy ( in neutropenic patients ) or for the treatment of documented fungal infections . The majority of patients ( 80 % ) received empirical amphotericin B treatment . The two groups were comparable with regard to age , gender , underlying disease , and the following baseline characteristics : use of other nephrotoxic drugs and serum levels of potassium and creatinine . The median cumulative doses of amphotericin B were 240 mg in group 1 and 245 mg in group 2 ( P = 0.73 ) . Acute adverse events occurred in 88 % of patients in group 1 and in 71 % of those in group 2 ( P = 0.11 ) . Forty percent of the infusions in group 1 were associated with fever , compared to 23 % in group 2 ( P < 0.0001 ) . In addition , patients in group 2 required less meperidine for the control of acute adverse events ( P = 0.008 ) , and fewer members of this group presented with hypokalemia ( P = 0.004 ) or rigors ( P < 0.0001 ) . There was no difference in the proportions of patients with nephrotoxicity ( P = 0.44 ) . The success rates of empirical antifungal treatment were similar in the two groups ( P = 0.9 ) . Amphotericin B diluted in a lipid emulsion seems to be associated with a smaller number of acute adverse events and fewer cases of hypokalemia than amphotericin B diluted in 5 % dextrose In this double-blind study to compare safety of 2 lipid formulations of amphotericin B , neutropenic patients with unresolved fever after 3 days of antibacterial therapy were r and omized ( 1:1:1 ) to receive amphotericin B lipid complex ( ABLC ) at a dose of 5 mg/kg/d ( n=78 ) , liposomal amphotericin B ( L Amph ) at a dose of 3 mg/kg/d ( n=85 ) , or L Amph at a dose of 5 mg/kg/d ( n=81 ) . L Amph ( 3 mg/kg/d and 5 mg/kg/d ) had lower rates of fever ( 23.5 % and 19.8 % vs. 57.7 % on day 1 ; P<.001 ) , chills/rigors ( 18.8 % and 23.5 % vs. 79.5 % on day 1 ; P<.001 ) , nephrotoxicity ( 14.1 % and 14.8 % vs. 42.3 % ; P<.01 ) , and toxicity-related discontinuations of therapy ( 12.9 % and 12.3 % vs. 32.1 % ; P=.004 ) . After day 1 , infusional reactions were less frequent with ABLC , but chills/rigors were still higher ( 21.0 % and 24.3 % vs. 50.7 % ; P<.001 ) . Therapeutic success was similar in all 3 groups ABSTRACT In a prospect i ve , r and omized clinical trial , the toxicity of 1 mg of amphotericin B ( AmB ) per kg of body weight per day infused in 5 % dextrose was compared with that of AmB infused in lipid emulsion in children with malignant disease . In an analysis of 82 children who received a full course of 6 days or more of AmB ( 117 courses ) , it was shown that there were significant increases in plasma urea and creatinine concentrations and in potassium requirement after 6 days of therapy with both AmB infused in dextrose and AmB infused in lipid emulsion , with there being no difference between the two methods of AmB administration . An intent-to-treat comparison of the numbers of courses affected by acute toxicity ( fever , rigors ) and chronic toxicity ( nephrotoxicity ) also indicated that there was no significant difference between AmB infused in dextrose ( 78 courses ) and AmB infused in lipid emulsion ( 84 courses ) . The pharmacokinetics of AmB were investigated in 20 children who received AmB in dextrose and 15 children who received AmB in lipid emulsion . Blood sample s were collected up to 24 h after administration of the first dose , and the concentration of AmB in plasma was analyzed by a high-performance liquid chromatography assay . The clearance ( CL ) of AmB in dextrose ( 0.039 ± 0.016 liter · h−1 · kg−1 ) was significantly lower ( P < 0.005 ) than the CL of AmB in lipid emulsion ( 0.062 ± 0.024 liter · h−1 · kg−1 ) . The steady-state volume of distribution for AmB in dextrose ( 0.83 ± 0.33 liter · kg−1 ) was also significantly lower ( P < 0.005 ) than that for AmB in lipid emulsion ( 1.47 ± 0.77 liter · kg−1 ) . Although AmB in lipid emulsion is apparently cleared faster and distributes more widely than AmB in dextrose , this study did not reveal any significant advantage with respect to safety and tolerance in the administration of AmB in lipid emulsion compared to its administration in dextrose in children with malignant disease The study objective was to obtain preliminary information regarding the safety and efficacy of amphotericin B ( AmB ) lipid complex ( ABLC ) in the treatment of AIDS-associated cryptococcal meningitis . Of 55 patients r and omly assigned to 6 weeks of therapy with ABLC ( 1.2 - 5.0 mg/[kg.d ] , with ascending doses for three sequential cohorts ) or AmB ( 0.7 - 1.2 mg/[kg.d ] ) , 46 received > or = 12 doses . Transfusion requirements , mean decreases in hemoglobin level , and mean increases in creatinine level were significantly greater with AmB than with ABLC . The total number of adverse events , infusion-related events , and occurrences of hypomagnesemia and hypokalemia associated with each form of therapy were similar . Among 21 recipients of ABLC at a dosage of 5 mg/kg ( daily for 2 weeks and then thrice weekly for 4 weeks ) , symptoms and signs resolved for 18 ( 86 % ) . Of those receiving > or = 12 doses of ABLC , cultures converted to negative for 8 ( 42 % ) , were undeterminable for 3 ( 16 % ) , and remained positive for 8 ( 42 % ) despite resolution of symptoms . Although preliminary , these data suggest ABLC has significant activity in patients with AIDS-associated cryptococcal meningitis . Because this formulation has less hematologic and renal toxicity than does AmB , further evaluation of ABLC is warranted In 2005 , several groups , including the European Group for Blood and Marrow Transplantation , the European Organization for Treatment and Research of Cancer , the European Leukemia Net and the Immunocompromised Host Society created the European Conference on Infections in Leukemia ( ECIL ) . The main goal of ECIL is to elaborate guidelines , or recommendations , for the management of infections in leukemia and stem cell transplant patients . The first sets of ECIL slides about the management of invasive fungal disease were made available on the web in 2006 and the papers were published in 2007 . The third meeting of the group ( ECIL 3 ) was held in September 2009 and the group up date d its previous recommendations . The goal of this paper is to summarize the new proposals from ECIL 3 , based on the results of studies published after the ECIL 2 meeting : ( 1 ) the prophylactic recommendations for h
Output:
| No significant differences between conventional amphotericin B and any of the five formulations evaluated were observed , with regard to the efficacy analysis .
With respect to the adverse events of nephrotoxicity , fever , chills and vomiting , all lipid formulations presented better profiles than the conventional formulation .
The present systematic review and meta- analysis showed that conventional amphotericin B presents the same efficacy profile as lipid-based formulations , although the latter were associated with a safer profile |
MS211552 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: OBJECTIVES : It has been suggested that the variation in the prevalence of irritable bowel syndrome ( IBS ) may be due to the application of different diagnostic criteria . New criteria for IBS have been proposed ( Rome II ) . It is unknown whether persons meeting different criteria for IBS have similar psychological and symptom features . The aim of this study was to measure the prevalence of IBS according to Manning and Rome definitions of IBS and to evaluate the clinical and psychological differences between diagnostic categories . METHODS : A total of 4500 r and omly selected subjects , with equal numbers of male and female subjects aged ≥18 yr and representative of the Australian population , took part in this study . Subjects were mailed a question naire ( response rate , 72 % ) . Characteristics measured were gastrointestinal symptoms over the past 12 months , neuroticism and extroversion ( Eysenck Personality Question naire ) , anxiety and depression ( Delusions-Symptoms-States Inventory ) , mental and physical functioning ( SF-12 ) , and somatic distress ( Sphere ) . RESULTS : The prevalence for IBS according to Manning , Rome I , and Rome II was 4.4 % ( 95 % confidence interval [ CI ] = 3.5–5.1 % ) , 6.9 % ( CI 6.0–7.8 % ) , and 13.6 % ( CI 12.3–14.8 % ) , respectively . Only 12 persons with Rome I did not also meet Rome II criteria ; 196 persons with Manning criteria did not meet Rome II cut-offs . Having IBS regardless of which criteria were used was significantly associated with psychological morbidity , but psychological factors were not important in discriminating between diagnostic categories . However , pain and bowel habit severity independently discriminated between diagnostic groups . CONCLUSIONS : IBS is a relatively common disorder in the community . The new Rome II criteria may be unnecessarily restrictive in practice Over a 3‐year period , all patients referred for barium enema examination had a double‐contrast barium enema and flexible sigmoidoscopy performed on the same day . A total of 462 joint examinations were performed . Abnormalities were found in 193 patients by the use of barium enema , 164 patients by using sigmoidoscopy and 294 by the use of both methods of investigation . Sigmoidoscopy was superior to barium enema in the detection of polyps and inflammatory bowel disease but barium enema was more sensitive for diverticular disease . The presenting symptoms had no predictive value in distinguishing carcinoma , polyps and diverticular disease . Diverticular disease did not reduce the sensitivity of barium enema examination to polyps in the sigmoid colon . Fibreoptic sigmoidoscopy immediately before barium enema was well tolerated by patients . The investigations were complementary in the diagnosis of colonic polyps , inflammatory bowel disease and diverticular disease In a prospect i ve study involving 833 consecutive outpatient and open-access colonoscopies , attempts were made to characterize the benefit of colonoscopy in terms of both predicted and unpredicted findings and therapeutic procedures . The endoscopist therefore predicted the endoscopic findings before the endoscopy . The results were compared for the different indications for colonoscopy . The overall agreement between the predictions and the colonoscopic findings was 61 % . Clinical ly significant abnormalities were found in about half the examinations . The most frequent abnormal findings were benign polyps ( 24 % ) , inflammatory bowel disease ( 17 % ) , and malignancy ( 5 % ) . In about half the patients with a malignancy the indication for colonoscopy was rectal bleeding , and half of the malignancies were not predicted . The greatest benefit of colonoscopy was found in patients referred because of overt rectal bleeding or occult faecal blood , and abnormal barium enema or endoscopy findings . The importance of complete colonoscopy in connection with operation for colorectal carcinoma is emphasized Colonoscopy is an integral part of the clinician armamentarium in the diagnosis of colorectal cancer and its precursor , the adenoma . Polypoid lesions when identified can be excised at colonoscopy and in turn reduce the risk of colorectal cancer . We prospect ively evaluated the yield of colorectal cancer and adenomatous polyps by indication for colonoscopy over a one-year period . A total of 375 colonoscopies were carried out . The more common indications of colonoscopy were rectal bleeding , abdominal pain , surveillance of colorectal cancer and altered bowel habit . The highest yield for cancer was for rectal bleeding with 12.5 % while surveillance of patients with a history of polyps yielded the highest percentage of new polyps . We conclude that rectal bleeding as an indication for colonoscopy yielded the highest number of cancers OBJECTIVES To assess the clinical yield of colonoscoping in patients who present with rectal bleeding , persistent abdominal pain , or change in bowel habits in the absence of bleeding . DESIGN A prospect i ve study of colonoscopy patients . SETTING Three colonoscopy practice s in New York City between April 1986 and November 1989 . PATIENTS Eight hundred sixty-one patients with rectal bleeding , 113 patients with abdominal pain , 154 with change in bowel habits , and 44 patients with both abdominal pain and bowel change . MAIN RESULTS Of 861 patients with rectal bleeding , 293 ( 33.6 % ) had colonic neoplasia ( 8.6 % cancer and 25 % adenomatous polyps ) . In patients who had colonoscopy because of abdominal pain ( n = 113 ) , change in bowel habits ( n = 154 ) , or both abdominal pain and bowel change ( n = 44 ) , respectively 25 ( 22.1 % ) , 42 ( 27.3 % ) , and 10 ( 22.7 % ) had colonic neoplasms . If one looks at significant neoplasia ( cancer or adenomas > 1 cm ) , then the findings in rectal bleeders were 14.5 % , whereas the abdominal pain , change in bowel habits , and both groups had 7.1 % , 7.1 % , and 13.6 % , respectively . Patients with rectal bleeding were more likely to have multiple adenomas than those with nonbleeding symptoms ( p < 0.05 ) . CONCLUSIONS Patients with persistent nonbleeding GI symptoms , including abdominal pain and change in bowel habits , have almost as high a yield of colorectal neoplasia as those with rectal bleeding BACKGROUND AND STUDY AIMS Appropriateness of use of colonoscopy is an important issue in health care in the quest to improve quality of care while at the same time containing costs . This prospect i ve study examined whether detailed and explicit appropriateness criteria significantly improve the diagnostic yield of colonoscopy . PATIENTS AND METHODS Consecutive patients referred for diagnostic colonoscopy at five centers ( one university hospital and its outpatient department , two district hospitals , and two gastroenterology practice s ) were prospect ively studied over a 17-month period . The appropriateness of the indications for these colonoscopies was assessed using explicit Swiss criteria developed by the R and Corporation/University of California at Los Angeles ( R AND /UCLA ) panel method , and the relationship between appropriateness of use and the presence of clinical ly relevant endoscopic lesions was analysed . RESULTS 1188 patients were included in the study . Indications for 1144 ( 96.3 % ) of the colonoscopies could be evaluated using explicit criteria ; 64.1 % of the colonoscopies were judged appropriate , 13.3 % uncertain and 22.6 % inappropriate . Significant endoscopic lesions were found in 23.8 % of the colonoscopies . Colonoscopies judged appropriate or uncertain yielded significantly more relevant lesions than did those judged to be inappropriate ( 25.6 % vs. 17.4 % ; P = 0.007 ) . Of 51 colon cancers , all but one were found in colonoscopies judged to be appropriate or uncertain . In a multivariate analysis , the diagnostic yield of colonoscopy was significantly influenced by appropriateness , patient gender and treatment setting . CONCLUSIONS The use of detailed and explicit appropriateness criteria for colonoscopy significantly enhances the identification of relevant lesions and in particular of colon cancer . The use of such criteria could therefore improve patient selection for colonoscopy and thus contribute to efforts aim ed at enhancing the quality and efficiency of care Objective : Little data on rectal bleeding in the U.S. population are available . We therefore sought to assess the prevalence of different types of rectal bleeding , their association with potential risk factors including other colonic symptoms , and predictors of health care seeking in a U.S. community . Methods : We used a crossectional survey by mail , applying a previously vali date d self-report symptom question naire . Our population comprised an age- and gender-stratified r and om sample of Olmsted County , Minnesota residents aged 20–64 yr . Results : In total , 1643 responded ( 77 % ) . Rectal bleeding was reported by 235 subjects ( age- and gender-adjusted prevalence , 15.5 per 100 ; 95 % confidence interval [ CI ] , 13.6–17.4 ) ; 218 found blood on wiping , 74 noted blood coating the stools , and 46 reported dark blood mixed in the stools . The prevalence of rectal bleeding was significantly higher in younger persons ( 18.9 % , 20–40 yr vs 11.3 % > 40 yr ; p < 0.001 ) . By stepwise logistic regression analysis , constipation ( odds ratio [ OR ] = 3.03 ; 95 % CI , 2.09–4.41 ) and diarrhea ( OR = 1.90 ; 95 % CI , 1.25–2.84 ) were independent predictors of rectal bleeding . Among those with rectal bleeding , 13.9 % ( 95 % CI , 9.6–19.1 % ) had visited a physician for bowel problems in the prior yr ; only a history of abdominal surgery was an independent predictor of physician visits but this explained just 15.9 % of the deviance . Conclusions : In otherwise healthy young and middle-aged persons , approximately one in seven have a history of rectal bleeding and this is more frequent in younger people ; only a minority seek health care and this is not related to symptom status BACKGROUND Open-access endoscopy allows physicians to directly schedule endoscopic procedures for their patients without prior consultation . Evaluation of both appropriateness and diagnostic yield of endoscopic procedures is critical when assessing the costs and benefits of endoscopy in an open-access setting . The aim of this study was to assess the appropriate use of colonoscopy in an open-access system and to establish the yield of diagnostic information relevant to patient care . METHODS Overall , 1123 consecutive patients referred for open-access colonoscopy were prospect ively enrolled in the study . The American Society for Gastrointestinal Endoscopy ( ASGE ) guidelines were used to assess the relationship between the appropriate use of colonoscopy and the presence of relevant endoscopic findings . RESULTS The rate of colonoscopies " generally not indicated " according to ASGE guidelines was 29 % ( 39 % for primary care physicians and 23 % for specialists ; p < 0.0001 ) . A relevant endoscopic finding was detected in 338 examinations ( 35 % ) . The diagnostic yield was significantly higher for " generally indicated " colonoscopies ( 43 % ) compared with " generally not indicated " procedures ( 16 % ) ( p < 0.001 ) . CONCLUSIONS Although the rate of inappropriate use of colonoscopy was high , open-access colonoscopy was effective in detecting neoplastic lesions . Because most of these were detected during examinations performed for appropriate indications , the appropriateness of the indication emerges as crucial to the cost-effectiveness of an open-access system
Output:
| Most alarm features had poor sensitivity and specificity for the diagnosis of colorectal carcinoma , whilst statistical models performed better in terms of sensitivity . |
MS211553 | ***TASK*** the task is to summarize an input biomedical literature 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 Secondary prevention in patients with critical limb ischemia ( CLI ) is crucial for the reduction of cardiovascular morbidity and mortality . Nonetheless , current recommendations are extrapolated from other high‐risk population s because of the lack of CLI‐dedicated trials . The aim of this explorative study was to evaluate the association of statin therapy with the outcomes of CLI patients . Methods The First‐Line Treatments in Patients With Critical Limb Ischemia ( CRITISCH ) registry is a prospect i ve multicenter registry analyzing the effectiveness of all available treatment strategies in 1200 CLI patients . For the purpose s of this analysis , patients were divided into two groups based on statin administration . Treatment crossovers and nonadherent patients were excluded from analysis . The primary composite end point of this study was the amputation‐free survival ( AFS ) . Major adverse cardiovascular and cerebral events ( MACCEs ) , time to death , and time to major amputation were also analyzed . Results Statin therapy was applied in 445 individuals ( 37 % ) , 371 ( 31 % ) patients received no statins , and 384 subjects were excluded from analysis ( treatment crossovers ) . Patients receiving statins were more likely to be younger ( P < .001 ) and to have a history of coronary heart disease ( P < .001 ) or previous intervention at index limb ( P < .001 ) . Patients receiving statin therapy had a lower hazard regarding AFS ( hazard ratio [ HR ] , 0.45 ; 95 % confidence interval [ CI ] , 0.34‐0.63 ; P < .001 ) and death ( HR , 0.40 ; 95 % CI , 0.24‐0.66 ; P < .001 ) as well as lower odds of MACCE ( odds ratio , 0.41 ; 95 % CI , 0.23‐0.69 ; P = .001 ) . However , statin therapy was not associated with reduced amputation rates ( HR , 1.02 ; 95 % CI , 0.67‐1.56 ; P = .922 ) . Statin effect on AFS was consistent among diabetics ( HR , 0.47 ; 95 % CI , 0.31‐0.70 ; P < .001 ) , patients with chronic kidney disease ( HR , 0.53 ; 95 % CI , 0.32‐0.87 ; P = .012 ) , and patients older than 75 years ( HR , 0.40 ; 95 % CI , 0.26‐0.60 ; P < .001 ) . Statin administration was also associated with an improved AFS in patients with antiplatelet medication ( HR , 0.64 ; 95 % CI , 0.41‐0.99 ; P = .049 ) and without antiplatelet medication ( HR , 0.26 ; 95 % CI , 0.12‐0.57 ; P = .001 ) and after both endovascular therapy ( HR , 0.51 ; 95 % CI , 0.34‐0.76 ; P = .001 ) and bypass revascularization ( HR , 0.38 ; 95 % CI , 0.21‐0.68 ; P = .001 ) . Conclusions Statin therapy in CLI patients is associated with an increased AFS and lower rates of mortality and MACCEs without improving , however , the salvage rates of the affected limb In patients with peripheral artery disease ( PAD ) , statins may improve the symptoms of claudication . The Intermittent Claudication Proof of Principle ( ICPOP ) study tested the hypothesis that the combination of extended release niacin plus lovastatin would improve exercise performance in patients with PAD and claudication compared with a diet intervention . A phase 3 double-blind , parallel-group , multi-center , 28-week multi-national study evaluated subjects with a history of claudication who had an ankle — brachial index ( ABI ) ≤ 0.90 , a reproducible peak treadmill walking time ( PWT ) of 1—20 minutes , and a low-density lipoprotein (LDL)-cholesterol level < 160 mg/dl ( < 4.1 mmol/l ) . Subjects were r and omly assigned to low-dose niacin 1000 mg plus lovastatin 40 mg ( low niacin — statin ) , high-dose niacin 2000 mg plus lovastatin 40 mg ( high niacin — statin ) , or diet intervention ( diet ) . The co- primary efficacy endpoint of percent change in PWT and claudication onset time ( COT ) at 28 weeks was assessed using a grade d treadmill protocol . At completion , 385 subjects were analyzed for safety and 370 subjects were analyzed for efficacy . The primary efficacy analysis showed no statistical significance for overall treatment effect at week 28 for the co- primary endpoint of PWT and COT . The PWT component of the primary endpoint increased 26.5 % on diet , 37.8 % on high niacin — statin ( p = 0.137 ) and 38.6 % on low niacin — statin ( p = 0.096 ) . Flushing as the most common event leading to discontinuation and treatment was associated with increases in liver enzymes , fasting blood glucose concentration and a decrease in platelet count OBJECTIVE A population -based point-prevalence study was conducted to determine the prevalence of peripheral arterial disease ( PAD ) in Sweden , with special attention to critical limb ischemia and sex differences . METHODS An age-st and ardized r and omly selected population sample of 8000 women and men , aged 60 to 90 years , from four different regions in Sweden was invited to participate . The sample had the same age and gender distribution as the Swedish population in this age group . Participating subjects completed question naires on medical history , present medication , and symptoms , and their ankle-brachial index ( ABI ) was measured . Subjects were analyzed for presence of PAD according to reported symptoms and an ABI<0.9 . RESULTS A total of 5080 subjects were included , giving a participation rate of 64 % . The prevalence of any PAD , asymptomatic PAD , intermittent claudication , and severe limb ischemia was , respectively , 18 % ( 95 % confidence interval [ CI ] , 16 % to 20 % ) 11 % ( 9 % to 13 % ) , 7 % ( 6.5 to 7 % ) and 1.2 % ( 1 % to 1.5 % ) . Women had a higher prevalence than men when PAD was diagnosed with ABI only ; that is , asymptomatic PAD ( 12.6 % vs 9.4 % , P=.03 ) and severe limb ischemia ( 1.5 % vs 0.8 % , P<.008 ) . The prevalence of any PAD was 7.9 % in the age group 60 to 65 years and increased to 47.2 % among the age group 85 to 90 years . Severe limb ischemia occurred in 0.3 % in the youngest age group , was highest in the age group 80 to 84 years at 3.3 % , and declined to 2.5 % among the oldest . The prevalence of PAD differed between regions ( P<.0001 ) . CONCLUSIONS PAD is common in Sweden , and almost a fifth of all elderly individuals have some stage of this disease . Women are more often afflicted than men . The prevalence of severe ischemia , as a measure of critical limb ischemia , is about 1 % the population Background —Cholesterol modification reduces cardiovascular events in patients with atherosclerosis , including those with peripheral arterial disease . The purpose of this study was to determine whether cholesterol lowering with atorvastatin improves walking performance in patients with intermittent claudication . Methods and Results —This r and omized , double-blind , parallel- design study included 354 persons with claudication attributable to peripheral arterial disease . Patients were treated with placebo , atorvastatin ( 10 mg per day ) , or atorvastatin ( 80 mg per day ) for 12 months . The outcome measures included change in treadmill exercise time and patient-reported measures of physical activity and quality of life based on question naires . Maximal walking time after 12 months of treatment with atorvastatin did not change significantly . However , there was improvement in pain-free walking time after 12 months of treatment for the 80-mg ( P = 0.025 ) group compared with placebo . A physical activity question naire demonstrated improvement in ambulatory ability for the 10- and 80-mg groups ( P = 0.011 ) , whereas 2 quality of life instruments , the Walking Impairment Question naire and Short Form 36 Question naire , did not show significant change . Conclusions —Atorvastatin improves pain-free walking distance and community-based physical activity in patients with intermittent claudication . When treated with atorvastatin , patients with peripheral arterial disease may experience improvement in symptoms to complement the anticipated reduction in cardiovascular events reported in other studies of statins Background : The PCSK9 ( proprotein convertase subtilisin/kexin type 9 ) inhibitor evolocumab reduced low-density lipoprotein cholesterol and cardiovascular events in the FOURIER trial ( Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk ) . We investigated the efficacy and safety of evolocumab in patients with peripheral artery disease ( PAD ) as well as the effect on major adverse limb events . Methods : FOURIER was a r and omized trial of evolocumab versus placebo in 27 564 patients with atherosclerotic disease on statin therapy followed for a median of 2.2 years . Patients were identified as having PAD at baseline if they had intermittent claudication and an ankle brachial index of < 0.85 , or if they had a prior peripheral vascular procedure . The primary end point was a composite of cardiovascular death , myocardial infa rct ion , stroke , hospital admission for unstable angina , or coronary revascularization . The key secondary end point was a composite of cardiovascular death , myocardial infa rct ion , or stroke . An additional outcome of interest was major adverse limb events defined as acute limb ischemia , major amputation , or urgent peripheral revascularization for ischemia . Results : Three thous and six hundred forty-two patients ( 13.2 % ) had PAD ( 1505 with no prior myocardial infa rct ion or stroke ) . Evolocumab significantly reduced the primary end point consistently in patients with PAD ( hazard ratio [ HR ] 0.79 ; 95 % confidence interval [ CI ] , 0.66–0.94 ; P=0.0098 ) and without PAD ( HR 0.86 ; 95 % CI , 0.80–0.93 ; P=0.0003 ; Pinteraction=0.40 ) . For the key secondary end point , the HRs were 0.73 ( 0.59–0.91 ; P=0.0040 ) for those with PAD and 0.81 ( 0.73–0.90 ; P<0.0001 ) for those without PAD ( Pinteraction=0.41 ) . Because of their higher risk , patients with PAD had larger absolute risk reductions for the primary end point ( 3.5 % with PAD , 1.6 % without PAD ) and the key secondary end point ( 3.5 % with PAD , 1.4 % without PAD ) . Evolocumab reduced the risk of major adverse limb events in all patients ( HR , 0.58 ; 95 % CI , 0.38–0.88 ; P=0.0093 ) with consistent effects in those with and without known PAD . There was a consistent relationship between lower achieved low-density lipoprotein cholesterol and lower risk of limb events ( P=0.026 for the beta coefficient ) that extended down to < 10 mg/dL. Conclusions : Patients with PAD are at high risk of cardiovascular events , and PCSK9 inhibition with evolocumab significantly reduced that risk with large absolute risk reductions . Moreover , lowering of low-density lipoprotein cholesterol with evolocumab reduced the risk of major adverse limb events . Clinical Trial Registration : URL : https://www . clinical trials.gov . Unique identifier : NCT01764633 Non-r and omised studies of the effects of interventions are critical to many areas of healthcare evaluation , but their results may be biased . It is therefore important to underst and and appraise their strengths and weaknesses . We developed ROBINS-I ( “ Risk Of Bias In Non-r and omised Studies - of Interventions ” ) , a new tool for evaluating risk of bias in estimates of the comparative effectiveness ( harm or benefit ) of interventions from studies that did not use r and omisation to allocate units ( individuals or clusters of individuals ) to comparison groups . The tool will be particularly useful to those undertaking systematic review s that include non-r and omised studies OBJECTIVES The Heart Protection Study ( HPS ) provides an opportunity to assess directly the effects of cholesterol-lowering therapy on major vascular events ( defined as myocardial infa rct ion , coronary death , stroke , or revascularization ) in patients with peripheral arterial disease ( PAD ) . In addition , the
Output:
| Statin therapy was also associated with increased overall patency rates and lower incidence of MACCE .
In conclusion , statins are associated with decreased risk for amputation , mortality , and MACCE , as well as increased overall patency rates among patients with CLI . |
MS211554 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: A r and omised , controlled trial of 1429 women was carried out to compare ' active ' management of the third stage of labour , using i.v . Ergometrine 0.5 mg , with a method of ' physiological ' management , in women at ' low risk ' to haemorrhage . In the " active " management group a higher incidence of the following complications was found:- manual removal of placenta ( p less than 0.0005 ) , problems such as nausea ( p less than 0.0005 ) , vomiting ( p less than 0.0005 ) , and severe after-birth pains ( p less than 0.02 ) , hypertension ( p less than 0.0001 ) and secondary postpartum haemorrhage ( p less than 0.02 ) . The incidence of postpartum haemorrhage ( blood loss greater than 500 ml ) and postnatal haemoglobins less than 10 gm/100 were higher in the ' physiological ' group ( p less than 0.0005 , p less than 0.002 ) . No difference was found in the need for blood transfusion in either group . The routine use of i.v . Ergometrine 0.5 mg during the third stage of labour in women at ' low risk ' to haemorrhage does not appear to be necessary and has many adverse effects . Further studies comparing different methods of ' physiological ' management are recommended in order to reduce to a minimum the incidence of postpartum haemorrhage and anaemia Objective To compare intravenous oxytocin administration ( Partocon ® 10 IU ) with saline solution in the management of postpartum haemorrhage in the third stage of labour BACKGROUND Postpartum haemorrhage is a leading cause of maternal morbidity and mortality . Active management of the third stage of labour , including use of a uterotonic agent , has been shown to reduce blood loss . Misoprostol ( a prostagl and in E1 analogue ) has been suggested for this purpose because it has strong uterotonic effects , can be given orally , is inexpensive , and does not need refrigeration for storage . We did a multicentre , double-blind , r and omised controlled trial to determine whether oral misoprostol is as effective as oxytocin during the third stage of labour . METHODS In hospitals in Argentina , China , Egypt , Irel and , Nigeria , South Africa , Switzerl and , Thail and , and Vietnam , we r and omly assigned women about to deliver vaginally to receive 600 microg misoprostol orally or 10 IU oxytocin intravenously or intramuscularly , according to routine practice , plus corresponding identical placebos . The medications were administered immediately after delivery as part of the active management of the third stage of labour . The primary outcomes were measured postpartum blood loss of 1000 mL or more , and the use of additional uterotonics without an unacceptable level of side-effects . We chose an upper limit of a 35 % increase in the risk of blood loss of 1000 mL or more as the margin of clinical equivalence , which was assessed by the confidence interval of the relative risk . Analysis was by intention to treat . FINDINGS 9264 women were assigned misoprostol and 9266 oxytocin . 37 women in the misoprostol group and 34 in the oxytocin group had emergency caesarean sections and were excluded . 366 ( 4 % ) of women on misoprostol had a measured blood loss of 1000 mL or more , compared with 263 ( 3 % ) of those on oxytocin ( relative risk 1.39 [ 95 % CI 1.19 - 1.63 ] , p<0.0001 ) . 1398 ( 15 % ) women in the misoprostol group and 1002 ( 11 % ) in the oxytocin group required additional uterotonics ( 1.40 [ 1.29 - 1.51 ] , p<0.0001 ) . Misoprostol use was also associated with a significantly higher incidence of shivering ( 3.48 [ 3.15 - 3.84 ] ) and raised body temperature ( 7.17 [ 5.67 - 9.07 ] ) in the first hour after delivery . INTERPRETATION 10 IU oxytocin ( intravenous or intramuscular ) is preferable to 600 microg oral misoprostol in the active management of the third stage of labour in hospital setting s where active management is the norm It has been recognised that , if the length of the third stage of labour exceeds 30 min , then there is an increased risk of a post‐partum haemorrhage . Recent information has suggested that 18 min is the optimal time for removal of the undelivered placenta to prevent a post‐partum haemorrhage . A r and omised trial comparing 20 vs. 30 min was stopped after an interim analysis because only eight of 1607 patients ’ placentas had not delivered by 20 min . A third stage of labour that exceeded 10 min was observed to be significantly correlated with an increased risk of post‐partum haemorrhage Abstract The distribution of the circulatingblood volume in the infant-placental circuit at birth and in the first minutes after birth was studied in 111 normal full-term deliveries . The blood-volume of the infants , divided in groups where umbilical cords were clamped at various times , was measured by the 125 I-serum-albumin dilution method , and the placental residual blood-volume was measured by drainage both when the placenta was still in utero and after its delivery . The distribution of the blood between the infant 's and placental circuits was about 67%/33 % at birth , 80%/20 % at 1 minute , and 87%/13 % at the termination of placental transfusion Methods We describe a prospect i ve study , done over a 2-year period in which a total of 958 women having a vaginal delivery were r and omised to the drainage method ( 478 women ) or controlled cord traction method ( 480 women ) for placental delivery . Results The mean age , parity , gestation and birth weight were similar in the two groups . The mean duration of third stage of labor was 3.24 min and 3.2 min in the placental drainage group in contrast to 8.57 min and 6.20 min in controlled cord traction method in primigravida and multigravida respectively . Conclusion Placental drainage significantly reduces the duration of third stage of labour in vaginal deliveries BACKGROUND The cardiovascular effects of oxytocin in animal models and women undergoing Caesarean section include tachycardia , hypotension and decrease in cardiac output . These can be sufficient to cause significant compromise in high-risk patients . We aim ed to find a simple way to decrease these risks whilst retaining the benefits of oxytocin in decreasing bleeding after delivery . Method . We recruited 30 women undergoing elective Caesarean section . They were r and omly allocated to receive 5 u of oxytocin either as a bolus injection ( bolus group ) or an infusion over 5 min ( infusion group ) . These women had their heart rate and intra-arterial blood pressure recorded every 5 s throughout the procedure . The haemodynamic data , along with the estimated blood loss , were compared between the groups . RESULTS Marked cardiovascular changes occurred in the bolus group ; the heart rate increased by 17 ( 10.7 ) beats min(-1 ) [ mean ( sd ) ] compared with 10 ( 9.7 ) beats min(-1 ) in the infusion group . The mean arterial pressure decreased by 27 ( 7.6 ) mm Hg in the bolus group compared with 8 ( 8.7 ) mm Hg in the infusion group . There were no differences in the estimated blood loss between the two groups . CONCLUSION We recommend that bolus doses should be used with caution , and further studies should ascertain if oxytocin is equally effective in reducing blood loss when given at a slower rate OBJECTIVE : To assess the effects of oxytocin bolus or infusion on maternal hemodynamics in the third stage of labor . METHODS : In a r and omized , double-blind , double-dummy fashion , 99 women received an intravenous oxytocin bolus ( 10 IU push ) and 102 women received an infusion ( 10 IU in 500 mL saline at 125 mL/h ) at delivery of the anterior shoulder . Mean arterial pressure and heart rate were measured every minute for 10 minutes , then every 5 minutes for the next 20 minutes . These serial measurements were analyzed using a 2-factor analysis of variance for repeated measures . RESULTS : Serial mean arterial pressure measures varied significantly between groups ( interaction effect , P = .002 ) . Mean arterial pressure ( ± st and ard deviation ) nadirs were reached after 10 minutes , 80.9 ( ± 11.0 ) mm Hg in the bolus group compared with 77.0 ( ± 12.1 ) mm Hg in the dilute infusion group . The mean difference ( 95 % confidence interval ) between groups was 4.0 ( 0.7–7.2 ) mm Hg . Serial heart rate measures also varied between groups ( interaction effect , P < .001 ) . Mean heart rate ( ± st and ard deviation ) peaked 1 minute after the oxytocin infusion , 115 ( ± 27 ) beats per minute ( bpm ) in the bolus group compared with 109 ( ± 21 ) bpm in the dilute infusion group . The mean difference ( 95 % confidence interval ) between groups was 6.6 bpm ( −0.1 to 13.3 ) . The dilute oxytocin infusion group experienced a greater mean estimated blood loss ( 423.7 mL compared with 358.1 mL , P = .029 , t test ) , increased use of additional oxytocics ( 35.3 % compared with 22.2 % , P = .044 , Fisher exact test ) and a greater drop in hemoglobin ( admission minus postpartum ) ( 17.4g/L compared with 11.4g/L , P = .002 , t test ) compared with the oxytocin bolus group . CONCLUSION : Bolus oxytocin of 10 IU is not associated with adverse hemodynamic responses and can safely be administered to women with intravenous access in the third stage of labor for postpartum hemorrhage prophylaxis . LEVEL OF EVIDENCE : OBJECTIVES Our purpose was to compare the controlled cord traction technique with the minimal intervention technique for delivery of the placenta . The primary outcome was the incidence of postpartum hemorrhage . Secondary outcomes included duration of third stage of labor , frequency of retained placenta , hemorrhagic shock , the need for blood transfusion , and the need for uterotonic agents to control postpartum hemorrhage . STUDY DESIGN A total of 1648 women who were delivered vaginally were r and omly allocated during labor to the controlled cord traction group ( n = 827 ) or the minimal intervention group ( n = 821 ) . In the controlled cord traction group women received oxytocin , 10 units intramuscularly , with delivery of the baby 's anterior shoulder , after which the placenta was delivered actively by controlled cord traction ( Br and t- And rews method ) . In the minimal intervention group the placenta was delivered by maternal pushing . Continuous intravenous oxytocin was given after delivery of the placenta . Odds ratios with 95 % confidence intervals were calculated for each variable . RESULTS The overall incidence of postpartum hemorrhage was significantly lower in the controlled cord traction group ( 5.8 % vs 11 % ; odds ratio 0.50 , 95 % confidence interval 0.34 to 0.73 ) . The incidence of retained placenta ( > or = 30 minutes ) was 1.6 % in the controlled cord traction group and 4.5 % in the minimal intervention group ( odds ratio 0.31 , 95 % confidence interval 0.15 to 0.63 ) . Significantly more patients in the minimal intervention group required additional uterotonic agents to control hemorrhage ( 5.1 % vs 2.3 % ; odds ratio 0.44 , 95 % confidence interval 0.24 to 0.78 ) . CONCLUSION The controlled cord traction technique for delivery of the placenta results in a significantly lower incidence of postpartum hemorrhage and retained placenta , as well as less need for uterotonic agents , compared with the minimal intervention technique OBJECTIVE The goal of this study was to compare carbetocin , a long-acting oxytocin analog , with oxytocin in the prevention of uterine atony after cesarean section . STUDY DESIGN We enrolled 694 patients undergoing elective cesarean section in a Canadian multicenter , double-blind , r and omized clinical trial . We compared the effect of a single 100 microg dose of carbetocin with that of a st and ard 8-hour infusion of oxytocin . The primary outcome was the proportion of patients requiring additional oxytocic intervention for uterine atony . A variable sample size , sequential design was used . RESULTS The overall oxytocic intervention rate was 7.4 % . The odds of treatment failure requiring oxytocic intervention was 2.03 ( 95 % confidence interval 1.1 to 2.8 ) times higher in the oxytocin group compared with the carbetocin group , respectively , 32 of 318 ( 10.1 % ) versus 15 of 317 ( 4.7 % ) , P < .05 . CONCLUSIONS Carbetocin , a new drug for the prevention
Output:
| Oxytocin ( 10 IU ) , administered intramuscularly , is the preferred medication and route for the prevention of PPH in low-risk vaginal deliveries .
For women delivering vaginally with 1 risk factor for PPH , carbetocin 100 microg IM decreases the need for uterine massage to prevent PPH when compared with continuous infusion of oxytocin .
There is no evidence that , in an uncomplicated delivery without bleeding , interventions to accelerate delivery of the placenta before the traditional 30 to 45 minutes will reduce the risk of PPH .
( II-2C ) 12 .
Placental cord drainage can not be recommended as a routine practice since the evidence for a reduction in the duration of the third stage of labour is limited to women who did not receive oxytocin as part of the management of the third stage .
There is no evidence that this intervention prevents PPH .
Evidence for the benefit of recombinant activated factor VII has been gathered from very few cases of massive PPH . |
MS211555 | ***TASK*** the task is to summarize an input biomedical literature 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: Transcranial direct current stimulation ( tDCS ) of the human motor cortex results in polarity-specific shifts of cortical excitability during and after stimulation . Anodal tDCS enhances and cathodal stimulation reduces excitability . Animal experiments have demonstrated that the effect of anodal tDCS is caused by neuronal depolarisation , while cathodal tDCS hyperpolarises cortical neurones . However , not much is known about the ion channels and receptors involved in these effects . Thus , the impact of the sodium channel blocker carbamazepine , the calcium channel blocker flunarizine and the NMDA receptor antagonist dextromethorphane on tDCS-elicited motor cortical excitability changes of healthy human subjects were tested . tDCS- protocol s inducing excitability alterations ( 1 ) only during tDCS and ( 2 ) eliciting long-lasting after-effects were applied after drug administration . Carbamazepine selectively eliminated the excitability enhancement induced by anodal stimulation during and after tDCS . Flunarizine result ed in similar changes . Antagonising NMDA receptors did not alter current-generated excitability changes during a short stimulation , which elicits no after-effects , but prevented the induction of long-lasting after-effects independent of their direction . These results suggest that , like in other animals , cortical excitability shifts induced during tDCS in humans also depend on membrane polarisation , thus modulating the conductance of sodium and calcium channels . Moreover , they suggest that the after-effects may be NMDA receptor dependent . Since NMDA receptors are involved in neuroplastic changes , the results suggest a possible application of tDCS in the modulation or induction of these processes in a clinical setting . The selective elimination of tDCS-driven excitability enhancements by carbamazepine proposes a role for this drug in focussing the effects of cathodal tDCS , which may have important future clinical applications OBJECTIVE Recent evidence suggests that fibromyalgia is a disorder characterized by dysfunctional brain activity . Because transcranial direct current stimulation ( tDCS ) can modulate brain activity noninvasively and can decrease pain in patients with refractory central pain , we hypothesized that tDCS treatment would result in pain relief in patients with fibromyalgia . METHODS Thirty-two patients were r and omized to receive sham stimulation or real tDCS with the anode centered over the primary motor cortex ( M1 ) or the dorsolateral prefrontal cortex ( DLPFC ) ( 2 mA for 20 minutes on 5 consecutive days ) . A blinded evaluator rated the patient 's pain , using the visual analog scale for pain , the clinician 's global impression , the patient 's global assessment , and the number of tender points . Other symptoms of fibromyalgia were evaluated using the Fibromyalgia Impact Question naire and the Short Form 36 Health Survey . Safety was assessed with a battery of neuropsychological tests . To assess potential confounders , we measured mood and anxiety changes throughout the trial . RESULTS Anodal tDCS of the primary motor cortex induced significantly greater pain improvement compared with sham stimulation and stimulation of the DLPFC ( P < 0.0001 ) . Although this effect decreased after treatment ended , it was still significant after 3 weeks of followup ( P = 0.004 ) . A small positive impact on quality of life was observed among patients who received anodal M1 stimulation . This treatment was associated with a few mild adverse events , but the frequency of these events in the active-treatment groups was similar to that in the sham group . Cognitive changes were similar in all 3 treatment groups . CONCLUSION Our findings provide initial evidence of a beneficial effect of tDCS in fibromyalgia , thus encouraging further trials Transcranial direct current stimulation ( tDCS ) can up- and down-regulate cortical excitability depending on current direction , however our abilities to measure brain-tissue effects of the stimulation and its after-effects have been limited so far . We used regional cerebral blood flow ( rCBF ) , a surrogate measure of brain activity , to examine regional brain-tissue and brain-network effects during and after tDCS . We varied the polarity ( anodal and cathodal ) as well as the current strength ( 0.8 to 2.0mA ) of the stimulation . Fourteen healthy subjects were r and omized into receiving either anodal or cathodal stimulation ( two subjects received both , one week apart ) while undergoing Arterial Spin Labeling ( ASL ) in the MRI scanner with an alternating off-on sampling paradigm . The stimulating , MRI-compatible electrode was placed over the right motor region and the reference electrode over the contralateral supra-orbital region . SPM5 was used to process and extract the rCBF data using a 10 mm spherical volume of interest ( VOI ) placed in the motor cortex directly underneath the stimulating scalp electrode . Anodal stimulation induced a large increase ( 17.1 % ) in rCBF during stimulation , which returned to baseline after the current was turned off , but exhibited an increase in rCBF again in the post-stimulation period . Cathodal stimulation induced a smaller increase ( 5.6 % ) during stimulation , a significant decrease compared to baseline ( -6.5 % ) after cessation , and a continued decrease in the post-stimulation period . These changes in rCBF were all significant when compared to the pre-stimulation baseline or to a control region . Furthermore , for anodal stimulation , there was a significant correlation between current strength and the increase in rCBF in the on-period relative to the pre-stimulation baseline . The differential rCBF after-effects of anodal ( increase in resting state rCBF ) and cathodal ( decrease in resting state rCBF ) tDCS support findings of behavioral and cognitive after-effects after cathodal and anodal tDCS . We also show that tDCS not only modulates activity in the brain region directly underlying the stimulating electrode but also in a network of brain regions that are functionally related to the stimulated area . Our results indicate that ASL may be an excellent tool to investigate the effects of tDCS and its stimulation parameters on brain activity OBJECTIVE To investigate in a r and omized , double-blind design , cumulative effects of anodal tDCS on EEG oscillations and neuropsychological tests among patients with traumatic brain injury ( TBI ) undergoing subacute neurorehabilitation . METHODS Twenty-six patients were r and omly assigned to active ( n=13 ) or sham ( n=13 ) tDCS groups . EEGs were recorded at 6 different time points , assessing both immediate and cumulative effects of tDCS on EEG oscillations . Twenty minute sessions of 1mA anodal stimulation to the left dorsolateral prefrontal cortex ( F3 , cathode placed at right supraorbital site , Fp2 ) , were provided on 10 consecutive days . Neuropsychological tests were administered before and after the series of tDCS sessions . RESULTS Theta was significantly reduced for active tDCS patients following the first tDCS session . Delta decreased and alpha increased , both significantly , for the active tDCS group after 10 consecutive tDCS sessions . No significant changes were seen for sham group . Decreases in delta were significantly correlated with improved performance on neuropsychological tests for the active tDCS group to far greater degree than for the sham group . Participants in the active tDCS group who had excess slow EEG activity in their initial recordings showed greater improvement on neuropsychological tests than other groups . CONCLUSION Results suggest that 10 anodal tDCS sessions may beneficially modulate regulation of cortical excitability for patients with TBI . SIGNIFICANCE EEG-guided tDCS warrants further investigation as a potential intervention for TBI during subacute neurorehabilitation BACKGROUND The brain-derived neurotrophic factor ( BDNF ) gene is involved in mechanisms of synaptic plasticity in the adult brain . It has been demonstrated that BDNF also plays a significant role in shaping externally induced human brain plasticity . Plasticity induced in the human motor cortex by intermittent theta-burst stimulation ( iTBS ) was impaired in individuals expressing the Val66Met polymorphism . METHODS To explore whether this polymorphism is also important for other neuroplasticity-inducing tools in humans with modes of action differing from that of iTBS , namely , transcranial direct current ( tDCS ) and r and om noise stimulation ( tRNS ) , we retrospectively analyzed the data of 64 subjects studied in our laboratory with regard to BDNF genotype . RESULTS Fifteen subjects with the Val66Met allele , 46 subjects with the Val66Val allele , and 3 Met66Met carriers were identified . The response of the Val66Met allele carriers to stimulation differed in two protocol s compared with the response of Val66Val individuals . For iTBS ( 15 subjects , 5 heterozygotes ) , plasticity could be only induced in the Val66Val allele carriers . However , for facilitatory tDCS ( 24 subjects , 10 heterozygotes ) , as well as for inhibitory tDCS , ( 19 subjects , 8 heterozygotes ) , carriers of the Val66Met allele displayed enhanced plasticity , whereas for transcranial r and om noise stimulation ( 29 subjects , 8 heterozygotes ) , the difference between groups was not so pronounced . CONCLUSIONS BDNF polymorphism has a definite impact on plasticity in humans , which might differ according to the mechanism of plasticity induction . This impact of BDNF on plasticity should be taken into account for future studies , as well as having wider ranging implication s for the treatment of neuropsychiatric disorders with transcranial stimulation tools , as it may predetermine their efficacy for the treatment of disease and rehabilitation 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 The rising proportion of elderly people worldwide will yield an increased incidence of age-associated cognitive impairments , imposing major burdens on societies . Consequently , growing interest emerged to evaluate new strategies to delay or counteract cognitive decline in aging . Here , we assessed immediate effects of anodal transcranial direct current stimulation ( atDCS ) on cognition and previously described detrimental changes in brain activity attributable to aging . Twenty healthy elderly adults were assessed in a crossover sham-controlled design using functional magnetic resonance imaging ( fMRI ) and concurrent transcranial DCS administered to the left inferior frontal gyrus . Effects on performance and task-related brain activity were evaluated during overt semantic word generation , a task that is negatively affected by advanced age . Task-absent resting-state fMRI ( RS-fMRI ) assessed atDCS-induced changes at the network level independent of performance . Twenty matched younger adults served as controls . During sham stimulation , task-related fMRI demonstrated that enhanced bilateral prefrontal activity in older adults was associated with reduced performance . RS-fMRI revealed enhanced anterior and reduced posterior functional brain connectivity . atDCS significantly improved performance in older adults up to the level of younger controls ; significantly reduced task-related hyperactivity in bilateral prefrontal cortices , the anterior cingulate gyrus , and the precuneus ; and induced a more “ youth-like ” connectivity pattern during RS-fMRI . Our results provide converging evidence from behavioral analysis and two independent functional imaging paradigms that a single session of atDCS can temporarily reverse nonbeneficial effects of aging on cognition and brain activity and connectivity . These findings may translate into novel treatments to ameliorate cognitive decline in normal aging in the future Transcranial direct current stimulation ( tDCS ) over the primary motor cortex ( M1 ) has been shown to induce changes in motor performance and learning . Recent studies indicate that tDCS is capable of modulating widespread neural network properties within the brain . However the temporal evolution of online- and after-effects of tDCS on functional connectivity ( FC ) within and across the stimulated motor cortices ( M1 ) still remain elusive . In the present study , two different tDCS setups were investigated : ( i ) unilateral M1 tDCS ( anode over right M1 , cathode over the contralateral supraorbital region ) and ( ii ) bilateral M1 tDCS ( anode over right M1 , cathode over left M1 ) . In a r and omized single-blinded cross-over design , 12 healthy subjects underwent functional magnetic resonance imaging at rest before , during and after 20 min of either bi- , unilateral , or sham M1 tDCS . Seed-based FC analysis was used to investigate tDCS-induced changes across and within M1 . We found that bilateral M1 tDCS induced ( a ) a decrease in interhemispheric FC during stimulation and ( b ) an increase in intracortical FC within right M1 after termination of the intervention . While unilateral M1 tDCS also result ed in similar effects during stimulation , no such changes could be observed after termination of tDCS . Our results provide evidence that depending on the electrode montage , tDCS acts upon a modulation of either intracortical and /or interhemispheric processing of M1 Bihemispheric transcranial direct current stimulation ( tDCS ) is thought to upregulate excitability of the primary motor cortex ( M1 ) using anodal stimulation while concurrently downregulating contralateral M1 using cathodal stimulation . This “ dual ” tDCS method enhances motor learning in healthy subjects and facilitates motor recovery after stroke . However , its impact on motor system activity and connectivity remains unknown . Therefore , we assessed neural correlates of dual and unihemispheric anodal tDCS effects in 20 healthy older subjects in a r and omized , sham-controlled study using a cross-over design . Participants underwent tDCS and simultane
Output:
| Five analyses on moderator variables indicated significant tDCS beneficial effects : ( a ) on both cognitive and motor task performances , ( b ) across a wide-range of cognitive tasks , ( c ) on specific brain areas , ( d ) stimulation offline ( before ) or online ( during ) the cognitive and motor tasks . |
MS211556 | ***TASK*** the task is to summarize an input biomedical literature 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: Near-miss events are situations in which an action yields a negative result but is very close to being successful . They are known to influence behavior , especially in gambling scenarios . Previous neuroimaging studies have described an ' anomalous ' activity of brain reward areas following these events . The goal of the present research was to study electrophysiological correlates of near-misses in the expectation and outcome phases . Electroencephalography was recorded while participants were playing a simplified version of a slot machine . Four possible outcomes ( gain , near-miss , loss and no-information ) were presented in a pseudor and om order to ensure fixed proportions . Results from the time-frequency analysis for the theta ( 4 - 8 Hz ) , alpha ( 9 - 13 Hz ) , low beta ( 15 - 22 Hz ) and beta-gamma ( 25 - 35 Hz ) frequency-b and s presented larger power increases for wins and near-misses compared with losses . In the anticipation phase , power changes were lower than in the resolution phase . The current results are in agreement with previous studies showing that near-miss events recruit brain areas of the reward network . Likewise , the oscillatory activity in near-misses is very similar to the one elicited in the gain condition . In addition , present findings suggest that oscillatory activity in the expectation phase does not play a crucial role in near-miss events This study was conducted to examine the effects of the " near miss , " when a player almost wins , and the " big win , " a large early monetary gain , on persistence at slot machine gambling . One hundred eighty male and female undergraduates played a 4-wheel computerized slot machine . A 2 x 3 r and omized factorial design and an acquisition-extinction procedure were used . The dependent variable , persistence , was defined by the number of trials in the extinction phase . As hypothesized , the near miss had a statistically significant effect on the number of trials in extinction . An inverted U-shaped effect of the near miss showed that the 30 % near miss condition led to the greatest persistence , as compared to 45 % and 15 % near miss conditions . There was no statistically significant effect of the big win . Both cognitive and behavioral theories are discussed as explanations for effects of the near miss Problematic gambling is thought to be influenced by neurobiological mechanisms . However , the neuroendocrine response to gambling is largely unknown . Therefore , the effect of casino gambling on the sympathoadrenal system , the HPA-axis , and pituitary hormones were analyzed . Fourteen male problem gamblers and 15 non-problem gamblers were examined in a balanced cross-over design . In the experimental session , participants played blackjack in a casino wagering their own money . During the control session , subjects played cards for accumulation of points . Heart rate and endocrine measures were recorded at baseline , at 30 , 60 and 90 min during gambling/card playing , and after the game . Heart rate and norepinephrine levels increased with the onset of blackjack in both groups , with problem gamblers showing significantly higher levels across the entire gambling session . In addition , dopamine levels were significantly higher in problem gamblers during casino gambling compared to non-problem gamblers . Cortisol levels were transiently increased with the onset of blackjack in both groups . Casino gambling as a " real life " situation induces activation of the HPA-axis and the sympathoadrenergic system , with significantly more pronounced changes in problem gamblers . These findings may contribute to a better underst and ing of neuroendocrine disturbances in problem gambling A particularly rapid onset of pathological gambling ( PG-onset ) through the use of gambling machines has been widely alluded to , but this is the first study to empirically examine the phenomenon . This study compared the latency of PG-onset in those who gambled primarily on machines , compared to those who gambled primarily on more “ traditional ” forms of gambling at PG-onset . Subjects were 44 adult pathological gamblers ( PGs ) seeking outpatient treatment in Rhode Isl and ( 17 females ; mean age = 46.9 ) . Subjects completed question naires and a diagnostic interview including a complete history of gambling activities and the course of PG . The “ latency ” of PG-onset was defined as the time ( in years ) elapsed between the age of regular involvement in the primary form of gambling and the age at which DSM-IV criteria were first met . “ Machine ” PGs ( n = 25 ) had a significantly shorter latency of onset than did “ traditional ” PGs ( 1.08 years vs. 3.58 years ) . Females and machine PGs had a significantly older age of onset , but gender was not associated with latency of PG-onset . Lifetime comorbidity of either substance use disorders ( SUDS ) or depressive disorders ( DDS ) was also not associated with the latency of PG-onset . The results of the current study suggest that intrapersonal variables such as gender and comorbid disorders do not generally affect the speed with which people develop PG . Rather , the social , environmental , and stimulus features of mechanized gambling are implicated . Prospect i ve longitudinal studies on the onset and course of PG are needed , as well as more basic research on the features of machine gambling that may contribute to rapid onset Near-miss outcomes during gambling are non-win outcomes that fall close to a pay-out . While objective ly equivalent to an outright miss , near-misses motivate ongoing play and may therefore be implicated in the development of disordered gambling . Given naturalistic data showing increases in heart rate ( HR ) and electrodermal activity ( EDA ) during periods of real gambling play , we sought to explore the phasic impact of win , near-miss and full-miss outcomes on physiological arousal in a controlled laboratory environment . EDA and HR were monitored as healthy , student participants ( n = 33 ) played a simulated slot-machine task involving unpredictable monetary wins . A second gambling distortion , perceived personal control , was manipulated within the same task by allowing the participant to select the play icon on some trials , and having the computer automatically select the play icon on other trials . Near-misses were rated as less pleasant than full-misses . However , on trials that involved personal choice , near-misses produced higher ratings of ‘ continue to play ’ than full-misses . Winning outcomes were associated with phasic EDA responses that did not vary with personal choice . Compared to full-misses , near-miss outcomes also elicited an EDA increase , which was greater on personal choice trials . Near-misses were also associated with greater HR acceleration than other outcomes . Near-miss outcomes are capable of eliciting phasic changes in physiological arousal consistent with a state of subjective excitement , despite their objective non-win status Significance Gambling games are associated with a distorted psychological processing of r and om sequences ( the gambler ’s fallacy ) and unrewarded outcomes that fall close to a jackpot ( near misses ) . Problem gamblers appear more susceptible to these effects . Here , we show that these two gambling distortions are disrupted in patients with brain injury affecting the insula compared with patients with damage to the ventromedial prefrontal cortex or amygdala . In a roulette task ( red/black predictions ) , comparison groups chose either color less after longer runs of that color outcome . On a slot machine task , comparison groups rated higher motivation following near misses relative to full misses . Our results generate a clinical hypothesis that , in disordered gambling , these cognitions may be underpinned by excessive recruitment of insula circuitry . Gambling is a naturalistic example of risky decision-making . During gambling , players typically display an array of cognitive biases that create a distorted expectancy of winning . This study investigated brain regions underpinning gambling-related cognitive distortions , contrasting patients with focal brain lesions to the ventromedial prefrontal cortex ( vmPFC ) , insula , or amygdala ( “ target patients ” ) against healthy comparison participants and lesion comparison patients ( i.e. , with lesions that spare the target regions ) . A slot machine task was used to deliver near-miss outcomes ( i.e. , nonwins that fall spatially close to a jackpot ) , and a roulette game was used to examine the gambler ’s fallacy ( color decisions following outcome runs ) . Comparison groups displayed a heightened motivation to play following near misses ( compared with full misses ) , and manifested a classic gambler ’s fallacy effect . Both effects were also observed in patients with vmPFC and amygdala damage , but were absent in patients with insula damage . Our findings indicate that the distorted cognitive processing of near-miss outcomes and event sequences may be ordinarily supported by the recruitment of the insula . Interventions to reduce insula reactivity could show promise in the treatment of disordered gambling Responses to fear- and sadness-inducing films were assessed using a broad range of cardiovascular ( heart rate , T-wave amplitude , low- and high-frequency heart rate variability , stroke volume , preejection period , left-ventricular ejection time , Heather index , blood pressure , pulse amplitude and transit time , and finger temperature ) , electrodermal ( level , response rate , and response amplitude ) , and respiratory ( rate , tidal volume and its variability , inspiratory flow rate , duty cycle , and end-tidal pCO(2 ) ) measures . Subjective emotional experience and facial behavior ( Corrugator Supercilii and Zygomaticus Major EMG ) served as control measures . Results indicated robust differential physiological response patterns for fear , sadness , and neutral ( mean classification accuracy 85 % ) . Findings are discussed in terms of the fight-flight and conservation-withdrawal responses and possible limitations of a valence-arousal categorization of emotion in affective space
Output:
| The systematic review revealed that near misses motivate continued play , but have varying effects on the emotional state or betting behaviour of the player .
Near miss events were also shown to be associated with elevated skin conductance levels and diffuse activity across the brain , most consistently in areas processing reinforcement and reward . |
MS211557 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: PURPOSE The aims of this pilot study were the following : 1 ) to examine patterns of adherence to a brisk walking program in women receiving adjuvant chemotherapy or radiation therapy for newly diagnosed breast cancer using a prospect i ve , r and omized , controlled experimental design ; 2 ) to examine the influence of disease symptoms and treatment side effects on exercise levels ; and 3 ) to suggest methods that may improve future clinical trials of moderate-intensity exercise in similar population s. DESCRIPTION OF STUDY Fifty-two patients with newly diagnosed breast cancer were r and omly assigned to one of two treatment arms : usual care or usual care plus exercise . Those assigned to the exercise group received a st and ardized , self-administered , home-based brisk walking intervention in addition to usual care . Each day subjects completed self-report diary forms that elicited information about activity levels , and the occurrence of symptoms and side effects during cancer treatment . RESULTS Analyses of self-reported daily activity levels revealed a diffusion of treatment effect . Fifty percent of the usual-care group reported maintaining or increasing their physical activity to a moderate-intensity level , while 33 % of the exercise group did not exercise at the prescribed levels . Analyses of self-reported disease symptoms and treatment side effects did not reveal clinical ly meaningful differences between the two groups . CLINICAL IMPLICATION S The results of this study suggest that women who exercised regularly before receiving a breast cancer diagnosis attempted to maintain their exercise programs . Women who lead sedentary lifestyles may benefit from a structured exercise program that includes information and support related to exercise adherence strategies The primary aim of this study was to test the effect of a Protection Motivation Theory (PMT)-based patient education intervention on physiotherapy patients ' beliefs about their injury and physiotherapy , intentions to adhere , rehabilitation adherence , and ankle function . A secondary aim was to explore the relationships between the patients ' injury and physiotherapy beliefs , intentions , adherence behaviours , and ankle function . A r and omized controlled trial was undertaken in New Zeal and ; 71 people with ankle sprains were allocated to either PMT present video information or two control groups ( non-PMT information about ankle sprains and no formal information ) before commencing their course of physiotherapy . The two information groups watched a video about ankle sprains and physiotherapy before answering the Beliefs about Ankle Sprains and Physiotherapy Scale and behavioural intentions question naires that measured the PMT constructs . Adherence was assessed at each treatment and ankle function was measured before and after the physiotherapy program . After viewing the video , the PMT present information group 's beliefs about severity , vulnerability , and response efficacy were significantly higher than the other two groups . The groups did not differ significantly on their self-efficacy , intentions , rehabilitation adherence , and post-physiotherapy program ankle function . Significant correlations existed between the patients ' PMT-based beliefs and intentions , intentions and adherence , and adherence and post-physiotherapy ankle function . With the exception of self-efficacy , the findings indicate that persuasive information grounded in PMT does enhance physiotherapy patients ' beliefs about their injury and treatment The feasibility and efficacy of an additional progressive home-based strengthening exercise program ( PHSEP ) on subjects that already attended supervised institutional exercise therapy was investigated . Thirty-six hip patients with hip osteoarthritis ( OA ) and /or total hip replacement in at least one hip joint were r and omly assigned to an intervention group ( IG ) or a control group ( CG ) . IG ( 18 patients , mean age 64.9 , st and ard deviation ( SD ) 7.5 ) followed an 8-week PHSEP in addition to their weekly institutional exercise therapy , while CG ( 18 patients , mean age 64.7 , SD 9 ) solely continued the weekly institutional exercise sessions . Before and after the intervention period , strength of hip muscles was quantified applying isokinetic concentric and isometric measurements , and health-related quality of life was monitored using the SF36 question naire . Adherence to the exercise program was evaluated using exercise logs . The PHSEP was feasible for all subjects in IG with an adherence of 99 % . Exercise logs reported that pain result ing from the PHSEP was low . Increased strength in isokinetic concentric hip adduction ( 13 % ) and isometric hip abduction ( 9 % ) , adduction ( 12 % ) , and flexion ( 7 % ) was found in IG in comparison to CG . The results of the SF36 did not change during the intervention period . Consequently , supervised institutional exercise therapy supplemented by a PHSEP could increase hip muscle strength in patients with hip OA and /or total hip replacement . However , further research should evaluate the optimal frequency and duration of such supplementary sessions and their potential to increase physical function and reduce pain Background Despite emerging evidence that foot problems and inappropriate footwear increase the risk of falls , there is little evidence as to whether foot-related intervention strategies can be successfully implemented . The aim of this study was to evaluate adherence rates , barriers to adherence , and the predictors of adherence to a multifaceted podiatry intervention for the prevention of falls in older people . Methods The intervention group ( n = 153 , mean age 74.2 years ) of a r and omised trial that investigated the effectiveness of a multifaceted podiatry intervention to prevent falls was assessed for adherence to the three components of the intervention : ( i ) foot orthoses , ( ii ) footwear advice and footwear cost subsidy , and ( iii ) a home-based foot and ankle exercise program . Adherence to each component and the barriers to adherence were documented , and separate discriminant function analyses were undertaken to identify factors that were significantly and independently associated with adherence to the three intervention components . Results Adherence to the three components of the intervention was as follows : foot orthoses ( 69 % ) , footwear ( 54 % ) and home-based exercise ( 72 % ) . Discriminant function analyses identified that being younger was the best predictor of orthoses use , higher physical health status and lower fear of falling were independent predictors of footwear adherence , and higher physical health status was the best predictor of exercise adherence . The predictive accuracy of these models was only modest , with 62 to 71 % of participants correctly classified . Conclusions Adherence to a multifaceted podiatry intervention in this trial ranged from 54 to 72 % . People with better physical health , less fear of falling and a younger age exhibited greater adherence , suggesting that strategies need to be developed to enhance adherence in frailer older people who are most at risk of falling . Trial registration Australian New Zeal and Clinical Trials Registry ACTRN12608000065392 STUDY DESIGN A prospect i ve unblinded r and omized clinical trial . OBJECTIVES To compare the effectiveness of 2 types of home program instruction , videotape versus personal instruction by a physical therapist , on subjective outcomes and exercise compliance following arthroscopic repair of a full-thickness rotator cuff tear . BACKGROUND Advances in orthopedic surgery and rehabilitation have placed increased emphasis on home exercise programs . Therefore , assessing the effectiveness of different methods of home program instruction is important . METHODS AND MEASURES Patients who consented to undergo surgical repair were r and omly assigned to either a videotape or personal instruction group . A self-reported compliance log categorized subjects as fully compliant , partially compliant , or noncompliant . The Shoulder Pain and Disability Index and the University of Pennsylvania Shoulder Scale scores were obtained from subjects preoperatively and at 12 , 24 , and 52 weeks postoperatively . The null hypotheses that neither group would have better outcomes as measured by 2 shoulder outcome scales at any level of compliance over 4 levels of time , were assessed by 2 separate 2x3x4 multiple analyses of variances ( MANOVAs ) , 1 for each outcome measure ( alpha = 0.025 ) . RESULTS Neither MANOVA was significant and the null hypotheses were not rejected . The main effect of time ( number of weeks postsurgery ) was significant across all time intervals for both outcome measures ( P < 0.0005 ) . CONCLUSIONS With a therapist available for questions , patients who utilized the videotape method for their home program instruction had self-reported outcomes equal to patients instructed in their home program personally by a physical therapist . Self-reported compliance with the rehabilitation program had little effect on the outcomes OBJECTIVES The purpose s of this study were 1 ) to determine compliance with a pedometer and mobile phone- based physical activity diary , and 2 ) to assess concordance between self-reported daily steps recorded and transmitted by a mobile phone and pedometer-measured daily steps in sedentary women . METHODS In this 3-week pilot clinical study , 41 sedentary women who met all inclusion criteria were recruited from local communities . We asked the participants to wear a pedometer every day and to report their daily steps using a mobile phone diary each night before retiring . In the first week , women were asked to monitor their daily steps ( baseline steps ) . In the second and third weeks , they were asked to increase their steps by 20 % from the previous week . Although the pedometer can automatically store the most recent 41 days ' performance , the participants were not informed of this function of the pedometer . RESULTS Overall compliance was 93.8 % with pedometer use and 88.3 % with the mobile phone physical activity diary . Bl and Altman plots showed that the agreement between self-reported daily steps by mobile phone diary and pedometer-recorded daily steps from week 1 to week 3 was high . CONCLUSION The combination of a pedometer and a mobile phone diary may enhance the quality of self-reported data in clinical studies Despite the numerous benefits of physical activity for patients with diabetes , most healthcare providers in busy clinical setting s rarely find time to counsel their patients about it . A Web-based program for healthcare providers can be used as an effective counseling tool , when strategies are outlined for specific stages of readiness for physical activity . Seventy-three adults with type 2 diabetes were r and omly assigned to Web-based intervention , printed- material intervention , or usual care . After 12 weeks , the effects of the interventions on physical activity , fasting blood sugar , and glycosylated hemoglobin were evaluated . Both Web-based and printed material intervention , compared with usual care , were effective in increasing physical activity ( P < .001 ) and decreasing fasting blood sugar ( P<.01 ) and glycosylated hemoglobin ( P < .01 ) . Post hoc analysis for change scores indicated significant differences between Web-based intervention and usual care and between printed material intervention and usual care , but not between web-based and printed material intervention . The findings of this study support the value of Web-based and printed material interventions in healthcare counseling . With increasing Web access , the effectiveness of Web-based programs offered directly to patients needs to be tested OBJECTIVES /HYPOTHESES There are many documented barriers to successful adherence to voice therapy . However , methods for facilitating adherence are not well understood . The purpose of this study was to determine if patient adherence and motivation for practice could be improved by providing patients with practice support between sessions using mobile treatment videos . METHODS Thirteen voice therapy participants were provided with portable media players containing videos of voice exercises exemplified by their therapists and themselves . A r and omized crossover design of two conditions was used : ( 1 ) st and ard of care voice therapy where participants were provided with written homework descriptions ; and ( 2 ) video-enhanced voice therapy where participants received a portable digital media player with clinician and self-videos . The duration of each condition was 1 week . Self-report measures of practice frequency and aspects of motivation were obtained at the end of each session . RESULTS Practice of voice exercises was significantly greater in the video-enhanced voice therapy condition than in the st and ard of care " written " condition ( P<0.05 ) . Three aspects of participant motivation for practice -overall commitment to practice , importance of practice , and confidence in the ability to practice were also significantly greater after video-enhanced condition than after st and ard of care condition . CONCLUSION These results support the use of video examples and portable digital media players in voice therapy for individuals who are comfortable using such technology OBJECTIVE Great efforts have been made to find effective treatments for back pain . Nevertheless , the effectiveness of a particular treatment can depend on patient compliance . The objective of this study was to prospect ively investigate whether patients ' demographic factors , clinical factors , external barriers in following the treatment , and perceptions of disability , quality of life , depression , and control over health were predictive of compliance with a physical therapy program carried out with patients with low back pain . METHODS This was an exploratory prospect i ve cohort study that was carried out in New York City during 1999 . All study participants answered a question naire at the initial clinical evaluation by a physical therapist and were followed during the treatment . The study assessed compliance with the three treatment regimens that were prescribed for every patient : attending scheduled physical therapy sessions , following a program of home exercises , and watching back-education videotapes . Depending on the individual patient , the planned treatment program could last from 2 to 6 weeks . The study employed a battery of instruments to measure patient characteristics that included perceived functional limitations , perceived quality of life , depression , and their beliefs about their health . Student 's t tests and chi-square tests were used to determine if non- and low-compliant patients differed significantly from high-compliant patients . Logistic regression was used to estimate adjusted odds ratios expressing the association of selected variables with compliance . RESULTS We found that 51 % of the patients were either noncompliant or low-compliant overall with the low back pain treatment program . There were differences in compliance behavior among the three treatment regimens , with compliance being highest for watching the back-education videotapes and lowest for doing the home exercises . Po
Output:
| The results expose a gap in the literature for well-developed measures that capture self-reported adherence to prescribed but unsupervised home-based rehabilitation exercises |
MS211558 | ***TASK*** the task is to summarize an input biomedical literature 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 We combined real-time B-mode ultrasonography with a 2 MHz pulsed Doppler technique to record blood flow in the fetal descending aorta and in the intra-abdominal part of the umbilical vein in 14 pregnant women at term . The blood flow was studied before and after instillation into the vagina of either 4 mg prostagl and in E2 ( PGE2 ) gel or placebo gel . The PGE2 gel was significantly more effective in cervical priming and labor induction than the placebo gel . After instillation of the gel neither group showed a change in the fetal volume blood flow or in the aortic blood velocity waveform . We conclude that the instillation of 4 mg of PGE2 gel does not affect fetal hemodynamics at term Induction of labour is a common obstetric intervention . When the cervix is unfavourable ripening agents are used , commonly prostagl and in E2 . There are several methods of administration of prostagl and in E2 and little comparative work has been performed as to their acceptability by patients . Patients undergoing induction of labour by prostagl and in E2 were r and omised to receive either intravaginal gel or an intravaginal slow-release pessary . Patient satisfaction with the method received was then assessed . Sixty-nine patients were r and omised , 34 to receive gel and 35 to receive a pessary . Median scores for satisfaction of the induction process were the same for both methods ; however , satisfaction with the labour was increased with those who had been r and omised to the pessary group ( median pessary=5 , gel=4 ) . There may be a marginal improvement in patient satisfaction when a slow-release intravaginal prostagl and in E2 pessary is used for the induction of labour This study represents the first of its kind in Kuwait . Two preparations of prostagl and in E2 ( PGE2 ) have been compared as agents for induction of labor . In a r and omized controlled study of 200 women of low parity and unfavorable cervical induction features induction of labor by means of a single vaginal tablets of PGE2 was compared with locally prepared PGE2 vaginal pessaries . The gradual increase of uterine contractions and the establishment of labor in a similar way to that observed during spontaneous labor was more apparent after PGE2 tablets . Labor induction was successful in 80 % of patients in PGE2 tablet group compared with 59 % in PGE2 pessaries group . The incidence of cesarean section was equal in both groups ( 4 % ) , but none was performed due to uterine hyperactivity . The data presented indicate that the PGE2 vaginal tablet is safe and effective in induction of labor in healthy women at term The unfavorable cervix remains a major obstacle to the successful induction of labor . Reported are results from an ongoing study of topical prostagl and in preparations used to effect preinduction cervical ripening . The current study compares the efficacy of 40 mg of prostagl and in ( PG ) F2 alpha versus 5 mg of PGE2 , applied to the cervix in a methyltylose gel the night before attempted induction of labor . A prospect i ve double-blind protocol was used similar to that which previously established the efficacy of the 5 mg of PGE2 preparation versus placebo at this institution . Results indicate the superiority of the PGE2 preparation as measured by change in Bishop score , Pitocin requirement , rate of cervical dilatation , and percentage of failed inductions . Cesarean section rates were similar in the two study groups , and no fetal or maternal morbidity was attributable to the preinduction ripening technique In 345 women with a favorable cervical score at due date , labor was either induced by means of intravaginal application of tablets containing 3 mg of prostagl and in E2 or spontaneous onset of labor was awaited until the 42nd week of pregnancy . Eighty percent of the nulliparae and 96.3 % of the multiparae of the induction group gave birth within 24 h of the administration of the first tablet . All pertinent delivery intervals were significantly shorter in this group compared to those women where spontaneous onset of labor was awaited . The rate of operative deliveries was lower in the induction group . With the exception of 1 fetal death 3 days after due date , fetal outcome was excellent in both groups . Elective induction was at least equivalent to awaiting the onset of spontaneous labor and was not associated with higher complication rates due to the method of induction Two hundred consecutive women with uncomplicated pregnancies , at or within 4 days of their expected date of confinement , were prospect ively r and omized into 2 groups . One group had expectant management , with twice weekly surveillance tests , while the other group had 3 mg of vaginal prostagl and in E2 as outpatient treatment . There were 104 women in the expectant group and 70 in the induction group ( 26 women allocated to induction preferred no treatment ) . The average number of days to delivery was 1.6 in the induction group and 5.2 in the expectant group ( p < 0.001 ) . While meconium was much less frequent in the induction group ( p < 0.002 ) , all other outcome measures , including cesarean section rates , incidence of macrosomia , and Apgar scores , were similar in the two groups OBJECTIVE To compare the efficacy and safety of a prostagl and in E2 ( PGE2 ) vaginal insert with PGE2 administered as a vaginal tablet . STUDY DESIGN A r and omized , observational study was performed . Women requiring induction of labor were r and omly assigned to receive either a 10-mg PGE2 vaginal insert ( group 1 , n = 100 ) or 3-mg PGE2 tablets twice at six-hour intervals ( group 2 , n = 100 ) . The primary efficacy outcome variable was vaginal delivery within 24 hours of insertion . The criteria for safety were the occurrence of uterine hyperstimulation , abnormal fetal heart rate patterns , use of beta 2-sympathomimetic drugs and fetal outcome . RESULTS No differences in terms of vaginal delivery or cesarean section within 24 hours of induction were found . The cesarean section rate was 21 % in group 1 and 22 % in group 2 . The interval from insertion of the induction agent to the onset of regular uterine contractions and the insertion-to-delivery interval were not different between the two cohorts . No difference in the frequency of uterine hyperstimulation , use of beta 2-sympathomimetic drugs , abnormal fetal heart rate patterns , fetal outcome , or oxytocin and analgesic requirements were found . In seven of eight patients in group 1 who experienced uterine hyperstimulation , removal of the insert was sufficient to stop it , whereas in group 2 , of nine cases , eight needed medical interventions to end hyperstimulation ( P = .003 ) . CONCLUSION The continuous release of PGE2 from the vaginal insert permits controlled induction of labor , and easy removal of the drug in cases of uterine hyperstimulation is possible Summary In a r and omized double-blind study we evaluated the effects on cervical ripening and labor induction of 0.5 mg PGE2 in gel given intracervically and 2.0 mg PGE2 given as a vaginal suppository . All patients were at term with unfavorable cervical scores . The indications for induction were toxemia , diabetes mellitus , Rh-immunization , or intrauterine growth retardation . Significantly better results for both cervical priming and labor induction were obtained after intracervical PGE2-gel application than after treatment with placebo or vaginal suppositories . Eleven out of 19 patients ( 58 % ) were delivered within 24 h after intracervical PGE2-gel compared to two out of 19 patients given placebo ( p < 0.01 ) . In patients not delivered 24 h after the start of treatment , the mean cervical score had changed from 3.7 to 6.0 ( p < 0.05 ) after PGE2-gel application compared to a change from 3.9 to 4.3 after placebo treatment ( n.s . ) . The outcome after treatment with PGE2 suppositories did not differ significantly from that with placebo treatment . In a subsequent study 25 patients were given 0.5 mg PGE2-gel intracervically . The results were consistent with those obtained in patients receiving PGE2-gel intracervically in the double-blind study .Few side effects were noted . No patient complained of gastro-intestinal discomfort but increased myometrial activity was observed in two patients ; one after placebo and the other after active intracervical PGE2-gel treatment . The hyperactivity was readily countered with the β2-agonist , terbutaline . All infants were born in good condition with Apgar scores of 7 or more within 5 min . At pediatric examinations at 1 week and at 6 months of age all children seemed healthy BACKGROUND As the interval between rupture of the fetal membranes at term and delivery increases , so may the risk of fetal and maternal infection . It is not known whether inducing labor will reduce this risk or whether one method of induction is better then another . METHODS We studied 5041 women with prelabor rupture of the membranes at term . The women were r and omly assigned to induction of labor with intravenous oxytocin ; induction of labor with vaginal prostagl and in E2 gel ; or expectant management for up to four days , with labor induced with either intravenous oxytocin or vaginal prostagl and in E2 gel if complications developed . The primary outcome was neonatal infection . Secondary outcomes were the need for cesarean section and women 's evaluations of their treatment . RESULTS The rates of neonatal infection and cesarean section were not significantly different among the study groups . The rates of neonatal infection were 2.0 percent for the induction-with-oxytocin group , 3.0 percent for the induction-with-prostagl and in group , 2.8 percent for the expectant-management ( oxytocin ) group , and 2.7 percent for the expectant-management ( prostagl and in ) group . The rates of cesarean section ranged from 9.6 to 10.9 percent . Clinical chorioamnionitis was less likely to develop in the women in the induction-with-oxytocin group than in those in the expectant-management ( oxytocin ) group ( 4.0 percent vs. 8.6 percent , P<0.001 ) , as was postpartum fever ( 1.9 percent vs. 3.6 percent , P=0.008 ) . Women in the induction groups were less likely to say they liked " nothing " about their treatment than those in the expectant-management groups . CONCLUSIONS In women with prelabor rupture of the membranes at term , induction of labor with oxytocin or prostagl and in E2 and expectant management result in similar rates of neonatal infection and cesarean section . Induction of labor with intravenous oxytocin results in a lower risk of maternal infection than does expectant management . Women view induction of labor more positively than expectant management OBJECTIVE The aim of our study was to evaluate the optimum dose of intravaginal prostagl and in E2 gel for induction for labor in nulliparous women with a relatively ripe cervix ( modified Bishop score 4 or 5 ) . METHOD One hundred and sixty-seven nulliparous women at term with indications for the induction of labor were treated r and omly with two doses of intravaginal 2.0 ( group A ) or 3.0 mg ( group B ) of prostagl and in PGE2 gel every 12 h. Data were analyzed by chi 2-test and Student 's t-test . RESULTS Of 87 patients 64 went into labor after gel application in group A , compared with 68/80 in group B ( 73.5 % vs. 85.0 % ) ( P = NS ) . A second gel administration was needed for 9 women in group A and 6 women in group B. More side effects ( both local and systemic ) were noted in group B than in group A ( 28.7 % vs. 14.9 % ) ( P = 0.03 ) . In particular , more local ( hyperstimulation or hypertonus ) side effects were noted in group B ( 13.7 % vs. 2.3 % ) ( P = 0.01 ) . CONCLUSION The vaginal administration of 2.0 mg of PGE2 gel seems to be equally effective as 3.0 mg in terms of labor success rate with a significant lower incidence of side effects The effect of low-dose prostagl and in E2 vaginal gel specially prepared from commercially available material s , on subsequent indicated oxytocin induction of labor , was investigated in a r and omized , double-blind , placebo-controlled clinical trial . The stability of the gel after preparation was documented by radioimmunoassay in vitro . No differences between the treated and placebo groups were noted in subsequent modified Bishop scores , length of labor , use of analgesia or anesthesia , success of induction , mode of delivery , or perinatal outcome . Comparisons of this clinical trial with those previously reported are offered OBJECTIVE To compare two dosage regimens for the administration of vaginal prostagl and in gel in triacetin base for induction of labor . METHODS Seventy subjects planned for elective induction of labor at term were r and omized to treatment with PGE2 vaginal gel every 6 or 12 hours . The 6-hourly group received an initial dose of 1 mg , followed by 2 mg at 6 hour intervals for a maximum of two additional doses if not in active labor . The 12-hourly group had an initial dose of 2 mg followed by two additional doses at 12 hour intervals if not in active labor . RESULTS Successful induction rate was higher in the 12-hourly as compared to 6-hourly gel regimen ( 100 % vs. 91 % , P > 0.05 ) . Twelve hours after the
Output:
| Overall , vaginal prostagl and in E2 compared with placebo or no treatment probably reduces the likelihood of vaginal delivery not being achieved within 24 hours .
The overall effect on improving maternal and fetal outcomes ( across a variety of measures ) is uncertain .
PGE2 tablets , gels and pessaries ( including sustained release preparations ) appear to be as effective as each other , small differences are detected between some outcomes , but these maybe due to chance .
Prostagl and ins PGE2 probably increase the chance of vaginal delivery in 24 hours , they increase uterine hyperstimulation with fetal heart changes but do not effect or may reduce caesarean section rates .
They increase the likelihood of cervical change , with no increase in operative delivery rates . |
MS211559 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: OBJECTIVES Known disparities in pneumococcal vaccination in the community raise the question of whether disparities also exist in the nursing home setting , which is better controlled . This study used nationally representative nursing home data to compare black and white nursing home residents with respect to receiving , not receiving , or having an unknown PPV vaccination status , and to examine the interaction of race with various facility characteristics . DESIGN Multinomial logistic regression was used to analyze a 2-year merged file ( 1997 and 1999 ) of the National Nursing Home Survey , a cross-sectional national probability sample of nursing homes and residents . SETTING AND PARTICIPANTS Residents 65 years or older ( n = 14,782 ) residing in nursing homes between July and December of 1997 or 1999 . MEASUREMENTS Record-based staff report of whether residents ever had a pneumococcal immunization ( yes/no/unknown ) ; race measured as black or white . RESULTS Pneumococcal vaccination rates are lower for black nursing home residents than for white residents , as shown using a merged file of the 1997 and 1999 National Nursing Home Surveys . Participants include 14,303 r and omly sample d residents 65 years or older . In this sample , 31 % of black residents compared with 24 % of white residents 65 years or older had never received pneumococcal vaccination ( P < .01 ) . Multivariate logistic regression confirmed that blacks were more likely to be unimmunized than whites ( 95 % CIs ) , specifically in Medicaid-only facilities and dually certified Medicare and Medicaid facilities . Blacks also had higher odds of unknown vaccination status than whites in Medicaid-only facilities and lower odds of unknown status in government-owned facilities . CONCLUSIONS Results suggest that the racial difference in pneumococcal vaccination exists predominantly in certain facility types . In addition , facility-based interventions such as having an organized PPV immunization program or improving documentation of vaccination status can be effective in increasing vaccination rates for all races OBJECTIVE To examine the effects of the racial composition of residents on nursing homes ' financial and quality performance . The study examined Medicare and Medicaid-certified nursing homes across the United States that su bmi tted Medicare cost reports between the years 1999 and 2004 ( 11,472 average per year ) . DATA SOURCE Data were obtained from the Minimum Data Set , the On-Line Survey Certification and Reporting , Medicare Cost Reports , and the Area Re source File . STUDY DESIGN Panel data regression with r and om intercepts and negative binomial regression were conducted with state and year fixed effects . PRINCIPAL FINDINGS Financial and quality performance differed between nursing homes with high proportions of black residents and nursing homes with no or medium proportions of black residents . Nursing homes with no black residents had higher revenues and higher operating margins and total profit margins and they exhibited better processes and outcomes than nursing homes with high proportions of black residents . CONCLUSION Nursing homes ' financial viability and quality of care are influenced by the racial composition of residents . Policy makers should consider initiatives to improve both the financial and quality performance of nursing homes serving predominantly black residents OBJECTIVE : To test the feasibility of creating a valid and reliable checklist with the following features : appropriate for assessing both r and omised and non-r and omised studies ; provision of both an overall score for study quality and a profile of scores not only for the quality of reporting , internal validity ( bias and confounding ) and power , but also for external validity . DESIGN : A pilot version was first developed , based on epidemiological principles , review s , and existing checklists for r and omised studies . Face and content validity were assessed by three experienced review ers and reliability was determined using two raters assessing 10 r and omised and 10 non-r and omised studies . Using different raters , the checklist was revised and tested for internal consistency ( Kuder-Richardson 20 ) , test-retest and inter-rater reliability ( Spearman correlation coefficient and sign rank test ; kappa statistics ) , criterion validity , and respondent burden . MAIN RESULTS : The performance of the checklist improved considerably after revision of a pilot version . The Quality Index had high internal consistency ( KR-20 : 0.89 ) as did the subscales apart from external validity ( KR-20 : 0.54 ) . Test-retest ( r 0.88 ) and inter-rater ( r 0.75 ) reliability of the Quality Index were good . Reliability of the subscales varied from good ( bias ) to poor ( external validity ) . The Quality Index correlated highly with an existing , established instrument for assessing r and omised studies ( r 0.90 ) . There was little difference between its performance with non-r and omised and with r and omised studies . Raters took about 20 minutes to assess each paper ( range 10 to 45 minutes ) . CONCLUSIONS : This study has shown that it is feasible to develop a checklist that can be used to assess the method ological quality not only of r and omised controlled trials but also non-r and omised studies . It has also shown that it is possible to produce a checklist that provides a profile of the paper , alerting review ers to its particular method ological strengths and weaknesses . Further work is required to improve the checklist and the training of raters in the assessment of external validity BACKGROUND Influenza vaccination coverage among nursing home residents has consistently been reported well below the Healthy People goals . We sought to determine if st and ing order programs ( SOPs ) in long-term care facilities are associated with greater influenza vaccination coverage among residents . METHODS The National Nursing Home Survey ( 2004 ) is cross-sectional . A total of 1152 US long-term care facilities were systematic ally sample d with probability proportional to number of beds . A total of 11,939 people aged 65 years or older residing in sample d long-term care facilities between August and December 2004 were r and omly sample d. Influenza vaccination coverage of residents was obtained from facility records . Facility 's immunization program included st and ing orders versus other ( preprinted admission order , advance physician order , personal physician order , and no program ) . Multinomial logistic regression was used to examine the relationship between type of influenza immunization program and receipt of vaccination , adjusted for resident and facility confounders . RESULTS The proportion of residents aged 65 years or older who received influenza vaccination was 64 % ; 41 % of residents lived in a facility with an SOP . Influenza vaccination coverage among residents residing in facilities with st and ing orders was 68 % compared with 59 % to 63 % of residents in facilities with other program types . Logistic regression showed that st and ing order programs were independently associated with greater influenza vaccination coverage ( 66.7 % versus 62.0 % , P < .01 ) . CONCLUSION This study indicates that residents in long-term care facilities having st and ing order programs for influenza were more likely to be immunized . More research needs to be done to underst and how to facilitate adoption of these programs OBJECTIVE To evaluate collaborative efforts and intervention strategies by peer- review organizations ( PROs ) and long-term-care facilities ( LTCFs ) for improving pneumococcal vaccination rates among residents of LTCFs . DESIGN Prospect i ve , before-after quality improvement project . SETTING 133 LTCFs in Alaska , Idaho , Montana , and Wyoming . PATIENTS All residents of participating LTCFs . METHODS Baseline pneumococcal vaccination rates were determined by medical-record review , self-reporting by patient or family members , and review of Medicare cl aims information . Remeasurement of vaccination rates was accomplished from documentation of vaccination of eligible residents by each LTCF . RESULTS 133 LTCFs with 7,623 residents from Alaska , Idaho , Montana , and Wyoming participated in this quality -improvement project . This accounted for 41 % ( 133/321 ) of the potential nursing homes and resident population in the participating states . Baseline overall vaccination rates were 40 % ( 3,050/7,589 ) . The overall vaccination rate improved to 75 % ( 5,720/7,623 , P<.001 ) . The number of facilities meeting the Healthy People 2000 vaccination goal of 80 % improved from 18 % ( 24/133 ) to 62 % ( 83/133 , P<.001 ) . Initial use of chart stickers and implementation of st and ing orders led to similar increases in vaccination rates , but the st and ing-order strategy required commitment of fewer PRO re sources at a statewide level . Remeasurement of vaccination rates in a subset of participating Idaho LTCFs 1 year after initial vaccination efforts demonstrated a sustained vaccination rate of 70 % in facilities enforcing a st and ing-order policy . CONCLUSIONS Simple and straightforward vaccination strategies implemented in LTCFs over a short period of time can have a significant impact on vaccination rates . Collaborative efforts between state PROs and LTCFs enhance implementation of these strategies and can result in the achievement of national vaccination objectives . St and ing orders appear to be one intervention effective in sustaining successful vaccination efforts . Regardless of the specific interventions employed , PROs played a significant role in facilitating vaccination program development and intervention implementation OBJECTIVES To assess Advisory Committee for Immunization Practice s recommendations for the pneumococcal vaccine in nursing home residents using national surveys to examine factors associated with vaccination . DESIGN Cross-sectional national sample surveys of nursing homes and nursing home residents with a two-stage probability design , stratified on size and Medicare and Medicaid certification status . SETTING U.S. nursing homes during 1995 , 1997 , and 1999 . PARTICIPANTS Six current residents were r and omly selected from each facility ( n = approximately 8,000 each year ) . MEASUREMENTS Residents ' pneumococcal vaccination status was obtained by asking the facility respondent for each resident : " Has [ the resident ] EVER had a pneumococcal vaccine , that is a pneumonia vaccination ? " Vaccination status was coded as yes , no , and unknown . RESULTS The proportion of residents aged 65 and older that received pneumococcal vaccination increased significantly , from 23.6 % in 1995 to 28.2 % in 1997 to 37.4 % in 1999 ( P<.001 ) . The proportion of residents in homes with pneumococcal immunization programs increased significantly , from 65.2 % in 1995 to 88.9 % in 1999 . CONCLUSION The proportion of nursing home residents aged 65 and older receiving the pneumococcal vaccine increased significantly from 1995 to 1999 . Residents living in nursing homes with programs for pneumococcal immunizations were significantly more likely to be vaccinated OBJECTIVE To identify nursing home resident and facility characteristics associated with patients not receiving influenza immunization and having unknown immunization status . DESIGN Secondary data analysis using multinomial logistic regression of data from the National Nursing Home Survey , a nationally representative establishment-based survey . SETTING A total of 1,423 nursing facilities of all ownerships and certifications systematic ally sample d with probability proportional to number of beds . PATIENTS A total of 7,350 r and omly sample d people aged 65 years or older residing in nursing homes between July and December 1999 ( approximately 6 per facility ) . MAIN OUTCOME MEASURE Immunization status of residents . RESULTS Fifteen percent of residents were not immunized and 19 % had unknown immunization status . In multivariate analysis , lack of immunization and unknown immunization status were each separately associated with being newly admitted , with no or unknown pneumococcal immunization , and with facility failures to screen for immunization and to record inoculation in the medical record . High-risk status and staff immunization requirements had no effect . Separate analyses showed that residents with unknown immunization status are statistically significantly different from both those vaccinated and those not vaccinated . CONCLUSION This study indicates that both resident and facility characteristics are associated with failure to be immunized for influenza . Facilities should consider targeting younger , newly admitted , and residential care residents for influenza immunization , since they are more likely to be missed . Further research into the barriers to immunization specific to nursing home resident choice or opportunity may be warranted OBJECTIVES To determine whether the racial inequity between African Americans and Caucasians in receipt of influenza vaccine is narrower in residents of nursing homes with facility-wide vaccination strategies than in residents of facilities without vaccination strategies . DESIGN Secondary data analysis using the National Nursing Home Survey 2004 , a nationally representative survey . SETTING One thous and one hundred seventy-four participating nursing homes sample d systematic ally with probability proportional to bed size . PARTICIPANTS Thirteen thous and five hundred seven r and omly sample d residents of nursing homes between August and December 2004 . MEASUREMENTS Receipt of influenza vaccine within the last year . Logistic regression was used to examine the relationship between facility-level influenza immunization strategy and racial inequity in receipt of vaccination , adjusted for characteristics at the resident , facility , state , and regional levels . RESULTS Overall in the United States , vaccination coverage was higher for Caucasian and African-American residents ; the racial vaccination gaps were smaller ( < 6 percentage points ) and nons
Output:
| Research ers reported racial/ethnic minorities were more likely to refuse vaccinations and less likely to have vaccinations offered and their vaccination status tracked compared to Whites . |
MS211560 | ***TASK*** the task is to summarize an input biomedical literature 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 Irritable bowel syndrome ( IBS ) is a common functional bowel disorder for which there is no reliable medical treatment . OBJECTIVE To determine whether Chinese herbal medicine ( CHM ) is of any benefit in the treatment of IBS . DESIGN R and omized , double-blind , placebo-controlled trial conducted during 1996 through 1997 . SETTING Patients were recruited through 2 teaching hospitals and 5 private practice s of gastroenterologists , and received CHM in 3 Chinese herbal clinics . PATIENTS A total of 116 patients who fulfilled the Rome criteria , an established st and ard for diagnosis of IBS . INTERVENTION Patients were r and omly allocated to 1 of 3 treatment groups : individualized Chinese herbal formulations ( n = 38 ) , a st and ard Chinese herbal formulation ( n = 43 ) , or placebo ( n = 35 ) . Patients received 5 capsules 3 times daily for 16 weeks and were evaluated regularly by a traditional Chinese herbalist and by a gastroenterologist . Patients , gastroenterologists , and herbalists were all blinded to treatment group . MAIN OUTCOME MEASURES Change in total bowel symptom scale scores and global improvement assessed by patients and gastroenterologists and change in the degree of interference in life caused by IBS symptoms assessed by patients . RESULTS Compared with patients in the placebo group , patients in the active treatment groups ( st and ard and individualized CHM ) had significant improvement in bowel symptom scores as rated by patients ( P=.03 ) and by gastroenterologists ( P=.001 ) , and significant global improvement as rated by patients ( P=.007 ) and by gastroenterologists ( P=.002 ) . Patients reported that treatment significantly reduced the degree of interference with life caused by IBS symptoms ( P=.03 ) . Chinese herbal formulations individually tailored to the patient proved no more effective than st and ard CHM treatment . On follow-up 14 weeks after completion of treatment , only the individualized CHM treatment group maintained improvement . CONCLUSION Chinese herbal formulations appear to offer improvement in symptoms for some patients with IBS CONTEXT A prior national survey documented the high prevalence and costs of alternative medicine use in the United States in 1990 . OBJECTIVE To document trends in alternative medicine use in the United States between 1990 and 1997 . DESIGN Nationally representative r and om household telephone surveys using comparable key questions were conducted in 1991 and 1997 measuring utilization in 1990 and 1997 , respectively . PARTICIPANTS A total of 1539 adults in 1991 and 2055 in 1997 . MAIN OUTCOMES MEASURES Prevalence , estimated costs , and disclosure of alternative therapies to physicians . RESULTS Use of at least 1 of 16 alternative therapies during the previous year increased from 33.8 % in 1990 to 42.1 % in 1997 ( P < or = .001 ) . The therapies increasing the most included herbal medicine , massage , megavitamins , self-help groups , folk remedies , energy healing , and homeopathy . The probability of users visiting an alternative medicine practitioner increased from 36.3 % to 46.3 % ( P = .002 ) . In both surveys alternative therapies were used most frequently for chronic conditions , including back problems , anxiety , depression , and headaches . There was no significant change in disclosure rates between the 2 survey years ; 39.8 % of alternative therapies were disclosed to physicians in 1990 vs 38.5 % in 1997 . The percentage of users paying entirely out-of-pocket for services provided by alternative medicine practitioners did not change significantly between 1990 ( 64.0 % ) and 1997 ( 58.3 % ) ( P=.36 ) . Extrapolations to the US population suggest a 47.3 % increase in total visits to alternative medicine practitioners , from 427 million in 1990 to 629 million in 1997 , thereby exceeding total visits to all US primary care physicians . An estimated 15 million adults in 1997 took prescription medications concurrently with herbal remedies and /or high-dose vitamins ( 18.4 % of all prescription users ) . Estimated expenditures for alternative medicine professional services increased 45.2 % between 1990 and 1997 and were conservatively estimated at $ 21.2 billion in 1997 , with at least $ 12.2 billion paid out-of-pocket . This exceeds the 1997 out-of-pocket expenditures for all US hospitalizations . Total 1997 out-of-pocket expenditures relating to alternative therapies were conservatively estimated at $ 27.0 billion , which is comparable with the projected 1997 out-of-pocket expenditures for all US physician services . CONCLUSIONS Alternative medicine use and expenditures increased substantially between 1990 and 1997 , attributable primarily to an increase in the proportion of the population seeking alternative therapies , rather than increased visits per patient OBJECTIVE To determine whether clinical trials originating in certain countries always have positive results . DATA SOURCES Abstract s of trials from Medline ( January 1966-June 1995 ) . STUDY SELECTION Two separate studies were conducted . The first included trials in which the clinical outcome of a group of subjects receiving acupuncture was compared to that of a group receiving placebo , no treatment , or a nonacupuncture intervention . In the second study , r and omized or controlled trials of interventions other than acupuncture that were published in China , Japan , Russia/USSR , or Taiwan were compared to those published in Engl and . DATA EXTRACTION Blinded review ers determined inclusion and outcome and separately classified each trial by country of origin . DATA SYNTHESIS In the study of acupuncture trials , 252 of 1085 abstract s met the inclusion criteria . Research conducted in certain countries was uniformly favorable to acupuncture ; all trials originating in China , Japan , Hong Kong , and Taiwan were positive , as were 10 out of 11 of those published in Russia/USSR . In studies that examined interventions other than acupuncture , 405 of 1100 abstract s met the inclusion criteria . Of trials published in Engl and , 75 % gave the test treatment as superior to control . The results for China , Japan , Russia/USSR , and Taiwan were 99 % , 89 % , 97 % , and 95 % , respectively . No trial published in China or Russia/USSR found a test treatment to be ineffective . CONCLUSIONS Some countries publish unusually high proportions of positive results . Publication bias is a possible explanation . Research ers undertaking systematic review s should consider carefully how to manage data from these countries The effects of prokinetic treatment with cisapride in patients with constipation-predominant irritable bowel syndrome ( IBS ) were evaluated in a r and omized , double-blind , placebo-controlled study . Sixty-nine IBS patients were assigned to a 12-week treatment with either 5 mg cisapride or placebo t.i.d . ; this dosage could be changed if necessary . The mean weekly number of days on which a stool was passed in the cisapride and placebo group increased to 5.3 and 4.4 ( p less than 0.05 ) during weeks 8 - 12 of treatment , and the number of days with stools of normal consistency increased to 3.5 and 1.9 ( p less than 0.05 ) , respectively . At week 12 , the reduction in severity and frequency scores for abdominal pain was significantly greater ( p less than or equal to 0.05 ) in the cisapride group ( 60 and 61 % ) than in the placebo group ( 40 and 32 % ) , as it was for abdominal distension ( p less than 0.05 ) . Cisapride tended to be better than placebo in diminishing flatulence . In 71 % versus 39 % of the patients the overall rating for the response to treatment was good or excellent at week 12 . Cisapride was well tolerated . These results suggest that the drug will be useful for the management of constipation-predominant IBS BACKGROUND Irritable bowel syndrome is a common cause of abdominal pain and discomfort and may be related to disordered gastrointestinal motility . Our aim was to assess the effects of long-term treatment with a prokinetic agent , cisapride , on postpr and ial jejunal motility and symptoms in the irritable bowel syndrome ( IBS ) . METHODS Thirty-eight patients with IBS ( constipation-predominant , n = 17 ; diarrhoea-predominant , n = 21 ) underwent 24-h ambulatory jejunal manometry before and after 12 week 's treatment [ cisapride , 5 mg three times daily ( n = 19 ) or placebo ( n = 19 ) ] . RESULTS In diarrhoea-predominant patients significant differences in contraction characteristics were observed between the cisapride and placebo groups . In cisapride-treated diarrhoea-predominant patients the mean contraction amplitude was higher ( 29.3 + /- 3.2 versus 24.9 + /- 2.6 mm Hg , cisapride versus placebo ( P < 0.001 ) ; pretreatment , 25.7 + /- 6.0 mm Hg ) , the mean contraction duration longer ( 3.4 + /- 0.2 versus 3.0 + /- 0.2 sec , cisapride versus placebo ( P < 0.001 ) ; pretreatment , 3.1 + /- 0.5 sec ) , and the mean contraction frequency lower ( 2.0 + /- 0.2 versus 2.5 + /- 0.4 cont./min , cisapride versus placebo ( P < 0.001 ) ; pretreatment , 2.5 + /- 1.1 cont./min ] than patients treated with placebo . No significant differences in jejunal motility were found in the constipation-predominant IBS group . Symptoms were assessed by using a visual analogue scale before and after treatment . Symptom scores relating to the severity of constipation were lower in cisapride-treated constipation-predominant IBS patients [ score , 54 + /- 5 versus 67 + /- 14 mm , cisapride versus placebo ( P < 0.05 ) ; pretreatment , 62 + /- 19 mm ] . Diarrhoea-predominant IBS patients had a higher pain score after cisapride therapy [ score , 55 + /- 15 versus 34 + /- 12 mm , cisapride versus placebo ( P < 0.05 ) ; pretreatment , 67 + /- 19 mm ] . CONCLUSION Cisapride affects jejunal contraction characteristics and some symptoms in IBS OBJECTIVE To observe the clinical efficacy of the combination of traditional Chinese medicine and western medicine in treating irritable bowel syndrome ( IBS ) and the result of intestinal flora regulation . METHODS Sixty IBS patients , 36 males and 24 females , were divided into two groups , with 30 patients in each group . Herbal formula of TongxieYaofang and clostridium butyricum ( Cb ) were used in the first group for four weeks , while only Cb was used for four weeks in the second group . We observed the changes of coliform group , enterococcus , lactobacillus , bifidobacterium after treatment . RESULTS The effective rate of the Tongxie Yaofang and Cb treated group was significantly higher than that of the Cb treated group ( P < 0.05 ) . The numbers of bifidobacterium and lactobacillus increased , while the numbers of coliform group and enterococcus decreased after the treatment , and the changes of intestinal flora in the integrative medicine treated group were significantly greater than those in the Cb treated group . CONCLUSION After treatment with the combination of traditional Chinese medicine and western medicine , the intestinal flora can be regulated to equilibrium state Background and Aims : Padma Lax , a complex Tibetan herbal formula for constipation was evaluated for safety and effectiveness in treating constipation-predominant irritable bowel syndrome in a 3-month double-blind r and omised pilot study . Methods : Patients were recruited from Hadassah Hospital ’s Gastroenterology clinic , using the Rome I Criteria for irritable bowel syndrome , and the international consensus criteria for constipation . Symptom severity was evaluated monthly by patients and gastroenterologist , using categorical and numerical rating scales . A patient diary recorded daily stool habit and trial medication . Results : In 61 patients , ( 34 Padma Lax , 27 placebo ) , significant improvement was demonstrated after 3 months in the Padma Lax group compared to placebo in constipation , severity of abdominal pain , and its effect on daily activities , incomplete evacuation , abdominal distension and flatus/flatulence . A global assessment indicated that significantly more Padma Lax patients , compared to placebo , rated the current treatment superior to previous therapies tried for irritable bowel . Laboratory parameters displayed no clinical ly significant changes . Side effects , primarily loose stools in 7 Padma Lax patients responded well to lowering treatment dosage from 2 to 1 capsule/day . Conclusions : Padma Lax is a safe and effective treatment for constipation-predominant irritable bowel syndrome and may offer an alternative to the current multi drug approach Background : Herbal medications have been used in many countries for the treatment of patients with irritable bowel syndrome .
Output:
| Compared with placebo , a St and ard Chinese herbal formula , individualised Chinese herbal medicine , STW 5 and STW 5-II , Tibetan herbal medicine Padma Lax , traditional Chinese formula Tongxie Yaofang , and Ayurvedic preparation showed significantly improvement of global symptoms .
Some herbal medicines may improve the symptoms of irritable bowel syndrome . |
MS211561 | ***TASK*** the task is to summarize an input biomedical literature 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 Subcutaneous body weight-adjusted low molecular weight heparin ( LMWH ) has been proven as effective and safe as intravenous aPTT-adjusted unfractionated heparin ( UFH ) for the treatment of patients with acute deep venous thrombosis ( DVT ) . In this study we evaluate the efficacy of the initial treatment of proximal DVT with a fixed-dose , body weight-independent application of the LMWH Certoparin with a six month follow-up . In a prospect i ve , multicentre , r and omized , active-controlled study 1220 patients with objective ly diagnosed proximal DVT were r and omly assigned to subcutaneous 8000 U anti-factor Xa of Certoparin twice daily for 10 to 14 days or intravenous aPTT-adjusted UFH for 5 to 8 days . Both regimen were followed by oral anticoagulation for 6 months . The primary end point was the rate of symptomatic and objective ly confirmed thromboembolic events within 6 months . The aim of the study was to demonstrate the non-inferiority of the Certoparin regimen as compared to UFH . The per- protocol analysis revealed 22 ( 3.8 % ) thromboembolic events in the Certoparin group and 24 ( 4.3 % ) in patients assigned to UFH within 6 months , thereby proving the non-inferiority ( p<0.01 ) , confirmed by intent-to-treat analysis ( p<0.001 ) . Major bleeding occurred in 6 and 7 patients started on Certoparin or UFH during the treatment period . Thromboembolic events were equally distributed in body weight categories with < 50 , 50 - 80 and > 80 kg as followed : 0 , 3.6 % and 4.1 % of patients for the Certoparin group and 0 , 4.6 % and 4.2 % of patients for the UFH group . The same was true for major bleeding complications with 0 , 2.9 % and 1.5 % for Certoparin and 0 , 3.5 % and 4.2 % for UFH . Overall mortality was 1.9 % in the Certoparin group and 2.7 % in the UFH group . Fixed-dose body weight-independent subcutaneous LMWH Certoparin is at least as efficacious and safe as intravenous aPTT-adjusted UFH for the initial treatment of acute proximal DVT . This effect is maintained during a 6-months follow-up of treatment with oral anticoagulation INTRODUCTION Trials comparing the use of full dose unfractionated heparin ( UFH ) or low molecular weight heparins ( LMWHs ) in very elderly patients with impaired renal function are lacking . IRIS aim ed to assess whether LMWH is at least as safe as UFH in this population . MATERIAL S AND METHODS The study included renally impaired patients ≥70 years with acute symptomatic lower limb deep vein thrombosis ( DVT ) . Patients were r and omized to initial treatment with either tinzaparin 175 IU/kg once daily ( n=269 ) or activated partial thromboplastin time-adjusted UFH twice daily ( n=270 ) . After acute management both groups received vitamin K antagonist to day 90 . RESULTS The trial was stopped prematurely due to a difference in mortality favoring the UFH group ( 11.5 vs. 6.3 % ; p=0.035 ) . Rates of clinical ly relevant bleedings by day 90 were similar in the tinzaparin ( 11.9 % ) and UFH ( 11.9 % ) groups , as were rates of confirmed recurrent venous thromboembolism ( VTE ) ( 2.6 vs. 1.1 % ; p=0.34 ) . As the mortality difference could not be explained by bleedings or recurrent VTE , a post-hoc analysis was performed . This identified six baseline characteristics significantly correlated with mortality , of which five were over-represented in the tinzaparin group . CONCLUSION The IRIS study was a challenging study involving patients ( mean age 83 years ) usually excluded from clinical studies , but its early termination has left questions unanswered . The mortality difference observed with tinzaparin vs. UFH in elderly , renally-impaired patients with DVT can not be explained on the basis of bleedings or recurrent VTE , and may reflect an imbalance of mortality risk factors at baseline Intravenous heparin followed by oral anticoagulant therapy ( e. g. with coumarin ) is still the most widely used treatment for deep venous thromboembolism . Self-administered subcutaneous injections of heparin have been thought of as a promising alternative to coumarin , but the high doses required for ongoing prophylaxis have raised concerns about the possible development of bone disease . Certainly , long-term heparin therapy has been reported to cause osteoporosis in both laboratory animals and humans . This study aim ed to compare the efficacy and safety of unfractionated ( UF ) heparin with that of a low molecular weight heparin ( Fragmin , Kabi Pharmacia ) in the prevention of recurrent deep venous thrombosis ( DVT ) and pulmonary embolism ( PE ) in a consecutive series of patients with contraindications to coumarin therapy . The patients comprised 40 men and 40 women , aged between 19 and 92 years ( mean age , 68 years ) . They had all previously been diagnosed as having acute DVT and had been treated with conventional doses of heparin while in hospital . All patients had at least one of the following conditions : recent blood loss ( either spontaneous or during admission while receiving heparin therapy ) ; active gastroduodenal ulcer disease ; psychological or physical inability or unwillingness to underst and and accept the need for regular laboratory monitoring during coumarin treatment ; chronic alcoholism ; dementia ; pregnancy ; recent neurosurgery , and pericardial effusion ; or were over 80 years of age . They were r and omly allocated to receive either UF heparin , 10,000 IU s.c . b.d . , or Fragmin , 5000 IU anti-Factor Xa s.c . b.d . , for a period of 3 - 6 months . ( ABSTRACT TRUNCATED AT 250 WORDS BACKGROUND Body weight-adjusted subcutaneous low-molecular-weight heparin ( LMWH ) has been proven to be at least as effective and safe as dose-adjusted intravenous unfractionated heparin ( UFH ) for the treatment of patients with venous thromboembolism . However , body weight-adjusted dosage of low-molecular-weight heparin may be cumbersome and could lead possibly to incorrect dosing . Therefore a fixed LMWH dose , independent of body-weight , might rationalize initial treatment for venous thromboembolism . METHODS Patients with proven proximal deep-vein thrombosis were r and omly assigned to fixed dose subcutaneous LMWH Certoparin ( 8,000 anti-factor Xa U b.i.d . ; 265 patients ) or to adjusted dose i.v . UFH ( 273 patients ) for 12 days . Vitamin K antagonists were started between day 3 and 7 and continued for up to 6 months . The primary outcome measure was a 30 percent or greater improvement in the Marder Score , as revealed by repeated venography on day 12 ( end of the initial treatment ) . The secondary composite outcome measure included death , recurrent venous thromboembolism and major bleeding and was assessed at day 12 and after 6 months by a blinded adjunction committee . RESULTS The Marder score improved by 30 % or more in 30.3 % and 25.0 % of patients assigned to LMWH ( 198 paired venograms ) and UFH ( 192 paired venograms ) , respectively ( 2p = 0.26 ) . At the end of the initial treatment , the composite outcome was observed in 4 of the 265 patients ( 1.5 % ) r and omized to LMWH , as compared with 14 of the 273 patients ( 5.1 % ) r and omized to UFH ( 2p = 0.03 ) . At 6 months these figures were 6.8 % and 12.8 % , respectively ( risk reduction 0.53 , confidence interval 0.31 - 0.90 , 2p = 0.02 ) . CONCLUSION Fixed dose subcutaneous LMWH certoparin is at least as efficacious as UFH in resolving proximal vein thrombosis We performed a prospect i ve , r and omized , double-blind trial in 194 unselected patients to determine the safety and efficacy of low molecular weight heparin ( Fragmin ) compared with st and ard heparin as the initial treatment of acute venous thromboembolism . Ninety-eight patients received continuous intravenous heparin , and 96 patients received Fragmin for 5 - 10 days . Doses were adjusted to maintain anti-Xa levels between 0.3 and 0.6 unit/ml for patients with a high risk for a bleeding complication and between 0.4 and 0.9 unit/ml for patients with a low risk for bleeding . Treatment was stopped when a therapeutic level of anticoagulation ( International Normalized Ratio greater than 3.5 ) was reached with coumarins . Thirteen patients in the heparin group and 10 patients in the Fragmin group had a major bleeding complication . The incidence of major and minor bleeding complications combined decreased from 48.9 % to 38.5 % ( 95 % confidence interval for the difference , -3.5 % to + 24.2 % ) , corresponding with a relative bleeding risk reduction of 21.2 % . There were no significant differences in efficacy as defined by new high-probability defects on repeat ventilation-perfusion scintigraphy of the lung in 80 patients : six of 46 patients in the heparin group and 3 of 34 patients in the Fragmin group had new defects ( 95 % confidence interval for the difference , -9.4 % to + 17.8 % ) . We conclude that low molecular weight heparin ( Fragmin ) given in adjusted , continuous , and intravenous doses is safe and effective as initial treatment of acute venous thromboembolism compared with heparin . There is a trend in risk reduction for bleeding in favor of low molecular weight heparin , a trend , however , that is smaller than expected compared with animal studies BACKGROUND An intravenous course of st and ard ( unfractionated ) heparin with the dose adjusted to prolong the activated partial-thromboplastin time to a desired length is the st and ard initial in-hospital treatment for patients with deep-vein thrombosis , but fixed-dose subcutaneous low-molecular-weight heparin appears to be as effective and safe . Because the latter treatment can be given on an outpatient basis , we compared the two treatments in symptomatic out patients with proximal-vein thrombosis but no signs of pulmonary embolism . METHODS We r and omly assigned patients to adjusted-dose intravenous st and ard heparin administered in the hospital ( 198 patients ) or fixed-dose subcutaneous low-molecular-weight heparin administered at home , when feasible ( 202 patients ) . We compared the treatments with respect to recurrent venous thromboembolism , major bleeding , quality of life , and costs . RESULTS Seventeen of the 198 patients who received st and ard heparin ( 8.6 percent ) and 1
Output:
| This review presents moderate- quality evidence that fixed dose LMWH reduced the incidence of recurrent thrombotic complications and occurrence of major haemorrhage during initial treatment ; and low- quality evidence that fixed dose LMWH reduced thrombus size when compared to UFH for the initial treatment of VTE .
There was no difference in overall mortality between participants treated with LMWH and those treated with UFH ( moderate- quality evidence ) . |
MS211562 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
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Input: RésuméLe repos au lit est habituellement considéré comme un traitement efficace de la lombalgie aiguë . Cependant la durée optimale de cette mise au repos au lit est encore discutée , variant selon les écoles de 2 jours à 2 semaines . C'est un paramètre imporant à considérer , compte tenu des préjudices économiques et fonctionnels d'une inactivité prolongée . Le but de ce travail est de faire une évaluation objective de l'efficacité de deux durées de repos différentes , à l'aide d'une mesure dynamométrique de la fonction musculaire du tronc pratiquée à la suite d'une mise au repos plus ou moins longue . Cinquante et un patients , étudiants ou travaillant à leur propre compte , consultant pour des lombalgies aiguës , ont été r and omisés en deux groupes . Au groupe I a été prescrit un repos au lit de 3 jours et au groupe II un repos de 7 jours . Nous avons utilisé un appareil dynamométrique ( Isostation B200 , Isotechnologies , USA ) pour l'évaluation isoinertielle de la fonction musculaire du tronc dans les différents plans . Les patients ont été évalués au ler et au 5e jour dans le groupe I ; la seconde évaluation a été reportée au 9e jour dans le groupe II . Les variables mesurées dans le plan sagittal ont été les forces isometriques en flexion et extension , l'amplitude des mouvements sans résistance , la valeur moyenne des forces développées dans les mouvements de flexion et d'extension ainsi que les vitesses moyennes . On a également dem and é aux patients de situer sur une échelle graphique l'intensité de la douleur ressentie le jour de l'évaluation . L'amélioration de tous les paramètres mesurées a été importante et hautement significative ( P<0,001 ) dans les deux groupes . Les résultats du testing fonctionnel et de l'échelle des douleurs n'ont pas montré de différences significatives entre ces deux groupes . Chez ces patients relativement jeunes et motivés , un repos au lit de trois jours a abouti à la même amélioration de la fonction et de la douleur que le repos de sept jours . Compte tenu des résultats objectifs identiques et aussi des avantages physiologiques et économiques indiscutables , il est préférable de prescrire une mise au repos plus brève . Summary Bed rest is usually considered an efficient treatment for acute low back pain . However , the optimal duration of bed rest is still being discussed . The recommended periods vary from 2 days to 2 weeks . The duration of optimum length is an important topic given the economical and physiological drawbacks of prolonged inactivity . The purpose of this work is to measure objective ly the efficacy of two different duration s of bed rest through a dynamometric measure of trunk function . Some 51 male patients , students or self-employed , being treated for acute low back pain were r and omized into two groups . Group I was prescribed a bed rest period of 3 days and group II , a period of 7 days . We used a multiaxis isoinertial trunk testing dynamometric device ( Isostation B200 , Isotechnologies , USA ) . Patients were all assessed on day 1 and also on day 5 for group I or on day 9 for group II . The variables measured in the sagittal plane were isometric torques in flexion and extension , unresisted range of motion , average dynamic torques and average velocities . Patients were also asked to fill in a visual analogue pain scale on both assessment days . The improvement of all performance measures were important and highly significant ( P<0.001 ) in both groups . The results of the functional testing and the visual analogue pain scale showed no significant differences between the groups . In these relatively young and motivated patients , a duration of bed rest of 3 days result ed in the same objective functional improvement of trunk function and pain rating as a period of 7 days . This shorter duration should be considered as preferable , given the same objective results but important physiological and economical advantages The roles of bedrest , antiinflammatory medication , and analgesic medication in the treatment of acute back strain were objective ly analyzed to determine whether they have a measurable effect on the return of patients to full daily activities as well as on the relief of pain . Two hundred patients were studied prospect ively . Each patient had the diagnosis of acute back strain , which was defined as nonradiating low-back pain . The results of the patient 's neurologic examination , straight leg raising test , and lumbosacral spine roentgenograms had to be within normal limits for the patient to be included in the study . The results showed that bedrest , as compared with ambulation , will decrease the amount of time lost from work by 50 % . Bedrest will also decrease the amount of discomfort by 60 % . Analgesic medication , when combined with bedrest , will further decrease the amount of pain incurred , particularly when used in the first three days of the healing process . However , analgesic medication will not allow a more prompt return to work . Antiinflammatory medication , when added to bedrest in the treatment of lumbago , does not provide an advantage over bedrest alone The aim of this study was to determine whether grade d activity restored occupational function in industrial blue-collar workers who were sick-listed for 8 weeks because of subacute , nonspecific , mechanical low back pain ( LBP ) . Patients with LBP , who had been examined by an orthopedic surgeon and a social worker , were r and omly assigned to either an activity group ( n = 51 ) or a control group ( n = 52 ) . Patients with defined orthopedic , medical , or psychiatric diagnoses were excluded before r and omization . The grade d activity program consisted of four parts : ( 1 ) measurements of functional capacity ; ( 2 ) a work-place visit ; ( 3 ) back school education ; and ( 4 ) an individual , submaximal , gradually increased exercise program , with an operant-conditioning behavioral approach , based on the results of the tests and the dem and s of the patient 's work . Records of the amount of sick leave taken over a 3-year period ( ie , the 1-year periods before , during , and after intervention ) were obtained from each patient 's Social Insurance Office . The patients in the activity group returned to work significantly earlier than did the patients in the control group . The median number of physical therapist appointments before return to work was 5 , and the average number of appointments was 10.7 ( SD = 12.3 ) . The average duration of sick leave attributable to LBP during the second follow-up year was 12.1 weeks ( SD = 18.4 ) in the activity group and 19.6 weeks ( SD = 20.7 ) in the control group . Four patients in the control group and 1 patient in the activity group received permanent disability pensions . The grade d activity program made the patients occupationally functional again , as measured by return to work and significantly reduced long-term sick leave A controlled trial of continuous lumbar traction in the treatment of back pain and sciatica showed similar improvements in both the treated group ( weighted traction ) and the control group ( simulated traction ) . The findings of this study question the justification of admitting patients with back pain into hospitals for purpose s of traction alone The results of a multicentered r and omised clinical trial are reported of bed rest and of a physiotherapy and education programme for patients who presented in family practice with an acute episode of low back pain . No beneficial effect of either treatment was observed on several clinical outcome measures , including straight leg raising , lumbar flexion , activities of daily living , and pain . In fact the results favoured early mobilisation over bed rest and suggested that the physiotherapy and education programme was doing more harm than good . Moreover , additional analyses , which focused on clinical ly interesting patient subgroups , discovered no subset of patients who benefited from either of the treatments under study . Having failed to identify any clinical ly important benefits , or other explanations for these negative results , we can only conclude that family doctors have little reason to prescribe either bed rest or isometric exercises to patients who suffer from low back pain Because back pain is a widespread and costly condition that tends to recur , treatment must focus on both the amelioration of acute symptoms and prevention over the long term . This paper reports a longitudinal evaluation of a program from a community hospital that emphasizes both these aspects . One hundred twenty patients routinely admitted to this program were r and omly assigned to treatment and control groups . These groups were assessed for differences in demonstrated physical strength , mobility , body mechanics , and self-care knowledge , and in levels of self-reported exercise , anxiety , and pain . There were significant immediate gains on physical measures of fitness and in observed body mechanics ; patients also reported significant gains in physical capabilities at home and in leisure activities . Self-care knowledge also improved . When assessed one year later , original gains in physical strength and mobility were being maintained , and self-reported physical capabilities also remained high . Although demonstrated knowledge of correct body mechanics declined over this period , it was still significantly greater than before the program . In light of these results , we believe that outpatient programs like the one reported here merit careful consideration in an era of concern about rising costs for primary health care & NA ; The current investigation studied the effectiveness of a secondary prevention program for nurses with back pain who were deemed at risk for developing a chronic problem . A 2 × 3 repeated measures design was employed with 2 groups and 3 assessment periods . The treatment group received an intervention design ed to reduce current problems , but above all to prevent reinjury and minor pains from becoming chronic medical problems , and it included a physical and behavioral therapy package . The control group was placed on a waiting‐list . Results indicated that the treatment group had significantly greater improvements than the control group for pain intensity , anxiety , sleep quality and fatigue ratings , observed pain behavior , activities , mood , and helplessness . These differences were generally maintained at the 6 month follow‐up . In addition , the treatment group broke a trend for increasing amounts of pain‐related absenteeism , while the control group did not . Taken as a whole , the results suggest that a secondary prevention program aim ed at altering life style factors may represent an effective method for dealing with musculoskeletal pain problems Patients with nonspecific mechanical low back pain ( n = 103 ) , examined by an orthopaedic surgeon and a social worker , were r and omized to an activity group ( n = 51 ) and a control group ( n = 52 ) . Patients with defined orthopaedic , medical , or psychiatirc diagnoses were excluded before r and omization . No patients were excluded due to place of birth or difficulties in speaking or underst and ing the Swedish language . The purpose of the study was to compare mobility , strength and fitness after traditional care and after traditional care plus a grade d activity program with a behavioral therapy approach . A grade d activity program , with a behavioral therapy approach was given under the guidance of a physical therapist . The endpoint of the grade d activity program was return to work . This program significantly increased mobility , strength , and fitness more than could be explained by only a time recovery effect , especially in males . The patients in the activity group returned to work earlier than did the patients in the control group . Spinal rotation , abdominal muscle endurance time and lifting capacity were significantly correlated to rate of return to work . Traditional care plus a grade d activity program were superior to only traditional care , evaluated in terms of mobility , strength and fitness . The grade d activity program proved to be a successful method of restoring occupational function and facilitating return to work in subacute low back pain patients . The patients in the grade d activity program learned that it is safe to move , while regaining function Objective . This r and omized clinical trial was design ed to determine the effect of treating low back pain as a benign , self limiting condition by light normal activity . Methods . Patients on sickness leave from work for more than 8 weeks were r and omized into two groups : intervention ( n = 463 ) and control ( n = 512 ) . Those in the intervention group were examined , provided information , and given instruction . Outcome was measured by return or failure to return to work ( still on sickness leave ) . Results . Survival analysis showed a highly significant ( P = 0.000 ) reduction in sickness leave in the intervention group as compared with the control group . At 200 days 60 % were still on sickness leave in the control group vs. 30 % in the intervention group . A multivariate analysis with age , sex , and treatment as cofactors showed that sex had no effect on length of sickness leave and that treatment retained its effect when adjusting for differences in age composition . Conclusion . This study indicates that low back pain treated as a benign , self limiting condition recommended to light mobilization gives superior results as compared to treatment within a conventional medical system & NA ; Current conceptions of chronic pain clearly suggest that proper care at the acute stage should prevent the development of chronic problems . Patients ( 198 ) seeking help for acute musculoskeletal pain ( MSP ) , e.g. , back and neck pain participated in two studies of the effects of an Early Active intervention which underscored ‘ well ’ behavior and function compared to a Treatment as Usual control group . The quantity of the Early Active treatment was a median of 1 doctor 's appointment and 3 meetings with a physical therapist . Study I concerned patients with a prior history of sick‐listing for MSP , while study II involved patients with no prior history of MSP . Treatment satisfaction , pain experience , activities and sickness absenteeism were assessed before , after and at a 12‐month follow‐up . In study I ( patients with a history of MSP ) , the results showed significant improvements for both groups , but virtually no differences between the groups . Similarly , in study II ( no history of MSP ) both groups demonstrated significant improvements e.g. , for pain intensity and activity levels . However , the Early Active treatment result ed in significantly less sick‐listing relative to the control group . Moreover , the risk of developing chronic ( > 200 sick days ) pain was 8 times lower for the Early Activation group . This investigation shows that relatively simple changes in treatment result in reduced sickness absenteeism for ‘ first‐time ’ sufferers only . Consequently , the content and timing of treatment for pain appear to be crucial . Properly administered early intervention may therefore decrease sick leave and prevent chronic problems , thus saving considerable re sources BACKGROUND Bed rest and back-extension exercises are often prescribed for patients with acute low back pain , but the effectiveness of these two competing treatments remains controversial . METHODS We conducted a controlled trial among employees of
Output:
| Consistent findings showed that bed rest is not an effective treatment for acute low back pain but may delay recovery .
Advice to stay active and to continue ordinary activities results in a faster return to work , less chronic disability , and fewer recurrent problems .
CONCLUSION A simple but fundamental change from the traditional prescription of bed rest to positive advice about staying active could improve clinical outcomes and reduce the personal and social impact of back pain |
MS211563 | ***TASK*** the task is to summarize an input biomedical literature 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 purpose of this study was to evaluate primary and team nursing on two 45-bed geriatric units . A 2 year longitudinal study with a quasi-experimental ABA cross-over design and a staff survey , permitted comparisons of the two nursing systems on indices of patient well-being , nursing practice , staff morale and costs . Differences in nursing practice , in selected measures of patient well-being and in responses to the staff survey were positively associated with primary nursing . No differences emerged in relation to staff morale or costs . The benefits of primary nursing and implication s for further research are discussed This study is part of a project that aim ed to increase the participation of informal caregivers in the hospital care for elderly patients . The staff who worked in the wards that were studied created activity programmes for caregivers and changed their ward policies to encourage the participation of the caregivers . In addition , quality assurance programmes were developed and primary nursing was introduced to ensure individualized , need-based and family centered care . In order to explore the changes in perceived quality of care , and to test the differences in care quality between the study and the control wards ( i.e. two wards in a university hospital , two wards in a geriatric unit and two wards of a nursing home ) , the interrupted time series with a non-equivalent control group time series design was used . During periods of 2 months in 1991 , 1992 and 1993 the data were collected from elderly patients ( n = 97 ) and their informal caregivers ( n = 369 ) using a structured question naire based on need theories . The results indicated that the quality of care was improved , especially in the study wards of the university hospital and of the nursing home . This care quality measure was found to be a useful tool for getting feedback from patients and their caregivers concerning care given . Aspects of nursing practice that needed to be improved were identified ( i.e. poor communication between the patient , their caregiver and staff , and lack of support to the patient and caregiver by staff ) In a resident-oriented care model applied in nursing homes , the residents are assigned to primary nurses . These primary nurses are responsible for the total care of the residents assigned to them . The purpose of the present study , using a pretest , post-test and control group quasi-experimental design , was to evaluate the effects of the implementation of resident-oriented care on the following aspects of quality of care : coordination of care , instrumental aspects , expressive aspects , resident wellbeing and satisfaction with care , and family satisfaction with care . The study was carried out on somatic and psycho-geriatric wards in three nursing homes in the Netherl and s. Data were collected by question naires , interviews and observations . The results of the study showed that the intervention was partly successful in the experimental group . Some aspects of the resident-oriented care model were not clearly evident . Moreover , the effects on quality -of-care aspects were limited . The results revealed that the ' coordination of care ' increased on half of the experimental wards . Furthermore , there was an indication that ' expressive aspects ' changed in favour of the experimental wards . The implementation of resident-oriented care had no effect on resident wellbeing and satisfaction or on family satisfaction . Finally , the results are discussed in the light of some method ological limitations that often go together with intervention studies in the real world OBJECTIVES To determine the effects of a small-house nursing home model , THE GREEN HOUSE ( GH ) , on residents ' reported outcomes and quality of care . DESIGN Two-year longitudinal quasi-experimental study comparing GH residents with residents at two comparison sites using data collected at baseline and three follow-up intervals . SETTING Four 10-person GHs , the sponsoring nursing home for those GHs , and a traditional nursing home with the same owner . PARTICIPANTS All residents in the GHs ( 40 at any time ) at baseline and three 6-month follow-up intervals , and 40 r and omly selected residents in each of the two comparison groups . INTERVENTION The GH alters the physical scale environment ( small-scale , private rooms and bathrooms , residential kitchen , dining room , and hearth ) , the staffing model for professional and certified nursing assistants , and the philosophy of care . MEASUREMENTS Scales for 11 domains of resident quality of life , emotional well-being , satisfaction , self-reported health , and functional status were derived from interviews at four points in time . Quality of care was measured using indicators derived from Minimum Data Set assessment s. RESULTS Controlling for baseline characteristics ( age , sex , activities of daily living , date of admission , and proxy interview status ) , statistically significant differences in self-reported dimensions of quality of life favored the GHs over one or both comparison groups . The quality of care in the GHs at least equaled , and for change in functional status exceeded , the comparison nursing homes . CONCLUSION The GH is a promising model to improve quality of life for nursing home residents , with implication s for staff development and medical director roles CONTEXT Death is common in nursing homes , but access to palliative care is limited . OBJECTIVE To test whether a quality improvement ( QI ) intervention in nursing homes increases hospice , pain management , and advance care planning . DESIGN AND SETTING The QI intervention was tested in seven nursing homes using a prepost study design . Two additional nursing homes served as control sites . PARTICIPANTS Nine nursing homes serving 1169 residents . INTERVENTION The intervention included recruitment and training of Palliative Care Leadership Teams in each facility , followed by six technical assistance meetings for team members . Hospice providers delivered six educational sessions for all nursing home staff using a structured curriculum . Teams received feedback of performance data on hospice enrollment , pain management , and advance care planning at 0 , 3 , and 6 months . MAIN OUTCOME MEASURES Percentage of residents receiving hospice or palliative services , pain assessment , pain treatment among residents in pain , and documented advance care planning discussion s. RESULTS Intervention facilities increased hospice enrollment from 4.0 % of residents at baseline to 6.8 % postintervention ( p = .01 ) and increased pain assessment s from 18 % to 60 % ( p < .001 ) . Among resident in pain , orders for nonpharmacologic pain treatments increased from 15 % to 35 % ( p < .001 ) , but pain medication use did not change . Residents with in-depth discussion s about end-of-life care increased from 4 % to 17 % ( p < .001 ) . There were no significant changes in control sites . CONCLUSIONS A quality improvement intervention was effective in increasing hospice enrollment , pain assessment , nonpharmacologic pain treatment , and advance care planning discussion BACKGROUND In nursing homes there is a gradual move from traditional care to integrated care . Integrated care means a dem and -oriented , small-scale , co-operated and coordinated provision of services by different caregivers . This integration has direct effect on the work of these separate disciplines . With the introduction of integrated care the quality of work of these caregivers should be assured or even be improved . OBJECTIVES The purpose of this study was to examine the implementation of integrated care in the nursing home sector and its effects on the quality of work of the caregivers ( work content , communication and co-operation and worker 's outcomes ) . DESIGN A non-equivalent pre-test/post-test control group design was used in this study . SETTING S AND PARTICIPANTS Two nursing homes in the Netherl and s participated in the study . One nursing home provided the five experimental nursing wards and the other nursing home provided four control wards . METHOD Data were selected by means of written question naires . RESULTS The results showed that the intervention appeared to be only successful on the somatic wards . The caregivers of these wards were more able to create a home-like environment for their residents , to use a dem and -oriented working method and to integrate the provision of care and services . Regarding the effects of the intervention on quality of work factors , the results included an increase of social support by the supervisor , an increase of the degree of collaboration and a decrease in job dem and s. No changes were found for the worker 's outcomes such as job satisfaction . CONCLUSIONS The intervention on the psycho-somatic wards was unsuccessful . Although the introduction of integrated care on the somatic wards was successful , the effects on quality of work were limited . Next to quantitative research , more qualitative in-depth research is needed to examine models of integrated care and their effects on the work of caregivers within health care organisations , with special attention for specific characteristics of different types of nursing home care ( somatic vs. psycho-geriatric ) Several studies have examined the effectiveness of geriatric assessment teams in outpatient and acute care setting s. This project compared medical records of 69 consecutive nursing home patients r and omly assigned on arrival to team ( n = 33 ) and nonteam ( st and ard care , n = 36 ) conditions . Quality -of-care indices and healthcare service utilization were compared over a 12-month postadmission period . Team patients had a significantly greater number of diagnoses and ancillary services combined with nonsignificant trends toward decreased mortality , fewer emergency department visits , and fewer drugs prescribed . The team approach improves quality of care . Additional clinical studies evaluating the effectiveness of geriatric assessment teams should be made in other nursing homes OBJECTIVES To examine the effect of integrated emotion-oriented care on nursing home residents with dementia and nursing assistants . DESIGN A multi-site r and omized clinical trial with matched groups , and measurements at baseline and after seven months . SETTING Sixteen psychogeriatric wards in fourteen nursing homes in the Netherl and s. PARTICIPANTS One hundred and forty-six elderly residents with the diagnosis dementia of the Alzheimer ( DAT ) type , mixed DAT and vascular dementia , and dementia syndrome ( NAO ) and 99 nursing assistants . INTERVENTIONS Integrated emotion-oriented care and usual care . MESUREMENTS : Demented elderly : Behaviour and mood related to adaptation to the illness and the institutionalization . Nursing assistants : General health as measured by feelings of stress , stress reactions , feeling of competence and illness . RESULTS Positive effects in favour of the integrated emotion-oriented care were found in mild to moderately demented residents on two adaptive tasks : maintaining an emotional balance ( less anxiety ) and preserving a positive self-image ( less dissatisfaction ) . In the trained group of nursing assistants fewer stress reactions were found only in those who perceived improvement in their emotion-oriented care skills after training . CONCLUSION Emotion-oriented care is more effective with regard to the emotional adaptation in nursing homes of persons with a mild to moderate dementia . For the severely demented elderly we did not find this surplus value . This outcome is of clinical importance for elderly persons with dementia who are cared for in nursing homes . With respect to the nursing assistants it is concluded that emotion-oriented care has a positive influence on stress reactions in some of them OBJECTIVES --To assess the effect of preventive home visits by public health nurses on the state of health of and use of services by elderly people living at home . DESIGN --R and omised controlled trial . SETTING --General population of elderly people in one of the southern regions of the Netherl and s. SUBJECTS--580 subjects aged between 75 and 84 years r and omly allocated to intervention ( 292 ) or control ( 288 ) group . INTERVENTIONS --Four visits a year over three years in intervention group . Control group received no home visits . MAIN OUTCOME MEASURES --Self rated health , functional state , well being , loneliness , aspects of the mental state ( depressive complaints , memory disturbances ) , and mortality . Use of services and costs . RESULTS --Visits had no effect on the health of the subjects . In the group visited no higher scores were seen on health related measures , fewer died ( 42 ( 14 % ) v 50 ( 17 % ) ) , and community care increased slightly . In the control group more were referred to outpatient clinics ( 166 ( 66 % ) v 132 ( 55 % ) ) , and they had a 40 % increased risk of admission ( incidence rate ratio 1.4 ; 90 % confidence interval 1.2 to 1.6 ) . No differences were found in long term institutional care , and overall expenditure per person in the intervention group exceeded that in the control group by 4 % . Additional analyses showed that visits were effective for subjects who initially rated their health as poor . CONCLUSIONS --Preventive home visits are not beneficial for the general population of elderly people living at home but might be effective when restricted to subjects with poor health PURPOSE The purpose of this study was to describe the processes of care , organizational attributes , cost of care , staffing level , and staff mix in a sample of Missouri homes with good , average , and poor resident outcomes . DESIGN AND METHODS A three-group exploratory study design was used , with 92 nursing homes r and omly selected from all nursing homes in Missouri and classified into resident outcome groups . Resident outcomes were measured by use of quality indicators derived from nursing home Minimum Data Set resident assessment data . Cost and staffing information were derived from Medicaid cost reports . Participant observation methods were used to describe the care delivery processes . RESULTS In facilities with good resident outcomes , there are basics of care and processes surrounding each that staff consistently do : helping residents with ambulation , nutrition and hydration , and toileting and bowel regularity ; preventing skin breakdown ; and managing pain . The analysis revealed necessary organizational attributes that must be in place in order for those basics of care to be accomplished : consistent nursing and administrative leadership , the use of team and group processes , and an active quality improvement program . The only facility characteristic across the outcome groups that was significantly different was the number of licensed beds , with smaller facilities having better outcomes . No significant differences in costs , staffing , or staff mix were detected across the groups . A trend in higher total costs of 13.58 dollars per resident per day was detected in the poor- outcome group
Output:
| The primary -care model was found to provide slightly better results than the comparator for some outcomes such as resident well-being or behaviour .
Therefore , these studies should be regarded with caution and there is little clear evidence for the effective use of any specific model of care in residential aged care to benefit either residents or care staff . |
MS211564 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Objective To examine the risk of non-fatal idiopathic venous thromboembolism in current users of a combined oral contraceptive containing drospirenone , relative to current users of preparations containing levonorgestrel . Design Nested case-control study . Setting UK General Practice Research Data base . Participants Women aged 15 - 44 years without major risk factors for venous thromboembolism who started a new episode of use of an oral contraceptive containing 30 µg oestrogen in combination with either drospirenone or levonorgestrel between May 2002 and September 2009 . Cases were women with a first diagnosis of venous thromboembolism ; up to four controls , matched by age , duration of recorded information , and general practice , were r and omly selected for each case . Main outcome measures Odds ratios and 95 % confidence intervals estimated with conditional logistic regression ; age adjusted incidence rate ratio estimated with Poisson regression . Results 61 cases of idiopathic venous thromboembolism and 215 matched controls were identified . In the case-control analysis , current use of the drospirenone contraceptive was associated with a threefold higher risk of non-fatal idiopathic venous thromboembolism compared with levonorgestrel use ; the odds ratio adjusted for body mass index was 3.3 ( 95 % confidence interval 1.4 to 7.6 ) . Subanalyses suggested that referral , diagnostic , first time user , duration of use , and switching biases were unlikely explanations for this finding . The crude incidence rate was 23.0 ( 95 % confidence interval 13.4 to 36.9 ) per 100 000 woman years in current users of drospirenone and 9.1 ( 6.6 to 12.2 ) per 100 000 woman years in current users of levonorgestrel oral contraceptives . The age adjusted incidence rate ratio was 2.7 ( 1.5 to 4.7 ) . Conclusions These findings contribute to emerging evidence that the combined oral contraceptive containing drospirenone carries a higher risk of venous thromboembolism than do formulations containing levonorgestrel OBJECTIVE To determine the incidence of venous thromboembolism ( VTE ) , comprising deep vein thrombosis ( DVT ) and pulmonary embolism ( PE ) , in a well defined urban community broadly representative of the Australian population in terms of age , sex and ethnic distribution . DESIGN , SETTING AND PARTICIPANTS A prospect i ve , community-based study conducted over a 13-month period from 1 October 2003 to 31 October 2004 . People in a population of 151 923 permanent residents of north-eastern metropolitan Perth , Western Australia , who developed VTE during the study period were identified prospect ively and retrospectively through multiple overlapping sources . MAIN OUTCOME MEASURE Number of cases of symptomatic , objective ly verified DVT and PE . RESULTS 137 patients had 140 VTE events ( 87 DVT and 53 PE ) . The crude annual incidence per 1000 residents was 0.83 ( 95 % CI , 0.69 - 0.97 ) for VTE , 0.52 ( 95 % CI , 0.41 - 0.63 ) for DVT , and 0.31 ( 95 % CI , 0.22 - 0.40 ) for PE . The annual incidence per 1000 residents after age adjustment to the World Health Organization World St and ard Population was 0.57 ( 95 % CI , 0.47 - 0.67 ) for VTE , 0.35 ( 95 % CI , 0.26 - 0.44 ) for DVT , and 0.21 ( 95 % CI , 0.14 - 0.28 ) for PE . CONCLUSION If the crude annual incidence of VTE in this area of metropolitan Perth is externally valid , then VTE affects about 17 000 Australians annually . Future studies of trends in VTE incidence will be needed to measure the effectiveness of VTE prevention strategies OBJECTIVES The study was conducted to compare risks of adverse cardiovascular and other events associated with the use of drospirenone (DRSP)-containing oral contraceptives ( OCs ) and other OCs . METHODS AND MATERIAL S The European Active Surveillance study ( EURAS ) was a multinational , prospect i ve , noninterventional cohort study of new users of DRSP , levonorgestrel ( LNG ) and other progestin-containing OCs . Semiannual follow-up was based on mailed question naires , with additional follow-up procedures when needed . RESULTS Overall , 58,674 women were followed for 142,475 women-years of observation . Loss to follow-up was 2.4 % . Serious adverse and fatal events were rare , and rate ratios were close to unity ( 1.0 ) . Cox regression analysis of cardiovascular outcomes yielded hazard ratios for DRSP-containing vs. LNG-containing and other OCs of 1.0 and 0.8 ( upper 95 % confidence limits , 1.8 and 1.3 ) for venous , and 0.3 and 0.3 ( upper 95 % confidence limits , 1.2 and 1.5 ) for arterial thromboembolism , respectively . CONCLUSIONS Risks of adverse cardiovascular and other serious events in users of a DRSP-containing OC are similar to those associated with the use of other OCs OBJECTIVE To determine current contraceptive management by general practitioners in Australia . DESIGN , SETTING AND PARTICIPANTS Analysis of data from a r and om sample of 3910 Australian GPs who participated in the Bettering the Evaluation and Care of Health ( BEACH ) survey , a continuous cross-sectional survey of GP activity , between April 2007 and March 2011 . Consultations with female patients aged 12 - 54 years that involved all forms of contraception were analysed . MAIN OUTCOME MEASURES GP and patient characteristics associated with the management of contraception ; types of contraception used ; rates of encounters involving emergency contraception . RESULTS Increased age , ethnicity , Indigenous status and holding a Commonwealth Health Care Card were significantly associated with low rates of encounters involving management of contraception . The combined oral contraceptive pill was the most frequently prescribed method of contraception , with moderate prescription of long-acting reversible contraception ( LARC ) , especially among women aged 34 - 54 years . Rates of consultations concerned with emergency contraception were low , but involved high rates of counselling , advice or education ( 48 % ) compared with encounters for general contraception ( > 20 % ) . CONCLUSION A shift towards prescribing LARC , as recommended in clinical guidelines , has yet to occur in Australian general practice . Better underst and ing of patient and GP perspectives on contraceptive choices could lead to more effective contraceptive use OBJECTIVES The " International Active Surveillance Study of Women Taking Oral Contraceptives " investigated the risks of short- and long-term use of an extended 24-day regimen of drospirenone and ethinylestradiol ( DRSP24d ) compared to established oral contraceptives ( OCs ) in a routine clinical setting . STUDY DESIGN Prospect i ve , controlled , noninterventional cohort study conducted in the United States and six European countries with three main cohorts : new users of DRSP24d , DRSP21d ( 21-day regimens of DRSP-containing OCs ) , and non-DRSP ( OCs without DRSP ) . All self-reported clinical outcomes of interest ( OoI ) were vali date d via attending physicians and relevant source documents . Main OoI were serious clinical outcomes , in particular venous thromboembolism ( VTE ) . Comprehensive follow-up procedures were implemented . Statistical analyses were based on Cox regression models . Primary statistical variable was the VTE hazard ratio ( HR ) for DRSP24d vs. non-DRSP . RESULTS A total of 2285 study centers enrolled 85,109 women . Study participants were followed for 2 to 6 years , which generated 206,296 woman-years ( WY ) of observation . A low loss to follow-up of 3.3 % was achieved . DRSP24d , DRSP21d , non-DRSP and levonorgestrel-containing OCs ( LNG ) showed similar incidence rates of venous and arterial thromboembolism , fatal outcomes , cancer , severe depression and other serious adverse events . VTE incidence rates for DRSP24d , DRSP21d , non-DRSP and LNG were 7.2 , 9.4 , 9.6 and 9.8 VTE/10,000 WY , respectively . Adjusted HRs for DRSP24d vs. non-DRSP and DRSP24d vs. LNG were 0.8 [ 95 % confidence interval ( CI ) , 0.5 - 1.3 ] and 0.8 ( 95 % CI , 0.4 - 1.5 ) . CONCLUSION DRSP24d , DRSP21d , non-DRSP and LNG use was associated with similar risks of serious adverse events , and particularly VTE , during routine clinical use . IMPLICATION STATEMENT The 24-day regimen of drospirenone-containing combined OCs is associated with similar risks of venous and arterial thromboembolism , fatal outcomes , cancer , severe depression and other serious adverse events compared to 21-day regimens of drospirenone-containing combined OCs , OCs without drospirenone and LNGs
Output:
| DISCUSSION The difference in risk of VTE based on the choice of progestin in COCs is , at worst , very small in absolute terms and should not be the sole factor considered when choosing the ' right ' COC for each woman |
MS211565 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: A cross-sectional study to assess home glucose monitoring practice s was conducted in 200 non-insulin-treated diabetic patients consecutively attending our hospital clinic . Of the 200 , 97 ( 48 % ) patients ( Group 1 ) regularly monitored urine ( n = 74 ) , blood ( n = 19 ) or both ( n = 4 ) ; 103 ( 52 % ) patients ( Group 2 ) performed no home monitoring . The two groups were similar in terms of age , sex , duration of diabetes and type of treatment . The prevalence of diabetic complications was also closely comparable and only peripheral neuropathy differed between the groups , being more common in Group 1 ( n = 12 ) than Group 2 ( n = 4 ) ; p < 0.05 . There was also no significant difference between the HbA1 concentration ( mean + /- SD ) in Group 1 ( 9.7 + /- 2.2 % ) and Group 2 ( 9.4 + /- 2.0 % ) . The mean frequency of home monitoring was four tests weekly , but only 21 ( 22 % ) kept a written record and 60 ( 62 % ) would never alter their treatment on the basis of their results . Almost a third of patients could not interpret the results of monitoring or give the normal range of values . Home glucose monitoring , particularly of urine , is widely practised in Type 2 diabetes , at considerable overall expense . However , convincing evidence of its value in helping patients improve their blood glucose control or preventing the complications of the disease is lacking The goal of this study was to compare the relative efficacy and cost of self-monitoring of blood glucose ( SMBG ) with routine urine testing in the management of patients with type II ( non-insulin-dependent ) diabetes mellitus not treated with insulin . Fifty-four patients with type II diabetes mellitus , not treated with insulin , who had inadequate glucose control on diet aloneor diet and oral hypoglycemic agents were studied . Patients performed SMBG or urine glucose testing as part of a st and ardized treatment program that also included diet and exercise counseling . During the 6-mo study , both the urine-testing and SMBG groups showed similar improvement in glycemic control ; within each group , there were significant improvements in fasting plasma glucose ( reduction of 1.4 ± 3.2 mM , P < 0.03 ) and glycosylated hemoglobin ( reduction of 2.0 ± 3.4 % , P < 0.01 ) levels . Seventeen ( 31 % ) of54 patients actually normalized their glycosylated hemoglobin values , 9 in the urine-testing group and 8 in the SMBG group . Comparisons between the urine-testing and SMBG groups showed no significant differences in mean fasting plasma glucose ( P > 0.86 ) , glycosylated hemoglobin ( P > 0.95 ) , or weight ( P < 0.19 ) . In patients with type II diabetes mellitus not treated with insulin , SMBG is no more effective , but is 8–12 times more expensive , thanurine testing in facilitating improved glycemic control . Our results do not support widespread use of SMBG in diabetic patients not treated with insulin BACKGROUND Long-term microvascular and neurologic complications cause major morbidity and mortality in patients with insulin-dependent diabetes mellitus ( IDDM ) . We examined whether intensive treatment with the goal of maintaining blood glucose concentrations close to the normal range could decrease the frequency and severity of these complications . METHODS A total of 1441 patients with IDDM--726 with no retinopathy at base line ( the primary -prevention cohort ) and 715 with mild retinopathy ( the secondary -intervention cohort ) were r and omly assigned to intensive therapy administered either with an external insulin pump or by three or more daily insulin injections and guided by frequent blood glucose monitoring or to conventional therapy with one or two daily insulin injections . The patients were followed for a mean of 6.5 years , and the appearance and progression of retinopathy and other complications were assessed regularly . RESULTS In the primary -prevention cohort , intensive therapy reduced the adjusted mean risk for the development of retinopathy by 76 percent ( 95 percent confidence interval , 62 to 85 percent ) , as compared with conventional therapy . In the secondary -intervention cohort , intensive therapy slowed the progression of retinopathy by 54 percent ( 95 percent confidence interval , 39 to 66 percent ) and reduced the development of proliferative or severe nonproliferative retinopathy by 47 percent ( 95 percent confidence interval , 14 to 67 percent ) . In the two cohorts combined , intensive therapy reduced the occurrence of microalbuminuria ( urinary albumin excretion of > or = 40 mg per 24 hours ) by 39 percent ( 95 percent confidence interval , 21 to 52 percent ) , that of albuminuria ( urinary albumin excretion of > or = 300 mg per 24 hours ) by 54 percent ( 95 percent confidence interval 19 to 74 percent ) , and that of clinical neuropathy by 60 percent ( 95 percent confidence interval , 38 to 74 percent ) . The chief adverse event associated with intensive therapy was a two-to-threefold increase in severe hypoglycemia . CONCLUSIONS Intensive therapy effectively delays the onset and slows the progression of diabetic retinopathy , nephropathy , and neuropathy in patients with IDDM Most systematic review s rely substantially on the assessment of the method ological quality of the individual trials . The aim of this study was to obtain consensus among experts about a set of generic core items for quality assessment of r and omized clinical trials ( RCTs ) . The invited participants were experts in the field of quality assessment of RCTs . The initial item pool contained all items from existing criteria lists . Subsequently , we reduced the number of items by using the Delphi consensus technique . Each Delphi round comprised a question naire , an analysis , and a feedback report . The feedback report included staff team decisions made on the basis of the analysis and their justification . A total of 33 international experts agreed to participate , of whom 21 completed all question naires . The initial item pool of 206 items was reduced to 9 items in three Delphi rounds . The final criteria list ( the Delphi list ) was satisfactory to all participants . It is a starting point on the way to a minimum reference st and ard for RCTs on many different research topics . This list is not intended to replace , but rather to be used alongside , existing criteria lists Abstract Objective : To determine the relation between exposure to glycaemia over time and the risk of macrovascular or microvascular complications in patients with type 2 diabetes . Design : Prospect i ve observational study . Setting : 23 hospital based clinics in Engl and , Scotl and , and Northern Irel and . Participants : 4585 white , Asian Indian , and Afro-Caribbean UKPDS patients , whether r and omised or not to treatment , were included in analyses of incidence ; of these , 3642 were included in analyses of relative risk . Outcome measures : Primary predefined aggregate clinical outcomes : any end point or deaths related to diabetes and all cause mortality . Secondary aggregate outcomes : myocardial infa rct ion , stroke , amputation ( including death from peripheral vascular disease ) , and microvascular disease ( predominantly retinal photo-coagulation ) . Single end points : non-fatal heart failure and cataract extraction . Risk reduction associated with a 1 % reduction in up date d mean HbA1c adjusted for possible confounders at diagnosis of diabetes . Results : The incidence of clinical complications was significantly associated with glycaemia . Each 1 % reduction in up date d mean HbA1c was associated with reductions in risk of 21 % for any end point related to diabetes ( 95 % confidence interval 17 % to 24 % , P<0.0001 ) , 21 % for deaths related to diabetes ( 15 % to 27 % , P<0.0001 ) , 14 % for myocardial infa rct ion ( 8 % to 21 % , P<0.0001 ) , and 37 % for microvascular complications ( 33 % to 41 % , P<0.0001 ) . No threshold of risk was observed for any end point . Conclusions : In patients with type 2 diabetes the risk of diabetic complications was strongly associated with previous hyperglycaemia . Any reduction in HbA1c is likely to reduce the risk of complications , with the lowest risk being in those with HbA1c values in the normal range ( < 6.0 % ) To study if self-monitoring of glucose , urinary or capillary , could help them to improve their metabolic control through better compliance to diet and /or hypoglycaemic agents , 208 non-insulin-treated poorly controlled diabetic patients were r and omized to : group A -- regular HbA1c determinations but no self-monitoring , group B -- self-urine glucose monitoring , twice every other day , group C -- self blood glucose monitoring , twice every other day , and followed six months . At the end of the study period , the decrease of HbA1c over six months -- main endpoint -- was not significantly different between the three groups ( mean + /- SEM ; group A : -0.5 + /- 0.2 % ; group B : -0.1 + /- 0.3 % ; group C : -0.4 + /- 0.3 % ) . However , the degree of compliance to blood glucose self-monitoring in group C appeared to relate to the outcome : a significant correlation was found between the number of blood glucose strips used and the decrease of HbA1c ( r = .36 , p less than .02 ) . We conclude that regular self-monitoring has no definite advantage over the usual management for improving metabolic control in non-insulin-treated diabetic patients , though it may possibly help patients ready to comply with its use The Diabetes Control and Complications Trial ( DCCT ) provided much information towards settling the long-running controversy about the effectiveness of improving control of diabetes on the risk of its major complications . With the appearance or the advance of clinical ly significant retinopathy as its major outcome variable , DCCT r and omised 1,441 insulin-dependent diabetic patients to conventional or intensified control groups . In both primary prevention and secondary intervention arms of the trial , intensified control reduced retinopathy risk by half or more , and also reduced nephropathy and neuropathy risks -- however , risk of severe hypoglycaemic episodes was increased about three-fold . By contrast , there were no differences in quality of life , neurocognitive or emotional assessment s between the two groups . The application of trial findings to ' real life ' care is considered The purpose of the study was to determine whether blood glucose monitoring strips influence the management of patients with non-insulin dependent diabetes ( NIDDM ) in the primary care setting . The medical records of 115 patients with NIDDM taking a sulfonylurea drug ( oral hypoglycemic agent ) during the review period were r and omly selected for review . Patients were divided into two groups : those who did not receive a prescription for blood glucose monitoring strips during 1995 and 1996 and those who did for the same 2 years . The main outcome measures were hemoglobin A1c , blood sugar , number of laboratory tests ordered , and number and type of treatment interventions . No statistically significant differences between groups were noted for any measured parameter . Glucose control was independent of number of strips dispensed . Home glucose monitoring strips did not affect the management of patients with NIDDM taking a sulfonylurea agent in the primary care setting
Output:
| It has been suggested that patients with type 2 diabetes who are not using insulin might also benefit from SMBG ( 13 ) .
These patients might cope more independently with their disease when using SMBG , and they might achieve a better underst and ing about the factors that affect their disease and potentially a better perceived quality of life .
SMBG might also improve adherence to pharmacological treatment and motivate patients to make appropriate lifestyle changes ( 10,14 ) .
Other outcome measures like quality of life |
MS211566 | ***TASK*** the task is to summarize an input biomedical literature 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 assess the diagnostic accuracy of fused T2-weighted and high-b-value diffusion-weighted ( DW ) magnetic resonance ( MR ) images at 3 T for evaluation of myometrial invasion in patients with endometrial cancer . MATERIAL S AND METHODS Institutional review board approval and informed consent were obtained . From May 2006 to October 2007 , 48 consecutive patients aged 25 - 80 years ( mean age , 57 years ) who had endometrial cancer were prospect ively enrolled for preoperative evaluation by using a 3-T MR unit . Two radiologists interpreted the depth of myometrial invasion on T2-weighted images , dynamic contrast material -enhanced MR images , and fused T2-weighted and DW MR images ( b = 1000 sec/mm(2 ) ) . Statistical methods included kappa statistics for reader agreement , Pearson analysis for pathologic correlation , accuracy assessment , and receiver operating characteristic analysis for diagnostic performance comparison . Surgical pathologic findings were the reference st and ard . RESULTS Reader agreement was excellent for fused T2-weighted and DW images ( weighted kappa , 0.79 ) , with a significant pathologic correlation regarding the depth of myometrial invasion ( r = 0.94 , P < .0001 ) . For assessing any myometrial involvement , addition of fused T2-weighted and DW imaging to dynamic contrast-enhanced or dynamic contrast-enhanced and T2-weighted imaging was significantly better compared with dynamic contrast-enhanced imaging alone ( P < .001 ) or dynamic contrast-enhanced and T2-weighted ( P = .001 ) imaging ; T2-weighted imaging combined with fused T2-weighted and DW imaging also was better than dynamic contrast-enhanced and T2-weighted imaging ( P = .001 ) . Tumor apparent diffusion coefficients were 0.60 - 1.32 x 10(-3 ) mm(2)/sec ( median , 0.75 x 10(-3 ) mm(2)/sec ) , with no significant correlation with the depth of myometrial invasion ( P = .31 , r = -0.15 ) . CONCLUSION Fused T2-weighted and high-b-value DW images at 3 T can provide accurate information for preoperative evaluation of myometrial invasion Abstract Objectives To prospect ively assess the efficacy of 3-T magnetic resonance ( MR ) imaging using the three-dimensional turbo spin-echo T2-weighted and diffusion-weighted technique ( 3D-TSE/DW ) compared with that of conventional imaging using the two-dimensional turbo spin-echo T2-weighted and dynamic contrast-enhanced technique ( 2D-TSE/DCE ) for the preoperative staging of endometrial cancer , with pathological analysis as the reference st and ard . Methods Seventy-one women with endometrial cancer underwent MR imaging using 3D-TSE/DW ( b = 1,000 s/mm2 ) and 2D-TSE/DCE . Two radiologists independently assessed the two imaging sets . Accuracy , sensitivity , and specificity for staging were analysed with the McNemar test ; the areas under the receiver operating characteristic curve ( Az ) were compared with a univariate z-score test . Results The results for assessing deep myometrial invasion , accuracy , sensitivity , specificity and Az , respectively , were as follows : 3D-TSE/DW — observer 1 , 87 % , 95 % , 85 % and 0.96 ; observer 2 , 92 % , 84 % , 94 % and 0.95 ; 2D-TSE/DCE — observer 1 , 80 % , 79 % , 81 % and 0.89 ; observer 2 , 86 % , 84 % , 87 % and 0.86 . Most of the values were higher with 3D-TSE/DW without significant differences ( P > 0.12 ) . For assessing cervical stromal invasion , there were no significant differences in those values for both observers ( P > 0.6 ) . Conclusions Accuracy of 3D-TSE/DW was at least equivalent to that of the conventional technique for the preoperative assessment of endometrial cancer . Key Points• New techniques in MR imaging help assess patients with endometrial cancer . • A 3D T2-weighted TSE sequence seems equally as accurate as conventional techniques . • Three-dimensional TSE/DW imaging does not require intravenous contrast material and is relatively quick . • Tumour extent of endometrial cancer can be clearly shown on diffusion-weighted images . • Junctional zone can be visualised well on 3D-TSE T2-weighted images Objective To determine the diagnostic accuracy of diffusion-weighted ( DW ) magnetic resonance ( MR ) imaging in the preoperative assessment of myometrial invasion by endometrial cancer . Material s and methods In this prospect i ve study , 47 patients with histologically confirmed endometrial cancer underwent preoperative MR imaging and total hysterectomy . The MR protocol included spin-echo multishot T2-weighted , dynamic T1-weighted and DW images acquired with b-values of 0 and 500 s/mm2 . Myometrial tumour spread was classified as superficial ( < 50 % ) or deep ( ≥50 % myometrial thickness ) . Postoperative histopathological findings served as a reference st and ard . Indices of diagnostic performance were assessed for each sequence . Results At histopathological examination , superficial myometrial invasion was found in 34 patients and deep myometrial invasion in 13 . In the assessment of tumour invasion , sensitivity , specificity , positive and negative predictive values of T2-weighted images were 92.3 % , 76.5 % , 60.0 % and 96.3 % , respectively . The corresponding values for dynamic images were 69.2 % , 61.8 % , 40.9 % and 84.0 % , and for DW images 84.6 % , 70.6 % , 52.4 % and 92.3 % . T2-weighted and DW imaging proved to be the most accurate techniques for tumour spread determination . Conclusion DW imaging proved to be accurate in assessing myometrial invasion , and it could replace dynamic imaging as an adjunct to routine T2-weighted imaging for preoperative evaluation of endometrial cancer PURPOSE To prospect ively assess the usefulness of diffusion-weighted magnetic resonance imaging ( MRI ) with background body signal suppression ( DWIBS ) at 3 T for the preoperative evaluation of endometrial cancer . MATERIAL S AND METHODS Fifty-two consecutive patients with biopsy-proven endometrial cancer were examined with a 3 T MR scanner , followed by a hysterectomy . MR examinations included T2-weighted ( T2WI ) , DWIBS , and dynamic contrast-enhanced T1-weighted imaging ( DCEI ) . The apparent diffusion coefficient ( ADC ) was calculated in the tumor and normal myometrium . According to tumor grade , the mean ADC of the tumor was analyzed . The depth of myometrial invasion was independently assessed by two radiologists for three MRI data sets on a five-point scale . RESULTS The mean ADC of the tumors was significantly lower than that of normal myometrium ( P < 0.001 ) . The mean ADC of grade s 2 or 3 was significantly lower than grade 1 ( P < 0.01 ) . For predicting myometrial invasion , the specificity , accuracy , and area under the curve of combined T2WI and DWIBS in both readers were similar to DCEI ( P > 0.05 ) . Interreader agreement in all MRI data sets was excellent . CONCLUSION DWIBS at 3 T has potential for being an effective method for the preoperative evaluation of endometrial cancer A prospect i ve study was undertaken to assess the value of both T2-weighted spin-echo ( SE ) and contrast-enhanced dynamic gradient-echo ( GRE ) sequences using MR imaging in differentiating the deep myometrial invasion from lower stages produced by endometrial carcinoma . For the correlation of MR findings with the histopathologic findings , patients who had no myometrial invasion ( stage 1 a ) and patients in whom tumors were confined to the superficial myometrium ( stage 1 b ) at pathologic examination were combined as lower stages . Twenty patients with endometrial carcinoma were studied using both techniques . The absence of any detectable tumor ( stage 1 a ) or the presence of a tumor confined to inner half of myometrium ( stage 1 b ) and extention of tumor to the outer half of myometrium ( stage 1 c ) were used as the diagnostic criteria . In pathologic examination of excised specimens , deep myometrial invasion was detected in 9 of 20 patients . The sensitivity , specificity , accuracy , positive predictive values ( PPV ) and negative predictive values ( NPV ) of T2-weighted SE in differentiating deep myometrial invasion from combined lower stages were 88 , 91 , 90 , 88 , and 91 % , respectively , whereas corresponding values for contrast-enhanced dynamic GRE sequences were 78 , 100 , 90 , 100 , and 85 % . Statistical difference between two sequences did not reach a significant level . We conclude that in cases of absence of visible junctional zone with SE sequence , contrast-enhanced dynamic GRE MR imaging may be helpful BACKGROUND Despite their low risk for recurrence , many women with endometrial adenocarcinoma receive postoperative radiation therapy ( RT ) . This study was developed to determine if adjunctive external beam irradiation lowers the risk of recurrence and death in women with endometrial cancer International Federation of Gynaecology and Obstetrics ( FIGO ) stages IB , IC , and II ( occult disease ) . METHODS Four hundred forty-eight consenting patients with " intermediate risk " endometrial adenocarcinoma were r and omized after surgery to either no additional therapy ( NAT ) or whole pelvic radiation therapy ( RT ) . They were followed to determine toxicity , date and location of recurrence , and overall survival . A high intermediate risk ( HIR ) subgroup of patients was defined as those with ( 1 ) moderate to poorly differentiated tumor , presence of lymphovascular invasion , and outer third myometrial invasion ; ( 2 ) age 50 or greater with any two risk factors listed above ; or ( 3 ) age of at least 70 with any risk factor listed above . All other eligible participants were considered to be in a low intermediate risk ( LIR ) subgroup . RESULTS Three hundred ninety-two women met all eligibility requirements ( 202 NAT , 190 RT ) . Median follow-up was 69 months . In the entire study population , there were 44 recurrences and 66 deaths ( 32 disease or treatment-related deaths ) , and the estimated 2-year cumulative incidence of recurrence ( CIR ) was 12 % in the NAT arm and 3 % in the RT arm ( relative hazard ( RH ) : 0.42 ; P=0.007 ) . The treatment difference was particularly evident among the HIR subgroup ( 2-year CIR in NAT versus RT : 26 % versus 6 % ; RH=0.42 ) . Overall , radiation had a substantial impact on pelvic and vaginal recurrences ( 18 in NAT and 3 in RT ) . The estimated 4-year survival was 86 % in the NAT arm and 92 % for the RT arm , not significantly different ( RH : 0.86 ; P=0.557 ) . CONCLUSIONS Adjunctive RT in early stage intermediate risk endometrial carcinoma decreases the risk of recurrence , but should be limited to patients whose risk factors fit a high intermediate risk definition BACKGROUND Pelvic lymph nodes are the most common site of extrauterine tumor spread in early-stage endometrial cancer , but the clinical impact of lymphadenectomy has not been addressed in r and omized studies . We conducted a r and omized clinical trial to determine whether the addition of pelvic systematic lymphadenectomy to st and ard hysterectomy with bilateral salpingo-oophorectomy improves overall and disease-free survival . METHODS From October 1 , 1996 , through March 31 , 2006 , 514 eligible patients with preoperative International Federation of Gynecology and Obstetrics stage I endometrial carcinoma were r and omly assigned to undergo pelvic systematic lymphadenectomy ( n = 264 ) or no lymphadenectomy ( n = 250 ) . Patients ' clinical data , pathological tumor characteristics , and operative and early postoperative data were recorded at discharge from hospital . Late postoperative complications , adjuvant therapy , and follow-up data were collected 6 months after surgery . Survival was analyzed by use of the log-rank test and a Cox multivariable regression analysis . All statistical tests were two-sided . RESULTS The median number of lymph nodes removed was 30 ( interquartile range = 22 - 42 ) in the pelvic systematic lymphadenectomy arm and 0 ( interquartile range = 0 - 0 ) in the no-lymphadenectomy arm ( P < .001 ) . Both early and late postoperative complications occurred statistically significantly more frequently in patients who had received pelvic systematic lymphadenectomy ( 81 patients in the lymphadenectomy arm and 34 patients in the no-lymphadenectomy arm , P = .001 ) . Pelvic systematic lymphadenectomy improved surgical staging as statistically significantly more patients with lymph node metastases were found in the lymphadenectomy arm than in the no-lymphadenectomy arm ( 13.3 % vs 3.2 % , difference = 10.1 % , 95 % confidence interval [ CI ] = 5.3 % to 14.9 % , P < .001 )
Output:
| Conclusion DWI has high sensitivity and specificity for detecting deep myometrial invasion and more importantly can reliably rule out deep myometrial invasion .
Therefore , it would be worthwhile to add a DWI sequence to the st and ard MRI protocol s in preoperative evaluation of endometrial cancer in order to detect deep myometrial invasion , which along with other poor prognostic factors like age , tumor grade , and LVSI would be useful in stratifying high risk groups thereby helping in the tailoring of surgical approach in patient with low risk of endometrial carcinoma |
MS211567 | ***TASK*** the task is to summarize an input biomedical literature 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 construction of an autogenous radial-cephalic direct wrist arteriovenous fistula ( RCAVF ) is the primary and best option for vascular access for hemodialysis . However , 10%-24 % of RCAVFs thrombose directly after operation or do not function adequately due to failure of maturation . In case of poor arterial and /or poor venous vessels for anastomosis , the outcome of RCAVFs may be worse and an alternative vascular access is probably indicated . A prosthetic graft implant may be a second best option . Therefore , a r and omized multicenter study comparing RCAVF with prosthetic ( polytetrafluoroethylene [ PTFE ] ) graft implantation in patients with poor vessels was performed . METHODS A total of 383 consecutive new patients needing primary vascular access were screened for enrollment in a prospect i ve r and omized study . According to defined vessel criteria from the preoperative duplex scanning , 140 patients were allocated to primary placement of an RCAVF and 61 patients to primary prosthetic graft implantation . The remaining 182 patients were r and omized to receive either an RCAVF ( n = 92 ) or prosthetic graft implant ( n = 90 ) . Patency rate was defined as the percentage of AVFs that functioned well after implantation . RESULTS Primary and assisted primary 1-year patencies were 33 % + /- 5.3 % vs 44 % + /- 6.2 % ( P = .03 ) and 48 % + /- 5.5 % vs 63 % + /- 5.9 % ( P = .035 ) for the RCAVF and prosthetic AVF , respectively . Secondary patencies were 52 % + /- 5.5 % vs 79 % + /- 5.1 % ( P = .0001 ) for the RCAVF and prosthetic AVF , respectively . Patients with RCAVFs developed a total of 102 ( 1.19/patient-year [ py ] ) vs 122 ( 1.45/py ; P = .739 ) complications in the prosthetic AVFs . A total of 43 ( 0.50/py ) interventions in the RCAVF group and 79 ( 0.94/py ) in the prosthetic graft group were needed for access salvage ( P = .077 ) . CONCLUSIONS Although there were more interventions needed for access salvage in the patients with prosthetic graft implants , we may conclude that patients with poor forearm vessels do benefit from implantation of a prosthetic graft for vascular access OBJECTIVE To compare the patency of autologous and graft-bridging ( prosthetic ) arteriovenous ( AV ) fistulas in patients 70 years of age or more . DESIGN Non-r and omised comparative study . SETTING University hospital , Greece . PATIENTS 114 patients aged 70 years or more ( mean 78 ) who required 135 consecutive angioaccess procedures during the 8-year period January 1990-December 1997 . INTERVENTIONS 68 autologous and 67 prosthetic procedures , 64 of the prosthetic procedures being proximal brachioaxillary AV arm grafts . MAIN OUTCOME MEASURES Primary and secondary cumulative patency rates and cumulative survival . RESULTS Life table analysis showed that the 3-year secondary patency ( medium term patency ) was significantly superior in the prosthetic group ( 58 % compared with 44 % , p = 0.04 ) . Cumulative survival at 3-years was 21 % . CONCLUSIONS A proximal brachioaxillary prosthetic AV graft is a good alternative as initial primary access in elderly patients who are not suitable for an autologous proximal AV fistula . At this age long term patency and conservation of proximal access sites are of minimum importance because of their limited life expectancy BACKGROUND Vascular access is a necessity for patients with end-stage renal disease who need chronic intermittent hemodialysis . According to Kidney Disease Outcomes Quality Initiative ( KDOQI ) guidelines , radial-cephalic ( RC ) and brachial-cephalic ( BC ) arteriovenous fistulas ( AVF ) are the first and second choice for vascular access , respectively . If these options are not possible , an autogenous brachial-basilic fistula in the upper arm ( BBAVF ) or a prosthetic brachial-antecubital forearm loop ( PTFE loop ) may be considered . Until now , it was not clear which access type was preferable . We have performed a r and omized study comparing BBAVF and prosthetic implantation in patients without the possibility for RCAVF or BCAVF . METHODS Patients with failed primary / secondary access or inadequate arterial and /or venous vessels were r and omized for either BBAVF or PTFE loop creation . The numbers of complications and interventions were recorded . Kaplan-Meier method was used to calculate primary , assisted- primary and secondary patency rates . The patency rates were compared with the log-rank test . Complication and intervention rates were compared with the Mann-Whitney test . RESULTS A total of 105 patients were r and omized for a BBAVF or PTFE loop ( 52 vs 53 , respectively ) . Primary and assisted- primary 1-year patency rates were significantly higher in the BBAVF group : 46 % + /- 7.4 % vs 22 % + /- 6.1 % ( P = .005 ) and 87 % + /- 5.0 % vs 71 % + /- 6.7 % ( P = .045 ) for the BBAVF and PTFE group , respectively . Secondary patencies were comparable for both groups ; 89 % + /- 4.6 % vs 85 % + /- 5.2 % for the BBAVF and PTFE group , respectively . The incidence rate of complications was 1.6 per patient-year in the BBAVF group vs 2.7 per patient-year in the PTFE group . Patients in the BBAVF group needed a total of 1.7 interventions per patient-year vs 2.7 per patient-year for the PTFE group . CONCLUSION These data show a significantly better primary and assisted- primary patency in the BBAVF group compared with the PTFE group . Furthermore , in the BBAVF group , fewer interventions were needed . Therefore , we conclude that BBAVF is the preferred choice for vascular access if RCAVF or BCAVF creation is impossible , or when these types of access have already failed The increased incidence of vascular access thrombosis ( VAT ) associated with recombinant human erythropoietin ( r-HuEPO ) therapy is multifactorial and controversial . Sixty-three hemodialysis patients who received > or = 12 weeks of r-HuEPO therapy were prospect ively followed for the incidence of VAT . Those who experienced VAT ( Group 1 ) were compared with those who did not ( Group 2 ) . The patients initially received r-HuEPO 50 U/kg intravenously three times a week . The dose was adjusted for a target hematocrit ( t-Hct ) of 30 - 33 % . Twenty-five of the 63 patients ( 40 % ) experienced VAT ( Group 1 ) . These patients were older ( mean , 54.0 + /- 14.0 years versus 47.3 + /- 15.0 years , p = 0.08 ) . There was no difference between Groups 1 and 2 with respect to the baseline Hct level ( 21.5 + /- 2.9 % versus 21.4 + /- 4.3 % ) , the number of patients who achieved t-Hct ( 20 versus 28 ) , and the mean time to reach t-Hct ( 18.6 + /- 15.1 weeks versus 16.9 + /- 16.2 weeks ) . However , 20 of 25 Group 1 patients ( 80 % ) were diabetic compared with only 18 of 38 Group 2 patients ( 47 % , p = 0.0169 , by Fisher 's exact test ) . In addition , the types of vascular access differed markedly between the two groups : arteriovenous ( AV ) grafts/AV fistulae/Permcaths , Group 1 : 21/3/1 versus Group 2 : 15/21/2 , p = 0.0018 . It was concluded that the occurrence of VAT in r-HuEPO treated patients was not related to the patient 's hematologic response to the drug , but rather , it depended upon the integrity of the patient 's vasculature and the type of vascular access used The native arteriovenous fistula ( AVF ) is the preferred vascular access because of its longevity and its lower rates of infection and intervention . Recent studies suggest that the AVF may offer a survival advantage . Because these data were derived from observational studies , they are prone to potential bias . The use of propensity scores offers an additional method to reduce bias result ing from nonr and omized treatment assignment . Adult ( age 18 yr or more ) patients who commenced hemodialysis in Australia and New Zeal and on April 1 , 1999 , until March 31 , 2002 , were studied by using the Australian and New Zeal and Dialysis and Transplant Association ( ANZ DATA ) Registry . Cox regression was used to determine the effect of access type on total mortality . Propensity scores were calculated and used both as a controlling variable in the multivariable model and to construct matched cohorts . The catheter analysis was stratified by dialysis duration at entry to ANZ DATA to satisfy the proportional-hazard assumption . There were 612 deaths in 3749 patients ( median follow-up , 1.07 yr ) . After adjustment for confounding factors and propensity scores , catheter use was predictive of mortality . Patients with arteriovenous grafts ( AVG ) also had a significantly increased risk of death . Effect estimates were also consistent in the smaller propensity score-matched cohorts . Both AVG and catheter use in incident hemodialysis patients are associated with significant excess of total mortality . Reducing catheter use and increasing the proportion of patients commencing hemodialysis with a mature AVF remain important clinical objectives BACKGROUND H and ischemia result ing from arterial steal is a serious complication in patients undergoing hemodialysis access , but specific risk factors for steal remain in dispute . The purpose of this study was to determine whether plethysmographically derived finger pressures ( FPs ) or digital-brachial indices ( DBIs ) are predictive of symptomatic arterial steal . METHODS We prospect ively studied 72 patients ( 37 men , 35 women ; mean age , 57 + /- 10 years ) who were undergoing brachial artery-based hemodialysis access . All patients had complete pre- and postoperative h and examinations and FP determinations . Surgeons were blinded to preoperative FP results . RESULTS Prosthetic graft was used in 60 patients ( 6-mm polytetrafluoroethylene [ PTFE ] in 50 , tapered PTFE in 10 ) , and brachial-based arteriovenous fistulas were created in 12 . Fourteen ( 19 % ) patients developed arterial steal symptoms . The mean preoperative FP was significantly lower in steal patients than in those without steal ( 131 + /- 27 vs 151 + /- 31 mm Hg , P < .03 ) . Nine ( 64 % ) of the patients with steal had DBIs < 1.0 , compared to 18 ( 31 % ) of the patients without steal ( P = .02 ) . However , there was no absolute FP or DBI threshold below which steal was inevitable . The occurrence of steal was attributed to proximal arterial stenoses in seven , to distal arterial disease in five , and was unknown in two . When comparing the 14 patients who developed steal to the 58 who did not , we noted that a higher proportion of steal patients had coronary artery disease ( 57 % vs 17 % , P = .005 ) . Steal was more likely to develop in patients with arteriovenous fistulas than in patients with prosthetic grafts ( 43 % vs 14 % , P = .009 ) . There were no significant differences in demographic factors , atherosclerotic risks ( diabetes , smoking , hypertension , dyslipidemia ) , prevalence of peripheral vascular disease , cerebrovascular disease , shunt location , tapered vs straight graft , or number of prior grafts placed . CONCLUSIONS These data indicate that preoperative FPs are lower in patients who develop steal syndrome after hemodialysis access . Patients with preoperative DBIs < 1.0 are more likely to develop steal , but there is no DBI threshold below which steal is inevitable . Steal is more likely in patients undergoing brachial-based arteriovenous fistulas than in those receiving prosthetic grafts OBJECTIVES To compare patency and complication rates of polytetrafluoroethylene ( PTFE ) grafts and denatured homologous vein ( DHV ) grafts for long-term haemodialysis . DESIGN A prospect i ve r and omised multicentre trial . MATERIAL S One hundred and thirty-one patients were enrolled between September 1994 and April 1997 . Sixty-three DHV grafts and 68 PTFE grafts were implanted in 60 meals and 71 females . Complications and interventions were monitored . Patency rates , complication rates , and intervention rates of PTFE and DHV were compared .
Output:
| Low- quality evidence from inconsistent studies with limited protection against bias shows that autogenous access for chronic hemodialysis is superior to prosthetic access |
MS211568 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Objective : This study examined the role of demographic characteristics , psychological factors , and family functioning on attendance in a r and omized controlled trial of a family-based pediatric obesity program . Method : Participants included 155 children between the ages of 4 and 7 years ( M age = 5.77 , 57.4 % female , 73.6 % black , M body mass index = 25.5 ) and their primary caregivers who were r and omized to the treatment group . Three groups of participants were created based on their patterns of attendance during the program : ( 1 ) noncompleters , ( 2 ) partial completers , and ( 3 ) completers . Results : Results indicated no differences among the attendance groups in child gender , child body mass index , or child psychological functioning . Significant group differences were found with respect to race/ethnicity , parent marital status , and family income , such that noncompleters were more likely to be racial/ethnic minorities , to living in single parent households , and to have lower incomes than partial completers and completers . After controlling for the effects of these sociodemographic risk factors , noncompleters , and partial completers reported more family dysfunction characterized by high levels of disengagement than completers . Conclusion : Adapting existing weight management programs to include a focus on family engagement in the early stages of treatment may help to improve participation in family-based obesity interventions targeting high risk , socioeconomically disadvantaged youth OBJECTIVE To assess height growth over 10 years in children treated for obesity . DESIGN Longitudinal , prospect i ve follow-up of a series of r and omized , controlled weight control trials . SETTING Specialized pediatric weight control clinic . PARTICIPANTS One hundred fifty-eight 6- to 12-year-old obese children who were followed up for 10 years after treatment . INTERVENTIONS Family-based behavioral weight control . MEASUREMENTS /MAIN RESULTS At entry the height percentiles of the obese children were significantly higher ( 71.6 percentile ) than same-sex parent ( 52.0 percentile ) or midparent ( 51.5 percentile ) height ( an estimate of parental contribution to height ) . After an average growth of 22.7 cm , children were 2.2 cm taller than their same-sex parent and decreased to an average height percentile of 57.8 . Multiple regression analysis showed that child sex , age , baseline height and percent overweight , midparent height , and height change of the child from baseline to 5 years accounted for 94 % of the variance in growth . Child percent overweight change made no contribution to predicting height change . Comparison between children obese and nonobese at 10 years showed no differences in growth . CONCLUSIONS Moderate energy restriction with dietary guidance by overweight children did not negatively influence long-term growth Background Recruitment to trials evaluating the effectiveness of childhood obesity management interventions is challenging . We report our experience of recruitment to the Families for Health study , a r and omised controlled trial evaluating the effectiveness of a family-based community programme for children aged 6–11 years , versus usual care . We evaluated the effectiveness of active recruitment ( contacting eligible families directly ) versus passive recruitment ( informing the community through flyers , public events , media ) . Methods Initial approaches included passive recruitment via the media ( newspapers and radio ) and two active recruitment methods : National Child Measurement Programme ( letters to families with overweight children ) and referrals from health-care professionals . With slow initial recruitment , further strategies were employed , including active ( e.g. targeted letters from general practice s ) and passive ( e.g. flyers , posters and public events ) methods . At first enquiry from a potential participant , families were asked where they heard about the study . Further quantitative ( question naire ) and qualitative data ( one-to-one interviews with parents/carers ) , were collected from recruited families at baseline and 3-month follow-up and included questions about recruitment . Results In total , 194 families enquired about Families for Health , and 115 ( 59.3 % ) were recruited and r and omised . Active recruitment yielded 85 enquiries , with 43 families recruited ( 50.6 % ) ; passive recruitment yielded 99 enquiries with 72 families recruited ( 72.7 % ) . Information seen at schools or GP surgeries accounted for over a quarter of enquiries ( 28.4 % ) and over a third ( 37.4 % ) of final recruitment . Eight out of ten families who enquired this way were recruited . Media-led enquiries were low ( 5 % ) , but all were recruited . Children of families recruited actively were more likely to be Asian or mixed race . Despite extensive recruitment methods , the trial did not recruit as planned , and was awarded a no-cost extension to complete the 12-month follow-up . Conclusions The higher number of participants recruited through passive methods may be due to the large number of potential participants these methods reached and because participants may see the information more than once . Recruiting to a child obesity treatment study is complex and it is advisable to use multiple recruitment strategies , some aim ing at blanket coverage and some targeted at families with children who are overweight . Trial registration Current Controlled Trials IS RCT N45032201 ( Date : 18 August 2011 INTRODUCTION The present study describes a r and omised controlled trial ( RCT ) based on a novel , generalisable intervention for childhood obesity , comparing the intervention with a no-treatment control group . METHOD The Malaysian Childhood Obesity Treatment Trial ( MASCOT ) was a single-blind RCT of a dietetic treatment for childhood obesity in children of primary school age ( 7 to 11 years old ) in Kuala Lumpur , Malaysia . The MASCOT comprising eight sessions , of an 8-hour family-centred group treatment programme is described , based on behavioural change techniques . The study sample was characterised by BMI z-score , health related quality of life reported by participants and their parents ( PedsQL question naire ) , objective ly measured habitual physical activity and sedentary behaviour ( Actigraph accelerometry ) RESULTS The MASCOT sample of 107 children was characterised by a low quality of life , mean total score on PedsQL 67.7 ( 4.5 ) as reported by the children , and 66.0 ( 16.4 ) as reported by their parents . The children spent , on average , 89 % of their waking day on sedentary activity , and 1 % of the day in moderate-vigorous intensity physical activity , equivalent to only around 8 minutes/day . CONCLUSION Obese children in the MASCOT study had an impaired quality of life , high levels of sedentary behaviour and very low levels of physical activity OBJECTIVE The objective was to compare targeting increased eating of healthy foods vs. reducing intake of high energy-dense foods within the context of a family-based behavioral weight control program . METHODS AND PROCEDURES Forty-one 8 - 12 year-old children > 85th BMI percentile were r and omly assigned to a 24-month family-based behavioral treatment that targeted increasing fruits and vegetables and low-fat dairy vs. reducing intake of high energy-dense foods . RESULTS Children in the increase healthy food group showed greater reduction in z BMI compared to children in the reduce high energy-dense food group at 12- ( -0.30 z BMI units vs. -0.15 z BMI units , P = 0.01 ) and 24- ( -0.36 z BMI units vs -0.13 z BMI units , P = 0.04 ) month follow-up . Parents in the increase healthy food group showed greater reductions in concern about child weight ( P = 0.007 ) , and these changes were associated with child z BMI change ( P = 0.008 ) . Children in the reduce high energy-dense group showed larger sustained reductions in high energy-dense foods ( P < 0.05 ) . Baseline levels of high energy-dense foods ( P < 0.05 ) , parent food restraint ( P = 0.01 ) , parent concern over parent weight ( P = 0.01 ) and parent acceptance of the child ( P < 0.05 ) moderated child z BMI change , with greater sustained reductions in z BMI for children in the increase healthy food group for each measure . Parent z BMI change followed the same pattern as child changes , and parent and child z BMI changes were correlated ( P < 0.001 ) . DISCUSSION Focusing on healthy food choices within an energy restricted diet may be useful in family-based weight control programs Background Child obesity internationally has been identified as one of the major threats to future population health . Indigenous people and those from lower socio-economic background s are over-represented in obesity statistics . There is a need for evidence of effect of interventions for child obesity with long-term follow-up . Whether engaging with those that are more motivated to make lifestyle changes is a useful strategy has not been fully explored . We hypothesise that in obese/overweight children , assessed as psychologically “ ready for change ” , delivery of a 12-month multi-disciplinary intervention programme results in a significant reduction in body mass index st and ard deviation score . Methods / Design Whanau Pakari is an unblinded r and omised controlled clinical trial comparing a 12 month intervention programme with st and ard practice , with 6 monthly assessment s for 2 years , conducted in Taranaki , New Zeal and ( a region where 15.8 % of the population are indigenous ) . It specifically targets indigenous people and those in more deprived households . Obese/overweight children and adolescents aged 5–16 years are eligible . Exclusion criteria are medical/psychological conditions leading to inability to undertake physical activity/participate in group sessions ; those not “ ready ” to make lifestyle changes ; and those without a committed family member . Assessment s of health parameters , dietary history , physical activity and overall health-related quality of life/psychological functioning are completed in the participant ’s home . Fasting blood tests are obtained at baseline , 12 and 24 months . The primary outcome is body mass index st and ard deviation score . Secondary outcomes include quality of life , dietary behaviour and physical activity , cardiovascular and metabolic profile ( blood pressure , resting heart rate , waist circumference ) , glycaemic control ( fasting glucose and glycated Haemoglobin ) , fasting insulin , and lipids . A general linear mixed model will be used to assess change from baseline using the 6 , 12 , 18 and 24 month measures , adjusting for age , gender , socioeconomic status and ethnicity , and whether at the contemplative or preparation/action stages of readiness for change . Discussion This trial will inform the development of management programmes for obese children and adolescents that are appropriate for indigenous population s. It will investigate whether those at the preparation/action stage of “ readiness ” to make lifestyle changes are more successful in making changes than those who are contemplative . Trial registration Australian New Zeal and Clinical Trials Registry (ANZCTR):12611000862943 . ( Date registered 15/08/2011 ) The objective of the present study was to evaluate the effectiveness of a one-year multi-component immersive day-camp weight-loss intervention for children with overweight and obesity . The study design was a parallel-group r and omized controlled trial . One hundred fifteen 11 - 13-year-old children with overweight and obesity were r and omized into either : A six-week day-camp intervention arm focusing on increased physical activity , and healthy diet followed by a subsequent one-year family-based intervention , or a st and ard intervention arm consisting of one weekly exercise session for six weeks . Body mass index ( BMI ) was the primary outcome . BMI z-score , clustered cardiovascular risk z-score , and body composition were secondary outcomes . All outcomes were measured at baseline , six week- , and 52 week follow-up . After six weeks , children from the day-camp intervention arm had improved their BMI ( -2.2 kg/m2 ( 95 % CI -2.6 to -1.7 , P<0.001 ) ) and all secondary outcomes when compared to the children from the st and ard intervention arm . After 52 weeks , the day-camp intervention arm had a lower BMI ( -1.2 kg/m2 ( 95 % CI -1.8 to -0.5 , P = 0.001 ) ) , and BMI z-score ( -0.20 ( 95 % CI -0.35 to -0.05 , P = 0.008 ) ) , and clustered cardiovascular risk z-score ( -0.23 ( 95 % CI -0.37 to -0.08 , P = 0.002 ) ) compared to the st and ard intervention arm . No group differences were detected in body composition after 52 weeks . This study shows that the day-camp intervention arm is effective in reducing BMI and improving the metabolic health of children with overweight and obesity . However , the effects seem to be diminishing over time OBJECTIVE To evaluate the feasibility , acceptability , and efficacy of an after-school team sports program for reducing weight gain in low-income overweight children . DESIGN Six-month , 2-arm , parallel-group , pilot r and omized controlled trial . SETTING Low-income , racial/ethnic minority community . PARTICIPANTS Twenty-one children in grade s 4 and 5 with a body mass index at or above the 85th percentile . INTERVENTIONS The treatment intervention consisted of an after-school soccer program . The " active placebo " control intervention consisted of an after-school health education program . MAIN OUTCOME MEASURES Implementation , acceptability , body mass index , physical activity measured using accelerometers , reported television and
Output:
| No subgroup effects were shown for any of the subgroups on any of the outcomes .
Multi-component behaviour-changing interventions that incorporate diet , physical activity and behaviour change may be beneficial in achieving small , short-term reductions in BMI , BMI z score and weight in children aged 6 to 11 years .
The evidence suggests a very low occurrence of adverse events . |
MS211569 | ***TASK*** the task is to summarize an input biomedical literature 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: Eighty-seven morbidly obese patients were prospect ively r and omized to two operations : gastric bypass was performed on 42 and gastric partition on 45 . Gastric bypass proved to be more effective ; gastric bypass patients lost 15 % more of their original weight at 12 months and 21 % more at 18 months . There were no failures in the gastric bypass group ; 28 of the 45 operations failed in the gastric partition group . An additional 60 patients underwent gastric bypass since the completion of the study . In the total series of 147 patients who underwent gastric bypass or gastric partition , there was no mortality , and the surgical complication rate was 12 % . Because the gastric pouches and the anastomoses were similar in the two operations , the superiority of the gastric bypass may well be due to a heretofore unexplained effect of distal gastric and duodenal exclusion The present status of 38 patients comprising a clinical trial of jejunoileal and gastric bypass for the treatment of morbid obesity , begun four years ago at North Carolina Memorial Hospital , is reported . Weight loss was greater in patients treated by jejunoileal bypass than those treated by gastric bypass . The poorer weight loss noted in the gastric bypass patients is associated with an excessively large proximal gastric pouch , which had characterized the 19 gastric bypass operations done prior to May 1977 . The weight loss achieved with the current version of the gastric bypass , a smaller proximal gastric pouch , is comparable to that achieved with jejunoileal bypass . The objective and subjective sequelae and complications of jejunoileal bypass are more common and more serious than those of gastric bypass . Gastric bypass is the better operation for the treatment of morbid obesity For 2 years , 12 Danish hospitals have conducted a r and omized clinical trial to evaluate the hazards and benefits of jejunoileal bypass operations for severe obesity . At present ( January , 1976 ) , there are 92 operated and 46 unoperated patients . There has been no mortality in the operated group . One control patient has died . Weight loss is significantly better in the operated group , but not always satisfactory . The well-known postoperative complications have not been deterring in frequency or seriousness . On the whole , but not invariably , the operation has been followed by an improvement in psychosocial status Background : The feasibility of laparoscopic Roux-en-Y gastric bypass ( Lap-RYGBP ) for morbid obesity is well documented . In a prospect i ve r and omized trial , we compared laparoscopic and open surgery . Methods : 51 patients ( 48 females , mean ( ± SD ) age 36 ± 9 years and BMI 42 ± 4 kg/m2 ) were r and omly allocated to either laparoscopy ( n=30 ) or open surgery ( n=21 ) . All patients were followed for a minimum of 1 year . Results : In the laparoscopy group , 7 patients ( 23 % ) were converted to open surgery due to various procedural difficulties . In an analysis , with the converted patients excluded , the morphine doses used postoperatively were significantly ( p < 0.005 ) lower in the laparoscopic group compared to the open group . Likewise , postoperative hospital stay was shorter ( 4 vs 6 days , p<0.025 ) . Six patients in the laparoscopy group had to be re-operated due to Roux-limb obstruction in the mesocolic tunnel within 5 weeks . The weight loss expressed in decrease in mean BMI units after year was 14 and 13 after 1 ± 3 ± 3 laparoscopy and open surgery , respectively ( not significant ) . Conclusions : Both laparoscopic and open RYGBP are effective and well received surgical procedures in morbid obesity . Reduced postoperative pain , shorter hospital stay and shorter sick-leave are obvious benefits of laparoscopy but conversions and /or reoperations in 1/4 of the patients indicate that Lap-RYGBP at present must be considered an investigational procedure OBJECTIVE To examine the effect of a large , long st and ing and intentional weight reduction on the incidence of diabetes , hypertension and lipid disturbances in severely obese individuals as compared to weight-stable obese controls . RESEARCH METHODS AND PROCEDURES The ongoing prospect i ve SOS ( Swedish Obese Subjects ) intervention consists of a surgically treated group and a matched control group obtaining conventional obesity treatment . This report is based on 845 surgically treated patients and 845 controls ( BMI 41.0+/-4.6 kg/m2 ( mean+/-st and ard deviation [ S ] ) ) followed for 2 years . RESULTS Surgically treated patients lost 28+/-15 kg and controls 0.5+/-8.9 kg ( p<0.0001 ) . Two-year incidence of hypertension , diabetes , hyperinsulinemia , and lipid disturbances was compared in the two treatment groups . Adjusted odds ratios ( 95 % CI ) for the surgically treated group versus controls were 0.38 ( 0.22 , 0.65 ) for hypertension , 0.02 ( 0.00 , 0.16 ) for diabetes , 0.10 ( 0.03 , 0.28 ) for hyperinsulinemia , 0 . 10 ( 0.04 , 0.25 ) for hypertriglyceridemia , 0.28 ( 0.16 , 0.49 ) for low HDL-cholesterol and 1.24 ( 0.84 , 1.8 ) for hypercholesterolemia . Compared to controls , the 2-year recovery rates from hypertension , diabetes , hypo-HDL , and hypertriglyceridemia were significantly higher in the surgically treated group . DISCUSSION Intentional weight loss in the obese causes a marked reduction in the 2-year incidence of hypertension , diabetes and some lipid disturbances . The results suggest that severe obesity can and should be treated 57 morbidly obese patients were r and omized and operated upon with gastric bypass ( GBY ) or gastroplasty ( GPL ) . The patients were followed for three years . GBY had a slightly higher early complication rate but a significantly ( p less than 0.001 ) greater weight loss . GBY lost 42.3 + /- 10.9 kg after one year and 38.4 + /- 12.3 kg after three years compared to 29.9 + /- 10.0 kg one year and 24.7 + /- 13.1 kg three years after GPL . No GBY but 10 GPL patients were reoperated upon due to failure to lose or to maintain lost weight . An endoscopic method was developed for postoperative measurement of stoma diameter . Use of this method showed no significant difference in stoma diameter between GBY and GPL . A correlation between weight loss and stoma diameter was found one year after GPL but not after GBY . Also a correlation between peroperative pouch volume and weight loss was seen after GPL but not after GBY . The two methods differed in emptying rate of a semi-solid test meal from the upper gastric pouch . For both methods the energy intake was highly reduced postoperatively , but significantly more after GBY . For a number of nutrients the intake was below minimum recommended levels . Fat cell weight was reduced postoperatively , most pronounced for the abdominal regions and least for the femoral-gluteal regions . The reduction was also significantly more pronounced after GBY than after GPL . Calculated fat cell number was significantly reduced after both methods . It is concluded that the effect on body weight of GPL and GBY can not be explained by the same mode of action . In GPL mechanical fractures such as pouch volume and stoma size are of great importance , which is in accordance with earlier theories . In contrast to this , the results of GBY can not be satisfactorily explained by such mechanical factors and additional mechanisms , probably of neuro-endocrinologic origin , must be sought for A prospect i ve r and omized clinical trial was undertaken to compare the effects of gastric bypass with Roux-en-Y gastro-jejunostomy and a gastric partitioning procedure . Operative groups were comparable , with regard to preoperative weight , age , sex , historic findings and operative complications . Postoperative weight loss was followed for one year . Patients receiving the gastric partitioning procedure showed significantly poorer weight loss as early as three months postoperatively than did those receiving gastric bypass . This poorer performance persisted throughout the study period Fifty-one morbidly obese women were r and omized to surgical treatment with gastric bypass ( GBY ) or gastroplasty ( GPL ) . Their dietary intake was assessed preoperatively and 12 months postoperatively by two methods : diet history and 4-day weighted intake . Their protein intake was also checked against urinary nitrogen losses . There was a good correspondence between the results of the two dietary methods and also between estimated protein intake and urinary loss . This makes the results reliable . After 1 year the GBY patients demonstrated a mean weight loss of 41.6 + /- 10.8 kg ( P less than 0.001 versus GPL ) and a mean energy intake preoperatively of about 2400 kcal/day and postoperatively of 1050 kcal/day ( P less than 0.05 versus GPL ) . The GPL patients lost 28.9 + /- 9.6 kg as a mean and had a preoperative intake of about 2500 kcal/day and a postoperative intake of about 1300 kcal/day . There were only minor changes in the quality of the food from the preoperative to the postoperative situation . Postoperatively the daily intake of several nutrients was below minimum values of recommended or required intake The beneficial effects of weight loss in the obese have been widely accepted . Still , there is a lack of controlled studies displaying large maintained weight losses over long periods ( > 4 years ) . We wanted to examine the results of long-st and ing intentional weight loss on the development of diabetes and hypertension in severely obese individuals over an 8-year period . In the ongoing prospect i ve Swedish Obese Subjects ( SOS ) study , 346 patients awaiting gastric surgery were matched with 346 obese control subjects on 18 variables by a computerized matching program . The controls were drawn from a registry consisting of 1508 obese potential controls examined at primary health care centers in Sweden . Of the 692 selected patients ( body mass index 41.2+/-4.7 kg/m(2 ) [ mean+/-SD ] ) , 483 ( 70 % ) were followed for 8 years . No significant weight changes occurred in the obese control group over 8 years . Gastric surgery result ed in a maximum weight loss of -31.1+/-13.6 kg after 1 year . After 8 years , the maintained weight loss was still 20.1+/-15.7 kg ( 16.3+/-12.3 % ) . Whereas this weight reduction had a dramatic effect on the 8-year incidence of diabetes ( odds ratio 0.16 , 95 % CI 0.07 to 0.36 ) , it had no effect on the 8-year incidence of hypertension ( odds ratio 1.01 , 95 % CI 0.61 to 1.67 ) . A differentiated risk factor response was identified : a maintained weight reduction of 16 % strongly counteracted the development of diabetes over 8 years but showed no long-term effect on the incidence of hypertension Vertical b and ed gastroplasty ( VBGP ) was compared with Roux-en-Y gastric bypass ( RYGBP ) in a r and omized prospect i ve trial that included preoperative dietary separation of " sweets eaters " versus " non-sweets eaters . " R and omization was stopped at 9 months after 20 patients had undergone each procedure because a greater weight loss ( p less than 0.05 ) was noted after RYGBP than VBGP . This difference became more significant ( p less than 0.001 ) at each 3-month interval through 3 years , when patients who had VBGPs had lost 37 + /- 20 % of excess weight compared with 64 + /- 19 % for patients who had RYGBPs . The members of the groups were comparable with regard to age , sex , eating habits , morbidity rates before surgery , ideal body weight , and weight before surgery . Although there was no significant difference between the loss of excess weight in " sweets eaters " ( 69 + /- 17 % ) or " non-sweets eaters " ( 67 + /- 17 % ) after RYGBP at 1 year , " sweets eaters " who had VBGPs lost significantly less excess weight ( 36 + /- 13 % ) than did " non-sweets eaters " who had VBGPs ( 57 + /- 18 % ) , p less than 0.02 , or " sweets eaters " who had RYGBPs , p less than 0.0001 . No significant differences were noted for electrolytes , renal or liver function tests , and most vitamins between patients who had VBGPs and RYGBPs ; however , patients who had RYGBPs had lower ( p less than 0.05 ) serum vitamin B12 levels ( 286 + /- 149 pg/dl ) than did patients who had VBGPs ( 461 + /- 226 pg/dl ) at 2 years . By 3 years , the vitamin B12 levels were equal in members of the two groups . Five patients who had RYGBPs required endoscopic stomal dilatation for stomal stenosis and one had a marginal ulcer develop , which responded to cimet
Output:
| Surgery result ed in a significantly greater loss of weight ( 23–37 kg more weight ) than nonsurgical treatment , which was maintained to 8 years and led to improvements in quality of life and comorbidities .
: Surgery for morbid obesity appears to be clinical ly and cost effective .
Because of the nature of the evidence , particularly the uncertainty in the clinical and economic evaluations , it is difficult to distinguish between the different surgical procedures |
MS211570 | ***TASK*** the task is to summarize an input biomedical literature 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 vali date and refine two sets of c and i date criteria for the classification/diagnosis of axial spondyloarthritis ( SpA ) . Methods : All Assessment of SpondyloArthritis international Society ( ASAS ) members were invited to include consecutively new patients with chronic ( ⩾3 months ) back pain of unknown origin that began before 45 years of age . The c and i date criteria were first tested in the entire cohort of 649 patients from 25 centres , and then refined in a r and om selection of 40 % of cases and thereafter vali date d in the remaining 60 % . Results : Upon diagnostic work-up , axial SpA was diagnosed in 60.2 % of the cohort . Of these , 70 % did not fulfil modified New York criteria and , therefore , were classified as having “ non-radiographic ” axial SpA. Refinement of the c and i date criteria result ed in new ASAS classification criteria that are defined as : the presence of sacroiliitis by radiography or by magnetic resonance imaging ( MRI ) plus at least one SpA feature ( “ imaging arm ” ) or the presence of HLA-B27 plus at least two SpA features ( “ clinical arm ” ) . The sensitivity and specificity of the entire set of the new criteria were 82.9 % and 84.4 % , and for the imaging arm alone 66.2 % and 97.3 % , respectively . The specificity of the new criteria was much better than that of the European Spondylarthropathy Study Group criteria modified for MRI ( sensitivity 85.1 % , specificity 65.1 % ) and slightly better than that of the modified Amor criteria ( sensitivity 82.9 , specificity 77.5 % ) . Conclusion : The new ASAS classification criteria for axial SpA can reliably classify patients for clinical studies and may help rheumatologists in clinical practice in diagnosing axial SpA in those with chronic back pain . Trial registration number : NCT00328068 Study Design . In 151 adult patients with ankylosing spondylitis who participated in an inpatient rehabilitation program of 3–4 weeks , 10 different range of motion ( ROM ) values were measured , and their lumbar spine and sacroiliac joints were radiographed . Objectives . To determine whether a correlation obtained between restriction of ROM and progression of radiologic findings in ankylosing spondylitis , together with a high enough reliability level in measurements . Summary of Background Data . A significant correlation was observed between the restriction of eight ROMs : the Schober test , thoracolumbar rotation , thoracolumbar flexion , cervical rotation , occiput-wall distance , chin-chest distance , chest expansion , finger-floor distance , and overall radiologic changes in both lumbar spine and sacroiliac joints ; straight leg raise did not correlate , and vital capacity only with sacroiliac joint changes . Spearman 's correlation coefficients for ROMs were slightly higher to lumbar spine changes than to sacroiliac joint changes . A corresponding correlation was also observed between spinal mobility restrictions and six detailed changes in lumbar roentgenogram : syndesmophytes , apophyseal arthritis , sclerotic anterior borders of vertebrae , straightened anterior surface of vertebrae , and ossification of interspinous and anterior longitudinal ligaments . Other detailed lumbar spine findings did not correlate . As assessed by erythrocyte sedimentation rate values the disease activity increased in the course of radiologic progression , decreasing again , however , to the end stage . Methods . Conventional methods with a tape and ( Myrin ) inclinometer were used to measure thoracolumbar flexion , cervical rotation , occiput-wall distance , chin-chest distance , finger-floor distance , chest expansion , vital capacity , and straight leg raise . In addition , a new method of thoracolumbar rotation and a new modification of the Schober test were introduced . Thirty-nine patients were r and omized for a reliability assessment using repeated measurements of ROMs . Radiologic changes were evaluated ( in a masked fashion ) using the method of Dale and Vinje . Results . The reliability of all ROMs was good ( except for interraler intraclass correlation coefficients of chest expansion : 0.53 ) . Conclusions : The clear correlation between radiologic sacroiliac joint and lumbar spine progression and eight ROMs showed that these are useful noninvasive measurements of disease progression and severity in ankylosing spondylitis that can be used in daily practice OBJECTIVE To evaluate a magnetic resonance imaging ( MRI ) scoring system for the assessment of spinal inflammation in patients with ankylosing spondylitis ( AS ) who participated in a r and omized , placebo-controlled trial of infliximab , and to examine whether infliximab is also effective for the reduction of MRI-proven spinal inflammation . METHODS Twenty patients with AS ( 9 women and 11 men , mean age 40.9 years ) were examined at baseline and after 3 months . Nine patients had received infusions of infliximab ( 5 mg/kg body weight ) at weeks 0 , 2 , and 6 , and 11 patients had received placebo . Three MRI sequences and 2 scoring systems were used . Chronic lesions were evaluated by T1-weighted turbo spin-echo ( TSE ) sequences and were assigned a chronicity score . Active lesions were evaluated either by repetition of T1-weighted TSE sequences after infusion of gadolinium-diethylenetriaminepentaacetic acid ( Gd-DTPA ) or by short tau inversion recovery ( STIR ) sequences , and were assigned an activity score . The 40 images were evaluated twice by 2 readers who were blinded to the names of the patients and the date s of the examinations , and were analyzed in relation to the clinical results . RESULTS Active spinal lesions were detected in 15 of 20 patients ( 75 % ) ; the frequency as determined by STIR was equal in the 2 groups . At baseline , the total MRI scores determined using Gd-DTPA , STIR , and T1 were 112.5 , 156 , and 253.5 , respectively . The interrater variance and intrarater variance were , respectively , 6.4 and 7.7 for the active lesion score as determined by Gd-DTPA , 15.7 and 5.3 for the active lesion score as determined by STIR sequence , and 167.3 and 75.5 for the chronic lesion score as determined by T1 sequence . Based on the means of the scores assigned by the 2 readers , the active lesion score as determined by Gd-DTPA improved by 40 % in the infliximab group compared with 6 % in the placebo group , the active lesion score as determined by STIR improved by 60 % in the infliximab group but deteriorated by 21 % in the placebo group , and the chronic lesion score as determined by T1 improved by 7 % in the infliximab group but worsened by 35 % in the placebo group . Five patients in the infliximab group and 2 in the placebo group were clinical responders . The acute MRI changes correlated with clinical improvement as assessed by the Bath Ankylosing Spondylitis Disease Activity Index . CONCLUSION This novel MRI scoring system performed well in assessing acute inflammation by using STIR and post-Gd-DTPA sequences . In correlation with clinical improvement in patients with active AS who were treated with infliximab , significant regression of spinal inflammation was shown by using the MRI activity scores OBJECTIVE To develop a reproducible and simple radiologic scoring system for the spine in patients with ankylosing spondylitis ( AS ) : the Bath Ankylosing Spondylitis Radiology Index for the spine ( BASRI-s ) . METHODS Radiographs of 470 patients with AS were scored using the New York criteria for the sacroiliac joints and , similarly , grading the lumbar and cervical spine on a scale of 0 - 4 ( for normal , suspicious , mild , moderate , and severe ) . These 3 scores were added together to produce the BASRI-s score ( scored 2 - 12 ) . Radiographs of 188 patients were used to test reproducibility . Blinded radiographs of 89 non-AS patients were included , r and omly , to assess disease specificity . Sensitivity to change was assessed using 177 radiographs from 58 AS patients . RESULTS Intra- and interobserver variation showed 75 - 86 % and 73 - 79 % complete agreement at all sites , respectively . Specificities of 0.83 - 0.89 suggested that the lumbar and cervical spine BASRI scores were disease specific . Sensitivity to change became apparent at 2 years ( P < 0.001 ) . Using a lateral view and an anteroposterior view of the lumbar spine was more sensitive than using a lateral view alone . Grading a set of radiographs ( sacroiliac joints , lumbar spine , and cervical spine ) took 30 seconds . CONCLUSION BASRI is a reliable method for grading radiographic changes in patients with AS . It is disease specific , sensitive to change , valid , simple , and rapid to perform OBJECTIVE To evaluate the role of MRI in predicting a Bath Ankylosing Spondylitis Disease Activity Index ( BASDAI ) improvement of at least 50 % ( BASDAI 50 ) upon anti-tumour necrosis factor ( TNF ) therapy of active ankylosing spondylitis ( AS ) . METHODS MRIs from patients with active AS who participated in r and omised controlled trials were analysed with respect to presence and extent of active inflammatory lesions as detected in the spine ( n = 46 ) , sacroiliac ( SI ) joints ( n = 42 ) and both sites ( n = 26 ) . Univariate and multivariate logistic regression analyses were applied to evaluate MRI and clinical data in predicting a BASDAI 50 response . RESULTS The Berlin MRI spine score ( odds ratio ( OR ) 1.16 , 95 % CI 1.02 to 1.33 ) and disease duration ( OR 0.9 , 95 % CI 0.63 to 0.97 ) were statistically significant predictors of a BASDAI 50 response using regression analysis while there was only a trend for C-reactive protein ( CRP ) . The likelihood ratio ( LR ) for achievement of BASDAI 50 was increased in patients with a Berlin MRI spine score > /=11 ( LR 6.7 ) , disease duration < 10 years ( LR 4.2 ) and CRP > /=40 mg/litre ( LR 3.4 ) . All patients with two or three of these predictors improved clinical ly ( as assessed by BASDAI ) by at least 45 % . Disease duration > 20 years , normal CRP and no active inflammatory lesion in the spine were highly predictive of not achieving BASDAI 50 . A trend was only found for the MRI score of SI joints to be predictive . CONCLUSIONS Widespread inflammation in the spine as detected by MRI contributes to predicting a BASDAI 50 response in active patients with AS treated with anti-TNF agents Objective To study the relationship between spinal mobility , radiographic damage of the spine and spinal inflammation as assessed by MRI in patients with ankylosing spondylitis ( AS ) . Methods In this sub analysis of the Ankylosing Spondylitis Study for the Evaluation of Recombinant Infliximab Therapy cohort , 214 patients , representing an 80 % r and om sample , were investigated . Only baseline data were used . MRI inflammation was assessed by the AS spinal MRI activity ( ASspiMRI-a ) score , structural damage by the modified Stoke AS Spine Score ( mSASSS ) and spinal mobility by the linear definition of the Bath Ankylosing Spondylitis Metrology Index ( BASMI ) . Univariate correlations were calculated on baseline values using Spearman rank correlation . Independent associations between the variables of interest were investigated by multivariate linear regression analysis . Associations with clinical disease activity , C-reactive protein , disease duration , age , gender , body mass index and HLA-B27 status were also investigated . Subanalyses were performed according to disease duration . Results BASMI correlated moderately well with mSASSS ( Spearman 's ρ=0.6 ) and weakly with ASspiMRI-a ( ρ=0.3 ) . A best-fit model for BASMI included both mSASSS ( regression coefficient (B)=0.865 , p<0.001 ) and ASspiMRI-a ( B=0.236 , p=0.018 ) . In patients with a disease duration ≤3 years , B was greater for ASspiMRI-a than for mSASSS ( 0.595 vs 0.380 ) , while in patients with a disease duration > 3 years B was greater for mSASSS than for ASspiMRI-a ( 0.924 vs 0.156 ) . Conclusion Spinal mobility impairment in AS is independently determined both by irreversible spinal damage and by reversible spinal inflammation . Spinal mobility impairment is more influenced by spinal inflammation in early disease , and by structural damage in later disease Study Design . A prospect i ve , controlled clinical study performed in a tertiary care center . Objective . To determine reliability and validity of low-tech measurements in assessment of range of motion ( ROM ) of lumbar flexion in ankylosing spondylitis ( AS ) . Summary of Background Data . ROM measurements of lumbar flexion in patients with AS and healthy subjects are evaluated using original Schober test ( OST ) , modified Schober index ( MSI ) , and modified-modified Schober test ( MMST ) and compared with radiography . Methods . Fifty patients with AS and
Output:
| Spinal mobility measures do not reflect levels of inflammation at either the sacroiliac joints and /or the spine |
MS211571 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: Study Design . A r and omized trial . Objective . To evaluate the effectiveness of a semi-intensive multidisciplinary rehabilitation for patients with chronic low back pain in an outpatient setting . Summary and Background Data . Systematic review s have shown that there is strong evidence that intensive multidisciplinary treatment ( > 100 hours ) , which includes functional restoration , improves function among chronic patients with low back pain , and moderate evidence that it reduces pain but contradictory evidence regarding improvement of working ability . However , there is paucity of data whether semi-intensive outpatient multidisciplinary rehabilitation in groups is more effective than individual physiotherapy . Material s and Methods . A total of 120 women employed as healthcare and social care professionals with nonspecific chronic low back pain were recruited from two occupational healthcare centers . The patients were r and omized into two intervention programs . Multidisciplinary rehabilitation ( n = 59 ) was conducted in groups and comprised of physical training , workplace interventions , back school , relaxation training , and cognitive-behavioral stress management methods for 70 hours . The individual physiotherapy ( n = 61 ) included physical exercise and passive treatment methods administered for 10 hours . Main outcome measures were : back pain and sciatic pain intensity , disability , sick leaves , healthcare consumption , symptoms of depression , and beliefs of working ability after 2 years . Results . There were no statistically significant differences between the two treatment groups in main outcome measures just after rehabilitation , at 6- , at 12- , or 24-month follow-up . In both intervention arms , however , the before- and -after comparison showed favorable effects , and the effects were still maintained at 2 years follow-up . Conclusions . The results of this study indicate that semilight outpatient multidisciplinary rehabilitation program for female chronic low back pain patients does not offer incremental benefits when compared with rehabilitation carried out by a physiotherapist having a cognitive-behavioral way of administering the treatment Background Psychosocial prognostic factors are important in the development of chronic pain , but treatment providers often lack knowledge and skills to assess and address these risk factors . Objective The aim of this study was to examine the effects on outcomes ( pain and disability ) in patients of a course about psychosocial prognostic factors for physical therapists . Design This study was a r and omized , controlled trial . Setting The setting was primary care practice . Participants Forty-two primary care physical therapists attended an 8-day university course ( over 8 weeks ) aim ed at identifying and addressing psychosocial risk factors . Intervention The physical therapists were r and omly assigned to either the course or a waiting list . They treated consecutive patients with acute and subacute musculoskeletal pain both before and after the course . Measurements We measured physical therapists ' attitudes and beliefs about psychosocial factors , knowledge , and skills before and after the course . We measured patients ' pain , disability , catastrophizing , and mood at the start of treatment and at a 6-month follow-up . Methods The physical therapists were r and omly assigned to either the course or a waiting list . They treated consecutive patients with acute and subacute musculoskeletal pain both before and after the course . Results Pain and disability outcomes in all patients of physical therapists who had participated in the course or in patients at risk of developing long-term disability who had higher levels of catastrophizing or depression were not significantly different from those outcomes in patients of physical therapists who had not participated in the course . Pain and disability outcomes in patients with a low risk of developing long-term disability— and pain outcomes in patients with a high risk of developing long-term disability — were not dependent upon whether the attitudes and beliefs of their physical therapists changed during the course . However , disability outcomes in patients with a high risk of developing long-term disability may have been influenced by whether the attitudes and beliefs of their physical therapists changed . Limitations A limitation of this study was that actual practice behavior was not measured . Conclusions An 8-day university course for physical therapists did not improve outcomes in a group of patients as a whole or in patients with a risk of developing long-term disability . However , patients who had a risk of developing long-term disability and had higher levels of catastrophizing or depression may have shown greater reductions in disability if the attitudes and beliefs of their physical therapists changed during the course & NA ; A cognitive – behavioral return‐to‐work focused program was evaluated in a r and omized controlled design , and the effects were compared between two groups of women with musculoskeletal pain . One group of patients ( n=36 ) had a history of long‐term sick leave ( > 12 months ) at the start of the program and the other ( n=36 ) had a history of short‐term sick leave ( 2–6 months ) . The outpatient treatment program , conducted by a psychologist , included 12 sessions with the primary aim to help the patients return‐to‐work . The treatment first included teaching of coping strategies such as applied relaxation , stress management , grade d activity training and pacing . Thereafter the patients were taught how to manage difficulties at their return‐to‐work and how to generalize coping strategies to different risk factors at their work places . The control condition received treatment‐as‐usual . The results showed that the cognitive – behavioral return‐to‐work program was more effective than the treatment‐as‐usual control condition in reducing the number of days on sick leave for patients on short‐term sick leave , but not for patients on long‐term sick leave . The treatment program also helped the patients on short‐term sick leave to increase their ability to control and decrease pain and to increase their general activity level compared to the control condition . These results underscore the need for an early return‐to‐work focused rehabilitation to prevent long‐term sick leave and disability Background : Non-specific chronic low back pain disorders have been proven resistant to change , and there is still a lack of clear evidence for one specific treatment intervention being superior to another . Methods : This r and omized controlled trial aim ed to investigate the efficacy of a behavioural approach to management , classification-based cognitive functional therapy , compared with traditional manual therapy and exercise . Linear mixed models were used to estimate the group differences in treatment effects . Primary outcomes at 12-month follow-up were Oswestry Disability Index and pain intensity , measured with numeric rating scale . Inclusion criteria were as follows : age between 18 and 65 years , diagnosed with non-specific chronic low back pain for > 3 months , localized pain from T12 to gluteal folds , provoked with postures , movement and activities . Oswestry Disability Index had to be > 14 % and pain intensity last 14 days > 2/10 . A total of 121 patients were r and omized to either classification-based cognitive functional therapy group n = 62 ) or manual therapy and exercise group ( n > = 59 ) . Results : The classification-based cognitive functional therapy group displayed significantly superior outcomes to the manual therapy and exercise group , both statistically ( p < 0.001 ) and clinical ly . For Oswestry Disability Index , the classification-based cognitive functional therapy group improved by 13.7 points , and the manual therapy and exercise group by 5.5 points . For pain intensity , the classification-based cognitive functional therapy improved by 3.2 points , and the manual therapy and exercise group by 1.5 points . Conclusions : The classification-based cognitive functional therapy produced superior outcomes for non-specific chronic low back pain compared with traditional manual therapy and exercise & NA ; Psychological and social factors have been shown , separately , to predict outcome in individuals with chronic low back pain . Few previous studies , however , have integrated both psychological and social factors , using prospect i ve study of clinic population s of low back pain patients , to identify which are the most important targets for treatment . One hundred and eight patients with chronic low back pain , newly referred to an orthopaedic outpatient clinic , completed assessment s of demographic characteristics , details of back pain , measures of anxiety and depression ( Hospital Anxiety and Depression Scale , HADS ) , fearful beliefs about pain ( Fear Avoidance Beliefs Question naire ) , social stresses ( Life Events and Difficulties Schedule ) and physical aspects of health‐related quality of life [ SF‐36 Physical Component summary Score scale ( PCS ) ] . Six months later subjects completed the SF‐36 PCS and the number of healthcare contacts during follow‐up was recorded . Independent predictors of SF‐36 PCS at 6‐month follow‐up were duration of pain [ ( st and ardised regression coefficient ( β ) = −0.18 , p = 0.04 ) , HADS score ( β ) = −0.27 , p = 0.003 ] and back pain related social difficulties ( β = −0.42 , p < 0.0005 ) . Number of healthcare contacts over the 6 months ranged from 1 to 29 , and was independently predicted by perceived cause of pain [ Incident Rate Ratio ( IRR ) = 1.46 , p = 0.03 ] , Fear Avoidance Beliefs about work ( IRR = 1.02 , p = 0.009 ) and back pain related social difficulties ( IRR = 1.16 , p = 0.03 ) . To conclude , anxiety , depression , fear avoidance beliefs relating to work and back pain related stresses predict impairment in subsequent physical health‐related quality of life and number of healthcare contacts . Interventions targeting these psychosocial variables in clinic patients may lead to improved quality of life and healthcare costs BACKGROUND Cognitive-behavioural treatment can nowadays be delivered through the Internet . This form of treatment can have various advantages with regard to availability and accessibility . Previous studies showed that Internet-based treatment for chronic pain is effective compared to waiting-list control groups . METHODS We conducted a r and omized controlled trial comparing an Internet-based cognitive-behavioural intervention with e-mail therapist contact to a face-to-face cognitive-behavioural group intervention . Of the 72 participants who were r and omly assigned to an Internet or a group course , 50 participants completed the intervention . Participants were assessed at baseline ( T0 ) , immediately after the 7-week course ( T1 ) and at the booster session 2 months later ( T2 ) . Pain-related catastrophizing was the primary outcome measure . Pain intensity , fatigue , pain-related interference , locus of control , pain coping , global health-related quality of life and medical expenses were secondary outcome variables . RESULTS Significant improvement was found on catastrophizing , pain coping , locus of control and aspects of global health-related quality of life in both the Internet and the group courses directly after the course and at the booster session . Pain intensity was improved in both courses at the booster session . At T2 , improvement in catastrophizing , pain intensity , pain coping and some quality of life dimensions was significantly greater in completers of the Internet course than in the group course . Furthermore , the Internet course was cost-effective compared to the group course . CONCLUSIONS We conclude that the Internet-based cognitive-behavioural intervention was at least as effective as the face-to-face group intervention and , on some outcome measures appeared to be even more effective SUMMARY OF BACKGROUND DATA The incidence of chronic pain is higher among immigrants in Europe than among the native European population . Therapeutic interventions in this population are far less effective than in patients for whom these programmes were originally developed . OBJECTIVES In a r and omised trial , we investigated whether a cognitive behavioural treatment ( CBT ) programme supplemented with culturally sensitive aspects ( CsCBT ) improves pain intensity , pain disability and quality of life among immigrant patients , compared with a treatment of culturally sensitive exercise therapy ( CsET ) alone . Furthermore , we investigated whether healthcare costs would decrease . METHODS First-generation Turkish immigrants residing in Switzerl and ( 20 - 65 years of age ) who suffered from chronic pain were enrolled in the trial . Patients were r and omised to attend either CsCBT or CsET . The CsCBT intervention was based upon a manualised cognitive-behavioural group treatment programme for chronic pain patients and adapted to the needs of a Turkish immigrant population . The CsET intervention was based on principles of exercise therapy for treatment of nonspecific low back pain . RESULTS A total of 116 out patients were recruited between October 2004 and November 2006 . The intervention was completed by 89 patients ( 77 % ) . A total of 78 subjects ( 67 % ) completed follow-up , 12 months after the completion of the intervention programme . The intervention showed no effects in reducing pain , pain disability or quality of life . The analysis of healthcare utilisation yielded no intervention effect . CONCLUSIONS Cognitive behavioural intervention is feasible with immigrants with chronic disabling pain , but the evidence -based CBT programme , as well as exercise therapy supplemented with culturally sensitive aspects , showed no improvement & NA ; Mindfulness‐based stress reduction ( MBSR ) is a structured 8‐week group program teaching mindfulness meditation and mindful yoga exercises . MBSR aims to help participants develop nonjudgmental awareness of moment‐to‐moment experience . Fibromyalgia is a clinical syndrome with chronic pain , fatigue , and insomnia as major symptoms . Efficacy of MBSR for enhanced well‐being of fibromyalgia patients was investigated in a 3‐armed trial , which was a follow‐up to an earlier quasi‐r and omized investigation . A total of 177 female patients were r and omized to one of the following : ( 1 ) MBSR , ( 2 ) an active control procedure controlling for nonspecific effects of MBSR , or ( 3 ) a wait list . The major outcome was health‐related quality of life ( HRQoL ) 2 months post‐treatment . Secondary outcomes were disorder‐specific quality of life , depression , pain , anxiety , somatic complaints , and a proposed index of mindfulness . Of the patients , 82 % completed the study . There were no significant differences between groups on primary outcome , but patients overall improved in HRQoL at short‐term follow‐up ( P = 0.004 ) . Post hoc analyses showed that only M
Output:
| There were moderate effects for psychological interventions compared with active controls , treatment as usual and waiting list controls in reducing health care use , with confidence in the findings .
No benefits were found for medication reduction , but with less confidence in this result .
The results are encouraging for the potential of routine psychological intervention to reduce posttreatment health care use , with associated cost savings , but it is likely that the range and complexity of problems affecting work necessitate additional intervention over st and ard group psychological intervention |
MS211572 | ***TASK*** the task is to summarize an input biomedical literature 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: Whole-body active warm-ups ( AWU ) and inspiratory muscle warm-up ( IMW ) prior to exercise improves performance on some endurance exercise tasks . This study investigated the effects of AWU with and without IMW upon 2.4-km running time-trial performance while carrying a 25-kg backpack , a common task and backpack load in physically dem and ing occupations . Participants ( n = 9 ) performed five 2.4-km running time-trials with a 25-kg thoracic load preceded in r and om order by ( i ) IMW comprising 2 × 30 inspiratory efforts against a pressure-threshold load of 40 % maximal inspiratory pressure ( PImax ) , ( ii ) 10-min unloaded running ( AWU ) at lactate turnpoint ( 10.33 ± 1.58 km·h-1 ) , ( iii ) placebo IMW ( PLA ) comprising 5-min breathing using a sham device , ( iv ) AWU+IMW , and ( v ) AWU+PLA . Pooled baseline PImax was similar between trials and increased by 7 % and 6 % following IMW and AWU+IMW ( P < 0.05 ) . Relative to baseline , pooled PImax was reduced by 9 % after the time-trial , which was not different between trials ( P > 0.05 ) . Time-trial performance was not different between any trials . Whole-body AWU and IMW performed alone or combination have no ergogenic effect upon high-intensity , short- duration performance when carrying a 25-kg load in a backpack Fatigue of the respiratory muscles during intense exercise might compromise leg blood flow , thereby constraining oxygen uptake ( Vo(2 ) ) and limiting exercise tolerance . We tested the hypothesis that inspiratory muscle training ( IMT ) would reduce inspiratory muscle fatigue , speed Vo(2 ) kinetics and enhance exercise tolerance . Sixteen recreationally active subjects ( mean + or - SD , age 22 + or - 4 yr ) were r and omly assigned to receive 4 wk of either pressure threshold IMT [ 30 breaths twice daily at approximately 50 % of maximum inspiratory pressure ( MIP ) ] or sham treatment ( 60 breaths once daily at approximately 15 % of MIP ) . The subjects completed moderate- , severe- and maximal-intensity " step " exercise transitions on a cycle ergometer before ( Pre ) and after ( Post ) the 4-wk intervention period for determination of Vo(2 ) kinetics and exercise tolerance . There were no significant changes in the physiological variables of interest after Sham . After IMT , baseline MIP was significantly increased ( Pre vs. Post : 155 + or - 22 vs. 181 + or - 21 cmH(2)O ; P < 0.001 ) , and the degree of inspiratory muscle fatigue was reduced after severe- and maximal-intensity exercise . During severe exercise , the Vo(2 ) slow component was reduced ( Pre vs. Post : 0.60 + or - 0.20 vs. 0.53 + or - 0.24 l/min ; P < 0.05 ) and exercise tolerance was enhanced ( Pre vs. Post : 765 + or - 249 vs. 1,061 + or - 304 s ; P < 0.01 ) . Similarly , during maximal exercise , the Vo(2 ) slow component was reduced ( Pre vs. Post : 0.28 + or - 0.14 vs. 0.18 + or - 0.07 l/min ; P < 0.05 ) and exercise tolerance was enhanced ( Pre vs. Post : 177 + or - 24 vs. 208 + or - 37 s ; P < 0.01 ) . Four weeks of IMT , which reduced inspiratory muscle fatigue , result ed in a reduced Vo(2 ) slow-component amplitude and an improved exercise tolerance during severe- and maximal-intensity exercise . The results indicate that the enhanced exercise tolerance observed after IMT might be related , at least in part , to improved Vo(2 ) dynamics , presumably as a consequence of increased blood flow to the exercising limbs The purpose was to determine the effect of moderate-intensity exercise training ( ET ) on inspiratory muscle fatigue ( IMF ) and if an additional inspiratory load during ET ( ET+IL ) would further improve inspiratory muscle strength , IMF , and time-trial performance . 15 subjects were r and omly divided to ET ( n=8 ) and ET+IL groups ( n=7 ) . All subjects completed six weeks of exercise training three days/week at ∼70%V̇O2peak for 30min . The ET+IL group breathed through an inspiratory muscle trainer ( 15 % PImax ) during exercise . 5-mile , and 30-min time-trials were performed pre-training , weeks three and six . Inspiratory muscle strength increased ( p<0.05 ) for both groups to a similar ( p>0.05 ) extent . ET and ET+IL groups improved ( p<0.05 ) 5-mile time-trial performance ( ∼10 % and ∼18 % ) and the ET+IL group was significantly faster than ET at week 6 . ET and ET+IL groups experienced less ( p<0.05 ) IMF compared to pre-training following the 5-mile time-trial . In conclusion , these data suggest ET leads to less IMF , ET+IL improves inspiratory muscle strength and IMF , but not different than ET alone Inspiratory threshold loading ( ITL ) induces cortical activation . It is sustained over time and is resistant to distraction , suggesting automaticity . We hypothesized that ITL-induced changes in cerebral activation may differ between single-breath ITL and continuous ITL , with differences resembling those observed after cortical automatization of motor tasks . We analyzed the brain blood oxygen level dependent ( BOLD ) signal of 11 naive healthy volunteers during 5 min of r and om , single-breath ITL and 5 min of continuous ITL . Single-breath ITL increased BOLD in many areas ( premotor cortices , bilateral insula , cerebellum , reticular formation of the lateral mesencephalon ) and decreased BOLD in regions co-localizing with the default mode network . Continuous ITL induced signal changes in a limited number of areas ( supplementary motor area ) . These differences are comparable to those observed before and after overlearning of motor tasks . We conclude that the respiratory-related cortical activation observed in response to ITL is likely due to automated , attention-independent mechanisms . Also , ITL activates cortical circuits right from the first breath Inspiratory muscle training ( IMT ) has been shown to improve time trial performance in competitive athletes across a range of sports . Surprisingly , however , the effect of specific IMT on surface swimming performance remains un-investigated . Similarly , it is not known whether any ergogenic influence of IMT upon swimming performance is confined to specific race distances . To determine the influence of IMT upon swimming performance over 3 competitive distances , 16 competitive club-level swimmers were assigned at r and om to either an experimental ( pressure threshold IMT ) or sham IMT placebo control group . Participants performed a series of physiological and performance tests , before and following 6 weeks of IMT , including ( 1 ) an incremental swim test to the limit of tolerance to determine lactate , heart rate and perceived exertion responses ; ( 2 ) st and ard measures of lung function ( forced vital capacity , forced expiratory volume in 1 s , peak expiratory flow ) and maximal inspiratory pressure ( MIP ) ; and ( 3 ) 100 , 200 and 400 m swim time trials . Training utilised a h and -held pressure threshold device and consisted of 30 repetitions , twice per day . Relative to control , the IMT group showed the following percentage changes in swim times : 100 m , −1.70 % ( 90 % confidence limits , ±1.4 % ) , 200 m , −1.5 % ( ±1.0 ) , and 400 m , 0.6 % ( ±1.2 ) . Large effects were observed for MIP and rates of perceived exertion . In conclusion , 6 weeks of IMT has a small positive effect on swimming performance in club-level trained swimmers in events shorter than 400 Inspiratory muscle training ( IMT ) has consistently been shown to reduce exertional dyspnea in health and disease ; however , the physiological mechanisms remain poorly understood . A growing body of literature suggests that dyspnea intensity can be explained largely by an awareness of increased neural respiratory drive , as measured indirectly using diaphragmatic electromyography ( EMGdi ) . Accordingly , we sought to determine whether improvements in dyspnea following IMT can be explained by decreases in inspiratory muscle electromyography ( EMG ) activity . Twenty-five young , healthy , recreationally active men completed a detailed familiarization visit followed by two maximal incremental cycle exercise tests separated by 5 wk of r and omly assigned pressure threshold IMT or sham control ( SC ) training . The IMT group ( n = 12 ) performed 30 inspiratory efforts twice daily against a 30-repetition maximum intensity . The SC group ( n = 13 ) performed a daily bout of 60 inspiratory efforts against 10 % maximal inspiratory pressure ( MIP ) , with no weekly adjustments . Dyspnea intensity was measured throughout exercise using the modified 0 - 10 Borg scale . Sternocleidomastoid and scalene EMG was measured using surface electrodes , whereas EMGdi was measured using a multipair esophageal electrode catheter . IMT significantly improved MIP ( pre : -138 ± 45 vs. post : -160 ± 43 cmH2O , P < 0.01 ) , whereas the SC intervention did not . Dyspnea was significantly reduced at the highest equivalent work rate ( pre : 7.6 ± 2.5 vs. post : 6.8 ± 2.9 Borg units , P < 0.05 ) , but not in the SC group , with no between-group interaction effects . There were no significant differences in respiratory muscle EMG during exercise in either group . Improvements in dyspnea intensity ratings following IMT in healthy humans can not be explained by changes in the electrical activity of the inspiratory muscles . NEW & NOTEWORTHY Exertional dyspnea intensity is thought to reflect an increased awareness of neural respiratory drive , which is measured indirectly using diaphragmatic electromyography ( EMGdi ) . We examined the effects of inspiratory muscle training ( IMT ) on dyspnea , EMGdi , and EMG of accessory inspiratory muscles . IMT significantly reduced submaximal dyspnea intensity ratings but did not change EMG of any inspiratory muscles . Improvements in exertional dyspnea following IMT may be the result of nonphysiological factors or physiological adaptations unrelated to neural respiratory drive ABSTRACT This study was conducted to determine the effects of inspiratory muscle training ( IMT ) on respiratory and peripheral muscles oxygenation during a maximal exercise tolerance test and on repeated-sprint ability ( RSA ) performance in professional women football players . Eighteen athletes were r and omly assigned to one of the following groups : SHAM ( n = 8) or IMT ( n = 10 ) . After a maximal incremental exercise test , all participants performed ( on a different day ) a time-to-exhaustion ( Tlim ) test . Peripheral and respiratory muscles oxygenation by near-infrared spectroscopy , breath-by-breath ventilatory and metabolic variables , and blood lactate concentration were measured . The RSA test was performed on a grass field . After a 6 week intervention , all athletes were reevaluated . Both groups showed increases in inspiratory muscles strength , exercise tolerance and RSA performance , however only the IMT group presented lower deoxyhemoglobin and total hemoglobin blood concentrations on intercostal muscles concomitantly to an increased oxyhemoglobin and total hemoglobin blood concentrations on vastus lateralis muscle during Tlim . In conclusion , these results may indicate the potential role of IMT to attenuate inspiratory muscles metaboreflex and consequently improve oxygen and blood supply to limb muscles during high-intensity exercise , with a potential impact on inspiratory muscle strength , exercise tolerance and sprints performance in professional women football players We have recently demonstrated that changes in the work of breathing during maximal exercise affect leg blood flow and leg vascular conductance ( C. A. Harms , M. A. Babcock , S. R. McClaran , D. F. Pegelow , G. A. Nickele , W. B. Nelson , and J. A. Dempsey . J. Appl . Physiol . 82 : 1573 - 1583 , 1997 ) . Our present study examined the effects of changes in the work of breathing on cardiac output ( CO ) during maximal exercise . Eight male cyclists [ maximal O2 consumption ( VO2 max ) : 62 + /- 5 ml . kg-1 . min-1 ] performed repeated 2.5-min bouts of cycle exercise at VO2 max . Inspiratory muscle work was either 1 ) at control levels [ inspiratory esophageal pressure ( Pes ) : -27.8 + /- 0.6 cmH2O ] , 2 ) reduced via a proportional-assist ventilator ( Pes : -16.3 + /- 0.5 cmH2O ) , or 3 ) increased via resistive loads ( Pes : -35.6 + /- 0.8 cmH2O ) . O2 contents measured in arterial and mixed venous blood were used to calculate CO via the direct Fick method . Stroke volume , CO , and pulmonary O2 consumption ( VO2 ) were not different ( P > 0.05 ) between control and loaded trials at VO2 max but were lower (-8 , -9 , and -7 % , respectively ) than control with inspiratory muscle unloading at VO2 max . The arterial-mixed venous O2
Output:
| Recent evidence confirms the ergogenic effects of RMT and explores different loading protocol s , such as concurrent exercise and RMT ( i.e. , “ functional ” RMT ) .
These studies suggest that adapting new training protocol s may have an additive improvement effect , but evidence of the efficacy of such an approach is conflicting thus far .
Importantly , changes in ventilatory efficiency , oxygen delivery , cytokine release , motor recruitment patterns , and respiratory muscle fatigue resistance are highlighted as potential mechanistic factors linking RMT with performance improvements . |
MS211573 | ***TASK*** the task is to summarize an input biomedical literature 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: To investigate safety and efficacy of high-dose chemotherapy followed by autologous stem cell transplantation ( HCT-ASCT ) in relapsed/refractory ( r/r ) primary central nervous system lymphoma ( PCNSL ) , we conducted a single-arm multicentre study for immunocompetent patients ( < 66 years ) with PCNSL failing high-dose methotrexate)-based chemotherapy . Induction consisted of two courses of rituximab ( 375 mg/m2 ) , high-dose cytarabine ( 2 × 3 g/m2 ) and thiotepa ( 40 mg/m2 ) with collection of stem cells in between . Conditioning for HCT-ASCT consisted of rituximab 375 mg/m2 , carmustine 400 mg/m2 and thiotepa ( 4 × 5 mg/kg ) . Patients commenced HCT-ASCT irrespective of response after induction . Patients not achieving complete remission ( CR ) after HCT-ASCT received whole-brain radiotherapy . Primary end point was CR after HCT-ASCT . We enrolled 39 patients ; median age and Karnofsky performance score are 57 years and 90 % , respectively . About 28 patients had relapsed and 8 refractory disease . About 22 patients responded to induction and 32 patients commenced HCT-ASCT . About 22 patients ( 56.4 % ) achieved CR after HCT-ASCT . Respective 2-year progression-free survival ( PFS ) and overall survival ( OS ) rates were 46.0 % ( median PFS 12.4 months ) and 56.4 % ; median OS not reached . We recorded four treatment-related deaths . Thiotepa-based HCT-ASCT is an effective treatment option in eligible patients with r/r PCNSL . Comparative studies are needed to further scrutinise the role of HCT-ASCT in the salvage setting Treatment of primary central nervous system lymphoma ( PCNSL ) improved in recent years . However , the high neurotoxicity and low survival rates associated with this condition remain unresolved . We report 13 consecutive patients with PCNSL for whom upfront melphalan , cyclophosphamide , etoposide , and dexamethasone ( known as LEED ) followed by autologous stem-cell transplantation ( ASCT ) was planned at the Anjo Kosei Hospital . All patients were pathologically diagnosed with diffuse large B-cell lymphoma and were negative for human immunodeficiency virus . All patients were to receive three cycles of high-dose methotrexate-based induction chemotherapy , two cycles of high-dose AraC-based chemotherapy , and LEED followed by ASCT . All 13 patients achieved a partial response , and the 3-year overall survival ( OS ) rate was 76.2 % . Seven of the 13 patients were alive at the last follow-up , without any adverse events , including neurotoxicity . Six of the 13 ( 46.2 % ) patients underwent ASCT and the 3-year OS rate was 80.0 % . Although this study included only a limited number of patients , these preliminary signs of efficacy and tolerability merit further consideration . To make further improvements in survival , the rate of patients undergoing ASCT should be increased . Other prospect i ve studies involving greater numbers of patients are required to confirm these findings BACKGROUND High-dose methotrexate-based chemotherapy is st and ard for primary CNS lymphoma , but most patients relapse . High-dose chemotherapy with autologous stem cell transplantation ( HCT-ASCT ) is supposed to overcome the blood-brain barrier and eliminate residual disease in the CNS . We aim ed to investigate the safety and efficacy of HCT-ASCT in patients with newly diagnosed primary CNS lymphoma . METHODS In this prospect i ve , single-arm , phase 2 trial , we recruited patients aged 18 - 65 years with newly diagnosed primary CNS lymphoma and immunocompetence , with no limitation on clinical performance status , from 15 hospitals in Germany . Patients received five courses of intravenous rituximab 375 mg/m(2 ) ( 7 days before first high-dose methotrexate course and then every 10 days ) and four courses of intravenous high-dose methotrexate 8000 mg/m(2 ) ( every 10 days ) and then two courses of intravenous rituximab 375 mg/m(2 ) ( day 1 ) , cytarabine 3 g/m(2 ) ( days 2 and 3 ) , and thiotepa 40 mg/m(2 ) ( day 3 ) . 3 weeks after the last course , patients commenced intravenous HCT-ASCT ( rituximab 375 mg/m(2 ) [ day 1 ] , carmustine 400 mg/m(2 ) [ day 2 ] , thiotepa 2 × 5 mg/kg [ days 3 and 4 ] , and infusion of stem cells [ day 7 ] ) , irrespective of response status after induction . We restricted radiotherapy to patients without complete response after HCT-ASCT . The primary endpoint was complete response at day 30 after HCT-ASCT in all registered eligible patients who received at least 1 day of study treatment . This trial is registered at Clinical Trials.gov , number NCT00647049 . FINDINGS Between Jan 18 , 2007 , and May 23 , 2011 , we recruited 81 patients , of whom two ( 2 % ) were excluded , therefore we included 79 ( 98 % ) patients in the analysis . All patients started induction treatment ; 73 ( 92 % ) commenced HCT-ASCT . 61 ( 77·2 % [ 95 % CI 66·1 - 86·6 ] ) patients achieved a complete response . During induction treatment , the most common grade 3 toxicity was anaemia ( 37 [ 47 % ] ) and the most common grade 4 toxicity was thrombocytopenia ( 50 [ 63 % ] ) . During HCT-ASCT , the most common grade 3 toxicity was fever ( 50 [ 68 % ] of 73 ) and the most common grade 4 toxicity was leucopenia ( 68 [ 93 % ] of 73 ) . We recorded four ( 5 % ) treatment-related deaths ( three [ 4 % ] during induction and one [ 1 % ] 4 weeks after HCT-ASCT ) . INTERPRETATION HCT-ASCT with thiotepa and carmustine is an effective treatment option in young patients with newly diagnosed primary CNS lymphoma , but further comparative studies are needed . FUNDING University Hospital Freiburg and Amgen The optimum treatment of primary CNS lymphoma ( PCNSL ) is not yet determined . The objective of this study was to assess the safety and efficacy of initial methotrexate-based chemotherapy followed by high-dose chemotherapy ( HDT ) with autologous stem cell transplantation ( ASCT ) in patients with newly diagnosed PCNSL . Twenty-five patients received two courses of initial chemotherapy combining methotrexate , etoposide , carmustine and methylprednisolone , and one course of ifosfamide – cytarabine followed by peripheral stem cell collection . Seventeen responsive patients then received HDT using carmustine , etoposide , cytarabine and melphalan with autologous stem cell rescue . After ASCT for responding patients or after salvage therapy for non-responders , whole brain radiation therapy at a dose of 30 Gy was delivered . The objective response rate to the induction chemotherapy was 84 % . Four of the 21 responding patients did not have ASCT because of toxicity or refusal . With a median follow-up time of 34 months , the projected event free survival rate is 46 % at 4 years . Projected overall survival is 64 % at 4 years . Sixteen patients are actually in continuous complete response . No evidence of late treatment-related toxicity was observed . This treatment approach appears feasible in newly diagnosed PCNSL with encouraging results In the GRADE approach , r and omized trials start as high- quality evidence and observational studies as low- quality evidence , but both can be rated down if most of the relevant evidence comes from studies that suffer from a high risk of bias . Well-established limitations of r and omized trials include failure to conceal allocation , failure to blind , loss to follow-up , and failure to appropriately consider the intention-to-treat principle . More recently recognized limitations include stopping early for apparent benefit and selective reporting of outcomes according to the results . Key limitations of observational studies include use of inappropriate controls and failure to adequately adjust for prognostic imbalance . Risk of bias may vary across outcomes ( e.g. , loss to follow-up may be far less for all-cause mortality than for quality of life ) , a consideration that many systematic review s ignore . In deciding whether to rate down for risk of bias -- whether for r and omized trials or observational studies -- authors should not take an approach that averages across studies . Rather , for any individual outcome , when there are some studies with a high risk , and some with a low risk of bias , they should consider including only the studies with a lower risk of bias BACKGROUND We investigated the efficacy and safety of t and em high-dose methotrexate ( HD-MTX ) induction followed by high-dose busulfan/thiotepa ( HD-BuTT ) with autologous peripheral blood stem-cell transplantation ( aPBSCT ) and response-adapted whole-brain radiation therapy ( WBRT ) in patients with newly diagnosed primary central nervous system lymphoma . PATIENTS AND METHODS Twenty-three patients were treated with HD-MTX on days 1 and 10 . In case of at least a partial remission ( PR ) , HD-BuTT followed by aPBSCT was given . Patients without response to induction or without complete remission ( CR ) after HD-BuTT received WBRT . RESULTS Sixteen patients received HD-MTX and HD-BuTT achieving a CR/PR rate of 69%/13 % . CR/PR rates for all patients ( n = 23 ) were 70%/13 % . There were three deaths during therapy . With longer follow-up three neurotoxic deaths occurred in irradiated patients ( n = 9 ) , while no persistent neurotoxicity was seen after HD-BuTT without subsequent WBRT . At a median follow-up of 15 months ( range 1 - 69 ) median event-free survival ( EFS ) and overall survival ( OS ) for all patients were 17 and 20 months ( Kaplan-Meier ) , after HD-BuTT 27 months and " not reached " , respectively . Estimated 2-year EFS and OS were 45 % and 48 % for all patients versus 56 % and 61 % for the HD-BuTT group , respectively . CONCLUSION MTX induction followed by HD-BuTT is an effective and very short time-on-treatment regimen . Median survival for patients treated with high-dose chemotherapy is not reached yet . The induction regimen needs optimisation . In this study WBRT was associated with a high incidence of severe neurotoxicity High-dose methotrexate-based chemotherapy is the mainstay of treatment of primary central nervous system lymphoma ( PCNSL ) , but relapses remain frequent . High-dose chemotherapy ( HDC ) with autologous stem-cell transplant ( ASCT ) may provide an alternative to address chemoresistance and overcome the blood-brain barrier . In this single-center phase-2 study , newly diagnosed PCNSL patients received 5 to 7 cycles of chemotherapy with rituximab , methotrexate ( 3.5 g/m(2 ) ) , procarbazine , and vincristine ( R-MPV ) . Those with a complete or partial response proceeded with consolidation HDC with thiotepa , cyclophosphamide , and busulfan , followed by ASCT and no radiotherapy . Primary end point was 1-year progression-free survival ( PFS ) , N = 32 . Median age was 57 , and median Karnofsky performance status 80 . Following R-MPV , objective response rate was 97 % , and 26 ( 81 % ) patients proceeded with HDC-ASCT . Among all patients , median PFS and overall survival ( OS ) were not reached ( median follow-up : 45 months ) . Two-year PFS was 79 % ( 95 % confidence interval [ CI ] , 58 - 90 ) , with no events observed beyond 2 years . Two-year OS was 81 % ( 95 % CI , 63 - 91 ) . In transplanted patients , 2-year PFS and OS were 81 % . There were 3 treatment-related deaths . Prospect i ve neuropsychological evaluations suggested relatively stable cognitive functions posttransplant . In conclusion , this treatment was associated with excellent disease control and survival , an acceptable toxicity profile , and no evidence of neurotoxicity thus far . This trial was registered at www . clinical trials.gov as NCT00596154 BACKGROUND Chemotherapy with high-dose methotrexate is the conventional approach to treat primary CNS lymphomas , but superiority of polychemotherapy compared with high-dose methotrexate alone is unproven . We assessed the effect of adding high-dose cytarabine to methotrexate in patients with newly diagnosed primary CNS lymphoma . METHODS This open , r and omised , phase 2 trial was undertaken in 24 centres in six countries . 79 patients with non-Hodgkin lymphoma exclusively localised into the CNS , cranial nerves , or eyes , aged 18 - 75 years , and with Eastern Cooperative Oncology Group performance status of 3 or lower and meas
Output:
| Subgroup analysis showed that the use of carmustine and thiotepa as a conditioning regimen carried the lowest risk of transplant‐related mortality .
The thiotepa , busulfan , and cyclophosphamide regimen , on the other h and , showed numerically superior OS and PFS rates .
This systematic review and meta‐ analysis provides estimates response and survival after ASCT and suggests improved rates compared to the historical data |
MS211574 | ***TASK*** the task is to summarize an input biomedical literature 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 Physicians often experience work-related stress that may lead to personal harm and impaired professional performance . Biofeedback has been used to manage stress in various population s. Objective To determine whether a biofeedback-based stress management tool , consisting of rhythmic breathing , actively self-generated positive emotions and a portable biofeedback device , reduces physician stress . Design R and omized controlled trial measuring efficacy of a stress-reduction intervention over 28 days , with a 28-day open-label trial extension to assess effectiveness . Setting Urban tertiary care hospital . Participants Forty staff physicians ( 23 men and 17 women ) from various medical practice s ( 1 from primary care , 30 from a medical specialty and 9 from a surgical specialty ) were recruited by means of electronic mail , regular mail and posters placed in the physicians ’ lounge and throughout the hospital . Intervention Physicians in the intervention group were instructed to use a biofeedback-based stress management tool three times daily . Participants in both the control and intervention groups received twice-weekly support visits from the research team over 28 days , with the intervention group also receiving re-inforcement in the use of the stress management tool during these support visits . During the 28-day extension period , both the control and the intervention groups received the intervention , but without intensive support from the research team . Main outcome measure Stress was measured with a scale developed to capture short-term changes in global perceptions of stress for physicians ( maximum score 200 ) . Results During the r and omized controlled trial ( days 0 to 28 ) , the mean stress score declined significantly for the intervention group ( change –14.7 , st and ard deviation [ SD ] 23.8 ; p = 0.013 ) but not for the control group ( change –2.2 , SD 8.4 ; p = 0.30 ) . The difference in mean score change between the groups was 12.5 ( p = 0.048 ) . The lower mean stress scores in the intervention group were maintained during the trial extension to day 56 . The mean stress score for the control group changed significantly during the 28-day extension period ( change –8.5 , SD 7.6 ; p < 0.001 ) . Conclusion A biofeedback-based stress management tool may be a simple and effective stress-reduction strategy for physicians Biofeedback application is an evidence -based technique to induce relaxation . A primary mechanism of action is the improvement of self-efficacy , which is needed to facilitate the translation of health behavioral intentions into action . Obesity is often associated with low self-efficacy and dysfunctional eating patterns , including comfort eating as an inexpedient relaxation technique . This is the first study investigating the effects of biofeedback on self-efficacy and relaxation in obesity . In the present experiment , 31 women , mean body mass index 35.5 kg/m² , were r and omized to a food-specific biofeedback paradigm , a non-specific relaxation biofeedback paradigm , or a waiting list control . Eight sessions of biofeedback of the electrodermal activity were performed while presenting either a challenging food stimulus or a non-specific l and scape stimulus . Self-efficacy , stress , ability to relax , eating behavior , and electrodermal activity were assessed before , directly after , and 3 months after the intervention . The food-specific biofeedback predominantly showed effects on food-related self-efficacy and perceived stress . The non-specific relaxation biofeedback showed effects on the ability to relax . Self-reported improvements were confirmed by corresponding decrease in the electrodermal reaction to food stimuli . Biofeedback treatment is effective in improving self-efficacy in individuals with obesity and might therefore be a valuable additional intervention in obesity treatment A large proportion of children experience sub clinical levels of anxiety and cognitive-behavioral therapy ( CBT ) aim ed at preventing anxiety disorders is moderately effective . However , most at-risk children do not seek help or drop out of programs prematurely because of stigma , lack of motivation , and accessibility barriers . Applied games have received increased attention as viable alternatives and have shown promising results , but direct comparisons between applied games and the gold-st and ard CBT are lacking . Our aim was to investigate whether the applied game MindLight is as effective as CBT ( i.e. , Coping Cat ) within an indicated prevention context . We conducted a r and omized controlled non-inferiority trial with a sample of 174 children ( 7- to 12-year olds ) with elevated levels of anxiety , comparing MindLight to CBT . Anxiety was assessed with self- and parent-reports at pre- and post-program , and at 3- and 6-month follow-ups . Intention-to-treat and completers-only confidence interval approach and latent growth curve modeling showed an overall significant quadratic decrease in child- and parent-reported anxiety symptoms over time and , as predicted , the magnitude of improvement was the same for MindLight and CBT . The within-group effect sizes were small to medium at post-test ( − 0.32 to − 0.63 ) , and medium to large ( − 0.60 to − 1.07 ) at 3- and 6-month follow-ups . Furthermore , MindLight and CBT were rated equally anxiety inducing , difficult , and appealing ; CBT was rated as more relevant to daily life than MindLight . The current study adds to the growing research on applied games for mental health and shows that these games hold potential as alternative delivery models for evidence -based therapeutic techniques Although r and omized studies have high internal validity , generalizability of the estimated causal effect from r and omized clinical trials to real-world clinical or educational practice may be limited . We consider the implication of r and omized assignment to treatment , as compared with choice of preferred treatment as it occurs in real-world conditions . Compliance , engagement , or motivation may be better with a preferred treatment , and this can complicate the generalizability of results from r and omized trials . The doubly r and omized preference trial ( DRPT ) is a hybrid r and omized and nonr and omized design that allows for estimation of the causal effect of r and omization versus treatment preference . In the DRPT , individuals are first r and omized to either r and omized assignment or choice assignment . Those in the r and omized assignment group are then r and omized to treatment or control , and those in the choice group receive their preference of treatment versus control . Using the potential outcomes framework , we apply the algebra of conditional independence to show how the DRPT can be used to derive an unbiased estimate of the causal effect of r and omization versus preference for each of the treatment and comparison conditions . Also , we show how these results can be implemented using full matching on the propensity score . The methodology is illustrated with a DRPT of introductory psychology students who were r and omized to r and omized assignment or preference of mathematics versus vocabulary training . We found a small to moderate benefit of preference versus r and omization with respect to the mathematics outcome for those who received mathematics training 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 : Chronic pain is an emotionally and physically debilitating form of pain that activates the body 's stress response and over time can result in lowered heart rate variability ( HRV ) power , which is associated with reduced resiliency and lower self-regulatory capacity . This pilot project was intended to determine the effective-ness of HRV coherence biofeedback ( HRVCB ) as a pain and stress management intervention for veterans with chronic pain and to estimate the effect sizes . It was hypothesized that HRVCB will increase parasympathetic activity result ing in higher HRV coherence measured as power and decrease self-reported pain symptoms in chronic pain patients . Study design : Fourteen veterans receiving treatment for chronic pain were enrolled in the pre-post intervention study . They were r and omly assigned , with 8 subjects enrolled in the treatment group and 6 in the control group . The treatment group received biofeedback intervention plus st and ard care , and the other group received st and ard care only . The treatment group received four HRVCB training sessions as the intervention . Measures : Pre-post measurements of HRV amplitude , HRV power spectrum variables , cardiac coherence , and self-ratings of perceived pain , stress , negative emotions , and physical activity limitation were made for both treatment and control groups . Results : The mean pain severity for all subjects at baseline , using the self-scored Brief Pain Inventory ( BPI ) , was 26.71 ( SD=4.46 ; range=21—35 ) indicating a moderate to severe perceived pain level across the study subjects . There was no significant difference between the treatment and control groups at baseline on any of the measures . Post-HRVCB , the treatment group was significantly higher on coherence ( P=.01 ) and lower ( P=.02 ) on pain ratings than the control group . The treatment group showed marked and statistically significant ( 1-tailed ) increases over the baseline in coherence ratio ( 191 % , P=.04 ) and marked , significant ( 1-tailed ) reduction in pain ratings ( 36 % , P<.001 ) , stress perception ( 16 % , P=.02 ) , negative emotions ( 49 % , P<.001 ) , and physical activity limitation ( 42 % , P<.001 ) . Significant between-group effects on all measures were found when pre-training values were used as covariates . Conclusions : HRVCB intervention was effective in increasing HRV coherence measured as power in the upper range of the LF b and and reduced perceived pain , stress , negative emotions , and physical activity limitation in veterans suffering from chronic pain . HRVCB shows promise as an effective non-pharmacological intervention to support st and ard treatments for chronic pain BACKGROUND Patients with coronary heart disease ( CHD ) who experience depressed mood or psychological stress exhibit decreased vagal control of heart rate ( HR ) , as assessed by spectral analysis of HR variability ( HRV ) . Myocardial infa rct ion and sudden cardiac death are independently associated with depression and stress , as well as impaired vagal HR control . This study examined whether a behavioral neurocardiac intervention to reduce stress or depression can augment cardiovagal modulation in CHD patients . We hypothesized that ( 1 ) cognitive-behavioral training with HRV biofeedback would augment vagal recovery from acute stress , and ( 2 ) vagal regulation of HR would be inversely associated with stress and depression after treatment . METHODS This r and omized controlled trial enrolled 46 CHD patients from 3 clinics of CHD risk reduction in Toronto and Vancouver , Canada . Subjects were r and omized to five 1.5-hour sessions of HRV biofeedback or an active control condition . Outcome was assessed by absolute and normalized high-frequency spectral components ( 0.15 - 0.50 Hz ) of HRV , and by the Perceived Stress Scale and Centre for Epidemiologic Studies in Depression scale . RESULTS Both groups reduced symptoms on the Perceived Stress Scale ( P = .001 ) and Centre for Epidemiologic Studies in Depression scale ( P = .004 ) . Hierarchical linear regression determined that improved psychological adjustment was significantly associated with the high-frequency index of vagal HR modulation only in the HRV biofeedback group . Adjusted R 2 was as follows : HRV biofeedback group , 0.86 for stress ( P = .02 ) and 0.81 for depression ( P = .03 ) ; versus the active control group , 0.04 ( P = .57 ) and 0.13 ( P = .95 ) , respectively . CONCLUSION A novel behavioral neurocardiac intervention , HRV biofeedback , can augment vagal HR regulation while facilitating psychological adjustment to CHD Introduction : Stress is one of the leading global causes of disease and premature mortality . Despite this , interventions aim ed at reducing stress have low adherence rates . The proliferation of mobile phone devices along with gaming-style applications allows for a unique opportunity to broaden the reach and appeal of stress-reduction interventions in modern society . We assessed the effectiveness of two smartphone applications games combined with biofeedback in reducing stress . Methods : We compared a control game to gaming-style smartphone applications combined with a skin conductance biofeedback device ( the Pip ) . Fifty participants aged between 18 and 35 completed the Trier Social Stress Test . They were then r and omly assigned to the intervention ( biofeedback game ) or control group ( a non-biofeedback game ) for thirty minutes . Perceived stress , heart rate and mood were measured before and after participants had played the games . Results : A mixed factorial ANOVA showed a significant interaction between time and game type in predicting perceived stress [ F(1,48 ) = 14.19 , p < 0.001 ] . Participants in the biofeedback intervention had significantly reduced stress compared to the control group . There was also a significant interaction between time and game in predicting heart rate [ F(1,48 ) = 6.41 , p < 0.05 ] . Participants in the biofeedback intervention showed significant reductions in heart rate compared to the control group . Discussion : This illustrates the potential for gaming-style smartphone applications combined with biofeedback as stress reduction interventions The aim of this study was to examine the effect of resonant breathing biofeedback training for reducing stress among manufacturing operators . Resonant breathing biofeedback works by teaching people to recognize their involuntary heart rate variability and to control patterns of this physiological response . Thirty-six female operators from an electronic manufacturing factory were r and omly assigned as the experimental group ( n = 19 ) and the control group ( n = 17 ) . The participants of the intervention received 5 weekly sessions of biofeedback training . Physiological stress profiles and self-perceived depression , anxiety , and stress scale ( DASS ) were assessed at pre- and post-intervention . Results indicated that depression , anxiety
Output:
| Nevertheless , there is preliminary evidence that the use of biofeedback can improve both physiological and psychological indicators of stress .
Biofeedback could provide an accessible and low-cost addition to stress interventions . |
MS211575 | ***TASK*** the task is to summarize an input biomedical literature 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 Reporting r and omised controlled trials is a key element in order to disseminate research findings . The CONSORT statement was introduced to improve the reporting quality . We assessed the adherence to the CONSORT statement of r and omised controlled trials published 2011 in the top ten ranked journals of critical care medicine ( ISI Web of Knowledge 2011 , Thomson Reuters , London UK ) . Methods Design . We performed a retrospective cross sectional data analysis . Setting . This study was executed at the University Hospital of RWTH , Aachen . Participants . We selected the following top ten listed journals according to ISI Web of Knowledge ( Thomson Reuters , London , UK ) critical care medicine ranking in the year 2011 : American Journal of Respiratory and Critical Care Medicine , Critical Care Medicine , Intensive Care Medicine , CHEST , Critical Care , Journal of Neurotrauma , Resuscitation , Pediatric Critical Care Medicine , Shock and Minerva Anestesiologica . Main outcome measures . We screened the online table of contents of each included journal , to identify the r and omised controlled trials . The adherence to the items of the CONSORT Checklist in each trial was evaluated . Additionally we correlated the citation frequency of the articles and the impact factor of the respective journal with the amount of reported items per trial . Results We analysed 119 r and omised controlled trials and found , 15 years after the implementation of the CONSORT statement , that a median of 61,1 % of the checklist-items were reported . Only 55.5 % of the articles were identified as r and omised trials in their titles . The citation frequency of the trials correlated significantly ( rs = 0,433 ; p<0,001 and r = 0,331 ; p<0,001 ) to the CONSORT statement adherence . The impact factor showed also a significant correlation to the CONSORT adherence ( r = 0,386 ; p<0,001 ) . Conclusion The reporting quality of r and omised controlled trials in the field of critical care medicine remains poor and needs considerable improvement Background Stroke prevention in atrial fibrillation ( AF ) , most commonly with warfarin , requires maintenance of a narrow therapeutic target ( INR 2.0 to 3.0 ) and is often poorly controlled in practice . Poor patient-underst and ing surrounding AF and its treatment may contribute to the patient ’s willingness to adhere to recommendations . Method A theory-driven intervention , developed using patient interviews and focus groups , consisting of a one-off group session ( 1–6 patients ) utilising an “ expert-patient ” focussed DVD , educational booklet , self-monitoring diary and worksheet , was compared in a r and omised controlled trial ( IS RCT N93952605 ) against usual care , with patient postal follow-ups at 1 , 2 , 6 , and 12-months . Ninety-seven warfarin-naïve AF patients were r and omised to intervention ( n=46 , mean age ( SD ) 72.0 ( 8.2 ) , 67.4 % men ) , or usual care ( n=51 , mean age ( SD ) 73.7 ( 8.1 ) , 62.7 % men ) , stratified by age , sex , and recruitment centre . Primary endpoint was time within therapeutic range ( TTR ) ; secondary endpoints included knowledge , quality of life , anxiety/depression , beliefs about medication , and illness perceptions . Main Findings Intervention patients had significantly higher TTR than usual care at 6-months ( 76.2 % vs. 71.3 % ; p=0.035 ) ; at 12-months these differences were not significant ( 76.0 % vs. 70.0 % ; p=0.44 ) . Knowledge increased significantly across time ( F ( 3 , 47 ) = 6.4 ; p<0.01 ) , but there were no differences between groups ( F ( 1 , 47 ) = 3.3 ; p = 0.07 ) . At 6-months , knowledge scores predicted TTR ( r=0.245 ; p=0.04 ) . Patients ’ scores on subscales representing their perception of the general harm and overuse of medication , as well as the perceived necessity of their AF specific medications predicted TTR at 6- and 12-months . Conclusions A theory-driven educational intervention significantly improves TTR in AF patients initiating warfarin during the first 6-months . Adverse clinical outcomes may potentially be reduced by improving patients ’ underst and ing of the necessity of warfarin and reducing their perception of treatment harm . Improving education provision for AF patients is essential to ensure efficacious and safe treatment . The trial is registered with Current Controlled Trials , IS RCT N93952605 , and details are available at www.controlled-trials.com/IS RCT N93952605 Background Effective and safe management of oral anticoagulant treatment ( OAT ) requires a high level of patient knowledge and adherence . The aim of this study was to assess patient knowledge about OAT and factors associated with patient knowledge . Methods This is a baseline survey of a cluster-r and omized controlled trial in 22 general practice s with an educational intervention for patients or their caregivers . We assessed knowledge about general information on OAT and key facts regarding nutrition , drug-interactions and other safety pre caution s of 345 patients at baseline . Results Participants rated their knowledge about OAT as excellent to good ( 56 % ) , moderate ( 36 % ) or poor ( 8 % ) . However , there was a discrepancy between self-rated knowledge and evaluated actual knowledge and we observed serious knowledge gaps . Half of the participants ( 49 % ) were unaware of dietary recommendations . The majority ( 80 % ) did not know which non-prescription analgesic is the safest and 73 % indicated they would not inform pharmacists about OAT . Many participants ( 35 - 75 % ) would not recognize important emergency situations . After adjustment in a multivariate analysis , older age and less than 10 years education remained significantly associated with lower overall score , but not with self-rated knowledge . Conclusions Patients have relevant knowledge gaps , potentially affecting safe and effective OAT . There is a need to assess patient knowledge and for structured education programs . Trial registration Deutsches Register Klinischer Studien ( German Clinical Trials Register ) : DRKS00000586.Universal Trial Number ( UTN U1111 - 1118 - 3464 ) BACKGROUND The knowledge of warning symptoms and risk factors for stroke has not been studied among patients with stroke in developing countries . AIMS We aim ed to assess the knowledge of stroke among patients with stroke and their relatives . SETTING S AND DESIGN Prospect i ve tertiary referral hospital-based study in Northwest India . MATERIAL S AND METHODS Trained nurses and medical interns interviewed patients with stroke and transient ischemic attack and their relatives about their knowledge of stroke symptoms and risk factors . STATISTICAL ANALYSIS Univariable and multivariable logistic regression were used . RESULTS Of the 147 subjects interviewed , 102 ( 69 % ) were patients and 45 ( 31 % ) were relatives . There were 99 ( 67 % ) men and 48 ( 33 % ) women and the mean age was 59.7+/-14.1 years . Sixty-two percent of respondents recognized paralysis of one side as a warning symptom and 54 % recognized hypertension as a risk factor for stroke . In the multivariable logistic regression analysis , higher education was associated with the knowledge of correct organ involvement in stroke ( OR 2.6 , CI 1.1- 6.1 , P = 0.02 ) , whereas younger age ( OR 2.7 , CI 1.1 - 7.0 , P = 0.04 ) and higher education ( OR 4.1 , CI 1.5 - 10.9 , P = 0.005 ) correlated with a better knowledge regarding warning symptoms of stroke . CONCLUSIONS In this study cohort , in general , there is lack of awareness of major warning symptoms , risk factors , organ involvement and self-recognition of stroke . However younger age and education status were associated with better knowledge . There is an urgent need for awareness programs about stroke in this study cohort OBJECTIVE Previous research has demonstrated that patients with atrial fibrillation ( AF ) possess very little knowledge of their disease , the consequences of AF and the benefits /risks of anti-coagulant therapy . The aim of this pilot study was to examine patient 's knowledge and perceptions of AF and their anticoagulant treatment before and after a brief educational intervention . MATERIAL S AND METHODS Ninety-three patients ( 47 male ; mean ( S.D. ) age 67.3 ( 11.6 ) years ) completed the baseline interview to assess their knowledge and perceptions of AF . All patients were given an information booklet which explained what AF was , associated symptoms , the possible causes and consequences of AF , treatment options and their benefits /risks , what the INR is and what factors may effect it . The booklet was explained to each patient by the research er and given to the patient to take away for reference . Thirty-three ( 35.5 % ) patients ( 12 men ; mean ( S.D. ) age 68.0 ( 13.6 ) years ) completed the follow-up assessment to re-assess their knowledge and perceptions of AF . RESULTS Only 49 % of patients could name their cardiac condition at baseline , although the majority were aware that AF was an arrhythmia ( 80 % baseline vs. 91 % follow-up ) . Only about half the patients perceived AF as a serious condition or were aware that AF predisposes to thromboembolism at baseline . Following the educational intervention there was a non-significant increase in patient knowledge of the risks associated with AF . Of those who completed both question naires , 52 % were aware that anticoagulants prevented blood clots , which increased to 70 % post-intervention . However , few patients were aware of the benefit of stroke prevention associated with anticoagulants at baseline ( 21 % ) or after the educational intervention ( 27 % ) . The intervention had little effect on increasing awareness of the bleeding risks associated with anticoagulants , although three in five people appeared to appreciate these risks . However , the educational intervention significantly improved patient 's knowledge of the target INR range and factors that may affect INR levels ( p=0.001 and p=0.014 , respectively ) for those who completed both question naires . CONCLUSIONS Most patients with AF possess very limited knowledge about their cardiac condition , its consequences , and how anticoagulant treatment can benefit them . This pilot study has demonstrated that a brief educational intervention with an information booklet can help to somewhat improve their knowledge about anticoagulation therapy for AF Of 125 patients aged 65 years or over , with atrial fibrillation taking warfarin for at least 12 months , with a st and ard deviation ( SD ) of prothrombin time , expressed as the International Normalized Ratio ( INR ) > 0·5 over the previous 6 months , 40 were r and omized to continue with usual clinic care and 85 to receive education about warfarin . Of these , 44 were r and omized to self‐monitor their INR and 41 returned to clinic . Compared with the previous 6 months there was a significant increase in percentage time within the therapeutic range for the 6 months following education [ 61·1 vs. 70·4 ; mean difference 8·8 ; 95 % confidence interval ( CI ) : −0·2–17·8 ; P = 0·054 ] and following education and self‐monitoring ( 57 vs. 71·1 ; mean difference 14·1 ; 95 % CI : 6·7–21·5 ; P < 0·001 ) , compared with those patients following usual clinic care ( 60·0 vs. 63·2 ; mean difference 3·2 ; 95 % CI : −7·3–13·7 ) . Using the same comparative periods , the INR SD fell by 0·24 ( P < 0·0001 ) in the group allocated to education and self‐monitoring , 0·26 ( P < 0·0001 ) in the group receiving education alone and 0·16 ( P = 0·003 ) in the control group . Inter‐group differences were not statistically significant ( intervention groups 0·26 ± 0·30 vs. control 0·16 ± 0·3 , P = 0·10 ) . Quality ‐of‐life measurements and health beliefs about warfarin were unchanged ( apart from emotional role limitation ) with education or education and self‐monitoring . Patient education regarding anticoagulation therapy could be a cost‐effective initiative and is worthy of further study
Output:
| Conclusion and Relevance : This systematic review identified several AF patient knowledge gaps about their condition and its treatment that can inform the development of AF patient education programs |
MS211576 | ***TASK*** the task is to summarize an input biomedical literature 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 early bactericidal and sterilizing activities of ciprofloxacin were evaluated in the treatment of adult patients with smear positive pulmonary tuberculosis . Two r and omized prospect i ve studies were performed in Northern Tanzania . In study 1 , ten patients received either 750 mg ciprofloxacin or 300 ng isoniazid daily for 7 days . Counts of colony-forming units ( cfu ) of Mycobacterium tuberculosis in early morning sputum were performed . In study 2 , twenty patients received either a st and ard regimen of rifampin ( R ) , isoniazid ( H ) , pyrazinamide ( Z ) , and ethambutol ( E ) ( regimen HRZE ) or a trial regimen of ciprofloxacin ( C ) , isoniazid ( H ) , and rifampin ( R ) ( regimen HRC ) . Sputum colony counts were performed for 8 wk . Patients were tested for antibodies to human immunodeficiency virus (HIV)-1 . The results demonstrate that ciprofloxacin alone has useful early bactericidal activity , result ing in a mean daily fall of 0.20 log10cfu/ml/day during 7 days compared with 0.25 log10cfu/ml/day for isoniazid . When HRZE and HRC regimens were compared , the HRC regimen appeared to be inferior in its sterilizing ability , with a culture conversion rate of 67 % at 2 months compared with 100 % for HRZE . The difference in outcome was most marked in HIV-1 positive patients . The role of ciprofloxacin in combination regimens may be as a bactericidal rather than a sterilizing agent Previously untreated patients with smear-positive pulmonary tuberculosis were r and omly allocated to treatment with 600 , 300 , 150 or 75 mg doses of rifabutin ( LM427 , ansamycin ) , 600 , 300 or 150 mg of rifampicin , 300 mg isoniazid or to no drug daily for 2 days . The fall in viable counts of Mycobacterium tuberculosis in sputum collection s during the 2 days , termed the early bactericidal activity ( EBA ) , was estimated from counts of colony-forming units ( cfu ) on selective 7H-11 agar medium . The EBA for rifabutin ranged from -0.039 ( an increase in counts ) to 0.049 log10 cfu/ml/day whereas the EBA increased from 0.071 for 150 mg rifampicin to 0.293 log10 cfu/ml/day for 600 mg rifampicin and was 0.43 log10 cfu/ml/day for 300 mg isoniazid . The difference between the EBAs for rifabutin and rifampicin just attained significance ( P = 0.05 ) suggesting that rifabutin was inactive or less active than rifampicin against the extracellular bacilli in pulmonary cavities . Peak plasma concentrations of rifabutin after the initial doses were found to be proportional to dose size and were approximately 7 times lower than those after the same dose size of rifampicin . The lower EBA of rifabutin as compared to rifampicin is probably due to the low plasma concentrations which are not fully compensated for by slightly greater antituberculosis activity of rifabutin in vitro ABSTRACT We studied the early bactericidal activity of twice the st and ard dose of rifampin in subjects with pulmonary tuberculosis evidence d by positive smears . The observed mean 2-day activity was almost double that reported at the st and ard dose . Further studies are warranted to establish whether higher rifampin doses might assist in shortening tuberculosis treatment ABSTRACT Bedaquiline is a new antituberculosis agent targeting ATP synthase . This r and omized , double-blinded study enrolling 68 sputum smear-positive pulmonary tuberculosis patients evaluated the 14-day early bactericidal activity of daily doses of 100 mg , 200 mg , 300 mg , and 400 mg bedaquiline , preceded by loading doses of 200 mg , 400 mg , 500 mg , and 700 mg , respectively , on the first treatment day and 100 mg , 300 mg , 400 mg , and 500 mg on the second treatment day . All groups showed activity with a mean ( st and ard deviation ) daily fall in log10 CFU over 14 days of 0.040 ( 0.068 ) , 0.056 ( 0.051 ) , 0.077 ( 0.064 ) , and 0.104 ( 0.077 ) in the 100-mg , 200-mg , 300-mg , and 400-mg groups , respectively . The linear trend for dose was significant ( P = 0.001 ) , and activity in the 400-mg dose group was greater than that in the 100-mg group ( P = 0.014 ) . All of the bedaquiline groups showed significant bactericidal activity that was continued to the end of the 14-day evaluation period . The finding of a linear trend for dose suggests that the highest dose compatible with safety considerations should be taken forward to longer-term clinical studies The clinical utility of therapeutic drug monitoring in tuberculosis has not been adequately evaluated by controlled clinical trials . To examine the relationship between slow culture conversion and peak plasma rifampicin level ( Cmax-rfm ) in a case-control study , patients with persistence of positive sputum smear despite at least 8 weeks of directly observed treatment with st and ard pyrazinamide-containing regimens were enrolled prospect ively in government chest clinics from 16 December 2005 to 15 November 2006 . Patients with multidrug-resistant tuberculosis , human immunodeficiency virus infection , or poor treatment adherence were excluded . Cases referred to patients with persistence of positive culture whereas controls had negative culture despite positive smear . Blood was checked at 2 and 4 hours post-dosing to capture Cmax-rfm . A cohort of 88 patients was identified . After excluding 16 patients , there were 36 controls and 36 cases . None had symptoms of malabsorption . Cmax-rfm was below 6 mg/l among 47 % of controls and 44 % of cases . Univariate and multiple logistic regression analyses showed no significant association between slow culture conversion and Cmax-rfm after logarithmic transformation . Thus , there is probably no association between Cmax-rfm and slow culture conversion It is widely acknowledged that new regimens are urgently needed for the treatment of tuberculosis . The primary endpoint in the Phase III trials is a composite outcome of failure at the end of treatment or relapse after stopping treatment . Such trials are usually both long and expensive . Valid surrogate endpoints measured during or at the end of treatment could dramatically reduce both the time and cost of assessing the effectiveness of new regimens . The objective of this study was to evaluate sputum culture results on solid media during treatment as surrogate endpoints for poor outcome . Data were obtained from twelve r and omised controlled trials conducted by the British Medical Research Council in the 1970s and 80s in East Africa and East Asia , consisting of 6974 participants and 49 different treatment regimens . The month two culture result was shown to be a poor surrogate in East Africa but a good surrogate in Hong Kong . In contrast , the month three culture was a good surrogate in trials conducted in East Africa but not in Hong Kong . As well as differences in location , ethnicity and probable strain of Mycobacteria tuberculosis , Hong Kong trials more often evaluated regimens with rifampicin throughout and intermittent regimens , and patients in East African trials more often presented with extensive cavitation and were slower to convert to culture negative during treatment . An endpoint that is a summary measure of the longitudinal profile of culture results over time or that is able to detect the presence of M. tuberculosis later in treatment is more likely to be a better endpoint for a phase II trial than a culture result at a single time point and may prove to be an acceptable surrogate . More data are needed before any endpoint can be used as a surrogate in a confirmatory phase III trial BACKGROUND Rifapentine administered 5 days per week has potent activity in mouse models of antituberculosis chemotherapy , but efficacy and safety data are limited in humans . We compared the antimicrobial activity and safety of rifapentine vs rifampin during the first 8 weeks of pulmonary tuberculosis treatment . METHODS In total , 531 adults with sputum smear-positive pulmonary tuberculosis were r and omized to rifapentine 10 mg/kg/dose or rifampin 10 mg/kg/dose , administered 5 days per week for 8 weeks ( intensive phase ) , with isoniazid , pyrazinamide , and ethambutol . Co primary outcomes were negative sputum culture on liquid and on solid media at completion of intensive phase . RESULTS Negative cultures on solid media occurred in 145 of 174 participants ( 83.3 % ) in the rifampin group and 171 of 198 participants ( 86.4 % ) in the rifapentine group ( difference , 3.0 % ; 95 % confidence interval [ CI ] : -4.3 , 10.5 ) ; negative cultures in liquid media occurred in 110 of 169 ( 65.1 % ) in the rifampin group and 133 of 196 ( 67.9 % ) in the rifapentine group ( difference , 2.8 % ; 95 % CI : -6.9 , 12.4 ) . Among 529 participants who received study therapy , 40 of 254 participants ( 15.7 % ) in the rifampin group and 40 of 275 participants ( 14.5 % ) in the rifapentine group prematurely discontinued treatment ( P=.79 ) . CONCLUSIONS The rifapentine regimen was safe but not significantly more active than a st and ard rifampin regimen , by the surrogate endpoint of culture status at completion of intensive phase . Assessment of higher exposures to rifapentine for tuberculosis treatment is warranted . CLINICAL TRIALS REGISTRATION NCT00694629 RATIONALE Moxifloxacin has potent activity against Mycobacterium tuberculosis in vitro and in a mouse model of antituberculosis ( TB ) chemotherapy , but data regarding its activity in humans are limited . OBJECTIVES Our objective was to compare the antimicrobial activity and safety of moxifloxacin versus isoniazid during the first 8 weeks of combination therapy for pulmonary TB . METHODS Adults with sputum smear-positive pulmonary TB were r and omly assigned to receive either moxifloxacin 400 mg plus isoniazid placebo , or isoniazid 300 mg plus moxifloxacin placebo , administered 5 days/week for 8 weeks , in addition to rifampin , pyrazinamide , and ethambutol . All doses were directly observed . Sputum was collected for culture every 2 weeks . The primary outcome was negative sputum culture at completion of 8 weeks of treatment . MEASUREMENTS AND MAIN RESULTS Of 433 participants enrolled , 328 were eligible for the primary efficacy analysis . Of these , 35 ( 11 % ) were HIV positive , 248 ( 76 % ) had cavitation on baseline chest radiograph , and 213 ( 65 % ) were enrolled at African sites . Negative cultures at Week 8 were observed in 90/164 ( 54.9 % ) participants in the isoniazid arm , and 99/164 ( 60.4 % ) in the moxifloxacin arm ( P = 0.37 ) . In multivariate analysis , cavitation and enrollment at an African site were associated with lower likelihood of Week-8 culture negativity . The proportion of participants who discontinued assigned treatment was 31/214 ( 14.5 % ) for the moxifloxacin group versus 22/205 ( 10.7 % ) for the isoniazid group ( RR , 1.35 ; 95 % CI , 0.81 , 2.25 ) . CONCLUSIONS Substitution of moxifloxacin for isoniazid result ed in a small but statistically nonsignificant increase in Week-8 culture negativity RATIONALE Moxifloxacin has promising pre clinical activity against Mycobacterium tuberculosis , but has not been evaluated in multidrug treatment of tuberculosis in humans . OBJECTIVE To compare the impact of moxifloxacin versus ethambutol , both in combination with isoniazid , rifampin , and pyrazinamide , on sputum culture conversion at 2 mo as a measure of the potential sterilizing activity of alternate induction regimens . METHODS Adults with smear-positive pulmonary tuberculosis were r and omized in a factorial design to receive moxifloxacin ( 400 mg ) versus ethambutol given 5 d/wk versus 3 d/wk ( after 2 wk of daily therapy ) . All doses were directly observed . MEASUREMENTS The primary endpoint was sputum culture status at 2 mo of treatment . RESULTS Of 336 patients enrolled , 277 (
Output:
| Bacteriological results were as often expressed in terms of positivity as negativity , with varying definitions of culture conversion . |
MS211577 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: Objective To determine whether mobile phone based monitoring improves asthma control compared with st and ard paper based monitoring strategies . Design Multicentre r and omised controlled trial with cost effectiveness analysis . Setting UK primary care . Participants 288 adolescents and adults with poorly controlled asthma ( asthma control question naire ( ACQ ) score ≥1.5 ) from 32 practice s. Intervention Participants were central ly r and omised to twice daily recording and mobile phone based transmission of symptoms , drug use , and peak flow with immediate feedback prompting action according to an agreed plan or paper based monitoring . Main outcome measures Changes in scores on asthma control question naire and self efficacy ( knowledge , attitude , and self efficacy asthma question naire ( KASE-AQ ) ) at six months after r and omisation . Assessment of outcomes was blinded . Analysis was on an intention to treat basis . Results There was no significant difference in the change in asthma control or self efficacy between the two groups ( ACQ : mean change 0.75 in mobile group v 0.73 in paper group , mean difference in change −0.02 ( 95 % confidence interval −0.23 to 0.19 ) ; KASE-AQ score : mean change −4.4 v −2.4 , mean difference 2.0 ( −0.3 to 4.2 ) ) . The numbers of patients who had acute exacerbations , steroid courses , and unscheduled consultations were similar in both groups , with similar healthcare costs . Overall , the mobile phone service was more expensive because of the expenses of telemonitoring . Conclusions Mobile technology does not improve asthma control or increase self efficacy compared with paper based monitoring when both groups received clinical care to guidelines st and ards . The mobile technology was not cost effective . Trial registration Clinical Trials NCT00512837 AIMS There is increasing international interest in using emerging technologies to enhance chronic disease management . We aim ed to explore the attitudes of patients and primary care professionals to using mobile technology in order to monitor asthma . METHODS A piloted question naire containing closed and open-ended questions assessing attitudes to using electronic self-monitoring was posted to a r and om sample of general practitioners , asthma nurses , and people with asthma ( 12 years and over ) in Lothian and Kent , UK , with 2 reminders . In addition to descriptive statistics , patient and clinician responses were compared using Chi-squared or independent sample t-tests . Free-text responses were analysed thematically . RESULTS Responses were obtained from 130/300 professionals ( 43 % ) and 202/389 patients ( 52 % ) . Patients rated the technology positively and considered that it may help clinicians to provide care , especially during acute attacks . Although rated similarly , professionals were more sceptical about benefits . Both professionals and patients had concerns about the time and cost implication s. Of the respondents , 28 professionals ( 10 % ) and 62 patients ( 16 % ) returned uncompleted question naires citing lack of perceived relevance . CONCLUSIONS The low completion rate probably reflects the current status of mobile phone-facilitated care as a minority interest for ' early adopters ' of technology . Even for the enthusiastic minority , using mobile phone technology raised questions of clinical benefit , impact on self-management , and concerns about workload and cost , which will need to be addressed prior to wider acceptance The self-management of asthma can improve clinical outcomes . Recently , mobile telephones have been widely used as an efficient , instant personal communication tool . This study investigated whether a self-care system will achieve better asthma control through a mobile telephone-based interactive programme . This was a prospect i ve , controlled study in outpatient clinics . From 120 consecutive patients with moderate-to-severe persistent asthma , 89 were eventually recruited for the study , with 43 in the mobile telephone group ( with a mobile telephone-based interactive asthma self-care system ) . In the mobile telephone group , mean±sem peak expiratory flow rate significantly increased at 4 ( 378.2±9.3 L·min−1 ; n = 43 ; p = 0.020 ) , 5 ( 378.2±9.2 L·min−1 ; n = 43 ; p = 0.008 ) and 6 months ( 382.7±8.6 L·min−1 ; n = 43 ; p = 0.001 ) compared to the control group . Mean±sem forced expiratory volume in 1 s significantly increased at 6 months ( 65.2±3.2 % predicted ; n = 43 ; p<0.05 ) . Patients in the mobile telephone group had better quality of life after 3 months , as determined using the Short Form-12 ® physical component score , and fewer episodes of exacerbation and unscheduled visits than the control group . Patients in the mobile telephone group significantly increased their mean daily dose of either systemic or inhaled corticosteroids compared with the control group . The mobile telephone-based interactive self-care system provides a convenient and practical self-monitoring and -management of asthma , and improves asthma control Objectives : To determine whether well trained lay people could deliver asthma self-management education with comparable outcomes to that achieved by primary care based practice nurses . Design : R and omised equivalence trial . Setting : 39 general practice s in West London and North West Engl and . Participants : 567 patients with asthma who were on regular maintenance therapy . 15 lay educators were recruited and trained to deliver asthma self-management education . Intervention : An initial consultation of up to 45 min offered either by a lay educator or a practice based primary care nurse , followed by a second shorter face to face consultation and telephone follow-up for 1 year . Main outcome measures : Unscheduled need for healthcare . Secondary outcome measures : Patient satisfaction and need for courses of oral steroids . Results : 567 patients were r and omised to care by a nurse ( n = 287 ) or a lay educator ( n = 280 ) and 146 and 171 , respectively , attended the first face to face educational session . During the first two consultations , management changes were made in 35/146 patients seen by a practice nurse ( 24.0 % ) and in 56/171 patients ( 32.7 % ) seen by a lay educator . For 418/567 patients ( 73.7 % ) , we have 1 year data on use of unscheduled healthcare . Under an intention to treat approach , 61/205 patients ( 29.8 % ) in the nurse led group required unscheduled care compared with 65/213 ( 30.5 % ) in the lay led group ( 90 % CI for difference −8.1 % to 6.6 % ; 95 % CI for difference −9.5 % to 8.0 % ) . The 90 % CI contained the predetermined equivalence region ( −5 % to + 5 % ) giving an inconclusive result regarding the equivalence of the two approaches . Despite the fact that all patients had been prescribed regular maintenance therapy , 122/418 patients ( 29.2 % ) required courses of steroid tablets during the course of 1 year . Patient satisfaction following the initial face to face consultation was similar in both groups . Conclusions : It is possible to recruit and train lay educators to deliver a discrete area of respiratory care , with comparable outcomes to those seen by nurses . Trial registration number : AIM To evaluate patient underst and ing of their asthma and determine patient preferences regarding the delivery of asthma care and treatment . METHODS Adults with asthma receiving treatment for mild to moderate asthma were recruited to a two-part study : a qualitative phase using a semi-structured interview schedule followed by a quantitative phase based on a structured interview schedule . All interviews were undertaken face-to-face . SETTING AND SUBJECTS A r and om sample of 40 patients with mild to moderate asthma from seven areas of the UK took part in the qualitative phase of the study . In the quantitative phase , 517 patients on treatment for mild to moderate asthma were interviewed in person by market research ers . This population was achieved using a quota sampling approach that also achieved a representative demographic profile . Initial contact was made in door-to-door calls . Interviews took place in 64 locations across the UK . RESULTS Ninety-one percent ( n=468 ) of respondents felt their asthma was under control , yet two-thirds ( n=339 ) experienced symptoms at least 2 - 3 times a week . Only 24 % ( n=123 ) felt their asthma could improve over time , and 71 % ( n=366 ) received no advice from healthcare professionals on how their asthma might change in the future . Fourteen percent ( n=74 ) of respondents had no ongoing contact with any healthcare professional regarding their asthma . Fifty-eight percent ( n=301 ) were very satisfied with their asthma care , but this dropped to 33 % ( n=173 ) when respondents were shown asthma guidelines regarding what to expect from treatment . Sixty-two percent ( n=318 ) of respondents said their asthma varied at different times of the day , and 86 % ( n=444 ) stated that their asthma varied at different times of the year . Eighty percent ( n=414 ) of respondents had never been provided with a written , personal asthma action plan recommending changes patients could make themselves to prescribed treatment according to symptom severity , though 68 % ( n=353 ) said they would feel comfortable following such a plan . CONCLUSIONS Most patients have low expectations of what can be achieved by asthma management and do not realise their condition can be improved . Many are resigned to the effects of poor asthma control until made aware that guidelines indicate this can be better . Given that many are receptive to the notion of written , personal asthma action plans , the implementation of these , supported by appropriate education , could help patients achieve improved asthma control BACKGROUND Adherence to medication regimens is poor in the management of chronic diseases , including asthma . OBJECTIVE To determine whether an audiovisual reminder device improves adherence with inhaled corticosteroid ( ICS ) therapy in adult asthma . METHODS A r and omized open-label parallel group study of 110 adult or adolescent subjects with asthma was undertaken . Subjects were r and omized to receive 24 weeks of fluticasone propionate 250 microg , 1 actuation twice daily via a metered dose inhaler ( MDI ) with or without an audiovisual reminder function ( AVRF ) . All MDIs had electronic covert adherence monitors . The primary outcome variable was adherence , defined as the proportion of medication taken as prescribed over the final 12 weeks of the study . Adherence was also assessed as the proportion of subjects who took > 50 % , > 80 % , or > 90 % of prescribed medication . RESULTS The proportion of medication taken in the last 12 weeks was greater in the AVRF group ( 93 % ) compared with the control group ( 74 % ) , with a difference of 18 % ( 95 % confidence interval [ CI ] 10 - 26 % ; P < .0001 ) . The proportion of subjects taking > 50 % , > 80 % , or > 90 % of their medication was greater in the AVRF group , with a ratio of proportions adherent of 1.33 ( 95 % CI , 1.10 - 1.61 ; P = .003 ) , 2.27 ( 95 % CI , 1.56 - 3.3 ; P < .0001 ) , and 3.25 ( 95 % CI , 1.74 - 6.1 % ; P < .0001 ) , respectively . CONCLUSION An audiovisual reminder function can significantly improve adherence with ICS therapy in adult asthma . CLINICAL IMPLICATION S An audiovisual reminder function has potential to improve adherence with medication regimens across a wide spectrum of diseases , in both research and clinical practice Objective . To evaluate the impact of peak flow or symptom-based self – management plans on asthma control and patients ' quality of life and to determine the main psychosocial factors that affect compliance with these plans . Methods . The study sample consisted of 63 patients with persistent asthma out patients . Data collection included demographics , pulmonary functions , symptom scores , and asthma control parameters recorded over the previous 2 consecutive years . A st and ard asthma self-management education program including personal action plans was given to the patients who were r and omly divided into peak flow meter ( PFM ) ( n = 31 ) or symptom-based ( n = 32 ) action plan groups . Patients were then assessed prospect ively for various study outcomes including symptoms , drug compliance , psychiatric co-morbidities , quality of life , and asthma control over the next 12 months . Psychiatric co-morbidities were assessed using Rotter 's Internal and External Locus of Control Scale ( RIELCS ) , Beck Depression Inventory ( BDI ) , Structured Clinical Interview for DSM-IV ( SCID-I ) , Spielberger State-Trait-Anxiety Inventory ( STAI ) , and Short Form-36 ( SF-36 ) . Results . Of the 63 patients ( 79 % female ; mean age 43 ) , 85 % of them had moderately or severely persistent asthma . Baseline demographics , clinical parameters , psychiatric diagnosis , and quality of life were not different between groups . Personal asthma plans increased optimal asthma control significantly . Emergency visits , antibiotic treatments , systemic corticosteroid treatments , and unscheduled visits were fewer than the previous year . Control parameters were better in the PFM group . After the self-management education , the quality of life dimensions , i.e. , vitality , total mental and general scores of both groups increased . Frequency of psychiatric co-
Output:
| Both studies failed to find any statistical differences in terms of adherence to the intervention and occurrence of other asthma-related complications . |
MS211578 | ***TASK*** the task is to summarize an input biomedical literature 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: Acitretin , the principal and free acid metabolite of etretinate , was used to treat patients with stable , plaque-type psoriasis . For the first 8 weeks , 38 patients received placebo or acitretin , 10 , 25 , 50 , or 75 mg daily , in a double-blind manner . After the double-blind phase , the patients were allowed to continue for a total of 6 months of acitretin therapy at an average dosage of 50 mg/day . When the patients flared after stopping therapy , an additional 6-month course of acitretin therapy was offered . Acitretin , which was as effective as etretinate , had to be given at a dosage of 50 mg/day or more to obtain a significant benefit . Side effects frequently occurred in patients receiving acitretin , 25 mg/day or more , but were generally mild and did not warrant discontinuation of therapy . They were similar to those of etretinate therapy ; cheilitis , peeling of palms and soles , and alopecia occurred most frequently . The most common abnormal laboratory test results were elevations in serum triglycerides and , to a lesser extent , serum cholesterol and liver transaminase levels . Acitretin , in view of its much shorter half-life and similar efficacy and side-effect profile compared with etretinate , may be a preferable therapy for psoriasis , especially in women of childbearing age Acitretin , the active metabolite of etretinate , has the clinical advantage of a much shorter terminal elimination half-life . We report the results of a double-blind , placebo-controlled trial of acitretin ( Soriatane ) in 15 patients with moderate to severe psoriasis . Patients received 25 mg or 50 mg daily of acitretin or placebo in a double-blind fashion for 8 weeks and then were given 25 to 75 mg acitretin daily during an open study . Only two placebo patients completed the double-blind phase ; one patient 's psoriasis worsened , and one showed no significant change . All 15 patients then completed at least 8 weeks with 25 to 75 mg acitretin daily , with a moderate change in erythema , scaling , and in duration ( mean 28 % to 37 % improvement ) but with minimal change in the percentage of body surface area involved . Prolonged treatment ( greater than or equal to 20 weeks ) with acitretin result ed in further significant improvement and a 44 % reduction of involved surface area from baseline Acitretin , a metabolite of etretinate , was given to 38 patients for the treatment of psoriasis . During the first 8 weeks patients received either placebo , 10 mg , 25 mg , 50 mg , or 75 mg of acitretin daily in a double-blind manner . The dosages of 10 mg and 25 mg daily did not achieve any statistically significant improvement in psoriasis over placebo ; however , both the 50 and 75 mg dosages were statistically significantly better than placebo . Side effects were primarily mucocutaneous and occurred in most patients receiving 25 mg or more of acitretin daily . After the double-blind period , patients continued treatment in an open fashion until they had received a total of 24 weeks of acitretin therapy . Most patients received 50 mg of acitretin daily , which adequately cleared their psoriasis . After approximately 3 months without acitretin , most patients required retreatment . Subsequent 24-week courses of therapy were generally effective and well tolerated . The most common laboratory abnormalities were elevations of triglyceride , cholesterol , and liver transaminase levels . The efficacy and side effects of acitretin appear to be similar to those of etretinate ; the principal advantage of acitretin is its shorter half-life . Although acitretin is a potent teratogen , its rapid elimination makes it a viable treatment for psoriasis among women of childbearing potential BACKGROUND Psoriasis vulgaris may benefit from treatment with fumaric acid and /or its derivatives ; however , because different preparations have been used , results have been contradictory and difficult to interpret . OBJECTIVE The purpose of this clinical trial was to evaluate the therapeutic value of fumaric acid derivatives . METHODS A r and omized double-blind study was carried out in patients with psoriasis , comparing a well-characterized formulation of fumaric acid derivatives with placebo . RESULTS The results indicated statistically significant superiority of the fumaric acid derivatives over placebo . Adverse events ( flush , gastrointestinal disturbances ) were initially relatively frequent , but decreased thereafter . CONCLUSION Fumaric acid derivatives were found to be effective and safe in the treatment of psoriasis In a 4-month double-blind study the effects of dimethylfumaric acid esters ( DMFAE-EC ) and DMFAE plus salts of monoethylfumaric acid esters ( fumaric acid combination , FAC-EC ) in enteric-coated tablets were compared in 22 respectively 23 patients with psoriasis . In both groups about 50 % showed a considerable improvement , i.e. the initial score was more than halved . The therapeutic effects showed no significant differences in both groups with respect to the total psoriasis score or the different parameters . In the FAC-EC group the effects were obtained more rapidly . Most frequently observed side effects in both groups were flushings , stomachache and diarrhea . Due to these complaints 3 respectively 8 patients discontinued therapy . Eosinophilia , leukopenia and lymphopenia were the most frequently observed differences in lab tests . It was concluded that FAC-EC had no significantly better effect than monotherapy with DMFAE-EC . Moreover , enteric coating of the tablets did not prevent stomach complaints . Until more information has been obtained about the pharmacokinetics , the toxicity and optimal composition of the drug , the fumaric acid therapy in psoriasis should be seen as experimental Background : Calcipotriol is an established topical therapy for psoriasis vulgaris . Objective : This study aim ed to investigate whether the addition of calcipotriol to fumaric acid ester ( FAE ) monotherapy had an additive efficacy and an FAE-sparing effect in patients with severe plaque psoriasis . Methods : This multicentre , r and omised , double-blind , vehicle-controlled study included 143 patients for up to 13 weeks treatment . Group A received FAE tablets ( Fumaderm ® ) with an increasing daily dosage from 105 to 1,075 mg + ointment vehicle . Group B received FAE tablets + calcipotriol ointment ( 50 µg/g ) . Ointments were applied twice daily . Clinical response was assessed using percentage changes in the Psoriasis Area and Severity Index ( PASI ) , from baseline to treatment end . Results : The mean percentage change in the PASI was –76.1 % in group B and –51.9 % in group A , the difference between treatments was –24.2 % ( 95 % CI from –34.2 to –14.2 % ; p < 0.001 ) . Group B responded more rapidly to treatment . Investigators ’ and patients ’ overall efficacy assessment s were significantly more favourable for group B ( p ≤ 0.001 ) . Group B was prescribed less FAE than group A. This difference was greatest at the last visit ( mean daily dose 529 and 685 mg , respectively ; p = 0.006 ) . Overall adverse events in the two groups were similar . Conclusion : This study shows that the combination of calcipotriol and FAEs is significantly more effective and faster acting than FAE monotherapy in the treatment of severe plaque psoriasis . The combination has a slight FEA-sparing effect and therefore a superior benefit/risk ratio
Output:
| One head‐to‐head study of very low‐ quality evidence comparing FAEs with methotrexate reported comparable efficacy and dropout rates , although FAEs caused more flushing . |
MS211579 | ***TASK*** the task is to summarize an input biomedical literature 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: Wilms tumor gene ( WT1 ) protein is an attractive target for cancer immunotherapy . We aim ed to investigate the feasibility of a combination therapy consisting of gemcitabine and WT1 peptide – based vaccine for patients with advanced pancreatic cancer and to make initial assessment s of its clinical efficacy and immunologic response . Thirty-two HLA-A*24:02 + patients with advanced pancreatic cancer were enrolled . Patients received HLA-A*24:02-restricted , modified 9-mer WT1 peptide ( 3 mg/body ) emulsified with Montanide ISA51 adjuvant ( WT1 vaccine ) intradermally biweekly and gemcitabine ( 1000 mg/m2 ) on days 1 , 8 , and 15 of a 28-day cycle . This combination therapy was well tolerated . The frequencies of grade 3–4 adverse events for this combination therapy were similar to those for gemcitabine alone . Objective response rate was 20.0 % ( 6/30 evaluable patients ) . Median survival time and 1-year survival rate were 8.1 months and 29 % , respectively . The association between longer survival and positive delayed-type hypersensitivity to WT1 peptide was statistically significant , and longer survivors featured a higher frequency of memory-phenotype WT1-specific cytotoxic T lymphocytes both before and after treatment . WT1 vaccine in combination with gemcitabine was well tolerated for patients with advanced pancreatic cancer . Delayed-type hypersensitivity-positivity to WT1 peptide and a higher frequency of memory-phenotype WT1-specific cytotoxic T lymphocytes could be useful prognostic markers for survival in the combination therapy with gemcitabine and WT1 vaccine . Further clinical investigation is warranted to determine the effectiveness of this combination therapy Background Advanced pancreatic cancer has a poor prognosis , and the current st and ard of care ( gemcitabine based chemotherapy ) provides a small survival advantage . However the drawback is the accompanying systemic toxicity , which targeted treatments may overcome . This study aim ed to evaluate the safety and tolerability of KAb201 , an anti-carcinoembryonic antigen monoclonal antibody , labelled with I131 in pancreatic cancer ( IS RCT N 16857581 ) . Methods Patients with histological/cytological proven inoperable adenocarcinoma of the head of pancreas were r and omised to receive KAb 201 via either the intra-arterial or intravenous delivery route . The dose limiting toxicities within each group were determined . Patients were assessed for safety and efficacy and followed up until death . Results Between February 2003 and July 2005 , 25 patients were enrolled . Nineteen patients were r and omised , 9 to the intravenous and 10 to the intra-arterial arms . In the intra-arterial arm , dose limiting toxicity was seen in 2/6 ( 33 % ) patients at 50 mCi whereas in the intravenous arm , dose limiting toxicity was noted in 1/6 patients at 50 mCi , but did not occur at 75 mCi (0/3).The overall response rate was 6 % ( 1/18 ) . Median overall survival was 5.2 months ( 95 % confidence interval = 3.3 to 9 months ) , with no significant difference between the intravenous and intra-arterial arms ( log rank test p = 0.79 ) . One patient was still alive at the time of this analysis . Conclusion Dose limiting toxicity for KAb201 with I131 by the intra-arterial route was 50 mCi , while dose limiting toxicity was not reached in the intravenous arm Genetically modified lymphoblastoid cell lines ( LCL ) have been shown to be an attractive alternative source of antigen-presenting cells for cancer vaccination in vitro . We tested their application in patients with pancreatic cancer in a phase I clinical trial . As a model tumor antigen , we selected the point-mutated ( codon 12 ) Ki-Ras p21 oncogene ( muRas ) frequently ( ∼85 % ) present in pancreatic adenocarcinoma . Autologous LCLs were established in vitro by spontaneous outgrowth from peripheral blood lymphocytes of seven pancreatic carcinoma patients and were genetically modified with an episomal Epstein-Barr virus (EBV)-based expression vector to express muRas ( muRas-LCL ) . Weekly vaccinations with subcutaneous injection of 5 × 10(6 ) muRas-LCL were done . In six of seven patients , therapeutic vaccination elicited a T-cell response with an increase in the frequency of muRas-specific precursor cytotoxic T lymphocytes in the peripheral blood and positive delayed-type hypersensitivity reactions at the injection site . Besides local reactions and flu-like symptoms , there were no signs of toxicity and no acute EBV infection , onset of EBV-associated lymphoma , or other severe complications . A clinical response ( stable disease ) was observed for a short time period ( 2 - 4 months ) in four of seven patients ( 57 % ) , mostly in earlier tumor stages . Our results indicate that LCL presenting genetically modified antigen represent a valuable and easily available tool for in vivo autologous tumor vaccination . LCL can be transfected with any known tumor antigen and therefore should be further clinical ly investigated Background Dendritic cell (DC)-based and cytokine-induced killer cell (CIK)-based therapy can induce specific antitumor T-cell responses . This clinical pilot study examined the safety , the feasibility , and the outcome of tumor-specific immunotherapy for patients with advanced pancreatic adenocarcinoma . Methods Alpha-Gal epitopes were synthesis ed on pancreatic carcinoma cell membranes with α1,3-galactosyltransferase in vitro . Subsequently , the addition of natural human anti-Gal IgG to the processed membranes result ed in opsonization and effective phagocytosis by DCs , which were co-cultured with newly differentiated CIKs from bone marrow stem cells to generate tumor-specific immune responders ex vivo . Fourteen patients with inoperable stage III/IV pancreatic adenocarcinoma were enrolled in the study ; the treatment procedure consisted of injections of DCs and CIKs . Results Clinical observation showed that the procedure was safe and lacked serious side effects . Tests showed that 12 patients had strong positive delayed-type IV hypersensitivity to the autologous cancer cell lysate ; robust systemic cytotoxicity elicited by interferon (IFN)γ expression by peripheral blood mononuclear cells ; and significant increases in CD3+CD8 + , CD3+CD45RO+ , and CD3+CD56 + cells in peripheral blood lymphocytes after 3 injections . During the follow up , the percentages of CD3+CD8 + , CD3+CD45RO+ , and CD3+CD56 + cells returned to the normal range at 6 to 9 months after the third injection and IFNγ expression in the cells stayed at the higher level from the third injection to 24 months after the treatment . Conclusions This new tumor-specific immunotherapy is safe , feasible , and has great potential for pancreatic carcinoma treatment We evaluated the safety of , and clinical and immune responses to personalized peptide vaccination with gemcitabine ( GEM ) as the first line therapy in patients with non-resectable pancreatic cancer . Pre-vaccination peripheral blood mononuclear cells ( P BMC s ) and plasma were prepared to examine cellular and humoral responses to 14 and 16 peptides in human leukocyte antigen (HLA)-A24 + or -A2 + patients , respectively . Only the reactive peptides ( maximum of 4 ) were administered weekly at 3 mg/peptide . GEM was administered at 1000 mg/m(2 ) per week for 3 weeks , followed by 1 week of rest . Twenty-one patients with untreated and non-resectable pancreatic cancer were enrolled . The combination therapy was generally well tolerated . Boosting of cellular and humoral responses to the vaccinated peptides was observed in the post-vaccination ( eighth ) P BMC s and plasma from 14 of 18 and 13 of 18 patients tested , respectively . The best clinical responses were 7 cases of partial response , 9 cases of stable disease , and 5 cases of progressive disease . Median survival time of all 21 patients was 9.0 months ( 95 % CI , 6 - 15.5 months ) with a one year survival rate of 38 % . Immune boosting in both cellular and humoral responses was well correlated with overall survival with a hazard ratio of 0.2 ( 95 % CI , 0.06 - 0.73 ; log-rank p=0.0239 ) . These results suggest a potential clinical benefit of this combination therapy for non-resectable pancreatic cancer patients as the first line therapy . Further exploration of this approach is warranted Background We previously developed an immunotherapy treatment utilizing a cancer vaccine reagent KIF20A-66 in order to treat pancreatic cancer . KIF20A-66 is HLA-A24-restricted epitope peptide derived from KIF20A , a member of kinesin super family protein 20A that is significantly transactivated in pancreatic cancer . In this report , we further demonstrated non-r and omized , open-label , single centered phase I/II clinical trial of immunotherapy using the KIF20A-66 peptide for the patients with advanced pancreatic cancer . Methods Vaccination was performed to the patients with metastatic pancreatic cancer , in whom gemcitabine-based therapy had failed . In phase I study , KIF20A-66 peptide was subcutaneously injected weekly in a dose-escalation manner ( doses of 1.0 and 3.0 mg/body , 6 patients /1 cohort ) . After safety was assessed , phase II study was conducted using 3.0 mg of KIF20A-66 peptide . Results KIF20A-66 peptide vaccination was well tolerated in the doses we examined and tumor responses after 1 month of the treatment were evaluated . Among 29 patients who completed one course of the treatment at least , stable disease ( SD ) was found in 21 cases , while progressive disease ( PD ) was found in 8 cases , indicating that the disease control rate was 72 % . Objective tumor shrinkage was observed in 8 cases , including 1 case of complete response ( CR ) . The median survival time ( MST ) and progression free survival time ( PFS ) were 142 days and 56 days , respectively . These results clearly demonstrate that overall survival of the patients was significantly prolonged , compared to the historical controls of 9 cases with unmatched HLA in the same hospital ( MST : 83 days ) , as well as 81 cases in our and other hospitals ( MST : 63 days ) . Conclusion The patients vaccinated with KIF20A-66 peptide had better prognosis than the control group with best supportive care ( BSC ) . Thus , we concluded that KIF20A-66 vaccination is significantly effective as an immunotherapy against advanced pancreatic cancer . KIF20A-66 peptide was well tolerable in the dose of either 1.0 mg or 3.0 mg/body , and effectively induced peptide-specific response of cytotoxic T lymphocyte ( CTL ) . Further clinical study using this peptide is a promising approach for advanced pancreatic cancer to achieve high potential benefit for better prognosis . Clinical trial registration UMIN-CTR , number Purpose : We performed a phase I trial to investigate the safety , clinical responses , and Wilms ' tumor 1 (WT1)-specific immune responses following treatment with dendritic cells ( DC ) pulsed with a mixture of three types of WT1 peptides , including both MHC class I and II – restricted epitopes , in combination with chemotherapy . Experimental Design : Ten stage IV patients with pancreatic ductal adenocarcinoma ( PDA ) and 1 patient with intrahepatic cholangiocarcinoma ( ICC ) who were HLA-positive for A*02:01 , A*02:06 , A*24:02 , DRB1 * 04:05 , DRB1 * 08:03 , DRB1 * 15:01 , DRB1 * 15:02 , DPB1 * 05:01 , or DPB1 * 09:01 were enrolled . The patients received one course of gemcitabine followed by biweekly intradermal vaccinations with mature DCs pulsed with MHC class I ( DC/WT1-I ; 2 PDA and 1 ICC ) , II ( DC/WT1-II ; 1 PDA ) , or I/II – restricted WT1 peptides ( DC/WT1-I/II ; 7 PDA ) , and gemcitabine . Results : The combination therapy was well tolerated . WT1-specific IFNγ-producing CD4 + T cells were significantly increased following treatment with DC/WT1-I/II . WT1 peptide-specific delayed-type hypersensitivity ( DTH ) was detected in 4 of the 7 patients with PDA vaccinated with DC/WT1-I/II and in 0 of the 3 patients with PDA vaccinated with DC/WT1-I or DC/WT1-II . The WT1-specific DTH-positive patients showed significantly improved overall survival ( OS ) and progression
Output:
| We found that significantly improved OS was noted for PC patients utilizing specific immunotherapy and an improved immune response was also observed .
In conclusion , specific immunotherapy was superior in prolonging the survival time and enhancing immunological responses in PC patients |
MS211580 | ***TASK*** the task is to summarize an input biomedical literature 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 wished to determine the short-term safety and efficacy of a Chinese medicinal herb preparation in treating symptoms of human immunodeficiency virus ( HIV ) infection in a 12-week r and omized , double-blind , placebo-controlled clinical trial in a University-affiliated acquired immunodeficiency syndrome ( AIDS ) clinic at a public general hospital . Thirty adults with symptomatic HIV infection , no previous AIDS-defining diagnosis , and CD4 + counts of 0.200 - 0.499 x 10(9)/L ( 200 - 499/mm3 ) received 28 tablets each day of either a st and ardized oral preparation of 31 Chinese herbs or a cellulose placebo . Primary outcome measures were changes in life satisfaction , perceived health , and number and severity of symptoms . Other outcomes included adherence , and changes in weight , CD4 + count , depression , anxiety , physical and social function , and mental health . Two placebo- and no herb-treated subjects had mild adverse events ( AE ) . Subjects on both arms reported taking 94 % of prescribed tablets . No differences between treatment groups reached the p < 0.05 level . Life satisfaction improved in herb-treated [ + 0.86 , 95 % confidence interval ( CI ) : + 0.29 , + 1.43 ] but not in placebo-treated subjects ( + 0.20 , 95 % CI -0.35 , + 0.75 ) . Number of symptoms was reduced in subjects receiving herbs ( -2.2 , 95 % CI -4.1 , -0.3 ) but not in those receiving placebo ( -0.3 , 95 % CI -3.2 , + 2.7 ) . There were trends toward greater improvements among herb-treated subjects on all symptom subscales except dermatologic . Believing that one was receiving herbs was strongly associated with reporting that the treatment had helped ( p < 0.005 ) , but not with changes in life satisfaction or symptoms . There were improvements in life satisfaction and symptoms among subjects receiving the herbal therapy . Whether Chinese herbs are effective in the management of symptomatic HIV infection can be adequately addressed only by larger trials of longer duration Assigned r and omly 28 neonates born to HIV-positive mothers to a massage therapy or control group . The treatment infants were given three 15-minute massages daily for 10 days . The massaged group showed superior performance on almost every Brazelton newborn cluster score and had a greater daily weight gain at the end of the treatment period unlike the control group who showed declining performance CONTEXT Peripheral neuropathy is common in persons infected with the human immunodeficiency virus ( HIV ) but few data on symptomatic treatment are available . OBJECTIVE To evaluate the efficacy of a st and ardized acupuncture regimen ( SAR ) and amitriptyline hydrochloride for the relief of pain due to HIV-related peripheral neuropathy in HIV-infected patients . DESIGN R and omized , placebo-controlled , multicenter clinical trial . Each site enrolled patients into 1 of the following 3 options : ( 1 ) a modified double-blind 2 x 2 factorial design of SAR , amitriptyline , or the combination compared with placebo , ( 2 ) a modified double-blind design of an SAR vs control points , or ( 3 ) a double-blind design of amitriptyline vs placebo . SETTING Terry Beirn Community Programs for Clinical Research on AIDS ( HIV primary care providers ) in 10 US cities . PATIENTS Patients with HIV-associated , symptomatic , lower-extremity peripheral neuropathy . Of 250 patients enrolled , 239 were in the acupuncture comparison ( 125 in the factorial option and 114 in the SAR option vs control points option ) , and 136 patients were in the amitriptyline comparison ( 125 in the factorial option and 11 in amitriptyline option vs placebo option ) . INTERVENTIONS St and ardized acupuncture regimen vs control points , amitriptyline ( 75 mg/d ) vs placebo , or both for 14 weeks . MAIN OUTCOME MEASURE Changes in mean pain scores at 6 and 14 weeks , using a pain scale ranging from 0.0 ( no pain ) to 1.75 ( extremely intense ) , recorded daily . RESULTS Patients in all 4 groups showed reduction in mean pain scores at 6 and 14 weeks compared with baseline values . For both the acupuncture and amitriptyline comparisons , changes in pain score were not significantly different between the 2 groups . At 6 weeks , the estimated difference in pain reduction for patients in the SAR group compared with those in the control points group ( a negative value indicates a greater reduction for the " active " treatment ) was 0.01 ( 95 % confidence interval [ CI ] , -0.11 to 0.12 ; P=.88 ) and for patients in the amitriptyline group vs those in the placebo group was -0.07 ( 95 % CI , -0.22 to 0.08 ; P=.38 ) . At 14 weeks , the difference for those in the SAR group compared with those in the control points group was -0.08 ( 95 % CI , -0.21 to 0.06 ; P=.26 ) and for amitriptyline compared with placebo was 0.00 ( 95 % CI , -0.18 to 0.19 ; P=.99 ) . CONCLUSIONS In this study , neither acupuncture nor amitriptyline was more effective than placebo in relieving pain caused by HIV-related peripheral neuropathy A pretest-posttest design ( with a 6-week wait-list control and a 6-month comparison group ) was used to compare the effectiveness of a 6-week stress management training program with st and ard outpatient care for 45 men with HIV disease . Outcomes included stress levels , coping patterns , quality of life , psychological distress , illness-related uncertainty , and CD4 + T-lymphocyte levels . At 6 weeks , intervention was associated with increases in the emotional well-being dimension of quality of life . After 6 months , the intervention group had a relative decline in HIV-related intrusive thinking , indicating that stress management training may have buffered illness-related psychological distress over time The objective of the present study was to compare the efficacy and safety of two doses of SPV(30 ) in HIV asymptomatic patients . The study was design ed as a r and omized double-blind multicentre trial of two doses of SPV(30 ) ( 990 mg/d and 1980 mg/d ) versus placebo . 145 previously untreated subjects with asymptomatic HIV infection ( CDC group IV ) and CD4 cell counts between 250 and 500 × 10(6)/1 were recruited . There was a statistically significant difference in therapeutic failures between groups in favor of SPV(30 ) 990 mg including decreases of CD4 cell count < 200 × 10(6)/1 and /or number of clinical aggravations ( progression to AIDS or AIDS related complex ) . The treatment groups differed statistically in the rate of disease progression also in favor of SPV(30 ) 990 mg/d . Fewer patients receiving SPV(30 ) 990 mg/d had at the end an increase of viral load greater than 0.5 log ( P = 0.029 ) . No severe side-effects were reported in the 3 groups . From these results we conclude that SPV(30 ) 990 mg/d has beneficial effects in HIV asymptomatic patients and appears to delay the progression of HIV disease This study tested the effects of a 10-week group cognitive-behavioral stress management ( CBSM ) intervention on mood and immunologic parameters in HIV-seropositive gay men whose disease had progressed to a symptomatic stage . Men were r and omized to either CBSM or a modified waiting-list control group . The CBSM intervention significantly decreased self-reported dysphoria , anxiety , and total distress . Individuals who practice d relaxation more consistently had significantly greater drops in dysphoria . The intervention also decreased herpes simplex virus-Type 2 ( HSV-2 ) immunoglobulin G antibody titers . The control group showed no significant changes in either mood or antibody titers . Individual difference analyses revealed that decreases in dysphoria significantly predicted lower HSV-2 antibody titers by the end of the 10-week period . Neither group displayed changes in HSV-Type 1 antibody titers or in CD4 + or CD8 + cell numbers We tested the impact of stress management training on sexual behavior and immune functioning in 64 gay men infected with human immunodeficiency virus ( HIV ) . Subjects r and omized to the stress management group met for eight two-hour sessions and one all day retreat to learn systematic relaxation , health behavior change , and stress management skills . Compared to those r and omized to a wait list control , treatment subjects reported significantly fewer sexual partners in the prior month at post-test ( 1.10 vs 2.29 for controls ) . There were no differences between groups in lymphocyte numbers and function Objective Reduced levels of serum carnitines ( 3-hydroxy-4-N-trimethyl-ammonio-butanoate ) are found in most patients treated with zidovudine . However , since serum carnitines do not strictly reflect cellular concentrations we examined whether a carnitine depletion could be found in peripheral blood mononuclear cells ( P BMC ) from AIDS patients with normal serum carnitine levels . In addition , we explored whether it was posssible to relate the host 's immunoreactivity to the content of carnitine in P BMC and whether carnitine levels can be corrected by oral supplementation of L-carnitine . Design Immunopharmacologic study . Methods Twenty male patients with advanced AIDS ( Centers for Disease Control and Prevention stage IVCI ) and normal serum levels of carnitines were enrolled . Patients were r and omly assigned to receive either L-carnitine ( 6g/day ) or placebo for 2 weeks . At baseline and at the end of the trial , we measured carnitines in both sera and P BMC , serum triglycerides , CD4 cell counts , and the frequency of cells entering the S and G2-M phases of cell cycle following mitogen stimulation . Results Concentrations of total carnitine in P BMC from AIDS patients was lower than in healthy controls . A significant trend towards the restoration of appropriate intracellular carnitine levels was found in patients treated with high-dose L-carnitine and was associated with an increased frequency of S and G2-M cells following mitogen stimulation . Furthermore , at the end of the trial we found a strong reduction in serum triglycerides in the L-carnitine group compared with baseline levels . Conclusions Our data indicate that carnitine deficiency occurs in P BMC from patients with advanced AIDS , despite normal serum concentrations . The increase in cellular carnitine content strongly improved lymphocyte proliferative responsiveness to mitogens . Because carnitine status is an important contributing factor to immune function in patients with advanced AIDS , we therefore believe that L-carnitine supplementation could have a role as a complementary therapy for HIV-infected individuals The use of vitamin A therapy during human immunodeficiency virus ( HIV ) infection is under clinical investigation , and vitamin A could potentially modulate HIV replication because the virus genome contains a retinoic acid response element . A r and omized , double-masked , placebo-controlled clinical trial was conducted to determine the impact of single high-dose vitamin A supplementation , 60-mg retinol equivalent ( 200,000 IU ) , on HIV load and CD4 lymphocyte count . HIV-infected injection drug users ( 120 ) were r and omly allocated to receive vitamin A or placebo . Plasma vitamin A level , CD4 lymphocyte count , and HIV load were measured at baseline and 2 and 4 weeks after treatment . Vitamin A supplementation had no significant impact on HIV load or CD4 lymphocyte count at 2 and 4 weeks after treatment . This study suggests that high-dose vitamin A supplementation does not influence HIV load Objectives : The HIV-infected population is known to be oxidatively stressed and deficient in antioxidant micronutrients . Since in vitro replication of HIV is increased with oxidative stress , this study assessed the effect of antioxidant vitamin supplementation on lipid peroxidation , a measure of oxidative stress , and viral load in humans . Design : A r and omized placebo-controlled , double-blind study . Methods : Forty-nine HIV-positive patients were r and omized to receive supplements of both DL-α-tocopherol acetate ( 800 IU daily ) and vitamin C ( 1000 mg daily ) , or matched placebo , for 3 months . Plasma antioxidant micronutrient status , breath pentane output , plasma lipid peroxides , malondialdehyde and viral load were measured at baseline and at 3 months . New or recurrent infections for the 6-month period after study entry were also recorded . Results : The vitamin group ( n = 26 ) had an increase in plasma concentrations of α-tocopherol ( P < 0.0005 ) and vitamin C ( P < 0.005 ) and a reduction in lipid peroxidation measured by breath pentane ( P < 0.025 ) , plasma lipid peroxides ( P < 0.01 ) and malondialdehyde ( P < 0.0005 ) when compared with controls (
Output:
| While the former category yields few encouraging results , the latter group of studies is more promising .
In particular , stress management may prove to be an effective way to increase the quality of life .
The domain of complementary medicine may lie in the care for HIV-infected individuals with a view of increasing their quality of life . |
MS211581 | ***TASK*** the task is to summarize an input biomedical literature 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 : Meta-analyses of r and omized controlled trials support the use of laparoscopically assisted resection for colon cancer . The evidence supporting its use in rectal cancer is weak . OBJECTIVE : The purpose of this work was to investigate the uptake of laparoscopically assisted resection for colon and rectal cancer and to compare short- and long-term outcomes using population data . DESIGN : This was a retrospective cohort study using linked administrative health data . SETTING S : The study encompassed all of the public and private hospitals in New South Wales , Australia , between 2000 and 2008 . PATIENTS : A total of 27,947 patients with colon or rectal cancer undergoing surgery with curative intent were included in the study . MAIN OUTCOME MEASURES : We summarized the proportion of resections performed laparoscopically . Short-term outcomes were extended stay , 28-day readmission , 28-day emergency readmission , 30- and 90-day mortality , and 90-day readmission with pulmonary embolism or deep-vein thrombosis . Long-term outcomes were all-cause and cancer-specific death and admission with obstruction or incisional hernia repair . RESULTS : Laparoscopic procedures increased between 2000 and 2008 for colon ( 1.5%–20.7 % ) and rectal cancer ( 0.6%–15.5 % ) . Laparoscopic procedures reduced rates of extended stay ( OR , 0.60 ; 95 % CI , 0.49–0.72 ) and 28-day readmission ( OR , 0.86 ; 95 % CI , 0.74–0.99 ) for colon cancer . For rectal cancer , laparoscopic procedures had lower rates of 28-day readmission ( OR , 0.58 ; 95 % CI , 0.42–0.78 ) and 28-day emergency readmission ( OR , 0.54 ; 95 % CI , 0.34–0.85 ) . Laparoscopic procedures improved cancer-specific survival for rectal cancer ( HR , 0.71 ; 95 % CI , 0.51–1.00 ) . Survival benefits were observed for laparoscopically assisted colon resection in higher-caseload hospitals but not lower-caseload hospitals . LIMITATIONS : It was not possible to identify laparoscopically assisted resections converted to open procedures because of the cl aims -based nature of the data . CONCLUSIONS : Despite increases in laparoscopically assisted resections for colon and rectal cancer , the majority of resections are still treated by open procedures . Our data suggest that laparoscopic resection reduces the lengths of stay and rates of readmission and may result in improved cancer-specific survival for both colon and rectal resections Background : Complete mesocolic excision ( CME ) and a high ( apical ) vascular tie may improve oncologic outcome after surgery for colon cancer . Our primary aim was to emulate a previous national result of 73.8 % overall survival ( OS ) with both the open and laparoscopic techniques . Methods : A prospect i ve study of radical colon cancer was initiated in a Norwegian community teaching hospital in 2007 and comprised a consecutive group of 251 patients with TNM stages I-III that had surgery according to the CME principle . Oncological outcome was assessed as OS , disease-free survival ( DFS ) and cancer-specific survival ( CSS ) , as well as time to recurrence ( TTR ) , using Cox regression analysis . Results : In-hospital mortality was 3.6 % , 2.3 % for laparoscopic surgery and 4.9 % for open management . Significantly more patients in the open CME group developed complications in the short term ( p < 0.001 ) . Twelve or more lymph nodes were retrieved from 82.9 % ( 208/251 ) of the specimens . Overall 3-year OS was 84.5 % , DFS 77.4 % , CSS 91.5 % and TTR 86.8 % . The surgical approach was not a significant predictor for any of the survival parameters . Conclusions : There was no survival difference between open and laparoscopic CME colonic resections , and the present OS improved from a previous OS from 2000 BACKGROUND Minimally invasive , laparoscopically assisted surgery was first considered in 1990 for patients undergoing colectomy for cancer . Concern that this approach would compromise survival by failing to achieve a proper oncologic resection or adequate staging or by altering patterns of recurrence ( based on frequent reports of tumor recurrences within surgical wounds ) prompted a controlled trial evaluation . METHODS We conducted a noninferiority trial at 48 institutions and r and omly assigned 872 patients with adenocarcinoma of the colon to undergo open or laparoscopically assisted colectomy performed by credentialed surgeons . The median follow-up was 4.4 years . The primary end point was the time to tumor recurrence . RESULTS At three years , the rates of recurrence were similar in the two groups--16 percent among patients in the group that underwent laparoscopically assisted surgery and 18 percent among patients in the open-colectomy group ( two-sided P=0.32 ; hazard ratio for recurrence , 0.86 ; 95 percent confidence interval , 0.63 to 1.17 ) . Recurrence rates in surgical wounds were less than 1 percent in both groups ( P=0.50 ) . The overall survival rate at three years was also very similar in the two groups ( 86 percent in the laparoscopic-surgery group and 85 percent in the open-colectomy group ; P=0.51 ; hazard ratio for death in the laparoscopic-surgery group , 0.91 ; 95 percent confidence interval , 0.68 to 1.21 ) , with no significant difference between groups in the time to recurrence or overall survival for patients with any stage of cancer . Perioperative recovery was faster in the laparoscopic-surgery group than in the open-colectomy group , as reflected by a shorter median hospital stay ( five days vs. six days , P<0.001 ) and briefer use of parenteral narcotics ( three days vs. four days , P<0.001 ) and oral analgesics ( one day vs. two days , P=0.02 ) . The rates of intraoperative complications , 30-day postoperative mortality , complications at discharge and 60 days , hospital readmission , and reoperation were very similar between groups . CONCLUSIONS In this multi-institutional study , the rates of recurrent cancer were similar after laparoscopically assisted colectomy and open colectomy , suggesting that the laparoscopic approach is an acceptable alternative to open surgery for colon cancer Background and aims Evidence demonstrating improved short-term outcomes with laparoscopic surgery compared with open surgery for colorectal cancer is accumulating . In addition , programmes optimising peri-operative care for major abdominal surgery are becoming widespread . Evaluating laparoscopic surgery and enhanced recovery programmes usually focuses on short-term recovery . The aim of this study was to compare recovery after laparoscopic and open surgery for colorectal cancer up to 1 year post-operatively , using a combination of self-report and observer data . Patients / Methods From January 2002 to March 2004 , 62 patients were r and omised ( 2:1 ) to receive laparoscopic ( n = 43 ) or open surgery ( n = 19 ) within an enhanced recovery programme . Functional outcomes up to 1 year were assessed using interview-administered question naires . Results / Findings Question naire and health-related quality of life data were obtained in over 85 % of patients . Patients undergoing laparoscopic surgery felt fully recovered and resumed driving more quickly than those having open surgery ( p = 0.016 and p = 0.048 respectively ) . Fifty-eight percent of patients having open surgery felt fully recovered by 12 months versus 88 % of laparoscopic patients .Interpretation/ Conclusion Within an enhanced recovery programme , patients undergoing laparoscopic surgery recovered more quickly than after open resection . Both approaches however , were associated with slow recovery despite a relatively short hospital stay BACKGROUND The safety and short-term benefits of laparoscopic colectomy for cancer remain debatable . The multicentre COLOR ( COlon cancer Laparoscopic or Open Resection ) trial was done to assess the safety and benefit of laparoscopic resection compared with open resection for curative treatment of patients with cancer of the right or left colon . METHODS 627 patients were r and omly assigned to laparoscopic surgery and 621 patients to open surgery . The primary endpoint was cancer-free survival 3 years after surgery . Secondary outcomes were short-term morbidity and mortality , number of positive resection margins , local recurrence , port-site or wound-site recurrence , metastasis , overall survival , and blood loss during surgery . Analysis was by intention to treat . Here , clinical characteristics , operative findings , and postoperative outcome are reported . FINDINGS Patients assigned laparoscopic resection had less blood loss compared with those assigned open resection ( median 100 mL [ range 0 - 2700 ] vs 175 mL [ 0 - 2000 ] , p<0.0001 ) , although laparoscopic surgery lasted 30 min longer than did open surgery ( p<0.0001 ) . Conversion to open surgery was needed for 91 ( 17 % ) patients undergoing the laparoscopic procedure . Radicality of resection as assessed by number of removed lymph nodes and length of resected oral and aboral bowel did not differ between groups . Laparoscopic colectomy was associated with earlier recovery of bowel function ( p<0.0001 ) , need for fewer analgesics , and with a shorter hospital stay ( p<0.0001 ) compared with open colectomy . Morbidity and mortality 28 days after colectomy did not differ between groups . INTERPRETATION Laparoscopic surgery can be used for safe and radical resection of cancer in the right , left , and sigmoid colon Background : We compared the perioperative parameters and outcomes achieved with h and -assisted laparoscopic colectomy ( HALC ) vs open colectomy ( OC ) for the management of benign and malignant colorectal disease , including cancer patients treated with curative intent . Methods : Sixty eligible patients were r and omized to either HALC ( n = 30 ) or OC ( n = 30 ) treatment groups . We used Pearson ’s chi-square and two- sample t-tests to compare the differences in demographics and perioperative parameters . Results : There were no significant differences in age , gender distribution , disease pattern , operative procedure , comorbidity , or history of abdominal surgery . The HALC patients had significantly shorter hospital stays and incision lengths , faster recovery of gastrointestinal function , less analgesic use and blood loss , and lower pain scores on postoperative days 1 , 3 , and 14 . There were no significant differences in operative time , complications , or time to return to normal activity . Conclusion : H and -assisted laparoscopic colectomy ( HALC ) is safe and produces better therapeutic results in terms of perioperative parameters than OC OBJECTIVE The quality of surgery with D3 resection in r and omized controlled clinical trial [ Japan Clinical Oncology Group study ( JCOG0404 ) ] was assessed by evaluation of the photo documentation of both open and laparoscopic surgeries . METHODS A multi-institutional r and omized-controlled trial ( JCOG0404 ) was conducted to evaluate open and laparoscopic D3 resection ( complete mesocolic excision + ligation and dissection at the root of the main vessels ) for Stage II/III colon cancer ( UMIN-CTR number C000000105 ) . A total of 1057 ( open , 528 ; laparoscopic , 529 ) eligible patients were enrolled . For quality control , it was ensured that the surgeries were performed by accredited surgeons , and a central committee review ed each surgery on the basis of the su bmi tted photographs of the resected field , specimen and skin incision . RESULTS For right-sided tumors , the rate of D3 resection was 98.5 % ( 131/133 ) in the open arm and 100 % ( 136/136 ) in the laparoscopic arm , and for left-sided tumors , they were 97.9 % ( 322/329 ) and 98.2 % ( 320/326 ) , respectively . Sufficient length of the resected longitudinal margin was ensured in all cases . The skin incisions made in all the cases were < 8 cm as defined in the protocol in laparoscopic arm . CONCLUSIONS Completion of high quality surgery with D3 resection was confirmed in JCOG0404 by central peer review of photographs of the surgical procedures in addition to operator regulations . This study suggests that the central review of the photo documentation is one of the important tools to assure a quality control of surgical technique in the Phase III r and omized-controlled study Objective : The aim of this study was to compare the long-term outcome of laparoscopy-assisted colectomy ( LAC ) and open colectomy ( OC ) for nonmetastatic colon cancer . Methods : From November 1993 to July 1998 all patients with adenocarcinoma of the colon were assessed for entry in this single center , clinical ly r and omized trial .
Output:
| CONCLUSION The laparoscopic approach offers the same quality of the resected specimen as the open approach in complete mesocolic excision with central vascular ligation for colon cancer .
The laparoscopic complete mesocolic excision with central vascular ligation is superior in all perioperative results and at least non-inferior in long-term oncological outcomes |
MS211582 | ***TASK*** the task is to summarize an input biomedical literature 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 authors examined several restorative material s to evaluate their ability to inhibit demineralization and enhance remineralization of incipient carious lesions on the interproximal enamel of teeth adjacent to those restored with the material s. METHODS Twenty-one subjects in need of a crown on a m and ibular molar and a Class II inlay on an adjacent tooth took part in this six-phase study . Artificial enamel lesions were created and positioned within the interproximal portion of a crown . Lesions were photographed with polarized light microscopy and characterized before and after 30-day intraoral exposures . Each phase included the placement of a new section in the crown model and a new Class II inlay restorative material in the adjacent tooth . RESULTS Results demonstrated that nonfluori date d resin composite , fluori date d resin composite and resin-modified glass ionomer restorative material s , when placed in subjects who brushed with a fluori date d dentifrice , demonstrated significantly ( P < .05 ) less enamel demineralization than the nonfluori date d resin composite control placed in subjects who brushed with a nonfluori date d dentifrice . The resin-modified glass ionomer cement , however , even when brushed with a nonfluori date d dentifrice , exhibited significantly ( P < .05 ) less demineralization than the nonfluori date d resin composite control brushed with a nonfluori date d dentifrice . CONCLUSIONS Resin-modified glass ionomer cement appears to significantly inhibit demineralization of interproximal enamel of teeth adjacent to those restored with the material . CLINICAL IMPLICATION S Resin-modified glass ionomer cement restorations can enhance prevention of enamel demineralization on adjacent teeth AIM The purpose of the study was to determine the retention of glassionomer sealants in primary teeth of preschool children . METHODS Fissure sealants ( Fuji II LC ) were placed on primary molars , without conditioner , by two experienced dentists under good clinical conditions in well equipped clinics and with the assistance of a chair side dental assistant . Sealants were scored as " fully retained " , " partly retained " , or " completely lost " after two years . RESULTS There were 65 children included , out of which 29 had all primary molars . Mean age at the time of sealing was slightly less than 41/2 years . Mean follow-up time was two years . About 75 % of the sealants placed in second primary molars were fully or partly retained after 12 months , compared with less that 50 % of the sealants placed in first primary molars . New carious lesions were too few to allow for an assessment of whether the sealants were effective in preventing caries . CONCLUSION Retention rates for glass ionomer fissure sealants were satisfactory . However , high quality r and omised clinical trials to estimate the caries preventive effect are still needed AIM This was to evaluate the efficacy of pit and fissure sealant ( FS ) using two different application techniques for caries prevention assessed at five and ten years . METHODS The study was conducted using Delton(R ) pit and fissures sealant applied with either rubber dam ( RD ) ( Group A : 50 children , 200 first permanent molars , 120 second permanent molars ) or cotton wool rolls ( CR ) ( Group B : 50 children , 200 first permanent molars , 112 second permanent molars ) . At five and ten years FS were evaluated for retention , loss and incidence of occlusal and proximal carious lesions recorded . STATISTICS The data were analysed with the Chi- square test comparing the results obtained for first permanent molars and second permanent molars at five and ten years . RESULTS There was no statistical difference between results in the two groups ( p < or = 0.05 ) . The highest retention rate , 81.7 % , was found for second permanent molars sealed under RD at the five year assessment . The lowest , 64.3 % also for second molars sealed under CR humidity control at ten years . CONCLUSIONS Pit and fissure sealants are a valid preventive approach that can be applied with similar results with rubber dam or cotton rolls This study compared two techniques for placing sealant in an elementary school setting . Eighty-five children in grade s 1 to 4 in two schools were assigned r and omly to two sealant treatment groups : 1 ) acid etch technique ( AE ) , and 2 ) air abrasion with no acid etch ( KCP-1000 ) . Noncarious , nonfilled occlusal , distolingual and buccal pit surfaces of first permanent molars were sealed . A total of 300 teeth received sealants , and 230 were evaluated at 6 months . Rates of complete sealant retention at 6 months were : occlusal surfaces , 97 % for AE and 96 % for KCP-1000 ; distolingual surfaces , 82 % for AE and 49 % for KCP-1000 ; and buccal surfaces , 77 % for AE and 7 % for KCP-1000 . Differences in complete retention at 6 months between AE and KCP-1000 were not significant for occlusal surfaces ( P = 0.14 ) but were significant for buccal and distolingual surfaces ( P < 0.0001 ) . Results suggest that sealants placed with air abrasion have retention rates for occlusal surfaces similar to AE . More research is needed to identify factors contributing to low retention rates on other surfaces for KCP-1000 The aim of the present trial was to ( 1 ) compare the caries-preventive effect of glass ionomer sealants , placed according to the atraumatic restorative treatment ( ART ) procedure , with composite resin sealants over time and ( 2 ) investigate the caries-preventive effect after complete disappearance of sealant material . Forty-six boys and 57 girls , mean age 7.8 years , were r and omly divided into two treatment groups in a parallel-group study design . A light-polymerized composite resin sealant material and a high-viscosity glass ionomer were each placed in 180 fully erupted first molars in their respective treatment groups . Evaluation took place annually for 5 years by calibrated examiners . After 5 years , 86 % composite resin and 88 % glass ionomer sealants did not survive . Three categories of re-exposure periods for caries development in pits and fissures after complete loss of sealants were distinguished : 0–1 , 1–2 and 2–3 years . In the 2- to 3-year group , 13 and 3 % of pits and fissures previously sealed with composite resin and glass ionomer , respectively , were diagnosed as having developed a dentine lesion . The relative risks ( 95 % CI ) of dentine lesion development in surfaces sealed with glass ionomer compared to those sealed with composite resin after 3 , 4 and 5 years were 0.22 ( 0.06–0.82 ) , 0.32 ( 0.14–0.73 ) and 0.28 ( 0.13–0.61 ) , respectively . The relative risks of dentine lesion development in pits and fissures previously sealed with glass ionomer compared with composite resin over re-exposure periods of 1–2 and 2–3 years were 0.26 ( 0.14–0.48 ) and 0.25 ( 0.09–0.68 ) , respectively . We conclude that the caries-preventive effect of high-viscosity glass ionomer sealants , placed using the ART procedure , was between 3.1 and 4.5 times higher than that of composite resin sealants after 3–5 years . Furthermore , high-viscosity ( ART ) glass ionomer sealants appear to have a four times higher chance of preventing caries development in re-exposed pits and fissures of occlusal surfaces in first molars than light-cured composite resin sealant material over a 1- to 3-year period . A well- design ed clinical trial using different types of oral health personnel should be implemented to confirm these initial results Retention of sealant material is the main determinant for the caries preventive eect of sealants . This may partly explain the low interest in using ® ssure sealants in young children , where sucient moisture control may be dicult to obtain . Consequently , almost no data are available in the literature on the eect of ® ssure sealants in young pre-school children . The purpose of the present communication is to report the retention of a light polymerized ® ssure sealant ( Prisma -Shield ) and an autopolymerized sealant ( Delton ) in primary molars of young children . The study included 52 children ( 25 boys and 27 girls ) with a median age of 3 years 7 months ( range 2 years 11 months to 4 years 11 months ) who were attending municipal dental clinics for regular dental care in and around the municipality of AÊ rhus and in the paediatric dentistry section of the department . All children were examined by the same dentist ( E.H. ) , who also placed all the sealants . Caries was diagnosed at the cavitation level and only children with pairs of sound primary molars were included . The teeth within each tooth pair were r and omly assigned to sealing with Delton or Prisma -Shield . The manufacturer 's instructions were carefully followed for both material s. Mean follow-up period was 2.8 years ( range 2.0±3.3 years ) , at which time 20 pairs of upper second molars , two pairs of upper ® rst molars , 28 pairs of lower second molars , and one pair of lower ® rst molars were re-examined . Complete retention was found in 70.6 % of the teeth sealed with Delton and in 76.5 % of the teeth sealed with Prisma -Shield ( Table 1 ) . The slightly better retention of the light polymerized ® ssure sealant could be due to the shorter period of moisture control needed for placing a light polymerized sealant . However , McNemar 's test showed that the dierence was not statistically signi ® cant in this group ( P = 0.49 ) . Table 2 shows that caries development after sealing was low with both types of material s ( 5.9 % for Delton and 9.8 % for Prisma -Shield ) . 67 % ( four out of six ) of the pairs with dierent caries development in the two teeth developed caries in the tooth sealed with Prisma -Shield , but not in the tooth sealed with Prisma -Shield . The 95 % con ® dence limits for this parameter calculated according to the method described by Armitage & Berry [ 1 ] were 0.045 and 3.49 and included the value 0.5 , indicating no dierence in caries development after the two sealants PURPOSE To evaluate the 2-year clinical sealant success when using Prompt L-Pop ( 3M-ESPE ) , the first self-etching adhesive , as the sole etching and adhesive step prior to sealant placement . METHODS Patients ages 7 - 13 years with matched pairs of permanent molars needing sealants were enrolled into an ongoing clinical study of sealant success . First and /or second permanent molars were r and omly assigned to control ( sealant only after phosphoric acid etch ) or Prompt plus sealant groups in a split-mouth , matched pair study design . St and ard methods were used for sealant ( Delton , Dentsply ) placement , except for the Prompt group in which the self-etching adhesive was brushed on the surface , air thinned , followed by immediate placement of the sealant and polymerization . All sealants were placed using appropriate cotton-roll isolation and a dental assistant . Sealant scoring was done at 24 months using strict clinical criteria for failure , previously published , and photos of the sealed surfaces were archived on video . RESULTS Percentages of sealants scored as successful ( no significant loss of material or need for repair ) through 24 months were : ( a ) Occlusal sealants : Control = 61 % , versus Prompt = 61 % ; ( b ) Bu/Lingual sealants : Control = 54 % , versus Prompt = 62 % ; McNemar 's Chi Square tests indicate no difference in success between the Prompt sealants and their matched controls ( P > 0.80 ) . Time of placement for sealants , timed from start of the etch step through polymerization , averaged 3.1 minutes for Control and 1.8 minutes for Prompt . We conclude that Prompt L-Pop self-etching adhesive is effective in bonding sealant to enamel and that the simplified method dramatically shortens treatment time and treatment complexity OBJECTIVE To compare the retention and the caries preventive effect of a glass-ionomer developed for fissure sealing ( Fuji III ) and a chemically polymerized resin-based fissure sealant ( Delton ) . DESIGN A split mouth r and omized design using contralateral teeth . SETTING WHO Regional Demonstration , Training and Research Center for Oral Health , Damascus , Syrian Arab Republic . SAMPLE AND METHODS 179 children , 7 years old at the start of the study , were recruited from schools close to the Center . Only children with at least one pair of permanent first molars that were caries free or only had incipient lesions were included in the study . Follow-up examinations for sealant retention were done after 6 months , 1 year , 2 years and 3 years . The number of children available for reexamination was 129 ( after 6 months ) ; 121 ( after 1 year ) ; 115 ( after 2 years ) and 116 ( after 3 years ) . Four dental hygienists were trained in the sealant procedures and did approximately one fourth of the sealants each . R
Output:
| The panel concluded that sealants are effective in caries prevention and that sealants can prevent the progression of early noncavitated carious lesions .
The evidence indicates that sealants can be used effectively to prevent the initiation and progression of dental caries |
MS211583 | ***TASK*** the task is to summarize an input biomedical literature 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 / PURPOSE A relatively long incubation time is needed for photosensitizer absorption in conventional photodynamic therapy ( PDT ) for actinic keratosis ( AK ) . The use of ablative CO2 fractional lasers ( AFXLs ) to increase drug delivery could shorten the incubation time . Here , we aim ed to compare the efficacy between AFXL-assisted PDT with a short incubation time and conventional PDT for AK . METHODS Patients with histopathologically confirmed facial AK were r and omly divided into two groups . The lesions were histopathologically classified into grade s I-III . In the AFXL-assisted PDT group , an ablative fractional laser was used for pretreatment , prior to the application of methyl aminolevulinate , with an incubation time of 90 min . Irradiation was performed with a 630-nm light-emitting diode . In the conventional PDT group , the incubation time was 180 min . All the patients received two rounds of PDT at 2-week intervals and underwent clinical or histological evaluation at 10 weeks after the first PDT course . RESULTS Twenty-two patients underwent conventional PDT and 24 patients underwent AFXL-assisted PDT . Thirty-four AKs were included in the conventional PDT group , and 35 AKs were included in the AFXL-assisted PDT group . The clearance rate was 64.7 % in the conventional PDT and 71.4 % in the AFXL-assisted PDT group ; no significant differences in the clearance rate were noted between the groups ( P = 0.55 ) . The clearance rates for each grade also did not significantly differ between the two groups . CONCLUSIONS The use of AFXL before PDT reduced the incubation time , but yielded similar treatment efficacy as compared to conventional PDT BACKGROUND Iontophoresis is a transdermal drug-delivery technique that enhances the transport of ionic species across membranes and may have significant benefit for the treatment of actinic keratosis ( AK ) by ablative fractional laser-primed photodynamic therapy ( AFL-PDT ) . The aims of this study were to compare the efficacy , recurrence rate , cosmetic outcome and safety of iontophoresis-assisted AFL-PDT with 2h of incubation vs. those of conventional AFL-PDT with 2- and 3-h incubation in patients with facial and scalp AK . METHODS Patients were r and omly assigned to iontophoresis-assisted AFL-PDT with a 2-h incubation time ( group A ) and conventional AFL-PDT with a 2-h ( group B ) and 3-h ( group C ) incubation time . All patients underwent AFL-PDT , and group A patients were assigned to treatment with iontophoresis after methyl-aminolevulinate ( MAL ) application . After 2 or 3h , MAL-applied lesions were irradiated using a red light . Patients were followed up at 1-week , 3 months and 12 months after treatment . Efficacy , cosmetic outcomes and adverse events were assessed . RESULTS In total , 41 patients ( 160 AK lesions ) completed the study and were evaluated . Efficacy was significantly higher in Group A ( 88.7 % ) than in Group B ( 73.2 % ) ; the efficacy of groups A and C ( 92.2 % ) at 3 months follow-up was comparable . The recurrence rates were not significantly different between the groups at 12 months ( P=0.841 ) . The three groups did not differ in terms of cosmetic outcomes and safety . CONCLUSIONS Iontophoresis-assisted AFL-PDT showed higher efficacy than AFL-PDT with short incubation time . Iontophoresis may effectively reduce the incubation time in AFL-PDT BACKGROUND Photodynamic therapy ( PDT ) with methyl aminolevulinate ( MAL ) is effective for treating multiple actinic keratoses ( AKs ) . Ablative fractional laser ( FL ) creates vertical channels that may facilitate MAL delivery and improve PDT response . OBJECTIVE To evaluate the efficacy of FL-assisted PDT ( FL-PDT ) in treating facial AKs in Korean patients . METHODS A prospect i ve r and omized non-blinded trial initially evaluated 271 facial AKs in 45 patients . All patients underwent one session of MAL-PDT using a red light-emitting diode lamp at 37 J/cm(2 ) , and 23 patients with 135 AK lesions were r and omly assigned to pre-treatment with a 2940-nm ablative fractional erbium : Yag laser . Patients were followed up at 1 , 2 and 4 weeks and every month until 6 and 12 months post-treatment . Response , adverse events , cosmetic outcome and patient satisfaction were documented . Finally , a total of 236 facial AKs in 40 patients were enrolled and analysed in this study . RESULTS FL-PDT was significantly more effective than MAL-PDT at treating all AK grade s ( 86.9 % vs. 61.2 % ; P < 0.001 ) . The efficacy of FL-PDT was most pronounced in treating Olsen grade III AKs ( 69.4 % vs. 32.5 % ; P = 0.001 ) . FL-PDT also showed a lower lesion recurrence rate than MAL-PDT ( 9.7 % vs. 26.6 % ; P = 0.004 ) . Excellent or good cosmetic outcome was reported in > 90 % cases . Erythema and hyperpigmentation intensities were higher in the FL-PDT group ( P > 0.05 ) . Side-effects were more frequent in the FL-PDT group , but these were mild and well tolerated ( P > 0.05 ) . CONCLUSION FL-PDT is effective for treating AKs , especially moderate-to-thick lesions BACKGROUND Aminolevulinic acid ( ALA ) photodynamic therapy ( PDT ) is an established treatment option for actinic keratosis ( AK ) , and recently fractional carbon dioxide ( CO2 ) laser was shown to improve outcomes ; but studies of short incubation photosensitizer are lacking . OBJECTIVE Assess the efficacy of short incubation ALA followed by blue light PDT with and without previous fractional CO2 treatment for the treatment of AK . METHODS R and omized , paired split- design , controlled trial of fractional CO2 followed by ultrashort 15-minute versus 30-minute incubation ALA and blue light PDT for the treatment of AK on the face . RESULTS The complete clearance rates ( CRs ) at 8 weeks after ALA PDT with and without FxCO2 at 30- and 15-minute ALA incubation times were 89.78 % ( + FxCO2 ) versus 71.20 % CR ( −FxCO2 ) at 30′ , and 86.38 % ( + FxCO2 ) versus 69.23 % ( −FxCO2 ) at 15′ ALA incubation . All lesion improvements were statistically significant . CONCLUSION This r and omized , comparative paired group controlled clinical study demonstrates that ultrashort 15- and 30-minute incubation ALA PDTs are of limited efficacy for the treatment of AK . Pretreatment with fractional ablative resurfacing yields statistically significant greater AK clearance with ALA-PDT at ultrashort ALA incubations followed by blue light BACKGROUND AND OBJECTIVE Continuous wave lasers or incoherent lamps are used effectively for photodynamic therapy ( PDT ) . As the mechanism of action of pulsed lasers in PDT is not known , we investigated the efficacy of PDT with 5-aminolevulinic acid ( ALA ) using a long-pulse ( 1.5 ms ) tunable flashlamp-pumped pulsed dye laser ( LPDL ) in vitro and in vivo . STUDY DESIGN / MATERIAL S AND METHODS HaCaT human keratinocytes were incubated with ALA ( 3 mmol/l ) and irradiated ( 0 - 50 J/cm(2 ) ) using the LPDL at 585 nm , 595 nm , or 600 nm vs. an incoherent light source ( 580 - 740 nm ) . Topical ALA-PDT was performed on 24 patients with actinic keratoses ( AK ) on the head ( n = 200 ) after incubation with a 20 % ALA emulsion and irradiation by either an incoherent light source ( 160 mW/cm(2 ) , 60 - 160 J/cm(2 ) ) or the LPDL ( 585 nm , 18 J/cm(2 ) ) . RESULTS Maximal cytotoxic effects in vitro were achieved using the LPDL at 585 nm or the incoherent lamp ( 50 J/cm(2 ) ) . Sodium azide , a quencher of singlet oxygen , significantly reduced cell killing , suggesting that the cytotoxic effects are mainly mediated by singlet oxygen . This is supported by an increase of lipid peroxides as determined by malondialdehyde after adding D(2)O. Complete remission was achieved in 79 % of 100 AK treated by ALA and the LPDL and in 84 % of 100 AK treated by ALA and the incoherent lamp . Pain during light treatment was significantly reduced by using the LPDL . Control lesions ( LPDL without ALA ) did not clear . CONCLUSION These results show the in vitro and in vivo efficacy of ALA-PDT using a pulsed light source mediated by singlet oxygen BACKGROUND AND OBJECTIVE Photodynamic therapy ( PDT ) with 5-aminolevulinic acid ( ALA ) and intense pulsed light ( IPL ) is a relatively new combination for the treatment of actinic keratosis ( AK ) and photodamage . The objective of this study was to determine the effect of increasing the fluence of IPL on the outcome of patients with these skin conditions . METHODS Patients ( N = 24 ) were r and omly assigned to five treatment treatment groups : control ( IPL alone ) and ALA with 20 , 25 , 40 , and 50 J/cm(2 ) fluence of IPL . Each patient received a single treatment . ALA was applied twice and allowed to incubate 2 h before IPL irradiation . Results were evaluated 5 - 7 days and 8 weeks after treatment . Clearance of AK lesions was evaluated by counting lesions before and after treatment , and improvement in photodamage was assessed by comparing pre- and post-treatment photographs . Statistical evaluation was based at nonparametric tests with a cut-off level at p < 0.10 and a confidence interval at 95 % . RESULTS Responses to treatment were greatest in patients who received ALA and IPL fluences of 40 and 50 J/cm(2 ) . Responses were " marked " in 19 % of the patients receiving 50 J and " moderate " in 19 % of the patients receiving 40 J. Compared to the mean pre-treatment AK grade s , the mean post-treatment grade s were 56 % lower in the 50 J treatment group , 32 % lower in the 25 J group , 50 % lower in the 40 J group , 20 % lower in the 20 J group , and 7 % lower in the control group . Erythema , edema , crusts and erosion , and pain did not cause any patient to discontinue the study . CONCLUSION AK clearance , but not photorejuvenation , appears to improve with increasing fluence at the ALA PDT-IPL levels used in this study without serious adverse effects BACKGROUND Unmet needs exist in actinic keratosis ( AK ) treatment . Daylight photodynamic therapy ( DL-PDT ) has shown good efficacy and safety results compared to conventional PDT ( c-PDT ) in a recent Phase III multi-centre r and omised controlled trial in Australia among 100 subjects with AKs . OBJECTIVES Demonstrate non-inferior efficacy and superior safety of DL-PDT compared to c-PDT in treating multiple mild and /or moderate facial/scalp AKs . METHODS Phase III , 12 week , multi-centre , r and omised , investigator-blinded , controlled , intra-individual study conducted at different latitudes in Europe . AKs of adult subjects were treated once with methyl aminolevulinate ( MAL ) DL-PDT on one side of the face and MAL c-PDT contralaterally . Endpoints for DL-PDT concerned efficacy ( non-inferiority regarding complete lesion response at week 12 ) and safety ( superiority regarding subject 's assessment of pain after treatment , on an 11-point numeric rating scale ) . Safety evaluation also included incidence of adverse events . Subject satisfaction was described using a question naire at baseline and last visit . RESULTS At week 12 , the total lesion complete response rate with DL-PDT was similar ( non-inferior ) to c-PDT ( 70 % vs. 74 % , respectively ; 95 % CI [ -9.5 ; 2.4 ] in PP analysis , confirmed in ITT analysis ) . In addition , efficacy of DL-PDT was demonstrated regardless of weather conditions ( sunny or cloudy ) . DL-PDT was nearly painless compared to c-PDT ( 0.7 vs. 4.4 , respectively ; P
Output:
| Conclusion : Laser‐assisted PDT is more efficient but not more painful than PDT or laser treatment only |
MS211584 | ***TASK*** the task is to summarize an input biomedical literature 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 There is little systematic research on the efficacy and tolerability of the addition of adjunctive analgesic agents in paravertebral analgesia . The addition of adjunctive analgesics , such as fentanyl and clonidine , to local anesthetics has been shown to enhance the quality and duration of sensory neural blockades , and decrease the dose of local anesthetic and supplemental analgesia . OBJECTIVES Investigation of the safety and the analgesic efficacy of adding 1 μg/kg dexmedetomidine to bupivacaine 0.25 % in thoracic paravertebral blocks ( PVB ) in patients undergoing modified radical mastectomy . STUDY DESIGN A r and omized , double-blind trial . SETTING Academic medical center . METHODS Sixty American Society of Anesthesiologists physical status -I - III patients were r and omly assigned to receive thoracicPVB with either 20 mL of bupivacaine 0.25 % ( Group B , n = 30 ) , or 20 mL of bupivacaine 0.25 % + 1 μg/kg dexmedetomidine ( Group BD , n= 30 ) . Assessment parameters included hemodynamics , sedation score , pain severity , time of first analgesics request , total analgesic consumption , and side effects in the first 48 hours . RESULTS There was a significant reduction in pulse rate and diastolic blood pressure starting at 30 minutes in both groups , but more evidence d in group BD ( P < 0.001 ) . Intraoperative Systolic blood pressure showed a significant reduction at 30 minutes in both groups ( P < 0.001 ) then returned to baseline level at 120 minutes in both groups . There was a significant increase in pulse rate starting 2 hours postoperative until 48 hours postoperatively in group B but only after 12 hours until 48 hours in group BD ( P < 0.001 ) . The time of the first rescue analgesic requirement was significantly prolonged in the group BD ( 8.16 ± 42 hours ) in comparison to group B ( 6.48 ± 5.24 hours ) ( P = 0.04 ) . The mean total consumption of intravenous tramadol rescue analgesia in the postanesthesia care unit in the firtst 48 hours postoperatively was significantly decreased in group BD ( 150.19 ± 76.98 mg ) compared to group B ( 194.44 ± 63.91 mg ) ( P = 0.03 ) . No significant serious adverse effects were recorded during the study . LIMITATIONS This study is limited by its sample size . CONCLUSION The addition of dexmedetomidine 1 μg/kg to bupivacaine 0.25 % in thoracic PVB in patients undergoing modified radical mastectomy improves the quality and the duration of analgesia and also provides an analgesic sparing effect with no serious side effects Background : The present study aim ed to assess the efficacy and safety of thoracic paravertebral regional anesthesia ( TPVBRA ) in patients with breast cancer surgery . Methods : In total , 72 patients undergoing breast cancer surgery were r and omly divided into an intervention group and a control group ; each group contained 36 subjects . Both groups received TPVBRA with 20 mL 0.25 % bupivacaine . In addition , subjects in the intervention group also received an additional 1 & mgr;g/kg dexmedetomidine . Heart rate ( HR ) , systolic blood pressure ( SBP ) , diastolic blood pressure ( DBP ) , pain intensity ( measured by visual analogue scale , VAS ) , and analgesic consumption were assessed ; adverse events were also recorded . Results : Significant differences were observed in HR ( P < .05 ) , SBP ( P < .05 ) , and DBP ( P < .05 ) at the 30-minute point during surgery between the 2 groups . In addition , the time of the first administration of analgesia ( P = .043 ) and the mean consumption of analgesic agents ( P = .035 ) in the intervention group were much better than those in the control group . However , no significant differences in HR or VAS were found at any time point after surgery ( P > .05 ) . Furthermore , similar adverse events were detected in both groups ( P > .05 ) . Conclusion : The results of this study showed that TPVBRA combined with bupivacaine and dexmedetomidine can enhance the duration and quality of analgesia without serious adverse events OBJECTIVE The goals of this study were to examine agreement and estimate differences in sensitivity between pain assessment scales . DESIGN Multiple simultaneous pain assessment s by patients in acute pain after oral surgery were used to compare a four-category verbal rating scale ( VRS-4 ) and an 11-point numeric rating scale ( NRS-11 ) with a 100-mm visual analog scale ( VAS ) . The sensitivity of the scales ( i.e. , their ability [ power ] to detect differences between treatments ) was compared in a simulation model by sampling from true pairs of observations using varying treatment differences of predetermined size . RESULTS There was considerable variability in VAS scores within each VRS-4 or NRS-11 category both between patients and for repeated measures from the same patient . Simulation experiments showed that the VAS was systematic ally more powerful than the VRS-4 in all simulations performed . The sensitivity of the VAS and NRS-11 was approximately equal . CONCLUSIONS In this acute pain model , the VRS-4 was less sensitive than the VAS . The simulation results demonstrated similar sensitivity of the NRS-11 and VAS when comparing acute postoperative pain intensity . The choice between the VAS and NRS-11 can thus be based on subjective preferences BACKGROUND Dexmedetomidine is an α-2-receptor agonist which might be used as an additive to local anaesthetics for various regional anaesthetic techniques . We therefore design ed this prospect i ve , double-blinded , controlled volunteer study to investigate the effects of dexmedetomidine as an adjuvant to ropivacaine on peripheral nerve block . METHODS Ultrasound-guided ulnar nerve block ( UNB ) was performed in 36 volunteers with either 3 ml ropivacaine 0.75 % ( R ) , 3 ml ropivacaine 0.75 % plus 20 µg dexmedetomidine ( RpD ) , or 3 ml ropivacaine 0.75 % plus systemic 20 µg dexmedetomidine ( RsD ) . UNB-related sensory and motor scores were evaluated . RESULTS Sensory onset time of UNB was not different between the study groups , whereas motor onset time was significantly faster in Group RpD when compared with the other study groups [ mean ( sd ) ] [ 21 ( 15 ) vs 43 ( 25 ) min in Group RsD and 47 ( 36 ) min in Group R , P<0.05 Group RpD vs other groups ] . The duration of sensory block was 350 ( 54 ) min in Group R , 555 ( 118 ) min in Group RpD , and 395 ( 40 ) min in Group RsD ( P<0.01 Group RpD vs other groups , P<0.05 Group RsD vs Group R ) . Motor block duration was similar to the duration of sensory block . CONCLUSIONS A profound prolongation of UNB of ∼60 % was detected with perineural dexmedetomidine when added to 0.75 % ropivacaine . The systemic administration of 20 µg dexmedetomidine result ed in a prolongation of ∼10 % during UNB with 0.75 % ropivacaine . Eudra-CT No. : 2012 - 000030 - 19 Various analgesic modalities have been tried to prolong the duration and to improve the quality of postoperative analgesia for the early rehabilitation and discharge from hospital after nephrectomy . Using local anaesthetic along with perineural steroids as adjuvant may prove promising for peripheral nerve block , especially paravertebral block ( PVB ) . This article aims to assess the efficacy of dexamethasone with bupivacaine as adjuvant for single bolus injection of thoracic PVB in patients undergoing elective nephrectomy . Sixty patients of American Society of Anesthesiologists physical status I and II were r and omly assigned to 2 groups of 30 patients each . Group D patients received 8 mg ( 2 mL ) of dexamethasone mixed to 18 mL of 0.25 % bupivacaine , whereas patients in group B received 18 mL of 0.25 % bupivacaine and 2 mL of 0.9 % saline as placebo to make a total volume of 20 mL infiltrated in PVB . Degree of analgesia achieved and duration of analgesia were recorded in each group along with total dose requirement of rescue analgesic and side effects in first 24 hours postoperatively . Group D patients with dexamethasone had VAS score of 0–3 after 09 minutes of block up to 610.48 ± 12.24 minutes and after 16 minutes up to 402.34 ± 28.12 minutes in another group B patient , respectively . The total dose of intravenous fentanyl in the first 24 hours postoperatively in group D was 98.6 ± 14.14 & mgr;g as compared with 147.6 ± 18.22 & mgr;g in group B. No other significant side effects were noted except for nausea and vomiting in 5 patients of placebo group . Dexamethasone , along with bupivacaine as adjunct for thoracic PVB , helps in improving the quality and enhancing the postoperative analgesia duration in patients undergoing nephrectomy Background and Objectives Research suggests that the addition of dexmedetomidine to local anesthetics can prolong peripheral nerve blocks ; however , clinical safety data are limited , and interscalene blocks have not been studied . The present study was design ed to test the hypothesis that dexmedetomidine added to ropivacaine would safely enhance the duration of analgesia without adverse effects when compared with ropivacaine alone . Methods We conducted a single-center , prospect i ve , r and omized , triple-blind , controlled trial of 62 patients undergoing elective shoulder surgery under general anesthesia with an interscalene block . Patients underwent ultrasound-guided interscalene blocks using either 12 mL of 0.5 % ropivacaine or 0.5 % ropivacaine plus 150-µg dexmedetomidine . The primary outcomes were self-reported duration of the nerve block and safety assessment ( adverse effects and neurological sequelae ) . Data were analyzed in a blinded fashion . Results The median duration of the nerve block was 18 hours ( 95 % confidence interval , 18–20 ) in the dexmedetomidine group and 14 hours ( 95 % confidence interval , 14–16 ) in the ropivacaine group ( P = 0.0001 ) . Dexmedetomidine also lowered pain scores for the first 14 hours postoperatively and significantly hastened the time to sensory ( P = 0.04 ) and motor ( P = 0.002 ) block onset . Dexmedetomidine lowered heart rate but blood pressures were stable . Plasma levels of ropivacaine were not different between groups , and plasma dexmedetomidine levels were relatively low . There were no adverse events or neurological sequelae . Conclusions Dexmedetomidine added to ropivacaine for interscalene blocks increased the duration of the nerve block and improved postoperative pain . These additional efficacy and safety data should encourage further study of peripheral perineural dexmedetomidine in humans Background This study determined the responses to increasing plasma concentrations of dexmedetomidine in humans . Methods Ten healthy men ( 20–27 yr ) provided informed consent and were monitored ( underwent electrocardiography , measured arterial , central venous [ CVP ] and pulmonary artery [ PAP ] pressures , cardiac output , oxygen saturation , end-tidal carbon dioxide [ ETCO2 ] , respiration , blood gas , and catecholamines ) . Hemodynamic measurements , blood sampling , and psychometric , cold pressor , and baroreflex tests were performed at rest and during sequential 40-min intravenous target infusions of dexmedetomidine ( 0.5 , 0.8 , 1.2 , 2.0 , 3.2 , 5.0 , and 8.0 ng/ml ; baroreflex testing only at 0.5 and 0.8 ng/ml ) . Results The initial dose of dexmedetomidine decreased catecholamines 45–76 % and eliminated the norepinephrine increase that was seen during the cold pressor test . Catecholamine suppression persisted in subsequent infusions . The first two doses of dexmedetomidine increased sedation 38 and 65 % , and lowered mean arterial pressure by 13 % , but did not change central venous pressure or pulmonary artery pressure . Subsequent higher doses increased sedation , all pressures , and calculated vascular resistance , and result ed in significant decreases in heart rate , cardiac output , and stroke volume . Recall and recognition decreased at a dose of more than 0.7 ng/ml . The pain rating and mean arterial pressure increase to cold pressor test progressively diminished as the dexmedetomidine dose increased . The baroreflex
Output:
| DEX also increased the odds of hypotension by odds ratio ( OR ) 4.40 ( 95 % CI [ 1.37 , 14.17 ] , P = .01 ) ; however , there was no statistically significant difference for intraoperative fentanyl consumption and the incidence of the bradycardia .
Conclusions DEX combined with LAs in PVB significantly improved postoperative pain scores , prolonged the duration of analgesia , reduced postoperative analgesic consumption , and increased the odds of hypotension . |
MS211585 | ***TASK*** the task is to summarize an input biomedical literature 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: Introduction No existing patient-reported outcome instrument focuses solely on assessment of varicose veins symptoms that are bothersome to patients . Methods The VVSymQ ® instrument is a five-item patient-reported outcome that assesses symptoms most important to patients with varicose veins ( heaviness , achiness , swelling , throbbing and itching ) . This paper describes how the VVSymQ ® instrument was incorporated into an electronic daily diary to monitor key outcomes over time and capture treatment benefit in two r and omized , controlled , phase 3 clinical trials . Results Patients were highly compliant in completing the electronic daily diary , and the VVSymQ ® instrument demonstrated ability to detect overall change and ability to detect change that is meaningful to patients . Conclusion The VVSymQ ® instrument is a reliable , valid instrument responsive to measuring change in the patient experience of varicose vein symptoms pre- and post-intervention , and is uniquely focused on patient-reported symptoms compared with other widely used question naires completed by clinicians OBJECTIVE The natural history in the general population of chronic venous disease in the legs is not well understood . This has limited our ability to predict which patients will deteriorate and to assign clinical priorities . The aims of this study were to describe the progression of trunk varicose veins and chronic venous insufficiency ( CVI ) in the general population , to identify important lifestyle and clinical prognostic factors , and to determine the relationship between venous reflux and progression . METHODS The Edinburgh Vein Study is a population -based cohort study in which r and omly selected adults aged 18 to 64 years had an examination at baseline . This included a question naire on lifestyle and clinical factors , st and ardized assessment and classification of venous disease in the legs , and duplex scan to detect venous reflux in eight segments of each leg . A follow-up examination 13 years later included a reclassification of venous disease to ascertain progression in the development or increase in severity of varicose veins and CVI . RESULTS Among 1566 adults seen at baseline , 880 had a follow-up examination , of whom 334 had trunk varicose veins or CVI at baseline and composed the study sample . The mean ( st and ard deviation ) duration of follow-up was 13.4 ( 0.4 ) years . Progression was found in 193 ( 57.8 % ) , equivalent to 4.3 % ( 95 % confidence interval [ CI ] , 3.7 - 4.9 ) annually . In 270 subjects with only varicose veins at baseline , 86 ( 31.9 % ) developed CVI , with the rate increasing consistently with age ( P = .04 ) . Almost all subjects ( 98 % ) with both varicose veins and CVI at baseline deteriorated . Progression of chronic venous disease did not differ by gender or leg , but a family history of varicose veins and history of deep venous thrombosis increased risk ( odds ratio [ OR ] , 1.85 [ 95 % CI , 1.14 - 1.30 ] and 4.10 [ 95 % CI , 1.07 - 15.71 ] , respectively ) . Overweight was associated with increased risk of CVI in those with varicose veins ( OR , 1.85 ; 95 % CI , 1.10 - 3.12 ) . Reflux in the superficial system increased the likelihood of progression , especially in combination with deep reflux ( OR , 2.57 ; 95 % CI , 1.55 - 4.25 ) and when located in the small saphenous vein ( OR , 4.73 ; 95 % CI , 1.37 - 16.39 ) . CONCLUSIONS Nearly half of the general population with chronic venous disease deteriorated during 13 years , and almost one third with varicose veins developed skin changes of CVI , increasing their risk of ulceration . Age , family history of varicose veins , history of deep venous thrombosis , overweight , and superficial reflux , especially in the small saphenous vein and with deep reflux , might influence the risk of progression
Output:
| The overall key theme to emerge was adaptation , with patients demonstrating how they adapted to the various impacts .
This review demonstrates that varicose veins have a wide range of symptoms and may have a significant impact on quality of life ; people made significant adaptations to enable them to live their lives as fully as possible .
The use of PROMs to gather information about quality of life and symptoms is well established globally ; however , PROMs currently used may not capture the full extent of the impact on patient 's quality of life |
MS211586 | ***TASK*** the task is to summarize an input biomedical literature 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: Women with a history of venous thromboembolism ( VTE ) , thrombophilia or both may be at increased risk of thrombosis during pregnancy , but the optimal management strategy is not well defined in clinical guidelines because of limited trial data . A strategy of risk assessment and heparin prophylaxis was evaluated in pregnant women at increased risk of VTE . In a prospect i ve trial ( Efficacy of Thromboprophylaxis as an Intervention during . Gravidity [ EThIG ] ) , 810 pregnant women were assigned to one of three management strategies according to pre-defined risk factors related to history of VTE and thrombophilic profile . Low-risk women ( group I ) , received 50 - 100 IU dalteparin/kg body weight/day for 14 days postpartum , or earlier when additional risk factors occurred . Women at high ( group II ) or very high risk ( group III ) received dalteparin from enrollment until six weeks postpartum ( 50 - 100 IU and 100 - 200 IU/kg/day , respectively ) . Objective ly confirmed , symptomatic VTE occurred in 5/810 women ( 0.6 % ; 95 % confidence interval [ CI ] , 0.2 to 1.5 % ) ( group I , 0 of 225 ; II , 3/469 ; III , 2/116 ) . The rate of serious bleeding was 3.0 % ( 95 % CI , 1.9 to 4.4 % ) ; 1.1 % ( 95 % CI , 0.5 to 2.2 % ) was possibly dalteparin-related . There was no evidence of heparin-induced thrombocytopenia , one case of osteoporosis , and rates of miscarriage and stillbirth were similar to previous , retrospective studies . Risk-stratified heparin prophylaxis was associated with a low incidence of symptomaticVTE and few clinical ly important adverse events . Antepartum heparin prophylaxis is , therefore , warranted in pregnant women with idiopathic thrombosis or symptomatic thrombophilia Intravenous heparin followed by oral anticoagulant therapy ( e. g. with coumarin ) is still the most widely used treatment for deep venous thromboembolism . Self-administered subcutaneous injections of heparin have been thought of as a promising alternative to coumarin , but the high doses required for ongoing prophylaxis have raised concerns about the possible development of bone disease . Certainly , long-term heparin therapy has been reported to cause osteoporosis in both laboratory animals and humans . This study aim ed to compare the efficacy and safety of unfractionated ( UF ) heparin with that of a low molecular weight heparin ( Fragmin , Kabi Pharmacia ) in the prevention of recurrent deep venous thrombosis ( DVT ) and pulmonary embolism ( PE ) in a consecutive series of patients with contraindications to coumarin therapy . The patients comprised 40 men and 40 women , aged between 19 and 92 years ( mean age , 68 years ) . They had all previously been diagnosed as having acute DVT and had been treated with conventional doses of heparin while in hospital . All patients had at least one of the following conditions : recent blood loss ( either spontaneous or during admission while receiving heparin therapy ) ; active gastroduodenal ulcer disease ; psychological or physical inability or unwillingness to underst and and accept the need for regular laboratory monitoring during coumarin treatment ; chronic alcoholism ; dementia ; pregnancy ; recent neurosurgery , and pericardial effusion ; or were over 80 years of age . They were r and omly allocated to receive either UF heparin , 10,000 IU s.c . b.d . , or Fragmin , 5000 IU anti-Factor Xa s.c . b.d . , for a period of 3 - 6 months . ( ABSTRACT TRUNCATED AT 250 WORDS We have previously reported that long-term therapy with warfarin is effective for preventing recurrent venous thromboembolism in patients with proximal-vein thrombosis but that there is an appreciable risk of hemorrhage . To determine whether that risk could be reduced without a loss of effectiveness , we r and omly allocated 96 patients with proximal-vein thrombosis to a group receiving less intense anticoagulant therapy , with a mean prothrombin time of 26.9 seconds using the Manchester comparative reagent ( corresponding Simplastin time , 15 seconds ) , or a group given more intense therapy , with a mean Simplastin time of 19.4 seconds ( corresponding prothrombin time 41 seconds with the Manchester comparative reagent ) ( P less than 0.001 ) . Two of 47 patients ( 4 per cent ) in the less intensely treated group had hemorrhagic complications , as compared with 11 of 49 patients ( 22 per cent ) in the more intensely anticoagulated group ( P = 0.015 by the two-tailed test ) . This difference was due to minor bleeding episodes . The frequency of recurrent venous thromboembolism was low in both groups ( 2 per cent ) . Our findings indicate that less intense anticoagulant therapy is associated with a low frequency of recurrent venous thromboembolism ( 2 per cent ) and a reduced risk of hemorrhage OBJECTIVE To assess the maternal response to low molecular weight heparin during pregnancy , by estimation of plasma anti-Xa activity , at three specified gestation points and in the nonpregnant state . METHODS A longitudinal , prospect i ve , observational study was set in a tertiary referral recurrent miscarriage clinic . Twenty-four women , attending consecutively , were invited to participate and gave informed consent . Each woman had a history of recurring pregnancy loss and positive preconception screening for antiphospholipid syndrome . After confirmation of a viable pregnancy all subjects began taking 5000 IU of dalteparin once daily subcutaneously . Serial measurement of plasma anti-Xa activity after administration of dalteparin was performed at three st and ard gestation points ( 12 , 24 , and 36 weeks ) and in the nonpregnant state ( 6 weeks postpartum ) . RESULTS Peak anti-Xa levels occurred at 4 hours postbolus in pregnancy , as compared with 2 hours in the nonpregnant state . The mean anti-Xa levels at 12 , 24 , and 36 weeks ' gestation were significantly reduced , at 2 hours postinjection , as compared with the nonpregnant state ( P < .001 , P < .01 , P < .001 , respectively ) . The lowest dose – response curve was at 36 weeks ' gestation . A repeated- measures analysis of variance found a significant difference ( P < .05 ) between the 36-week group and the postterm group but not between any of the other groups . CONCLUSION During pregnancy , differences in the pharmacokinetics of low molecular weight heparin were observed , with an overall reduction in anti-Xa activity . On the basis of this study it is question able to extrapolate dosing and lack of dose monitoring , in pregnant women , using data derived from a nonpregnant OBJECTIVE The purpose of this study was to compare the use of low-dose aspirin alone with heparin and low-dose aspirin in the treatment of the antiphospholipid antibody syndrome . STUDY DESIGN A prospect i ve , single-center trial included 50 patients who were alternately assigned to treatment . Each patient had at least three consecutive spontaneous pregnancy losses , positive antiphospholipid antibodies on two occasions , and a complete evaluation . Data were compared by chi(2 ) analysis and Fisher 's exact test . RESULTS Viable infants were delivered of 11 of 25 ( 44 % ) women treated with aspirin and 20 of 25 ( 80 % ) women treated with heparin and aspirin ( p < 0.05 ) . There were no significant differences between the low-dose aspirin and the heparin plus low-dose aspirin groups with respect to gestational age at delivery ( 37.8 + /- 2.1 vs 37.2 + /- 3.4 weeks ) , number of cesarean sections ( 18 % vs 20 % ) , or complications . CONCLUSION Heparin plus low-dose aspirin provides a significantly better pregnancy outcome than low-dose aspirin alone does for antiphospholipid antibody-associated recurrent pregnancy loss OBJECTIVES To determine if a prophylactic dose of dalteparin , 5000 IU daily , and if the adjusted-weight dalteparin therapeutic dose of 100 IU/kg twice daily are appropriate in pregnancy . METHOD Anti-Xa activity levels were used to assess prophylactic ( 33 women ) and therapeutic ( 15 women ) dalteparin dosage throughout pregnancy . Analysis of variance was used and P-values less than 0.05 were considered statistically significant . RESULTS In the prophylactic group , anti-Xa activity levels did not vary significantly throughout pregnancy ( P=0.15 ) . The initial dalteparin dose was modified on the first anti-Xa activity measurement in eight women , whose weight was statistically different from those remaining on the initial dose ( P<0.001 ) . The adjusted-weight therapeutic dalteparin dose induced adequate anti-Xa activity levels . CONCLUSIONS Dalteparin , 5000 IU daily , is suitable for most pregnant women and does not need to be modified in the third trimester . A therapeutic dalteparin dose adjusted according to pregnancy weight is appropriate BACKGROUND The aim of this study was to assess the effect of long-term low molecular weight heparin ( LMWH ) on bone mineral density ( BMD ) during pregnancy . METHODS Fifty-five patients with recurrent miscarriage and known thrombophilia ( antiphospholipid syndrome ) were followed through pregnancy in an ethically approved prospect i ve observational study . All women had dual energy X-ray absorptiometry ( DEXA ) scans at the lumbar spine ( L1-L4 ) performed within 6 months prior to conception and in the immediate post-natal period , within 6 weeks of delivery . LMWH ( 5000 U/day ) plus low-dose aspirin was commenced after a positive urine pregnancy test and continued throughout pregnancy and after delivery until 6 weeks post-partum . A group of 20 volunteers with recurrent miscarriage , not requiring any treatment intervention , acted as controls and were monitored in an identical fashion . RESULTS Characteristics were not significantly different between treated patients and controls . Both groups showed a similar loss in lumbar spine ( L1-L4 ) BMD by the end of the pregnancy [ LMWH 4.17 % or 0.045 g/cm(3 ) , 95 % confidence interval ( CI ) 0.036 - 0.062 versus control 3.56 % or 0.043 g/cm(3 ) , 95 % CI 0.027 - 0.059 ] . However , the difference in bone loss between the groups was not statistically significant ( 0.002 g/cm(3 ) , CI -0.0124 to 0.00865 ; P = 0.88 ) . No patient suffered vertebral fracture . CONCLUSIONS Bone loss associated with the use of long-term LMWH is not significantly different from physiological losses during pregnancy Mechanical valve thrombosis is a life-threatening event , while pregnancy is associated with a hypercoagulable state . Thus , in pregnant women with mechanical valves , adequate anticoagulation becomes even more critical . This prospect i ve study was conducted to establish a uniform anticoagulation regimen for these women . A total of 250 pregnancies in 245 women with mechanical heart valves were evaluated . The patients were divided into 2 groups : group 1 ( n = 150 ) took oral warfarin throughout pregnancy and group 2 ( n = 100 ) received subcutaneous heparin in the 1st trimester and oral warfarin for the other trimesters . Both groups received heparin at the time of delivery . There were no coumarin-induced fetal malformations . Minor thromboembolic episodes took place in 5 women in group 1 and 3 in group 2 . Valve thrombosis occurred in 1 woman in group 2 and led to 1 maternal death in this series . The incidence of spontaneous abortion was similar between the groups . We conclude that warfarin is safe and convenient to use during pregnancy . The teratogenic effects of warfarin during the 1st trimester are overstated , and switching to heparin is not m and atory BACKGROUND Women with a history of venous thromboembolism may be at increased risk for venous thromboembolic events during pregnancy . In these women , the decision to give or withhold heparin in the antepartum period is controversial , because accurate estimates of the frequency of recurrent thromboembolic events if antepartum heparin is withheld are not available . METHODS We prospect ively studied 125 pregnant women with a single previous episode of venous thromboembolism . Antepartum heparin was withheld , but anticoagulant therapy was given for four to six weeks post partum . Our primary objective was to determine the rate of antepartum recurrence of venous thromboembolism . Laboratory studies were performed to identify thrombophilia in 95 women . RESULTS Three of the 125 women ( 2.4 percent ) had an antepartum recurrence of venous thromboembolism (
Output:
| There is no evidence from r and omised controlled trials to evaluate the effectiveness and safety of different methods of administering subcutaneous heparin ( UFH or LMWH ) to pregnant women |
MS211587 | ***TASK*** the task is to summarize an input biomedical literature 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 purpose of this study was to determine the association between posttraumatic stress disorder ( PTSD ) , diagnosed prospect ively during pregnancy , and the risk of delivering a low birth weight ( < 2500 g ) or preterm ( < 37 weeks gestational age ) infant . METHODS Pregnant women were recruited from obstetrics clinics and screened for major and minor depressive disorder , panic disorder , PTSD , and substance use . Current episodes of PTSD were diagnosed according to the MINI International Neuropsychiatric Interview , and pregnancy outcomes were abstract ed from hospital records . RESULTS Among the 1100 women included in analysis , 31 ( 3 % ) were in episode for PTSD during pregnancy . Substance use in pregnancy , panic disorder , major and minor depressive disorder , and prior preterm delivery were significantly associated with a diagnosis of PTSD . Preterm delivery was non-significantly higher in pregnant women with ( 16.1 % ) compared to those without ( 7.0 % ) PTSD ( OR=2.82 , 95 % C.I. 0.95 , 8.38 ) . Low birth weight ( LBW ) was present in 6.5 % of women and was not significantly associated with a diagnosis of PTSD in pregnancy after adjusting for potential confounders . However , LBW was significantly associated with minor depressive disorder ( OR=1.82 , 95 % C.I. 1.01 , 3.29 ) . LIMITATIONS There was a low prevalence of PTSD in this cohort , result ing in limited power . CONCLUSIONS These data suggest a possible association between PTSD and preterm delivery . Coupled with the association found between LBW and a depressive disorder , these results support the utility of screening for mental health disorders in pregnancy BACKGROUND Childbirth has been linked to postpartum impairment . However , controversy exists regarding the onset and prevalence of post-traumatic stress disorder ( PTSD ) after childbirth , with seminal studies being limited by method ological issues . This longitudinal prospect i ve study examined the prevalence of PTSD following childbirth in a large sample while controlling for pre-existing PTSD and affective symptomatology . METHOD Pregnant women in their third trimester were recruited over a 12-month period and interviewed to identify PTSD and anxiety and depressive symptoms during the last trimester of pregnancy , 4 - 6 weeks postpartum , 12 weeks postpartum and 24 weeks postpartum . RESULTS Of the 1067 women approached , 933 were recruited into the study . In total , 866 ( 93 % ) were retained to 4 - 6 weeks , 826 ( 89 % ) were retained to 12 weeks and 776 ( 83 % ) were retained to 24 weeks . Results indicated that , uncontrolled , 3.6 % of women met PTSD criteria at 4 - 6 weeks postpartum , 6.3 % at 12 weeks postpartum and 5.8 % at 24 weeks postpartum . When controlling for PTSD and partial PTSD due to previous traumatic events as well as clinical ly significant anxiety and depression during pregnancy , PTSD rates were less at 1.2 % at 4 - 6 weeks , 3.1 % at 12 weeks and 3.1 % at 24 weeks postpartum . CONCLUSIONS This is the first study to demonstrate the occurrence of full criteria PTSD result ing from childbirth after controlling for pre-existing PTSD and partial PTSD and clinical ly significant depression and anxiety in pregnancy . The findings indicate that PTSD can result from a traumatic birth experience , though this is not the normative response BACKGROUND AND OBJECTIVES Pregnant women face considerable barriers to smoking cessation . The purpose of this study was to determine the prevalence of major depressive disorder ( MDD ) and post-traumatic stress disorder ( PTSD ) and response to smoking cessation treatment in pregnant smokers participating in a r and omized , placebo-controlled trial of nicotine gum . METHODS Participants were 194 low-income , ethnically diverse pregnant smokers . RESULTS Utilizing a structured interview , 45 % and 18 % of the subjects met criteria for a lifetime diagnosis of MDD and PTSD , respectively . There was no difference in response to treatment , based on the presence of either of these psychiatric disorders . CONCLUSIONS Cumulatively , these findings provide evidence of the high degree of unmet mental health needs in pregnant smokers . SCIENTIFIC SIGNIFICANCE Pregnant women with a history of MDD and PTSD appear to be as likely to benefit from smoking cessation treatment as those without such a history OBJECTIVE To test the effectiveness of a trauma-specific , psychoeducational intervention for pregnant women with a history of childhood maltreatment on six intrapartum and postpartum psychological outcomes . DESIGN Quasi-experimental study comparing women from a single-group , pretest-posttest pilot intervention study with women matched from a prospect i ve observational study . SETTING Rural and university-based prenatal clinics . PARTICIPANTS Pregnant women entered the study by responding to an advertisement or by referral from a maternity care provider . Women could take part whether or not they met posttraumatic stress disorder diagnostic criteria . Outcomes data exist for 17 pilot intervention study participants and 43 matched observational study participants . INTERVENTIONS Participants in the observational study received usual care . Participants in the pilot intervention study received usual care plus the intervention , a fully manualized , self- study program supported by weekly phone tutoring sessions with a health professional . MAIN OUTCOME MEASURES The National Women 's Study PTSD Module , the Peritraumatic Dissociation Experience Question naire , the Perception of Care Question naire , the Postpartum Depression Screening Scale , the Postpartum Bonding Question naire , and a semantic differential appraisal of the labor experience . RESULTS Participants in the intervention study had better scores on all measures . Differences in means between participants in the intervention study and participants in the observational study equated to medium effect sized for dissociation during labor , rating of labor experience , and perception of care in labor and small effect sizes for postpartum posttraumatic stress disorder ( PTSD ) symptoms , postpartum depression symptoms , and motherinfant bonding . CONCLUSION This trauma-specific intervention reaches and benefits pregnant women with a history of childhood maltreatment OBJECTIVE The purpose of this study was to examine symptoms of posttraumatic stress disorder ( PTSD ) in a community sample of low-income pregnant women who met the DSM-IV diagnostic criteria for the disorder . METHOD Pregnant women ( N=948 ) were screened for trauma , PTSD , depression , and co-occurring illicit substance use . PTSD symptoms were compared in traumatized pregnant women and a sample of nonpregnant traumatized women from the National Comorbidity Survey . RESULTS Suicidal thoughts and a high degree of psychiatric comorbidity were common in pregnant women with PTSD . Pregnant women were selectively and significantly less likely to endorse reexperiencing symptoms of PTSD ( 29.5 % , N=82 ) , compared to nonpregnant women ( 79.4 % , N=464 ) . CONCLUSIONS PTSD in pregnancy was associated with comorbidity , poor health behaviors , and lower recall of memory-related PTSD symptoms . Further prospect i ve study is needed IMPORTANCE Posttraumatic stress disorder ( PTSD ) occurs in about 8 % of pregnant women . Stressful conditions , including PTSD , are inconsistently linked to preterm birth . Psychotropic treatment has been frequently associated with preterm birth . Identifying whether the psychiatric illness or its treatment is independently associated with preterm birth may help clinicians and patients when making management decisions . OBJECTIVE To determine whether a likely diagnosis of PTSD or antidepressant and benzodiazepine treatment during pregnancy is associated with risk of preterm birth . We hypothesized that pregnant women who likely had PTSD and women receiving antidepressant or anxiolytic treatment would be more likely to experience preterm birth . DESIGN , SETTING , AND PARTICIPANTS Longitudinal , prospect i ve cohort study of 2654 women who were recruited before 17 completed weeks of pregnancy from 137 obstetrical practice s in Connecticut and Western Massachusetts . EXPOSURES Posttraumatic stress disorder , major depressive episode , and use of antidepressant and benzodiazepine medications . MAIN OUTCOMES AND MEASURES Preterm birth , operationalized as delivery prior to 37 completed weeks of pregnancy . Likely psychiatric diagnoses were generated through administration of the Composite International Diagnostic Interview and the Modified PTSD Symptom Scale . Data on medication use were gathered at each participant interview . RESULTS Recursive partitioning analysis showed elevated rates of preterm birth among women with PTSD . A further split of the PTSD node showed high rates for women who met criteria for a major depressive episode , which suggests an interaction between these 2 exposures . Logistic regression analysis confirmed risk for women who likely had both conditions ( odds ratio [ OR ] , 4.08 [ 95 % CI , 1.27 - 13.15 ] ) . For each point increase on the Modified PTSD Symptom Scale ( range , 0 - 110 ) , the risk of preterm birth increased by 1 % to 2 % . The odds of preterm birth are high for women who used a serotonin reuptake inhibitor ( OR , 1.55 [ 95 % CI , 1.02 - 2.36 ] ) and women who used a benzodiazepine medication ( OR , 1.99 [ 95 % CI , 0.98 - 4.03 ] ) . CONCLUSIONS AND RELEVANCE Women with likely diagnoses of both PTSD and a major depressive episode are at a 4-fold increased risk of preterm birth ; this risk is greater than , and independent of , antidepressant and benzodiazepine use and is not simply a function of mood or anxiety symptoms Background : Many women experience childbirth as traumatic and 2 % develop post-traumatic stress disorder . This study examined the role of health practitioner support and personal control during birth as predictors of post-traumatic stress ( PTS ) symptoms , adjusting for vulnerability factors of prior trauma , depression , control beliefs and birth intervention . It also investigated interactions between support , prior trauma and birth intervention and their association with PTS symptoms . Methods : A prospect i ve longitudinal survey of 138 women recruited from UK NHS maternity clinics . Measures were taken in pregnancy , 3 weeks and 3 months after the birth . Results : Support and control during birth were not predictive of postnatal PTS symptoms . However , support was predictive of PTS symptoms in a subset of women with prior trauma ( β = −0.41 , R 2 = 16 % ) at both 3-weeks and 3-months postpartum . The interaction of birth intervention and support was associated with PTS symptoms 3 months after birth , the relationship between support and PTS symptoms was stronger in women experiencing more intervention . Conclusions : Low support from health practitioners is predictive of postnatal PTS symptoms in women who have a history of trauma . Longer term effects of low support on postnatal PTS symptoms are also found in women who had more intervention during birth Background Prenatal assessment for psychosocial risk factors and prevention and intervention is scarce and , in most cases , nonexistent in obstetrical care . In this study we aim ed to evaluate if the KINDEX , a short instrument developed in Germany , is a useful tool in the h and s of non-trained medical staff , in order to identify and refer women in psychosocial risk to the adequate mental health and social services . We also examined the criterion-related concurrent validity of the tool through a validation interview carried out by an expert clinical psychologist . Our final objective was to achieve the cultural adaptation of the KINDEX Greek Version and to offer a valid tool for the psychosocial risk assessment to the obstetric care providers . Methods Two obstetricians and five midwives carried out 93 KINDEX interviews ( duration 20 minutes ) with pregnant women to assess psychosocial risk factors present during pregnancy . Afterwards they referred women who they identified having two or more psychosocial risk factors to the mental health attention unit of the hospital . During the validation procedure an expert clinical psychologist carried out diagnostic interviews with a r and omized sub sample of 50 pregnant women based on established diagnostic instruments for stress and psychopathology , like the PSS-14 , ESI , PDS , HSCL-25 . Results Significant correlations between the results obtained through the assessment using the KINDEX and the risk areas of stress , psychopathology and trauma load assessed in the validation interview demonstrate the criterion-related concurrent validity of the KINDEX . The referral accuracy of the medical staff is confirmed through comparisons between pregnant women who have and have not been referred to the mental health attention unit . Conclusions Prenatal screenings for psychosocial risks like the KINDEX are feasible in public health setting s in Greece . In addition , validity was confirmed in high correlations between the KINDEX results and the results of the validation interviews . The KINDEX Greek version can be considered a valid tool , which can be used by non-trained medical staff providing obstetrical care to identify high-risk women and refer them to adequate mental health and social services . These kind of assessment s are indispensable for the promotion of a healthy family environment and child development Background High levels of stress due to diverse psychosocial factors have a direct impact on the mothers ’ wellbeing during pregnancy and both direct and indirect effects on
Output:
| PTSD is prevalent during pregnancy and after birth and may increase postpartum if not identified and treated . |
MS211588 | ***TASK*** the task is to summarize an input biomedical literature 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 Guided self-help interventions for PTSD ( post-traumatic stress disorder ) are a promising tool for the dissemination of contemporary psychological treatment . Objective This study investigated the efficacy of the Chinese version of the My Trauma Recovery ( CMTR ) website . Methods In an urban context , 90 survivors of different trauma types were recruited via Internet advertisements and allocated to a r and omized controlled trial ( RCT ) with a waiting list control condition . In addition , in a rural context , 93 survivors mainly of the 2008 Sichuan earthquake were recruited in-person for a parallel RCT in which the website intervention was conducted in a counseling center and guided by volunteers . Assessment was completed online on a professional Chinese survey website . The primary outcome measure was the Post-traumatic Diagnostic Scale ( PDS ) ; secondary outcome measures were Symptom Checklist 90-Depression ( SCL-D ) , Trauma Coping Self-Efficacy Scale ( CSE ) , Post-traumatic Cognitive Changes ( PCC ) , and Social Functioning Impairment ( SFI ) question naires adopted from the My Trauma Recovery website . Results For the urban sample , findings indicated a significant group × time interaction in post-traumatic symptom severity ( F 1,88=7.65 , P=.007 ) . CMTR reduced post-traumatic symptoms significantly with high effect size after one month of treatment ( F 1,45=15.13 , Cohen ’s d=0.81 , P<.001 ) and the reduction was sustained over a 3-month follow-up ( F 1,45=17.29 , Cohen ’s d=0.87 , P<.001 ) . In the rural sample , the group × time interaction was also significant in post-traumatic symptom severity ( F 1,91=5.35 , P=.02 ) . Post-traumatic symptoms decreased significantly after treatment ( F 1,48=43.97 , Cohen ’s d=1.34 , P<.001 ) and during the follow-up period ( F 1,48=24.22 , Cohen ’s d=0.99 , P<.001 ) . Additional outcome measures ( post-traumatic cognitive changes , depression ) indicated a range of positive effects , in particular in the urban sample ( group × time interactions : F 1,88=5.32 - 8.37 , all Ps<.03 ) , contributing to the positive evidence for self-help interventions . Differences in the effects in the two RCTs are exploratorily explained by sociodemographic , motivational , and setting feature differences between the two sample s. Conclusions These findings give support for the short-term efficacy of CMTR in the two Chinese population s and contribute to the literature that self-help Web-based programs can be used to provide mental health help for traumatized persons . Trial Registration Australia New Zeal and Clinical Trials Registry ( ANZCTR ) : ACTRN12611000951954 ; https://www.anzctr.org.au/Trial/ Registration /Trial Review .aspx?ACTRN=12611000951954 ( Archived by WebCite at http://www.webcitation.org/6G7WyNODk ) Online therapy offers many advantages over face-to-face therapy . Interapy includes psychoeducation , screening , effect measures , and a protocol -driven treatment via the Internet for people suffering from posttraumatic stress . The present article reports the results of a controlled trial on the Internet-driven treatment of posttraumatic stress and grief in a group of people who manifested mild to relatively severe trauma symptoms . Participants in the treatment condition ( n=69 ) improved significantly more than participants in the waiting-list control condition ( n=32 ) on trauma-related symptoms and general psychopathology . The effect sizes were large . On most subscales , more than 50 % of the treated participants showed reliable change and clinical ly significant improvement , with the highest percentages being found for depression and avoidance BACKGROUND Posttraumatic stress disorder ( PTSD ) is a severe and disabling condition and few receive appropriate care . Internet-based treatment of PTSD shows promise in reducing barriers to care and preliminary evidence suggests it is efficacious in treating symptoms of PTSD . METHODOLOGY Forty-two individuals with a diagnosis of PTSD confirmed by clinician interview completed a r and omized controlled comparison of Internet-based cognitive behavioral therapy ( CBT ) with a waitlist control condition . PRINCIPLE FINDINGS Large pre- to posttreatment effect sizes ( ESs ) were found for the Treatment group on measures of PTSD symptoms , depression , anxiety , and disability . A small between-group ES was found for PTSD symptoms and moderate between-group ESs were found for depression , anxiety , and disability . CONCLUSIONS Results provide preliminary support for Internet-based CBT as an efficacious treatment for individuals with a confirmed primary diagnosis of PTSD This study was an open trial evaluation of a 10-week therapist-assisted cognitive behavior therapy ( CBT ) internet intervention ( PTSD Online ) undertaken with people with a primary clinical diagnosis of posttraumatic stress disorder ( PTSD ) ( n=22 ) at pre- assessment . Participants were re-assessed at post- assessment and 3-month follow-up . Significant improvements on PTSD severity ratings and related PTSD symptomatology were observed at post- assessment and maintained at 3-month follow-up . At post- assessment , 69.2 % of the sample showed clinical ly significant improvement and 77 % of the sample at follow-up assessment . Non-significant , yet improved , change was observed on all other general psychological measures . Overall , treatment satisfaction was good ( 69 % ) , participant therapeutic alliance ratings were high ( 87.5 % ) , and the average total therapist time required was 194.5 min . PTSD Online appears to be an efficacious treatment option for people with PTSD that can be provided entirely remotely , with far less therapist time than traditional face-to-face treatment , and without compromising therapeutic alliance Background In recent years , armed conflicts in the Middle East have result ed in high rates of exposure to traumatic events . Despite the increasing dem and of mental health care provision , ongoing violence limits conventional approaches of mental health care provision . Internet-based interventions for posttraumatic stress disorder ( PTSD ) have proved feasible and effective in Western countries , but their applicability and efficacy in war and conflict regions remains unknown . Objective This study investigated the efficacy of a cognitive behavioral Internet-based intervention for war-traumatized Arab patients , with focus on Iraq . Methods A total of 159 individuals with PTSD participated in a parallel group r and omized trial . Participants were r and omly allocated by a computer-generated sequence to a treatment group ( n=79 ) or a waiting list control group ( n=80 ) . The treatment group received 2 weekly 45-minute cognitive behavioral interventions via Internet over a 5-week period ( 10 sessions in total ) . The primary outcome was recovery from posttraumatic stress symptoms . Results Posttraumatic stress symptoms were significantly reduced from baseline to posttreatment ( intention-to-treat analysis ) in the treatment group relative to the control group ( F1,157=44.29 , P<.001 , d=0.92 ) . Treatment effects were sustained at 3-month follow-up . Completer analysis indicated that 29 of 47 patients ( 62 % ) in the treatment group had recovered from posttraumatic stress symptoms at posttreatment ( reliable change and Posttraumatic Stress Diagnostic Scale score < 20 ) versus 1 patient ( 2 % ) in the control group ( OR 74.19 , 95 % CI 9.93 - 585.8 , P<.001 ) indicating that the chance of recovering was 74.19 times higher in the treatment than in the control group . Conclusions The results indicate , even in unstable and insecure setting s with ongoing exposure to human rights violations through war and dictatorships , people with posttraumatic stress symptoms benefit from a cognitive behavioral treatment provided entirely through the Internet . This method of delivery could improve patients ’ access to humanitarian aid in the form of e-mental health services . Trial Registration Australian New Zeal and Clinical Trial Registry , ACTRN12611001019998 ; https://www.anzctr.org.au/Trial/ Registration /Trial Review .aspx?id=347505 ( Archived by WebCite at http://www.webcitation.org/6Wto4HCdH ) OBJECTIVE The use of interactive videoconferencing to provide psychiatric services to geographically remote regions , often referred to as telepsychiatry , has gained wide acceptance . However , it is not known whether clinical outcomes of telepsychiatry are as good as those achieved through face-to-face contact . This study compared a variety of clinical outcomes after psychiatric consultation and , where needed , brief follow-up for out patients referred to a psychiatric clinic in Canada who were r and omly assigned to be examined face to face or by telepsychiatry . METHODS A total of 495 patients in Ontario , Canada , referred by their family physician for psychiatric consultation were r and omly assigned to be examined face to face ( N=254 ) or by telepsychiatry ( N=241 ) . The treating psychiatrists had the option of providing monthly follow-up appointments for up to four months . The study tested the equivalence of the two forms of service delivery on a variety of outcome measures . RESULTS Psychiatric consultation and follow-up delivered by telepsychiatry produced clinical outcomes that were equivalent to those achieved when the service was provided face to face . Patients in the two groups expressed similar levels of satisfaction with service . An analysis limited to the cost of providing the clinical service indicated that telepsychiatry was at least 10 % less expensive per patient than service provided face to face . CONCLUSIONS Psychiatric consultation and short-term follow-up can be as effective when delivered by telepsychiatry as when provided face to face . These findings do not necessarily mean that other types of mental health services , for example , various types of psychotherapy , are as effective when provided by telepsychiatry OBJECTIVE This r and omized controlled trial examined the effectiveness of a nurse assisted online cognitive-behavioral self-management intervention for war-related posttraumatic stress disorder ( PTSD ) , compared to optimized usual primary care PTSD Treatment ( OUC ) to reduce PTSD symptoms . METHOD Participants were 80 veterans of recent military conflicts with PTSD as assessed by the PTSD Checklist ( PCL ) seeking primary care treatment at one of three Veterans Affairs ( VA ) and four Army clinics . DESTRESS-PC consisted of logins to a secure website three times per week for 6 weeks with monitoring by a study nurse . All participants received nurse care management in the form of phone check-ins every two weeks and feedback to their primary care providers . Blinded raters assessed outcomes 6 , 12 , and 18 weeks post-r and omization . RESULTS DESTRESS-PC was associated with a significantly greater decrease in PTSD symptoms compared to OUC ( F(3 , 186)=3.72 , p=.012 ) . The effect was largest at the 12-week assessment ( ∆PCL=12.6±16.6 versus 5.7±12.5 , p<0.05 ) with the treatment effect disappearing by the 18-week follow-up . Notably , there was a dose effect ; number of logins correlated significantly with PTSD outcomes , with more logins associated with greater PTSD symptom improvement . None of the secondary outcomes ( depression , anxiety , somatic symptoms , and functional status ) showed statistically significant improvement ; however , the treatment effect on depression approached significance ( F(3 , 186)=2.17 , p=.093 ) . CONCLUSIONS DESTRESS-PC shows promise as a means of delivering effective , early PTSD treatment in primary care . Larger trials are needed Background : The loss of a child during pregnancy causes significant psychological distress for many women and their partners , and may lead to long-lasting psychiatric disorders . Internet-based interventions using exposure techniques and cognitive restructuring have proved effective for posttraumatic stress disorder ( PTSD ) and prolonged grief . This study compared the effects of an Internet-based intervention for parents after prenatal loss with a waiting list condition ( WLC ) . Methods : The Impact of Event Scale - Revised assessed symptoms of PTSD ; the Inventory of Complicated Grief and the Brief Symptom Inventory assessed depression , anxiety , and general mental health . The 228 participants ( 92 % female ) were r and omly allocated to a treatment group ( TG ; n = 115 ) or a WLC group ( n = 113 ) . The TG received a 5-week cognitive behavioral intervention including ( 1 ) self-confrontation , ( 2 ) cognitive restructuring , and ( 3 ) social sharing . Results : The TG showed significantly reduced symptoms of posttraumatic stress , prolonged grief , depression , and anxiety relative to the WLC control group . Intention-to-treat analysis revealed treatment effects of between d = 0.84 and d = 1.02 for posttraumatic stress and prolonged grief from pre- to posttreatment time points . Further significant improvement in all symptoms of PTSD and prolonged grief was found from the posttreatment evaluation to the 12-month follow-up . The attrition rate of 14 % was relatively low . Conclusions : The Internet-based intervention proved to be a feasible and cost-effective treatment , reducing symptoms of posttraumatic stress , grief , depression , anxiety , and general mental health after pregnancy loss . Low-threshold e-
Output:
| The quality of care given by telepsychiatry both through video conferencing as well as web- and application-based is comparable to that of face-to-face therapy .
Patient satisfaction , quality of doctor-patient relationship also remains high , with lower costs and shorter therapeutic time when compared to face-to-face therapy .
CONCLUSION Various studies have shown that telepsychiatry is an effective solution for the management of PTSD .
Studies have also reported that the quality of treatment through telepsychiatry is as effective as face-to-face therapy , with greater efficiency . |
MS211589 | ***TASK*** the task is to summarize an input biomedical literature 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 popular method to attempt to enhance performance is for athletes to sleep at natural or simulated moderate altitude ( SMA ) when training daily near sea level . Based on our previous observation of periodic breathing in athletes sleeping at SMA , we hypothesised that athletes ' sleep quality would also suffer with hypoxia . Using two typical protocol s of nocturnal SMA ( 2650 m ) , we examined the effect on the sleep physiology of 14 male endurance-trained athletes . The selected protocol s were Consecutive ( 15 successive exposure nights ) and Intermittent ( 3x 5 successive exposure nights , interspersed with 2 normoxic nights ) and athletes were r and omly assigned to follow either one . We monitored sleep for two successive nights under baseline conditions ( B ; normoxia , 600 m ) and then at weekly intervals ( nights 1 , 8 and 15 ( N1 , N8 and N15 , respectively ) ) of the protocol s. Since there was no significant difference in response between the protocol s being followed ( based on n=7 , for each group ) we are unable to support a preference for either one , although the likelihood of a Type II error must be acknowledged . For all athletes ( n=14 ) , respiratory disturbance and arousal responses between B and N1 , although large in magnitude , were highly individual and not statistically significant . However , SpO2 decreased at N1 versus B ( p<0.001 ) and remained lower on N8 ( p<0.001 ) and N15 ( p<0.001 ) , not returning to baseline level . Compared to B , arousals were more frequent on N8 ( p=0.02 ) and N15 ( p=0.01 ) . The percent of rapid eye movement sleep ( REM ) increased from N1 to N8 ( p=0.03 ) and N15 ( p=0.01 ) . Overall , sleeping at 2650 m causes sleep disturbance in susceptible athletes , yet there was some improvement in REM sleep over the study duration OBJECTIVES To assess sleep patterns and associations between sleep and match performance in elite Australian female basketball players . DESIGN Prospect i ve cohort study . METHODS Seventeen elite female basketball players were monitored across two consecutive in-season competitions ( 30 weeks ) . Total sleep time and sleep efficiency were determined using triaxial accelerometers for Baseline , Pre-match , Match-day and Post-match timings . Match performance was determined using the basketball efficiency statistic ( EFF ) . The effects of match schedule ( Regular versus Double-Header ; Home versus Away ) and sleep on EFF were assessed . RESULTS The Double-Header condition changed the pattern of sleep when compared with the Regular condition ( F(3,48)=3.763 , P=0.017 ) , where total sleep time Post-match was 11 % less for Double-Header ( mean±SD ; 7.2±1.4h ) compared with Regular ( 8.0±1.3h ; P=0.007 ) . Total sleep time for Double-Header was greater Pre-match ( 8.2±1.7h ) compared with Baseline ( 7.1±1.6h ; P=0.022 ) and Match-day ( 7.3±1.5h ; P=0.007 ) . Small correlations existed between sleep metrics at Pre-match and EFF for pooled data ( r=-0.39 to -0.22 ; P≥0.238 ) . Relationships between total sleep time and EFF ranged from moderate negative to large positive correlations for individual players ( r=-0.37 to 0.62 ) and reached significance for one player ( r=0.60 ; P=0.025 ) . CONCLUSIONS Match schedule can affect the sleep patterns of elite female basketball players . A large degree of inter-individual variability existed in the relationship between sleep and match performance ; nevertheless , sleep monitoring might assist in the optimisation of performance for some athletes To determine whether exercise duration effects the recovery sleep following exercise , eight fit male endurance athletes , ages 23 - 42 yr , had their sleep electrophysiologically studied . This was done on four separate occasions : after a day on which no specific exercise was performed ; after a day of a 15-km run ; after a 42.2-km run day ; after a day in which the athletes participated in a strenuous ultra-triathlon . Sleep patterns following the no exercise day and the 15-km and the 42.2-km run days were similar . The sleep pattern of the ultra-triathlon day when compared with the other three days showed significantly increased wakefulness and delayed and decreased rapid eye movement ( REM ) sleep . The duration of slow wave sleep ( SWS ) in the first 6 h after lights out , however , was no different . The increased wakefulness and decreased REM clearly indicate increased stress after the ultra-triathlon . REM sleep appears to be a more sensitive index of exercise induced stress than SWS PURPOSE This study aim ed to examine whether ( i ) objective markers of sleep quantity and quality are altered in endurance athletes experiencing overreaching in response to an overload training program and ( ii ) potential reduced sleep quality would be accompanied with a higher prevalence of upper respiratory tract infections in this population . METHODS Twenty-seven trained male triathletes were r and omly assigned to either overload ( n = 18 ) or normal ( CTL , n = 9 ) training groups . Respective training programs included a 1-wk moderate training phase followed by a 3-wk period of overload or normal training , respectively , and then a subsequent 2-wk taper . Maximal aerobic power and oxygen uptake ( VO2max ) from incremental cycle ergometry were measured after each phase , whereas mood states and incidences of illness were determined from question naires . Sleep was monitored every night of the 6 wk using wristwatch actigraphy . RESULTS Of the 18 overload training group subjects , 9 were diagnosed as functionally overreached ( F-OR ) after the overload period , as based on declines in performance and VO2max with concomitant high perceived fatigue ( P < 0.05 ) , whereas the other 9 overload subjects showed no decline in performance ( AF , P > 0.05 ) . There was a significant time-group interaction for sleep duration ( SD ) , sleep efficiency ( SE ) , and immobile time ( IT ) . Only the F-OR group demonstrated a decrease in these three parameters ( -7.9 % ± 6.7 % , -1.6 % ± 0.7 % , and -7.6 % ± 6.6 % for SD , SE , and IT , respectively , P < 0.05 ) , which was reversed during the subsequent taper phase . Higher prevalence of upper respiratory tract infections were also reported in F-OR ( 67 % , 22 % , and 11 % incidence rate for F-OR , AF , and CTL , respectively ) . CONCLUSION This study confirms sleep disturbances and increased illness in endurance athletes who present with symptoms of F-OR during periods of high volume training Background Tart Montmorency cherries have been reported to contain high levels of phytochemicals including melatonin , a molecule critical in regulating the sleep-wake cycle in humans . Purpose The aim of our investigation was to ascertain whether ingestion of a tart cherry juice concentrate would increase the urinary melatonin levels in healthy adults and improve sleep quality . Methods In a r and omised , double-blind , placebo-controlled , crossover design , 20 volunteers consumed either a placebo or tart cherry juice concentrate for 7 days . Measures of sleep quality recorded by actigraphy and subjective sleep question naires were completed . Sequential urine sample s over 48 h were collected and urinary 6-sulfatoxymelatonin ( major metabolite of melatonin ) determined ; cosinor analysis was used to determine melatonin circadian rhythm ( mesor , acrophase and amplitude ) . In addition , total urinary melatonin content was determined over the sample d period . Trial differences were determined using a repeated measures ANOVA . Results Total melatonin content was significantly elevated ( P < 0.05 ) in the cherry juice group , whilst no differences were shown between baseline and placebo trials . There were significant increases in time in bed , total sleep time and sleep efficiency total ( P < 0.05 ) with cherry juice supplementation . Although there was no difference in timing of the melatonin circardian rhythm , there was a trend to a higher mesor and amplitude . Conclusions These data suggest that consumption of a tart cherry juice concentrate provides an increase in exogenous melatonin that is beneficial in improving sleep duration and quality in healthy men and women and might be of benefit in managing disturbed sleep Purpose In athletes , caffeine use is common although its effects on sleep have not been widely studied . This r and omised , double-blind , placebo-controlled crossover trial investigated the effects of late-afternoon caffeine and carbohydrate-electrolyte ( CEB ) co-ingestion on cycling performance and nocturnal sleep . Methods Six male cyclists/triathletes ( age 27.5 ± 6.9 years ) completed an afternoon training session ( TS ; cycling 80 min ; 65 % VO2max ) followed by a 5 kJ kg−1 cycling time trial ( TT ) . Caffeine ( split dose 2 × 3 mg kg−1 ) or placebo was administered 1 h prior and 40 min into the TS . A 7.4 % CEB ( 3 ml kg−1 every 15 min ) was administered during the TS , followed 30 min after by a st and ardised evening meal . Participants retired at their usual bedtime and indices of sleep duration and quality were monitored via polysomnography . Data : mean ± SD . Results All participants performed better in the caffeine TT ( caffeine 19.7 ± 3.3 ; placebo 20.5 ± 3.5 min ; p = 0.006 ) , while ratings of perceived exertion ( caffeine 12.0 ± 0.6 ; placebo 12.9 ± 0.7 ; p = 0.004 ) and heart rate ( caffeine 175 ± 6 ; placebo 167 ± 11 bpm ; p = 0.085 ) were lower in the caffeine TS . Caffeine intake induced significant disruptions to a number of sleep indices including increased sleep onset latency ( caffeine 51.1 ± 34.7 ; placebo 10.2 ± 4.2 min ; p = 0.028 ) and decreased sleep efficiency ( caffeine 76.1 ± 19.6 ; placebo 91.5 ± 4.2 % ; p = 0.028 ) , rapid eye movement sleep ( caffeine 62.1 ± 19.6 ; placebo 85.8 ± 24.7 min ; p = 0.028 ) and total sleep time ( caffeine 391 ± 97 ; placebo 464 ± 49 min ; p = 0.028 ) . Conclusions This study supports a performance-enhancing effect of caffeine , although athletes ( especially those using caffeine for late-afternoon/evening training and competition ) should consider its deleterious effects on sleep OBJECTIVES To evaluate sleep in professional football players and describe clinical features of players at risk for sleep for sleep-disordered breathing ( SDB ) . METHODS The Multivariable Apnea Prediction ( MAP ) index was used to stratify players into high ( MAP > or = 0.5 ) and low ( MAP<0.5 ) risk for SDB . Players from both risk groups were r and omly selected for overnight polysomnography , with over-sampling from the High-risk group . Of 302 players from eight professional football teams ; 52 underwent attended polysomnography . Anthropometrics including neck circumference , airway size ( Mallampati score , maxillary overjet ) and sleepiness measured by Epworth scores ( ESS ) were recorded . The primary outcome measures were ESS and an apnea-hypopnea index ( AHI ) > or = 10 . RESULTS Ninety-two percent of players were < 30 years old ( mean ( SD ) age : 25.5+/-2.7 years ) with large necks ( 45.2+/-3.6 cm ) and elevated BMI ( 31.5+/-4.6 ) . More than 20 % of players had an ESS>10 with ESS highest in habitual snorers . An AHI of > or = 10 was found in 13 ( 34 % , 95 % confidence interval ( CI ) 21 - 50 % ) high-risk players but only one ( 7 % , 95 % CI 1 - 31 % ) of 14 low-risk players . Offensive ( 9 ) or defensive ( 3 ) linemen accounted for the majority of the positive cases . Based on our sample , we estimate the prevalence of SDB to be 14 % ( 2 - 25 % ) . CONCLUSIONS Excessive daytime sleepiness ( EDS ) is present in a large fraction of professional football players . Some but not all of this may be due to an increased prevalence of SDB . Further study is required to underst and all of the factors responsible for EDS and to determine which of the biggest players will have SDB , which may impact not only performance and productivity but also future health INTRODUCTION Elite athletes frequently undergo periods of intensified training ( IT ) within their normal training program . These periods can lead athletes into functional overreaching , characterized by high perceived fatigue , impaired sleep , and performance . Because whole-body cryostimulation ( WBC ) has been proven to be an effective recovery method in the short term ( < 76 h ) , we investigated whether daily WBC sessions during IT could prevent exercise and sleep-related signs of overreaching . METHODS After a normal training week ( BASE ) ,
Output:
| Reduced SE was attributed to high wake after sleep onset rather than sleep onset latency .
Athletes ' sleep duration was found to be short with low SE , in comparison to the general consensus for non-athlete healthy adults .
Notable sleep issues were revealed in young athletes .
Sleep quality and architecture tend to change across different training periods |
MS211590 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: OBJECTIVE To determine the effects of fixed orthodontic appliances on periodontal health and microbiological composition of subgingival dental plaque . MATERIAL AND METHODS This prospect i ve longitudinal self-controlled study was conducted on 32 adolescents ( 13 males , 19 females ) , who were scheduled for fixed orthodontic treatment between 2002 and 2005 . Dental plaque accumulation , gingival inflammation and pocket probing depth were measured at the mesio-vestibular angle of the examined group of teeth followed by collection of subgingival dental plaque sample s in the same points . These periodontal indices and microbiological parameters were determined prior to the placement of fixed appliances and 1 , 3 and 6 months after the beginning of orthodontic treatment . RESULTS All values of both clinical and microbiological parameters started to increase after the placement of fixed appliances . Maximum values were reached 3 months after fixed appliance placement followed by their decrease in the last registration period of 6 months after the placement of fixed appliances . CONCLUSIONS Treatment with fixed appliances in adolescents may transitionally increase the values of all periodontal indices and stimulate the growth of periodontopathogenic bacteria , but without destructive effects on deep periodontal tissues BACKGROUND The outcome of microbiological diagnostics may depend on the sampling technique . It was the aim of the present study to compare two widely used sampling techniques for subgingival bacteria using quantitative real-time polymerase chain reaction . METHODS Twenty patients with chronic periodontitis were r and omized into two groups . In group A , sample s were taken first with a paper point and then with a curet at the same site ( single-rooted teeth with probing depth > 5 mm ) before scaling and root planing and after 10 weeks . The sampling sequence was reversed in group B. The analysis enabled the quantification of Actinobacillus actinomycetemcomitans , Fusobacterium nucleatum , Porphyromonas gingivalis , Prevotella intermedia , Treponema denticola , and Tannerella forsythensis and total bacterial counts ( TBCs ) . Statistical analysis included t test , kappa , and Spearman correlation . RESULTS Higher TBC was harvested with curets than by paper points ( P = 0.008 ) . The plaque composition with regard to total target pathogens was similar for both sampling techniques . A strong positive correlation was found between curet and paper point sample s for TBC and single target bacteria . CONCLUSIONS Overall , there was a relatively good agreement for the results of paper point and curet sampling . Thus , both techniques seem to be suitable for microbiological diagnostics BACKGROUND Patients with fixed orthodontic appliances often experience an absolute increase in the number of Streptococci mutans colony-forming units ( cfu ) . The aim of this investigation was to study the development of biofilm and S. mutans cfu in connection with stainless steel ligatures and elastomeric rings in orthodontic patients treated with and without 0.4 % stannous fluoride gel ( SFG ) . MATERIAL Forty-seven patients were divided into 2 groups : those treated with 0.4 % SFG for 4 minutes ( experimental ) and those without 0.4 % SFG ( control ) . In each patient , elastomeric rings were used for ligation on 1 side of the dental arch midline , and stainless steel ligatures were used on the opposite side . Saliva sample s were collected before and after appliance placement . At 15 and 30 days after appliance placement , biofilm sample s from the stainless steel ligatures and the elastomeric rings were collected and subjected to microbiologic procedures and scanning electron microscopy ( SEM ) analysis . RESULTS The numbers of S. mutans cfu in the saliva and biofilm were not statistically different between the teeth fitted with elastomeric rings and stainless steel ligatures , or between the experimental and control groups . SEM analysis showed biofilm formation on both ligature ties . CONCLUSIONS Topical application of 0.4 % SFG in orthodontic patients with elastomeric rings or stainless steel ligatures does not cause a significant decrease in S. mutans cfu in the saliva and biofilm Fixed or removable orthodontic appliances impede the maintenance of oral hygiene and result in plaque accumulation . Plaque retention surrounding orthodontic appliances leads to enamel demineralization caused by organic acids produced by bacteria in the dental plaque . Many studies have evaluated the effects of fixed orthodontic appliances on microbial flora and periodontal status , but only a few have evaluated the method of ligation as an additional factor . The aim of this study was to determine the changes in microbial flora and periodontal status after orthodontic bonding and to determine whether two different archwire ligation techniques affect these changes . A total of 21 orthodontic patients scheduled for fixed orthodontic treatment were selected for this split-mouth study . Two commonly used auxiliaries ( elastomeric rings and ligature wires ) for tying archwires were tested . Microbial and periodontal records were obtained before bonding ( T0 ) , one week later ( T1 ) , and five weeks after bonding ( T2 ) . Paired t-test and Wilcoxon signed rank test were used to compare the groups statistically . Although , teeth ligated with elastomeric rings exhibited slightly greater numbers of microorganisms than teeth ligated with steel ligature wires , the differences were not statistically significant and could be ignored . The two archwire ligation techniques showed no significant differences in the gingival index , bonded bracket plaque index , or pocket depths of the bonded teeth . However , teeth ligated with elastomeric rings were more prone to bleeding . Therefore , elastomeric ring use is not recommended in patients with poor oral hygiene The aim of this investigation was to evaluate the prevalence of C and ida and Enterobacteriaceae in a group of adolescents during fixed orthodontic appliance ( FOA ) therapy . The experimental group was recruited from a larger sample of orthodontic patients who were clinical ly examined once to obtain baseline data before active treatment . The group comprised 27 subjects ; 13 males , 14 females ( mean age 15.5 + /- 2.3 years ) . Thereafter , the experimental group was examined three times during a 3 month follow-up period after insertion of the FOA . The whole mouth plaque score was obtained , and the oral cavity was then sample d for C and ida species and Enterobacteriaceae using three different microbiological culture techniques , namely the oral rinse , pooled plaque and the imprint culture . A significant increase in c and idal numbers was observed after FOA insertion when the imprint technique was used ( P < 0.001 ) , although the overall c and idal prevalence rates obtained using the oral rinse and pooled plaque techniques did not demonstrate such a change . The predominant C and ida species isolated was C. albicans and the number of coliform carriers significantly increased after the insertion of a FOA , as detected by the oral rinse ( P < 0.05 ) and the pooled plaque ( P < 0.05 ) techniques . In total , eight coliform species were isolated following FOA therapy compared with the three species isolated before insertion of the appliance . The results also revealed a significant increase in plaque index due to the introduction of a FOA . Taken together , these data imply that insertion of a FOA is likely to promote oral carriage of C and ida and coliform species . Furthermore , it appears that routine oral hygiene instruction and information on appliance hygiene given to these patients may not necessarily reduce plaque accumulation and possible attendant effects . Further work with a larger cohort is required to confirm these findings White spot or areas of decalcification are carious lesions of varying extent . The incidence and severity of white spots after a full term of orthodontic treatment were studied among patients in the separate private practice s of two of the authors . To establish a base line of comparison , the presence of white spots in a r and om sample of untreated persons was observed . The incidence of white spots among patients treated by a multibonded technique was recorded at the time of debonding . In addition , white spots were sought in the before- and after-treatment Kodachrome slides of persons whose maxillary incisors had been h and ed . It was found that individual teeth , b and ed or bonded , exhibited significantly more white spot formation than was found in the control group . For the teeth studied , there was no difference in white spot formation in those that were b and ed or bonded . The labiogingival area of the maxillary lateral incisors had the highest incidence of white spots . When studied by segments , the highest incidence occurred among the maxillary incisors ; the lowest was in the maxillary posterior segment . No white spots were found on the lingual surfaces of m and ibular canines and incisors after prolonged use of a canine-to-canine bonded retainer . These findings suggest a relationship between resistance to white spot formation and the rate of salivary flow . Despite the lack of any preventive fluoride program among the study groups , 50 % of the patients demonstrated resistance to white spot formation . The obvious degree of latrogenic damage during orthodontic treatment suggests the need for preventive programs using fluoride . Further clinical research is needed
Output:
| The literature revealed moderate evidence that the presence of fixed appliances influences the quantity and quality of oral microbiota |
MS211591 | ***TASK*** the task is to summarize an input biomedical literature 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 Behavioural and psychological symptoms of dementia ( BPSD ) can not be regarded as a single clinical syndrome , but rather as a heterogeneous group of symptoms , each of which can be considered as possible targets for therapy . OBJECTIVE To compare the efficacy of risperidone and haloperidol on specific manifestations of BPSD . METHODS A post-hoc analysis was conducted using data from an 18-week , r and omized , double-blind , crossover head-to-head trial of risperidone vs haloperidol in treating 114 nursing-home residents with BPSD . Dependent variables were item scores of the Korean versions of the Behavioural Pathology in Alzheimer 's Disease Rating Scale ( BEHAVE-AD-K ) and Cohen-Mansfield Agitation Inventory ( CMAI-K ) . RESULTS On the BEHAVE-AD-K , risperidone was significantly more effective than haloperidol in treating w and ering ( p = 0.0496 ) , agitation ( p = 0.0091 ) , diurnal rhythm disturbances ( p = 0.0137 ) , anxiety regarding upcoming events ( p = 0.0002 ) , and other anxieties ( p = 0.0088 ) . On the CMAI-K , risperidone was significantly more effective in treating physical sexual advances ( p = 0.0202 ) , pacing and aim less w and ering ( p = 0.0123 ) , intentional falling ( p = 0.0398 ) , hoarding things ( p = 0.0499 ) , performing repetitious mannerisms ( p = 0.0048 ) , repetitive sentence or questions ( p = 0.0025 ) , complaining ( p = 0.0101 ) , and negativism ( p = 0.0027 ) . Haloperidol was not significantly superior to risperidone on any individual item in either scale . CONCLUSIONS When comparing treatment effects on individual symptoms frequently occurring in patients with dementia , risperidone significantly improved symptoms of agitation , w and ering , diurnal rhythm disturbance and anxieties , among other symptoms , compared with haloperidol OBJECTIVES The objectives of this study were to evaluate the efficacy , safety , and tolerability of quetiapine for treating psychosis in patients with probable/possible Alzheimer disease and assess its impact on other psychopathology and social and daily functioning . METHOD The authors conducted a multicenter , double-blind , placebo-controlled , r and omized trial of flexibly dosed quetiapine and haloperidol . Primary outcomes were change in total Brief Psychiatric Rating Scale ( BPRS ) and Clinical Global Impressions-Severity of Illness ( CGI-S ) scores at week 10 . Secondary outcomes included BPRS factors , Neuropsychiatric Inventory ( NPI ) , Multidimensional Observation Scale for Elderly Subjects ( MOSES ) , and Physical Self-Maintenance Scale ( PSMS ) . RESULTS Two hundred eighty-four participants ( mean age : 83.2 years ) were r and omized ; 63.4 % completed ; and mean Mini-Mental State Examination score was 12.8 . Median of the mean daily dose was 96.9 mg for quetiapine and 1.9 mg for haloperidol . No differential benefit was seen on any psychosis measure . BPRS agitation factor scores improved with quetiapine versus placebo and not quetiapine versus haloperidol . BPRS anergia scores worsened with haloperidol versus quetiapine but not quetiapine versus placebo . No NPI factors showed change , including the agitation factor . MOSES Withdrawal Subscale and PSMS total scores worsened with haloperidol versus quetiapine . Somnolence occurred in 25.3 % , 36.2 % , and 4.1 % of the quetiapine , haloperidol , and placebo groups , respectively ; parkinsonism was most prevalent in the haloperidol group ; other safety and tolerability measures differed little among groups . CONCLUSION All treatment groups showed improvement in measures of psychosis without significant differences between them when planned comparisons were performed . Participants treated with quetiapine or haloperidol showed inconsistent evidence of improvement in agitation . Tolerability was better with quetiapine compared with haloperidol SETTING Treating elderly patients with Alzheimer 's disease ( AD ) and behavioral and psychological symptoms of dementia ( BPSD ) is challenging due to the increased risk of iatrogenic movement disorders with old neuroleptics and the seemingly increasing risk of cardiovascular events with newer atypical agents . Quetiapine is an atypical antipsychotic agent that warrants further investigation . OBJECTIVES To assess tolerability , safety , and clinical benefit of quetiapine in AD patients with BPSD . PARTICIPANTS AND DESIGN AD patients with BPSD participated in a 6-week r and omized , double-blind , placebo-controlled trial . Quetiapine was increased on the basis of clinical response and tolerability . Primary efficacy assessment s included the Neuropsychiatric Inventory ( NPI ) and Clinical Global Impression of Change ( CGI-C ) . Secondary efficacy measures included the Mini-Mental State Examination ( MMSE ) , the Simpson-Angus Scale ( SAS ) and the Abnormal Involuntary Movement Scale ( AIMS ) . RESULTS Forty patients ( 26 women ) , mean age 82.2 ( SD 6.4 ) years were enrolled , 27 completed treatment . Median dose of quetiapine was 200 mg/day . Significant NPI total scores reductions ( 79 % for placebo and 68.5 % for quetiapine ) were observed . The CGI-C score decreased significantly in the quetiapine group ( p = 0.009 at 6 weeks ) and did not change significantly in the placebo group ( p = 0.48 ) . The MMSE , AIMS , SAS scores and adverse events did not differ significantly between the two arms . CONCLUSIONS Quetiapine did not significantly improve psychosis scores . It did not cause cognitive and motor deterioration . These results might possibly be due to small sample size Objective : Previous studies stressed the role of decision-making functioning in predicting antiobsessive treatment outcome with serotonin reuptake inhibitors drugs in patients with obsessive-compulsive disorder . Nevertheless , the use of an augmentation strategy with atypical antipsychotic drugs has proved to be effective in obsessive-compulsive patients nonresponding to serotonin reuptake inhibitors treatment . We investigated whether the performance at the Iowa Gambling Task ( IGT ) , a used neuropsychologic task which assesses decision-making , can be an effective criterion for pharmacologic treatment choice in these patients and whether the use of different treatment strategies , according IGT performance , can increase the rate of antiobsessive outcome . Method : Thirty patients with obsessive-compulsive disorder were treated in a single-blind design with fluvoxamine plus placebo or fluvoxamine plus risperidone according to their IGT performance . Treatment outcome was recorded after 6 and 12 weeks . Results : Patients with good IGT performance showed a good antiobsessive treatment outcome with fluvoxamine only , while only adopting an augmentation strategy with risperidone , the number of responders patients within the subjects with bad IGT performance increased . Conclusions : IGT performance may be considered an effective criterion for pharmacologic treatment choice in obsessive-compulsive patients given that antiobsessive treatment outcome is increased to 85 % of responders choosing an appropriate drug strategy according to the IGT performance OBJECTIVE To compare citalopram and risperidone for the treatment of psychotic symptoms and agitation associated with dementia , with a priori hypotheses that risperidone would be more efficacious for psychosis and citalopram for agitation . METHODS A 12-week r and omized , controlled trial in nondepressed patients with dementia hospitalized because of behavioral symptoms ( N = 103 ) was conducted at the University of Pittsburgh Medical Center . Participants were consecutively recruited on an inpatient unit if they had at least one moderate to severe target symptom ( aggression , agitation , hostility , suspiciousness , hallucinations , or delusions ) . Once they improved sufficiently , they were discharged to nursing homes , personal care homes , or residential homes for continued treatment . Planned pre-post and mixed model analyses of the main outcome measures of Neurobehavioral Rating Scale and Side Effect Rating Scale at baseline and at weekly/biweekly intervals were conducted . RESULTS Completion rates did not differ for citalopram and risperidone ( overall completion rate : 44 % ) . Agitation symptoms ( aggression , agitation , or hostility ) and psychotic symptoms ( suspiciousness , hallucinations , or delusions ) decreased in both treatment groups but the improvement did not differ significantly between the two groups . There was a significant increase in side effect burden with risperidone but not with citalopram such that the two groups differed significantly . CONCLUSION No statistical difference was found in the efficacy of citalopram and risperidone for the treatment of either agitation or psychotic symptoms in patients with dementia . These findings need to be replicated before citalopram or other serotonergic antidepressants can be recommended as alternatives to antipsychotics for the treatment of agitation or psychotic symptoms associated with dementia Background Although serotonin reuptake inhibitors are effective in the treatment of OCD , many patients fail to respond to these agents . Growing evidence from open-label and placebo-controlled trials suggests a role for augmentation of SRIs with atypical antipsychotics in OCD . Quetiapine is generally well tolerated and previous open-label data has produced mixed results in OCD and additional controlled data is needed . Methods We undertook a double-blind , r and omised , parallel-group , flexible-dose , placebo-controlled study of quetiapine augmentation in subjects who had responded inadequately to open-label treatment with an SRI for 12 weeks . Following informed consent and screening , forty-two subjects were r and omised to either placebo or quetiapine for six weeks . Results There was significant improvement from baseline to endpoint on the Yale-Brown Obsessive-Compulsive Scale in both the quetiapine and placebo groups ( quetiapine , n = 20 , p < 0.0001 ; placebo , n = 21 , p = 0.001 ) with 40 % ( n = 8) of quetiapine and 47.6 % ( n = 10 ) of placebo treated subjects being classified as responders . Quetiapine did not demonstrate a significant benefit over placebo at the end of the six-week treatment period ( p = .636 ) . Similarly quetiapine failed to separate from placebo in the subgroup of subjects ( n = 10 ) with co-morbid tics . Quetiapine was generally well tolerated . Conclusions In this study , quetiapine augmentation was no more effective than placebo augmentation of SRIs . A number of limitations in study design make comparisons with previous studies in this area difficult and probably contributed to our negative findings . Future work in this important clinical area should address these limitations The objective of this study was to evaluate the efficacy and tolerability of extended release quetiapine fumarate ( quetiapine XR ) as maintenance monotherapy for patients with generalized anxiety disorder ( GAD ) . Time-to-event ( anxiety symptom recurrence ; maximum 52 weeks ) multicenter , r and omized-withdrawal , parallel-group , double-blind , placebo-controlled study of quetiapine XR ( 50–300 mg/day ) following open-label run-in ( 4–8 weeks ) and open-label stabilization ( ≥12 weeks ) . Primary variable : time from r and omization to anxiety event . Secondary variables included : Hamilton Anxiety Rating Scale ( HAM-A ) total , HAM-A psychic/somatic anxiety factors , Clinical Global Impression-Severity of Illness ( CGI-S ) , and Quality of Life , Enjoyment and Satisfaction Question naire ( Q-LES-Q ) scores ; adverse events ( AE ) reporting . Four hundred and thirty-two patients , stabilized on quetiapine XR , were r and omized to continue quetiapine XR ( N=216 ) or switch to placebo ( N=216 ) . Risk of anxiety symptom recurrence was significantly reduced by 81 % for quetiapine XR versus placebo : hazard ratio=0.19 ( 95 % confidence interval 0.12–0.31 ; P<0.001 ) . Fewer patients receiving quetiapine XR ( N=22 , 10.2 % ) than placebo ( N=84 , 38.9 % ) experienced anxiety symptom recurrence . Significant differences were observed between quetiapine XR and placebo in : HAM-A total , psychic/somatic , CGI-S ( all P<0.001 ) and Q-LES-Q ( P<0.05 ) scores . AEs ( > 10 % ) during open-label treatment were dry mouth , sedation , somnolence , dizziness , fatigue , and constipation . During r and omized treatment , the most common AEs for quetiapine XR were headache and nasopharyngitis . Quetiapine XR monotherapy reduced the risk of anxiety symptom recurrence in patients with GAD stabilized on quetiapine XR , with tolerability results consistent with the known profile of quetiapine Context Recent reports suggest that antipsychotics are associated with increased risk for death in patients with dementia . Contribution This large , population -based study from Canada assessed the risk for death after dispensation of antipsychotics in older adult
Output:
| CONCLUSIONS Benefits and harms vary among atypical antipsychotic medications for off-label use .
For global behavioral symptom scores associated with dementia in elderly patients , small but statistically significant benefits were observed for aripiprazole , olanzapine , and risperidone .
Quetiapine was associated with benefits in the treatment of generalized anxiety disorder , and risperidone was associated with benefits in the treatment of obsessive-compulsive disorder ; however , adverse events were common |
MS211592 | ***TASK*** the task is to summarize an input biomedical literature 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 Presumptive treatment of malaria is common practice in malaria endemic re source -limited setting s. With the changing epidemiology of malaria and the introduction of artemisinin-based combination therapy ( ACT ) , there is increasing need for parasite-based malaria case management to prevent unnecessary use of anti-malarial medicines , improve patient care in parasite-positive patients and identify parasite-negative patients in whom another diagnosis must be sought . Although parasitological confirmation by microscopy or alternatively by malaria rapid diagnostic tests ( RDTs ) is recommended in all patients suspected of malaria before treatment , gaps remain in the implementation of this policy in re source -limited setting s. There is need to evaluate the use of RDTs among highly active anti-retroviral therapy (HAART)-treated people living with HIV ( PLHIV ) . Methods Within an urban prospect i ve observational research cohort of 559 PLHIV initiated on HAART and cotrimoxazole prophylaxis between April , 2004 and April , 2005 , 128 patients with sustained HIV-RNA viral load < 400 copies/ml for four years were evaluated , in a cross-sectional study , for asymptomatic malaria infection using a histidine-rich protein-2 ( HRP-2 ) RDT to detect Plasmodium falciparum antigen in peripheral blood . Patients with positive RDT results had microscopy performed to determine the parasite densities and were followed for clinical signs and symptoms during the subsequent six months . Results Of the 128 asymptomatic patients screened , only 5 ( 4 % ) had asymptomatic P. falciparum antigenaemia . All the patients with positive HRP2 RDT results showed malaria parasites on thick film with parasite densities ranging from 02 - 15 malaria parasites per high power field . None of the patients with positive RDT results reported signs and symptoms of malaria infection during the subsequent six months . Conclusions In an urban area of low to moderate stable malaria transmission , there was low HRP2 P. falciparum antigenaemia among PLHIV after long-term HAART and cotrimoxazole prophylaxis . Parasite-based malaria diagnosis ( PMD ) is recommended among PLHIV that are on long-term anti-retroviral therapy . RDTs should be utilized to exp and PMD in similar setting s where microscopy is unavailable The purpose of this prospect i ve cohort study was to assess the effect of cotrimoxazole prophylaxis taken by human immunodeficiency virus (HIV)-infected persons on the selection of sulfadoxine-pyrimethamine (SP)-resistant malaria parasites among HIV-uninfected household members . A total of 2,567 HIV-uninfected persons from 605 households were followed and blood specimens were collected each time an episode of Plasmodium falciparum malaria was diagnosed . Study participants were living in households where HIV-infected persons were either taking ( exposed ) or not taking ( unexposed ) cotrimoxazole prophylaxis . From all malaria episodes diagnosed , 50 % of the specimens were r and omly selected and tested for the presence of five key mutations known to mediate resistance to SP ( dihydrofolate reductase [ dhfr ] Asn-108 , Ile-51 , and Arg-59 , and dihydropteroate synthase [ dhps ] Gly-437 and Glu-540 ) . Plasmodium falciparum isolates were recovered from 163 specimens in the exposed households and 113 specimens in the unexposed households , with similar proportions containing the dhfr triple mutant ( 37 % versus 45 % ; P = 0.18 ) , the dhps double mutant ( 64 % versus 62 % ; P = 0.81 ) , and the dhfr/dhps quintuple mutant ( 30 % versus 32 % ; P = 0.74 ) . The HIV-uninfected persons living with HIV-infected household members taking cotrimoxazole prophylaxis had a lower incidence of malaria ( incidence rate ratio [ IRR ] = 0.64 , 95 % confidence interval [ CI ] = 0.50 - 0.83 , P = 0.001 ) and fewer malaria episodes due to parasites containing the dhfr/dhps quintuple mutant ( IRR = 0.61 , 95 % CI = 0.41 - 0.91 , P = 0.014 ) . Cotrimoxazole prophylaxis taken by HIV-infected persons did not select for SP-resistant malaria parasites among HIV-uninfected household members , and was associated with a lower overall incidence of SP-resistant malaria among household members Background : The effect of cotrimoxazole prophylaxis taken by persons with HIV on community health and antimicrobial resistance is unknown . Objective : To assess the effect of cotrimoxazole prophylaxis taken by persons with HIV on morbidity , mortality , and antimicrobial resistance of diarrheal pathogens infecting their HIV-negative family members . Design : Prospect i ve cohort in rural Ug and a. Methods : A total of 879 persons with HIV and 2771 HIV-negative family members received weekly home-visits . After 5 months , persons with HIV received daily cotrimoxazole prophylaxis and households were followed for an average of 17 additional months . Findings : During the study , 224 participants with HIV ( 25 % ) and 29 household members ( 1 % ) died . Mortality among HIV-negative family members < 10 years old was 63 % less during the cotrimoxazole period than before [ hazard ratio , 0.37 ; 95 % confidence interval ( CI ) , 0.14–0.95 ; P = 0.04 ] . Malaria among family members was less common during cotrimoxazole treatment [ incidence rate ratio ( IRR ) , 0.62 ; CI , 0.53–0.74 ; P < 0.0001 ] , as were diarrhea ( IRR , 0.59 ; CI , 0.45–0.76 ; P = 0.0001 ) , and hospitalizations ( IRR , 0.57 ; CI , 0.36–0.92 ; P = 0.02 ) . Death of a parent with HIV was associated with a threefold increase in mortality among HIV-negative children < 10 years old ( hazard ratio , 2.9 ; CI , 1.1–8.1 ; P = 0.04 ) . Of 134 bacterial isolates from family members before cotrimoxazole treatment , 89 ( 66 % ) were resistant to cotrimoxazole ; of 75 recovered during cotrimoxazole treatment , 54 ( 72 % ) were resistant ( P = 0.41 ) . Interpretation : Cotrimoxazole prophylaxis taken by persons with HIV was associated with decreased morbidity and mortality among family members . Antimicrobial resistance among diarrheal pathogens infecting family members did not increase . Concerns regarding the spread of bacterial resistance should not impede implementation of cotrimoxazole programs Objective To evaluate the proposed WHO/UNAIDS criteria for initiating co-trimoxazole prophylaxis in adult HIV-infected patients in Africa [ WHO clinical stages 2–4 or CD4 count < 500 × 106 /l or total lymphocyte count ( TLC ) equivalent ] . Design Observational cohort study of 5-year follow-up . Setting Adult HIV clinics , University of Cape Town , South Africa . Methods Effect of prophylactic low dose co-trimoxazole ( 480 mg per day or 960 mg three times per week ) on survival and morbidity was assessed in patients stratified by WHO clinical stage , CD4 T-lymphocyte count or TLC . Patients receiving antiretroviral therapy were excluded . Results Co-trimoxazole reduced mortality [ adjusted hazard ratio ( AHR ) , 0.56 ; 95 % confidence interval ( CI ) , 0.33–0.85;P > 0.001 ] and the incidence of severe HIV-related illnesses ( AHR , 0.52 ; 95 % CI , 0.38–0.68;P < 0.001 ) in patients with evidence of advanced immune suppression on clinical ( WHO stages 3 and 4 ) or laboratory assessment ( TLC < 1250 × 106/l or CD4 count < 200 × 106/l ) . No significant evidence of efficacy was found in patients with WHO stage 2 or CD4 count 200–500 × 106/l/TLC 1250–2000 × 106/l . If we had applied the WHO/UNAIDS recommendations 88.3 % of our patients would have received co-trimoxazole prophylaxis at their initial clinic visit . Conclusion Co-trimoxazole in HIV-infected adults from an area in which Pneumocystis carinii pneumonia is uncommon demonstrated a survival benefit consistent with previous r and omized trials . Further studies are needed to assess the optimal time of commencement of prophylaxis , as widespread co-trimoxazole use will lead to increasing antimicrobial resistance to other major pathogens in Africa Treatment of malaria with sulfadoxine/pyrimethamine and of presumed bacterial infections with trimethoprim/sulfamethoxazole ( cotrimoxazole ) was assessed to see if either increases the carriage of cotrimoxazole-resistant Streptococcus pneumoniae in Malawian children . Children < 5 years old treated with sulfadoxine/pyrimethamine , cotrimoxazole , or no antimicrobial agent were enrolled in a prospect i ve observational study . Nasopharyngeal swabs were taken before treatment and 1 and 4 weeks later . Pneumococci were tested for antibiotic susceptibility by broth microdilution . In sulfadoxine/pyrimethamine-treated children , the proportion colonized with cotrimoxazole-nonsusceptible pneumococci increased from 38.1 % at the initial visit to 44.1 % at the 4-week follow-up visit ( P=.048 ) . For cotrimoxazole-treated children , the proportion colonized with cotrimoxazole-nonsusceptible pneumococci increased from 41.5 % at the initial visit to 52 % at the 1-week follow-up visit ( P=.0017 ) and returned to 41.7 % at the 4-week follow-up . Exp and ing use of sulfadoxine/pyrimethamine to treat chloroquine-resistant malaria may have implication s for national pneumonia programs in developing countries where cotrimoxazole is widely used BACKGROUND Patients with human immunodeficiency virus ( HIV ) infection are at increased risk for bacterial pneumonia in addition to opportunistic infection . However , the risk factors for bacterial pneumonia and its incidence in this population are not well defined . METHODS In a multicenter , prospect i ve , observational study , we monitored 1130 HIV-positive and 167 HIV-negative participating adults for up to 64 months for pulmonary disease . The HIV-positive group comprised 814 homosexual or bisexual men , 261 injection-drug users , and 55 female partners of HIV-infected men . RESULTS There were 237 episodes of bacterial pneumonia among the HIV-positive participants ( rate , 5.5 per 100 person-years ) , as compared with 6 episodes among the HIV-negative participants ( rate , 0.9 per 100 person-years ; P < 0.001 ) . The rate of bacterial pneumonia increased with decreasing CD4 lymphocyte counts ( 2.3 , 6.8 , and 10.8 episodes per 100 person-years in the strata with more than 500 , 200 to 500 , and fewer than 200 cells per cubic millimeter , respectively ; P < or = 0.022 for each comparison ) . Injection-drug users had a higher rate of bacterial pneumonia than did homosexual or bisexual men or female partners . In the stratum with the fewest CD4 lymphocytes , cigarette smoking was associated with an increased rate of pneumonia . Mortality was almost four times higher among participants with an episode of pneumonia than among the others . Prophylaxis with trimethoprim-sulfamethoxazole was associated with a 67 percent reduction in confirmed episodes of bacterial pneumonia ( P = 0.007 ) . CONCLUSIONS Bacterial pneumonia is more frequent in HIV-positive persons than in seronegative controls , and the risk is highest among those with CD4 lymphocyte counts below 200 per cubic millimeter and among injection-drug users Objective To evaluate the protective efficacy of co-trimoxazole prophylaxis against malaria in HIV exposed children ( uninfected children born to HIV infected mothers ) in Africa . Design Non-blinded r and omised control trial Setting Tororo district , rural Ug and a , an area of high malaria transmission intensity Participants 203 breastfeeding HIV exposed infants enrolled between 6 weeks and 9 months of age Intervention Co-trimoxazole prophylaxis from enrolment until cessation of breast feeding and confirmation of negative HIV status . All children who remained HIV uninfected ( n=185 ) were then r and omised to stop co-trimoxazole prophy
Output:
| RESULT CTX is safe and efficacious against malaria .
CONCLUSION CTX is safe and still efficacious for the treatment of P.falciparum malaria in non-pregnant adults and children irrespective of HIV status and antifolate resistance profiles .
CTX prophylaxis in HIV infected individuals protects against malaria and CTX may have a role for malaria prophylaxis in specific HIV negative target groups |
MS211593 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
***INPUT*** the input is a biomedical literature
***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
***DOCUMENTATION***
***EXAMPLES***
Input: OBJECTIVE To determine whether serum lipid intervention , in addition to conventional diabetes treatment , could alter cardiovascular outcomes in type 2 diabetes . RESEARCH DESIGN AND METHODS There were 164 type 2 diabetic subjects ( 117 men , 47 women ) without a history of clinical cardiovascular disease r and omized to receive either bezafibrate or placebo daily on a double-blind basis in addition to routine diabetes treatment and followed prospect ively for a minimum of 3 years . Serial biochemical and noninvasive vascular assessment s , carotid and femoral artery B-mode ultrasound measurements , and those pertaining to coronary heart disease (CHD)— clinical history , the World Health Organization ( WHO ) cardiovascular question naire , and resting and exercise electrocardiogram (ECG)—were recorded . RESULTS Bezafibrate treatment was associated with significantly greater reductions over 3 years in median serum triglyceride ( −32 vs. 4 % , P = 0.001 ) , total cholesterol ( −7 vs. −0.3 % , P = 0.004 ) , and total−to-HDL cholesterol ratio ( −12 vs. −0.0 % , P = 0.001 ) , and an increase in HDL cholesterol ( 6 vs. −2 % , P = 0.02 ) as compared with placebo . There was a trend toward a greater reduction of fibrinogen ( −18 vs. −6 % , P = 0.08 ) at 3 years . No significant differences between the two groups were found in the progress of ultrasonically measured arterial disease . In those treated with bezafibrate , there was a significant reduction ( P = 0.01 , log-rank test ) in the combined incidence of Minnesota-coded probable ischemic change on the resting ECG and of documented myocardial infa rct ion . CONCLUSIONS Improving dyslipidemia in type 2 diabetic subjects had no effect on the progress of ultrasonically measured arterial disease , although the lower rate of “ definite CHD events ” in the treated group suggests that this might result in a reduction in the incidence of coronary heart disease Few studies have evaluated the efficacy of cholesterol-lowering interventions in a community setting and have included a control or comparison group . As part of a preventive health demonstration project in rural Pennsylvania , Medicare beneficiaries underwent cholesterol screening to identify high-risk individuals with serum cholesterol levels > or = 240 mg/dL. These high-risk individuals were r and omized to a cholesterol-lowering intervention through either local hospitals or physicians ' offices or to a control group . Baseline and follow-up serum cholesterol levels collected two to three years later were compared according to service location ( hospital versus physician 's office ) , intervention attendance , degree of participation , baseline heart disease history , and cholesterol-lowering medication use at follow-up . Serum cholesterol levels decreased between 5.7 % and 6.6 % in the hospital-based and physician-based groups , as well as in a control group not offered the intervention . Participation rates did not differ between treatment groups , nor did participation affect serum cholesterol levels . Attendance level and heart disease history were not associated with a greater decrease in serum cholesterol levels . Individuals reporting cholesterol-lowering drug use at follow-up had significantly higher baseline serum cholesterol levels and a significantly greater decrease in total serum cholesterol ( P < .0001 ) than those not on medication . Both nonpharmacological ( diet ) and pharmacological ( drug ) interventions will reduce serum cholesterol levels and heart attack risk . The study results suggest that , at least for older individuals , the impact of nonpharmacological interventions on the community is minimal . We conclude that only very aggressive treatment will significantly loser serum cholesterol levels in older individuals at risk for heart attack Abstract Objective : To describe , and to test against trial data , a simple and flexible computer program for calculating cardiovascular risk in individual patients as an aid to managing risk factors and prescribing drugs to lower cholesterol concentration and blood pressure . Design : Descriptive comparison of actual cardiovascular risk in r and omised controlled trials of cholesterol reduction with risk predicted by a computer program based on the Framingham risk equation . Comparison of the program 's performance with that of tables and guidelines by means of hypothetical case examples . Main outcome measures : Average risk of coronary heart disease and myocardial infa rct ion . Results : The computer program accurately predicted baseline absolute risk in a UK population as well as the relative and absolute reduction in risk from cholesterol lowering for primary prevention of coronary heart disease . The program also allowed a more refined estimate of absolute risk of coronary heart disease than some existing tables and enabled the impact of prescribing decisions to be quantified and costed . Conclusions : This simple computer program to estimate individuals ' cardiovascular disease risk and display the benefits of intervention should help clinicians and patients decide on the most effective packages of risk reduction and identify those most likely to benefit from modulation of risk factors CONTEXT Although cholesterol-reducing treatment has been shown to reduce fatal and nonfatal coronary disease in patients with coronary heart disease ( CHD ) , it is unknown whether benefit from the reduction of low-density lipoprotein cholesterol ( LDL-C ) in patients without CHD extends to individuals with average serum cholesterol levels , women , and older persons . OBJECTIVE To compare lovastatin with placebo for prevention of the first acute major coronary event in men and women without clinical ly evident atherosclerotic cardiovascular disease with average total cholesterol ( TC ) and LDL-C levels and below-average high-density lipoprotein cholesterol ( HDL-C ) levels . DESIGN A r and omized , double-blind , placebo-controlled trial . SETTING Outpatient clinics in Texas . PARTICIPANTS A total of 5608 men and 997 women with average TC and LDL-C and below-average HDL-C ( as characterized by lipid percentiles for an age- and sex-matched cohort without cardiovascular disease from the National Health and Nutrition Examination Survey [ NHANES ] III ) . Mean ( SD ) TC level was 5.71 ( 0.54 ) mmol/L ( 221 [ 21 ] mg/dL ) ( 51 st percentile ) , mean ( SD ) LDL-C level was 3.89 ( 0.43 ) mmol/L ( 150 [ 17 ] mg/dL ) ( 60th percentile ) , mean ( SD ) HDL-C level was 0.94 ( 0.14 ) mmol/L ( 36 [ 5 ] mg/dL ) for men and 1.03 ( 0.14 ) mmol/L ( 40 [ 5 ] mg/dL ) for women ( 25th and 16th percentiles , respectively ) , and median ( SD ) triglyceride levels were 1.78 ( 0.86 ) mmol/L ( 158 [ 76 ] mg/dL ) ( 63rd percentile ) . INTERVENTION Lovastatin ( 20 - 40 mg daily ) or placebo in addition to a low-saturated fat , low-cholesterol diet . MAIN OUTCOME MEASURES First acute major coronary event defined as fatal or nonfatal myocardial infa rct ion , unstable angina , or sudden cardiac death . RESULTS After an average follow-up of 5.2 years , lovastatin reduced the incidence of first acute major coronary events ( 1 83 vs 116 first events ; relative risk [ RR ] , 0.63 ; 95 % confidence interval [ CI ] , 0.50 - 0.79 ; P<.001 ) , myocardial infa rct ion ( 95 vs 57 myocardial infa rct ions ; RR , 0.60 ; 95 % CI , 0.43 - 0.83 ; P=.002 ) , unstable angina ( 87 vs 60 first unstable angina events ; RR , 0.68 ; 95 % CI , 0.49 - 0.95 ; P=.02 ) , coronary revascularization procedures ( 157 vs 106 procedures ; RR , 0.67 ; 95 % CI , 0.52 - 0.85 ; P=.001 ) , coronary events ( 215 vs 163 coronary events ; RR , 0.75 ; 95 % CI , 0.61 - 0.92 ; P = .006 ) , and cardiovascular events ( 255 vs 194 cardiovascular events ; RR , 0.75 ; 95 % CI , 0.62 - 0.91 ; P = .003 ) . Lovastatin ( 20 - 40 mg daily ) reduced LDL-C by 25 % to 2.96 mmol/L ( 115 mg/dL ) and increased HDL-C by 6 % to 1.02 mmol/L ( 39 mg/dL ) . There were no clinical ly relevant differences in safety parameters between treatment groups . CONCLUSIONS Lovastatin reduces the risk for the first acute major coronary event in men and women with average TC and LDL-C levels and below-average HDL-C levels . These findings support the inclusion of HDL-C in risk-factor assessment , confirm the benefit of LDL-C reduction to a target goal , and suggest the need for re assessment of the National Cholesterol Education Program guidelines regarding pharmacological intervention BACKGROUND The atherosclerotic progression-reducing effect of LDL cholesterol ( LDL-C ) lowering has been established in subjects with severe atherosclerotic disease but not in persons with elevated LDL cholesterols without severe atherosclerosis . KAPS ( Kuopio Atherosclerosis Prevention Study ) is the first population -based trial in the primary prevention of carotid and femoral atherosclerosis . METHODS AND RESULTS The eligibility requirements were serum LDL-C > or = 4.0 mmol/L and total cholesterol < 7.5 mmol/L. Out of a geographically defined population , 447 men aged 44 to 65 years ( mean , 57 ) were r and omized to pravastatin ( 40 mg/d ) or placebo for 3 years . Less than 10 % of the subjects had prior myocardial infa rct ion . Thirty-nine men discontinued study medication ; however , efficacy data were available for 424 men . The primary outcome was the rate of carotid atherosclerotic progression , measured as the linear slope over annual ultrasound examinations in the average of the maximum carotid intima-media thickness ( IMT ) of the far wall of up to four arterial segments ( the right and left distal common carotid artery and the right and left carotid bulb ) . For the carotid arteries , at the overall mean baseline IMT of 1.66 mm , the rate of progression of carotid atherosclerosis was 45 % ( 95 % CI , 16 to 69 % ) less in the pravastatin ( 0.017 mm/y ) than the placebo ( 0.031 mm/y ) group ( P = .005 ) . In the common carotid artery there was a treatment effect of 66 % ( 95 % CI , 30 to 95 % ; pravastatin 0.010 mm/y ; placebo 0.029 mm/y ; P < .002 ) at the overall mean baseline IMT of 1.35 mm . A treatment effect of 30 % ( 95 % CI , -1 % to 54 % ) was found for the carotid bulb ( pravastatin , 0.028 ; placebo , 0.040 ; P = .056 ) at the overall mean baseline IMT of 2.0 mm . The treatment effect was larger in subjects with higher baseline IMT values , in smokers and in those with low plasma vitamin E levels . There was no significant treatment effect on atherosclerotic progression in the femoral arteries . CONCLUSIONS These data establish the antiatherogenic effect of LDL-C lowering by pravastatin in hypercholesterolemic men in a primary prevention setting and suggest a greater effect in smokers than in nonsmokers BACKGROUND Familial combined hyperlipidaemia ( FCH ) , characterized by elevated very-low-density lipoprotein ( VLDL ) and /or low-density lipoprotein ( LDL ) , is associated with an increased prevalence of premature cardiovascular disease . Therefore , lipid-lowering is frequently indicated . METHODS We evaluated in a parallel , double-blind r and omized fashion the effect of gemfibrozil ( 1200 mg/day ) ( n = 40 ) or simvastatin ( 20 mg/day ) ( n = 41 ) on lipids , apolipoprotein-B (apo-B)-containing lipoproteins , apo-CIII and lipoprotein(a ) [ Lp(a ) ] , in 81 well-defined FCH patients . RESULTS While both drugs lowered plasma cholesterol and triglyceride levels , gemfibrozil lowered plasma triglycerides more effectively by reduction of triglycerides in VLDL and LDL , whereas simvastatin was more effective in its reduction of total plasma cholesterol by exclusively decreasing LDL cholesterol . High-density lipoprotein ( HDL ) increased to an equal extent on both therapies . Total serum apo-B
Output:
| When statin drugs were considered alone , no substantial differences in results were found .
Treatment with lipid lowering drugs lasting five to seven years reduces coronary heart disease events but not all cause mortality in people with no known cardiovascular disease |
MS211594 | ***TASK*** the task is to summarize an input biomedical literature 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 Determine treatment adherence in patients with multiple chronic conditions ( MCC ) . METHODS A r and om patient sample ≥ 15 years , discharged from hospital with ≥1 chronic conditions ( CC ) was interviewed after 6 - 12 months . Analysis included variables in 5 dimensions ( WHO ) : socio-demographics , disease , treatment , patient and health system characteristics . Morisky-Green adherence question naire was used . High chronic treatment complexity was defined as : > 3 pills/day , > 6 inhalations/day , > 1 injection/day , pharmacological treatment plus diet or self-monitoring techniques . RESULTS 301 patients were interviewed ( 62 ± 15 years , 59 % males ) . Despite good treatment information perception ( 79 % ) , only 3 % followed the patient education programme . Poor adherents ( 82 % ) were older ( 64 ± 14 years vs. 55 ± 16 years ) , had more CC ( 3.25 ± 2.02 vs. 2.62 ± 2.72 ) , a higher frequency of hypertension ( 44 % vs. 15 % ) , ischaemic heart diseases : ( 21 % vs. 4 % ) , hyperlipidaemia ( 19 % vs. 6 % ) , more pills/day ( 5.78 ± 4.14 vs. 3.20 ± 4.70 ) and more complex treatments ( 95 % vs. 70 % ) ( p<0.05 ) . On multivariate analysis number of CC [ 3.68 ( 0.75 - 18.15 ) ] , pills/day [ 2.23 ( 1.02 - 4.84 ) ] , treatment complexity [ 4.00 ( 1.45 - 11.04 ) ] , and hypertension [ 2.57 ( 1.06 - 6.25 ) ] were predictive of poor adherence ( OR 95 % CI p<0.05 ) . CONCLUSION The WHO conceptual framework allows the construction of poor adherence risk profiles in patients with MCC after hospital discharge . PRACTICE IMPLICATION S Predictive variables of poor adherence could help clinicians detect patients with MCC most likely to present poor adherence Background The objective of this study was to develop and psychometrically evaluate a general measure of patients ' satisfaction with medication , the Treatment Satisfaction Question naire for Medication ( TSQM ) . Methods The content and format of 55 initial questions were based on a formal conceptual framework , an extensive literature review , and the input from three patient focus groups . Patient interviews were used to select the most relevant questions for further evaluation ( n = 31 ) . The psychometric performance of items and result ing TSQM scales were examined using eight diverse patient groups ( arthritis , asthma , major depression , type I diabetes , high cholesterol , hypertension , migraine , and psoriasis ) recruited from a national longitudinal panel study of chronic illness ( n = 567 ) . Participants were then r and omized to complete the test items using one of two alternate scaling methods ( Visual Analogue vs. Likert-type ) . Results A factor analysis ( principal component extraction with varimax rotation ) of specific items revealed three factors ( Eigenvalues > 1.7 ) explaining 75.6 % of the total variance ; namely Side effects ( 4 items , 28.4 % , Cronbach 's Alpha = .87 ) , Effectiveness ( 3 items , 24.1 % , Cronbach 's Alpha = .85 ) , and Convenience ( 3 items , 23.1 % , Cronbach 's Alpha = .87 ) . A second factor analysis of more generally worded items yielded a Global Satisfaction scale ( 3 items , Eigenvalue = 2.3 , 79.1 % , Cronbach 's Alpha = .85 ) . The final four scales possessed good psychometric properties , with the Likert-type scaling method performing better than the VAS approach . Significant differences were found on the TSQM by the route of medication administration ( oral , injectable , topical , inhalable ) , level of illness severity , and length of time on medication . Regression analyses using the TSQM scales accounted for 40–60 % of variation in patients ' ratings of their likelihood to persist with their current medication . Conclusion The TSQM is a psychometrically sound and valid measure of the major dimensions of patients ' satisfaction with medication . Preliminary evidence suggests that the TSQM may also be a good predictor of patients ' medication adherence across different types of medication and patient population Objectives Poor adherence is one of the biggest obstacles in therapeutic control of high blood pressure . The objectives of this study were ( i ) to measure adherence to antihypertensive therapy in a representative sample of the hypertensive Pakistani population and ( ii ) to investigate the factors associated with adherence in the studied population . Methods and Results A cross-sectional study was conducted on a simple r and om sample of 460 patients at the Aga Khan University Hospital ( AKUH ) and National Institute of Cardiovascular Diseases , Karachi , from September 2005–May 2006 . Adherence was assessed using the Morisky Medication Adherence Scale ( MMAS ) , with scores ranging from 0 ( non-adherent ) to 4 ( adherent ) . In addition to MMAS , patient self-reports about the number of pills taken over a prescribed period were used to estimate adherence as a percentage . AKU Anxiety and Depression Scale ( AKU-ADS ) was incorporated to find any association between depression and adherence . At a cut-off value of 80 % , 77 % of the cases were adherent . Upon univariate analyses , increasing age , better awareness and increasing number of pills prescribed significantly improved adherence , while depression showed no association . Significant associations , upon multivariate analyses , included number of drugs that a patient was taking ( P<0.02 ) and whether he/she was taking medication regularly or only for symptomatic relief ( P<0.00001 ) . Conclusions Similar to what has been reported worldwide , younger age , poor awareness , and symptomatic treatment adversely affected adherence to antihypertensive medication in our population . In contrast , monotherapy reduced adherence , whereas psychosocial factors such as depression showed no association . These findings may be used to identify the subset of population at risk of low adherence who should be targeted for interventions to achieve better blood pressure control and hence prevent complications Background Self-report scales are used to assess medication adherence . Data on how to discriminate change in self-reported adherence over time from r and om variability are limited . Objective : To determine the minimal detectable change for scores on the 8-item Morisky Medication Adherence Scale ( MMAS-8 ) . Methods : The MMAS-8 was administered twice , using a st and ard telephone script , with administration separated by 14 - 22 days , to 210 participants taking antihypertensive medication in the CoSMO ( Cohort Study of Medication Adherence among Older Adults ) . MMAS-8 scores were calculated and participants were grouped into previously defined categories ( < 6 , 6 to < 8 , and 8 for low , medium , and high adherence ) . Results : The mean ( SD ) age of participants was 78.1 ( 5.8 ) years , 43.8 % were black , and 68.1 % were women . Overall , 8.1 % ( 17/210 ) , 16.2 % ( 34/210 ) , and 51.0 % ( 107/210 ) of participants had low , medium , and high MMAS-8 scores , respectively , at both survey administrations ( overall agreement 75.2 % ; 158/210 ) . The weighted κ statistic was 0.63 ( 95 % CI 0.53 to 0.72 ) . The intraclass correlation coefficient was 0.78 . The within-person st and ard error of the mean for change in MMAS-8 scores was 0.81 , which equated to a minimal detectable change of 1.98 points . Only 4.3 % ( 9/210 ) of the participants had a change in MMAS-8 of 2 or more points between survey administrations . Conclusions : Within-person changes in MMAS-8 scores of 2 or more points over time may represent a real change in antihypertensive medication adherence Background The majority of patients using antihypertensive medications fail to achieve their recommended target blood pressure . Poor daily adherence with medication regimens and a lack of persistence with medication use are two of the major reasons for failure to reach target blood pressure . There is no single intervention to improve adherence with antihypertensives that is consistently effective . Community pharmacists are in an ideal position to promote adherence to chronic medications . This study aims to test a specific intervention package that could be integrated into the community pharmacy workflow to enable pharmacists to improve patient adherence and /or persistence with antihypertensive medications - Hypertension Adherence Program in Pharmacy ( HAPPY ) . Methods / Design The HAPPY trial is a multi-centre prospect i ve r and omised controlled trial . Fifty-six pharmacies have been recruited from three Australian states . To identify potential patients , a software application ( MedeMine CVD ) extracted data from a community pharmacy dispensing software system ( FRED Dispense ® ) . The pharmacies have been r and omised to either ' Pharmacist Care Group ' ( PCG ) or ' Usual Care Group ' ( UCG ) . To check for ' Hawthorne effect ' in the UCG , a third group of patients ' Hidden Control Group ' ( HCG ) will be identified in the UCG pharmacies , which will be made known to the pharmacists at the end of six months . Each study group requires 182 patients . Data will be collected at baseline , three and six months in the PCG and at baseline and six months in the UCG . Changes in patient adherence and persistence at the end of six months will be measured using the self-reported Morisky score , the Tool for Adherence Behaviour Screening and medication refill data . Discussion To our knowledge , this is the first research testing a comprehensive package of evidence -based interventions that could be integrated into the community pharmacy workflow to enable pharmacists to improve patient adherence and /or persistence with antihypertensive medications . The unique features of the HAPPY trial include the use of MedeMine CVD to identify patients who could potentially benefit from the service , control for the ' Hawthorne effect ' in the UCG and the offer of the intervention package at the end of six months to patients in the UCG , a strategy that is expected to improve retention . Trial Registration Australian New Zeal and Clinical Trial Registry Background Disparities in blood pressure ( BP ) control may be a function of disparities in treatment intensification ( TI ) . Objective To examine racial differences in TI , underst and modifiable factors that may mediate this relationship , and explore the relative effects of TI and race on blood pressure . Design Prospect i ve cohort study . Participants Participants were 819 black and white patients with hypertension from an urban , safety-net hospitalMain Measures We sequentially explored the effects of patient race , sociodemographic and clinical characteristics , beliefs about BP/medications , perceptions of provider/discrimination , sodium intake , medication adherence , and provider counseling on TI , performing a series of r and om effects analyses . To assess the effects of race and TI on BP , we performed linear regressions , using systolic BP ( SBP ) as the outcome .Key Results Unadjusted analyses and those including sociodemographic and clinical characteristics revealed that black patients had less TI than whites ( −0.31 vs.−0.24 , p < 0.001 ) , but adjustment for patient beliefs and experiences eliminated the effects of race ( β = −0.02 , p = 0.5 ) . Increased patient concerns about BP medications were related to lower TI , as was more provider counseling ( β = −0.06 , p = 0.02 and β = −0.01 , p = 0.001 , respectively ) . In the unadjusted analysis , black race was a significant predictor of SBP ( 134 mm/Hg for blacks vs. 131 mm/Hg for whites , p = 0.009 ) , but when both race and TI were included in the model , TI was a significant predictor of SBP ( final SBP 2.0 mm/Hg lower for each additional therapy increase per 10 visits , p < 0.001 ) , while race was not ( Blacks 1.6 mm/Hg higher than whites , p = 0.17 ) . Conclusions Improved patient – provider communication targeted towards addressing patient concerns about medications may have the potential to reduce racial disparities in TI and ultimately , BP control Background : Although hypertension is , in most cases , a controllable major risk factor in the development of cardiovascular disease , studies have demonstrated that hypertension remains poorly controlled in Portugal . Our aim was to evaluate the covariates associated with poor blood pressure ( BP ) control in a Portuguese hypertensive population . Patients and Results : We conducted a cross-sectional survey in a hospital hypertension outpatient clinic , located in the Eastern Central Region of Portugal . Patients attending the clinic from July to September 2009 were asked to participate in a structured interview including medication adherence and knowledge about hypertension . Eligible participants were all adults aged 18 or over with an established diagnosis of arterial hypertension and had been on antihypertensive drug treatment for at least 6 months . Exclusion criteria were dementia , pregnancy , and breastfeeding . Detailed clinical information was prospect ively
Output:
| According to the WHO Adherence Model domains , patient-related barriers were most commonly addressed , while condition , therapy , and socioeconomic barriers were underrepresented . |
MS211595 | ***TASK*** the task is to summarize an input biomedical literature 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 Endoscopic ultrasonography ( EUS ) appears to be the best imaging method for the diagnosis of choledocholithiasis . The aim of this preliminary , prospect i ve , controlled study was to assess the accuracy of EUS and magnetic resonance cholangiopancreatography ( MRCP ) in the diagnosis of common bile duct stones . METHODS From December 1995 through April 1997 , all patients referred because of suspicion of the presence of common bile duct stones were included in the study . EUS and MRCP were performed . Each examination was performed by a different operator unaware of the result of the other procedure . The definitive diagnosis was established by means of endoscopic retro grade cholangiography with sphincterotomy or a surgical procedure . RESULTS Forty-three patients ( 18 men , 25 women ) with a mean age of 60.9 + /- 14.5 years ( range 25 to 81 years ) were included in the study . Eleven patients were excluded because of unavailability of magnetic resonance imaging(n = 5 ) or EUS ( n = 6 ) . Ten patients ( 31.2 % ) had choledocholithiasis . For this diagnosis , the sensitivity of EUS was 100 % , the specificity was 95.4 % , the positive predictive value was 90.9 % , and the negative predictive value was 100 % . The corresponding values for MRCP were 100 % , 72.7 % , 62.5 % , and 100 % , not significantly different from EUS results . The accuracy of EUS was 96.9 % , and that of MRCP was 82.2 % . CONCLUSION This preliminary study confirmed EUS as an accurate and noninvasive procedure for the diagnosis of common bile duct stones . MRCP , which had a high sensitivity and high negative predictive value , might be an accurate technique for patients with a contraindication to EUS This prospect i ve study compares repetitive thick-slab single-shot projection magnetic resonance cholangiopancreatography ( MRCP ) with endoscopic ultrasonography ( EUS ) for the detection of choledocholithiasis . Fifty-seven consecutive patients ( 36 women , mean age 61 ) referred for suspected choledocholithiasis underwent MRCP , followed by EUS . Each procedure was performed by different operators blinded to the results of the other investigation . MR technique included a turbo spin-echo T2-weighted axial sequence with selective fat saturation ( SPIR/TSE , TE=70 ms , TR=1,600 ms ) , followed by coronal dynamic MRCP . The same thick-slab slice was sequentially acquired 12 times as breath-hold single-shot projection imaging ( SSh , TE=900 ms , TE=8,000 ms ) centred on the common bile duct ( CBD ) . Two experienced radiologists independently and blindly evaluated MR images for the detection of CBD stones . Their inter-observer agreement kappa was determined . Secondly , the two observers read MR images in consensus again . CBD stones were demonstrated in 18 out of 57 patients ( 31.6 % ) and confirmed by endoscopic retro grade cholangiography ( ERCP , n=17 ) or intraoperative cholangiography ( n=1 ) . Clinical follow-up served as the “ gold st and ard ” in patients with negative results without following invasive procedure ( n=28 ) . Sensitivity , specificity , accuracy , positive and negative predictive value for MRCP result ing from consensus reading were 94.9 % , 94.4 % , 94.7 % , 97.4 % and 89.5 % , respectively . Corresponding values of EUS were 97.4 % , 94.4 % , 96.5 % , 97.4 % and 94.4 % . Inter-observer agreement kappa was 0.81 . Repetitive thick-slab single-shot projection MRCP is an accurate non-invasive imaging modality for suspected choledocholithiasis and should be increasingly used to select those patients who require a subsequent therapeutic procedure , namely ERCP Endoscopic ultrasonography ( EUS ) is a sensitive and specific modality for the detection of choledocholithiasis . In experienced h and s , it can be completely effective in almost all patients without significant risk . Prospect i ve studies have shown that the sensitivity and specificity of EUS for the detection of choledocholithiasis rival that of ERCP . The clinical roles for EUS in these setting s are currently evolving and will also likely be shaped by the continued forces to practice the most effective medicine BACKGROUND AND STUDY AIMS It is still unknown whether there is a difference in diagnostic accuracy and clinical impact between endoscopic ultrasonography ( EUS ) and magnetic resonance cholangiopancreatography ( MRCP ) . PATIENTS AND METHODS The test performance and potential clinical impact of EUS and MRCP , had each investigation been performed as the first examination method , were compared prospect ively in 163 patients admitted for and examined by endoscopic retro grade cholangiopancreatography ( ERCP ) . RESULTS The accuracies of EUS and MRCP were 0.93 and 0.91 , respectively ( no significant difference , P > 0.05 ) . Had EUS or MRCP been performed as the first investigation in the 75 patients who had a presumed high probability for needing therapeutic ERCP , only 15 and nine patients , respectively , would have avoided ERCP . In this group of patients , one patient needed other diagnostic investigations following EUS compared with 11 patients following MRCP ( P = 0.004 ) . For the 57 patients with an intermediate probability of needing endoscopic therapy , EUS and MRCP would have spared 37 and 38 patients , respectively , from the need to have an ERCP . In 31 patients with a presumed low risk of needing endoscopic therapy , 30 and 29 patients would have been spared from ERCP had EUS and MRCP , respectively , been performed initially . CONCLUSIONS There was no difference in the diagnostic accuracy and clinical impact between EUS and MRCP in the majority of the patients . The impact of EUS or MRCP on the ERCP workload was highly dependent on the presumed probability of needing endoscopic therapy Background Magnetic resonance cholangiography ( MRC ) is a new technique for non-invasive imaging of the biliary tract . Aim To assess the results of MRC in patients with suspected bile duct stones as compared with those obtained with reference imaging methods . Patients / Methods 70 patients ( 34 men and 36 women , mean ( SD ) age 71 ( 15.5 ) years ; median 75 ) with suspected bile duct stones were included ( cholangitis , 33 ; pancreatitis , three ; suspected post-cholecystectomy choledocholithiasis , nine ; cholestasis , six ; stones suspected on ultrasound or computed tomography scan , 19 ) . MR cholangiograms with two dimensional turbo spin echo sequences were acquired . Endoscopic retro grade cholangiography with or without sphincterotomy ( n = 63 ) , endosonography ( n = 5 ) , or intraoperative cho- langiography ( n = 2 ) were the reference imaging techniques used for the study and were performed within 12 hours of MRC . Radiologists were blinded to the results of endoscopic retro grade cholangiography and previous investigations . Results 49 patients ( 70 % ) had bile duct stones on reference imaging ( common bile duct , 44 , six of which impacted in the papilla ; intrahepatic , four ; cystic duct stump , one ) . Stone size ranged from 1 to 20 mm ( mean 6.1 , median 5.5 ) . Twenty seven patients ( 55 % ) had bile duct stones smaller than 6 mm . MRC diagnostic accuracy for bile duct lithiasis was : sensitivity , 57.1 % ; specificity , 100 % ; positive predictive value , 100 % ; negative predictive value , 50 % . Conclusions Stones smaller than 6 mm are still often missed by MRC when st and ard equipment is used . The general introduction of new technical improvements is needed before this method can be considered reliable for the diagnosis of bile duct stones BACKGROUND The management of possible common bile duct ( CBD ) stones in patients scheduled for laparoscopic cholecystectomy remains controversial . METHODS Prospect i ve evaluation of 609 patients who underwent laparoscopic cholecystectomy was carried out in relation to the use of selective preoperative ERCP for detection of common duct stones . Preoperative ERCP was performed if there is or has been ( 1 ) cholangitis , biliary pancreatitis , or jaundice ; ( 2 ) abnormal serum liver tests or ( 3 ) ultrasonogram showing a dilated CBD or ductal stones . RESULTS A total of 139 patients underwent preoperative ERCP , and cannulation of CBD was successful in 133 patients ( 96 % ) . CBD stones were found in 60 patients ( 45 % ) and extracted after sphincterotomy . High prevalence of CBD stones was noted in patients with acute cholangitis and CBD stones on ultrasonogram . There were six endoscopic sphincterotomy-related complications ( complication rate , 4.5 % ) : bleeding ( 2 ) , pancreatitis ( 3 ) , retroduodenal perforation ( 1 ) . No patient required surgery as the result of a complication . The prediction of the occurrence of ductal stones was further analyzed using stepwise logistic regression . Acute cholangitis and CBD stones on ultrasonogram were shown to be independent significant risk factors with odds ratios of 8.9 and 13.5 , respectively . CONCLUSIONS With selective preoperative ERCP , suspected CBD stones can be identified and removed prior to laparoscopic cholecystectomy OBJECTIVES New modalities , namely , endoscopic ultrasonography ( EUS ) , magnetic resonance cholangiopancreatography ( MRCP ) , and helical computed-tomographic cholangiography ( HCT-C ) , have been introduced recently for the detection of common bile duct ( CBD ) stones and shown improved detectability compared to conventional ultrasound or computed tomography . We conducted this study to compare the diagnostic ability of EUS , MRCP , and HCT-C in patients with suspected choledocholithiasis . METHODS Twenty-eight patients clinical ly suspected of having CBD stones were enrolled , excluding those with cholangitis or a definite history of choledocholithiasis . Each patient underwent EUS , MRCP , and HCT-C prior to endoscopic retro grade cholangio-pancreatography ( ERCP ) , the result of which served as the diagnostic gold st and ard . RESULTS CBD stones were detected in 24 ( 86 % ) of 28 patients by ERCP/IDUS . The sensitivity of EUS , MRCP , and HCT-C was 100 % , 88 % , and 88 % , respectively . False negative cases for MRCP and HCT-C had a CBD stone smaller than 5 mm in diameter . No serious complications occurred while one patient complained of itching in the eyelids after the infusion of contrast agent on HCT-C. CONCLUSIONS When examination can be scheduled , MRCP or HCT-C will be the first choice because they were less invasive than EUS . MRCP and HCT-C had similar detectability but the former may be preferable considering the possibility of allergic reaction in the latter . When MRCP is negative , EUS is recommended to check for small CBD stones OBJECTIVE Our purpose was to compare the accuracy of MR cholangiopancreatography and endoscopic sonography for the diagnosis of common bile duct stones in patients with a mild to moderate clinical suspicion of common bile duct stones . SUBJECTS AND METHODS Forty-seven patients were prospect ively enrolled . Inclusion criteria included acute pancreatitis , sub clinical jaundice , and clinical features of common bile duct stone migration . Radial endoscopic sonography and MR cholangiopancreatography with the single-shot fast spin-echo technique were performed a maximum of 48 hr apart . The gold-st and ard diagnosis was obtained with ERCP ( n = 20 ) or intraoperative cholangiography ( n = 14 ) if the results of endoscopic sonography or MR cholangiopancreatography were abnormal or if a cholecystectomy was performed , or by clinical and biochemical follow-up ( n = 11 ) if the results of endoscopic sonography and MR cholangiopancreatography were normal . RESULTS The final diagnosis was common bile duct stones in 16 patients , malignant obstructions in four , and another biliary disease in two ( lithiasis migration aspect with papillary edema ) ; 23 patients had no biliary disease . The sensitivity and specificity of MR cholangiopancreatography were , respectively , 90.5 % and 87.5 % for etiologic diagnosis and 87.5 % and 96.6 % for the detection of common bile duct stones . The corresponding values for endoscopic sonography were 86.4 % and 91.3 % for etiologic diagnosis and 93.8 % and 96.6 % for visualization of choledocholithiasis . Accuracy did not significantly differ between the techniques . CONCLUSION In cases of mild to moderate suspicion of choledocholithiasis , the accuracies of endoscopic sonography and MR cholangiopancreatography are similar . Because MR cholangiopancreatography is noninvasive , it may be preferred for this indic
Output:
| The analysis demonstrated that , with respect to sensitivity , specificity and accuracy , there was no statistically significant difference between EUS and MRCP for the detection of choledocholithiasis .
Our meta- analysis of prospect i ve comparison of MRCP and EUS for the detection of choledocholithiasis yielded statistically similar diagnostic values for both techniques |
MS211596 | ***TASK*** the task is to summarize an input biomedical literature in six sentences
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***OUTPUT*** the output is the summary of an input biomedical literature in six sentences
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Input: OBJECTIVE To determine the factors associated with participation in cervical cancer screening and follow-up treatment in the context of a r and omized controlled trial . The trial was initiated to evaluate the efficacy and cost effectiveness of visual inspection with acetic acid , cytological screening and testing for human papillomavirus in reducing the incidence of and mortality from cervical cancer in Maharashtra , India . METHODS Between October 1999 and November 2003 women aged 30 - 59 years were r and omized to receive one of the three tests or to a control group . Participation was analysed for all three intervention arms . The differences between those who were screened versus those who were not was analysed according to the sociodemographic characteristics of the 100,800 eligible women invited for screening . Those who were treated versus those who were not were analysed according to the sociodemographic characteristics of the 932 women diagnosed with high- grade lesions . Participation in screening and compliance with treatment were also analysed according to the type of test used . FINDINGS Compared with women who were not tested , screened women were younger ( aged 30 - 39 ) , better educated and had ever used contraception . A higher proportion of screened women were married and a lower proportion had never been pregnant . Of the 932 women diagnosed with high- grade lesions or invasive cancer , 85.3 % ( 795 ) received treatment . Women with higher levels of education , who had had fewer pregnancies and those who were married were more likely to comply with treatment . There were no differences in rates of screening or compliance with treatment when results were analysed by the test received . CONCLUSIONS Irrespective of the test being used , good participation levels for cervical cancer screening can be achieved in rural areas of developing countries by using appropriate strategies to deliver services . Communication methods and delivery strategies aim ed at encouraging older , less-educated women , who have less contact with reproductive services , are needed to further increase screening uptake BACKGROUND The proportion of women infected with human papillomavirus ( HPV ) varies greatly across population s , as might the distribution of HPV types . We aim ed to compare HPV-type distribution in representative sample s of women from different world regions . METHODS Women were r and omly selected from the general population of 13 areas from 11 countries ( Nigeria , India , Vietnam , Thail and , Korea , Colombia , Argentina , Chile , the Netherl and s , Italy , and Spain ) . A st and ardised protocol was used for cervical specimen collection . All HPV testing was by GP5+/6 + PCR-based EIA . The proportion of HPV-positive women infected with different HPV types was compared by study area and between pooled regions with age-adjusted odds ratios ( ORs ) with corresponding 95 % floating CIs . FINDINGS 15 613 women aged 15 - 74 years without cytological abnormalities were included in a pooled analysis . Age-st and ardised HPV prevalence varied nearly 20 times between population s , from 1.4 % ( 95 % CI 0.5 - 2.2 ) in Spain to 25.6 % ( 22.4 - 28.8 ) in Nigeria . Although both overall HPV prevalence and HPV16 prevalence were highest in sub-Saharan Africa , HPV-positive women in Europe were significantly more likely to be infected with HPV16 than were those in sub-Saharan Africa ( OR 2.64 , p=0.0002 ) , and were significantly less likely to be infected with high-risk HPV types other than HPV16 ( OR 0.57 , p=0.004 ) and /or low-risk HPV types ( OR 0.44 . p=0.0002 ) . Women from South America had HPV-type distribution in between those from sub-Saharan Africa and Europe . Heterogeneity between areas of Asia was significant . INTERPRETATION Heterogeneity in HPV type distribution among women from different population s should be taken into account when developing screening tests for the virus and predicting the effect of vaccines on the incidence of infection The objectives of this paper are to ( 1 ) underst and the nature of men ’s extramarital sexuality in three low income communities in Mumbai , India ; ( 2 ) explore the associations between marital relationships and extramarital sex ; and ( 3 ) assess the implication s of the research results for intervention . Results are based on survey data collected from 2,408 r and omly selected men from the three study communities and a matched subset of 260 r and omly selected men and their wives who responded to a female version of the men 's survey . These surveys produced a unique data set , which allows sociodemographic , attitudinal and behavioral variables from husb and and wife and variables that are the product of husb and and wife interaction to be utilized to predict men 's extramarital sex through multiple sequential logistic regression analysis . Results indicate that men 's extramarital sex is significantly associated with husb and 's and wife 's age , wife 's perception of domestic violence , husb and 's education and place of birth , husb and 's alcohol use , wife 's willingness to engage in marital sex , and types of marital sexual acts . These results confirm the need to move from the individual to the couple as the unit of research and the need for intervention to reduce the risk of HIV/STI transmission within marriage both in India and internationally The authors evaluated direct visual inspection of the cervix after the application of 5 % acetic acid ( DVI ) as a cervical cancer screening test for use in low‐re source setting We evaluated the feasibility and performance of visual inspection with acetic acid ( VIA ) and Lugol 's iodine ( VILI ) for cervical cancer screening in a primary health-care setting in Kinshasa , Congo . Women ( 1,528 ) aged > or = 30 years were screened independently by nurses and physicians by VIA and VILI and Pap cytology . Biopsy sample s were obtained from women with abnormal colposcopies and from 290 r and omly chosen women with normal colposcopy . Cytological and histological examinations were performed in Lyon and Montreal , respectively . The prevalence of cervical intraepithelial neoplasia ( CIN ) of grade s 1 , 2 and 3 was 4.5 , 1.3 and 4 % , respectively . Using biopsy as the reference , the sensitivity , specificity and negative predictive value ( NPV ) for > or = CIN 2 for VIA-nurse were 55.5 % ( 95 % CI : 34.7 - 76.2 ) , 64.6 % ( 95 % CI : 62.0 - 67.1 ) and 96.8 % ( 95 % CI : 93.5 - 98.7 ) , respectively . The corresponding values for VILI-nurse were 44.0 % ( 95 % CI : 24.2 - 63.8 ) , 74.6 % ( 95 % CI : 72.3 - 76.9 ) and 96.7 % ( 95 % CI : 93.7 - 98.6 ) . The equivalent parameters for physicians were 71.1 % ( 95 % CI : 46.7 - 95.5 ) , 71.3 % ( 95 % CI : 68.9 - 73.6 ) and 98.6 % ( 95 % CI : 96.0 - 99.7 ) for VIA and 68.3 % ( 95 % CI : 42.5 - 94.0 ) , 76.2 % ( 95 % CI : 74.0 - 78.4 ) and 97.2 % ( 95 % CI : 95.3 - 98.5 ) for VILI . The sensitivity of cytology ranged between 31 and 72 % , depending on the abnormality threshold used to define positivity , with a corresponding specificity range of 94 - 99 % and a NPV range of 97 - 99 % . Our results show that VIA and VILI performed by nurses and physicians are slightly more sensitive but less specific than Pap cytology across multiple combinations of test and lesion thresholds . Given their lower cost and easy deployment , visual inspection methods merit further assessment as cervical cancer screening methods for low-re source countries The efficacy of a single round of screening of visual inspection with acetic acid ( VIA ) on cervical cancer incidence and mortality is investigated in a cluster r and omized controlled trial in south India . Women aged 30 - 59 years in 113 clusters in Dindigul District were r and omized to VIA screening by nurses ( 57 clusters , 48,225 eligible women ) and to a control group ( 56 clusters , 30,167 women ) . 30,577 ( 63.4 % ) eligible women participated in screening . Younger , educated , married , multiparous , low-income women and those who have had tubal sterilization had a higher compliance with screening . Of the 2069 women diagnosed with CIN and invasive cancer , 1498 ( 72.4 % ) received treatment . Young women , those who practice d contraception and women with high- grade precursor lesions and invasive cancers were more likely to comply with treatment . In summary , our study indicates that women accept screening with VIA by nurses and a moderate level of compliance with screening and treatment can be reached through appropriate service delivery systems including health education activities , personal invitations , clinics in proximity to the target women , and testing and treatment in the same session . Our results imply that integration of screening activities with primary health services seems to have the potential to replicate most of these service delivery conditions in routine programs A prospect i ve study was undertaken to determine the sensitivity and specificity of acetic application to the cervix followed by naked eye visualization as a screening test for detection of cervical intraepithelial neoplasia . Three hundred and seventy two sexually active woman in the reproductive age group were studied . All the women underwent Papanicolaou test , acetic acid test and colposcopy . One hundred and seventy five woman were acetic acid test negative , 197 women were acetic acid test positive . The sensitivity of acetic acid test was 72.4 % , specificity 54 % and false negative rate 15.2 % , as compared to papanicolaou test which had a sensitivity of 13.2 % , specificity of 96.3 % and false negative rate of 24.4 % . The advantage of the acetic acid test lies in its easy technique , low cost and high sensitivity which are important factors for determining the efficacy of any screening programme in developing countries The impact of screening by visual inspection with acetic acid ( VIA ) , cytology or HPV testing on cervical cancer incidence and mortality is investigated in a cluster r and omized controlled trial in India . We report findings after the screening phase , when 52 clusters , with a total of 142,701 women aged 30 - 59 years in Osmanabad District , India , were r and omized into 4 arms for a single round of screening by trained midwives with either VIA , cytology or HPV testing as well as a control group . All laboratory tests were done locally . Test-positive women underwent investigations ( colposcopy/biopsy ) and treatment in the base hospital . Data on participation , test positivity , positive predictive value and detection rates of cervical neoplasia were analyzed using cluster design methodology . Of the eligible women , 72 - 74 % were screened . Test positivity rates were 14.0 % for VIA , 7.0 % for cytology and 10.3 % for HPV . The detection rate of high- grade lesions was similar in all intervention arms ( 0.7 % for VIA , 1.0 % for cytology and 0.9 % for HPV testing ) ( p = 0.06 , Mann-Whitney test ) . While the detection rate for VIA dropped to 0.5 % with declining test positivity during the course of the study , it remained constant for cytology and HPV testing . Over 85 % of women with high- grade lesions received treatment . Our results show that a high level of participation and good- quality cytology can be achieved in low-re source setting s. VIA is a useful alternative but requires careful monitoring . Detection rates obtained by HPV testing were similar to cytology , despite higher investments The impact of a single round of screening of visual inspection with acetic acid ( VIA ) on cervical cancer incidence and mortality was investigated in a cluster r and omized trial in south India . Women 30 - 59 years of age in 113 clusters in Dindigul District were r and omized to VIA screening ( 57 clusters , 48,225 women ) by nurses and to a control group ( 56 clusters , 30,167 women ) . 30,577 eligible women were screened between May 2000 and April 2003 ; 2,939 ( 9.6 % ) screen-positive women were investigated with colposcopy by nurses and 2,777 ( 9.1 % ) women had biopsy . CIN 1 was diagnosed in 1,778 women , CIN 2 - 3 lesions were found in 222 , and there were 69 screen detected invasive cervical cancers . The detection rates of lesions per 1,000 screened women were 58.2 for CIN 1 , 7.3 for CIN 2 - 3 , and 2.3 for invasive cancer . The detection rate of high- grade lesions in our study was 2 - 3-fold higher than those observed in repeatedly screened population s in developed countries . 71 % of women with CIN 1 and 80 % of those with CIN 2 - 3 lesions accepted cryotherapy
Output:
| New HPV vaccines will also help prevent HPV infection and the precancerous changes that lead to cervical cancer . |
MS211597 | ***TASK*** the task is to summarize an input biomedical literature 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 Women with polycystic ovary syndrome ( PCOS ) have symptoms of depression and anxiety and impaired health related quality of life ( HRQoL ) . Here we test the post-hoc hypothesis that acupuncture and exercise improve depression and anxiety symptoms and HRQoL in PCOS women . Methods Seventy-two PCOS women were r and omly assigned to 16 weeks of 1 ) acupuncture ( n = 28 ) ; 2 ) exercise ( n = 29 ) ; or 3 ) no intervention ( control ) ( n = 15 ) . Outcome measures included : change in Montgomery Åsberg Depression Rating Scale ( MADRS-S ) , Brief Scale for Anxiety ( BSA-S ) , Swedish Short-Form 36 ( SF-36 ) , and PCOS Question naire ( PCOSQ ) scores from baseline to after 16-week intervention , and to 16-week post-intervention follow-up . Results A reduction in MADRS-S and BSA-S from baseline to 16-weeks post-intervention follow-up was observed for the acupuncture group . The SF-36 domains role physical , energy/vitality , general health perception and the mental component of summary scores improved in the acupuncture group after intervention and at follow-up . Within the exercise group the role physical decreased after treatment , while physical functioning and general health perception scores increased at follow-up . The emotion domain in the PCOSQ improved after 16-weeks of intervention within all three groups , and at follow-up in acupuncture and exercise groups . At follow-up , improvement in the infertility domain was observed within the exercise group . Conclusion There was a modest improvement in depression and anxiety scores in women treated with acupuncture , and improved HRQoL scores were noted in both intervention groups . While not a primary focus of the trial , these data suggest continued investigation of mental health outcomes in women treated for PCOS.Trial registration number Clinical Trials.gov Identifier : Abstract Polycystic ovary syndrome ( PCOS ) is a common endocrine disorder with a significant psychological burden throughout the life course of affected women . Thus , use of mindful awareness may be beneficial as an adjunct to conventional medical management of women with PCOS . A r and omized , controlled trial was conducted at the Evgenideion Hospital of the Athens University Medical School to explore the impact of an 8-week mindfulness stress management program on measures of depression , anxiety and stress as well as on the quality of life in reproductive age women with PCOS . The study was approved by the Research Ethics Committee . Twenty-three and 15 women with PCOS were r and omly allocated to the intervention or control group , respectively . All participants were administered DASS21 , PSS-14 , PCOSQ , Daily Life and General Life Satisfaction Question naires and provided three-timed daily sample s of salivary cortisol , before and after the intervention . Intervention group participants were provided with the Credibility/Expectancy Question naire at the day of enrolment , to check for possible placebo effect on the outcome . Post-intervention , between-group results revealed statistically significant reductions in stress , depressive and anxiety symptoms , as well as in salivary cortisol concentrations , along with an increase in Life Satisfaction and Quality of Life scores in the intervention group only . There was no significant “ placebo ” effect on the outcome measures . Mindfulness techniques seem promising in ameliorating stress , anxiety , depression and the quality of life in women with PCOS and could be used as an adjunct method to the conventional management of these women In most of South Asia , prevalences and phenotypes of polycystic ovary syndrome ( PCOS ) among women in the community are unknown . The authors aim ed to estimate prevalence and phenotype in a community setting in Sri Lanka and to test a valid , feasible screening approach to early diagnosis . A community-based , cross-sectional study was carried out in 2005 - 2006 . A r and om sample of 3,030 women aged 15 - 39 years was selected by cluster sampling proportionate to population size . An interviewer-administered question naire was utilized to screen for " probable cases " of PCOS based on menstrual history and clinical manifestations of hyper and rogenism . Selected " probable cases " underwent clinical , biochemical , and ovarian ultrasound assessment . The response rate was 96.2 % ( n = 2,915 ) . A total of 220 ( 7.5 % ) " probable cases " were identified : 209 women with oligo/amenorrhea ( 95 % ) and 11 women with hirsutism ( 5 % ) . Further evaluation of the 220 probable cases confirmed 164 newly diagnosed cases of PCOS based on the 2003 Rotterdam diagnostic criteria . With 19 previously diagnosed cases already present , total prevalence was 6.3 % ( 95 % confidence interval : 5.9 , 6.8 ) . Of the women with " oligo/amenorrhea and /or hirsutism , " 91.1 % were confirmed to have PCOS ; 99.4 % of women with " regular cycles in the absence of clinical hyper and rogenism " were confirmed as normal . The most common phenotypes of PCOS were oligo/amenorrhea and polycystic ovaries ( 91.4 % ) and oligo/amenorrhea and hirsutism ( 48.3 % ) CONTEXT Polycystic ovary syndrome ( PCOS ) is associated with reduced health-related quality of life ( HRQOL ) and increased prevalence of depressive and anxiety disorders . The impact of PCOS-specific treatments on these co-morbidities is unclear . OBJECTIVE To assess the impact of weight loss and decreasing hyper and rogenism on HRQOL and mood and anxiety disorders in women with PCOS . DESIGN / SETTING / PARTICIPANTS A secondary analysis of a r and omized controlled trial ( OWL-PCOS ) of preconception treatment conducted at two academic centers in women ( age , 18 - 40 years ; body mass index , 27 - 42 kg/m(2 ) ) with PCOS defined by Rotterdam criteria . INTERVENTION Continuous oral contraceptive pill ( OCP ) or intensive lifestyle intervention or the combination ( Combined ) for 16 weeks . MAIN OUTCOME MEASURE(S ) Changes in HRQOL assessed by PCOSQ and SF-36 and prevalence of depression and anxiety disorder assessed by PRIME-MD PHQ . RESULTS The lowest scores were noted on the general health domain of the SF-36 and the weight and infertility domains on the PCOSQ . All three interventions result ed in significant improvement in the general health score on the SF-36 . Both the OCP and Combined groups showed improvements in all domains of the PCOSQ ( P < .01 ) compared to baseline scores . The Combined group had significant improvements in the weight , body hair , and infertility domains compared to a single treatment group ( P < .05 ) . In a linear regression model , change in weight correlated with improvements in the weight domain ( P < .001 ) and physical well-being ( P < .02 ) , change in T correlated with improvements in the hair domain ( P < .001 ) , and change in both weight and T correlated with the infertility ( P < .001 ) and menstrual domains ( P < .05 ) . CONCLUSIONS Both weight loss and OCP use result in significant improvements in several physical and mental domains related to quality of life , depressive symptoms , and anxiety disorders , and combined therapies offer further benefits in overweight/obese women with PCOS Background Few studies have assessed whether the amelioration of the clinical signs of polycystic ovary syndrome ( PCOS ) achieved by treatment leads to improvement in the health-related quality of life ( HRQoL ) of patients . This study was aim ed to examine the HRQoL of ethnic Chinese women with PCOS who received metformin treatment . Methods This prospect i ve study was conducted at a medical center in Taiwan . Study participants aged 18–45 years were diagnosed as having PCOS according to the Rotterdam criteria , and all received metformin treatment . Their HRQoL was assessed using generic ( WHOQOL-Bref ) and PCOS-specific ( Chi-PCOSQ ) instruments . Mixed effect models were used to examine the effects of metformin on repeatedly measured HRQoL. Additional analyses using stratified patients characteristics ( overweight vs. normal ; hyper and rogenism vs. non-hyper and rogenism ) were done . Results We recruited 109 participants ( 56 % were overweight , 80 % had hyper and rogenism ) . Among the domain scores of WHOQOL-Bref , the psychological domain score was the lowest one ( 12.64 ± 2.2 , range 4–20 ) . Weight ( 3.25 ± 1.59 , range 1–7 ) and infertility ( 3.38 ± 1.93 , range 1–7 ) domain scores were relatively low among the domain scores of Chi-PCOSQ . Overweight and hyper and rogenic patients had significantly lower HRQoL as compared with those of normal weight and non-hyper and rogenic patients , respectively . Metformin significantly improved the physical domain of WHOQOL-Bref ( p = 0.01 ) , and the infertility ( p = 0.043 ) and acne and hair loss aspects ( p = 0.008 ) of PCOS-specific HRQoL. In the subgroup analysis , significantly improved HRQoL following metformin treatment appeared for only overweight and hyper and rogenism subgroups . Conclusions Metformin might improve health-related quality of life of polycystic ovary syndrome women by ameliorating psychological disturbances due to acne , hair loss and infertility problems , especially for overweight and hyper and rogenic patients BACKGROUND In polycystic ovary syndrome ( PCOS ) , changes in physical appearance , menstrual disturbances and infertility result in psychological distress and reduced quality -of-life . Metformin improves biochemical , clinical and reproductive parameters in PCOS women . In a prospect i ve , observational study , we analysed the effects of metformin treatment on health-related quality -of-life ( HRQL ) , emotional well-being and sexuality in PCOS . No placebo-treated control group was included . METHODS Before , during and after 6 months of treatment , changes in clinical and endocrine parameters , quality -of-life , psychological disturbances and sexuality were assessed in 64 PCOS patients using vali date d question naires ( SF-36 , SCL-90-R ) and visual analogue scales . Patients were also compared with published normative data for the vali date d question naires . RESULTS During treatment , HRQL , particularly the psychosocial aspects ( indicated by significant increases in SF-36 scales Vitality , Social Function , Emotional Role Function , Mental Health , Psychological Sum scale ) and emotional well-being ( reflected by significant lowering of SCL-90-R scales ) improved . These improvements in HRQL were significantly correlated with a reduction in body weight and significantly more pronounced in patients with normalized menstrual cycles . In addition , PCOS women were significantly more satisfied with their sex life and reported higher frequencies of sexual intercourse following treatment . CONCLUSION Treatment can improve the psychosocial , emotional and psychosexual situation of PCOS patients . Although at least some of these effects may be related to the reduction of individual clinical symptoms ( i.e. weight loss , normalization of menstrual disturbances , improvement of acne ) , this observational study does not allow us to clearly discern the role of symptom constellation and does not preclude non-specific and /or placebo effects . Nevertheless , emotional distress and reduced quality -of-life are clearly not an inevitable consequence of PCOS and should be considered as adjunct treatment goals in future studies BACKGROUND Ovulation induction with gonadotrophins is the st and ard treatment strategy for women with clomiphene citrate (CC)-resistant polycystic ovary syndrome ( PCOS ) . Laparoscopic electrocautery of the ovaries is an alternative treatment modality , leading to a comparable cumulative pregnancy rate . In deciding which treatment to opt for , women 's health-related quality of life ( HRQoL ) should be taken into account . METHODS A total of 168 CC-resistant women with PCOS were r and omly assigned to receive either the electrocautery strategy , entailing laparoscopic electrocautery of the ovaries followed by CC and recombinant FSH ( rFSH ) if anovulation persisted , or ovulation induction with rFSH . We assessed women 's HRQoL with the st and ard question naires Short Form-36 , Rotterdam Symptom Checklist and Center for Epidemiological Studies Depression Scale , administered before r and omization and 2 , 12 and 24 weeks thereafter . RESULTS The intention to treat analysis revealed no significant differences between the treatment groups on any of the scales at any point during follow-up . In women without an ongoing pregnancy , those treated with rFSH showed significantly more depressive symptoms than women allocated to the electrocautery strategy , with or without CC , although differences were small . CONCLUSIONS Overall , HRQoL was not affected in both groups . In women still under treatment , rFSH was slightly more burdensome for women 's HRQoL than electrocautery with or without CC OBJECTIVE This study was design ed to evaluate the reliability , validity , and responsiveness of a newly developed , health-related quality -of-life measure . STUDY DESIGN A total of 137 women ( 122 from a Phase III clinical trial and 15 from a private practice setting ) with endometriosis completed the question naire several times . RESULTS Reproducibility and
Output:
| All studies assessed different aspects of QoL in PCOS women and found that PCOS had negative effects on QoL in this population .
Conclusion The PCOSQ and the SF-36 were used most frequently for the assessment of QoL in PCOS women .
Perhaps using either a specific question naire solely or a specific question naire in conjunction with a generic measure would be more appropriate when measuring QoL in PCOS women .
However , both question naires showed that they are able to capture different aspects of QoL in PCOS women and to identify areas that can help to improve QoL in these women |
MS211598 | ***TASK*** the task is to summarize an input biomedical literature 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 assess the safety and feasibility of aquablation in a first‐in‐man study . Aquablation is a novel minimally invasive water ablation therapy combining image guidance and robotics ( AquaBeam ® ) for the targeted and heat‐free removal of prostatic tissue in men with lower urinary tract symptoms ( LUTS ) secondary to benign prostatic hyperplasia ( BPH ) In recent years quality of life instruments have been featured as primary outcomes in many r and omized trials . One of the challenges facing the investigator using such measures is determining the significance of any differences observed , and communicating that significance to clinicians who will be applying the trial results . We have developed an approach to elucidating the significance of changes in score in quality of life instruments by comparing them to global ratings of change . Using this approach we have established a plausible range within which the minimal clinical ly important difference ( MCID ) falls . In three studies in which instruments measuring dyspnea , fatigue , and emotional function in patients with chronic heart and lung disease were applied the MCID was represented by mean change in score of approximately 0.5 per item , when responses were presented on a seven point Likert scale . Furthermore , we have established ranges for changes in question naire scores that correspond to moderate and large changes in the domains of interest . This information will be useful in interpreting question naire scores , both in individuals and in groups of patients participating in controlled trials , and in the planning of new trials Purpose : We compared the safety and efficacy of Aquablation and transurethral prostate resection for the treatment of lower urinary tract symptoms related to benign prostatic hyperplasia . Material s and Methods : In a double‐blind , multicenter , prospect i ve , r and omized , controlled trial 181 patients with moderate to severe lower urinary tract symptoms related to benign prostatic hyperplasia underwent transurethral prostate resection or Aquablation . The primary efficacy end point was the reduction in International Prostate Symptom Score at 6 months . The primary safety end point was the development of Clavien‐Dindo persistent grade 1 , or 2 or higher operative complications . Results : Mean total operative time was similar for Aquablation and transurethral prostate resection ( 33 vs 36 minutes , p = 0.2752 ) but resection time was lower for Aquablation ( 4 vs 27 minutes , p < 0.0001 ) . At month 6 patients treated with Aquablation and transurethral prostate resection experienced large I‐PSS improvements . The prespecified study noninferiority hypothesis was satisfied ( p < 0.0001 ) . Of the patients who underwent Aquablation and transurethral prostate resection 26 % and 42 % , respectively , experienced a primary safety end point , which met the study primary noninferiority safety hypothesis and subsequently demonstrated superiority ( p = 0.0149 ) . Among sexually active men the rate of anejaculation was lower in those treated with Aquablation ( 10 % vs 36 % , p = 0.0003 ) . Conclusions : Surgical prostate resection using Aquablation showed noninferior symptom relief compared to transurethral prostate resection but with a lower risk of sexual dysfunction . Larger prostates ( 50 to 80 ml ) demonstrated a more pronounced superior safety and efficacy benefit . Longer term followup would help assess the clinical value of Aquablation Purpose : We sought to establish the safety and effectiveness of aquablation , a novel , image guided , robotic assisted , water jet tissue ablation technology , for the treatment of benign prostatic hyperplasia . Material s and Methods : We performed a prospect i ve , single arm , multicenter trial at a total of 3 centers in Australia and New Zeal and with 1‐year followup . Participants were men 50 to 80 years old with moderate to severe lower urinary tract symptoms as determined by urodynamics . All patients underwent aquablation under image guidance . Primary end points included procedural and perioperative safety . The main clinical end point was the change from baseline in I‐PSS ( International Prostate Symptom Score ) . Other secondary end points included uroflow measures , prostate volume on transrectal ultrasound and detrusor pressure . Detrusor pressure at maximum flow was only measured at 6 months . Results : A total of 21 men underwent aquablation at a mean age of 69.7 years ( range 62 to 78 ) . Prostate volume was 57.2 ml ( range 30 to 102 ) . Procedural duration averaged 38 minutes with a mean aquablation treatment time of 5 minutes . All but 1 subject were catheterized for 1 day only and 19 of 21 were discharged home the day after the procedure . Detrusor pressure at maximum flow decreased from 65 cm H2O at baseline to 39 cm H2O at 6 months ( p < 0.0027 ) . Prostate volume decreased from 57 ml at baseline to 35 ml ( p < 0.0001 ) . Mean I‐PSS score improved from 23.0 at baseline to 6.8 at 12 months ( p < 0.0001 ) and maximum urinary flow increased from 8.7 to 18.3 ml per second ( p < 0.0001 ) . There were no important perioperative adverse events . No urinary incontinence developed and sexual function was preserved postoperatively . Conclusions : This phase II study provides early evidence to support the safety and effectiveness of aquablation for symptomatic benign prostatic hyperplasia Introduction TURB is the st and ard approach to bladder tumors but suffers from several disadvantages . Waterjet hydrodissection is a new technology for removing superficial tumors in the GI tract promising to preserve the histological structures of biopsy specimens with favorable long-term results as recent studies have shown . The aim of this study was to show the feasibility and applicability of waterjet hydrodissection for removing papillary superficial bladder tumors . Material s and methods In five patients diagnosed with superficial papillary bladder tumor , transurethral submucosal dissection was conducted using the T-type I-Jet HybridKnife ( Erbe , Tuebingen ) . The resection edges were labeled by means of electrical coagulation with the HybridKnife . Subsequently , a submucosal fluid cushion specific to the tissue layer was formed by the waterjet implementation function of the HybridKnife , thereby elevating the tumorous tissue . The tumor was endoscopically extracted with a retrieval bag . Biopsy specimens of the tumor edges and base were subsequently collected . Results All tumors could be resected en bloc , and the lamina propria was intact in all specimens , allowing the pathologist to distinguish between superficial and invasive tumors . Pathological analysis confirmed R0 resection in all sample s. Conclusion These initial results prove the feasibility of waterjet hydrodissection for removing bladder tumors . In contrast to conventional TURB , this new technique allows the pathologist to assess the entire lamina propria and the resection edges due to the en-bloc resection and to determine invasiveness as well as R0 versus R1 resection . These first results are promising , long-term oncological follow-up , and prospect i ve r and omized surveys investigating the recurrence rate have to be evaluated PURPOSE We analyzed data from the placebo arm of the MTOPS trial to determine clinical predictors of BPH progression . MATERIAL S AND METHODS A total of 3,047 patients with LUTS were r and omized to either placebo , doxazosin ( 4 to 8 mg ) , finasteride ( 5 mg ) , or a combination of doxazosin and finasteride . Average length of followup was 4.5 years . The primary outcome was time to overall clinical progression of BPH , defined as either a confirmed 4-point or greater increase in AUA SS , acute urinary retention , incontinence , renal insufficiency , or recurrent urinary tract infection . We analyzed BPH progression event data from the 737 men who were r and omized to placebo . RESULTS The rate of overall clinical progression of BPH events in the placebo group was 4.5 per 100 person-years , for a cumulative incidence ( among men who had at least 4 years of followup data ) of 17 % . The risk of BPH progression was significantly greater in patients on placebo with a baseline TPV of 31 ml or greater vs less than 31 ml ( p < 0.0001 ) , a baseline PSA of 1.6 ng/dl or greater vs PSA less than 1.6 ng/dl ( p = 0.0009 ) , a baseline Qmax of less than 10.6 ml per second vs 10.6 ml per second or greater ( p = 0.011 ) , a baseline PVR of 39 ml or greater vs less than 39 ml ( p = 0.0008 ) and baseline age 62 years or older vs younger than 62 years ( p = 0.0002 ) . CONCLUSIONS Among men in the placebo arm , baseline TPV , PSA , Qmax , PVR and age were important predictors of the risk of clinical progression of BPH To present early safety and feasibility data from a multicentre prospect i ve study ( WATER II ) of aquablation in the treatment of symptomatic men with large‐volume benign prostatic hyperplasia ( BPH ) Non-r and omised studies of the effects of interventions are critical to many areas of healthcare evaluation , but their results may be biased . It is therefore important to underst and and appraise their strengths and weaknesses . We developed ROBINS-I ( “ Risk Of Bias In Non-r and omised Studies - of Interventions ” ) , a new tool for evaluating risk of bias in estimates of the comparative effectiveness ( harm or benefit ) of interventions from studies that did not use r and omisation to allocate units ( individuals or clusters of individuals ) to comparison groups . The tool will be particularly useful to those undertaking systematic review s that include non-r and omised studies Background No study has compared the bothersomeness of all lower urinary tract symptoms ( LUTS ) using a population -based sample of adults . Despite this lack of evidence , investigators have often cited their LUTS of interest as the “ most bothersome ” or “ one of the most bothersome . ” Objective To compare the population - and individual-level burden of LUTS in men and women . Design , setting , and participants In this population -based cross-sectional study , question naires were mailed to 6000 individuals ( 18–79 yr of age ) r and omly identified from the Finnish Population Register . Outcome measurements and statistical analysis The vali date d Danish Prostatic Symptom Score question naire was used for assessment of bother of 12 different LUTS . The age-st and ardized prevalence of at least moderate bother was calculated for each symptom ( population -level burden ) . Among symptomatic individuals , the proportion of affected individuals with at least moderate bother was calculated for each symptom ( individual-level bother ) . Results and limitations A total of 3727 individuals ( 62.4 % ) participated ( 53.7 % female ) . The LUTS with the greatest population -level burden were urgency ( 7.9 % with at least moderate bother ) , stress urinary incontinence ( SUI ) ( 6.5 % ) , nocturia ( 6.0 % ) , postmicturition dribble ( 5.8 % ) , and urgency urinary incontinence ( UUI ) ( 5.0 % ) . Burden from incontinence symptoms was higher in women than men , and the opposite was true for voiding and postmicturition symptoms . At the individual level , UUI was the most bothersome for both genders . Although the response proportion was high , approximately a third did not participate . Conclusions Both men and women with UUI report moderate or major bother more frequently than individuals with other LUTS . At the population level , the most prevalent bothersome symptoms are urgency , SUI , and nocturia . Patient summary Urinary urgency was the most common troubling symptom in a large population -based study ; however , for individuals , urgency incontinence was the most likely to be rated as bothersome BACKGROUND Despite widespread adoption of the six-item erectile function ( EF ) domain of the International Index of Erectile Function ( IIEF ) as a clinical trial end point , there are currently no objective data on what constitutes a minimal clinical ly important difference ( MCID ) in the EF domain . OBJECTIVE Estimate the MCID for the IIEF EF domain . DESIGN , SETTING , AND PARTICIPANTS Anchor-based MCIDs were estimated using data from 17 r and omized , double-blind , placebo-controlled , parallel-group clinical trials of the phosphodiesterase type 5 inhibitor ( PDE5-I ) tadalafil for 3345 patients treated for 12 wk . MEASUREMENTS The anchor for the MCID is the minimal improvement measure calculated using change from baseline to 12 wk on IIEF question 7 : " Over the past 4 weeks , when you attempted sexual intercourse how often was it satisfactory for you ? " MCIDs were developed using analysis of variance (ANOVA)- and receiver operating characteristic (ROC)-based methods in a subset of studies ( n=11 ) by comparing patients with and without minimal improvement ( n=863 ) . MCIDs were vali date d in the remaining six studies ( n=377 ) . RESULTS AND LIMITATIONS The ROC-based MCID for the EF domain was 4 , with estimated sensitivity and specificity of 0.74 and 0.73 , respectively . MCIDs varied significantly ( p<0.0001 ) according to baseline ED severity ( mild : 2 ; moderate : 5 ; severe : 7 ) . MCIDs consistently distinguished between patients in the validation sample classified as no change or minimally improved overall and by geographic region , ED etiology , and age group . MCIDs did not differ by age group , geographic region , or ED etiology
Output:
| Based on short-term ( up to 12 months ) follow-up , the effect of Aquablation on urological symptoms is probably similar to that of TURP ( moderate-certainty evidence ) .
The effect on quality of life may also be similar ( low-certainty evidence ) . |
MS211599 | ***TASK*** the task is to summarize an input biomedical literature 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: Whether velocity-specific resistance training is important for improving functional sporting performance was investigated by study ing the effect of isoinertial training velocity on netball chest pass throwing velocity . Twenty-one female netball players were r and omly assigned to a strength-trained group ( 80 % 1RM - average training velocity = .308 m/s ) , power-trained group ( 60 % 1RM - average training velocity = .398 m/s ) and a control group . Resistance training was combined with sport specific motion training for both groups over a ten-week training duration . Pre- and post-training testing revealed that the training velocity associated with the strength-trained group produced significantly greater improvement in mean volume of weight lifted ( 85 kg ) and mean power output ( 13.25 W ) as compared to the power and control groups ( P < 0.05 ) . The strength-trained and power-trained groups significantly improved netball throw velocity by 12.4 % and 8.8 % respectively . There was no significant difference between the two groups . The validity of velocity-specific training and subsequent adaptations to improve functional sporting performance appears highly question able , due to the disparity between training velocity and actual movement velocity ( 11.38 m x s(-1 ) ) for a given sport specific task such as the netball throw it was proposed that the repeated intent to move an isoinertial load as rapidly as possible coupled with performance of the sport-specific movement promote efficient coordination and activation patterns . Such mechanisms might be more important determinants of sport-specific high velocity adaptation Bishop , DC , Smith , RJ , Smith , MF , and Rigby , HE . Effect of plyometric training on swimming block start performance in adolescents . J Strength Cond Res 23(7 ) : 2137 - 2143 , 2009-This study aim ed to identify the effect of plyometric training ( PT ) , when added to habitual training ( HT ) regimes , on swim start performance . After the completion of a baseline competitive swim start , 22 adolescent swimmers were r and omly assigned to either a PT ( n = 11 , age : 13.1 ± 1.4 yr , mass : 50.6 ± 12.3 kg , stature : 162.9 ± 11.9 cm ) or an HT group ( n = 11 , age : 12.6 ± 1.9 yr , mass : 43.3 ± 11.6 kg , stature : 157.6 ± 11.9 cm ) . Over an 8-week preseason period , the HT group continued with their normal training program , whereas the PT group added 2 additional 1-hour plyometric-specific sessions , incorporating prescribed exercises relating to the swimming block start ( SBS ) . After completion of the training intervention , post-training swim start performance was reassessed . For both baseline and post-trials , swim performance was recorded using videography ( 50Hz Canon MVX460 ) in the sagital plane of motion . Through the use of Silicon Coach Pro analysis package , data revealed significantly greater change between baseline and post-trials for PT when compared with the HT group for swim performance time to 5.5 m ( −0.59 s vs. −0.21 s ; p < 0.01 ) and velocity of take-off to contact ( 0.19 ms−1 vs. −0.07 ms−1 ; p < 0.01 ) . Considering the practical importance of a successful swim start to overall performance outcome , the current study has found that inclusion of suitable and safely implemented PT to adolescent performers , in addition to HT routines , can have a positive impact on swim start performance Crewther , BT , Kilduff , LP , Cook , CJ , Middleton , MK , Bunce , PJ , and Yang , G-Z. The acute potentiating effects of back squats on athlete performance . J Strength Cond Res 25(12 ) : 3319–3325 , 2011—This study examined the acute potentiating effects of back squats on athlete performance with a specific focus on movement specificity and the individual timing of potentiation . Nine subelite male rugby players performed 3 protocol s on separate occasions using a r and omized , crossover , and counterbalanced design . Each protocol consisted of performance testing before a single set of 3 repetition maximum ( 3RM ) back squats , followed by retesting at ∼15 seconds , 4 , 8 , 12 , and 16 minutes . The 3 tests were countermovement jumps ( CMJs ) , sprint performance ( 5 and 10 m ) , and 3-m horizontal sled pushes with a 100-kg load . Relationships between the individual changes in salivary testosterone and cortisol concentrations and performance were also examined . The 3RM squats significantly ( p < 0.001 ) improved CMJ height at 4 ( 3.9 ± 1.9 % ) , 8 ( 3.5 ± 1.5 % ) , and 12 ( 3.0 ± 1.4 % ) minutes compared with baseline values , but no temporal changes in sprinting and sled times were identified . On an individual level , the peak relative changes in CMJ height ( 6.4 ± 2.1 % , p < 0.001 ) were greater than the 3-m sled ( 1.4 ± 0.6 % ) , 5-m ( 2.6 ± 1.0 % ) , and 10-m sprint tests ( 1.8 ± 1.0 % ) . In conclusion , a single set of 3RM squats was found effective in acutely enhancing CMJ height in the study population , especially when the recovery period was individualized for each athlete . The study results also suggest that the potentiating effects of squats may exhibit some degree of movement specificity , being greater for those exercises with similar movement patterns . The current findings have practical implication s for prescribing warm-up exercises , individualizing training programs , and for interpreting postactivation potentiation research Abstract Cuenca-Fernández , F , López-Contreras , G , and Arellano , R. Effect on swimming start performance of two types of activation protocol s : Lunge and YoYo squat . J Strength Cond Res 29(3 ) : 647–655 , 2015—The purpose of this study was to compare the effects of 2 protocol s of postactivation potentiation ( PAP ) on swimming start perfomance ( SS ) . Fourteen trained swimmers ( 10 men and 4 women ) volunteered for this study . An intragroup design of r and omized repetitive measurements was applied . A previous SS trial , performed after a st and ard warm-up ( SWU ) , served as a reference . Two methods of PAP , performed after 1 hour of rest , were r and omly added to the SWU : ( a ) 3 lunges at 85 % of 1 repetition maximum ( LWU ) and ( b ) 4 repetitions on the flywheel device YoYo squat ( YWU ) . Swimmers were tested in an SS 8 minutes after the PAP warm-ups . Kinematic variables were collected using 3 underwater digital video cameras fixed poolside and operating at 25 Hz , and 1 high-speed camera focused on the block and operating at 300 Hz . Data obtained from the video analysis were processed using a repeated measures analysis of the variance . The mean horizontal velocity of the swimmer 's flight improved after both PAP methods , with the greatest improvement after YWU ( F 2,12 = 47.042 , p < 0.001 ; SWU = 3.63 ± 0.11 ; LWU = 4.15 ± 0.122 ; YWU = 4.89 ± 0.12 m·s−1 ) . After YWU , it took the subjects less time to cover a distance of 5 m ( F 2,12 = 24.453 , p < 0.001 ) and 15 m ( F 2,12 = 4.262 , p < 0.04 ) . Subjects also achieved a higher mean angular velocity of the knee extension ( F 2,12 = 23.286 , p < 0.001 ) and a reduction of the time on the block ( F 2,12 = 6.595 , p ⩽ 0.05 ) . These results demonstrate that muscle performance in the execution of an SS is enhanced after a warm-up with specific PAP protocol s. YWU leads to the greatest improvement in the performance of the swimmer 's start and , therefore , may be especially beneficial in short events PURPOSE To quantify the effects of a 12-wk isolated core-training program on 50-m front-crawl swim time and measures of core musculature functionally relevant to swimming . METHODS Twenty national-level junior swimmers ( 10 male and 10 female , 16±1 y , 171±5 cm , 63±4 kg ) participated in the study . Group allocation ( intervention [ n=10 ] , control [ n=10 ] ) was based on 2 preexisting swim-training groups who were part of the same swimming club but trained in different groups . The intervention group completed the core training , incorporating exercises targeting the lumbopelvic complex and upper region extending to the scapula , 3 times/wk for 12 wk . While the training was performed in addition to the normal pool-based swimming program , the control group maintained their usual pool-based swimming program . The authors made probabilistic magnitude-based inferences about the effect of the core training on 50-m swim time and functionally relevant measures of core function . RESULTS Compared with the control group , the core-training intervention group had a possibly large beneficial effect on 50-m swim time ( -2.0 % ; 90 % confidence interval -3.8 to -0.2 % ) . Moreover , it showed small to moderate improvements on a timed prone-bridge test ( 9.0 % ; 2.1 - 16.4 % ) and asymmetric straight-arm pull-down test ( 23.1 % ; 13.7 - 33.4 % ) , and there were moderate to large increases in peak EMG activity of core musculature during isolated tests of maximal voluntary contraction . CONCLUSION This is the first study to demonstrate a clear beneficial effect of isolated core training on 50-m front-crawl swim performance 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 . Cuenca-Fernández , F , Ruiz-Teba , A , López-Contreras , G , and Arellano , R. Effects of 2 types of activation protocol s based on postactivation potentiation on 50-m freestyle performance . J Strength Cond Res XX(X ) : 000 - 000 , 2018-Postactivation potentiation ( PAP ) is a phenomenon which improves muscle contractility , strength , and speed in sporting performances through previously applied maximal or submaximal loads on the muscle system . This study aim ed to assess the effects of 2 types of activation protocol s based on PAP , on sprint swimming performance . A repeated- measures design was used to compare 3 different scenarios before a 50-m race . First , all of the participants performed a st and ard warm-up ( SWU ) , consisting of a 400-m swim followed by dynamic stretching . This protocol acted as the control . Subsequently , the swimmers were r and omly assigned into 2 groups : the swimmers in the first group performed the SWU followed by a PAP one-repetition maximum warm-up ( RMWU ) , consisting of 3 " lunge " and 3 " arm stroke " repetitions , both at 85 % of the one-repetition maximum . The swimmers in the second group performed the SWU followed by a PAP eccentric flywheel warm-up ( EWU ) , consisting of one set of 4 repetitions of exercises of both the lower and upper limbs on an adapted eccentric flywheel at the maximal voluntary contraction . The time required for the swimmers to swim 5 and 10 m was shorter with the PAP protocol s. The swimming velocity of the swimmers who underwent the EWU and RMWU protocol s was faster at 5 and 10 m. The best total swimming time was not influenced by any of the protocol s. When isolating swimming ( excluding start performance and turn ) , best time was achieved
Output:
| Post-activation potentiation and plyometrics were found to produce significant improvements in acute and chronic swim start performance , respectively . |
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